CN2855366Y - Artificial cardiac valves stand and its delivery placer - Google Patents
Artificial cardiac valves stand and its delivery placer Download PDFInfo
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- CN2855366Y CN2855366Y CNU2005200463866U CN200520046386U CN2855366Y CN 2855366 Y CN2855366 Y CN 2855366Y CN U2005200463866 U CNU2005200463866 U CN U2005200463866U CN 200520046386 U CN200520046386 U CN 200520046386U CN 2855366 Y CN2855366 Y CN 2855366Y
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- stent valve
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2439—Expansion controlled by filaments
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- Oral & Maxillofacial Surgery (AREA)
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- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
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Abstract
The utility model provides an artificial heart bracket valve and its implanting device. The bracket valve comprises a pipe-shaped reticulated bracket, valve leaves connected in the middle section of the reticulated bracket, a sealing film covering the reticulated bracket and an X-ray proof sign and a flexible connection ring arranged on the reticulated bracket. The implanting device comprises a canal head, an inner pipe, a proximal end controller, a middle pipe, a wire pipe, an outer protection mechanism, at least one locking wire and at least one bracket pulling wire. The utility model has advantages of that it can prevent the valve rubbing the metal bracket while opening and closing, prevent blood leakage around the valve; friction between the artificial bracket and sheath pipe is small when the artificial bracket is compressed, which is favorable for the accurate release of the artificial bracket valve; the artificial bracket valve can be adapted to the shape of the blood vessel wall both in radial and axial directions when released; the bracket valve is easy to transmit and release;the expanded bracket valve can be effectively fixed. The utility model can be used for intervention or minimally invasive replacement of the ill heart valve.
Description
Technical field
This utility model relates to a kind of succedaneum and apparatus for delivering thereof of tissue, relates in particular to a kind of artificial heart stent valve and apparatus for delivering thereof.
Background technology
Heart is the most important organ of human body, and heart is divided into left and right sides two parts, and each part comprises atrium and ventricle again.Left atrium and left and right ventricles are separated by interatrial septum and interventricular septum respectively.In heart, there are four cardiac valve, i.e. Tricuspid valve, valve of pulmonary trunk, Bicuspid valve and aortic valve.In the blood of human body cycling mechanism, four cardiac valve play crucial effects.The anoxia blood of body cycling mechanism enters right atrium through caval vein, enter right ventricle by Tricuspid valve then, right ventricle shrinks blood is pressed into pulmonary circulation mechanism by valve of pulmonary trunk, get back to left atrium through the blood behind the lung oxygen saturation through pulmonary vein, arrive left ventricle through Bicuspid valve again, the left ventricle contraction enters aorta with blood by aortic valve and returns to the body cycling mechanism.Left and right sides coronary ostium is arranged under the aortic valve.Close when valve-open when four valvular structures have guaranteed blood along direction, contrary direction, prevented blood reflux and the heart burden that causes.But, because a variety of causes can cause valvular posteriority damage or pathological changes, as rheumatism, atherosclerosis etc.In addition, congenital heart disease such as fallot's disease, postoperative also can produce the cusps of pulmonary valve pathological changes long term.Show as valvular function after the valve pathological changes and lose gradually, cause blood reflux as valvular insufficiency, valvular stenosis causes blood circulation not smooth, or incompetence and narrow the two merger, so that increase the weight of the heart burden, causes cardiac failure.For valvular posteriority damage or pathological changes, traditional Therapeutic Method is out breast, after the cardiac arrest, under the cryotron outer circulation is supported, opens heart and carries out the surgical repair of pathological changes valve or use artificial cardiac valve replacement.Existing Cardiac valve prosthesis divides two big classes: metal mechanical valve prosthesis and biovalve.Biovalve is made after being handled by animal materials such as bovine pericardium, bovine jugular vein lobe, porcine aortic valve.The method of above-mentioned open heart operation, operating time is long, the expense height, wound is big, has a big risk, and metal mechanical valve prosthesis displacement back patient needs long-term anticoagulant therapy, and the material lifetime of biovalve is limited, needs operation more usually.
In order to solve the problem that above-mentioned open heart operation treatment cardiac valve exists, existing now people attempts not doing open heart operation, and adopts the defeated Cardiac valve prosthesis of putting of percutaneous interventional method.The insertion type Cardiac valve prosthesis of prior art has two kinds:
1, balloon-expandable
This balloon-expandable Cardiac valve prosthesis is a biovalve, its interventional method is a difference fixed biologically valve on the support of a plastically deformable, diminishes by radial compression back diameter on a sacculus, and percutaneous is defeated to be put, pressurization makes the support expansion fixing to sacculus then, reaches duty.
1989 Henning Rud ANDERSEN (patent No. WO9117720) take the lead in having carried out porcine aortic valve through conduit cardiac-valve prosthesis displacement (document ... European Heart Journal 1,992 13,704-708).
Philippe BONHOEFFER (patent No. EP1057460) in 2000 and Alain CRIBIER (patent No. EP0967939) have carried out respectively first in the cusps of pulmonary valve of getting involved through conduit of human body and the Cardiac valve prosthesis displacement of aortic valve.
Shortcoming and problem that balloon-expandable artificial valve exists are: its diameter is determined by balloon diameter, if artificial valve's diameter does not choose at the beginning, or after some physiological change, as self-sow, pathologic vessels expansion etc., the caliber size of nature valve may increase, and artificial valve's bore can not increase by adaptability, and the artificial valve has the danger of loosening or slippage, can only carry out the further expansion of secondary sacculus.
2, self expandable type
This artificial valve is provided with a strain support, can expand voluntarily after the radial compression.
(patent No. FR2826863 FR2828091) has also designed through conduit cardiac-valve prosthesis and has replaced for Marc BESSLER (patent No. US5855601) and Jacques SEGUIN.Different is that they have used an elastically deformable support, can expand voluntarily after the radial compression.
(patent No. EP1281375, Cardiac valve prosthesis US2003036791) utilize an elastically deformable support to Philippe BONHOEFFER, at support upstream extremity or far-end contact are housed, and are pressed in inside and outside two sheath pipes.
The applicant had once used the stage casing to strengthen being combined to stent valve as the stent valve and the self-extending type of drum type in Chinese invention patent application number 200410054347.0, and the cluster apparatus for delivering.
Shortcoming and problem that self expandable type artificial valve exists are: frictional force is big between self expandable type Cardiac valve prosthesis and sheath pipe, influences the artificial valve and accurately discharges.
The support backguy of this cluster apparatus for delivering, frictional force is big when passing artificial valve's deformable unit, and backguy is easily dislocated when not passing.
Common drawback and problem that above-mentioned balloon-expandable and self expandable type Cardiac valve prosthesis exist are:
1, the apparatus for delivering of existing insertion type man-made support valve and the stent valve under the radial compression are harder, and bendability is poor, are not easy through aortic arch, can not aim at nature aortic valve mouth.
Even if 2 under the help of x x ray fluoroscopy x, the axial upstream and downstream location of insertion type man-made support valve and its apparatus for delivering also is not easy because of unstable the becoming of artificial valve under and the blood flow impact inaccurate to the judgement of anatomical position.The resistance coronary ostium if swimming on the upper side, insertion type prosthetic aortic valve position can influence Bicuspid valve, if downstream can be blocked up in the position.
3, the direction of rotation of insertion type aortic valve man-made support valve and its apparatus for delivering location fails to solve.If insertion type prosthetic aortic valve position of rotation is not to blocking up the resistance coronary ostium.
4, under the self-extending type man-made support valve high compression, the rollback of sheath pipe can run into very big resistance.Move back the resistance of sheath pipe and the man-made support valve displacement that difficulty also can make the operator locate.
5, in dispose procedure, stent valve partly is expanded to full expansion gradually, and required time surpasses a heart beat cycle.The stent valve of expansion can hinder blood flow, and stent valve also can make its position change because of blood flow impacts.Balloon-expandable man-made support valve complete blocking blood flow in the balloon expandable process particularly.
If 6 patients have coronary bypass (Coronary Artery Bypass), the man-made support valve of having implanted should not be in the hemoperfusion that the ascending aorta place influences the bridging opening.
7, the aortic valve self-expanding stent valve of Jacques SEGUIN and Philippe BONHOEFFER if can successfully be implanted, though postoperative can not influence perfusion coronarius at once, but mid-stent is not pasted blood vessel wall at aortic root, allow blood flow from the support mesh, flow through, have thrombotic possibility on the one hand; Can influence or hinder following possible coronary artery intervention diagnosis and treatment on the other hand.
8, also there is following problem in the fixing of stent valve that discharges after expanding:
A) systole and the impact of relaxing period blood flow can make fixing bad man-made support valve move.
B) existing pathologic expansion before its aortic root art of the patient of some aortic incompetence needs very big stent valve to coincide fixing with it.
C) some patient implants the part, back at the man-made support valve and has anatomical and change, as expansion, make can not respective change stent valve lose effectively fixing.
9, the man-made support valve after expansion is fixed has perivalvular leakage (Para valvularleaks) under many circumstances, and promptly blood leaked between stent valve and blood vessel wall.
If 10, touch metal rack in the valve leaflet switch, can cause the valve leaflet wearing and tearing.
Can to bear very big stress if 11 adopt major diameter stent valve, lobe leaf to unite point (Commissure) in order fixing, to cause valve leaflet to unite and a little tear damage.
Summary of the invention
The purpose of this utility model is to overcome the problems referred to above that prior art exists, and a kind of artificial heart stent valve and apparatus for delivering thereof of new structure is provided, and both can be used for the insertion type treatment, also can be used for the Minimally Invasive Surgery treatment.
The purpose of this utility model is achieved in that a kind of artificial heart stent valve, be characterized in, comprise one can be between expansion state and compressive state the pipe-shaped net rack of radial deformation, this network comprises Upstream section, stage casing and tract, constitute between each netting twine of network or surround a plurality of deformables unit, forming a plurality of open lines at the two ends of network turns, and be provided with the sealed line eye that separates with the deformable unit, being connected with in the inboard in network stage casing can switch and allow the unidirectional valve leaflet of passing through of blood, valve leaflet constitutes lobe leaf associating line with the network place of combining, the lobe leaf associating line of two adjacent valve leaflet intersects formation lobe leaf unites a little, on the inboard of network Upstream section and/or lateral surface, be coated with diaphragm seal and extend to the stage casing, on network, be provided with a plurality of radiopaque markers and flexibly jointed chain ring.
Above-mentioned artificial heart stent valve, wherein, described network integral body is tubular of the same size, is provided with carrier openings in the stage casing of tubular network.
Above-mentioned artificial heart stent valve, wherein, the stage casing of described network is outwards outstanding cydariform, is provided with carrier openings at the middle part in cydariform stage casing.
Above-mentioned artificial heart stent valve, wherein, the stage casing of described network is out of shape on the basis of tubular or slight cydariform and at least one outwards outstanding radial protrusion structure, be provided with a bigger carrier openings at the center of each radial protrusion structure, radial protrusion structure and network body connecting place form the upstream periphery of one and a half months shape and the downstream perimeter of one and a half months shape, and semi-moon shaped upstream periphery constitutes the lobe leaf associating line that links to each other with valve leaflet.
Above-mentioned artificial heart stent valve, wherein, the radial protrusion structure in described network stage casing is one.
Above-mentioned artificial heart stent valve, wherein, the radial protrusion structure in described network stage casing is two, two radial protrusion structures are that 90-180 degree corner distributes.
Above-mentioned artificial heart stent valve, wherein, the radial protrusion structure in described network stage casing is three, three radially uniform distributions of radial protrusion structure.
Above-mentioned artificial heart stent valve, wherein, the Upstream section flare of described network, the outer rim of tubaeform Upstream section are provided with and the corresponding waveform mouth of the radial protrusion structure in stage casing limit.
Above-mentioned artificial heart stent valve, wherein, the stage casing of described network is an outer double-layer structure in the tubular, on rack body, be connected with an outer circulus, outer circulus and internal layer link to each other with the intersection in stage casing at tract or tract and form fixed edge, and the intersection formation free edge that outer circulus terminates in Upstream section and stage casing also can be provided with sealed line eye to be separated with the deformable unit.
Above-mentioned artificial heart stent valve, wherein, the stage casing of described network is an internal layer with tubular or slight cydariform, the outside is connected with at least one and is surrounded the free tongue skin that forms by single netting twine, described free tongue and internal layer stake body link to each other with the intersection in stage casing at tract or tract and form fixed edge, and begin upstream the intersection formation free edge that section extends to Upstream section and stage casing from fixed edge, the free edge front end can be provided with sealed line eye, can be with radiopaque marker on the line eye.
Above-mentioned artificial heart stent valve, wherein, described free tongue is three, three free tongues distribute with 120 degree corners, and corresponding with valve leaflet.
Above-mentioned artificial heart stent valve, wherein, the stage casing of described network is out of shape on the basis of tubular or slight cydariform and at least one outwards outstanding radial protrusion structure, be connected with on each radial protrusion structure by single netting twine and surround the free tongue that forms, the free edge of free tongue is that semi-moon shaped upstream periphery is overlapping on two parallel curved surfaces with the periphery of radial protrusion structure at least.
Above-mentioned artificial heart stent valve, wherein, described valve leaflet is two to three, and three valve leaflet are 120 degree corners and distribute, and each valve leaflet comprises free limit and closed edge, forms between free limit and the closed edge and closes the closed zone.
Above-mentioned artificial heart stent valve, wherein, the diaphragm seal eye that described diaphragm seal is interlinked to the outside in corresponding being provided with in the sealed line eye place of network.
Above-mentioned artificial heart stent valve, wherein, described diaphragm seal can extend the mantle that formation does not have bracket supports in upstream direction beyond the network, can extend to lobe leaf associating line with interior downstream at network.
Above-mentioned artificial heart stent valve, wherein, described radiopaque marker is the tubular point-like sign that is sleeved on the netting twine, and the lobe leaf that this tubular point-like sign is arranged on the network stage casing is united a little, also can be arranged on the Upstream section of network or the intersection or the tract in Upstream section and stage casing.
Above-mentioned artificial heart stent valve, wherein, described radiopaque marker is a wire sign from beginning to end, this wire sign interweaves on the netting twine of network adjacent to lobe leaf associating line.
Above-mentioned artificial heart stent valve, wherein, the open line that described flexibly jointed chain ring is arranged on the network two ends turns the middle part with sealed line eye place and network.
Above-mentioned artificial heart stent valve, wherein, also comprise sealing ring, the sealing ring is arranged on the outside of the Upstream section and the stage casing intersection of network, described sealing ring is softish semi open model tubular structure, can be annular or with the corresponding waveform of radial protrusion structure, which is provided with inner face or the outside of a plurality of point-like openings, or be provided with the inner face of groove shape opening towards stent valve towards stent valve.
A kind of apparatus for delivering of artificial heart stent valve is characterized in, comprises conductor housing, interior pipe, near-end controller, middle pipe, wire leading pipe, outer protection mechanism, at least one locking silk and at least one support backguy; Described conductor housing, interior pipe and near-end controller fuse in proper order and are interconnected; the pipe box dress can slide along interior pipe on inner pipe in described; described wire leading pipe is arranged in the conductor housing that fuses, interior pipe and the near-end controller; the far-end of described outer protection mechanism big envelope pipe outside interior pipe and middle pipe and in being movable to, described locking silk and support backguy are located in respectively in the interior pipe and near-end controller that fuses.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described conductor housing is streamlined hollow cone body structure, its big end is that the rear end is connected with interior pipe far-end, its small end is that front end is provided with thread eye and is communicated with wire leading pipe, the leading portion of conductor housing is provided with at least one side opening and communicates with interior pipe, can contain the opacity material in the conductor housing, or is embedded with radiopaque marker.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, Guan Weiyi elongate tubular structure in described, comprise be used for the interior pipe that links to each other with artificial heart stent valve section far away, bow arcual near section of pipe stage casing and the interior pipe that is communicated with the near-end controller, be provided with the vestibule that at least one allows various silks, line pass through in the interior pipe, interior pipe section far away is provided with at least one side opening.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described in pipe for pipe in the single hole, only be provided with a big circular general vestibule in the interior pipe, described wire leading pipe is arranged in this vestibule and can slides along interior pipe.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described interior pipe is pipe in the single hole, only be provided with a big circular general vestibule in the interior pipe, described wire leading pipe is arranged in this vestibule, also is provided with a backguy pipe and a locking fiber tube in the vestibule, can slide mutually between each pipe.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described interior pipe is provided with a small circular wire leading pipe for pipe in the diplopore near interior tube edges, general pipe of big semilune of remainder formation, adhesion is fixing between two pipes can not slide.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, pipe in the described interior Guan Weisan hole, be provided with a small circular wire leading pipe near interior tube edges, remainder is divided into two halves, forms two identical general pipes of shape symmetry, and adhesion is fixing between each pipe can not slide.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, pipe in the Guan Weisi hole in described, be provided with a small circular wire leading pipe near interior tube edges, the interior tube edges on wire leading pipe opposite is provided with small circular locking fiber tube, remainder is divided into two halves, forms two identical general pipes of shape symmetry, and adhesion is fixing between each pipe can not slide.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, the side opening of pipe section far away is three in described being located at, and comprises distal openings, middle side opening and proximal open, three side openings are all at the same plane and the same side of interior pipe.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, the periphery of described side opening is provided with reinforcing ring, and this reinforcing ring is made of intensity height, metal material or macromolecular material that frictional property is good, and the reinforcing ring of metal material can constitute radiopaque marker.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, the middle level of described interior pipe can accompany the braiding reinforcing mat, and interior pipe side opening can be opened in a grid of braiding reinforcing mat.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described interior pipe is spiral bourdon tube, the spring wire of bourdon tube section far away forms distal openings, middle side opening and the proximal open of interior pipe at the part formation semi-ring or the domain.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described spiral bourdon tube is surrounded by the macromolecular material pipe outward, and the macromolecular material pipe is provided with opening at semi-ring or domain place corresponding to bourdon tube.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described near-end controller is a dendritic structure, comprise a main pipe and at least one backguy arm of being communicated with main pipe, at least one locking arm, one wash and radiography arm and at least one seal wire arm.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, the oblique side that is connected near-end controller main pipe of described backguy arm, and be positioned at same side with the side opening of interior pipe, be provided with resistant to blood refluence film in the backguy arm, be provided with the pin hole that allows backguy pass through in the middle of the film, being provided with the backguy fastener in the backguy arm can be fixed on a certain ad-hoc location of backguy on the backguy arm.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described backguy arm is three, three oblique respectively the same sides that are connected near-end controller main pipe of backguy arm, and correspond respectively to far-end backguy, stage casing backguy and near-end backguy in proper order by front and back, form far-end backguy arm, stage casing backguy arm and near-end backguy arm.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, the oblique side that is movably connected in near-end controller main pipe of described locking silk arm, on main pipe and connector locking silk arm, be provided with the resistant to blood film that backflows, be provided with the pin hole that allows lock-in line pass through in the middle of the film, be provided with a sliding bar in the locking silk arm, the front end of sliding bar links to each other with the locking silk, the rear end protruded tube of sliding bar forms operating grip outward, the middle part of sliding bar has a groove, position corresponding to this groove on the locking silk arm is provided with far-end dowel hole and proximally-located pin-and-hole, two alignment pins can pass two dowel holes on the locking silk arm respectively and will locks a silk arm with groove on the sliding bar and link to each other with sliding bar, by fixing or the releasing alignment pin can determine whether the locking silk of sliding bar and connection thereof slides and control its sliding distance.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described locking silk arm is two, two oblique respectively the same sides that are connected near-end controller main pipe of locking silk arm, and correspond respectively to two locking silks.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, the near-end of pipe is near the near-end controller in described, far-end is less than the proximal open of interior pipe, near section at middle pipe is connected with a side pipe, be provided with in one in the middle pipe and manage backguy, the remote port of pipe during the far-end of middle pipe backguy is fixed on, in the near-end of pipe backguy therefrom manage near section side pipe and draw, in the side pipe of the pipe far-end fixing point of backguy and the nearly section of middle pipe be arranged on same plane and with on one side, respectively be equipped with a shrink-ring at the port of middle pipe near-end and the port of side pipe, can slide along interior pipe when this shrink-ring loosens, fixing certain position on inner pipe during deflation.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described in pipe certain taper slightly, section far away is thinner, nearly section is thicker, make apparatus for delivering obtain simultaneously nearly section promotion and in section bendability far away.
40. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: the far-end of described wire leading pipe is communicated with conductor housing, near-end is communicated with seal wire arm on the near-end controller, and the part of wire leading pipe in interior pipe stage casing is positioned at the protruding side in pipe stage casing.
The apparatus for delivering of above-mentioned artificial heart stent valve; wherein; described outer protection mechanism is a tubulose epitheca pipe; the far-end tube wall of this epitheca pipe is embedded with radiopaque marker, and nearly section is provided with flushing/radiography opening and valve, is provided with elastica in the proximal port; elastica central authorities are provided with aperture; little bore closure or have only very little diameter under the normal condition, the diameter of aperture can enlarge when middle pipe passed, and slided and elastica is not leaked blood with pipe in guaranteeing.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described outer protection mechanism is peelable outer protection mechanism, comprises peelable sheath pipe and is used for the provisional take-up lock silk that tightens up the sheath pipe take-up of peelable sheath pipe and be used to lock the take-up of sheath pipe; Far away section of peelable sheath pipe is provided with a longitudinal opening and runs through far-end, longitudinal opening both sides sheath pipe is provided with a plurality of take-up eyes, and the distal diameter of peelable sheath pipe is dwindled, and it is streamlined to constitute bullet, nearly section part is a complete pipe in the peelable sheath pipe, and its diameter is less than or equal to far away section diameter; The far-end of sheath pipe take-up be provided with the take-up ring pass in a side opening of pipe section far away blocked by take-up lock silk, the near-end of sheath pipe take-up is temporarily fixed on the near-end controller, each take-up eye that the take-up of sheath pipe is passed on the peelable sheath pipe constitutes tightening structure, and can take the back releasing of take-up lock silk away; Take-up lock silk is located in the interior pipe and can slides along interior pipe, and its near-end is drawn from the near-end controller.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described peelable sheath pipe is the tubular cloth tubular construction, its tube wall is the tube wall of sealing.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described peelable sheath pipe is the tubular reticulum tubular construction, its tube wall is the tube wall that mesh is arranged.
The apparatus for delivering of above-mentioned artificial heart stent valve; wherein, described outer protection mechanism is for comprising at least one line ball lock silk and a support line ball around knot and the thread depressing mechanism that can unhitch; the two composition can be around the knot and the thread depressing mechanism that can unhitch, can be with the provisional radial compression of stent valve.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, Guan Bingke slided along interior pipe in described line ball lock silk ran through, and its near-end is drawn from an arm of near-end controller; The near-end of described support line ball is drawn from an arm of near-end controller, its far-end is provided with wire loop, pipe was blocked by line ball lock silk in a side opening of pipe entered in the far-end wire loop passed, before in the far-end wire loop enters, managing side opening, support line ball alternative is in stent valve outside process, or pass the part that does not have diaphragm seal on the stent valve, passed by same or different line ball lock silks midway and block, formation can be implemented provisional radial compression to stent valve around knot and also can unhitch after taking line ball lock silk away.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, also comprise the side wire leading pipe, described side wire leading pipe rises from the outside at interior pipe section far away middle part and with interior pipe section far away and links to each other, pipe stage casing in inwardly the pipe proximal direction extends to, in also can extending on nearly section of pipe or the near-end controller, the far-end of side wire leading pipe is between the distal openings of interior pipe and proximal open and outwards bending, and the side opening direction of the port direction of formation and interior pipe is angled.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described side wire leading pipe is one, maybe can be equipped with around knot and the thread depressing mechanism that can unhitch with peelable outer protection mechanism.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described side wire leading pipe is two, and can be equipped with around the knot and the thread depressing mechanism that can unhitch, and becomes 120 degree corners to arrange between the wire leading pipe of both sides.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described locking silk runs through interior pipe, and its section far away is passed stay thimble of one or more support backguy with one or more support backguy locking, and near-end links to each other with sliding bar in the near-end controller lock fixed thread arm.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described locking silk is two, two locking silks lock one or more support backguy respectively and also link to each other with two sliding bars that lock in the silk arms of near-end controller respectively.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, the vestibule of pipe in described support backguy is passed, its far-end is provided with a stay thimble, its near-end is drawn from the backguy arm of near-end controller, its section far away is drawn outer section that forms the support backguy from a side opening of interior pipe, outer section same side opening of support backguy around pipe in entering behind network one circle, and by the locked silk locking of the stay thimble of its far-end.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, outer section of described support backguy passes respectively around network the time that the unitary opening of deformable of network, open line turn, sealed line eye and flexibly jointed chain ring, constitutes a lasso trick.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, described support backguy is three, and the near-end of three support backguys is drawn from three backguy arms of near-end controller respectively, and the far-end of three support backguys is locked by same or different locking silks in three side openings of interior pipe respectively.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, in described three support backguys, the backguy of drawing from the near-end backguy arm of near-end controller, in the proximal open of pipe, from the backguy that the stage casing backguy arm of near-end controller is drawn, its far-end was connected in the middle side opening of interior pipe in its far-end was connected, from the backguy that the far-end backguy arm of near-end controller is drawn, its far-end is connected in the distal openings of interior pipe.
The apparatus for delivering of above-mentioned artificial heart stent valve, wherein, also comprise Ultrasonic-B probe, this Ultrasonic-B probe be arranged on the rear end of conductor housing or be arranged near the distal openings of pipe or near the proximal open, pipe was drawn from the near-end controller in the lead that connects Ultrasonic-B probe passed.
Artificial heart stent valve of the present utility model and apparatus for delivering thereof make it compared with prior art owing to adopted above-mentioned technical scheme, have following advantage and good effect:
1, man-made support valve shape, 26S Proteasome Structure and Function are more optimized.
2, deformable support both can cooperate with biovalve also and can cooperate with synthetic valve.
3, increase the intensity and the life-span of synthetic valve, do not needed anticoagulant, be expected to replace biovalve.
Contact friction with metal rack when 4, preventing the valve switch, prevent that the valve peripheral blood from leaking.
But 5, man-made support valve radial compression is accurately carried under intervention device helps and is put in place, expansion then.The man-made support valve does not separate with having an accident property of conveyer device before the expansion and when expanding.As find that the man-made support position of valve is undesirable in the process of expansion, can correct.
6, frictional force is low between man-made support valve under the compressive state and the sheath pipe, helps accurately discharging the man-made support valve.
7, the man-made support valve after expansion discharges is in the radial and axial blood vessel wall shape that meets.
8, can bring into normal play after the man-made support valve the is implanted effect of valve.
9, after the man-made support valve is implanted, can prevent that when the blood reflux valve is closed blood causes the artificial valve to slide in the other direction.
10, stent valve is carried and is discharged easily.
11, the man-made support valve axially and direction of rotation can accurately locate.
12, the man-made support valve can be between the secondary heart contraction with reference to electrocardiogram no blood situation next time or the expansion of segmented rapid release; Perhaps in progressive release expansion, blood flow is not obstructed because of the stent valve of half expansion, and the stent valve of half expansion does not change because of blood flow impacts yet.
13, the stent valve after the expansion can obtain effectively fixing.
14, the stent valve after the expansion does not produce perivalvular leakage.
15, reduce the valve leaflet wearing and tearing.
16, reduce the friction of support backguy, prevent the backguy dislocation.
Description of drawings
By the description of following a plurality of embodiment to this utility model artificial heart stent valve and apparatus for delivering thereof, can further understand the purpose of this utility model, specific structural features and advantage in conjunction with its accompanying drawing.Wherein, accompanying drawing is:
Fig. 1 is in this utility model artificial heart stent valve, and network integral body is the three-dimensional perspective of the stent valve of tubular;
Fig. 1 a is the plane outspread drawing of the single layer knit structure of stent valve shown in Figure 1;
Fig. 2 is in this utility model artificial heart stent valve, and the stage casing of network is the three-dimensional perspective of the stent valve of cydariform;
Fig. 3 is in this utility model artificial heart stent valve, and there is the three-dimensional perspective of the stent valve of radial protrusion structure in the stage casing of network;
Fig. 3 a is the front view of stent valve shown in Figure 3.
Fig. 3 b is the vertical view of Fig. 3 a;
Fig. 3 c is the upward view of Fig. 3 a;
Fig. 3 d is the side view of Fig. 3 a;
Fig. 3 e and Fig. 3 f are that Fig. 3 b is along side shaft bx crosscut sketch map;
Fig. 4 is in this utility model artificial heart stent valve, and the stage casing of network is the three-dimensional perspective of the inside and outside double-deck stent valve of tubular;
Fig. 4 a is the double braid structural plan expanded view of stent valve shown in Figure 4;
Fig. 5 is in this utility model artificial heart stent valve, and there is the three-dimensional perspective of the stent valve of free tongue in the stage casing of network;
Fig. 5 a is the double braid structural plan expanded view of stent valve shown in Figure 5;
Fig. 5 b is the vertical view of stent valve shown in Figure 5;
Fig. 6 is in this utility model artificial heart stent valve, and the stage casing of network has the three-dimensional perspective of the stent valve of radial protrusion structure and free tongue simultaneously;
Fig. 7 a is the front view of the apparatus for delivering of this utility model artificial heart stent valve;
Fig. 7 b is the sectional structure sketch map of Fig. 7 a;
Fig. 7 c is the B portion cutaway view Amplified image of Fig. 7 b;
Fig. 7 d is the sectional structure sketch map of the near-end controller in the apparatus for delivering shown in Fig. 7 a;
Fig. 8 a, Fig. 8 b, Fig. 8 c, Fig. 8 d are that interior pipe in the apparatus for delivering of artificial heart stent valve shown in Fig. 7 a is along the sectional structure sketch map of AA line;
Fig. 8 e is a far away section partial side view of pipe in the spring in the apparatus for delivering of this utility model artificial heart stent valve;
Fig. 9 a is the plan cross-section structural representation of the middle pipe in the apparatus for delivering of this utility model artificial heart stent valve;
Fig. 9 b is the plan cross-section structural representation of the epitheca pipe in the apparatus for delivering of this utility model artificial heart stent valve;
Figure 10 a is the front view of the monolayer stent valve of this utility model artificial heart stent valve under radial compression;
Figure 10 b, Figure 10 c are the front view that there is the stent valve of outer free tongue in this utility model artificial heart stent valve stage casing, and wherein, Figure 10 b is a radially full compression of stent valve, and Figure 10 c is that outer tongue has discharged expansion under the stent valve body compressive state;
Figure 10 d is that the C-C of Figure 10 a is to view;
After Figure 10 e is the stage casing crosscut of interior pipe, the above-below direction vertical view of Figure 10 b;
After Figure 10 f is the stage casing crosscut of interior pipe, the above-below direction vertical view of Figure 10 c;
Figure 11 a, Figure 11 b, Figure 11 c, Figure 11 d are in the apparatus for delivering of this utility model artificial heart stent valve, and interior pipe section far away contains the three-dimensional side view of dependency structure spare.Wherein, the stent valve among Figure 11 a, Figure 11 b, Figure 11 d only shows at far-end and near-end.Figure 11 a is that single locking silk is joined three support backguys, and two locking silks are arranged among Figure 11 b, a wherein locking silk far and near two support backguys of control in order, the control intermediate support backguy separately of another locking silk.Figure 11 c, Figure 11 d are the stent valve assembly process figure, and wherein, Figure 11 c shows assembling exhausting line and locked backguy, but does not have stent valve, and Figure 11 d shows the stent valve assembling process:
-rack far end: backguy prepares to pass sealed line eye of support and flexibly jointed chain ring;
-mid-stent: sealed line eye of support and flexibly jointed chain ring have been passed in backguy, reclaim the support lobe again
The film inboard prepares to be moved to outside the near-end controller by the interim exhausting line of the nearly section of backguy;
-mount proximal end: backguy has been assembled exhausting line and has moved to outside the near-end controller;
Figure 12 a, Figure 12 b, Figure 12 c are in the apparatus for delivering of this utility model artificial heart stent valve, interior pipe section far away side view with a side wire leading pipe, wherein, interior pipe among Figure 12 a, Figure 12 b and stent valve are surrounded by the peelable sheath pipe of tubular cloth tubular construction outward, and the take-up of sheath pipe is arranged on the opening; Interior pipe among Figure 12 c and stent valve are surrounded by the peelable sheath pipe of tubular reticulum tubular construction outward, and the take-up of sheath pipe is arranged on the opening;
Figure 13 is in the apparatus for delivering of this utility model artificial heart stent valve, and with the side view of far away section of the interior pipe of two side wire leading pipes, stent valve has the line ball that also can be unhitched around knot outward.
The specific embodiment
Referring to Fig. 1, cooperation is referring to Fig. 2, Fig. 3, Fig. 4, Fig. 5, Fig. 6, and Figure 10 a, Figure 10 b, Figure 10 c, Figure 10 d, Figure 10 e, Figure 10 f, the artificial heart stent valve 1 in this utility model comprises: but the self expandable type network 10 of radial deformation, not pass through x-ray sign 311,312, can switch and allow reinforcing fibre 39 and flexibly jointed chain ring 41 in the unidirectional valve leaflet of passing through 33 of blood, diaphragm seal 351,354, sealing ring 37, the synthetic film.
But the self expandable type network 10 of radial deformation is the pipe type netted structure of central hollow, is made by elastomeric material, and under the situation that does not have the external force restriction, the support expansion is expansion state.Support is compressive state by radial compression under external force.No matter under naturalness or expansion state, self expandable type network 10 all can divide three parts by outline: i.e. tract 13, stage casing 15 and Upstream section 18.
Can there be following six kinds of versions in the stage casing of the network in this utility model artificial heart stent valve 1:
Referring to Fig. 1, cooperate referring to Fig. 1 a, Fig. 1 is first kind of version in stage casing, in this structure, stage casing 15 is for being that the garden tubular 151 of major axis is around axle runner exterior feature with xx.There is carrier openings 158 at the middle part in garden tubular 151.
Referring to Fig. 2, Fig. 2 is second kind of version in stage casing, and in this structure, stage casing 15 is for being that the drum type 152 of major axis is around axle runner exterior feature with xx.The middle part 157 external diameter maximums of drum type 152 are had a common boundary with 133 external diameter greater than tract 13 and stage casing 15, have a common boundary with 183 external diameter greater than Upstream section 18 and stage casing 15.There is carrier openings 158 at the middle part 157 of drum type 152.
Referring to Fig. 3, cooperate referring to Fig. 3 a, Fig. 3 b, Fig. 3 c, Fig. 3 d, Fig. 3 e, Fig. 3 f, Fig. 3 is the third version in stage casing.In this structure, stage casing 15 is a composite construction, is that the garden of major axis is tubular by 151 with xx, or slight drum type 152 is around axle runner exterior feature, and having on the outer surface with ax, bx, cx is the one or more radial protrusion structure 153 of side shaft, extends radially outwardly.Ax, bx, cx side shaft are perpendicular to the xx major axis.Distribute with 120 degree corners between ax, bx, three side shafts of cx.Radial protrusion structure 153 so that 120 degree corners distribute is used for matching with coronary sinus or natural aortic valve leaf.Radial protrusion structure 153 is the support part of the whole.Each radial protrusion structure 153 middle part 157x external diameter is big, and there is a bigger carrier openings 158 at the center.All peripheral 159i, the 159o of each radial protrusion structure 153 with link to each other around the wide stake body of axle runner.The external diameter of the outstanding structure of the external diameter of periphery 159i, 159o middle part 157x is little, and peripheral 159i, 159o are divided into two semi-moon shaped upstream periphery 159i and downstream perimeter 159o, is the boundary to unite a little 160.Semi-moon shaped upstream periphery 159i constitutes the lobe leaf associating line 331 that links to each other with valve leaflet 33.Two adjacent radial protrusion structures 153 link to each other uniting a little 160, unite a little 160 overlapping uniting two into one.The external diameter of uniting a little 160 the outstanding structure of external diameter middle part 157x is little, constitutes the lobe leaf and unites a little 332 binding sites.Radial protrusion structure 153 is at least a leaf.The aortic valve place is the 1-3 leaf that 120 degree corners distribute.Figure 3 shows that network with three radial protrusion structures 153.
