CN110338857B - Clamp holder for repairing valve leaflet - Google Patents
Clamp holder for repairing valve leaflet Download PDFInfo
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- CN110338857B CN110338857B CN201910712065.1A CN201910712065A CN110338857B CN 110338857 B CN110338857 B CN 110338857B CN 201910712065 A CN201910712065 A CN 201910712065A CN 110338857 B CN110338857 B CN 110338857B
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- clamping elastic
- clamping
- elastic piece
- groove
- inner rod
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- 230000008439 repair process Effects 0.000 claims description 27
- 229910000831 Steel Inorganic materials 0.000 claims description 9
- 239000010959 steel Substances 0.000 claims description 9
- 230000000149 penetrating effect Effects 0.000 claims description 8
- 239000012634 fragment Substances 0.000 claims 4
- 230000005489 elastic deformation Effects 0.000 claims 1
- 210000004115 mitral valve Anatomy 0.000 description 23
- 230000000670 limiting effect Effects 0.000 description 10
- 238000000034 method Methods 0.000 description 5
- 206010027727 Mitral valve incompetence Diseases 0.000 description 4
- 206010067171 Regurgitation Diseases 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 208000031481 Pathologic Constriction Diseases 0.000 description 3
- 239000000560 biocompatible material Substances 0.000 description 3
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- 210000005240 left ventricle Anatomy 0.000 description 3
- 230000036262 stenosis Effects 0.000 description 3
- 208000037804 stenosis Diseases 0.000 description 3
- 238000011282 treatment Methods 0.000 description 3
- 210000000591 tricuspid valve Anatomy 0.000 description 3
- 238000010586 diagram Methods 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 230000003902 lesion Effects 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
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- 229910001000 nickel titanium Inorganic materials 0.000 description 2
- 210000005245 right atrium Anatomy 0.000 description 2
- 210000005241 right ventricle Anatomy 0.000 description 2
- 239000012781 shape memory material Substances 0.000 description 2
- 208000003430 Mitral Valve Prolapse Diseases 0.000 description 1
- 229910001257 Nb alloy Inorganic materials 0.000 description 1
- 229910001275 Niobium-titanium Inorganic materials 0.000 description 1
- 229910001252 Pd alloy Inorganic materials 0.000 description 1
- 208000012287 Prolapse Diseases 0.000 description 1
- 201000001943 Tricuspid Valve Insufficiency Diseases 0.000 description 1
- 206010044640 Tricuspid valve incompetence Diseases 0.000 description 1
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical class [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 description 1
- KHOFBPOVUAPBTF-UHFFFAOYSA-N [Ti].[Ni].[Nb] Chemical compound [Ti].[Ni].[Nb] KHOFBPOVUAPBTF-UHFFFAOYSA-N 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000010100 anticoagulation Effects 0.000 description 1
- 210000000709 aorta Anatomy 0.000 description 1
- 210000001765 aortic valve Anatomy 0.000 description 1
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- 238000010438 heat treatment Methods 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
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- 229920001296 polysiloxane Polymers 0.000 description 1
- 210000001147 pulmonary artery Anatomy 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00778—Operations on blood vessels
- A61B2017/00783—Valvuloplasty
Abstract
The invention relates to the technical field of medical instruments, and discloses a clamp for repairing valve leaflets. According to the clamp for repairing the valve leaflet, the locking assembly is driven to reciprocate by pushing and pulling the actuating rod so that the main body frame is inserted into or separated from the first through groove, the first clamping elastic piece and the second clamping elastic piece can be elastically deformed to clamp the position to be clamped on the valve leaflet, after the valve leaflet is clamped by the first clamping elastic piece and the second clamping elastic piece, the first clamping elastic piece can be limited to expand outwards by utilizing the opposite side walls of the first through groove, and the valve leaflet clamped between the first clamping elastic piece and the second clamping elastic piece is prevented from being separated. Compared with the existing holders, the holders for repairing the valve leaflets have the advantages of fewer parts, simple structure, convenient operation, shortened operation time and enhanced clamping stability of the valve leaflets.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a clamp holder for repairing valve leaflets.
