CN114795588A - Recoverable artificial intervention valve system - Google Patents
Recoverable artificial intervention valve system Download PDFInfo
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- CN114795588A CN114795588A CN202210433647.8A CN202210433647A CN114795588A CN 114795588 A CN114795588 A CN 114795588A CN 202210433647 A CN202210433647 A CN 202210433647A CN 114795588 A CN114795588 A CN 114795588A
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- prosthetic
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- 210000003709 heart valve Anatomy 0.000 claims abstract description 52
- 238000004873 anchoring Methods 0.000 claims description 25
- 230000001746 atrial effect Effects 0.000 claims description 9
- 238000009987 spinning Methods 0.000 claims description 5
- 238000009434 installation Methods 0.000 abstract description 5
- 210000002837 heart atrium Anatomy 0.000 description 14
- 238000003825 pressing Methods 0.000 description 7
- 230000003902 lesion Effects 0.000 description 4
- 238000011084 recovery Methods 0.000 description 4
- 238000000034 method Methods 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 230000002861 ventricular Effects 0.000 description 3
- 206010067171 Regurgitation Diseases 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- 210000001765 aortic valve Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 210000004115 mitral valve Anatomy 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 210000000591 tricuspid valve Anatomy 0.000 description 2
- 241001573881 Corolla Species 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 238000000429 assembly Methods 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000003412 degenerative effect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000001848 dysentery Diseases 0.000 description 1
- 208000018578 heart valve disease Diseases 0.000 description 1
- 230000013011 mating Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 238000004080 punching Methods 0.000 description 1
- 238000002601 radiography Methods 0.000 description 1
- 238000011272 standard treatment Methods 0.000 description 1
- 230000001360 synchronised effect Effects 0.000 description 1
Images
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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
-
- 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
-
- 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
- A61F2/243—Deployment by mechanical expansion
-
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2466—Delivery devices therefor
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- Prostheses (AREA)
Abstract
The invention provides a recyclable prosthetic intervention valve system. This recoverable artifical valve system of interveneeing includes artifical heart valve, valve fixed part, one-level transport portion, second grade transport portion and tertiary transport portion, form fixed space between valve fixed part and the second grade transport portion, artifical heart valve includes main part and connecting portion, the main part is the annular, connecting portion are located fixed space, and can release when second grade transport portion slides to fixed space axial outside, the main part cover is established outside the valve fixed part, tertiary transport portion can be fixed in fixed space time at connecting portion and slide towards the main part, and with the main part receipts bundle in tertiary transport portion. The recyclable artificial intervention valve system can recycle the heart valve, further realize the readjustment of the position of the heart valve and ensure the accurate installation position of the heart valve.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a recyclable artificial intervention valve system.
Background
Valvular disease is a common heart valve disease with increasing incidence with age. For a diseased valve, a surgical operation is usually adopted to perform a prosthetic heart valve, but some patients cannot accept the surgical operation due to the age and the like, and intervention valves can be adopted for the patients, so that the diseased valve has the advantages of small wound, quick recovery and the like because the patients do not need to open the chest, and is more and more widely concerned and valued.
Interventional aortic valves have advanced well over the last two decades and are now the standard treatment for non-surgical or surgical high risk patients. However, the mitral valve and the tricuspid valve, which are atrioventricular valves, have relatively slow development after being implanted into the body due to the complex anatomical structure of the valve position. Different from the narrow lesion caused by the main degenerative lesion of the aortic valve, the regurgitation lesion caused by various reasons of the atrioventricular valve, the calcified plaque around the valve of the regurgitation lesion is less, and the fixation after the intervention valve implantation is difficult. Meanwhile, atrioventricular valves are usually subjected to forces in two directions, namely, when the heart contracts, the ventricular blood impacts the valve in the direction of the atrium, and when the heart contracts, the ventricular blood impacts the valve in the direction of the ventricle. Therefore, to increase the security of the atrioventricular valve fixation, fixation assemblies are often added to both the atrial and ventricular faces of the interventional valve to achieve anchoring of the valve at the implantation site.
Meanwhile, after the valve is released, various complications are easy to occur due to inaccurate release positions. In order to reposition an inaccurately released valve, it is often desirable that the valve be capable of being retrieved and released again after release, or after partial release. However, in the case of mitral and tricuspid valves of artificial atrioventricular valves, the design of the fixation structure is relatively complicated in consideration of the presence of the leaflets, chordae, etc. of the natural valve inside, which greatly affects the recyclability of the valve after release, especially when the valve is provided with an anchoring structure. The valve with inaccurate release positioning can be effectively recovered into the delivery system and released again; the recoverability can effectively reduce the operation difficulty of doctors and improve the postoperative effect.
Disclosure of Invention
In order to solve the problems, the invention provides a recyclable artificial intervention valve system, which is particularly suitable for valves with anchoring structures.
