A mitral valve clip with high clamping force

Abstract

The present invention relates to the technical field of medical devices, and discloses a high-grip mitral valve clip, which includes a clamping assembly, a flow-blocking block, a first cuff and a second cuff; the clamping assembly is used to be fixed to a human valve, and the flow-blocking block is connected to the clamping assembly; the first cuff is connected to the flow-blocking block and extends towards the left side of the flow-blocking block; the second cuff is connected to the flow-blocking block and extends towards the right side of the flow-blocking block; wherein, both the first cuff and the second cuff are made of flexible materials. The first cuff and the second cuff in the present invention can better fill the gap of poor valve coaptation, thereby better eliminating heart reflux, and this high-grip mitral valve clip has better versatility, which helps to reduce the treatment cost of patients.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a mitral clip with high clamping force. Background Art

[0002] In recent years, medical device manufacturers at home and abroad have developed many interventional devices for treating mitral or tricuspid regurgitation. However, the currently used interventional devices cannot completely fill the gap of valve malcoaptation, resulting in an unsatisfactory effect of eliminating cardiac regurgitation. Moreover, some interventional devices cannot adapt to different patients and need to be customized according to the patient's condition during treatment, which will lead to high treatment costs for patients. Summary of the Invention

[0003] One technical problem to be solved by this application is that the currently used interventional devices cannot completely fill the gap of valve malcoaptation, resulting in an unsatisfactory effect of eliminating cardiac regurgitation.

[0004] In order to solve the deficiencies of the prior art, the present invention provides a mitral clip with high clamping force.

[0005] To achieve the above object, the present invention provides the following technical solutions:

[0006] A mitral clip with high clamping force, which includes a clamping assembly, a flow blocking block, a first cuff and a second cuff. The clamping assembly is used to fix to the human valve, and the flow blocking block is connected to the clamping assembly; the first cuff is connected to the flow blocking block and extends towards the left side of the flow blocking block; the second cuff is connected to the flow blocking block and extends towards the right side of the flow blocking block; wherein, both the first cuff and the second cuff are made of flexible materials.

[0007] Compared with the prior art, in the initial stage of implanting the mitral clip with high clamping force provided by the present invention into the human body, the first cuff and the second cuff can undergo self-adaptive deformation under the action of blood and match the gap of valve malcoaptation. Therefore, the first cuff and the second cuff can better fill the gap of valve malcoaptation, thereby better eliminating cardiac regurgitation. In addition, the mitral clip with high clamping force has better versatility, which is beneficial to reducing the treatment cost of patients.

[0008] In some embodiments, the surfaces of the first cuff and the second cuff are densely covered with holes.

[0009] This embodiment is conducive to endothelialization of the first cuff and the second cuff faster by providing holes on the surface of the cuff, so as to achieve the expected treatment effect faster.

[0010] In some embodiments, the first cuff includes a flat portion and a curved portion, both the flat portion and the curved portion are connected to the flow blocking block, and the middle of the curved portion protrudes away from the flat portion; the structure of the second cuff is mirror-symmetrical to that of the first cuff.

[0011] In this embodiment, the curved surface portion provided can better fill the gap of valve malalignment, thereby further improving the effect of eliminating cardiac regurgitation.

[0012] In some embodiments, both the flat plate portion and the curved surface portion are meshworks with biocompatibility. A part of the edge of the flat plate portion is connected to a part of the edge of the curved surface portion, so as to form a cavity between the flat plate portion and the curved surface portion, and an opening communicating with the cavity is formed at one end of the first cuff adjacent to the ventricle.

[0013] In this embodiment, the process of making the cuff with the biocompatible meshwork is also relatively simple, which is beneficial to reducing the processing difficulty and production cost. Moreover, in the initial stage when the high-holding-force mitral valve clip provided in this embodiment is implanted into the human body, blood can enter the cavity from the opening, causing the first cuff to congest and expand. The first cuff after congestion and expansion can better fill the gap of valve malalignment, thereby further eliminating cardiac regurgitation.

[0014] In some embodiments, the first cuff further includes a limiting member located at the opening position. One end of the limiting member is connected to the flat plate portion, and the other end of the limiting member is connected to the curved surface portion.

[0015] In this embodiment, the provided limiting member makes the shape of the opening flat or fusiform in the early stage when the high-holding-force mitral valve clip is implanted into the human body, which can avoid the formation of thrombus in the first cuff. Since the second cuff has the same structure as the first cuff, the second cuff and the first cuff can achieve the same technical effect.