Background
The heart has four valves, the valve between the left atrium and the left ventricle is the mitral valve, the valve between the right atrium and the right ventricle is the tricuspid valve, the valve between the aorta and the left ventricle is the aortic valve, and the valve between the pulmonary artery and the right ventricle is the pulmonary valve. A normal valve can maintain a unidirectional flow of blood by opening and closing in response to pressure differences on each side, ensuring that the blood of the chamber is pumped out without backflow. Valve lesions caused by endocarditis are lesions of the valve that are impaired in function, a wide variety of diseases, such as rheumatic heart disease, where stenosis and regurgitation are common valvular diseases. Stenosis is the inability of the valve to open completely, resulting in impeded blood flow, and thickening due to calcification of the valve leaflets is a common cause of stenosis. Regurgitation is due to the inability of the leaflets to close completely, resulting in blood flowing back to the pumping chamber, and valve annulus distension, valve leaflet prolapse, and obstruction of valve leaflet movement are the primary causes of regurgitation.
There are two main treatment regimens for valvular disease: valve replacement or valve repair. Compared with valve replacement, the valve repair utilizes a primary valve, has fewer complications, is quick to recover, does not need lifelong anticoagulation, and can better maintain the valve function. Thus, the mitral or tricuspid valve is somewhat more effective in treating with valve repair.
At present, valve regurgitation improvement by repairing a diseased valve of a human body by using a valve repair clamp is an important valve repair technology, wherein MitraClip is widely popularized in clinic and has better clinical curative effect. The main principle is that the prolapsed mitral valve leaflet/tricuspid valve leaflet is sutured with the corresponding anterior leaflet or posterior leaflet to form a double-hole mitral valve edge middle point suture, thereby reducing mitral regurgitation, and the flow into the left ventricle is not affected when the mitral valve in diastole is opened, but Mitraclip still has the following problems: complicated structure, difficult clamping of the valve leaflet, long operation time, etc.
Disclosure of Invention
The invention aims to provide the clamp for repairing the valve leaflet, which has the advantages of simple structure, convenient operation and strong stability.
To achieve the purpose, the invention adopts the following technical scheme:
a leaflet repair clip comprising:
the clamping assembly comprises a first clamping elastic sheet and a second clamping elastic sheet positioned at one side of the first clamping elastic sheet; the first clamping elastic sheet and the second clamping elastic sheet penetrate through the main body frame, and both ends of the first clamping elastic sheet and the second clamping elastic sheet extend out of the main body frame;
the locking assembly is provided with a first through groove;
the actuating rod penetrates through the main body frame, the second clamping elastic piece and the first clamping elastic piece in sequence, and is detachably connected to the locking assembly, the actuating rod can reciprocate along the axial direction of the actuating rod relative to the main body frame so that the main body frame can be inserted into or separated from the first through groove, and meanwhile the first clamping elastic piece and the second clamping elastic piece can be elastically deformed to clamp the position to be clamped on the valve leaf.
As a preferable embodiment of the holder for leaflet repair, the locking assembly is screwed to the actuating rod.
As a preferred technical scheme of the holder for repairing the valve leaflet, the locking assembly comprises a locking cap provided with the first through groove and an inner rod connected with the locking cap, wherein one end of the inner rod connected with the locking cap is provided with an inner threaded hole, one end of the actuating rod is provided with an outer thread matched with the inner threaded hole, and the detachable connection of the actuating rod and the inner rod is realized through the matching of the outer thread and the inner threaded hole.
As a preferred technical scheme of the holder for repairing the valve leaflet, one end of the main body frame is provided with the second through groove, the first through groove is opposite to the opening of the second through groove, the bottom wall of the second through groove is provided with the limit column, the first clamping elastic sheet and the second clamping elastic sheet are sleeved on the limit column, and both ends of the first clamping elastic sheet and both ends of the second clamping elastic sheet extend out of the second through groove.
As an preferable technical scheme of the holder for repairing the valve leaflet, in two opposite side walls of the second through groove, each side wall is provided with a limiting boss pointing to the other side wall, and the minimum distance between the two limiting bosses is smaller than the minimum width of the first clamping elastic sheet arranged in the second through groove.
As a preferable technical scheme of the holder for repairing the valve leaflet, the free end of the inner rod is provided with a second inverted tooth;
the free end of the inner rod passes through the main body frame and can be abutted against one end of the main body frame, which is far away from the second through groove, or the second inverted tooth is clamped between the inner rod and the main body frame.
As a preferred embodiment of the holder for leaflet repair, the holder further comprises:
the free end of the inner rod is inserted with one end of the inner rod along the radial direction of the inner rod, and one end of the actuating rod penetrates through the inner rod and is connected with the locking assembly in a threaded mode so that the inner rod and the inner rod are fixed relatively.