To achieve the above objects, the present invention provides a retrievable prosthetic access valve system, comprising a prosthetic heart valve portion, and a delivery portion,
wherein the valve part comprises a valve frame, and the valve frame comprises a main body, an anchoring part and a connecting part;
the conveying part comprises a petal frame fixing part, a primary conveying part and a tertiary conveying part; the first-stage conveying part is sleeved in the valve frame fixing part and can axially move relative to the valve frame fixing part, the third-stage conveying part is sleeved outside the valve frame fixing part and can axially move relative to the valve frame fixing part, and a fixing space is formed between the valve frame fixing part and the third-stage conveying part; the artificial heart valve connecting part is positioned in the fixed space and can be released from the fixed space when the three-stage conveying part slides to the outer side of the fixed space, and the three-stage conveying part and/or the first-stage conveying part can slide towards the main body when the connecting part is fixed in the fixed space and can be used for binding the main body in the three-stage conveying part and/or the first-stage conveying part; the valve can be retracted into the space between the three-stage delivery part and the one-stage delivery part before release; the end of the primary conveying part is provided with a tip head, the tip head is provided with a containing cavity, and the opening of the containing cavity faces the artificial heart valve.
Preferably, a second-stage conveying part capable of axially moving relative to the petal frame fixing part is arranged between the third-stage conveying part and the petal frame fixing part, the third-stage conveying part is sleeved outside the second-stage conveying part and capable of axially moving relative to the second-stage conveying part, and a fixing space is formed between the petal frame fixing part and the second-stage conveying part; the artificial heart valve connecting part is positioned in the fixed space and can be released from the fixed space when the secondary conveying part slides to the outer side of the fixed space, and the tertiary conveying part and/or the primary conveying part can slide towards the main body when the connecting part is fixed in the fixed space and can be restrained in the tertiary conveying part and/or the primary conveying part; the valve is retractable into the space between the tertiary and primary delivery portions prior to release.
Preferably, the conveying parts are all corresponding to the rotary wheels; and a linkage adjusting device is arranged between the rotary wheels corresponding to the first-stage conveying part and the third-stage conveying part.
Preferably, the rotary wheel corresponding to the primary conveying part is adjacent to the rotary wheel corresponding to the tertiary conveying part.
Preferably, the linkage adjusting device is provided with a first working position and a second working position, and in the first working position, the rotary wheels corresponding to the primary conveying part and the tertiary conveying part can rotate in a linkage manner; when the first working position is reached, the first-stage conveying part and the third-stage conveying part can rotate independently.
Preferably, the linkage adjustment means comprises a cam wrench and a locking ring; when the locking ring is in the second working position, the cam wrench is positioned on the non-protruding surface, and the locking ring is opened; in the first working position, the cam wrench is located on the protruding surface, and the locking ring is locked.
Preferably, the conveying part comprises a rotary wheel, an inner wheel and a pipeline; the inner wheel is provided with an outer layer, a connecting part and an inner layer; the outer layer is sleeved on a handle shell of the conveying system, the inner layer is positioned in the handle shell of the conveying system and is connected with a corresponding pipeline, and the connecting part is connected with the inner layer and the outer layer and is arranged in a clamping groove in the axial direction of the handle shell; the rotary wheel is arranged outside the inner wheel and is matched with the inner wheel through threads.
Preferably, the rotary wheels of the first-stage conveying part and the third-stage conveying part adopt the same spiral direction, and the corresponding threads are single spiral, double spiral or multi-spiral.
Preferably, the artificial heart valve further comprises an atrium part, the atrium part is connected to one end of the main body far away from the connecting part, and the atrium part can be constricted in the accommodating cavity of the tip head; and the anchoring part is positioned in the corresponding pipeline of the third-stage conveying part after being retracted.
Preferably, when the valve is released, the linkage adjusting device is arranged at the opening position, and the rotation of each rotary wheel drives the valve to release step by step; when the valve is recovered, the valve is recovered into the pipeline corresponding to the three-level conveying part by rotating the rotary wheel of the three-level conveying system, then the linkage adjusting device is arranged at the locking position, and meanwhile, the rotary wheel rotates reversely, the one-level conveying part and the three-level conveying part move in the same direction, the valve is released from the pipeline of the three-level conveying system and enters the accommodating cavity of the Tip head corresponding to the one-level conveying part, and the complete reset is realized.
The recoverable artificial intervention valve system can realize the conveying of the artificial heart valve by utilizing the matching of the valve frame fixing part, the first-level conveying part, the second-level conveying part and the third-level conveying part and the artificial heart valve, during the conveying process of the artificial heart valve, the connecting part can be limited in a fixed space without releasing, the main body part of the artificial heart valve is released firstly, whether the releasing position of the artificial heart valve is accurate or not is judged, when the releasing position of the artificial heart valve needs to be adjusted, the part of the connecting part limited in the fixed space can be used as a basis to control the three-stage conveying part to slide towards the main body and to constrict the main body in the three-stage conveying part, thereby realizing the recovery of the artificial heart valve, and then the delivery position of the artificial heart valve can be adjusted again, and the accurate installation position of the heart valve is ensured.
More specifically, when the valve is released, the linkage adjusting device is arranged at the opening position, and the rotating wheels of all stages drive the valve to release stage by stage. When the valve is recovered, the valve is recovered into the pipeline corresponding to the three-level conveying part by rotating the rotary wheel of the three-level conveying system, then the linkage adjusting device is arranged at the locking position, and simultaneously the rotary wheel rotates reversely, at the moment, the one-level conveying part and the three-level conveying part move in the same direction, the valve is released from the pipeline of the three-level conveying system and simultaneously enters the lumen of the Tip corresponding to the one-level conveying part, and complete restoration (valve restoration) is realized.
