WO2022016837A1 - 一种瓣膜支架及包含该瓣膜支架的人工心脏瓣膜 - Google Patents
一种瓣膜支架及包含该瓣膜支架的人工心脏瓣膜 Download PDFInfo
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- WO2022016837A1 WO2022016837A1 PCT/CN2021/072492 CN2021072492W WO2022016837A1 WO 2022016837 A1 WO2022016837 A1 WO 2022016837A1 CN 2021072492 W CN2021072492 W CN 2021072492W WO 2022016837 A1 WO2022016837 A1 WO 2022016837A1
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- Prior art keywords
- sheath
- sheathing
- stent
- valve
- face
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Classifications
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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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
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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
- A61F2/2436—Deployment by retracting a sheath
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
- A61F2250/0063—Nested prosthetic parts
Definitions
- the invention relates to the technical field of medical devices, in particular to a valve support and an artificial heart valve implanted in the heart.
- Heart valves are membrane-like structures that open and close in the organs of humans and certain animals. There are four valves in everyone's heart. That is, the aortic valve connecting the left ventricle and the aorta, the pulmonary valve connecting the right ventricle and the pulmonary artery, the mitral valve connecting the left atrium and the left ventricle, and the tricuspid valve connecting the right atrium and the right ventricle. They all act as one-way valves, so that blood can only flow from one direction to the other and not back.
- TMVR Transcatheter mitral valve replacement
- the implantation of traditional single-layer mitral prosthetic valve is not satisfactory.
- the functions of bearing artificial valve leaflets and bearing anchoring and sealing can be distributed to different single-layer valve components, so as to achieve the normal operation of other structures of the heart without affecting the normal operation of the heart. Better play the purpose of implant therapy.
- the invention provides a valve stent, which eliminates the gradient of the sheathing end surface between the double-layer stents, prevents the end of the outer layer stent from touching the end of the sheath tube, thereby affecting the stent entering the sheath tube, and reduces the loading resistance and the sheath tube. Risk of entry into dissection.
- a valve stent comprising a stent assembly
- the stent assembly includes at least two stents, an inner layer stent and an outer layer stent, the inner layer stent and the outer layer stent are inner and outer nested structures, and the inner layer stent nested inside, the stent assembly is configured to have at least one sheathing end set;
- the sheath entry end group includes a first sheath entry end and a second sheath entry end, the first sheath entry end is located on the inner layer support, the second sheath entry end is located on the outer layer support, and the first sheath entry end is located at the outer layer support.
- a sheath entry end and the second sheath entry end extend in the same direction, and the second sheath entry end is located outside the first sheath entry end.
- the sheath entry end group When at least one sheath entry end group is in the first sheath entry end, the first sheath entry end When the length of the sheath end is greater than the length of the second sheath entry end, the sheath entry end group is provided with a protruding portion, so as to prevent the sheath entry end group from interfering with the loading of the valve prosthesis.
- the protruding part relieves the interference of the sheathing end group on the loading of the valve prosthesis, and reduces the risk of the sheath tube entering the interlayer between the inner and outer stents and the risk of the end face of the second sheathing end colliding with the sheath tube during loading.
- first sheathing end One end of the valve prosthesis first enters the delivery system, and the end that first enters the delivery system is the sheathing end.
- first sheathing end may be a hanging ear provided on the inner layer bracket, and the bracket assembly is connected to the delivery system through the hanging ear.
- the specific structures and functions of the first sheath entry end and the second sheath entry end are not intended to limit the protection scope of the present invention.
- the valve prosthesis can be sheathed at one end first, such as the ventricular end first, or the atrial end first.
- the delivery system such as the sheath has a two-section structure
- the atrial end and the ventricular end of the stent assembly serve as the sheathing end at the same time, and are loaded into the delivery system.
- the stent assembly includes a plurality of the sheathing end groups, each of the sheathing end groups is located at the atrium end or the ventricular end, and the multiple sheathing end groups can ensure that the valve prosthesis is stably loaded in the delivery system.
- a plurality of sheathing end groups can be located at the atrial end, or at the ventricular end at the same time, or respectively arranged at the atrial end and the ventricular end; in each of the sheathing end groups, the length of the first sheathing end is greater than the length of the When the length of the second sheathing end is long, each of the sheathing end groups is provided with the protruding portion. Each protruding part can release the interference of each sheathing end group on the sheathing process.
- the protruding portion is provided on the first sheathing end, the protruding portion has a first end surface, and the first end surface is located on the side of the end surface near the second sheathing end, and the first end surface is The width of one end face is not less than the width of the second sheathing end.
- the protruding portion further has a second end surface, the second end surface is located on a side away from the first end surface, and the second end surface is flush with the end surface of the first sheathing end.
- the protruding part eliminates the gradient difference between the first sheath entry end and the second sheath entry end, further reducing the risk of the sheath tube entering the interlayer of the inner and outer stents, and when the length of the first end face of the protruding part is greater than or equal to When the width of the second sheathing end is wide, the end face of the second sheathing end will not touch the end face of the sheath tube, thereby avoiding the phenomenon that the end face of the second sheathing end and the end face of the sheath tube collide, reducing the loading resistance and avoiding the second sheathing. End damage sheath.
- the first end face of the protruding portion abuts against the end face of the second sheathing end. Due to the abutting effect from the protruding portion, when the sheath is inserted, the sheath tube will not enter the stent interlayer from the end of the second sheathing end.
- the first end face matches the end face of the second sheathing end.
- matching refers to the same size, and the shape of the end face forms a concave-convex matching, so that when the protruding part is abutted against the end face of the second sheathing end, the sheathing end group can form an integral sheathing, and the loading of the valve prosthesis Easier while reducing the risk of damaging the sheath at the second sheath entry end.
- the outer contour of the protruding portion is arc-shaped.
- the arc-shaped outer contour reduces the friction with the end of the sheath tube and the sheath tube wall, reducing the loading resistance.
- the protruding portion is integrally formed on the first sheathing end, the molding process is simple, and the connection between the protruding portion and the first sheathing end is more stable and reliable.
- the first sheathing end is a hanging ear connected to the delivery system.
- the length of the first sheathing end of the inner layer stent is longer, it is preferable to connect with the delivery system through the hanging ear of the inner layer stent, which is more reliable and stable.
- the axial contact surfaces of the first sheath entry end and the second sheath entry end are configured in a concave-convex matching connection.
- the first sheath end and the second sheath end will be pre-shaped by welding, etc.
- the concave-convex matching connection can replace the welding connection method, which has stable connection and easy implementation.
- a prosthetic heart valve comprising the valve stent as described above.