[0016] In some embodiments, the clamping assembly includes a first clamping arm, a second clamping arm and a connecting member; a first through hole is provided on the first clamping arm; a plurality of main spikes for piercing the human valve are provided on the second clamping arm, and the second clamping arm obliquely penetrates through the first through hole; a second through hole is provided on the connecting member, and both the first clamping arm and the second clamping arm are connected to the connecting member, and the connecting parts of the first clamping arm and the second clamping arm with the connecting member can be elastically deformed; wherein, both the first clamping arm and the second clamping arm are made of shape memory alloy, and a first threading hole and a second threading hole are provided at one end of the second clamping arm away from the connecting member.

[0017] In this embodiment, the first clamping arm and the second clamping arm are pre-shaped into an intersecting form, which can improve the clamping force of the first clamping arm and the second clamping arm, so that the clamping assembly is firmly fixed to the mitral valve, and the provided clamping assembly in this embodiment has the advantage of being easy to process.

[0018] In some embodiments, the clamping assembly further includes a left extension section and a right extension section connected to the second clamping arm and located on both sides of the second clamping arm respectively. The projections of the left extension section and the right extension section on the first clamping arm are at least partially located outside the first through hole.

[0019] In this embodiment, the left extension section and the right extension section are provided to define a predetermined angle between the first clamping arm and the second clamping arm, prevent the second clamping arm from being excessively bent, and avoid breaking the second clamping arm.

[0020] In some embodiments, the clamping assembly further includes a left secondary spike connected to the left extension section and a right secondary spike connected to the right extension section, and the first clamping arm is located between the left secondary spike and the right secondary spike.

[0021] The left secondary spike and the right secondary spike provided in this embodiment can further improve the fixing effect of the clamping assembly, enabling the high clamping force mitral valve clip to be firmly fixed to the mitral valve; moreover, the left secondary spike and the right secondary spike are indirectly connected to the second clamping arm through the corresponding extension sections, which can effectively avoid deforming the second clamping arm when bending the secondary spikes. And during the clamping process, the first clamping arm is always located between the left secondary spike and the right secondary spike, and the left secondary spike and the right secondary spike provided can effectively prevent the second clamping arm from swinging during the clamping process.

[0022] In some embodiments, the connection positions of the left extension section and the right extension section with the second clamping arm are adjacent to or located in the middle of the second clamping arm.

[0023] This embodiment is beneficial to ensuring that the first clamping arm and the second clamping arm have sufficient lengths to closely fit the mitral valve.

[0024] In some embodiments, one end of the first clamping arm away from the connecting member and / or one end of the second clamping arm away from the connecting member are bent, and the bending direction increases the distance between one end of the first clamping arm away from the connecting member and one end of the second clamping arm away from the connecting member.

[0025] In this embodiment, the bent portions of the first clamping arm and / or the second clamping arm can tightly clamp the mitral valve, further improving the clamping effect of the high clamping force mitral valve clip.

[0026] In some embodiments, a slot is provided on the connecting member, one end of the first clamping arm has a plug-in portion, and the plug-in portion and one end of the second clamping arm are both inserted into the slot.

[0027] This embodiment can conveniently realize the connection between the first clamping arm and the second clamping arm and the connecting member.

[0028] In some embodiments, the edge of the second clamping arm has a buffer portion, the number of buffer portions is equal to the number of main spikes, and one end of the main spike is connected to the corresponding buffer portion.

[0029] The buffer portion provided in this embodiment can effectively prevent the second clamping arm from deforming.

[0030] In some embodiments, a vertical plate is provided at one end of the second clamping arm away from the connecting member, a recovery hole is provided on the vertical plate, and the recovery hole and the main spike are respectively located on both sides of the second clamping arm.

[0031] This embodiment can perform a retrieval process on the high-gripping-force mitral valve clip, which helps reduce the risk of failure in gripping with the high-gripping-force mitral valve clip and avoids the need for the patient to undergo further thoracotomy due to gripping failure.

[0032] In some embodiments, a raised portion is provided at one end of the second clip arm away from the connecting member, and a retrieval hole is provided on the raised portion. The retrieval hole and the main thorn are respectively located on both sides of the second clip arm.

[0033] This embodiment can perform a retrieval process on the high-gripping-force mitral valve clip, which helps reduce the risk of failure in gripping with the high-gripping-force mitral valve clip and avoids the need for the patient to undergo further thoracotomy due to gripping failure.