As a preferable technical scheme of the holder for repairing the valve leaflet, the main body frame is provided with a penetrating hole for penetrating the inner rod, one of the outer wall of the inner rod or the inner wall of the penetrating hole is provided with a sliding groove extending along the axial direction of the inner rod, and the other one of the outer wall of the inner rod or the inner wall of the penetrating hole is provided with a protrusion matched with the sliding groove.
As a preferred embodiment of the holder for leaflet repair, the holder further comprises:
the first traction wire penetrates through the traction hole and is connected to the locking assembly;
and the traction steel wire is connected with the second traction holes through a conveying system.
As a preferable technical scheme of the holder for repairing the valve leaflet, the surface of the first clamping elastic sheet and/or the surface of the second clamping elastic sheet are provided with an anti-slip layer so as to further enhance the clamping action on the valve leaflet.
Simultaneously, the first clamping elastic sheet and the second clamping elastic sheet are all made of shape memory materials, and the main body frame, the clamping assembly, the locking assembly and the actuating rod are all made of biocompatible materials.
The invention has the beneficial effects that:
1. according to the clamp for repairing the valve leaflet, the locking assembly is driven to reciprocate by pushing and pulling the actuating rod so that the main body frame is inserted into or separated from the first through groove, and meanwhile, the first clamping elastic sheet and the second clamping elastic sheet can be elastically deformed to clamp the position to be clamped on the valve leaflet, the whole process is simple to operate, and the valve leaflet can be rapidly clamped, so that the operation time is shortened;
2. after the valve leaflet is clamped by the first clamping elastic piece and the second clamping elastic piece, the clamp for repairing the valve leaflet provided by the invention uses the opposite side walls of the first through groove to limit the outward expansion of the first clamping elastic piece, so that the valve leaflet between the first clamping elastic piece and the second clamping elastic piece cannot deviate from, and the stability of clamping is ensured;
3. compared with the existing clamp holder, the clamp holder for repairing the valve leaflet has the advantages of fewer parts, simple structure, low production cost and reduced medical cost of patients.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following description will briefly explain the drawings needed in the description of the embodiments of the present invention, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to the contents of the embodiments of the present invention and these drawings without inventive effort for those skilled in the art.
Fig. 1 is a schematic view showing a structure of a holder for leaflet repair according to an embodiment of the present invention in an open state;
FIG. 2 is a first cross-sectional view of a holder for leaflet restoration provided by an embodiment of the present invention in an open state;
FIG. 3 is a second cross-sectional view of the holder for leaflet restoration provided by the embodiment of the present invention in an open state;
FIG. 4 is a schematic view of a closed state of a holder for leaflet repair according to an embodiment of the present invention;
FIG. 5 is a cross-sectional view of a leaflet repair clip according to an embodiment of the present invention in a closed state;
FIG. 6 is a schematic structural view of a main body frame according to an embodiment of the present invention;
fig. 7 is a schematic structural diagram of a first clamping spring according to an embodiment of the present invention;
fig. 8 is a schematic structural diagram of a main body frame according to an embodiment of the present invention;
FIG. 9 is a schematic view of the structure of an inner rod according to an embodiment of the present invention;
fig. 10 is a schematic structural view of a release lever according to an embodiment of the present invention.
In the figure:
1. a main body frame; 11. a second through slot; 12. a limit column; 13. a limit boss; 14. penetrating holes; 15. a chute;
2. a clamping assembly; 21. a first clamping spring plate; 211. a first traction aperture; 212. a spline hole; 22. the second clamping elastic sheet; 221. a second traction aperture; 222. a first inverted tooth;
3. a locking assembly; 31. a locking cap; 311. a first through groove; 312. a third through slot; 32. an inner rod; 321. a groove; 322. a protrusion; 323. a second inverted tooth;
4. an actuating lever;
5. a release lever; 51. and a bump.
Detailed Description
In order to make the technical problems solved, the technical scheme adopted and the technical effects achieved by the invention more clear, the technical scheme of the invention is further described below by a specific embodiment in combination with the attached drawings. It is to be understood that the specific embodiments described herein are merely illustrative of the invention and are not limiting thereof. It should be further noted that, for convenience of description, only some, but not all of the drawings related to the present invention are shown.