Drawings
FIG. 1 is a schematic view of the overall appearance of a fixation portion of a retrievable prosthetic access valve system according to an embodiment of the invention;
FIG. 2 is a schematic cross-sectional view of a fixation portion of a retrievable prosthetic access valve system according to an embodiment of the invention;
FIG. 3 is a schematic view of the overall appearance of the tertiary delivery section of the retrievable prosthetic access valve system of an embodiment of the invention;
FIG. 4 is a schematic cross-sectional view of a tertiary delivery portion of a retrievable prosthetic access valve system according to an embodiment of the invention;
FIG. 5 is a schematic view of the overall appearance of the primary delivery section of a retrievable prosthetic access valve system according to an embodiment of the invention;
FIG. 6 is a schematic cross-sectional view of a primary delivery portion of a retrievable prosthetic access valve system according to an embodiment of the invention;
FIG. 7 is a schematic diagram illustrating the overall appearance of the secondary delivery portion of the retrievable prosthetic access valve system of the embodiment of the invention;
FIG. 8 is a schematic cross-sectional view of a secondary delivery portion of a retrievable prosthetic access valve system according to an embodiment of the invention;
FIG. 9 is a schematic view of a prosthetic heart valve of a retrievable prosthetic access valve system according to an embodiment of the invention;
FIG. 10 is a schematic illustration of a prosthetic heart valve of a retrievable prosthetic access valve system according to another embodiment of the invention;
FIG. 11 is a schematic view of a prosthetic heart valve of a retrievable prosthetic access valve system according to another embodiment of the invention;
FIG. 12 is a schematic view of a prosthetic heart valve of a retrievable prosthetic access valve system according to another embodiment of the invention;
FIG. 13 is a schematic view of a prosthetic heart valve of a retrievable prosthetic access valve system according to a second different aspect of the invention;
FIG. 14 is a perspective view of a head mount of a retrievable prosthetic access valve system according to an embodiment of the invention;
FIG. 15 is a schematic cross-sectional view of a head mount of a retrievable prosthetic access valve system according to an embodiment of the invention;
FIG. 16 is a schematic view of a retrievable prosthetic access valve system according to an embodiment of the invention with the valve frame fully released;
FIG. 17 is a schematic illustration of a first and second connectors of a valve frame of a retrievable prosthetic access valve system according to an embodiment of the invention in an unreleased state;
figure 18 is a schematic view of a valve portion (only the valve frame portion shown) in a compressed state;
FIGS. 19-20 are schematic views of the atrial portion of the valve with the first and second attachment members unreleased;
fig. 21 to 23 are schematic views illustrating a process of retracting a prosthetic heart valve tip of a retrievable prosthetic interventional valve system according to an embodiment of the present invention;
FIG. 24 is a schematic view of a retrievable prosthetic access valve system according to an embodiment of the invention;
FIG. 25 is a schematic view of the internal structure of the delivery portion of a retrievable prosthetic access valve system according to an embodiment of the invention;
FIG. 26 is a cross-sectional view of the front end of the delivery portion of the retrievable prosthetic access valve system of an embodiment of the invention;
FIG. 27 is a schematic view of the operation of a retrievable prosthetic access valve system according to an embodiment of the invention;
FIG. 28 is a perspective view of a delivery portion of a retrievable prosthetic access valve system according to an embodiment of the invention;
FIG. 29 is a cooperative view of a linkage adjustment mechanism of the delivery portion of the retrievable prosthetic access valve system according to one embodiment of the invention;
FIG. 30 is a schematic view of the internal structure of the delivery portion of a retrievable prosthetic access valve system according to an embodiment of the invention;
fig. 31 is a schematic view of an inner wheel structure of a delivery portion of a retrievable prosthetic access valve system, according to an embodiment of the invention.
Description of reference numerals:
1. a handle housing; 2. a front end luer fitting; 3. a three-stage handle rotary wheel; 4. a third-stage inner wheel; 5. a tertiary pipeline; 6. a primary handle spinning wheel; 7. a primary inner wheel; 8. a primary pipeline; 9. tip head; 10. a secondary handle rotary wheel; 11. a secondary inner wheel; 12. a secondary pipeline; 13. an end fixture; 14. a rear luer fitting; 15. a fixed tube; 16. a head mount; 17. a linkage adjusting device; 18. a main body; 19. an anchoring portion; 20. a first connecting member; 21. a second connecting member; 22. connecting the fixing part; 23. a large head section; 24. a small head section; 25. a pressing section; 26. a first fixing groove; 27. a second fixing groove; 28. a cam wrench; 29. locking a ring; 30. an outer layer; 31. a connecting portion; 32. an inner layer; 33. a clamping groove.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings and the embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Referring collectively to fig. 1-31, according to an embodiment of the present invention, a retrievable prosthetic interventional valve system comprises a prosthetic heart valve portion and a delivery portion, wherein the valve portion comprises a valve frame comprising a main body 18, an anchor 19 and a connector; the conveying part comprises a petal frame fixing part, a first-stage conveying part and a third-stage conveying part, the first-stage conveying part is sleeved in the petal frame fixing part and can axially move relative to the petal frame fixing part, the third-stage conveying part is sleeved outside the petal frame fixing part and can axially move relative to the petal frame fixing part, and a fixing space is formed between the petal frame fixing part and the third-stage conveying part; the artificial heart valve connecting piece is positioned in the fixed space and can be released from the fixed space when the three-stage conveying part slides to the outer side of the fixed space, and the three-stage conveying part and/or the primary conveying part can slide towards the main body 18 when the connecting piece is fixed in the fixed space and can be used for binding the main body 18 in the three-stage conveying part and/or the primary conveying part; the valve can be retracted into the space between the three-stage delivery part and the one-stage delivery part before release; the end of the primary conveying part is provided with a tip head 9, and the tip head 9 is provided with a containing cavity, and the opening of the containing cavity faces the artificial heart valve.