Referring to Fig. 4, cooperate referring to Fig. 4 a, Fig. 4 is the 4th kind of version in stage casing.In this structure, stage casing 15 is an outer double-layer structure in the tubular, comprises internal layer stake body 154 and outer circulus 155.Internal layer stake body 154 is with 133 to link to each other at tract 13 or tract 13 with 15 boundaries, stage casing with outer circulus 155, claims fixed edge 161.Outer circulus 155 terminates in Upstream section 18 and is with 183 with 15 boundaries, stage casing, is free state or active state, claims free edge 162.Internal layer stake body 154 is parallel with outer circulus 155 inside and outside two-layer supports under naturalness or the expansion state.Under internal layer stake body 154 radial compression, be the axle center with fixed edge 161, outer circulus 155 can radial compression near internal layer stake body 154, or entad remove after the restrained force expansion away from internal layer stake body 154 flares port one 84 openings upstream.
Referring to Fig. 5, cooperate referring to Fig. 5 a, Fig. 5 b, Fig. 5 is the 5th kind of version in stage casing.In this structure, stage casing 15 is inside and outside two layer composite structure.The garden that with xx is major axis is tubular by 151, or slight drum type 152 is around the internal layer stake body 154 of axle runner exterior feature, having on the outer surface with dx, ex, fx is that one or more of side shaft surround the free tongue 156 that forms by single netting twine, has a common boundary from tract 13 or tract 13 and stage casing 15 to be with 133 beginnings outwards upstream to hold 184 to extend to Upstream section 18 and have a common boundary with stage casing 15 and be with 183 to end.Dx, ex, fx side shaft are perpendicular to the xx major axis.Distribute with 120 degree corners between dx, ex, three side shafts of fx.The free tongue 156 of three 120 degree corners distribution is used for matching with coronary sinus or natural aortic valve leaf.Free tongue 156 is the support part of the whole.Free tongue 156 part peripheries link to each other with internal layer stake body 154 as the downstream periphery, claim fixed edge 163, and another part is free state or active state for the tongue shape structure, claims free edge 164.The fixed edge 163 of two adjacent free tongues 156 165 meets uniting a little.Unite a little 165 and unite a little 332 binding sites on same Plane of rotation with the lobe leaf.Under internal layer stake body 154 radial compression, be the axle center with fixed edge 163, free tongue 156 can radial compression near internal layer stake body 154, or entad remove after the restrained force expansion away from internal layer stake body 154 flares port one 84 openings upstream.
Referring to Fig. 6, Fig. 6 is the 6th kind of version in stage casing.In this structure, stage casing 15 is added with the free tongue 156 of Fig. 5 simultaneously for the radial protrusion structure 153 of Fig. 3.Radial protrusion structure 153 and free tongue 156 exist on same angle position simultaneously.The free edge 164 of free tongue 156 and peripheral 159i, the 159o of radial protrusion structure 153, semi-moon shaped at least upstream periphery 159i is overlapping on two parallel curved surfaces.
Continuation is referring to Fig. 1 to Fig. 6, and Upstream section 18 is the other end opposite with tract 13.Upstream section 18 and aortic valve zona match.With regard to aortic valve, when contrary blood flows into dataway operation, concerning the patient the far-end of support.This utility model adopts contrary blood flow approach.When antegrade blood flow is gone into dataway operation, concerning the patient the near-end of support.Upstream section 18 for xx be major axis around the wide structure of axle runner.The garden that can be under naturalness or the expansion state tubular by 181 (referring to Fig. 1, Fig. 5) and two kinds of planforms of tubaeform 182 (referring to Fig. 2, Fig. 3, Fig. 4, Fig. 6).Garden tubular 181 is extensions that stage casing 15 is the tubular port one upstream 84 in garden.Tubaeform 182 is the opening extensions of port one 84 upstream of stage casing 15 flares.Tubaeform 182 is small-bore by stage casing 15, and heavy caliber is a upstream port 184.The diameter of tubaeform 182 upstream port 184 has a common boundary much larger than Upstream section 18 and stage casing 15 with 183 diameter.Upstream section 18 length can become because of needs, are generally less than 20mm, not hinder Bicuspid valve.Upstream section 18 is no matter be garden tubular 181 or tubaeform 182 the sort of schemes, and the terminal deformable unit 101 of Upstream section 18 upstream ports 184 can be a level, and upstream port 184 is flat mouthful.The terminal deformable unit 101 of Upstream section 18 upstream ports 184 also can be a level.As: exist simultaneously with three hemispherical radial protrusion structures 153, the upstream port 184 of tubaeform 182 Upstream sections 18 is not a level.With radial protrusion structure unite a little 160 or the lobe leaf unite that a little tubaeform 182 Upstream sections 18 of 332 opposite positions are shorter, longer with tubaeform 182 Upstream sections 18 of radial protrusion structure 153 middle part 157x opposite positions, the upstream port 184 of the result is tubaeform 182 Upstream sections 18 is and three radial protrusion structures, 153 corresponding SANYE waveform mouths 185.The terminal deformable unit 101 of Upstream section 18 upstream ports 184 can have open line to turn 102 to lead to deformable unit 101, also can have sealed line eye 103 and deformable unit 101 to separate.
But this utility model adopts the self expandable type network 10 of radial deformation.Above-mentioned outline is the naturalness or the expansion state of self expandable type network 10.Self expandable type network 10 is made by elastomeric material.The biocompatible elastic material that oneself knows comprises niti-shaped memorial alloy Nitinol, cochrome Phynox, L605, etc.It is the balloon-expandable support that is made of plastic material that above-mentioned outline network is difficult to.Because needing the balloon expandable of given configuration, these outlines reach.The self expandable type network 10 of above-mentioned outline can be formed by the elastic wire braiding, also can be formed by the cutting of elasticity tubing.
Self expandable type woven mesh support 10 can be implemented by following method:
The basic weaving method of self expandable type woven mesh support 10 is as follows:
Referring to Fig. 1 a, Fig. 4 a, Fig. 5 a, cooperate referring to each figure among Fig. 1 to Fig. 6 and Figure 10 a, Figure 10 b, Figure 10 c, Figure 10 d, Figure 10 e, Figure 10 f, self expandable type woven mesh support 10 is formed by single elasticity litzendraht wire 104 braidings.In 104 liang of end points 105,106 of single line certain is a bit such as starting point 105 beginnings, along aforementioned specific outline 151 or 152 or 153 or 154 or 155 or 156,181 or 182 spirals advance, being folded to symmetric rightabout again behind the support end 134,184 advances along specific outline 151 or 152 or 153 or 154 or 155 or 156,181 or 182 spirals.Repeat all to set up up to all deformable unit 101 with this, certain that put in 105,106 with two ends a bit finishes such as terminal point 106 arrival or above starting point 105.The two-stage nitration line 104 ' of same single line 104 behind folding constitutes cross-point 107 up and down when intersecting.One cross-point 107 is just in time opposite with the upper-lower position relation of the most contiguous four cross-points 107 '.A deformable unit 101 is a tetragon or diamond structure, is made of same single line 104 four limits 104 ' of four sections lines and four cross-points 107,107 ' behind folding.The deformable unit 101 on four limits or by the support radial compression distortion of deformable unit, four limits 101 braiding is mixed with the axially-extending distortion.Single litzendraht wire 104, as behind upstream port 184 and downstream port 134 or behind a deformable unit 101 ends, is folded to symmetric rightabout formation again and turns 102 less than the 360 open lines of spending to the support end.If turning 102 litzendraht wire 104, open line can constitute sealed line eye 103 in the three-sixth turn angle again.Sealed line eye 103 can be at the support two ends, as upstream port one 84 and downstream port 134, and also can be between the two.One or more sealed line eyes 103 can be arranged on each section line.Sealed line eye 103 can with support on same outline curved surface or on the tangent plane, also can with the perpendicular plane of support on (on the diametric plane) inwardly or outwards, also can be between these two.The support end turns 102 as the open line of upstream port one 84 and downstream port 134, and sealed line eye 103 can be in same level, also can be at varying level.For three valve leaflet stent valves, be that three multiple helps three valve leaflet symmetries along the deformable unit number of girth.By the support 10 of single litzendraht wire 104 braidings along girth deformable unit number divided by should being a mark rather than an integer along major axis deformable unit number.Terminal point 106 in the single litzendraht wire 104 arrives and can repeat on same position after starting point 105 has woven a support, comprising: 1, all repeat on all positions, so just constituted the above higher support of radial strength of two-stage nitration line or two-stage nitration line; 2, in the part, repeat as Upstream section, stage casing or tract, the local radial elastic force after the above repetition of two-stage nitration line or two-stage nitration line strengthens.The two-stage nitration line to the multistage line can near or overlap deformable unit 101 not of uniform size, comprise bigger opening 158.The support that is formed by single line braiding also can be formed by multi-thread braiding.Two or more identical or different single lines can be woven together simultaneously.Each single line constitutes a support.But two or more supports overlap and constitute a sectional shelf-unit.Different single lines, thickness can be different.Different single lines, material can be different.Can be the single line of opacity material as a line wherein, as gold, tungsten, platinum, tantalum etc.
Below introduce the concrete weaving method of above-mentioned several structures of the network in this utility model artificial heart stent valve 1:
The weaving method of first kind of structure is adopted in the stage casing:
With xx is tubular by 151, the 181 together basic weaving methods of weaving method around axle runner exterior feature support in garden of major axis.
The weaving method of second kind of structure is adopted in the stage casing:
The weaving method of the third structure is adopted in the stage casing:
On weaving method two bases, the garden that with xx is major axis is tubular by 151, or slight drum type or garden sphere 152 be around axle runner exterior feature, and having with ax, bx, cx on 15 outer surfaces of stage casing is the composite construction support that the one or more radial protrusion structure 153 of side shaft extends radially outwardly.The similar basic weaving method of the weaving method of this profile support.Stage casing 15 can be formed by single litzendraht wire 104 braidings for the support of radial protrusion structure 153.The support that forms by 104 braidings of single litzendraht wire from downstream port 134 through three hemispherical radial protrusion structure 153 different parts, as middle part 157x or unite a little 160, having a common boundary to Upstream section 18 and stage casing 15, it is different to end the length of each section litzendraht wire with 183, and adjacent deformable unit is not isometric.But braided support cross-point 107, the 107 ' slip of going up between the adjacent segment litzendraht wire have guaranteed that support and radial protrusion structure 153 can radial compression, radial dilatation.Exist simultaneously with three hemispherical radial protrusion structures 153, tubaeform 182 Upstream sections 18 and radial protrusion structure unite a little 160 or the lobe leaf unite that a little 332 opposite positions are shorter, tubaeform 182 Upstream sections 18 are longer with radial protrusion structure 153 middle part 157x opposite positions, and the result is tubaeform, and 182 Upstream sections 18 are and three SANYE waveform mouths 185 that radial protrusion structure is relative.Tubaeform 182 Upstream sections 18 than the litzendraht wire of strong point through the outstanding structure of adjacent radial unite a little 160 or the lobe leaf unite a little 332 less external diameters, tubaeform 182 Upstream sections 18 than the litzendraht wire of weakness through radial protrusion structure middle part 157x than external diameter greatly.Support can be equally to the length of each section braided wires the downstream port 134 through three radial protrusion structures 153 from upstream port 184 like this.Each section line state under expansion state and compression is all isometric.It is corresponding with three radial protrusion structures 153 that expansion state lower carriage upstream port 184 is three waveform limits 185.When radial compression, axially-extending, the adjacent segment line slides on the cross-point, and three radial protrusion structures 153 and three waveform limits 185 disappear, and upstream port 184 each deformable unit are parallel.Single line 104 not only can be woven into a netted shell support 10 of monolayer, also can be woven into a multiwalled stereochemical structure support.
The weaving method of the 4th kind of structure is adopted in the stage casing:
After single line 104 was woven into a netted shell support 10 of monolayer, at support tract 13,104 ' two sections line in-situ locallies of another section of same braiding single line 104 repeated.15 single lines 104 stretch out and break away from the internal layer stake body that woven 154 and independent unofficial layer circulus 155 to the stage casing.Stage casing 15 single lines 104 of having compiled outer circulus 155 return 13 pairs of section lines of stake body tract in-situ locally and repeat, repeat back and forth and change the about 360 degree corners of support with this tract stake body 13 and stage casing 15 outer circuluses 155, until the outer circulus 155 that constitutes shown in Fig. 4 a.There is inside and outside two-layer support 154,155 in the stage casing like this.Between the middle and lower reaches section, be connected to fixed edge 161 between two-layer.From tract 13 and stage casing the outer circulus 155 of 15 combined belts, 133 beginnings outwards upstream port ones 84 extend to combined belt 183 horizontal stop between stage casing 15 and the Upstream section 18.Help under these outer circulus 155 radial compression carrying.Under internal layer stake body 154 radial compression, with fixed edge 161 is the axle center, outer circulus 155 can be separately in internal layer stake body 154 radial compression near internal layer stake body 154 or entad remove restrained force after be toroidal away from internal layer stake body 154 to discharging expansion.Be independent of internal layer stake body 154 compression or expansion states, these outer circuluses 155 have been expanded location, fixation separately.These outer circuluses 155 can be smooth on internal layer stake body 154 outer surfaces under internal layer stake body 154 and outer circulus 155 expansion states, also can flare upstream port one 84 extend on the stake body outer surface.13 pairs of section lines of support tract repeating part adds the girth cell number CN ' of the outer circulus 155 in stage casing and the ratio of axial length cell number LN ' is not an integer.These outer circuluses 155 not only can be by forming with same single lines 104 braidings of internal layer stake body 154, also can be woven simultaneously by the litzendraht wire different with internal layer stake body 154 to form.
The weaving method of the 5th kind of structure is adopted in the stage casing:
After single line 104 is woven into a netted shell support 10 of monolayer, at support tract 13,104 ' two sections line in-situ locallies of another section of same braiding single line 104 repeat, and changeing the about 60 degree angles of support, 15 single lines 104 ' stretch out and break away from 154 dozens of half circular arc lines 166 of stake body that woven or make a call to a full circle camber line 166 ' and return the repetition of 13 pairs of section lines of support tract in-situ locally to the stage casing.Like this single line 104 go out a little 167 with advance a little 167 ', or advance a little 167 and go out a little between 167 ' support commentaries on classics 120 and spend.With this tract stake body 13 and stage casing 15 outer free tongues 156 back and forth triplicate until the free tongue 156 of skin that constitutes shown in Fig. 5 a.There are internal layer stake body 154 and outer free tongue 156 two-layer supporting structures in the stage casing like this.Between the middle and lower reaches section, be connected to fixed edge 163 between two-layer.Outwards upstream hold 184 to extend to combined belt 183 horizontal stop between stage casing 15 and the Upstream section 18 from the outer free tongue 156 of 133 beginnings of combined belt between tract 13 and the stage casing 15.Free tongue 156 fixed edge 163 separately of two adjacent skins has one commonly to unite a little 165.Help carrying under these outer free tongue 156 radial compression.Under the stake body radial compression, be the axle center with fixed edge 163, outer free tongue 156 can be separately in internal layer stake body 154 radial compression near stake body, or entad remove and radially to discharge expansion after the restrained force and be toroidal away from stake body.Before stake body 154 expansion, the free tongue 156 of the skin of expansion separately can push up earlier in the natural valve leaf bag of aortic valve and play automatic positioning action.No matter stake body is in compressive state or expansion state, these outer free tongues 156 can independent radial compression, and independent radially release expanded fixation.These outer free tongues 156 enter nature valve leaflet bag, are pressed at the bottom of the natural valve leaf bag and natural lobe leaf is united a little.When the valve leaflet of diastole stent valve is closed, blood reflux stream, outer free tongue 156 can play fixation, prevents that stent valve from being rushed in the left ventricle by blood flow.These outer free tongues 156 can be smooth on the stake body outer surface under internal layer stake body 154 and outer free tongue 156 expansion states, and the opening of also can flare upstream holding extends on the stake body outer surface.The local multiple girth deformable unit number CN of two section lines of tract 13 same braiding single lines 104 and the ratio of axial length deformable unit number LN are an integer, guarantee that like this single line gets back to initial point 105,106.Single line goes out a little 167 and to advance a little can be one and half arcs 166 between 167 ', also can be one the 360 above collar-shaped 166 ' of degree.The collar 166 ' can dissociate entirely, also can enroll in the stake body again by tract.Outer free tongue 156 is a self expandable type single line support part of the whole.Outer free tongue 156 has two to three, between 120 degree angles.Outer free tongue 156 is generally the first quarter moon arc, and the curved line two ends are connected on the stake body.Outer free tongue 156 also can have other variation schemes.As: 1, small circle of the curved formation of 360 degree is made a call to increase distortion elastic force in the arc top; 2, great circle of the curved formation of 360 degree is made a call on the arc top, and the radius of great circle is almost with half radius of curvature; 3, the downstream of making a call to 360 degree great circles is enrolled the downstream stake body again.Outer free tongue 156 is because line is few, so elastic force is lower than stake body 154.The free tongue 156 of the skin of low elastic force does not hinder the stake body expansion in lumen of vessels.Outer free tongue 156 is consistent under expansion state with form with the stake body cross-sectional sizes.These outer free tongues 156 not only can be by forming with 154 same single lines 104 braidings of internal layer stake body, also can be woven simultaneously by the litzendraht wire different with internal layer stake body 154 to form.