As shown in fig. 1 to 5, the present embodiment provides a holder for repairing a leaflet, which can be used for mitral regurgitation treatment, and also for tricuspid regurgitation treatment, and this embodiment takes mitral regurgitation treatment as an example. The holder for repairing the valve leaflet comprises a main body frame 1, a clamping assembly 2, a locking assembly 3 and an actuating rod 4, wherein the clamping assembly 2 comprises a first clamping elastic piece 21 and a second clamping elastic piece 22 which are distributed along a first direction (L1 direction shown in fig. 1), the first clamping elastic piece 21 is positioned on one side of the second clamping elastic piece 22, and the first clamping elastic piece 21 and the second clamping elastic piece 22 can be elastically deformed to clamp a position to be clamped on the valve leaflet of the valve leaflet between the first clamping elastic piece 21 and the second clamping elastic piece 22. In this embodiment, the first clamping spring piece 21 and the second clamping spring piece 22 are made of a shape memory material through a heat treatment process, and the memory metal is preferably nickel-titanium alloy, titanium-nickel-niobium alloy or titanium-nickel-palladium alloy.
The two side walls of the width direction (the direction indicated by L3 in fig. 1) of the second clamping elastic piece 22 are provided with a plurality of first inverted teeth 222 which are obliquely arranged, the second clamping elastic piece 22 comprises a middle part and first ends and second ends which are positioned at two sides of the middle part, each first inverted tooth 222 of the first ends of the second clamping elastic piece 22 is gradually far away from the second clamping elastic piece 22 along the direction gradually approaching to the tail end of the first ends, and the inclination directions of the first inverted teeth 222 positioned at the same side on the first ends and the second ends are opposite. The quick capture of the mitral valve leaflet is realized through the cooperation between the first clamping elastic sheet 21 and the second clamping elastic sheet 22, and simultaneously, the friction between the second clamping elastic sheet 22 and the mitral valve leaflet is increased by the first inverted tooth 222 on the second clamping elastic sheet 22, so that the clamping strength of the clamping assembly is ensured.
The locking assembly 3 is provided with a first through groove 311, the depth direction of the first through groove 311 is consistent with the first direction, and the first clamping elastic piece 21 is positioned between the second clamping elastic piece 22 and the bottom wall of the first through groove 311. In this embodiment, the locking assembly 3 includes a locking cap 31 having a first through slot 311, and an inner rod 32 having one end connected to a bottom wall of the first through slot 311. Preferably, the first through groove 311 is a U-shaped groove.
Since the holder for leaflet restoration is placed in the human body, the actuating rod 4 is detached. For this purpose, one end of the actuating rod 4 passes through the main body frame 1, the second clamping spring 22 and the first clamping spring 21 in sequence and is detachably connected to the locking assembly 3. In this embodiment, the locking assembly 3 is threadedly coupled to the actuating rod 4. Specifically, the inner rod 32 is connected to the bottom wall of the first through groove 311 by means of laser welding, clamping or mortise and tenon joint, an inner threaded hole is formed in one end of the inner rod 32 connected to the bottom wall of the first through groove 311, an external thread matched with the inner threaded hole is formed in one end of the actuating rod 4, and detachable connection between the actuating rod 4 and the inner rod 32 is achieved through matching of the external thread and the inner threaded hole. In other embodiments, the actuating rod 4 may be directly screwed to the locking cap 31, while the inner rod 32 is eliminated.
As shown in fig. 1 and 6, in the present embodiment, one end of the main body frame 1 is provided with a second through slot 11 extending along a second direction (L2 direction shown in fig. 1), an opening of the second through slot 11 is opposite to an opening of the first through slot 311, a bottom wall of the second through slot 11 is provided with a limit post 12, the first clamping elastic piece 21 and the second clamping elastic piece 22 are sleeved on the limit post 12, and both ends of the first clamping elastic piece 21 and the second clamping elastic piece 22 extend out of the second through slot 11; in the opposite two side walls of the second through groove 11, each side wall is provided with a limiting boss 13 pointing to the other side wall, and the minimum distance between the two limiting bosses 13 is smaller than the minimum width of the first clamping elastic sheet 21 arranged in the second through groove 11. Through the arrangement, the middle parts of the first clamping elastic piece 21 and the second clamping elastic piece 22 are limited in the second through groove 11, so that the first clamping elastic piece 21 and the second clamping elastic piece 22 cannot be separated from the second through groove 11 along the first direction and the second direction.
As shown in fig. 6 and 7, in order to prevent the first clamping spring piece 21 and the second clamping spring piece 22 from rotating relative to the main body frame 1, the limiting post 12 is, but not limited to, a spline-shaped structure, and the first clamping spring piece 21 and the second clamping spring piece 22 are provided with spline holes 212 that are matched with the limiting post 12.