A second-stage conveying part capable of axially moving relative to the petal frame fixing part is arranged between the third-stage conveying part and the petal frame fixing part, the third-stage conveying part is sleeved outside the second-stage conveying part and can axially move relative to the second-stage conveying part, and a fixing space is formed between the petal frame fixing part and the second-stage conveying part; the prosthetic heart valve connector is positioned in the fixing space and can be released from the fixing space when the secondary delivery part slides to the outer side of the fixing space, and the tertiary delivery part and/or the primary delivery part can slide towards the main body 18 when the connector is fixed in the fixing space and can be used for binding the main body 18 in the tertiary delivery part and/or the primary delivery part; the valve is retractable into the space between the tertiary and primary delivery portions prior to release.
In this embodiment, when the delivery portion includes the valve frame fixing portion, the primary delivery portion, the secondary delivery portion, and the tertiary delivery portion at the same time, the primary delivery portion is sleeved in the valve fixing portion and is capable of moving axially relative to the valve fixing portion, the secondary delivery portion is sleeved in the valve fixing portion and is capable of moving axially relative to the valve fixing portion, the tertiary delivery portion is sleeved in the secondary delivery portion and is capable of moving axially relative to the secondary delivery portion, a fixing space is formed between the valve fixing portion and the secondary delivery portion, the artificial heart valve includes an atrium portion, a main body 18, and a connecting member, the connecting member is located in the fixing space during assembly and is capable of being released when the secondary delivery portion slides axially outward of the fixing space, the main body 18 is sleeved in the valve fixing portion, and the tertiary delivery portion is capable of sliding toward the main body 18 when the connecting member is fixed in the fixing space, and constricts the body 18 within the tertiary delivery section.
For some embodiments, in order to simplify the arrangement of the delivery system, the secondary delivery part may not be arranged, at this time, the tertiary delivery part is directly sleeved outside the arranged valve fixing part to form a corresponding fixing space, and the valve connecting piece is positioned in the space formed by the tertiary delivery part and the valve fixing part; the other parts of the valve are still positioned in the corresponding pipelines of the three-stage delivery part.
The recoverable artificial intervention valve system utilizes the valve fixing part, the primary conveying part, the secondary conveying part and the tertiary conveying part to be matched with the artificial heart valve, can realize the conveying of the artificial heart valve, can limit the connecting piece in the fixed space in the conveying process of the artificial heart valve without releasing, firstly releases all or part of other parts of the artificial heart valve, judges whether the releasing position of the artificial heart valve is accurate, when the releasing position of the artificial heart valve needs to be adjusted, can utilize the part limited in the fixed space by the connecting piece as a base, controls the movement of the tertiary conveying part and/or the primary conveying part to re-bundle the released valve part in the tertiary conveying part and/or the primary conveying part, realizes the recovery of the artificial heart valve, and further can adjust the conveying position of the artificial heart valve again, the accurate installation position of the heart valve is ensured.
Referring to fig. 1-24, in one embodiment, the valve fixing portion includes a fixing tube 15, a head fixing frame 16, and a handle housing 1, the fixing tube 15 is disposed in the handle housing 1, and the head fixing frame 16 is disposed at an end of the fixing tube 15 extending out of the handle housing 1. The handle shell 1 can be of an integral structure and can also be folded into two halves; it is recommended to use a two-half design and then to make the halves together. The involutive connection mode is not limited, and comprises various prior arts such as bayonet, screw thread and the like.
The conveying parts are provided with corresponding rotary wheels; and a linkage adjusting device 17 is arranged between the rotary wheels corresponding to the first-stage conveying part and the third-stage conveying part, and the linkage adjusting device 17 can realize the adjustment of the common motion state and the independent motion state between the rotary wheels of the first-stage conveying part and the third-stage conveying part. The rotary wheel corresponding to the first-level conveying part is adjacent to the rotary wheel corresponding to the third-level conveying part, and the linkage adjusting device 17 is more convenient to install and set.
The linkage adjusting device 17 is provided with a first working position and a second working position, and when the linkage adjusting device is arranged at the first working position, the rotary wheels corresponding to the first-stage conveying part and the third-stage conveying part can rotate in a linkage manner; when the first working position is reached, the first-stage conveying part and the third-stage conveying part can rotate independently.
When the valve is released, the linkage adjusting device 17 is arranged at the opening position, and the valve is gradually released by the rotation of each rotary wheel step by step; when the valve is recovered, the valve is recovered into the pipeline corresponding to the three-level conveying part by rotating the rotary wheel of the three-level conveying system, then the linkage adjusting device 17 is arranged at the locking position, and meanwhile, the rotary wheel rotates reversely, the one-level conveying part and the three-level conveying part move in the same direction, the valve is released from the pipeline of the three-level conveying system and enters the accommodating cavity of the Tip head corresponding to the one-level conveying part, and the complete reset is realized.