The weaving method of the 6th kind of structure is adopted in the stage casing:
Be added with the free tongue 156 of weaving method five simultaneously for the radial protrusion structure 153 of weaving method three.Support can have the radial protrusion structure 153 and the outer free tongue 156 of size, shape, position, quantity unanimity simultaneously.After the radial compression, outer free tongue 156 discharges expansion earlier, and corresponding back with natural valve cup embeds nature valve cup, reaches rotation location and axial length location with this.Radial protrusion structure 153 and stake body expansion then.Outer free tongue 156 is because line is few, so elastic force is lower than stake body.The free tongue 156 of the skin of low elastic force does not hinder the stake body expansion in lumen of vessels.Radial protrusion structure 153 and outer free tongue 156 all play fixation.The two 153 and 156 is clipped in the middle the nature valve leaflet and seals.
Open line in this utility model turn 102 and sealed line eye 103 also can form by tube of material cutting.Radial protrusion structure 153 also can be formed by tube of material cutting distortion.Outer circulus 155 and outer free tongue 156 also can be formed by tube of material cutting distortion, weld together then.
Continuation is provided with radiopaque marker referring to Fig. 1 to Fig. 6 in this utility model artificial heart stent valve 1, comprises point-like sign 311 and wire sign 312.
Point-like radiopaque marker 311 can be cast, coaxial being enclosed within on one or more litzendraht wires 104.The downstream 134 of support has one or more opacity point-like sign 311 at least.The upstream extremity 184 of support or Upstream section and stage casing intersection 183 have one or more opacity point-like signs 311 at least, and the position of these signs is near the cup end of valve leaflet.The stage casing 15 of support has one or more opacity point-like signs 311 at least, and the position of these signs can be positioned at the binding site 160 that two radial protrusion structures 153 link, suitable two a little 332 the positions of uniting adjacent to valve leaflet.
Referring to Fig. 5, from the Upstream section 18 and the stage casing 15 association region lines 183 of support, end to middle part, stage casing 157, radiopaque markings 312 are made two to three waveforms, and from beginning to end.Markings 312 shuttle back and forth up and down in support braiding netting twine 104.These markings are adjacent to the joint line 331 of valve leaflet and support.Three waveform markings can be used for the fixed biologically valve leaflet on support in the support.
Radiopaque material can be biocompatible heavy metals such as gold, tungsten, platinum, tantalum.
Continuation is referring to Fig. 1 to Fig. 6, and the valve leaflet 33 in this utility model artificial heart stent valve 1 can have two to three, as is that three valve leaflet then are 120 degree corners distribution.Each valve leaflet comprises free limit 333 and closed edge 334.Be closed zone 335, pass between free limit 333 and the closed edge 334.The valve leaflet cup is curved, is divided into falling the district and rising the district.The cup end, can be a little less than the associating line 331 of valve leaflet and support.Valve leaflet and the support place of combining constitute associating line 331.The associating line of two adjacent valve leaflet communicates and constitutes the lobe leaf and unite a little 332.The lobe leaf unites a little 332 on litzendraht wire 104 cross-points 107,107 '.The lobe leaf is united a little 332 levels that are equivalent to valve leaflet closed edge 334.Valve leaflet is made by softish material, and naturalness is closed condition, and the free limit 333 of adjacent valve leaflet and the closed zone, pass 335 between the closed edge 334 contact, and valve is closed, and blood can not pass through.It is tighter that the interior vasodilation pressure of diastole aorta is closed valve leaflet.Paradoxical expansion blood is broken through valve leaflet 33, makes valve leaflet 33 be affixed to support or blood vessel wall, and stent valve 1 is opened.Valve leaflet 33 can be made of biomaterial, also can be made of synthetic material.Synthetic material can be an elastomer, as silica gel or polyurethane.A bar reinforcing fibre 39 is at the most arranged in the synthetic material valve leaflet, work two different lobe leaves terminating in same valve leaflet 33 and unite a little 332 or unite line 331, be connected on the support 10.Reinforcing fibre 39 is mainly in aorta face 340 sides of valve leaflet, and making the valve blade face is the wire face, and valve leaflet ventricular side 341 sides are bright finish.
Continuation is provided with diaphragm seal referring to Fig. 1 to Fig. 6 in this utility model artificial heart stent valve 1, comprises Upstream section diaphragm seal 351 and stage casing diaphragm seal 354.
Be surrounded by diaphragm seal 351 at support Upstream section 18 tubulars 181 or horn opening 182.This diaphragm seal can extend the mantle 352 that formation does not have bracket supports in upstream direction beyond the support.This diaphragm seal can extend to lobe leaf associating line 331 with interior downstream at support.This diaphragm seal is at support upstream port 184, and open line turns 102 or sealed line eye 103 places, has the diaphragm seal eye 353 that is interlinked to the outside at least, passes through for the support backguy 70 of apparatus for delivering 2.Blood did not leak with the limit from stent valve 1 when this Upstream section diaphragm seal 351 guaranteed heart contraction.Do not make its damaged when contacting with natural mitral valve leaflet when mantle edge 352 guarantees heart contraction.
Upstream section diaphragm seal 351 continues downstream from lobe leaf joint line 331 and extends formation stage casing diaphragm seal 354.Stage casing diaphragm seal 354 is along the almost wide contoured shape film band of lobe leaf joint line 331.153 middle part 157x do not have film at radial protrusion structure.A little 160,332 places are narrower uniting for the ruffled membrane band, guarantee that blood flow is to arteria coronaria.At diastole, stage casing diaphragm seal 354 top under aorta blood backflows impact has guaranteed that to blood vessel wall diastole blood does not leak the transmission from one meridian to another aortic regurgitation to left ventricle from stent valve 1 with the limit.The support tract is played on diaphragm seal 354 limits in stage casing does not have diaphragm seal, guaranteed blood at diastole to side shoot such as arteria coronaria perfusion.Arteria coronaria is got involved after guaranteeing.
Do not have to comprise on the metal rack line of deformable unit 101 of diaphragm seal on the cross-point 107,107 ' and can be surrounded by elastic synthesis material.
Diaphragm seal 351,354 can be biomembrane or synthetic film.Biomembrane can be in support inboard, the outside, or the interior outside exists simultaneously.
Synthetic diaphragm seal 351,354 can be elastomer such as silica gel, in the middle of support is wrapped in.
Continuation is referring to Fig. 1 to Fig. 6, can contain reinforcing fibre 39 in the synthetic diaphragm seal 351,354, is peripheral annular and places, and link to each other with support or connect.Reinforcing fibre 39 can be in synthetic diaphragm seal border, as mantle 352 edges and stage casing diaphragm seal 354 edges.Synthetic diaphragm seal can be made up of the elasticity macromolecular material, as silica gel, latex, polyurethane.The deformable unit of insulting shape or other shape is surrounded by elastomer, during radial compression, insults shape deformable unit and prolongs along longitudinal axis X X, shortens along vertical transverse axis.Longitudinal axis X X prolongs prolongs elasticity macromolecular material elasticity, and external force is removed icepro shape deformable unit, back will recover the original length, and the elasticity macromolecular material makes support produce extra radially outer expansive force.The compression after-poppet is elongated, and material is to two side flow, and material reduces on each cross section, helps reducing the external diameter under the stent valve compressive state.
Referring to Fig. 3, can also be provided with sealing ring 37 in this utility model artificial heart stent valve 1, sealing ring 37 is a softish tubular structure, around one week of support, be positioned at support Upstream section 18 and have a common boundary with outside 183 the support, can be around the annular of XX axle or three waveforms of edge associating line 331 with stage casing 15.Tubular structure can be sealed, also can be semi open model.Point-like opening 373 (referring to Fig. 3 f) is arranged towards stent valve 1 inner face or outside on the sealing ring 37 of semi open model, or groove shape opening 373 ' (referring to Fig. 3 e) is arranged towards stent valve 1 inner face.Tubular structure can be made of biomaterial or synthetic material.It can link to each other with diaphragm seal 35.Head on blood vessel wall after the support expansion, tubulose sealing ring 37 can be compressed it is adapted to, and fills up the slit between support and the blood vessel wall.
Be provided with reinforcing fibre 39 in the elastic synthesis material film that adopts in this utility model artificial heart stent valve 1.Different with valve leaflet and diaphragm seal that biomaterial constitutes, in valve leaflet 33 that elastic synthesis material constitutes and the diaphragm seal 351,354 reinforcing fibre 39 can be arranged.A bar reinforcing fibre 39 is at the most arranged in the synthetic material valve leaflet, rise two of terminating in same valve leaflet different unite a little 332 or unite line 331, be connected on the support 10; Reinforcing fibre 39 can be in the free limit 333 of valve leaflet 33, mainly at the downstream face 340 of valve leaflet, make valve leaflet downstream face aorta side 340 be the linear drawn grain, and valve leaflet upstream face ventricular side 341 is a bright finish.The material of reinforcing fibre 39 comprises polyster fibre, high-molecular polythene fiber, nylon and carbon fiber etc.Reinforcing fibre 39 can be strengthened the elastic synthesis material film strength by selectivity, also can strengthen the intensity between synthetic film and support.Reinforcing fibre 39 can also be on the radiopaque marker 311,312.
Continuation is provided with flexibly jointed chain ring 41 referring to Fig. 1 to Fig. 6 in this utility model artificial heart stent valve 1.Turn 102 and sealed line eye 103 places at the open-ended line of support, two-stage nitration litzendraht wire cross-point 107,107 ' is located between two ends of the middle part of support, and the flexible cord that materials such as available terylene, nylon, polyester, polypropylene glycol are made constitutes flexibly jointed chain ring 41.Thin and soft flexible cord is at first formed a ring 412, the varying in size of ring, line different in size.Two the end of a thread on ring other one side of the 412 ring bundle 413 of tie a knot on support joins together with it, can not move.Apparatus for delivering backguy 70 can be passed from flexibly jointed chain ring 41, slides compressed stent.Flexibly jointed chain ring 41 is used to limit the hunting range of backguy 70 and prevents dislocation.
Referring to Fig. 7 to Figure 13, the apparatus for delivering 2 of artificial heart stent valve of the present utility model comprises: interior pipe 51, wire leading pipe 61, conductor housing 65, support backguy 70, locking silk 75, near-end controller 80, middle pipe 88, outer protection mechanism 90,92,96.Can also be provided with Ultrasonic-B probe 87 and side wire leading pipe 99.
Referring to Fig. 7 a, cooperate referring to Fig. 8 a, Fig. 8 b, Fig. 8 c, Fig. 8 d, the interior pipe 51 in the apparatus for delivering 2 of artificial heart stent valve of the present utility model is an elongate tubular structure.The cross section can be circle.Interior pipe 51 can be by good springiness, and the macromolecular material that intensity is high constitutes.Check the aerofluxus bubble before the transparent or semitransparent favourable Rhizoma Atractylodis Macrocephalae of interior pipe 51 colors.Interior pipe 51 length are 80-150cm, and its near-end 511 is external, and far-end 512 arrives the position of hearts nature valves.Interior pipe far-end 512 links to each other with conductor housing 65. Inner orifice chamber 52,54,54 ' links to each other with the taper light wall pipe chamber 651 of conductor housing 65.The structure of interior pipe 51 can have different schemes.The vestibules 52,53,54,54 ' that can have one or more distances to communicate in the interior pipe 51.
Referring to Fig. 8 a, the structure of interior pipe 51 can be for managing 51 in the single hole, and pipe 51 has only a big circular general vestibule 52 in the single hole.In big circular general vestibule 52, can be equipped with one or more wire leading pipes 61, one or more backguys 70 and one or more locking silk 75.Can slide mutually between their (61,70,75).Also can be equipped with one or more wire leading pipe 61, backguy pipe 71, lock fiber tube 76 in the big circular general vestibule 52, like this each line each advance corresponding pipe and do not intersect between mutual.A plurality of tubules 61,71,76 are combined as an antipriming pipe in the single hole pipe, can slide between each pipe.
Referring to Fig. 8 e, interior pipe 51 also can be made of spiral spring 57.Spring 57 can be made of monofilament 571, also can be made of multifibres.The diameter of spring wire 571 equals wall thickness, and interior external diameter can change, and section far away is thinner, in nearly section thicker.Spring wire 571 can constitute semi-ring 572d, 572p or domain 572c in the part, is equivalent to distal openings 516d, proximal open 516p and middle side opening 516c.The step pitch of spring 57 can be different: 1, equal filament diameter, spring can only prolong (extension spring); 2, greater than filament diameter, spring can prolong or shorten (stage clip).58 protections of macromolecular material pipe can be arranged outside the spring 57, reach: reduce external friction; Liquid does not leak outside; Macromolecular material pipe at least two ends closely link to each other with spring, and spring can guarantee fold resistance, but does not extend axially.
Referring to Fig. 8 b, interior pipe 51 also can be for managing in the diplopore, and pipe 51 has two tube chambers 53,54 in the diplopore.A small circular 0.035 " guidewire lumen 53 is for 0.035 " seal wire passes through, and is equivalent to wire leading pipe 61 and the common tube chamber 54 of big semilune passes through for support backguy 70, locking silk 75 and possible support line ball 98 and line ball lock silk 97.Between two tube chambers 53,54 is decentered distribution, and adhesion is fixing between each pipe does not slide.
Referring to Fig. 8 c, Fig. 8 d, interior pipe 51 also can be a porous inner tube, and porous inner tube 51 has a plurality of tube chambers 53,54 '.Antipriming pipe is on pipe basis, two holes big semilune tube chamber 54 to be further divided into two or more tubules chamber 54 '.A small circular 0.035 " guidewire lumen 53 is for 0.035 " seal wire passes through, be equivalent to wire leading pipe 61 and a plurality of tubules chamber 54 ' and pass through at separately tube chamber respectively for support backguy 70, locking silk 75 and possible support line ball 98 and line ball lock silk 97.Adhesion is fixing between each pipe does not slide.
Referring to Fig. 7 a, Fig. 7 b, cooperate referring to Figure 11 a, Figure 11 b, Figure 11 c, Figure 11 d, Figure 12 a, Figure 12 b, Figure 12 c and Figure 13, interior pipe section 513 far away is positioned at the nearside of pipe far-end 512.Pipe section 513 far away is positioned at man-made support valve 1 inboard in when assembling is carried, and is used for linking to each other with man-made support valve 1.Its internal diameter is about 1.5-2.5mm, and external diameter is about 1.8-3.0mm, and its length slightly is longer than the man-made support valve 1 under the compressive state.In pipe section 513 far away one or above side opening 516d, 516c, 516p are arranged on far and near varying level.Distal openings 516d, middle side opening 516c and proximal open 516p are all on the same plane of interior pipe with on one side, on concave surface limit 517.Distal openings 516d, middle side opening 516c are relative with upstream extremity 184, stage casing 15, the downstream 134 of man-made support valve 1 respectively with proximal open 516p.Distance between distal openings 516d and the proximal open 516p approximates the length under stent valve 1 compression.Side opening 516d, 516c, 516p or communicate with the general vestibule 52 of big circle of pipe 51 in the single hole, or communicate, or communicate simultaneously with support backguy tube chamber, locking fiber tube chamber, support line ball tube chamber and the line ball lock fiber tube chamber 54 ' of porous inner tube 51 with pipe 51 the general tube chamber 54 of big semilune in the diplopore.Far and near two side opening 516d, 516p supply with the independent opening that support backguy 70 is walked separately, also can be the unified openings that support backguy 70 and support line ball 98 share.Side opening 516d, 516c, 516p are used in the inner orifice chamber 52,54,54 ' backguy 70 and go out into and discharge with gas-liquid, as radiography in the art.Side opening on the same level also can have one or more.In the periphery of pipe side opening 516d, 516c, 516p reinforcing ring 55 is arranged, constitute by the good material of intensity height, frictional property such as metal or macromolecular material.Can increase backguy and slide, reduce pipe probability in the backguy cutting.The reinforcing ring 55 of metal material can constitute radiopaque marker.
Can there be braiding reinforcing mat 56 in interior pipe middle level, and interior pipe side opening 516d, 516c, 516p can open in a grid of braiding reinforcing mat 56.
Continuation is referring to Fig. 7 a, Fig. 7 b, and interior pipe stage casing 514 is positioned at the nearside of pipe section 513 far away.In pipe stage casing 514 oneself make bow shape in advance, constituted concave surface limit 517, interior pipe stage casing and convex surface limit 518.Be the arcual interior pipe of bow stage casing 514 and constituted datum plane.In pipe stage casing 514 do not link to each other with man-made support valve 1, its internal diameter and external diameter can be greater than the internal diameter and the external diameters of far away section 513 of interior pipe, but its external diameter should be less than the external diameter of compressive state man-made support valve.After internal diameter increased, the friction between the backguy 70 in it, the locking silk 75 reduced.After interior external diameter increased, interior pipe 51 bending resistances strengthened.Under external force, the bow shape of stage casing nature can be out of shape.
Continuation is referring to Fig. 7 a, Fig. 7 b, and the nearly section 515 of interior pipe is a straight tube, is the extension of interior pipe stage casing 514 proximads.The nearly section 515 of interior pipe stage casing 514 and interior pipe can be bourdon tube or braiding reinforced pipe 56.The near-end 511 of interior pipe links to each other with near-end controller 80.