In this embodiment, the actuating rod 4 can push the locking assembly 3 to reciprocate relative to the main body frame 1 along the axial direction (the direction indicated by L1 in fig. 1) of the actuating rod 4 so as to enable the main body frame 1 to be inserted into or separated from the first through slot 311, and simultaneously drive the clamping assembly 2 to move so as to enable the first clamping elastic sheet 21 and the second clamping elastic sheet 22 to elastically deform to clamp the position to be clamped on the mitral valve leaflet. In this embodiment, the clamping assembly 2 is capable of moving between a closed state and an open state, as shown in fig. 1 to 3, the clamping assembly 2 is in the open state, and the first clamping elastic piece 21 and the second clamping elastic piece 22 are in a natural state and are attached to each other; the locking cap 31 moves towards the direction approaching the main body frame 1 by pulling the actuating rod 4, as shown in fig. 4 and 5, the first clamping elastic piece 21 and the second clamping elastic piece 22 elastically deform to clamp the position to be clamped on the mitral valve leaflet between the first clamping elastic piece 21 and the second clamping elastic piece 22, so that the clamping assembly 2 gradually changes from an open state to a closed state, and simultaneously, the first clamping elastic piece 21 is limited to expand outwards through the opposite side walls of the first through groove 311, so that the limiting effect is achieved, and the clamping stability is ensured. Here, the actuating lever 4 is moved toward the operator side to be "pulled" in the present embodiment; conversely, by moving the actuating lever 4 away from the operator side, it is "pushed".
The holder for repairing a valve leaflet provided in this embodiment drives the locking assembly 3 to reciprocate by pushing and pulling the actuating rod 4 so that the main body frame 1 is inserted into or separated from the first through groove 311, and simultaneously drives the clamping assembly 2 to move so that the first clamping elastic sheet 21 and the second clamping elastic sheet 22 can elastically deform to clamp the position to be clamped on the valve leaflet, and the opposite side walls of the first through groove 311 limit the outward expansion of the first clamping elastic sheet 21. Compared with the existing clamp holder, the whole process is simple to operate, and the rapid clamping of the valve leaflet can be realized, so that the operation time is shortened.
Further, as shown in fig. 1 and 7, two first traction holes 211 are formed at both ends of the first clamping spring 21 in the length direction (the direction indicated by L2 in fig. 1), and a traction wire (not shown) is connected to the locking cap 31 through the first traction holes 211. In this embodiment, two ends of the traction wire are connected to the inner wall of the first through slot 311. Pushing the actuating rod 4 to drive the locking cap 31 to move so as to drive the traction wire to move, wherein the traction wire drives the first clamping elastic sheet 21 to expand outwards; pulling the actuating rod 4 drives the traction wire to move reversely, the traction wire drives the second clamping elastic piece 22 to close inwards, and the first clamping elastic piece 21 is opened and closed by pushing and pulling the actuating rod 4. When the opening and closing angle of the first clamping elastic piece 21 is adjusted by the actuating rod 4, the adjusting range of the opening and closing angle is 0-270 degrees, so that compared with the prior art, the clamp for repairing the valve leaflet has a larger opening and closing angle, and can clamp the valve leaflet more easily.
In this embodiment, the opposite side walls of the first through slot 311 are respectively provided with a third through slot 312 extending along the second direction, and the opening of the third through slot 312 is opposite to the opening of the second through slot 11. Both ends of the traction wire are respectively penetrated into the second through groove 11 from the corresponding third through groove 312 so as to be connected with the inner wall of the first through groove 311. The traction wire and the inner wall of the first through groove 311 may be welded or otherwise connected, which is not limited herein.
Further, as shown in fig. 1, the holder for repairing a leaflet according to the present embodiment further includes a pulling wire (not shown in the drawings) connected to the second pulling holes 221 at both ends of the second clamping elastic sheet 22 in the length direction by a conveying system. The stretching angle of the second clamping elastic sheet 22 is adjusted by adjusting the traction steel wire so as to be convenient for capturing mitral valve leaflets more quickly, and after the adjustment is finished, the traction steel wire can be pulled out from the tail end of the conveying system so as to prevent the traction steel wire from influencing operation. The above-mentioned conveying system is the prior art, and will not be described here in detail.
When the clamping assembly 2 is switched from the closed state to the open state, the actuating rod 4 is pushed to drive the locking cap 31 to move along the direction L1 in the figure away from the main body frame 1 so as to drive the traction wire to move, the traction wire drives the first clamping elastic piece 21 to expand outwards, and meanwhile, the actuating rod 4 drives the main body frame 1 to gradually separate from the first through groove 311.