[0034] In some embodiments, the flow-blocking block includes a support body and a sealing film covering the outside of the support body, and the support body and / or the sealing film are fixedly connected to the second clip arm.

[0035] The flow-blocking block provided in this embodiment can well fill the gap of poor valve coaptation to achieve the purpose of eliminating cardiac regurgitation.

[0036] In some embodiments, the flow-blocking block further includes a mesh cover covering the outside of the sealing film, and the mesh cover is densely covered with holes.

[0037] This embodiment is conducive to endothelialization of the flow-blocking block faster by providing a layer of mesh cover with holes on the outside of the sealing film. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0039] Figure 1 is a perspective view of an embodiment of the present invention.

[0040] Figure 2 is Figure 1 the structural diagram of the clamping assembly in

[0041] Figure 3 is Figure 2 the front view of

[0042] Figure 4 is Figure 2 the structural diagram of the first clip arm in

[0043] Figure 5 is Figure 2 the structural diagram of the second clip arm in

[0044] Figure 6 is Figure 2 The three-dimensional view of the connecting piece in

[0045] Figure 7 is Figure 2 The top view of the connecting piece in

[0046] Figure 8 is Figure 7 The sectional view along line A-A in

[0047] Figure 9 is the three-dimensional view of the flow-blocking block in the embodiment of the present invention.

[0048] Figure 10a is Figure 9 The top view of

[0049] Figure 10b is Figure 10a The sectional view along line B-B in

[0050] Figure 11 is Figure 9 The right view of

[0051] Figure 12 , 13 and 14 are three different embodiments of setting up the vertical plate on the second clamping arm in the present invention.

[0052] Figure 15 is Figure 14 Another three-dimensional view of the second clamping arm shown in

[0053] Figure 16 is the embodiment when setting up the raised part on the second clamping arm in the present invention.

[0054] Figure 17 is Figure 16 The partial enlarged view at position Ⅰ in

[0055] Figure 18 is the schematic diagram of the form when the clamping assembly is received in the conveying catheter in the present invention.

[0056] Figure 19 is the partial schematic diagram of the gauze used for the sleeve pocket in the embodiment of the present invention.

[0057] Figure 20 is the schematic diagram of the internal structure of the flow-blocking block in the embodiment of the present invention.

[0058] Figure 21 is the schematic diagram when the present invention is used in cooperation with the conveying catheter.

[0059] Figure 22 is the plane development view of a kind of second clamping arm in the embodiment of the present invention.

[0060] Figure 23 is Figure 22 the partial enlarged view at position II in the figure.

[0061] The reference numerals are explained as follows:

[0062] In the figure: 1, the first clamping arm; 101, the first through hole; 102, the insertion part; 103, the pin hole; 2, the second clamping arm; 201, the main thorn; 202, the first threading hole; 203, the second threading hole; 204, the left extension section; 205, the right extension section; 206, the left auxiliary thorn; 207, the right auxiliary thorn; 208, the first cutting groove; 209, the second cutting groove; 2010, the buffer part; 2011, the raised part; 2012, the pin hole; 2013, the third cutting groove; 2014, the fourth cutting groove; 3, the connecting piece; 301, the second through hole; 302, the slot; 303, the threaded hole; 4, the support body; 5, the sealing film; 6, the mesh cover; 7, the first sleeve pocket; 701, the flat part; 702, the curved surface part; 703, the cavity; 704, the opening; 705, the limiting piece; 8, the second sleeve pocket; 9, the hole; 10, the vertical plate; 1001, the insertion plate; 11, the set screw; 12, the recovery hole; 13, the gauze; 14, the dissociator; 15, the delivery catheter; 16, the first pull cord; 17, the second pull cord; 100, the clamping assembly; 200, the flow blocking block; 300, the heart implant surgical instrument. Detailed implementation manners

[0063] The following further describes the implementation manners of the present application in detail with reference to the drawings and embodiments. The detailed description and drawings of the following embodiments are used to exemplarily illustrate the principle of the present application, but cannot be used to limit the scope of the present application. The present application can be implemented in many different forms, is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

[0064] These embodiments of the present application are provided to make the present application thorough and complete, and to fully convey the scope of the present application to those skilled in the art. It should be noted that: unless otherwise specifically stated, the relative arrangements of the components and steps, the components of the materials, the numerical expressions and numerical values described in these embodiments should be interpreted as merely exemplary, rather than as limitations.

[0065] It should be noted that in the description of the present application, unless otherwise specified, the meaning of "a plurality" is greater than or equal to two; the orientation or positional relationships indicated by the terms "upper", "lower", "left", "right", "inner", "outer", etc. are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present application. When the absolute position of the described object changes, the relative position relationship may also change accordingly.