- the protruding part of the present invention relieves the interference caused by the sheathing end group to the loading of the valve prosthesis, and reduces the risk of the sheath tube entering the interlayer of the inner and outer stents and the risk of conflict between the end face of the second sheathing end and the sheath tube during loading;
- the protruding part When the protruding part is arranged on the first sheath entry end, and the length of the first end face is not less than the width of the second sheath entry end, the protruding part can effectively prevent the sheath tube from entering the stent interlayer;
- the protruding part eliminates the gradient difference between the first sheath entry end and the second sheath entry end.
- the end face of the second sheath entry end will not touch the end face of the sheath tube, thereby avoiding
- the end face of the second sheathing end is in conflict with the end face of the sheath tube, which reduces the loading resistance and reduces the risk of damaging the sheath tube.
- the integrity of the sheath entry end group is improved, and the second entry end face is further reduced.
- the risk of the sheath end damaging the sheath can ensure the valve prosthesis is loaded, transported, released smoothly and the sheath is recovered smoothly; when the outer contour of the protruding part is arc-shaped, the arc-shaped outer contour reduces the The friction between the sheath end and sheath wall further reduces loading resistance.
- FIG. 1 is a schematic structural diagram of a stent assembly according to Embodiment 1 of the present invention.
- Fig. 2 is the structural representation of the inner layer support of Example 1 of the present invention.
- Fig. 3 is the structural representation of the outer layer support of Example 1 of the present invention.
- Fig. 4 is the structural representation of the sheath end group of the embodiment of the present invention 1;
- Fig. 5 is the partial structure schematic diagram of the first sheathing end of Embodiment 1 of the present invention.
- FIG. 6 is a partial cross-sectional schematic diagram of the valve prosthesis according to Embodiment 1 of the present invention.
- FIG. 7 is a partial cross-sectional schematic view of the valve prosthesis sheathed in Embodiment 1 of the present invention.
- Fig. 8 is the sectional structure schematic diagram of the sheath end group of Embodiment 1 of the present invention.
- Fig. 9 is the sectional structure schematic diagram of the sheath end group of the embodiment 2 of the present invention.
- Fig. 10 is the sectional structure schematic diagram of the sheath end group of the embodiment 3 of the present invention.
- Fig. 11 is the structural representation of valve stent and sheath end in the prior art of the present invention.
- Fig. 12 is a partial structural schematic diagram of the sheathing of the valve prosthesis in the prior art of the present invention.
- stent assembly 100 inner stent 110; outer stent 120; inflow section 111; outflow section 113; transition section 112; first section 121; second section 122; third section 123; sheath end group 101
- the present invention provides a valve support and an artificial heart valve comprising the valve support.
- the artificial heart valve of the present invention can be used for implantation in the inflow tract of the left ventricle to replace the original mitral valve, and can also be used as a tricuspid valve to be implanted in the inflow tract of the right ventricle.
- the following takes the mitral valve as an example to illustrate the structure of the artificial heart valve of the present invention, wherein the heart valve is composed of a stent assembly 100, a valve and a skirt.
- the bracket assembly 100 is composed of two parts, an inner layer bracket 110 and an outer layer bracket 120.
- the inner layer bracket 110 and the outer layer bracket 120 are nested structures inside and outside, wherein the inner layer bracket 110 is sleeved inside, and the outer layer bracket 120 is nested inside and outside.
- the layer support 120 is sleeved outside.
- the inner layer bracket 110 and the outer layer bracket 120 are connected by means of riveting, welding, snapping, sewing, and skirt wrapping.
- the inner layer support 110 includes an inflow section 111, an outflow section 113 and a transition section 112 located therebetween.
- the inner layer support 110 further includes hanging ears.
- the outflow section 113 is located downstream of the inflow channel according to the direction of blood flow.
- the hanger is connected to the end of the stent inflow section 111 and/or the end of the outflow section 113. The hanger is used to connect with the delivery system to ensure that The relative position of the valve prosthesis to the delivery system does not change when the valve is loaded into the delivery system, released from the delivery system, and the valve is transported in vivo in the delivery system.
- the cross-sectional shape of the inner stent 110 may be circular, D-shaped, flower-shaped or other irregular shapes.
- the inner stent 110 may be made of, for example, Nitinol, titanium alloys, cobalt chromium alloys, MP35n, 316 stainless steel, L605, Phynox/Elgiloy, platinum chromium, or other biocompatible metals as known to those skilled in the art.
- elastically or plastically deformable materials are also included, such as balloon expandable, or may be a shape memory alloy that responds to temperature changes to transition between a contracted delivery state and an expanded deployed state.
- the inner layer support 110 can be a mesh structure composed of multiple rows of cells, and the constituent cells are triangular, rhombic, pentagonal, drop-shaped and other mesh cells that can form a closed shape, preferably a rhombus structure.
- the outer support 120 includes a first segment 121 , a second segment 122 and a third segment 123 .
- the outer layer bracket 120 further includes fixing ears, and the fixing ears are provided on either end of the outer layer bracket 120 , or on both ends.
- the fixed ear is used to connect with the delivery system to ensure that the relative position of the valve prosthesis and the delivery system remains unchanged when the valve is loaded into the delivery system, the valve is released from the delivery system, and the valve is transported in the delivery system in vivo.
- both the fixing ear and the hanging ear are connected to the delivery device to ensure that the valve stent is loaded as a whole. According to the release needs, you can choose one or both, and can be located at any end of the stent, not limited to the outflow section. .
- the cross-sectional shape of the outer layer stent 120 may be circular, D-shaped, flower-shaped or other irregular shapes.
- the outer stent 120 can be made of, for example, Nitinol, titanium alloys, cobalt chromium alloys, MP35n, 316 stainless steel, L605, Phynox/Elgiloy, platinum chromium, or other biocompatible metals as known to those skilled in the art.
- elastically or plastically deformable materials are also included, such as balloon expandable, or may be a shape memory alloy that responds to temperature changes to transition between a contracted delivery state and an expanded deployed state.
- the outer support 120 can be a mesh structure composed of multiple rows of cells, and the constituent cells are triangular, rhombic, pentagonal, teardrop-shaped, etc., which can form a closed-shaped mesh cell.
- the valve includes at least two artificial valve leaflets, which are made of animal pericardium or other biocompatible polymer materials.
- One end of the valve leaflet is directly or indirectly connected to the inner layer support 110 stably, and the other end of the valve leaflet is a free end.
- the number of leaflets may or may not be the same as the number of native leaflets.
- the artificial valve leaflet replaces the original valve leaflet to realize the function of opening and closing the blood channel.
- the entire inner surface or outer surface or both sides of the stent assembly 100 cover the skirt to achieve a sealing function and ensure that the single channel of blood flows from the inflow channel end of the prosthetic valve leaflet to the outflow channel end of the prosthetic valve leaflet.