Specifically, the end of the primary delivery portion is provided with a tip head 9, the tip head 9 having a receiving cavity opening towards the prosthetic heart valve, the prosthetic heart valve further comprising an atrial portion connected at an end of the main body 18 remote from the connector, the atrial portion being capable of collapsing within the receiving cavity.
The first-stage conveying part further comprises a first-stage pipeline 8, a first-stage inner wheel 7 and a first-stage handle rotary wheel 6, the first-stage inner wheel 7 is arranged in the first-stage handle rotary wheel 6, one end of the first-stage pipeline 8 is fixedly arranged on the first-stage inner wheel 7, and a tip head 9 is arranged at one end, far away from the first-stage handle rotary wheel 6, of the first-stage pipeline 8.
The second-stage conveying part comprises a second-stage handle rotary wheel 10 and a second-stage inner wheel 11 arranged in the second-stage handle rotary wheel 10, a second-stage pipeline 12 is fixedly arranged on the second-stage inner wheel 11, the second-stage pipeline 12 penetrates out from one end of the second-stage handle rotary wheel 10, and an end fixing part 13 matched with a head fixing frame 16 is arranged at the tail end of the penetrating part.
The three-stage conveying part comprises a three-stage pipeline 5, a three-stage handle rotary wheel 3 and a three-stage inner wheel 4, wherein the three-stage inner wheel 4 is sleeved in the three-stage handle rotary wheel 3, one end of the three-stage pipeline 5 is installed on the three-stage inner wheel 4, and the three-stage pipeline 5 is sleeved outside a second-stage pipeline 12.
Each level of inner wheel can be divided into an inner layer 32, an outer layer 30 and a connecting part 31; wherein the inner layer 32 is arranged in the handle shell 1, the outer layer 30 is sleeved on the handle shell 1, and the connecting part 31 between the inner layer and the outer layer is arranged in a groove on the handle shell 1. The inner wheel has an outer layer 30, a connecting portion 31 and an inner layer 32; the outer layer 30 is sleeved on the handle shell 1 of the conveying system, the inner layer 32 is positioned in the handle shell 1 of the conveying system and is connected with a corresponding pipeline, and the connecting part 31 is connected with the inner layer 30 and the outer layer 30 and is arranged in a clamping groove 33 in the axial direction of the handle shell 1; the rotary wheel is arranged outside the inner wheel and is matched with the inner wheel through threads.
The outer layer 30 is typically provided with threads that mate with corresponding internal threads of the secondary handle runner 10; in order to increase the amplitude of linear motion generated by rotation, threads of the rotary wheel and the inner wheel can be set to be of a double-thread or multi-thread structure, and a double-pitch mode is recommended; the screw thread can be right-handed or left-handed, and can be a standard screw thread or a non-standard screw thread; or the connecting rod can be directly connected in a certain mode without being arranged in a thread mode to realize push-pull movement. In addition, the rotary wheels and the inner wheels at all levels can be arranged into an integral structure and a two-half split structure as required, and the integral structure is preferably recommended to be arranged, as shown in the embodiment.
The valve portion comprises a frame comprising an atrial portion attached to the head of the body 18, a main body 18, an anchor portion 19 attached to the tail of the main body 18, and a first attachment 20, a leaflet and a sealing skirt (only the frame portion is shown, the leaflet and sealing skirt portions being referred to any prior art), the anchor portion 19 being attached to the first attachment 20, the anchor portion 19 extending towards the atrial portion.
The atrium portion is connected to the head portion of the main body 18 and is generally in a corolla shape, the first connecting piece 20 is connected to the tail portion of the main body 18, the anchoring portion 19 is connected with the first connecting piece 20, the anchoring portion 19 extends towards the atrium portion, the first connecting piece 20 is provided with a pressing section 25, when the pressing section 25 is acted by the conveying system portion, the anchoring portion 19 connected with the first connecting piece 20 is outwards opened, the conveying system portion is provided with a fixing portion, the fixing portion is used for containing the pressing section 25 of the valve frame, a head fixing frame 16 is arranged on one side, close to the main body 18, of the fixing portion, the head fixing frame 16 comprises first fixing grooves 26, the first fixing grooves 26 are alternately arranged along the circumferential direction of the fixing portion, and the pressing section 25 of the first connecting piece 20 can be contained in the first fixing grooves 26.
The head mount 16 further includes second fixing grooves 27, the second fixing grooves 27 and the first fixing grooves 26 are alternately arranged along a circumferential direction of the head mount 16, and the second coupling members 21 are installed in the second fixing grooves 27.
The far end of the head fixing frame 16 is provided with an inclined plane matched with the abutting section 25 of the valve frame, when the valve is assembled, the abutting section 25 of the first connecting piece 20 is correspondingly assembled on the inclined plane corresponding to the head fixing frame 16, and then the secondary conveying part moves towards the far end to fix the abutting section on the corresponding inclined plane. Then operating the conveying system part to assemble and sleeve the valve ventricle part into the corresponding tube sac of the three-stage conveying part; and the atrial portion is correspondingly fitted into the corresponding capsule of the primary delivery portion corresponding to the distal tip head 9. When the valve is released, the delivery system part is operated firstly to enable the three-stage delivery part to withdraw, the valve is exposed, at the moment, because the atrium part is still restrained in the capsule corresponding to the tip head 9, and meanwhile, the ventricle part is also partially restrained; the corresponding anchoring portion 19 of the petal cradle is thus flared outwardly by the combined forces of the delivery system part and the main body 18, as a result of the first connector 20 and the abutment section 25.