Referring to Fig. 7 a, cooperation is referring to Fig. 8 a, Fig. 8 b, Fig. 8 c, Fig. 8 d, wire leading pipe 61 in the apparatus for delivering 2 of artificial heart stent valve of the present utility model can have two kinds of schemes: 1, in a vestibule pipe be provided with in 51 one independently internal diameter can lead to 0.035 " wire leading pipe 61 of external diameter seal wire; this wire leading pipe 61 always with interior tubular axis line parallel; and come out from interior pipe far-end 512 and near-end 511 respectively; be positioned at protruding side 518 in interior pipe stage casing 514; wire leading pipe far-end 611 links to each other with the seal wire pore 652 of conductor housing 65, near-end links to each other with seal wire arm 86 on the near-end controller 80; 2, in two vestibules or porous intracavity pipe 51, be provided with a small circular guidewire lumen 53, form the fixing wire leading pipe 61 on inner pipe of an adhesion, its internal diameter can lead to 0.035 " the external diameter seal wire; this small circular guidewire lumen 53 is positioned at protruding side 518 in interior pipe stage casing 514; small circular guidewire lumen far-end 531 links to each other with the seal wire pore 652 of conductor housing 65, and near-end 532 links to each other with seal wire arm 86 on the near-end controller 80.
Referring to Fig. 7 c, cooperate referring to Fig. 7 a, Fig. 7 b, the conductor housing 65 in the apparatus for delivering 2 of artificial heart stent valve of the present utility model is positioned at the distally of pipe far-end 512, can be the part of interior pipe.Conductor housing 65 is streamlined hollow cone body structure, its big end 654 is connected with interior pipe far-end 512 for the rear end, its small end 653 communicates with wire leading pipe 61 or small circular guidewire lumen 53 for front end is provided with thread eye 652, and small end 653 is the hollow light wall pipe of a taper, and soft and thin tube wall 655 is arranged.The leading portion of conductor housing 65 is provided with the vestibule 52,54,54 ' that one or more side openings 657 communicate with interior pipe distance and communicates, for the flushing final vacuum, wear the lock silk.Big end 654 links to each other with interior pipe far-end 512.Conductor housing 65 is made of softish macromolecular material, can contain the opacity material, or is embedded with radiopaque marker.
Referring to Fig. 7 a, Fig. 7 b, Fig. 7 d, cooperation is referring to Figure 10 a, Figure 10 b, Figure 10 c, Figure 10 d, Figure 11 a, Figure 11 b, Figure 11 c, Figure 11 d, and the support backguy 70 in the apparatus for delivering 2 of artificial heart stent valve of the present utility model is fine rules of being made by macromolecular material or metal material.Require good springiness, do not have or very little plastic deformation, under pulling force, do not have or have only very little extension, do not have or have only very little cold plastic deformation.A support backguy 70 has a stay thimble 701, stay thimble 701 is positioned at the far-end 702 of backguy, can be the thin ring of 360 ° of sealings or the open semi-ring of the terminal 180 ° of discounting of two-wire, stay thimble 701 be arranged within one that manages distal openings 516d, side opening 516c and proximal open 516p and by a locking silk 75 and blocks.The outer section 703 of backguy is the continuity of stay thimble 701, be positioned at aforementioned pipe side opening 516d, 516c, outside the 516p, the outer section 703 of backguy can be two-wire, also can become and be single line, for assembling man-made support valve 1 on apparatus for delivering 2, the outer section 703 of backguy need be passed deformable unit 101 openings of support 10 or open line and be turned 102 or sealed line eye 103, arrive the support outside at least once, through other deformable unit 101, pass stent valve flexibly jointed chain ring 41, pass same or different deformables unit 101 openings or open line again and turn 102 or sealed line eye 103, get back to the support inboard, constitute a lasso trick 704.Backguy section 705 far away is 703 continuities to apparatus for delivering near-end 511 of the outer section of backguy, backguy section 705 far away is got back within aforementioned same or different interior pipe side opening 516d, 516c, the 516p, be positioned within the pipe section 513 far away, backguy section 705 far away also can be positioned within far away section 513 specific backguy vestibule of pipe 54,54 '.Can in aforementioned, manage side opening 516d, 516c, 516p slip between outer section 703 of backguy and the backguy section 705 far away.Backguy stage casing 706 is 705 continuities to apparatus for delivering near-end 511 of backguy section far away, be positioned at pipe stage casing 514 or specific backguy vestibule 54, within 54 ', it is two-wire that the stage casing 706 of backguy can be continued, also can become single line, also can link to each other with other material, reach good springiness, not prolong under the equal pulling force from certain-length.The nearly section 707 of backguy is the continuity of backguy stage casing 706 to apparatus for delivering near-end 511, and to the apparatus for delivering proximal extension, relevant backguy arm 81d, 81c, the 81p of the nearly section 707 of backguy from near-end controller 80 comes out in the nearly section 515 of interior pipe.Backguy near-end 708 is positioned at outside relevant backguy opening 81d, 81c, the 81p.Each apparatus for delivering 2 can have one or more support backguys 70,70d, 70c, 70p.Each stay thimble 701 is blocked by same or different locking silk 75,75c.Each backguy 70d, 70c, 70p outer section 703 respectively from interior pipe distal openings 516d, side opening 516c and proximal open 516p come out, its stay thimble returns behind support in each opening.Each backguy near-end 708 comes out from each backguy arm 81d, 81c, the 81p of near-end controller 80.Each backguy near-end 708 can two-in-one or three-in-one concentrating be backguy combination 709 outside each backguy arm 81d, 81c, 81p.
Referring to Fig. 7 b, Fig. 7 d, cooperate referring to Fig. 8 a, Fig. 8 b, Fig. 8 c, Fig. 8 d and Figure 11 a, Figure 11 b, Figure 11 c, Figure 11 d, one or two or more locking silks 75,75c can be arranged in the apparatus for delivering 2 of artificial heart stent valve of the present utility model.Each locking silk can lock one or more backguys 70,70d, 70c, 70p.Two covers or above locking silk 75, the 75c of two covers can work together, also can work independently respectively.Locking silk 75 is positioned within inner orifice chamber 52 or the specific locking silk vestibule 54,54 '.Two or more locking silks 75,75c can be positioned within same inner orifice chamber 52,54 or the specific separately locking silk vestibule 54 '.Two or more lockings silk 75,75c accounts for an inner chamber but two or more locking silk 75,75c distal length are the same.Each locking silk 75 far-end 751 is all above interior pipe distal openings 516d.Locking silk 75 passes stay thimble 701 in section far away can not deviate from it from interior pipe side opening 516d, 516c, 516p.Locking silk 75 proximal direction are extended, and come out from the locking silk arm 83 of near-end controller 80, and one or above locking silk 75 come out from different or a same locking arm 83 respectively.Locking silk near-end 752 links to each other with the slide bar head 844 of locking silk arm 84.Locking silk 75,75c can slide in interior pipe 51.
Referring to Fig. 7 d, the near-end controller 80 in the apparatus for delivering 2 of artificial heart stent valve of the present utility model links to each other with the near-end 511 of interior pipe.Near-end controller 80 comprises main pipe and a plurality of arm 81d, 81c, the 81p, 84,85,86 that are connected thereon.Vestibule 52 that these arms and interior pipe 51 are general or specific separately vestibule 54,54 ' communicate.These arms can also can come out by angled bifurcated on the axis of interior pipe 51.Comprise: one or more backguy arm 81 (81d, 81c, 81p); One or more locking silk arm 84; Flushing and radiography arm 85, with preceding two kinds of arms 81,84 and in the general vestibule 52 of pipe or specific separately vestibule 54,54 ' communicate; One or more seal wire arm 86, general vestibule 52 of pipe or specific separately vestibule 54,54 ' communicated in seal wire arm 86 can reach with above-mentioned three kinds of arms 81,84,85.Seal wire arm 86 also can different above-mentioned three kinds of arms 81,84,85 and in the general vestibule 52,54 of pipe communicate, and only communicate or the small circular 0.035 of porous inner tube with wire leading pipe 61 inner chambers " guidewire lumen 53 communicates.
Backguy arm 81 can have one, two or more.Backguy arm 81 can be at the side angle of near-end controller 80, also can be at the end on the axis of near-end controller 80.Each backguy arm 81 generally is to walk a backguy, and far-end backguy 70d comes out from far-end backguy arm 81d, and backguy 70c in stage casing comes out from stage casing backguy arm 81c, and near-end backguy 70p comes out from near-end backguy arm 81p.Two or more backguys 70 also can be come out from same backguy arm 81.In the backguy arm 81 resistant to blood refluence film 811 can be arranged, be made of the elasticity macromolecular material, the centre has a pin hole 812 to allow backguy 70 pass through.Backguy fastener 82 is arranged on the backguy arm 81, a certain ad-hoc location of backguy 70 can be fixed on the backguy arm 81.Backguy arm 81 can be the male and female threaded relation with the relation of backguy fastener 82.Backguy is tied up between the male and female screw thread.Backguy fastener 82 can be a solid stopper, and plug is stuck in backguy on the backguy opening in the backguy opening.Backguy fastener 82 also can be a rotation stopper 822 that backguy passage 821 is arranged, and after rotation stopper 822 and backguy arm 81 rotate, backguy is stuck on the backguy arm.
One or more locking silk arm 84 is arranged on the near-end controller 80.Locking silk arm 84 can be terminal on near-end controller axis, also can be in the side.Be provided with the resistant to blood film 831 that backflows on the connector 83 of main pipe and locking silk arm 84, be made of the elasticity macromolecular material, there is a pin hole 832 centre, can allow locking silk 75 pass through.On the connector 83 of main pipe connect mechanism 833 is arranged, as female thread, can with the connect mechanism 842 of locking silk arm 84, as external screw thread, link fixing.Do not having under the fixed situation, sliding in the pipe 51 in locking silk 75 can reach in locking silk arm 84.Being provided with a sliding bar 843 in the locking silk arm 84 can slide in the inner chamber 841 of locking silk arm 84.The front end 844 of sliding bar links to each other with locking silk near-end 752, the rear end protruded tube of sliding bar forms operating grip outward, the middle part of sliding bar has a groove, position corresponding to this groove on the locking silk arm is provided with far-end dowel hole and proximally-located pin-and-hole, two alignment pins 848 can pass two dowel holes on the locking silk arm respectively and will locks a silk arm with groove on the sliding bar and link to each other with sliding bar, by fixing or the releasing alignment pin can determine whether the locking silk of sliding bar and connection thereof slides and control its sliding distance.Alignment pin 848 is divided into far-end alignment pin 848d and proximally-located pin 848p, the distance in the distance between two alignment pins is less than between the pipe respective openings.One or more alignment pin 848 can prevent that locking silk 75 proximads from moving.After an alignment pin 848 is removed, but locking silk 75 proximads move a certain distance.
Near-end controller 80 is provided with flushing radiography arm 85, is furnished with switch 851 on it.
One or more seal wire arms 86 can be arranged on the near-end controller 80.Seal wire arm 86 is on near-end controller 80 terminal axis.Seal wire arm 86 separates with above-mentioned three arms 81,84,85 and the general vestibule 52 of interior pipe, and only communicates with wire leading pipe 61 or guidewire lumen 53.The diaphragm seal that is made of the elasticity macromolecular material is arranged on the seal wire arm 86, a pin hole is arranged on the diaphragm seal, distortion relief seal wire passes through.The normal condition lower pinhole is closed, and does not leak blood.
Referring to Fig. 7 c, Ultrasonic-B probe 87 in the apparatus for delivering 2 of artificial heart stent valve of the present utility model is arranged on the rear end 654 of conductor housing 65, or manage in being arranged on the section 513 far away, as establishing one or more Ultrasonic-B probe 87 by selectivity near the distal openings 516d or near the proximal open 516p.Lead to near-end controller 80 and joint 872 is arranged on the pipe 51 in the lead 871 of Ultrasonic-B probe 87 is attached to.
Referring to Figure 12 a, Figure 12 b, Figure 12 c, Figure 13; also be provided with side wire leading pipe 99 in the apparatus for delivering of artificial heart stent valve of the present utility model; this side wire leading pipe 99 and peelable outer protection mechanism or with can be equipped with around knot and the thread depressing mechanism 96 that can unhitch, can selectivity in interior pipe section far away 513 outsides fix one or more internal diameters and can lead to 0.014 " the side wire leading pipe 99 of external diameter seal wire.Extend at least to interior pipe stage casing 514 by proximad 511 directions from the outside at interior pipe section far away 513 middle parts for 99 of side wire leading pipes, also can arrive on nearly section 515 of interior pipe or the near-end controller 80.Side wire leading pipe 99 can link to each other with the nearly section 515 of interior pipe stage casing 514 and interior pipe, also can not link to each other.Side wire leading pipe far-end 991 is at the middle part of interior pipe section 513 far away, and between interior pipe distal openings 516d and the interior pipe proximal open 516p, unfixing have several millimeters length to separate with interior pipe section 513 far away on inner pipe, is free active state.Side wire leading pipe middle part 992 is fixed with interior pipe section 513 far away, and the near-end 993 of side wire leading pipe is at the nearside of interior pipe proximal open 516p.Side wire leading pipe pore 994 sizes can allow 0.014 at least " the diameter seal wire passes through.Rotary angle position between side wire leading pipe 99 and interior pipe side opening 516d, the 516p can determine in advance that if any two or more side wire leading pipes 99, the rotary angle position between them also can be determined in advance.Different side wire leading pipe far-ends 991 can be at same level or varying level, such as on cross section, a left side wire leading pipe 99 becomes about 60 degree (45-75 degree) corners with interior pipe side opening 516d, 516p, another right side wire leading pipe 99 becomes about 180 degree corners with interior pipe side opening 516d, 516p, become 120 degree corners between the both sides wire leading pipe 99.Both sides wire leading pipe 99 can have only wherein any one.Become 120-180 degree corner as right side wire leading pipe 99 with interior pipe side opening 516d, 516p, or become 0-60 degree corner with interior pipe side opening 516d, 516p as left side wire leading pipe 99.0.014 " side wire leading pipe 99 strengthened the intensity at interior pipe proximal open place.0.014 " position of side wire leading pipe 99 and length guaranteed to use lack (1.5m) 0.014 " the external diameter seal wire makes quick exchange.
Referring to Fig. 9 a, cooperate referring to Fig. 7 a, Fig. 7 b, pipe 88 in being provided with in the apparatus for delivering 2 of artificial heart stent valve of the present utility model, middle pipe 88 are tubular structural members independently, are positioned at pipe 51 outsides, can be along interior pipe 51 slips.Pipe 51 external diameters in middle pipe 88 internal diameters are slightly larger than are less than or equal to man-made support valve 1 external diameter under the compressive state.Middle pipe far-end 881 is less than interior pipe proximal open 516p; Middle pipe near-end 882 is near near-end controller 80.Pipe backguy 89 in one is arranged in the middle pipe 88, during being fixed on, the far-end 891 of middle pipe backguy 89 constitutes fixing point 893 on the pipe far-end 881, the side opening 884 that near-end 892 is therefrom managed near-end 882 comes out, and the far-end fixing point 893 of middle pipe backguy 89 and the side opening 884 of middle pipe near-end 882 are on same plane with on one side.After middle pipe backguy 89 tensions, tension force increases, and middle pipe 88 becomes curved, and support backguy 70 slides on the concave surface 517 of bending naturally, and this helps apparatus for delivering and passes through aortic arch.In middle pipe near-end 882 and the side opening 884 shrink-ring is arranged respectively, shrink-ring is the silica gel circulus, slides the certain position in being fixed in during deflation on the pipe when loosening along interior pipe.Middle pipe 88 colors are transparent or semitransparent, check the aerofluxus bubble before the favourable Rhizoma Atractylodis Macrocephalae.The intensity of the nearly section 514,515 of pipe in middle pipe 88 also is used for strengthening.In pipe 88 can be taper, section far away is thinner, nearly section is thicker, make apparatus for delivering obtain simultaneously nearly section promotion and in section bendability far away.Middle pipe 88 can be a braiding reinforced pipe.Middle pipe 88 slides along interior pipe, but the stent valve 1 under the middle pipe far-end 881 pushes compression states goes out epitheca pipe 90.
Referring to Fig. 9 b, Figure 12 a, Figure 12 b, Figure 12 c, Figure 13, the outer protection mechanism in the apparatus for delivering 2 of artificial heart stent valve of the present utility model can have following three kinds of Scheme Choice:
1, the epitheca pipe 90
Epitheca pipe 90 is a tubular structure, is made of macromolecular material, and epitheca pipe 90 colors are transparent or semitransparent, has or not bubble after the inspection flushing before the favourable Rhizoma Atractylodis Macrocephalae.Epitheca pipe section far away 901 tube walls are thin, and internal diameter is slightly larger than the external diameter of the man-made support valve 1 under the compression, and its length is slightly larger than the length of the man-made support valve 1 under the compression.Section 901 compressions far away of epitheca pipe, protective cradle valve 1.Epitheca pipe far-end 902 has radiopaque sign 903 to be embedded in the tube wall.Epitheca pipe stage casing 904 can be with far away section 901 the same pipe, also can be tube wall thicker but internal diameter and external diameter all less than the pipe of section 901 far away, its internal diameter is uneven in length greater than the external diameter of middle pipe, in the case, section junctional area pipe 905 far away in is arranged between stage casing and the section far away.The nearly section 906 of epitheca pipe is the pipe that an external diameter increases, the internal diameter of pipe 88 during its internal diameter is equal to or greater than, and be provided with flushing/radiography opening and valve 907.Epitheca pipe near-end 908 has an elastica or manages 909, and there is a pin hole 910 in elastica 909 central authorities, and normal condition lower pinhole 910 is closed or had only very little diameter, middle pipe 88 to pass pin hole 910 diameters and can enlarge, and does not leak blood with 88 slips of pipe in guaranteeing and elastica 909.
2, peelable outer protection mechanism 92
It comprises: take-up lock silk 93, peelable sheath pipe 94 and sheath pipe take-up 95.Pipe 51 in the central authorities of peelable outer protection mechanism 92 have; far away section 513 of interior pipe has far away section distal openings 516d and proximal open 516p; these two side opening 516d, 516p supply with the independent opening that sheath pipe take-up 95 is walked separately, also can be the unified openings that share with support backguy 70.The stage casing of interior pipe and nearly section are the same.