- the skirt is made of pericardium or other biocompatible polymer materials (such as PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), etc.).
- the present invention does not limit the anchoring form of the valve prosthesis.
- a flange can be provided on the stent assembly 100, and an Oversize anchoring form can be used, or anchoring structures such as thorns and anchoring claws can be set on the stent assembly 100 to grasp the native tissue. Fixation can also be done by anchoring the tether to the ventricular wall.
- the present invention exemplifies only a mitral valve prosthesis, but is not limited to aortic valve prostheses, pulmonary valve prostheses, tricuspid valve prostheses, and the like of similar structures.
- a problem in the prior art is that when the length of the sheathing end of the inner stent assembly 100 is greater than the length of the sheathing end of the outer stent 120, a sheathing end surface will be formed between the inner and outer stents. gradient.
- the sheath end face of the outer layer stent 120 will touch the end face of the sheath tube, and the two end faces are in conflict, thereby affecting the entry of the entire valve into the sheath tube, the loading resistance is large, and the sheath end face of the outer layer stent 120 is easy to damage the sheath Tube.
- the recovery resistance of the end is large, which will also affect the smooth progress of recovery.
- the present invention provides a valve stent and a valve prosthesis, which can solve the above problems.
- valve prosthesis during the loading process, one or both ends of the valve prosthesis need to be loaded into the delivery system, and the first end that enters the delivery system is the "sheathing end”.
- the term “sheathing end” should be understood in a broad sense, and is the end structure arranged at the atrial or ventricular end of the valve prosthesis, such as the above-mentioned “hanging ear” and “fixing ear”.
- Atrial end refers to the end located in the atrium
- ventricular end refers to the end located in the ventricle.
- heart valve cardiac prosthesis
- prosthetic heart valve have the same meaning.
- outside refers to a direction radially outward from the center of the valve prosthesis.
- length refers to the dimension in the axial direction and “width” refers to the dimension in the radial direction.
- the terms “installed”, “connected” and “connected” should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
- installed should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
- This embodiment provides a valve stent, including a stent assembly 100 , see FIGS. 1 to 8 , wherein the stent assembly 100 includes two stents, an inner layer stent 110 and an outer layer stent 120 , and an inner layer stent 110 and an outer layer stent 120
- the inner support 110 is sleeved inside, and the outer support 120 is sleeved outside.
- the stent assembly 100 is configured to have at least one sheathing end set 101 including a first sheathing end 114 and a second sheathing end 124, wherein the first sheathing end 114 is located at the inner stent 110
- the second sheathing end 124 is located on the outer bracket 120 , the first sheathing end 114 and the second sheathing end 124 extend toward the same direction, and the second sheathing end 124 is located outside the first sheathing end 114 .
- the length of the first sheath entry end 114 is greater than the length of the second sheath entry end 124, wherein at least one sheath entry end group 101 is configured with at least one protruding portion 200 for use In order to prevent the sheath end set 101 from interfering with the loading of the valve prosthesis.
- the sheathing end 124 Since the second sheathing end 124 is located outside the first sheathing end 114, when the length of the first sheathing end 114 is greater than the length of the second sheathing end 124, that is, there is a gradient difference between the two sheathing ends, the sheathing end At this time, the end surface of the outer second sheathing end 124 will touch the end surface of the sheath tube 410 , and the two end surfaces collide, resulting in a large loading resistance, thereby affecting the entry of the entire valve prosthesis into the sheath tube 410 .
- the arrangement of the protruding portion 200 can avoid the above situations, including preventing the sheath tube 410 from entering the gap between the first sheathing end 114 and the second sheathing end 124 , or preventing the end face of the sheath tube 410 and the end face of the second sheathing end 124 A conflict occurs, which affects the sheathing of the valve prosthesis.
- the ventricular end of the valve prosthesis is sheathed first, that is, the ventricular end is used as the sheathing end.
- the first sheathing end 114 is a hanging ear arranged at the ventricular end of the inner layer stent 110.
- the first sheathing end 114 is sheathed first, and the first sheathing ear is fixed with the delivery system, which is more reliable and stable.
- the second sheathing end 124 may not have any function, eg, be the end point of outer stent 120 .
- first sheath entry end 114 or the second sheath entry end 124 may also be a connecting rod with a predetermined function, and the specific structures and functions of the first sheath entry end 114 and the second sheath entry end 124 are not It is not intended to limit the protection scope of the present invention.
- the ventricular end of the stent assembly 100 is provided with a plurality of the described sheath end groups 101, and a plurality of The sheathing end groups 101 are evenly arranged along the circumferential direction.
- each sheathing end group 101 are configured with the protruding portion 200 described above.
- sheath tube can be prevented from entering into the interlayer of any sheathing end group 101 during the sheathing process, and any second sheathing end 124 can be prevented from colliding with the end face of the sheath tube, so that the valve prosthesis can be sheathed smoothly.
- a plurality of the sheathing end groups 101 can be simultaneously disposed at the atrial end of the stent assembly 100, or the atrial end and the ventricular end of the stent assembly 100 are both provided with a plurality of the sheathing end groups. Group 101.
- the setting position and quantity of the sheathing end group 101 should be selected according to the actual release method and the structure of the delivery system, which will not be repeated here.
- the end face 1141 of the first sheathing end is located at the free end of the first sheathing end 1141, and the end face 1241 of the second sheathing end is located at the free end of the second sheathing end 124,
- the protruding portion 200 is provided on the first sheath entry end 114 , the protruding portion 200 has a first end surface 201 , the first end surface 201 is located on the side of the end surface 1241 near the second sheath entry end, and the width of the first end surface 201 D1 is not less than the width D2 of the second sheathing end 124 .
- the width D1 of the first end surface 201 may be equal to the width D2 of the second sheathing end 124, as shown in FIG. 6 and FIG. 7 . In some embodiments, the width D1 of the first end surface may also be greater than the width D2 of the second sheathing end 124 , as shown in FIGS. 8 and 10 .
- the sheath When there is a gradient difference between the first sheathing end 114 and the second sheathing end 124, and the sheath is pressed into the sheath, the sheath can easily enter the gap between the first sheathing end 114 and the second sheathing end 124, and is located at the first sheathing end 114 and the outwardly extending protruding portion 200 can reduce the risk of the sheath entering the gap between the first sheath entry end 114 and the second sheath entry end 124 .
- the protruding portion 200 further has a second end surface 202 , and the second end surface 202 is located on the side away from the first end surface 201 , wherein the second end surface 202 of the protruding portion 200 is It is flush with the end face 1141 of the first sheathing end.
- the structure of the protruding portion 200 at this time eliminates the gradient difference between the two sheathing ends. As shown in FIG.