When the abutting section 25 opens the anchoring part 19, the main body 18 of the valve frame is not completely unfolded at the moment, and is not expanded to the maximum radius, under the condition, the anchoring part 19 is driven to be unfolded under the action of the abutting section 25, so that the unfolding radius of the anchoring part 19 is obviously larger than the current unfolding radius of the main body 18, therefore, the anchoring part 19 can be smoothly in contact fit with the natural valve leaflets of the human body in advance of the main body 18, the interference of the main body 18 is avoided, the clamping of the artificial heart valve system can be ensured to be stable, the loosening phenomenon is effectively prevented, the installation stability of the artificial heart valve system is improved, and the problems that under the existing medical conditions, the barb of the artificial heart valve system is not enough to be unfolded after the artificial heart valve system is implanted into the human body, and the clamping or the clamping is not firm or loosened are solved easily are solved.
The side surface of the first fixing groove 26 close to the main body 18 is formed with an inclined surface, the pressing section 25 presses against the inclined surface, and when the valve is released by the delivery system part, the anchoring part 19 can be expanded outwards under the action of the inclined surfaces of the delivery system part and the first fixing groove 26.
The connection fixed part that first connecting piece 20 and second connecting piece 21 correspond all can set up big head section 23 and little head section 24, little head section 24 is connected with main part 18, big head section 23 is connected in the one end that little head section 24 kept away from main part 18, the card is established and is formed backstop structure in the notch that conveying system part fixed part corresponds during the assembly, thereby make big head section 23 establish when connecting the fixed part outside at the conveyer pipe cover, can form the backstop, avoid connecting the fixed part and deviate from the conveyer pipe, guaranteed that the connection fixed part can not release along the conveyer pipe axial, can only follow the radial release of conveyer pipe, consequently, when conveyer pipe breaks away from big head section 23 place scope completely, it just can release completely to connect the fixed part, and then realize the complete release of artificial heart valve system. The connecting and fixing part can be in a T-shaped structure, or in a shape similar to a T shape or other shapes with a big end and a small end.
The recoverable artificial intervention valve system conveying part corresponding to the embodiment comprises a fixing part, a primary conveying part, a secondary conveying part and a tertiary conveying part, can be configured as described in the embodiment, and can be adjusted and increased or decreased according to needs. In addition, the linkage adjusting device 17 corresponding to the embodiment is provided with a locking ring 29 and a cam wrench 28 which are arranged on the primary conveying system, and the locking ring 29 is opened and contracted through the movement of different positions of the cam wrench 28, so that the part of the rotating wheel corresponding to the tertiary conveying system, which is inserted into the locking ring 29, is correspondingly locked; and then when moving, the two rotary wheels move together and drive the two-stage conveying part to move together. In the embodiment, the locking ring 29 is used as a part of the rotary wheel of the primary conveying system and can also be independently arranged; the spiral wheel can also be arranged as a part of the spiral wheel of the three-stage conveying system, and the concrete mode is not limited. Tensioning and retraction of the cam wrench 28 is accomplished by the mating of a bolt and nut.
The rotary wheel parts corresponding to the three-stage conveying part and the primary conveying part on the conveying system are adjacently arranged, so that the linkage adjusting device 17 on the primary conveying part can be directly linked with the three-stage conveying part without adding other devices, and the realization mode is simpler. The two-stage conveying system and the three-stage conveying system can be arranged in a non-adjacent mode or in an arbitrary mode, for example, the two-stage conveying system and the three-stage conveying system are arranged adjacently, when the three-stage conveying system and the one-stage conveying system are linked, an additional part is required to be arranged to cross the middle two-stage conveying part to realize linkage.
The inner wheels and the rotary wheels of the primary conveying part, the secondary conveying part and the tertiary conveying part can be same or different in screw pitch, but the screw pitch and the rotary direction of the primary conveying part and the tertiary conveying part are necessarily the same in consideration of linkage of the primary conveying part and the tertiary conveying part, and the secondary conveying part can be different. Meanwhile, in the embodiment, the corresponding pipeline parts move reversely when the valve is recyclable and the conveying system and the three-stage conveying system are linked, so that the threads are designed into a reverse structure. I.e. one is left-handed and the other is right-handed.
The linkage adjusting device 17 adopts a cam structure to realize a self-locking function (the rotary wheels of the first-level conveying part and the third-level conveying part are fixed together) during locking, and can also be realized by adopting a buckle or a screw nut (an inner hexagonal screw, an outer hexagonal screw, a plum screw and the like) to be screwed.