Have at least one take-up lock silk 93 to slide along interior pipe 51 in the interior pipe 51, silk 93 is locked in take-up a far-end 931 and near-end 932, and a take-up lock silk near-end 932 can come out from near-end controller 80.
Outside the interior pipe 51 is peelable sheath pipe 94.Peelable sheath pipe 94 is and interior pipe 51 concentric tube-shaped structures to be arranged in outside pipe 51, man-made support valve 1 and the pipe 88.Can slide between peelable sheath pipe 94 and the interior pipe 51.Peelable sheath pipe 94 can be by natural or synthetic tubulose stringing 941 or 942 two kinds of forecast scheme configurations of tubulose webmaster that spin and be made into.The tube wall of tubulose stringing 941 is the tube wall of sealing, and the tube wall of tubulose webmaster 942 is the tube wall that mesh 943 is arranged, and the mesh tube wall can be braiding gauze or a crocheted net, and mesh diameter is less than 1mm, mesh 943 shape variable shapes, but constant with the length on limit.The far away section part 944 of peelable sheath pipe 94 and interior pipe section 513 far away is in same level and an axial or longitudinal opening 945 is arranged, on the longitudinal opening 945 both sides sheath pipes take-up eye 946 is arranged, be the opening of sealed tube wall or certain eye 943 in the mesh tube wall, mesh 943 periphery sealings are complete on the webmaster on the both sides of opening.The diameter of section 944 far away or girth can be consistent.The far-end 947 of section 944 far away or and the diameter or the girth of near-end 948 can be inconsistent, under the situation of curling, constitute far-end vertebra shape 947 ' and near-end vertebra shape 948 '.Far-end 947 diameters of peelable sheath pipe 94 are less, and it is streamlined to constitute bullet.Longitudinal opening 945 runs through far-end 947.A nearly section part 949 is a complete pipe or a pipe network in the peelable sheath pipe 94, and its diameter or girth are less than or equal to far away section 944 diameter or girth.Between interior pipe section 513 far away and peelable sheath pipe section 944 far away, can accompany stent valve 1.Do not show at Figure 12 a, Figure 12 b, Figure 12 c medium-height trestle valve 1.Stent valve 1 is the same with interior pipe 51 combinations.
Peelable sheath pipe section 944 far away has longitudinal opening 945, and take-up eye 946 is arranged on the longitudinal opening limit.Under sheath pipe take-up 95 helped, the longitudinal opening 945 of peelable sheath pipe section 944 far away can provisionally tighten up, and the stent valve 1 in it vertically compresses.Far section 944 is in the distally and nearside and interior 51 provisional linking to each other of pipe of longitudinal opening 945 for peelable sheath pipe, and this moment, peelable sheath pipe 94 and 51 of interior pipes can not slide, and stent valve 1 vertically is being limited between these two.Sheath pipe take-up 95 has a far-end take-up ring 951 to pass interior of managing among distal openings or proximal open 516d, the 516p, is blocked by take-up lock silk 93.This sheath pipe take-up 95 can be passed stent valve 1 or outside stent valve (far away or nearside).95 one-tenth of sheath pipe take-ups are two, pass the take-up eye 946 of peelable sheath pipe section far away 944 longitudinal openings 945 both sides simultaneously, constitute the opposite single line line of both direction on first limit and turn 952, constitute a two-wire line on second limit and turn 953, the single line line turns 952 and constitutes and the vertical two-wire vertical section 954 of the sheath pipe longitudinal axis between turning 953 with the two-wire line.95 one-tenth pairs of sheath pipe take-ups are turned 953 from the two-wire line and are continued to walk then to constitute two-wire parallel-segment 955 along the longitudinal axis, constitute a take-up semi-ring 956 to adjacent take-up eye 946 places.Pilot process is shown in Figure 12 a, Figure 12 b, Figure 12 c.The other end of sheath pipe take-up 95 is turned 952 from the single line line and is continued proximads or single line parallel-segment 957 is walked to constitute in the distally, becomes two take-up eye 946 and aforesaid take-up semi-rings 956 that pass longitudinal opening 945 both sides successively to constitute another take-up semi-ring 956 to another adjacent take-up eye 946 places at next take-up eye 946 places.Take-up semi-ring 956 is turned 953 by two-wire 95 follow-up two-wire lines and blocks.Repeat with this: the single line line turns 952-two-wire vertical section 954-two-wire line and turns 953-two-wire parallel-segment 955-take-up semi-ring 956-single line parallel-segment 957.The length of two-wire vertical section 954 is represented the radial compression level of sheath pipe take-up 95 degrees of tightness or stent valve 1.Pipe 51 another side opening 516p, 516d were blocked by same or another take-up lock silk 93 in last take-up semi-ring 956e entered.This take-up semi-ring 956e can pass stent valve 1, also can not pass stent valve and outside it nearside.Sheath pipe take-up 95 is softish fine rule, any two-wire line turn 953 and take-up semi-ring 956 can be out of shape, become straight, the position between sheath pipe take-up 95 each sections can change.Nearly section 958 can be led to relieving mechanism nearside 511 through nearly section 949 inboards or the outside in the peelable sheath pipe in the take-up of sheath pipe.Sheath pipe take-up near-end 959 is temporarily fixed on the near-end controller 80.Between peelable sheath pipe section far away 944 longitudinal openings 945 both sides, and between 95 two adjacent two-wire vertical sections 954 of take-up, the interim little opening 945s of sheath pipe that is interlinked to the outside in constituting, longitudinal opening 945 can be divided into the interim little opening 945s of a plurality of sheath pipes.Peelable sheath pipe 94 longitudinal openings 945 tighten up under the situation, one or above lateral guide fiber tube 99 or seal wire, " wire leading pipe; can be from interior pipe 51; from inside to outside, pass the part of not sealing film on the stent valve 1 passes interim little opening 945s of sheath pipe or longitudinal opening 945 and comes out; enters the collateral artery opening, as coronary ostium as 0.014.If have only a longitudinal opening 945, lateral guide fiber tube 99 or seal wire can only come out to a direction opening on same cross section.
The operation principle of peelable outer protection mechanism 92 is as follows:
If a is pulled outwardly take-up lock silk near-end 932, take-up lock silk 93 slides to near-end, and take-up lock silk far-end 931 skids off far-end take-up ring 951 or last take-up semi-ring 956e, and sheath pipe take-up 95 is not blocked and obtained to discharge by take-up lock silk 93.
B, pulling take-up near-end 959, two-wire 953,954,955,956 can withdraw from the d/d two-wire ring 956 in back that is stuck earlier, the both sides of removing the longitudinal opening 945 of peelable sheath pipe 94 by opposite order connect, peelable sheath pipe 94 becomes real longitudinal opening 945, and sheath pipe take-up 95 can all be received the apparatus for delivering near-end.
3, can be around knot and the thread depressing mechanism 96 that can unhitch
It comprises: line ball lock silk 97 and support line ball 98, the two composition can be around knot and the thread depressing mechanism 96 that can unhitch.Being in can be ditto described around interior pipe 51 structures in knot and the thread depressing mechanism 96 that can unhitch.Pipe 51 can have a big circular general vestibule 52 in the single hole; Pipe 51 can have two tube chambers, one 0.035 in the diplopore " guidewire lumen 53 is for 0.035 " seal wire passes through and big semilune general tube chamber 54 voltage supply lines lock silk 97 and support line ball 98 pass through.Porous inner tube 51 can have a plurality of tube chambers, one 0.035 " guidewire lumen 53 is for 0.035 " seal wire passes through and a plurality of tube chamber 54 ' voltage supply line lock silk 97 and support line ball 98 pass through at separately tube chamber respectively.Interior pipe section 513 far away has at least two openings, distal openings 516d and proximal open 516p.Two openings or communicate with the interior tube chamber 52 of pipe in the single hole, or communicate with the general tube chamber 54 of pipe in the diplopore, or communicate simultaneously with the support line ball tube chamber 54 ' and the line ball lock fiber tube chamber 54 ' of porous inner tube.Distance between two openings approximates the length under the stent valve compression, and these two side opening 516d, 516p supply with the independent opening that support line ball 98 is walked separately, also can be the unified openings that share with support backguy 70.
In single hole in the interior tube chamber 52 of pipe, or in the diplopore in the common tube chamber 54 of pipe, or in the line ball of the porous inner tube lock fiber tube chamber 54 ', one or more line ball lock silk 97 is arranged, 511 run through from far-end 512 to near-end.Line ball lock silk 97 has a far-end 971 and near-end 972, and near-end 972 can come out from an arm of near-end controller 80.Line ball lock silk 97 can be along interior tube chamber 52, or along common tube chamber 54, or slides along line ball lock fiber tube chamber 54 '." seal wire comes out between stent valve 1 middle part and support line ball 98 each sections in that 99 guiding 0.014 of two side wire leading pipes can be arranged on same level or the cross section.
In the far away section of pipe 513 is outer that the stent valve that will be transferred 1 that entangles is with one heart arranged, stent valve 1 is not included in the apparatus for delivering 2, but stent valve 1 is discharging anteposition in thread depressing mechanism 96 structures.In stent valve 1 can be temporarily anchored to by aforesaid support backguy 70 on pipe 51 the same side opening or other side opening 516d, 516c, the 516p.
Stent valve 1 can be by support line ball 98 provisional radial compression.Support line ball 98 is a deformable fine rule of softness, is positioned at stent valve 1 outside.One end of support line ball 98 has far-end wire loop 981, manages among distal openings or proximal open 516d, the 516p in far-end wire loop 981 passes, and enters or interior tube chamber 52 or common tube chamber 54 or support line ball tube chamber 54 ', is blocked by line ball lock silk 97.In entering before far away or proximal open 516d, the 516p of pipe, far-end wire loop 981 alternatives are in stent valve 1 outside process, or pass the part that does not have diaphragm seal on the stent valve 1.Support line ball 98 extends at stent valve 1 outer surface, constitutes a single line line and turns 982.Support line ball 98 one-tenth two-wire 98a, 98a ' move on, around stent valve 1 about 360 degree, two-wire passes aforementioned single line line and turns 982 and constitute first two-wire lines and turn 983a, move on and constitute first line ball semi-ring 984a, support line ball 98 next section continue into two-wire 98b, 98b ' and spend around stent valve 1 about 180 along aforementioned opposite direction, pass second two-wire line of aforesaid first line ball semi-ring 984a formation and turn 983b, moving on constitutes second line ball semi-ring 984b.Repeat in this way, double bracket line ball 98 is first to a direction pitch of the laps at stent valve 1 outer surface, then to another opposite direction pitch of the laps, constitute the opposite two-wire line of other both directions and turn 983c, 983d and other two line ball semi-ring 984c, 984d, a back two-wire line turns 983d and passes previous line ball semi-ring 984c.Such two-wire unit can repeatable countless times.Support line ball 98 is softish fine rule, any two-wire line turn 983 and line ball semi-ring 984 can be out of shape, become straight, the position between them can change.But support line ball 98 two-wire in the process of shuttling back and forth, turn between 983a, 983b, 983c, 983d...983x and line ball semi-ring 984a, 984b, 984c, the 984d...984x at any one two-wire line, passing stent valve 1 does not simultaneously have the part of coverlay, from outside to inside, and then from inside to outside, support line ball 98 and stent valve 1 is together temporary fixed.Last line ball semi-ring 984z, after passing previous line ball semi-ring 984x and constituting last two-wire line and turn 983z, pass pipe side opening 516p, 516d in the other end, enter or interior tube chamber 52 or common tube chamber 54 or support line ball tube chamber 54 ', blocked by same or another line ball lock silk 97.Before in entering, managing side opening 516p, 516d, this last line ball semi-ring 984z optionally passes outside stent valve 1, or pass the part that stent valve 1 does not have diaphragm seal, far-end wire loop 981 and last line ball semi-ring 984z passed by same or different line ball lock silks 97 block after, draw support line ball near-end 985 can tighten up line ball 98 and the radial compression stent valve 1 below it.Far-end wire loop 981 and last line ball semi-ring 984z passed by same or different line ball lock silks 97 block after, support line ball 98 is also optionally in the same way for the second time around knot stent valve 1, for the second time the support line ball 98 around knot stent valve 1 be the continuity of same line ball, for the second time around 98 sections of the support line balls of knot for the first time around the outside of tying 98 sections of support line balls.Trend around 98 sections of the support line balls of tying is opposite around the overall trend of 98 sections of knot support line balls with the first time for the second time, and gets back near the initial far-end wire loop 981.Can enter and pipe side opening or different interior pipe side opening 516p in far-end wire loop 981 is same for the second time, and be passed by another line ball lock threads 97 and to block around last line ball semi-ring 984z of 98 sections of the support line balls of knot.Nearly section 986 is optionally walked between interior pipe 51 and middle pipe 88 in the support line ball, or walks at interior pipe 51 intracavity.Line ball near-end 985 can with 80 provisional linking to each other of near-end controller.Can there be the middle pipe 88 that entangles in the concentric circular mode in nearly section 514,515 outsides in the interior pipe.Middle pipe 88 internal diameters are greater than interior pipe 51 external diameters, and pipe 88 can slide along interior pipe 51 in making.Can walk support line ball 98 between middle pipe 88 and the interior pipe 51.
Can be as follows around the operation principle of knot and the thread depressing mechanism 96 that can unhitch:
A, support line ball 98 tensions and blocked by line ball lock silk 97 after, tighten up support line ball 98 and make self expandable type stent valve 1 radial compression below it, diameter diminishes, and is compressive state or feed status;
B, under aforementioned compressive state, the middle and lower reaches section 15,13 that one or more lateral guide fiber tube far-ends 991 or side direction seal wire can pass stent valve 1 does not from inside to outside have the deformable unit 101 of diaphragm seal, between support line ball 98, arrive stent valve 1 outside, enter the inlet of collateral blood vessels, as coronary ostium.Behind one or more side direction seal wire approaching side branch blood vessels, can determine the rotation location of apparatus for delivering 2 and stent valve 1.Because line ball 98 area occupied are little, side wire leading pipe far-end 991 can be drawn a plurality of different side direction seal wires in Different Plane and different rotary angle.Side wire leading pipe far-end 991 enters the open zone 987 between support line ball 98 each sections, even the side direction seal wire that makes side wire leading pipe far-end 991 and connected at support line ball 98 under the situation that knot is removed, when support line ball 98 reclaims to near-end, can not block mutually between side direction seal wire and the support line ball 98.
C, one or more line ball lock silk 97 are moved to near-end successively, and line ball lock silk far-end 971 skids off last line ball semi-ring 984z and far-end wire loop 981, and support line ball 98 is released.Can remove two-wire line outside the stent valve 1 to near-end 511 pulling line ball near-ends 985 and turn line ball between 983a, 983b, 983c, 983d...983x and line ball semi-ring 984a, 984b, 984c, 984d...984x, and support line ball 98 all is recovered to near-end 511 around knot.The side direction seal wire is positioned at the open zone 987 of 98 of support line balls, and the support line ball 98 that is not moved influences.
Use, operation principle and the function of artificial heart stent valve 1 of the present utility model and apparatus for delivering 2 thereof can comprehensively be described as follows:
1, assembling
In order to guarantee the performance of artificial stent valve 1, the man-made support valve 1 of biovalve leaf need be expanded at support and be kept under the valve leaflet closed condition in the specific preservation liquid, and the temperature of preservation has special restriction.Though the man-made support valve 1 of synthetic valve leaflet can be preserved in than large-temperature range, stent valve can not long preservation under compressive state.This needs the doctor to assemble in art temporarily and compresses.Man-made support valve 1 comprises with the assembling of apparatus for delivering 2: the preparation of interior pipe backguy 70 and interim exhausting line 72; Backguy 70 perforating branches frame valves 1 before the art, rotation pre-adjustment during assembling; Backguy 70 is got back to near-end controller 80 before the art under interim exhausting line 72 helps.For this process is simplified minimum level, two kinds of selectable schemes are arranged:
A, shown in Figure 11 c, Figure 11 d, interior pipe 51 internal lock silks 75 have put in place.Interior pipe each side opening 516d, 516c, the last backguy 70 of 516p are pinned by lock silk 75.But the outer section 703 of backguy is outside interior pipe.Also have near section interim exhausting line 72 of backguys in the interior pipe 51, it reclaims ring 721 outside side opening 516d, 516c, 516p, and exhausting line 72 is in interior pipe, and interim exhausting line near-end 722 is outside the specific backguy mouth 81 of near-end controller 80.Backguy 70 pass on the support certain open line turn 102 or sealed line eye 103 after, pass the recovery ring 721 of interim exhausting line 72, draw interim exhausting line near-end 722, by interim exhausting line 72 708 recovery of backguy near-end are moved to outside the specific backguy arm 81 of near-end controller 80, the interior exhausting line 72 temporarily of pipe changes backguy 70 in realizing.
B, identical with a, but backguy 70 pass open line on the support turn 102 or sealed line eye 103 backs be linked to be a long backguy 70 with interim exhausting line 72 knottings.Each side opening 516d, 516c of interior pipe section 513 far away, 516p are on same reference plane RP.Stent valve 1 under the help of backguy 70 and locking silk 75, be fixed and radial compaction to interior pipe 51.Backguy 70 passes, pierce into that deformable unit 101 on stent valve 1 girth, stent valve 1 just can determine with the anglec of rotation relation of side opening 516d, 516c, 516p or the reference plane RP of interior pipe section far away, and is the unit definite anglec of rotation of adjustment when the external assembling in advance with half to one the unitary arc length of deformable.Each apparatus for delivering 2 can have following combination that far-end, middle part and the near-end of backguy 70 at stent valve 1 temporarily anchored on the interior pipe 51 of apparatus for delivering 2: 1, single stay 70 and monolock silk 75; 2, Duola's line 70 and monolock silk 75; 3, two covers or above independent monolock silk 75 and corresponding backguy 70.