- the end face of the second sheathing end 124 will not touch the end face of the sheath tube, so it can be
- the end face of the second sheath entry end 124 is effectively prevented from colliding with the end surface of the sheath tube, thereby reducing the loading resistance, and at the same time, the second sheath entry end 124 will not damage the sheath tube.
- the protruding portion 200 can also extend toward the ventricular end to exceed the end surface 1141 of the first sheathing end, which can also solve the problem of the second sheathing end 124 colliding with the sheath tube 410 during sheathing. , no more restrictions here.
- the first end surface 201 of the protruding portion 200 is in contact with the end surface 1241 of the second sheathing end. Due to the abutting effect of the protruding portion 200, the sheath tube 410 will not enter the stent interlayer from the second sheathing end 124 during sheathing.
- the first end surface 201 of the protruding portion 200 matches the end surface 1241 of the second sheathing end.
- matching refers to the same size, and the two end faces form a concave-convex matching. Therefore, when the first sheathing end 114 and the second sheathing end 124 abut each other, each sheathing end group 101 is used as a On the whole, the risk of the sheath tube 410 entering into the dissection is reduced, and the process of loading and releasing the valve prosthesis is smoother.
- the protruding portion 200 is integrally formed on the first sheathing end 114 , which has the advantages of a simple, stable and reliable molding process.
- the protruding part 200 can be formed separately and then fixedly connected to the first sheathing end 114; or, the protruding part 200 can also be movably connected to the first sheathing end 114, such as a rotational connection .
- the protruding part 200 can also be a removable structure, and the cover is provided on the free end of the sheath end group 101 .
- the protruding part 200 should be made of a degradable material, such as polylactic acid.
- the protruding portion 200 may also have a certain function, such as being used as a hanging ear or a fixing ear.
- This embodiment provides a valve stent, which is an improvement on the basis of Embodiment 1, wherein the outer contour of the protruding portion 200 is arc-shaped.
- the arc-shaped outer contour can reduce the friction with the end surface of the sheath tube and the inner wall of the sheath tube force, further reducing the loading resistance.
- This embodiment provides a valve stent, which is an improvement on the basis of Embodiment 1 or Embodiment 2, wherein the axial contact surfaces of the first sheath entry end 114 and the second sheath entry end 124 are configured Connect for bump matching.
- the axial side of the second sheathing end 124 is provided with a plurality of second protrusions protruding outward, and a second concave portion is formed between two adjacent second protrusions; correspondingly, the first sheathing end 114 is A plurality of first concave portions are formed on the shaft side, and a first protrusion is formed between two adjacent first concave portions 116 .
- the first protrusions are respectively located in a corresponding second concave portion