In the embodiment, a first-stage pipeline 8 of a first-stage conveying part and a corresponding inner wheel are separated by a second-stage conveying part and a third-stage corresponding pipeline. Therefore, the connection between the primary pipeline 8 and the corresponding inner wheel is carried out by punching corresponding long grooves on the corresponding secondary and tertiary pipelines 5, and the existence of the long strip enables the primary system to correspondingly do corresponding linear motion; meanwhile, the inner wheel is provided with corresponding connecting parts such as screw holes and the like which are connected with the primary pipeline 8. The fixing mode of a boss fastening screw, gluing or pin connection and the like can be specifically adopted. The connection of the rear end Ruhr joint 14 and the fixed pipe 15 also adopts a similar mode, the connection of the primary pipeline 8 of the primary conveying part and the primary inner wheel 7 adopts that a groove is formed at a certain position in the middle of the primary pipeline 8, an intermediate piece is designed and processed to be clamped in the groove, and the connection of the intermediate piece and the inner wheel is still fixed by a boss set screw. The fixed pipe 15 and the secondary pipe 12 are provided with grooves in the middle, and the intermediate piece does not interfere with the fixed pipe 15 and the secondary pipe 12 when moving axially along with the primary inner wheel 7.
The installation, release and recovery process of the recoverable artificial intervention valve system corresponding to the embodiment for the artificial valve is as follows:
after the system is assembled, the system is placed in a proper position of a ventricle to ensure that the linkage adjusting device 17 is arranged at a loosening position, and is rotated to the position, when the three-stage handle spinning wheel 3 is rotated rightwards, the three-stage pipeline 5 continuously moves backwards, the valve frame is completely separated from the three-stage pipeline 5, the atrium part and the connecting and fixing part 22 of the valve frame are not opened, the anchoring part 19 is opened, the diameter of the opening part of the anchoring part 19 is larger than that of other parts of the valve frame, and the anchoring part 19 can be smoothly matched with the natural valve leaflet of a human body in a clamping mode before the main body 18 and cannot be interfered by the main body 18. If the release is not appropriate, the wheel can be rotated in the opposite direction to fully retract the valve into the conduit, and then released again as described above.
And step two, the primary handle spinning wheel 6 is rotated leftwards, the tip head 9 moves forwards until the tip head 9 is completely separated from the valve frame, at the moment, the atrium part and the main body 18 of the valve frame are completely opened, and the main body 18 and small barbs around the atrium can also be clamped and matched with natural valve leaflets of a human body.
Step three, observing whether the release angle and the position of the valve are proper or not according to the development, and if so, performing step four; if the valve is not suitable to be retracted into the tertiary pipeline 5 again, the specific steps are as follows: (1) and the levogyration tertiary handle rotary wheel 3 continuously moves forwards, the valve gradually contracts and completely enters the tertiary pipeline 5, the anchoring part 19 and the atrium part also sequentially enter the tertiary pipeline 5, and the levogyration tertiary handle rotary wheel 3 is stopped when the tertiary pipeline 5 is contacted with the tip head 9. (2) The linkage adjusting device 17 is locked by the handle of the linkage adjusting device 17, the first-stage handle rotating wheel 6 and the third-stage handle rotating wheel 3 are locked into a whole, the first-stage handle rotating wheel 6 (or the third-stage handle rotating wheel 3) is rotated rightwards, the tip head 9 and the third-stage pipeline 5 move backwards simultaneously until reaching the end, and at the moment, the front end of the valve frame enters the tip head 9, and the valve can be released again. And repeating the first step, the second step and the third step again until the valve is released to the proper position.
And fourthly, rotating the secondary handle spinning wheel 10 rightwards, moving the end fixing piece 13 backwards, separating the end fixing piece 13 from the fixed connection part of the valve frame, releasing the first connecting piece 20 and the second connecting piece 21 of the valve frame from the fixed space in sequence and preventing the first connecting piece 20 and the second connecting piece 21 of the valve frame from being in contact with the head fixing frame 16, so that the valve comprises the atrium part and the main body 18 on the valve frame, all the anchoring part 19, the first connecting piece 20 and the second connecting piece 21 are released, and the barbs on the anchoring part 19, the atrium part and the main body 18 are clamped on the natural valve leaflets of the human body.
And step five, taking out the system from the ventricle, and slowly and gently taking out the system as a whole according to the image prompt displayed by the radiography display.
In addition, in consideration of certain conditions, the corresponding pipe of the three-stage conveying system can be directly matched with the fixing part to fix the valve frame connecting piece, and the two-stage conveying part is not needed. The overall design of the conveying system is thus made simpler. This solution is more compact, especially for a valve without anchoring 19 or a pressing section design without anchoring 19.
The foregoing has outlined rather broadly the subject matter of the present invention in connection with the embodiments and the accompanying drawings, and in part, further details and sub-aspects of the present invention may be found in the detailed description. Such details are within the purview of one of ordinary skill in the art based on the teachings herein and are obtained in accordance with the general knowledge or practice of the art.
Those skilled in the art will readily appreciate that the specific embodiments presented herein are merely exemplary ways to achieve relative or synchronous movement between the components of the catheter sections of the present invention. For example, in order to move the member a and the member B relative to each other, the member a may be held stationary and the member B may be moved, or the member a may be moved in the opposite direction while the member B is held stationary. These different embodiments are either equivalent to the embodiments described above or further modifications, but do not depart from the essence of the corresponding technical solution, as defined in the claims.