2, radial compression
The radial compression of man-made support valve 1 comprises: stent valve 1 compression, backguy 70 tension after-poppet valves 1 radial compression; Enter an outer protection mechanism 90 or 92 or 96, radial compression lower carriage valve 1 enters epitheca pipe 90 or peelable outer protection mechanism 92 maybe can be around knot and the thread depressing mechanism 96 that can unhitch.
3, enter
Man-made support valve 1 comprises with entering of apparatus for delivering 2:
3.1, prepare before inserting: insert that one 0.035 " seal wire enters left ventricle; Using the peelable outer protection mechanism 92 maybe can be under thread depressing mechanism 96 situations that knot also can unhitch, can inserting one or two in case of necessity, 0.014 " seal wire enters a left side or right coronary artery.
3.2, corresponding seal wire enters corresponding wire leading pipe 53 or 61,99.
3.3, apparatus for delivering 2 is along the seal wire intravasation, epitheca pipe 90 or peelable outer protecting tube mechanism 92 maybe can be around stent valve 1 intravasations under knot and the thread depressing mechanism that can unhitch 96 protections.
3.4, enter aortic arch before, epitheca pipe 90 halts, compressed stent valve 1 and interior pipe 51 and in pipe go out epitheca pipe 90 and move on.
3.5, slide between interior pipe and middle pipe.
3.6, compressed stent valve 1 descended aortic arch in no epitheca pipe 90 situations.
3.7, after backguy 70 tension, backguy 70 tensions in the interior pipe 51, shorten, and interior pipe itself can not axial compression.Manage section 513 far away and stage casing 514 in the apparatus for delivering 2 because softer, so just make straight interior pipe become curved, and interior pipe stage casing 514 flexibility that are made as bow shape are in advance strengthened, then be arc, particularly interior pipe stage casing 514 is in aortic arch.Interior pipe section 513 far away has the reinforcing of compression lower carriage valve, and still linearly.The nearly section 515 of apparatus for delivering is reinforced because of having than thick harder middle pipe, and still linearly.
3.8, the backguy 70 of tension simultaneously and lock silk 75 slide into naturally in pipe concave surface limit 517, and straight seal wire and wire leading pipe are managed convex surface limit 518 in sliding into naturally.
4, location
The location of man-made support valve 1 comprises:
4.1, apparatus for delivering 2 be arciform in pipe stage casing 514 constituted consistent with the aortic arch plane or relevant datum level RP, with two coronary ostiums of making peace CA has been arranged fixed space rotate reference plane.
4.2, the side wire leading pipe 99 of apparatus for delivering 2 helps axial upstream and downstream and rotary angle position location.
4.3, man-made support valve 1 stage casing 15 helps axial upstream and downstream location positioning for drum type or garden sphere 152.
4.4, man-made support valve 1 stage casing 15 helps axial upstream and downstream and rotary angle position location for radial protrusion structure 153.
4.5, man-made support valve 1 stage casing 15 helps axial upstream and downstream location positioning for outer circulus 155.
4.6, man-made support valve 1 stage casing 15 helps axial upstream and downstream and rotary angle position location for outer free tongue 1 56.
5, the expansion but do not discharge
6, the possibility of expansion back recompression
7, discharge expansion
Locking silk 75 slides to near-end, relevant stay thimble 701 releases, and the release expansion of man-made support valve 1 comprises: once discharge radial dilatation; Merogenesis discharges radial dilatation; Elder generation's far-end upstream extremity, stage casing then, back near-end downstream discharges to be expanded; Or outer circulus 155 in first stage casing or outer free tongue 156 discharge expansion, and behind the location, far and near then end discharges expansion.Discharge position adjustment in the expansion.
8, after the radial dilatation, before near-end discharges, the possibility of repress withdrawal epitheca pipe 90
Man-made support valve 1 merogenesis discharges expansion, and is tapered before near-end discharges expansion.Man-made support valve 1 comprises drum type or garden sphere 152, radial protrusion structure 153, and outer circulus 155 and outer free tongue 156 can repress withdrawal epitheca pipes 90.
9, fixing
Man-made support valve 1 stage casing 15 helps the upstream and downstream direction to fix for drum type or garden sphere 152.Man-made support valve 1 stage casing 15 helps upstream and downstream direction and direction of rotation to fix for radial protrusion structure 153.Man-made support valve 1 stage casing 15 helps the upstream and downstream direction to fix for outer circulus 155.Man-made support valve 1 stage casing 15 helps upstream and downstream direction and direction of rotation to fix for outer free tongue 156.
10, valve leaflet switch
11, coronary artery perfusion and intervention
By there not being the bigger carrier openings 158 of diaphragm seal on man-made support valve 1 middle part 157, the 157x, blood flow is to coronary artery.At man-made support valve 1 middle part 157,157x, there is not the radial protrusion structure 153 of diaphragm seal to paste blood vessel wall, reduce support blood and fasten the formation probability, and help following possible arteria coronaria intervention diagnosis and treatment.
12, the perfusion of coronary bypass
By there not being the support deformable unit 101 of diaphragm seal on man-made support valve 1 tract 13, blood flow is to the opening part of coronary bypass.
13, anti-perivalvular leakage
Upstream section diaphragm seal 351, stage casing diaphragm seal 354 and sealing ring 37 prevent perivalvular leakage, and promptly blood leaked between stent valve and blood vessel wall.Radial protrusion structure 153 pastes blood vessel wall, helps preventing perivalvular leakage.Radial protrusion structure 153 and outer free tongue 156 are clipped in the middle the nature valve leaflet and seal.
14, self expandable type stent valve 1 is inserted back sacculus further expansion
Calcific aortic stenosis can pass through the sacculus further expansion after self expandable type stent valve 1 is inserted.
In sum, artificial heart stent valve of the present utility model and apparatus for delivering thereof have following characteristics and advantage:
But 1, on the stent valve 1 of radial compression, be provided with radially prominent projective structure 153
The circular section that cydariform expander 152 shapes at stent valve middle part 15 are changed tract 13 and Upstream section 18 can be divided into one or more radial protrusion structures 153.Radial protrusion structure 153 is a spherical shell face on the rack outer surface, the outstanding structure of shapes such as parabolic surface.Radial protrusion structure 153 on the stent valve 1 is support 10 part of the whole.Can be same braiding single line 104 constitutes.Be desirably the hemispheric radial protrusion structure 153 that distributes about three 120 degree.Three radial protrusion structure 153 middle part 157x diameters are bigger, help axially and around xx axle direction of rotation playing location and fixation along xx.With stage casing 15 is that the stent valve 1 in garden tubular 151 is opposite, and radial protrusion structure 153 pastes blood vessel wall.Adjacent two radial protrusion structures 153 link to each other uniting a little 160 on the same plane, constitute the lobe leaf and unite a little 332.Two adjacent radial protrusion structures unite a little 160 and the lobe leaf unite a little in 332 and receive, the external diameter of the outstanding structure of external diameter middle part 157x is little.The major diameter support has the minor diameter valve leaflet under the duty like this, but enough aperture areas are arranged, and valve leaflet tension force is descended; Valve leaflet 33 is united a little at the lobe leaf, and 332 damages reduce; Valve leaflet 33 open blood by the time do not reach support 10, make the valve leaflet can be not frayed because of colliding with support; Under the constant situation of valve leaflet 33 thickness, the valve leaflet diameter reduces then that volume reduces, and helps radial compression.Semi-moon shaped upstream periphery 159i constitutes the lobe leaf associating line 331 that links to each other with valve leaflet 33.Though the adjacent deformable unit of the outstanding structure 153 of same horizontal radial is not isometric, the slip on the braided support cross-point 107 between the adjacent segment braided wires 104 has guaranteed that support and radial protrusion structure can radial compression, radial dilatation.The upstream port 184 at the Upstream section horn mouth 182 of a level is not and three radial protrusion structures, 153 corresponding three waveform limits 185.134 braided wires, 104 every section length are the same from upstream extremity 184 to downstream for support.When radial compression, axially-extending, the adjacent segment line slides on the cross-point, and three radial protrusion structures 153 and three waveforms 185 disappear, and each deformable unit of upstream extremity is parallel.Help upstream extremity 184 open lines turn 102 and sealed line eye 103 cooperate with the support backguy 70 of apparatus for delivering 2.
2, can be provided with outer circulus 155 on the stent valve 1
Outer circulus 155 blow-by films allow blood pass through.Support backguy 70 specific on outer circulus 155 and the apparatus for delivering 2 cooperates, and can discharge separately prior to stake body 154.The outer circulus 155 of expansion has location and fixation.
3, can be provided with outer free tongue 156 on the stent valve 1
Outer free tongue 156 blow-by films allow blood pass through.Support backguy 70 specific on outer free tongue 156 and the apparatus for delivering 2 cooperates, and can discharge separately prior to stake body 154.The free tongue 156 of the skin of expansion has location and fixation.Outer free tongue 156 unite a little 165 and the lobe leaf unite a little 332 definite rotation relationship can be arranged, as on same Plane of rotation.
4, network 10 can be made of single elasticity litzendraht wire 104 braidings
The self expandable type support 10 that no matter is what profile all can be formed by single elasticity litzendraht wire 104 braidings.The support that single line constitutes, globality is strong, and is more solid on the mechanics, and do not need to weld between each line.The welding or overlapping that can link to each other of single line starting point 105 and terminal point 106.All 15 at litzendraht wire two 105,106 of single line support in support tract 13 and stage casing.Two statures 105,106 can be towards a direction, end upstream, or downstream.Single elasticity litzendraht wire 104 can the open line of coiled turns 102 and sealed line eye 103.Sealed line eye 103 can with support on same outline curved surface or on the tangent plane, also can with the perpendicular plane of support on (on the diametric plane) inwardly or outwards, also can be between these two.For three valve leaflet stent valves, be that three multiple helps three valve leaflet symmetries along the deformable unit number CN of girth.By the support 10 of single litzendraht wire 104 braidings along girth deformable unit number CN divided by should being a mark rather than an integer along major axis deformable unit number LN.Same single line 104 can constitute radial protrusion structure 153 on network 10.Cross-point 107, the 107 ' slip of going up between the adjacent segment litzendraht wire have guaranteed that support and radial protrusion structure 153 can radial compression, radial dilatation.Same single line 104 can or repeatedly repeat overlapping at twice of the same position of braided support 10.Same single line 104 can or all repeat at the local of braided support 10, can also be woven into the outer circulus 155 or the outer free tongue 156 of support.
5, can be provided with sealing ring 37 on the stent valve 1
Head on blood vessel wall after the stent valve expansion, tubulose sealing ring 37 can be compressed it is adapted to, and fills up the slit between support and the blood vessel wall.
6, stent valve 1 upstream extremity can be provided with the loudspeaker opening
The upstream port 184 of tubaeform 182 Upstream sections 18 is and three radial protrusion structures, 153 corresponding SANYE waveform mouths 185.Upstream section diaphragm seal 351 can extend the mantle 352 that formation does not have bracket supports in upstream direction beyond the support.
7, stent valve 1 is provided with radiopaque marker 311,312
If 8, stent valve 1 constitutes valve leaflet 33, diaphragm seal 351,354 and sealing ring 37 by elastic synthesis material and can have following four kinds of functions simultaneously:
A, valve leaflet 33 prevent backflowing the basic function of diaphragm seal 351,354 and sealing ring 37 leakproof barriers.
The strain of b, stent valve 1 is good
After intersecting, self expandable support litzendraht wire 104 constitutes tetragon deformable unit 101.Be coated with elastic synthesis material film 351,354 on the cross point, two wires 107 between coating or the tetragon.The two is elastomeric material support and film, strain simultaneously under the radial compression force effect.Tetragon deformable unit 101 is at the xx axially-extending, and coverlay prolongs at the xx axial elasticity in the tetragon deformable unit 101.With under the poised state that blood vessel wall is resisted mutually or the stent valve under the duty, before diaphragm seal 351,354 and elastic synthesis material surface layer did not return to the original length and shape on its support, the resilience force of elastic synthesis material film elasticity distortion had increased the expanded radially power and the axial resilience force of stent valve.Valve leaflet and diaphragm seal by elastomeric material is made after stent valve discharges, can pass through the super expansion of sacculus, and stent valve still are the unlikely damaged of strain.
C, elastic synthesis material wrap on the metal rack line, anti-hemostatic tube epithelial cell length on the metal rack line, make the man-made support valve not with the blood vessel wall adhesion, in order to taking out again.
D, different with the biovalve leaf, synthetic valve leaflet and diaphragm seal can be low temperature resistant below 0 ℃, can not propose special conditions of contract for transportation, particularly air transport.Before assembling and compression, drop to below the Af as Nitinol niti-shaped memorial alloy stent valve temperature, Nitinol becomes the Martensitic state from the Austenitic state, the material deliquescing, elasticity disappears, and helps radial compression.After entering in the body, heat 37 ℃, Ultimum Ti recovers the Austenitic state, gets back to the super-elastic property state.
9, be provided with reinforcing fibre 39 in the stent valve 1
Reinforcing fibre 39 in the stent valve 1 has directional selectivity ground to improve the intensity of elastic synthesis material valve leaflet 33 and diaphragm seal 351,354, reduces the probability that it is torn.Reinforcing fibre 39 in the synthetic stent valve 1 is reinforced synthetic valve leaflet 33 annulars, does not hinder the valve leaflet switch; Synthetic valve leaflet 33 free edge strengthenings prevent that it from tearing; The line reinforcing is united a little and united to synthetic valve leaflet 33 with the support interconnecting part, makes interconnecting part become solid, is not torn; Make interconnecting part become slick and sly, reduce thrombosis; 10 reinforcings of diaphragm seal 351,354 and support; Two lines are bound fixing on the litzendraht wire cross point 107.
10, the open line of stent valve 1 turn 102, the effect of sealed line eye 103 and with support backguy 70 cooperations of apparatus for delivering 2: make open line turn 102 and sealed line eye 103 increase radical elasticities, reduce material deformation; Reinforcing fibre in the synthetic film of elasticity can be fixed on open line and turn 102 and above the sealed line eye 103; Sealed line eye 103 can the secure valve leaf unite a little 332.If sealed line eye 103 turn 90 degrees angle and vertical with tangent plane to the inside, it can make to unite a little in 332 and move, and valve leaflet tension force descends; Open line turn 102 and sealed line eye 103 be used for cooperating with the support backguy 70 of apparatus for delivering 2, stent valve 1 is temporary fixed, be compressed on the interior pipe 51 of apparatus for delivering.Support backguy 70 as pass from sealed line eye 103, it will be can slippage and move.
11, stent valve 1 is provided with flexibly jointed chain ring 41
12, apparatus for delivering 2 makes stent valve 1 rotation location
Interior pipe section far away side opening 516d, 516c, 516p are all on the same anglec of rotation.After backguy 70 tensions, interior pipe stage casing 514 becomes curved under backguy 70 pulling force effects, interior pipe section far away side opening 516d, 516c, 516p have arrived the concave surface 517 of curved interior pipe naturally, backguy 70 and lock silk 75 slide into the recessed side 517 of bend pipe naturally, 0.035 " wire leading pipe 61 or guidewire lumen 53 slide into the protruding side 518 of bend pipe automatically under straight seal wire effect, be arranged off-centre.During particularly by aortic arch, interior like this pipe stage casing 514 becomes in backguy tension back bends, and has determined the datum level RP consistent with aortic arch.This datum level or interior pipe section far away side opening 516d, 516c, 516p and two arteria coronaria openings have fixed rotation relationship.On pipe section far away side opening 516d, 516c, the 516p, the rotation relationship between the two can half external in advance rotation adjustment in deformable unit 101 in stent valve 1 can be fixed to.
13, be provided with locking silk 75 in the apparatus for delivering 2
The locking silk 75 of apparatus for delivering 2 can discharge by quick non-resistance stent valve 1 between twice heart beating.Locking silk 75 can be from as far as discharging closely according to the order of sequence.Two or above locking silk 75 can discharge by selectivity.
14, can be provided with peelable outer protection mechanism 92 in the apparatus for delivering 2
15, can be provided with in the apparatus for delivering 2 can be around knot and the thread depressing mechanism 96 that can unhitch
Can replace harder epitheca pipe 90 around knot and thread depressing mechanism 96 good bandabilities that can unhitch.Support line ball 98 can pass stent valve 1, and support line ball 98 can tighten up radial compression stent valve 1, on the same cross section in stent valve 1 middle part, can walk one or more side direction seal wire through side wire leading pipe 99.
16, on the apparatus for delivering 2 Ultrasonic-B probe 87 is arranged
On the interior pipe section 513 far away one or more Ultrasonic-B probe 87 can be arranged optionally.
17, be provided with middle pipe 88 and middle pipe backguy 89 in the apparatus for delivering 2
After middle pipe backguy 89 tensions, tension force increases, and middle pipe 88 becomes curved, helps apparatus for delivering and passes through aortic arch.Middle pipe 88 slides along interior pipe, but the stent valve 1 under the middle pipe far-end 881 pushes compression states goes out epitheca pipe 90.
18, be provided with the interim exhausting line 72 of the nearly section of backguy in the apparatus for delivering 2
Interim exhausting line 72 can help backguy 70 to get back to near-end controller 80 before the art.
Claims (56)
1. artificial heart stent valve, it is characterized in that: comprise one can be between expansion state and compressive state the pipe-shaped net rack of radial deformation, this network comprises Upstream section, stage casing and tract, constitute between each netting twine of network or surround a plurality of deformables unit, forming a plurality of open lines at the two ends of network turns, and be provided with the sealed line eye that separates with the deformable unit, being connected with in the inboard in network stage casing can switch and allow the unidirectional valve leaflet of passing through of blood, valve leaflet constitutes lobe leaf associating line with the network place of combining, the lobe leaf associating line of two adjacent valve leaflet intersects formation lobe leaf unites a little, on the inboard of network Upstream section and/or lateral surface, be coated with diaphragm seal and extend to the stage casing, on network, be provided with a plurality of radiopaque markers and flexibly jointed chain ring.