- the second protrusions are respectively located in a corresponding first concave portion, so that the first sheath end 114 is connected to the second one.
- a concave-convex matching connection is formed between the two sheathed ends 124 .
- the protrusions and the recesses are matched and connected one by one, and the number and setting positions of the protrusions and recesses can be selected according to the actual connection requirements, and are not used to limit the protection scope of the present invention, and will not be repeated here.
- the concave-convex matching connection between the first sheathing end 114 and the second sheathing end 124 enables each sheathing end group 101 to be pre-shaped, which can replace the connection methods such as welding, and has the advantages of stable connection and easy implementation.
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- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
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- Prostheses (AREA)
Abstract
一种瓣膜支架,包括支架组件(100),支架组件(100)包括至少两个支架,内层支架(110)和外层支架(120),内层支架(110)、外层支架(120)为内外嵌套的结构,支架组件(100)被构造为具有至少一个入鞘端组(101),包括第一入鞘端(114)和第二入鞘端(124),第二入鞘端(124)位于第一入鞘端(114)外侧;至少一个入鞘端组(101)中,第一入鞘端(114)的长度大于第二入鞘端(124)的长度,该入鞘端组(101)配置有凸出部(200),用以防止入鞘端组(101)对瓣膜假体的装载造成干涉。瓣膜支架,凸出部(200)可以避免外层支架(120)的第二入鞘端(124)碰到鞘管(410)端部从而影响装载,降低了装载阻力和鞘管(410)进入夹层的风险。
Description
本发明涉及医疗器械技术领域,特别涉及一种瓣膜支架和植入心脏内的人工心脏瓣膜。
心脏瓣膜是人或某些动物的器官里面可以开闭的膜状结构。每个人的心脏内都有四个瓣膜。即连结左心室和主动脉的主动脉瓣、连结右心室和肺动脉的肺动脉瓣、连结左心房和左心室的二尖瓣和连结右心房和右心室的三尖瓣。它们均起单向阀门作用,使血液只能从一个方向流向另一个方向而不能倒流。
二尖瓣返流会导致心肌重构,心室进行性扩大,最终导致心力衰竭。经导管二尖瓣置换手术(TMVR)采用导管介入的方法,将人工瓣膜在体外压缩到输送系统,送达人体二尖瓣瓣环处,并将人工瓣膜释放固定在二尖瓣瓣环处替换原生瓣膜。与外科手术相比,TMVR无须体外循环辅助装置,创伤小、病人恢复快,术后患者血流动力学指标可以得到明显改善。
对于部分二尖瓣反流患者,传统单层二尖瓣假体瓣膜的植入治疗效果并不理想。而对于多层二尖瓣假体瓣膜而言,可将承载人工瓣叶和承担锚固、密封等作用分配到不同的单层瓣膜构件上,从而达到既不影响心脏其他结构的正常运转,又能较好的发挥植入治疗功能的目的。
多层支架的装载往往会遇到困难,参见图11、图12,为一双层支架结构,当内层支架的入鞘端的长度大于外层支架时,内外支架之间会形成入鞘端面的梯度。在装载时,外层支架的端面会碰到鞘管的端面,两个端面相抵触,从而影响整个瓣膜进入鞘管,装载阻力大,外层支架易损伤鞘管,存在鞘管进入两层支架夹层的风险。在植入过程中,如果需要回收再释放,该端部的回收阻力大,也会影响回收的顺利进行。
发明内容
本发明提供了一种瓣膜支架,消除了双层支架之间的入鞘端面的梯度,避免外层支架的端部碰到鞘管端部从而影响支架进入鞘管,降低了装载阻力和鞘管进入夹层的风险。
本发明的技术方案如下:
一种瓣膜支架,包括支架组件,所述支架组件包括至少两个支架,内层支架和外层支架,所述内层支架、所述外层支架为内外嵌套的结构,所述内层支架套设在内,所述支架组件被构造为具有至少一个入鞘端组;
所述入鞘端组包括第一入鞘端和第二入鞘端,所述第一入鞘端位于所述内层支架,所述第二入鞘端位于所述外层支架,所述第一入鞘端、所述第二入鞘端朝同一方向延伸,所述第二入鞘端位于所述第一入鞘端外侧,当至少一个所述入鞘端组中,所述第一入鞘端的长度大于所述第二入鞘端的长度时,所述入鞘端组配置有凸出部,防止所述入鞘端组对瓣膜假体的装载造成干涉。
由于第一入鞘端与第二入鞘端之间存在梯度差,在瓣膜假体压握入鞘时,第二入鞘端的端面会碰到输送系统如鞘管的端面,两个端面相抵触,导致装载阻力大,从而影响整个瓣膜假体进入鞘管,并且第二入鞘端易损伤鞘管,另外还会出现鞘管进入内外支架夹层的风险。凸出部解除了入鞘端组对瓣膜假体装载造成的干涉,降低了装载时鞘管进入内外支架夹层的风险及第二入鞘端的端面与鞘管抵触的风险。
瓣膜假体的一个端部首先进入输送系统,先入输送系统的一端即为入鞘端。其中,第一入鞘端可以为设置在内层支架的挂耳,支架组件通过挂耳与输送系统相连。第一入鞘端、第二入鞘端的具体结构以及功能并不用于限制本发明的保护范围。
根据输送系统结构以及释放方式的不同,瓣膜假体可以是一个端部首先入鞘,如心室端首先入鞘,或心房端首先入鞘。当输送系统如鞘管为两段结构时,支架组件的心房端、心室端同时作为入鞘端,装载入输送系统。
较佳地,所述支架组件包括多个所述入鞘端组,每一所述入鞘端组位于心房端或心室端,多个入鞘端组能够保证瓣膜假体稳定的装载在输送系统中,多个入鞘端组可以同时位于心房端,或同时位于心室端,或分别布设在心房端及心室端;各所述入鞘端组中,所述第一入鞘端的长度大于所述第二入鞘端的长度时,每一所述入鞘端组均配置有所述凸出部。每一凸出部均能够解除各入鞘端组对入鞘过程的干涉。
较佳地,所述凸出部设于所述第一入鞘端,所述凸出部具有第一端面,所述第一端面位于近所述第二入鞘端的端面一侧,所述第一端面的宽度不小于所述第二入鞘端的宽度。此时,由于凸出部的止挡作用,鞘管不会自第一入鞘端、第二入鞘端之间进入夹层,从而降低了鞘管进入内外支架夹层的风险。
较佳地,所述凸出部还具有第二端面,所述第二端面位于与所述第一端面相背离的一侧,所述第二端面与所述第一入鞘端的端面齐平。此时,凸出部消除了第一入鞘端与第二入鞘端之间的梯度差,进一步降低了鞘管进入内外支架夹层的风险,且当凸出部第一端面的长度大于或等于第二入鞘端的宽度时,第二入鞘端的端面不会碰到鞘管端面,从而避免了第二入鞘端的端面与鞘管端面抵触的现象,降低了装载阻力,同时避免第二入鞘端损伤鞘管。