Claims (10)
1. A retrievable prosthetic access valve system comprising a prosthetic heart valve portion and a delivery portion,
wherein the valve part comprises a valve frame, the valve frame comprises a main body (18), an anchoring part (19) and a connecting piece;
the conveying part comprises a petal frame fixing part, a primary conveying part and a tertiary conveying part; the first-stage conveying part is sleeved in the petal frame fixing part and can axially move relative to the petal frame fixing part, the third-stage conveying part is sleeved outside the petal frame fixing part and can axially move relative to the petal frame fixing part, and a fixing space is formed between the petal frame fixing part and the third-stage conveying part; the artificial heart valve connecting piece is positioned in the fixed space and can be released from the fixed space when the tertiary delivery part slides to the outside of the fixed space, and the tertiary delivery part and/or the primary delivery part can slide towards the main body (18) when the connecting piece is fixed in the fixed space and constrict the main body (18) in the tertiary delivery part and/or the primary delivery part; the valve can be retracted into the space between the tertiary delivery part and the primary delivery part before being released; the end part of the primary conveying part is provided with a tip head (9), the tip head (9) is provided with a containing cavity, and the opening of the containing cavity faces the artificial heart valve.
2. The retrievable prosthetic access valve system of claim 1, wherein a secondary delivery portion is disposed between the tertiary delivery portion and the valve frame fixing portion, the secondary delivery portion being axially movable relative to the valve frame fixing portion, the tertiary delivery portion being disposed over the secondary delivery portion and being axially movable relative to the secondary delivery portion, the valve frame fixing portion and the secondary delivery portion forming a fixing space therebetween; the artificial heart valve connecting piece is positioned in the fixed space and can be released from the fixed space when the secondary conveying part slides to the outer side of the fixed space, and the tertiary conveying part and/or the primary conveying part can slide towards the main body (18) when the connecting piece is fixed in the fixed space and constrict the main body (18) in the tertiary conveying part and/or the primary conveying part; the valve is retractable into the space between the tertiary and primary delivery portions prior to release.
3. The recoverable prosthetic intervention valve system of claim 1 or 2, wherein the delivery portions each correspond to a spinning wheel; and a linkage adjusting device (17) is arranged between the rotary wheels corresponding to the first-stage conveying part and the third-stage conveying part.
4. The retrievable prosthetic access valve system of claim 3, wherein the roller associated with the primary delivery segment is adjacent to the roller associated with the tertiary delivery segment.
5. The retrievable prosthetic access valve system of claim 3, wherein the linkage adjustment means (17) has a first operative position in which the respective wheels of the primary and tertiary delivery sections are rotatable in linkage; when the first working position is reached, the first-stage conveying part and the third-stage conveying part can rotate independently.
6. The retrievable prosthetic access valve system of claim 5, wherein the linkage adjustment means (17) includes a cam wrench (28) and a locking ring (29); in the second working position, the cam wrench (28) is located on the non-protruding surface, and the locking ring (29) is open; in the first working position, the cam wrench (28) is located on the protruding surface and the locking ring (29) is locked.
7. The retrievable prosthetic access valve system of claim 3, wherein the delivery portion includes a wheel, an inner wheel, a conduit; the inner wheel is provided with an outer layer (30), a connecting part (31) and an inner layer (32); the outer layer (30) is sleeved on the handle shell (1) of the conveying system, the inner layer (32) is located in the handle shell (1) of the conveying system and connected with a corresponding pipeline, and the connecting part (31) is connected with the inner layer (30) and arranged in an axial clamping groove (33) of the handle shell (1); the rotary wheel is arranged outside the inner wheel and is matched with the inner wheel through threads.
8. The retrievable prosthetic access valve system of claim 3, wherein the wheels of the primary and tertiary delivery portions are of the same helical orientation, and the corresponding threads are single, double or multiple helical.
9. The retrievable prosthetic access valve system of claim 1, wherein the prosthetic heart valve further comprises an atrial portion connected at an end of the body (18) remote from the connector, the atrial portion being adapted to be constricted within the receiving cavity of the tip head (9); the anchoring part (19) is positioned in the pipeline corresponding to the three-stage conveying part after being converged.
10. The retrievable prosthetic intervention valve system of claim 1, wherein the linkage adjustment means (17) is arranged in an open position when the valve is released, and the rotation of the rotary wheels progressively releases the valve; when the valve is recovered, the valve is recovered into a pipeline corresponding to the three-level conveying part by rotating the rotary wheel of the three-level conveying system, then the linkage adjusting device (17) is arranged at a locking position, meanwhile, the rotary wheel is rotated reversely, the first-level conveying part and the third-level conveying part move in the same direction at the same time, the valve is released from the pipeline of the three-level conveying system and enters an accommodating cavity of a Tip head corresponding to the first-level conveying part at the same time, and the valve is completely reset.
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CN202210433647.8A CN114795588A (en) | 2022-04-24 | 2022-04-24 | Recoverable artificial intervention valve system |
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CN111616835A (en) * | 2020-06-24 | 2020-09-04 | 科凯(南通)生命科学有限公司 | Artificial heart valve's implantation device |
CN112451174A (en) * | 2020-12-11 | 2021-03-09 | 启晨(上海)医疗器械有限公司 | Interventional transapical artificial heart valve conveying system |
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CN1745727A (en) * | 2004-09-08 | 2006-03-15 | 王蓉珍 | Intercurrent artificial heart valve, its implanting and recovering device |
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CN104983485A (en) * | 2015-07-27 | 2015-10-21 | 上海纽脉医疗科技有限公司 | Valve coupling mechanism of heart valve transporter |
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