2. artificial heart stent valve as claimed in claim 1 is characterized in that: described network integral body is tubular of the same size, is provided with carrier openings in the stage casing of tubular network.
3. artificial heart stent valve as claimed in claim 1 is characterized in that: the stage casing of described network is outwards outstanding cydariform, is provided with carrier openings at the middle part in cydariform stage casing.
4. artificial heart stent valve as claimed in claim 1, it is characterized in that: the stage casing of described network is out of shape on the basis of tubular or slight cydariform and at least one outwards outstanding radial protrusion structure, be provided with a bigger carrier openings at the center of each radial protrusion structure, radial protrusion structure and network body connecting place form the upstream periphery of one and a half months shape and the downstream perimeter of one and a half months shape, and semi-moon shaped upstream periphery constitutes the lobe leaf associating line that links to each other with valve leaflet.
5. artificial heart stent valve as claimed in claim 4 is characterized in that: the radial protrusion structure in described network stage casing is one.
6. artificial heart stent valve as claimed in claim 4 is characterized in that: the radial protrusion structure in described network stage casing is two, and two radial protrusion structures are that 90-180 degree corner distributes.
7. artificial heart stent valve as claimed in claim 4 is characterized in that: the radial protrusion structure in described network stage casing is three, three radially uniform distributions of radial protrusion structure.
8. artificial heart stent valve as claimed in claim 4 is characterized in that: the Upstream section flare of described network, the outer rim of tubaeform Upstream section are provided with and the corresponding waveform mouth of the radial protrusion structure in stage casing limit.
9. artificial heart stent valve as claimed in claim 1, it is characterized in that: the stage casing of described network is an outer double-layer structure in the tubular, on rack body, be connected with an outer circulus, outer circulus and internal layer link to each other with the intersection in stage casing at tract or tract and form fixed edge, and the intersection formation free edge that outer circulus terminates in Upstream section and stage casing also can be provided with sealed line eye to be separated with the deformable unit.
10. artificial heart stent valve as claimed in claim 1, it is characterized in that: the stage casing of described network is an internal layer with tubular or slight cydariform, the outside is connected with at least one and is surrounded the free tongue skin that forms by single netting twine, described free tongue and internal layer stake body link to each other with the intersection in stage casing at tract or tract and form fixed edge, and begin upstream the intersection formation free edge that section extends to Upstream section and stage casing from fixed edge, the free edge front end can be provided with sealed line eye, can be with radiopaque marker on the line eye.
11. artificial heart stent valve as claimed in claim 10 is characterized in that: described free tongue is three, and three free tongues distribute with 120 degree corners, and corresponding with valve leaflet.
12. artificial heart stent valve as claimed in claim 1, it is characterized in that: the stage casing of described network is out of shape on the basis of tubular or slight cydariform and at least one outwards outstanding radial protrusion structure, be connected with on each radial protrusion structure by single netting twine and surround the free tongue that forms, the free edge of free tongue is that semi-moon shaped upstream periphery is overlapping on two parallel curved surfaces with the periphery of radial protrusion structure at least.
13. artificial heart stent valve as claimed in claim 1 is characterized in that: described valve leaflet is two to three, and three valve leaflet are 120 degree corners and distribute, and each valve leaflet comprises free limit and closed edge, forms between free limit and the closed edge and closes the closed zone.
14. artificial heart stent valve as claimed in claim 1 is characterized in that: the diaphragm seal eye that described diaphragm seal is interlinked to the outside in corresponding being provided with in the sealed line eye place of network.
15. artificial heart stent valve as claimed in claim 1, it is characterized in that: described diaphragm seal can extend the mantle that formation does not have bracket supports in upstream direction beyond the network, can extend to lobe leaf associating line with interior downstream at network.
16. artificial heart stent valve as claimed in claim 1, it is characterized in that: described radiopaque marker is the tubular point-like sign that is sleeved on the netting twine, the lobe leaf that this tubular point-like sign is arranged on the network stage casing is united a little, also can be arranged on the Upstream section of network or the intersection or the tract in Upstream section and stage casing.
17. artificial heart stent valve as claimed in claim 1 is characterized in that: described radiopaque marker is a wire sign from beginning to end, and this wire sign interweaves on the netting twine of network adjacent to lobe leaf associating line.
18. artificial heart stent valve as claimed in claim 1 is characterized in that: the open line that described flexibly jointed chain ring is arranged on the network two ends turns the middle part with sealed line eye place and network.
19. artificial heart stent valve as claimed in claim 1, it is characterized in that: also comprise sealing ring, the sealing ring is arranged on the outside of the Upstream section and the stage casing intersection of network, described sealing ring is softish semi open model tubular structure, can be annular or with the corresponding waveform of radial protrusion structure, which is provided with inner face or the outside of a plurality of point-like openings, or be provided with the inner face of groove shape opening towards stent valve towards stent valve.
20. the apparatus for delivering of an artificial heart stent valve is characterized in that: comprise conductor housing, interior pipe, near-end controller, middle pipe, wire leading pipe, outer protection mechanism, at least one locking silk and at least one support backguy; Described conductor housing, interior pipe and near-end controller fuse in proper order and are interconnected; the pipe box dress can slide along interior pipe on inner pipe in described; described wire leading pipe is arranged in the conductor housing that fuses, interior pipe and the near-end controller; the far-end of described outer protection mechanism big envelope pipe outside interior pipe and middle pipe and in being movable to, described locking silk and support backguy are located in respectively in the interior pipe and near-end controller that fuses.
21. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: described conductor housing is streamlined hollow cone body structure, its big end is that the rear end is connected with interior pipe far-end, its small end is that front end is provided with thread eye and is communicated with wire leading pipe, the leading portion of conductor housing is provided with at least one side opening and communicates with interior pipe, can contain the opacity material in the conductor housing, or be embedded with radiopaque marker.
22. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: Guan Weiyi elongate tubular structure in described, comprise be used for the interior pipe that links to each other with artificial heart stent valve section far away, bow arcual near section of pipe stage casing and the interior pipe that is communicated with the near-end controller, be provided with the vestibule that at least one allows various silks, line pass through in the interior pipe, interior pipe section far away is provided with at least one side opening.
23. the apparatus for delivering of artificial heart stent valve as claimed in claim 20 is characterized in that: pipe only is provided with a big circular general vestibule for pipe in the single hole in described in the interior pipe, and described wire leading pipe is arranged in this vestibule and can slides along interior pipe.
24. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: pipe is pipe in the single hole in described, only be provided with a big circular general vestibule in the interior pipe, described wire leading pipe is arranged in this vestibule, also be provided with a backguy pipe and a locking fiber tube in the vestibule, can slide mutually between each pipe.
25. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: pipe is pipe in the diplopore in described, be provided with a small circular wire leading pipe near interior tube edges, remainder forms the general pipe of big semilune, and adhesion is fixing between two pipes can not slide.
26. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: pipe in the Guan Weisan hole in described, be provided with a small circular wire leading pipe near interior tube edges, remainder is divided into two halves, form two identical general pipes of shape symmetry, adhesion is fixing between each pipe can not slide.
27. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: pipe in the Guan Weisi hole in described, be provided with a small circular wire leading pipe near interior tube edges, the interior tube edges on wire leading pipe opposite is provided with small circular locking fiber tube, remainder is divided into two halves, form two identical general pipes of shape symmetry, adhesion is fixing between each pipe can not slide.
28. the apparatus for delivering of artificial heart stent valve as claimed in claim 22, it is characterized in that: the side opening of pipe section far away is three in described being located at, comprise distal openings, middle side opening and proximal open, three side openings are all at the same plane and the same side of interior pipe.
29. apparatus for delivering as claim 22 or 28 described artificial heart stent valves, it is characterized in that: the periphery of described side opening is provided with reinforcing ring, this reinforcing ring is made of intensity height, metal material or macromolecular material that frictional property is good, and the reinforcing ring of metal material can constitute radiopaque marker.
30. the apparatus for delivering of artificial heart stent valve as claimed in claim 22 is characterized in that: the middle level of pipe can accompany the braiding reinforcing mat in described, and interior pipe side opening can be opened in a grid of braiding reinforcing mat.
31. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: pipe is spiral bourdon tube in described, the spring wire of bourdon tube section far away constitutes the semi-ring or the domain in the part, distal openings, middle side opening and the proximal open of pipe in forming.
32. the apparatus for delivering of artificial heart stent valve as claimed in claim 31 is characterized in that: described spiral bourdon tube is surrounded by the macromolecular material pipe outward, and the macromolecular material pipe is provided with opening at semi-ring or domain place corresponding to bourdon tube.
33. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: described near-end controller is a dendritic structure, comprise a main pipe and at least one backguy arm of being communicated with main pipe, at least one locking arm, one wash and radiography arm and at least one seal wire arm.
34. the apparatus for delivering of artificial heart stent valve as claimed in claim 33, it is characterized in that: the oblique side that is connected near-end controller main pipe of described backguy arm, and be positioned at same side with the side opening of interior pipe, be provided with resistant to blood refluence film in the backguy arm, be provided with the pin hole that allows backguy pass through in the middle of the film, being provided with the backguy fastener in the backguy arm can be fixed on a certain ad-hoc location of backguy on the backguy arm.
35. the apparatus for delivering of artificial heart stent valve as claimed in claim 33, it is characterized in that: described backguy arm is three, three oblique respectively the same sides that are connected near-end controller main pipe of backguy arm, and correspond respectively to far-end backguy, stage casing backguy and near-end backguy in proper order by front and back, form far-end backguy arm, stage casing backguy arm and near-end backguy arm.
36. the apparatus for delivering of artificial heart stent valve as claimed in claim 33, it is characterized in that: the oblique side that is movably connected in near-end controller main pipe of described locking silk arm, on main pipe and connector locking silk arm, be provided with the resistant to blood film that backflows, be provided with the pin hole that allows lock-in line pass through in the middle of the film, be provided with a sliding bar in the locking silk arm, the front end of sliding bar links to each other with the locking silk, the rear end protruded tube of sliding bar forms operating grip outward, the middle part of sliding bar has a groove, position corresponding to this groove on the locking silk arm is provided with far-end dowel hole and proximally-located pin-and-hole, two alignment pins can pass two dowel holes on the locking silk arm respectively and will locks a silk arm with groove on the sliding bar and link to each other with sliding bar, by fixing or the releasing alignment pin can determine whether the locking silk of sliding bar and connection thereof slides and control its sliding distance.
37. apparatus for delivering as claim 33 or 36 described artificial heart stent valves, it is characterized in that: described locking silk arm is two, two oblique respectively the same sides that are connected near-end controller main pipe of locking silk arm, and correspond respectively to two locking silks.
38. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: the near-end of pipe is near the near-end controller in described, far-end is less than the proximal open of interior pipe, near section at middle pipe is connected with a side pipe, be provided with in one in the middle pipe and manage backguy, the remote port of pipe during the far-end of middle pipe backguy is fixed on, in the near-end of pipe backguy therefrom manage near section side pipe and draw, in the side pipe of the pipe far-end fixing point of backguy and the nearly section of middle pipe be arranged on same plane and with on one side, respectively be equipped with a shrink-ring at the port of middle pipe near-end and the port of side pipe, when loosening, this shrink-ring can slide fixing certain position on inner pipe during deflation along interior pipe.
39. the apparatus for delivering as claim 20 or 38 described artificial heart stent valves is characterized in that: pipe certain taper slightly in described, section far away is thinner, nearly section is thicker, make apparatus for delivering obtain simultaneously nearly section promotion and in section bendability far away.
40. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: the far-end of described wire leading pipe is communicated with conductor housing, near-end is communicated with seal wire arm on the near-end controller, and the part of wire leading pipe in interior pipe stage casing is positioned at the protruding side in pipe stage casing.
41. the apparatus for delivering of artificial heart stent valve as claimed in claim 20; it is characterized in that: described outer protection mechanism is a tubulose epitheca pipe; the far-end tube wall of this epitheca pipe is embedded with radiopaque marker; nearly section is provided with flushing/radiography opening and valve; be provided with elastica in the proximal port, elastica central authorities are provided with aperture, little bore closure or have only very little diameter under the normal condition; the diameter of aperture can enlarge when middle pipe passed, and did not leak blood with pipe slip and elastica in guaranteeing.
42. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: described outer protection mechanism is peelable outer protection mechanism, comprises peelable sheath pipe and is used for the provisional take-up lock silk that tightens up the sheath pipe take-up of peelable sheath pipe and be used to lock the take-up of sheath pipe; Far away section of peelable sheath pipe is provided with a longitudinal opening and runs through far-end, longitudinal opening both sides sheath pipe is provided with a plurality of take-up eyes, and the distal diameter of peelable sheath pipe is dwindled, and it is streamlined to constitute bullet, nearly section part is a complete pipe in the peelable sheath pipe, and its diameter is less than or equal to far away section diameter; The far-end of sheath pipe take-up be provided with the take-up ring pass in a side opening of pipe section far away blocked by take-up lock silk, the near-end of sheath pipe take-up is temporarily fixed on the near-end controller, each take-up eye that the take-up of sheath pipe is passed on the peelable sheath pipe constitutes tightening structure, and can take the back releasing of take-up lock silk away; Take-up lock silk is located in the interior pipe and can slides along interior pipe, and its near-end is drawn from the near-end controller.
43. the apparatus for delivering of artificial heart stent valve as claimed in claim 42 is characterized in that: described peelable sheath pipe is the tubular cloth tubular construction, and its tube wall is the tube wall of sealing.
44. the apparatus for delivering of artificial heart stent valve as claimed in claim 42 is characterized in that: described peelable sheath pipe is the tubular reticulum tubular construction, and its tube wall is the tube wall that mesh is arranged.
45. the apparatus for delivering of artificial heart stent valve as claimed in claim 20; it is characterized in that: described outer protection mechanism is can be around knot and the thread depressing mechanism that can unhitch; comprise at least one line ball lock silk and a support line ball; the two composition can be around the knot and the thread depressing mechanism that can unhitch, can be with the provisional radial compression of stent valve.
46. the apparatus for delivering of artificial heart stent valve as claimed in claim 45 is characterized in that: Guan Bingke slided along interior pipe in described line ball lock silk ran through, and its near-end is drawn from an arm of near-end controller; The near-end of described support line ball is drawn from an arm of near-end controller, its far-end is provided with wire loop, pipe was blocked by line ball lock silk in a side opening of pipe entered in the far-end wire loop passed, before in the far-end wire loop enters, managing side opening, support line ball alternative is in stent valve outside process, or pass the part that does not have diaphragm seal on the stent valve, passed by same or different line ball lock silks midway and block, formation can be implemented provisional radial compression to stent valve around knot and also can unhitch after taking line ball lock silk away.
47. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: also comprise the side wire leading pipe, described side wire leading pipe rises from the outside at interior pipe section far away middle part and with interior pipe section far away and links to each other, pipe stage casing in inwardly the pipe proximal direction extends to, manage in also can extending on nearly section or the near-end controller, the far-end of side wire leading pipe is between the distal openings of interior pipe and proximal open and outwards bending, and the side opening direction of the port direction of formation and interior pipe is angled.
48. the apparatus for delivering as claim 20 or 47 described artificial heart stent valves is characterized in that: described side wire leading pipe is one, maybe can be equipped with around knot and the thread depressing mechanism that can unhitch with peelable outer protection mechanism.
49. the apparatus for delivering as claim 20 or 47 described artificial heart stent valves is characterized in that: described side wire leading pipe is two, and can be equipped with around the knot and the thread depressing mechanism that can unhitch, and becomes 120 degree corners to arrange between the wire leading pipe of both sides.
50. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: described locking silk runs through interior pipe, its section far away is passed stay thimble of one or more support backguy with one or more support backguy locking, and near-end links to each other with sliding bar in the near-end controller lock fixed thread arm.
51. apparatus for delivering as claim 20 or 50 described artificial heart stent valves, it is characterized in that: described locking silk is two, and two locking silks lock one or more support backguy respectively and also link to each other with two sliding bars that lock in the silk arms of near-end controller respectively.
52. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: the vestibule of pipe in described support backguy is passed, its far-end is provided with a stay thimble, its near-end is drawn from the backguy arm of near-end controller, its section far away is drawn outer section that forms the support backguy from a side opening of interior pipe, outer section same side opening of support backguy around pipe in entering behind network one circle, and by the locked silk locking of the stay thimble of its far-end.
53. the apparatus for delivering of artificial heart stent valve as claimed in claim 52, it is characterized in that: outer section of described support backguy passes respectively around network the time that the unitary opening of deformable of network, open line turn, sealed line eye and flexibly jointed chain ring, constitutes a lasso trick.
54. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: described support backguy is three, the near-end of three support backguys is drawn from three backguy arms of near-end controller respectively, and the far-end of three support backguys is locked by same or different locking silks in three side openings of interior pipe respectively.
55. the apparatus for delivering of artificial heart stent valve as claimed in claim 54, it is characterized in that: in described three support backguys, the backguy of drawing from the near-end backguy arm of near-end controller, its far-end is connected in the proximal open of interior pipe, the backguy of drawing from the stage casing backguy arm of near-end controller, in the middle side opening of pipe, from the backguy that the far-end backguy arm of near-end controller is drawn, its far-end was connected in the distal openings of interior pipe in its far-end was connected.
56. the apparatus for delivering of artificial heart stent valve as claimed in claim 20, it is characterized in that: also comprise Ultrasonic-B probe, this Ultrasonic-B probe be arranged on the rear end of conductor housing or be arranged near the distal openings of pipe or near the proximal open, pipe was drawn from the near-end controller in the lead that connects Ultrasonic-B probe passed.
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CNU2005200463866U CN2855366Y (en) | 2005-11-09 | 2005-11-09 | Artificial cardiac valves stand and its delivery placer |
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CNU2005200463866U CN2855366Y (en) | 2005-11-09 | 2005-11-09 | Artificial cardiac valves stand and its delivery placer |
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