较佳地,所述凸出部的所述第一端面与所述第二入鞘端的端面相抵靠。由于受到来自凸出部的抵顶作用,入鞘时,鞘管不会自第二入鞘端的端部进入支架夹层。
较佳地,所述第一端面与所述第二入鞘端的端面相匹配。其中,匹配指的是大小相同,且端面的形状形成凹凸匹配,这样,当凸出部与第二入鞘端的端面相抵顶时,入鞘端组能够形成一整体入鞘,瓣膜假体的装载更加容易,同时降低了第二入鞘端损伤鞘管的风险。
较佳地,所述凸出部的外轮廓为圆弧形。圆弧形的外轮廓减小了与鞘管端部、鞘管壁之间的摩擦,降低了装载阻力。
较佳地,所述凸出部一体成型于所述第一入鞘端,成型工艺简单,且使凸出部与第一入鞘端的连接更加稳定、可靠。
较佳地,所述第一入鞘端为与输送系统连接的挂耳。当内层支架的第一入鞘端长度更长时,优选通过内层支架的挂耳与输送系统连接,更加可靠与稳定。
较佳地,所述第一入鞘端与所述第二入鞘端的轴向接触面配置为凹凸匹配连接。瓣膜支架成型时,各入鞘端组中,第一入鞘端与第二入鞘端之间会通过焊接等方式进行预定型,凹凸匹配连接可以取代焊接的连接方式,具有连接稳定、容易实施的优点。
一种包含如上任一所述瓣膜支架的人工心脏瓣膜。
与现有技术相比,本发明的有益效果如下:
第一,本发明的凸出部解除了入鞘端组对瓣膜假体装载造成的干涉,降低了装载时鞘管进入内外支架夹层的风险及第二入鞘端的端面与鞘管抵触的风险;凸出部设置在第一入鞘端,且第一端面的长度不小于所述第二入鞘端的宽度时,凸出部能够有效防止鞘管进入支架夹层;凸出部的第二端面与所述第一入鞘端的端面齐平时,凸出部消除了第一入鞘端与第二入鞘端之间的梯度差,此时第二入鞘端的端面不会碰到鞘管端面,从而避免了第二入鞘端的端面与鞘管端面抵触,降低了装载阻力,降低了损伤鞘管的风险。
第二,凸出部的第一端面与第二入鞘端的端面相抵,以及第一端面与第二入鞘端的端面相匹配时,提高了入鞘端组的整体性,进一步降低了第二入鞘端损伤鞘管的风险,能够保证瓣膜假体顺利的装载、运输、释放以及鞘管顺利回收;所述凸出部的外轮廓为圆弧形时,圆弧形的外轮廓减小了与鞘管端部、鞘管壁之间的摩擦,进一步降低了装载阻力。
当然,实施本发明的任一产品并不一定需要同时达到以上所述的所有优点。
图1是本发明实施例1的支架组件的结构示意图;
图2是本发明实施例1的内层支架的结构示意图;
图3是本发明实施例1的外层支架的结构示意图;
图4是本发明实施例1的入鞘端组的结构示意图;
图5是本发明实施例1的第一入鞘端的部分结构示意图;
图6是本发明实施例1的瓣膜假体的部分剖视示意图;
图7是本发明实施例1的瓣膜假体入鞘的部分剖视示意图;
图8是本发明实施例1的入鞘端组的剖视结构示意图;
图9是本发明实施例2的入鞘端组的剖视结构示意图;
图10是本发明实施例3的入鞘端组的剖视结构示意图;
图11是本发明现有技术中瓣膜支架及入鞘端的结构示意图;
图12是本发明现有技术中瓣膜假体入鞘的部分结构示意图。
附图标记:支架组件100;内层支架110;外层支架120;流入段111;流出段113;过渡段112;第一段121;第二段122;第三段123;入鞘端组101;第一入鞘端114;第二入鞘端124;凸出部200;鞘管410;第一端面201;第二端面202;第一入鞘端的端面1141;第二入鞘端的端面1241。
本发明提供一种瓣膜支架及包含该瓣膜支架的人工心脏瓣膜。
本发明的人工心脏瓣膜,可用于植入左室流入道内,替代原生二尖瓣瓣膜,也可用作三尖瓣膜,植入右室流入道内。
以下以二尖瓣膜为例,阐述本发明的人工心脏瓣膜的结构,其中,心脏瓣膜由支架组件100、瓣膜和裙边组成。
如图1所示,支架组件100由内层支架110和外层支架120两部分组成,内层支架110、外层支架120为内外嵌套的结构,其中内层支架110套设在内,外层支架120套设在外。内层支架110和外层支架120之间采用铆接、焊接、卡扣、缝合、裙边包覆等方式连接。
如图2所示,所述内层支架110包括流入段111、流出段113及位于两者 之间的过渡段112,可选地,内层支架110还包括挂耳。所述流出段113根据血流的方向位于流入道的下游,所述挂耳与支架流入段111的端部和(或)流出段113的端部相连,挂耳用于与输送系统相连,保证瓣膜装载进入输送系统、瓣膜释放脱离输送系统及瓣膜在输送系统中在体内运输时瓣膜假体与输送系统的相对位置不变。
内层支架110的截面形状可以为圆形、D形、花形或其他不规则形状。内层支架110可以采用如镍钛诺、钛合金、钴铬合金、MP35n、316不锈钢、L605、Phynox/Elgiloy、铂铬,或如本领域技术人员已知的其它生物相容性金属制成。可选地,也包括可弹性或可塑性变形的材料,如球囊可扩张的,或者可以是响应温度变化以在收缩的递送状态和扩张的展开状态之间转变的形状记忆合金。优选地,采用镍钛合金管材切割制造,管材外径为4~13mm,根据实际需要选取定型后的直径尺寸。内层支架110可由多排单元组成的网状结构,所述组成单元为三角形、菱形、五边形、水滴形等可形成封闭形状的网格单元,优选菱形结构。
如图3所示,所述外层支架120包括第一段121、第二段122和第三段123。可选地,外层支架120还包括固定耳,固定耳设置在外层支架120的任意一个端部上,或两个端部上。固定耳用于与输送系统相连,保证瓣膜装载进入输送系统、瓣膜释放脱离输送系统及瓣膜在输送系统中在体内运输时瓣膜假体与输送系统的相对位置不变。
其中,固定耳和挂耳均为了保证瓣膜支架整体装载时,与输送装置连接,根据释放需要可以任选其一,也可以两者皆有,可以位于支架的任何一端部,不仅限于流出段部分。
外层支架120的截面形状可以为圆形、D形、花形或其他不规则形状。外层支架120可以采用如镍钛诺、钛合金、钴铬合金、MP35n、316不锈钢、L605、Phynox/Elgiloy、铂铬,或如本领域技术人员已知的其它生物相容性金属制成。可选地,也包括可弹性或可塑性变形的材料,如球囊可扩张的,或者可以是响应温度变化以在收缩的递送状态和扩张的展开状态之间转变的形状记忆合金。外层支架120可由多排单元组成的网状结构,所述组成单元为 三角形、菱形、五边形、水滴形等可形成封闭形状的网格单元。
瓣膜包括至少两片人工瓣叶,采用动物心包或其他生物相容的高分子材料制备而成,瓣叶的一端与内层支架110直接或间接稳定连接,瓣叶的另一端为自由端。瓣叶的数量可以与原生瓣叶数量相同,也可以不同。所述的心脏瓣膜在工作状态下,由人工瓣叶替代原生瓣叶实现开启和关闭血液通道的功能。
支架组件100整体的内表面或外表面或双面覆盖裙边,实现密封功能,保证血液的单一通道为自假体瓣叶的流入道端流向假体瓣叶的流出道端。裙边为心包或其他生物相容的高分子材料(例如PET(聚对苯二甲酸乙二醇酯)、PTFE(聚四氟乙烯)等)制造而成。
本发明中不限定瓣膜假体的锚固形式,可以在支架组件100上设置法兰,采用Oversize的锚固形式、也可以在支架组件100上设置刺、锚爪等锚固结构对原生组织进行抓取,也可以采取系绳锚固到心室壁的方式进行固定。
本发明仅示例二尖瓣瓣膜假体,但是不限于类似结构的主动脉瓣膜假体、肺动脉瓣膜假体、三尖瓣瓣膜假体等。
如图11、图12所示,现有技术中存在的问题是当内层支架组件100的入鞘端的长度大于外层支架120的入鞘端长度时,内外支架之间会形成入鞘端面的梯度。在装载时,外层支架120的入鞘端端面会碰到鞘管的端面,两个端面相抵触,从而影响整个瓣膜进入鞘管,装载阻力大,外层支架120的入鞘端易损伤鞘管。在植入过程中,如果需要回收再释放,该端部的回收阻力大,也会影响回收的顺利进行。
另外,当内外层支架的入鞘端存在梯度差时,存在鞘管进入两层支架夹层的风险,甚至鞘管进入内外支架夹层的风险。
由此,本发明提供一种瓣膜支架以及瓣膜假体,可以解决上述的问题。