When the clamping assembly 2 is switched from the open state to the closed state, the actuating rod 4 is pulled to drive the locking cap 31 to move along the direction L1 in the figure to the direction close to the main body frame 1 so as to drive the traction wire to move, the traction wire drives the first clamping elastic piece 21 to be closed inwards, and meanwhile, the actuating rod 4 drives the main body frame 1 to gradually enter the first through groove 311.
In the embodiment, the push-pull actuating rod 4 is adopted to adjust the opening and closing of the first clamping elastic piece 21, the retraction and extension pulling steel wire is used for controlling the opening and closing of the second clamping elastic piece 22, the rapid capture of the valve leaflet and the clamping of the position to be clamped on the mitral valve leaflet are realized, the operation steps are simple, the operation time can be reduced, and the operation risk is reduced; and the first clamping spring piece 21 is limited to expand outwards by using the opposite side walls of the first through groove 311.
As shown in fig. 8 and 9, in order to enable the actuating rod 4 to move axially relative to the inner rod 32 when the actuating rod 4 is screwed, the main body frame 1 is provided with a through hole 14 for passing through the inner rod 32, one of the outer wall of the inner rod 32 or the inner wall of the through hole 14 is provided with a sliding groove 15 extending axially along the inner rod 32, and the other is provided with a protrusion 322 matched with the sliding groove 15. In this embodiment, the outer wall of the inner rod 32 is provided with a protrusion 322, the inner wall of the through hole 14 is provided with a chute 15 matched with the protrusion 322, and the inner rod 32 can only move along the first direction by matching the protrusion 322 with the chute 15.
Further, the holder for repairing a leaflet provided in this embodiment further includes a release rod 5, wherein the free end of the inner rod 32 is inserted into one end of the release rod 5 along the radial direction of the inner rod 32, and one end of the actuating rod 4 passes through the release rod 5 and is screwed to the locking assembly 3 so that the inner rod 32 and the release rod 5 are relatively fixed.
Specifically, as shown in fig. 9 and 10, one end of the release lever 5 is provided with a bump 51, the free end of the inner lever 32 is provided with a groove 321 which is inserted into the bump 51, and radial insertion of the release lever 5 and the inner lever 32 is achieved by cooperation of the bump 51 and the groove 321. After one end of the actuating rod 4 passes through the release rod 5 and is screwed to the inner rod 32, the actuating rod 4 can limit the radial movement and the axial movement between the release rod 5 and the inner rod 32; after screwing the actuating lever 4 to disengage the actuating lever 4 from the inner lever 32, the disengaging lever 5 can be moved radially to disengage from the inner lever 32. In the present embodiment, the bump 51 is formed by providing an S-shaped notch at one end of the release lever 5, and the bump 51 is not limited to the above configuration, but may be a rectangular bump or other shapes.
In other embodiments of the present invention, the positions of the tab 51 and the groove 321 may be interchanged, i.e., the tab 51 is provided on the inner rod 32 and the groove 321 is provided on the release rod 5.
Further, as shown in fig. 9, the free end of the inner rod 32 is provided with a second inverted tooth 323, and the second inverted tooth 323 is clamped between the inner rod 32 and the main body frame 1 in the process of capturing the position to be clamped on the mitral valve leaflet through the first clamping elastic sheet 21 and the second clamping elastic sheet 22; after the first clamping elastic piece 21 and the second clamping elastic piece 22 capture the position to be clamped on the mitral valve leaflet, the actuating rod 4 is pulled until the second clamping elastic piece 22 is completely closed, the position to be clamped on the mitral valve leaflet is clamped between the first clamping elastic piece 21 and the second clamping elastic piece 22, the second inverted tooth 323 on the inner rod 32 is ejected from the inside of the main body frame 1, the second inverted tooth 323 is clamped at one end of the main body frame 1, which is away from the second through groove 11, so that the movement of the inner rod 32 is limited, the relative position between the locking assembly 3 and the main body frame 1 is fixed, the outer side of the first clamping elastic piece 21 is abutted against the inner wall of the first through groove 311, and the mitral valve leaflet clamped between the first clamping elastic piece 21 and the second clamping elastic piece 22 is ensured not to deviate.
The body frame 1, the clamping assembly 2, the locking assembly 3, the actuating rod 4 and the connecting members used in this embodiment are all made of biocompatible materials. The biocompatible material can be nickel-titanium alloy, cobalt-chromium alloy, stainless steel, polymer, silicone, etc. The first and second barbs 222, 323 in this embodiment are atraumatic barbs, i.e., do not cause trauma to the mitral valve leaflet tissue when capturing the mitral valve leaflet.