[0066] In addition, the "first", "second" and similar terms used in this application do not denote any order, quantity or importance, but are merely used to distinguish different parts. "Vertical" does not mean strictly vertical, but within the allowable error range. "Parallel" does not mean strictly parallel, but within the allowable error range. Words such as "comprising" or "including" mean that the elements before this word cover the elements listed after this word, and do not exclude the possibility of also covering other elements.

[0067] It should also be noted that in the description of this application, unless otherwise clearly specified and limited, the terms "installed", "connected" and "coupled" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances. When it is described that a specific device is located between a first device and a second device, there may or may not be an intermediate device between the specific device and the first device or the second device.

[0068] All terms used in this application have the same meanings as understood by those of ordinary skill in the art to which this application pertains, unless otherwise specifically defined. It should also be understood that terms defined in a general dictionary, such as those, should be interpreted as having meanings consistent with their meanings in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense, unless specifically defined as such here.

[0069] Technologies, methods and devices known to those of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, the technologies, methods and devices should be regarded as part of the specification.

[0070] See Figures 1 - 21 As shown, the present invention provides a high-grip mitral valve clip, which includes a clamping assembly 100, a flow-blocking block 200, a first cuff 7 and a second cuff 8. The clamping assembly 100 is used to be fixed to the human mitral valve, and the flow-blocking block 200 is connected to the clamping assembly 100; the first cuff 7 is connected to the flow-blocking block 200 and extends towards the left side of the flow-blocking block 200, and the second cuff 8 is connected to the flow-blocking block 200 and extends towards the right side of the flow-blocking block 200; wherein, both the first cuff 7 and the second cuff 8 are made of flexible materials, and the disturbance of blood flow can cause the first cuff 7 and the second cuff 8 to deform according to the internal structure of the human body.

[0071] During use, the high-grip mitral valve clip is delivered to the target position using the accompanying cardiac implant instrument 300. During this process, the attitude of the flow-blocking member 200 can be adjusted to place the first cuff 7 and the second cuff 8 at the edge area of the regurgitation orifice. After the position of the flow-blocking member 200 is adjusted, the clamping assembly 100 is fixed to the valve, thus achieving the fixation between the high-grip mitral valve clip and the valve. After the high-grip mitral valve clip is implanted into the target position in the human body, the flow-blocking member 200 can expand the coverage of the valve during diastole of the heart, and fill the regurgitation orifice during systole of the heart, thereby achieving the effect of eliminating heart regurgitation.

[0072] In the initial stage when the high-grip mitral valve clip is implanted into the human body, the first cuff 7 and the second cuff 8 can undergo self-adaptive deformation under the action of blood and match the gap of poor valve coaptation. Therefore, the first cuff 7 and the second cuff 8 can better fill the gap of poor valve coaptation, thereby better eliminating heart regurgitation. In addition, when high-grip mitral valve clips of the same specification are used for different patients, the first cuff 7 and the second cuff 8 made of flexible materials enable the high-grip mitral valve clip to adapt to different patients. Therefore, the high-grip mitral valve clip has better versatility, which is beneficial to reducing the treatment cost of patients.

[0073] In some embodiments, the surfaces of the first cuff 7 and the second cuff 8 are densely covered with holes 9, and the holes 9 are evenly distributed on the surface of the cuff. The size of the holes 9 should be suitable for tissue ingrowth. By providing the holes 9 on the surface of the cuff, it is beneficial to endothelialize the first cuff 7 and the second cuff 8 faster, thereby achieving the expected treatment effect faster.

[0074] In some embodiments, the first cuff 7 includes a flat portion 701 and a curved portion 702. Both the flat portion 701 and the curved portion 702 are connected to the flow-blocking member 200, and the middle of the curved portion 702 protrudes in a direction away from the flat portion 701; the second cuff 8 is mirror-symmetric to the structure of the first cuff 7. The provided curved portion 702 can better fill the gap of poor valve coaptation, thereby further improving the effect of eliminating heart regurgitation.