在本发明的描述中,需要说明的是,因在装载过程中,瓣膜假体的一端或两端需要装载进入输送系统,首先进入输送系统的一端,即为所述的“入鞘端”。术语“入鞘端”应做广义理解,为设置在瓣膜假体心房端或心室端的 端部结构,如上述的“挂耳”、“固定耳”。
在本发明的描述中,需要说明的是,“心房端”指的是位于心房内的端部,“心室端”指的是位于心室内的端部。如本文所述的,“心脏瓣膜”、“瓣膜假体”及“人工心脏瓣膜”具有相同的含义。
在本发明的描述中,需要说明的是,“外侧”指的是自瓣膜假体中心沿径向向外的方向。如本文所述的,“长度”指的是沿轴向方向的尺寸,“宽度”指的是沿径向方向的尺寸。
在本发明的描述中,需要说明的是,术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。此外,术语“第一”、“第二”、“第三”仅用于描述目的,而不能理解为指示或暗示相对重要性。
在本发明的描述中,需要说明的是,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以具体情况理解上述术语在本发明中的具体含义。
如在本说明书中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,除非内容另外明确指出外。如在本说明书中所使用的,术语“或”通常是以包括“和/或”的含义而进行使用的,除非内容另外明确指出外。
下面结合具体实施例,进一步阐述本发明。
实施例1
本实施例提供一种瓣膜支架,包括支架组件100,参见图1-图8,其中,支架组件100包括两个支架,内层支架110和外层支架120,内层支架110、外层支架120为内外嵌套的结构,内层支架110套设在内,外层支架120套 设在外。
支架组件100被构造为具有至少一个入鞘端组101,至少一个入鞘端组101包括第一入鞘端114和第二入鞘端124,其中,第一入鞘端114位于内层支架110,第二入鞘端124位于外层支架120,第一入鞘端114与第二入鞘端124朝向同一方向延伸,且第二入鞘端124位于第一入鞘端114的外侧。
至少一个入鞘端组101中,第一入鞘端114的长度大于所述第二入鞘端124的长度,其中,至少一个所述入鞘端组101配置有至少一个凸出部200,用以防止入鞘端组101对瓣膜假体的装载造成干涉。
由于第二入鞘端124位于第一入鞘端114外侧,当第一入鞘端114的长度大于第二入鞘端124的长度时,即两个入鞘端之间存在梯度差,入鞘时外侧的第二入鞘端124的端面会碰到鞘管410的端面,两个端面相抵触,导致装载阻力大,从而影响整个瓣膜假体进入鞘管410。
凸出部200的设置可以避免以上情形,包括,防止鞘管410进入第一入鞘端114、第二入鞘端124的间隙,或者防止鞘管410的端面与第二入鞘端124的端面发生抵触,而影响瓣膜假体入鞘。
本实施例中瓣膜假体的心室端首先入鞘,即心室端作为入鞘端。其中,第一入鞘端114为设置在内层支架110心室端的挂耳,第一入鞘端114首先入鞘,先入鞘的挂耳与输送系统固定,更加可靠与稳定,第二入鞘端124可以不具有任何功能,例如,为外层支架120的端点。当然,在其他实施例中,第一入鞘端114或第二入鞘端124还可以是具有预定功能的连杆,第一入鞘端114、第二入鞘端124的具体结构及作用并不用于限制本发明的保护范围。
进一步的,参见图1,为了瓣膜假体能够稳定的固定在输送鞘管内,以及为了瓣膜假体的顺利释放,支架组件100的心室端设有多个所述的入鞘端组101,多个入鞘端组101沿周向均匀布设,当各所述入鞘端组101中,第一入鞘端114的长度大于第二入鞘端124的长度时,每一所述的入鞘端组101均配置有所述的凸出部200。这样,能够避免入鞘过程中鞘管进入任一入鞘端组101的夹层中,以及避免任一第二入鞘端124与鞘管端面相抵触的情形,使瓣膜假体能够顺利入鞘。当然,在其他实施例中,多个所述的入鞘端组101可 以同时设置在支架组件100的心房端,或者支架组件100的心房端、心室端均设置有多个所述的入鞘端组101。入鞘端组101的设置位置、数量应根据实际的释放方式、输送系统的结构进行选择,此处不再赘述。
参见图6、图8,第一入鞘端的端面1141位于第一入鞘端1141的自由端,第二入鞘端的端面1241位于第二入鞘端124的自由端,
本实施例中,凸出部200设于第一入鞘端114,凸出部200具有第一端面201,第一端面201位于近第二入鞘端的端面1241一侧,第一端面201的宽度D1不小于第二入鞘端124的宽度D2。
其中,第一端面201的宽度D1可以与第二入鞘端124的宽度D2相等,如图6、图7所示。在一些实施例中,第一端面的宽度D1也可以大于第二入鞘端124的宽度D2,如图8、图10所示。当第一入鞘端114、第二入鞘端124存在梯度差,压握入鞘时,鞘管容易进入第一入鞘端114、第二入鞘端124间隙,设于第一入鞘端114且向外延伸的凸出部200,可以降低鞘管进入第一入鞘端114、第二入鞘端124间隙的风险。
本实施例中,参见图6、图8,凸出部200还具有第二端面202,第二端面202位于与第一端面201相背离的一侧,其中,凸出部200的第二端面202与第一入鞘端的端面1141齐平。此时的凸出部200的结构消除了两个入鞘端之间的梯度差,如图7所示,入鞘时,第二入鞘端124的端面不会碰到鞘管端面,因此能够有效避免第二入鞘端124的端面对鞘管端面的抵触,降低了装载阻力,同时第二入鞘端124不会损伤鞘管。当然,在其他实施例中,所述凸出部200还可以朝向心室端方向延伸至超过第一入鞘端的端面1141,同样能够解决入鞘时第二入鞘端124对鞘管410的抵触问题,此处不再限制。
进一步的,本实施例中,所述凸出部200的第一端面201与第二入鞘端的端面1241相抵。由于受所述凸出部200的抵顶作用,入鞘时,鞘管410不会自第二入鞘端124进入支架夹层。
继续参见图4、图6、图7,本实施例中,所述凸出部200的第一端面201与第二入鞘端的端面1241相匹配。其中,相匹配指的是尺寸一致,并且两个端面形成凹凸匹配,因此,当第一入鞘端114、第二入鞘端124之间相互抵顶 时,每一入鞘端组101作为一个整体,降低了鞘管410进入夹层的风险,使瓣膜假体的装载、释放过程更加顺利。
本实施例中,凸出部200一体成型于所述第一入鞘端114,具有成型工艺简单、稳定、可靠的优点。当然,在其他替换实施例中,凸出部200可以单独成型,再固连至第一入鞘端114;或,凸出部200还可以活动连接在第一入鞘端114上,如转动连接。或者,凸出部200还可以设为可移除的结构,盖设在入鞘端组101的自由端,此时凸出部200应由可降解的材质制成,如聚乳酸。
本实施例中,凸出部200还可以具有一定的功能,如作为挂耳或固定耳使用。
实施例2
本实施例提供一种瓣膜支架,是在实施例1的基础上进行的改进,其中,所述凸出部200的外轮廓为圆弧形。
如图9所示,由于所述凸出部200的第一端面201与第二入鞘端的端面1241相抵顶,圆弧形的外轮廓能够减小与鞘管端面以及鞘管内壁之间的摩擦力,进一步降低了装载阻力。
实施例3
本实施例提供一种瓣膜支架,是在实施例1或实施例2的基础上进行的改进,其中,所述第一入鞘端114与所述第二入鞘端124的轴向接触面配置为凹凸匹配连接。
参见图10,第二入鞘端124的轴侧向外凸出设有多个第二突起,相邻两个第二突起之间形成了第二凹部;对应的,第一入鞘端114的轴侧形成有多个第一凹部,相邻两个第一凹部116之间为第一突起。内层支架110与外层支架120之间连接后,第一突起分别位于对应的一个第二凹部内,第二突起分别位于对应的一个第一凹部内,从而使第一入鞘端114与第二入鞘端124之间形成了凹凸匹配连接。其中,突起与凹部一一匹配连接,突起、凹部的数量、设置位置可以根据实际连接需求进行选择,并不用于限制本发明的保 护范围,此处不再赘述。