Further, the surface of the first clamping spring piece 21 and/or the second clamping spring piece 22 is provided with an anti-slip layer, so as to further enhance the clamping effect on the valve leaflet. The anti-slip layer may be a frosted layer, or protrusions may be provided on the surfaces of the first clamping elastic sheet 21 and the second clamping elastic sheet 22, and the shapes of the protrusions may be waves, protruding points, etc., which are not limited herein. Preferably, the anti-slip layer is provided on a side of the first clamping spring 21 facing the second clamping spring 22, and on a side of the second clamping spring 22 facing the first clamping spring 21.
The holder for leaflet repair of the present embodiment can be mounted in a delivery system for performing interventional procedures of the heart. The specific operation of the holder for leaflet repair will be described below by taking the mitral valve "rim-to-rim" closure repair as an example.
The holder for valve leaflet repair is in a fully closed state before entering the left atrium, and is placed in the delivery system, ensuring its fluency of intervention via the femoral vein passage, preventing excessive volume from affecting other tissues of the mitral valve. After the transseptal puncture, the delivery system is guided by the radiography equipment to adjust the position of the clamp holder for repairing the valve leaflet through the operation handle in the delivery system from the right atrium to the left atrium, after reaching the target position, the first clamping elastic sheet 21 is opened by pushing the actuating rod 4, meanwhile, the second clamping elastic sheet 22 is unfolded according to the shape memory function of the first clamping elastic sheet, and the unfolding angle of the second clamping elastic sheet 22 is adjusted by pulling the steel wire, so that the edge of the mitral valve can be captured more quickly. When the first clamping elastic piece 21 contacts the mitral valve, the traction steel wire of the second clamping elastic piece 22 is loosened, the second clamping elastic piece 22 and the first clamping elastic piece 21 are matched to clamp the edge of the mitral valve, and then the traction steel wire is pulled out. The outer clamping arm is gradually closed by adjusting the actuating rod 4, and the clamping of the edge of the mitral valve is realized by the second clamping elastic sheet 22 and the first clamping elastic sheet 21. Upon confirming that the above procedure is completed, the mitral regurgitation is relieved and the entire delivery system, actuating rod 4 and release rod 5 are withdrawn, leaving the remainder of the leaflet repair holder at the mitral valve margin.
It is to be understood that the above examples of the present invention are provided for clarity of illustration only and are not limiting of the embodiments of the present invention. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. Any modification, equivalent replacement, improvement, etc. which come within the spirit and principles of the invention are desired to be protected by the following claims.
In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. Wherein the terms "first position" and "second position" are two different positions.
In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
Claims (10)
1. A leaflet repair clip, comprising:
the clamping assembly (2) comprises a first clamping elastic sheet (21) and a second clamping elastic sheet (22) positioned at one side of the first clamping elastic sheet; the first clamping elastic piece (21) and the second clamping elastic piece (22) penetrate through the main body frame (1) and both ends of the first clamping elastic piece extend out of the main body frame (1); a plurality of first inverted teeth (222) which are obliquely arranged are arranged on two side walls of the second clamping elastic piece (22) in the width direction;
the locking assembly (3) is provided with a first through groove (311);
the actuating rod (4), one end of actuating rod (4) passes in proper order main part frame (1), second clamp shell fragment (22) with first clamp shell fragment (21) and can dismantle connect in locking subassembly (3), actuating rod (4) can follow its axial for main part frame (1) reciprocating motion so that main part frame (1) inserts or breaks away from first logical groove (311), simultaneously make first clamp shell fragment (21) with second clamp shell fragment (22) can take place elastic deformation in order to clamp the waiting to press from both sides tight position on the valve leaf.
2. The leaflet repair gripper according to claim 1, characterized in that the locking assembly (3) is screwed with the actuation rod (4).
3. Gripper for valve leaflet repair according to claim 2, characterized in that the locking assembly (3) comprises a locking cap (31) provided with the first through groove (311), and an inner rod (32) connected with the locking cap (31), wherein one end of the inner rod (32) connected with the locking cap (31) is provided with an inner threaded hole, one end of the actuating rod (4) is provided with an outer thread matched with the inner threaded hole, and the detachable connection of the actuating rod (4) and the inner rod (32) is realized through the matching of the outer thread and the inner threaded hole.