第一入鞘端114与第二入鞘端124之间的凹凸匹配连接,使每一入鞘端组101完成预定型,可以取代焊接等连接方式,具有连接稳定、容易实施的优点。
以上公开的仅为本发明优选实施例。优选实施例并没有详尽叙述所有的细节,也不限制该发明仅为所述的具体实施方式。显然,根据本说明书的内容,可作很多的修改和变化。本说明书选取并具体描述这些实施例,是为了更好地解释本发明的原理和实际应用,从而使所属领域技术人员能很好地利用本发明。本发明仅受权利要求书及其全部范围和等效物的限制。
Claims (11)
- 一种瓣膜支架,其特征在于,包括支架组件,所述支架组件包括至少两个支架,内层支架和外层支架,所述内层支架、所述外层支架为内外嵌套的结构,所述内层支架套设在内,所述支架组件被构造为具有至少一个入鞘端组;所述入鞘端组包括第一入鞘端和第二入鞘端,所述第一入鞘端位于所述内层支架,所述第二入鞘端位于所述外层支架,所述第一入鞘端、所述第二入鞘端朝同一方向延伸,且所述第二入鞘端位于所述第一入鞘端外侧;当至少一个所述入鞘端组中,所述第一入鞘端的长度大于所述第二入鞘端的长度时,所述入鞘端组配置有凸出部,用以防止所述入鞘端组对瓣膜假体的装载造成干涉。
- 根据权利要求1所述的瓣膜支架,其特征在于,所述支架组件包括多个所述入鞘端组,每一所述入鞘端组位于心房端或心室端;各所述入鞘端组中,所述第一入鞘端的长度大于所述第二入鞘端的长度时,每一所述入鞘端组均配置有所述凸出部。
- 根据权利要求2所述的瓣膜支架,其特征在于,所述凸出部设于所述第一入鞘端,所述凸出部具有第一端面,所述第一端面位于近所述第二入鞘端的端面一侧,所述第一端面的宽度不小于所述第二入鞘端的宽度。
- 根据权利要求3所述的瓣膜支架,其特征在于,所述凸出部还具有第二端面,所述第二端面位于与所述第一端面相背离的一侧,所述第二端面与所述第一入鞘端的端面齐平。
- 根据权利要求3所述的瓣膜支架,其特征在于,所述凸出部的所述第一端面与所述第二入鞘端的端面相抵靠。
- 根据权利要求5所述的瓣膜支架,其特征在于,所述第一端面与所述第二入鞘端的端面形状相匹配。
- 根据权利要求1-6任一所述的瓣膜支架,其特征在于,所述凸出部的外轮廓为圆弧形。
- 根据权利要求3-6任一所述的瓣膜支架,其特征在于,所述凸出部一体成型于所述第一入鞘端。
- 根据权利要求1所述的瓣膜支架,其特征在于,所述第一入鞘端与所述第二入鞘端的轴向接触面配置为凹凸匹配连接。
- 根据权利要求1所述的瓣膜支架,其特征在于,所述第一入鞘端为与输送系统连接的挂耳。
- 一种包含如权利要求1-10任一所述瓣膜支架的人工心脏瓣膜。
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Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20140180397A1 (en) * | 2012-12-26 | 2014-06-26 | Stryker Nv Operations Limited | Multilayer stent |
CN109394393A (zh) * | 2017-08-18 | 2019-03-01 | 上海微创心通医疗科技有限公司 | 心脏瓣膜假体 |
US20190167455A1 (en) * | 2017-12-01 | 2019-06-06 | Bcm Co., Ltd. | Stent having improved anti-migration function |
CN109890328A (zh) * | 2016-10-26 | 2019-06-14 | 曼尼美得医药技术工程局 | 双支架 |
CN111000663A (zh) * | 2011-10-19 | 2020-04-14 | 托尔福公司 | 人工心脏瓣膜装置、人工二尖瓣和相关系统及方法 |
CN111110398A (zh) * | 2018-10-30 | 2020-05-08 | 上海微创心通医疗科技有限公司 | 分体式心脏瓣膜支架及其假体 |
CN111772880A (zh) * | 2020-07-21 | 2020-10-16 | 江苏臻亿医疗科技有限公司 | 一种瓣膜支架及包含该瓣膜支架的人工心脏瓣膜 |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9387075B2 (en) * | 2011-09-12 | 2016-07-12 | Highlife Sas | Transcatheter valve prosthesis |
WO2014162306A2 (en) * | 2013-04-02 | 2014-10-09 | Tendyne Holdings, Inc. | Improved devices and methods for transcatheter prosthetic heart valves |
GB201720803D0 (en) * | 2017-12-13 | 2018-01-24 | Mitraltech Ltd | Prosthetic Valve and delivery tool therefor |
CN108578016B (zh) * | 2018-04-26 | 2020-09-08 | 赛诺医疗科学技术股份有限公司 | 一种经心尖植入式二尖瓣瓣膜装置 |
-
2021
- 2021-01-18 EP EP21785741.6A patent/EP3970667A4/en active Pending
- 2021-01-18 WO PCT/CN2021/072492 patent/WO2022016837A1/zh unknown
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN111000663A (zh) * | 2011-10-19 | 2020-04-14 | 托尔福公司 | 人工心脏瓣膜装置、人工二尖瓣和相关系统及方法 |
US20140180397A1 (en) * | 2012-12-26 | 2014-06-26 | Stryker Nv Operations Limited | Multilayer stent |
CN109890328A (zh) * | 2016-10-26 | 2019-06-14 | 曼尼美得医药技术工程局 | 双支架 |
CN109394393A (zh) * | 2017-08-18 | 2019-03-01 | 上海微创心通医疗科技有限公司 | 心脏瓣膜假体 |
US20190167455A1 (en) * | 2017-12-01 | 2019-06-06 | Bcm Co., Ltd. | Stent having improved anti-migration function |
CN111110398A (zh) * | 2018-10-30 | 2020-05-08 | 上海微创心通医疗科技有限公司 | 分体式心脏瓣膜支架及其假体 |
CN111772880A (zh) * | 2020-07-21 | 2020-10-16 | 江苏臻亿医疗科技有限公司 | 一种瓣膜支架及包含该瓣膜支架的人工心脏瓣膜 |
Non-Patent Citations (1)
Title |
---|
See also references of EP3970667A4 * |
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