4. A leaflet repair clamp according to claim 3, characterized in that one end of the main body frame (1) is provided with a second through groove (11), the openings of the first through groove (311) and the second through groove (11) are opposite, the bottom wall of the second through groove (11) is provided with a limit post (12), the first clamping elastic piece (21) and the second clamping elastic piece (22) are sleeved on the limit post (12), and both ends of the first clamping elastic piece (21) and both ends of the second clamping elastic piece (22) extend out of the second through groove (11).
5. Gripper for valve leaflet repair according to claim 4, characterized in that in the opposite side walls of the second through-going groove (11), each side wall is provided with a limit boss (13) pointing to the other side wall, the minimum distance between two limit bosses (13) being smaller than the minimum width of the first clamping spring piece (21) placed in the second through-going groove (11).
6. The leaflet repair clip according to claim 4, characterized in that the free end of the inner rod (32) is provided with a second pawl (323);
the free end of the inner rod (32) passes through the main body frame (1) and can be abutted against one end of the main body frame (1) deviating from the second through groove (11), or the second inverted tooth (323) is clamped between the inner rod (32) and the main body frame (1).
7. The leaflet repair clip according to claim 3, further comprising:
and the free end of the inner rod (32) is inserted with one end of the inner rod (5) along the radial direction of the inner rod (32), and one end of the actuating rod (4) penetrates through the inner rod (5) and is connected with the locking assembly (3) in a threaded manner so that the inner rod (32) and the inner rod (5) are relatively fixed.
8. A leaflet repair holder according to claim 3, characterized in that the main body frame (1) is provided with a penetrating hole (14) for penetrating the inner rod (32), one of the outer wall of the inner rod (32) or the inner wall of the penetrating hole (14) is provided with a sliding groove (15) extending along the axial direction of the inner rod (32), and the other is provided with a protrusion (322) matched with the sliding groove (15).
9. The leaflet repair clip according to any one of claims 1 to 8, further comprising:
the traction wire penetrates through the first traction hole (211) and is connected to the locking component (3);
and the traction steel wire is connected with the second traction holes (221) through a conveying system.
10. Gripper for leaflet repair according to any one of claims 1 to 8, characterized in that the surface of the first clamping dome (21) and/or the second clamping dome (22) is provided with an anti-slip layer.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910712065.1A CN110338857B (en) | 2019-08-02 | 2019-08-02 | Clamp holder for repairing valve leaflet |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910712065.1A CN110338857B (en) | 2019-08-02 | 2019-08-02 | Clamp holder for repairing valve leaflet |
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| CN110338857A CN110338857A (en) | 2019-10-18 |
| CN110338857B true CN110338857B (en) | 2024-03-29 |
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| CN201910712065.1A Active CN110338857B (en) | 2019-08-02 | 2019-08-02 | Clamp holder for repairing valve leaflet |
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| WO2016090308A1 (en) | 2014-12-04 | 2016-06-09 | Edwards Lifesciences Corporation | Percutaneous clip for repairing a heart valve |
| CN110433010A (en) | 2015-05-14 | 2019-11-12 | 爱德华兹生命科学公司 | Heart valve sealing device and its delivery apparatus |
| US10799675B2 (en) | 2016-03-21 | 2020-10-13 | Edwards Lifesciences Corporation | Cam controlled multi-direction steerable handles |
| US10653862B2 (en) | 2016-11-07 | 2020-05-19 | Edwards Lifesciences Corporation | Apparatus for the introduction and manipulation of multiple telescoping catheters |
| US10905554B2 (en) | 2017-01-05 | 2021-02-02 | Edwards Lifesciences Corporation | Heart valve coaptation device |
| LT3558169T (en) | 2017-04-18 | 2022-02-10 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| US11224511B2 (en) | 2017-04-18 | 2022-01-18 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| US11051940B2 (en) | 2017-09-07 | 2021-07-06 | Edwards Lifesciences Corporation | Prosthetic spacer device for heart valve |
| US11040174B2 (en) | 2017-09-19 | 2021-06-22 | Edwards Lifesciences Corporation | Multi-direction steerable handles for steering catheters |
| US10111751B1 (en) | 2018-01-09 | 2018-10-30 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
| US10231837B1 (en) | 2018-01-09 | 2019-03-19 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
| SG11202006509SA (en) | 2018-01-09 | 2020-08-28 | Edwards Lifesciences Corp | Native valve repair devices and procedures |
| US10945844B2 (en) | 2018-10-10 | 2021-03-16 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| EP4223258A1 (en) | 2019-02-14 | 2023-08-09 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
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