[0075] In specific implementation, both the flat portion 701 and the curved portion 702 are made of biocompatible mesh 13 or knitted film. A part of the edge of the flat portion 701 is connected to a part of the edge of the curved portion 702, so as to form a cavity 703 between the flat portion 701 and the curved portion 702, and an opening 704 communicating with the cavity 703 is formed at one end of the first cuff 7 close to the ventricle. As Figure 9 shown, there is only one opening 704 on the first cuff 7, and one end of the first cuff 7 far from the ventricle (i.e., Figure 9The left end of the first cuff 7 is blocked. The flat part 701 and the curved part 702 can be a single piece of mesh 13. The mesh 13 is folded in half at the middle position, and the edge of the mesh 13 is sutured to the flow-blocking block 200. When one edge of the mesh 13 is sewn to the flow-blocking block 200, pleats are made at the sewing position so that the mesh 13 forms the aforementioned curved part 702. The biocompatible mesh 13 is relatively easy to obtain, and the process of making the cuff with the biocompatible mesh 13 is also relatively simple, which is beneficial to reducing the processing difficulty and production cost. In the initial stage when the high-gripping mitral valve clip is implanted into the human body, blood can enter the cavity 703 from the opening 704, causing the first cuff 7 to expand due to blood filling. After expanding due to blood filling, the first cuff 7 has a larger blocking area and adapts to the gap with poor valve alignment, further eliminating heart regurgitation.

[0076] In some embodiments, the first cuff 7 further includes a limiting member 705 located at the opening 704. The limiting member 705 divides the opening 704 into two parts. The limiting member 705 can be made of a biocompatible cord. One end of the limiting member 705 is sewn to the flat part 701, and the other end of the limiting member 705 is sewn to the curved part 702. The provided limiting member 705 pulls the flat part 701 and the curved part 702 respectively, so that in the early stage when the high-gripping mitral valve clip is implanted into the human body, the shape of the opening 704 is flat or fusiform. In the later stage when the high-gripping mitral valve clip is implanted into the human body, the first cuff 7 will gradually be endothelialized. During the process of endothelialization of the first cuff 7, the flat part 701 and the curved part 702 gradually approach, and with the assistance of the limiting member 705, the opening 704 gradually closes, and the blood in the cavity 703 is discharged from the opening 704, thus avoiding the formation of thrombus in the first cuff 7. Since the second cuff 8 is mirror-symmetric to the first cuff 7 in structure, the second cuff 8 has the same functions as the first cuff 7.

[0077] In some embodiments, the clamping assembly 100 includes a first clamping arm 1, a second clamping arm 2, and a connecting member 3. The first clamping arm 1 is provided with a first through hole 101. The first through hole 101 is elongated, and the length of the first through hole 101 should be suitable for the end of the second clamping arm 2 far from the connecting member 3 to pass through. The second clamping arm 2 is provided with a plurality of main spikes 201 for piercing into the human valve. The main spikes 201 can be distributed along the edge of the second clamping arm 2, and the second clamping arm 2 obliquely penetrates through the first through hole 101. The connecting member 3 is provided with a second through hole 301 for a guide wire to pass through. Both the first clamping arm 1 and the second clamping arm 2 are connected to the connecting member 3, and the connecting parts of the first clamping arm 1 and the second clamping arm 2 with the connecting member 3 can be elastically deformed. Among them, both the first clamping arm 1 and the second clamping arm 2 are made of a shape memory alloy such as nitinol. The end of the second clamping arm 2 far from the connecting member 3 is provided with a first threading hole 202 and a second threading hole 203.

[0078] The first clamping arm 1 and the second clamping arm 2 are pre-shaped asFigure 2 In the shown configuration, the first clamping arm 1 and the second clamping arm 2 cross each other. When pulling the first clamping arm 1 and the second clamping arm 2, both the first clamping arm 1 and the second clamping arm 2 can rotate around their connection parts with the connecting member 3. The first wire passing hole 202 and the second wire passing hole 203 both penetrate through the second clamping arm 2, and the first wire passing hole 202 and the second wire passing hole 203 are spaced apart along the length direction of the second clamping arm 2. In this embodiment, the position of the opening 704 on the first sleeve pocket 7 can be either at the end close to the ventricle or at the end close to the connection end of the first clamping arm 1 and the second clamping arm 2.

[0079] In some embodiments, the clamping assembly 100 further includes a left extension section 204 and a right extension section 205 that are connected to the second clamping arm 2 and are respectively located on both sides of the second clamping arm 2. The projections of the left extension section 204 and the right extension section 205 on the first clamping arm 1 are at least partially located outside the first through hole 101. The provided left extension section 204 and right extension section 205 can define a predetermined angular shape between the first clamping arm 1 and the second clamping arm 2, prevent the second clamping arm 2 from being bent excessively, and avoid the second clamping arm 2 from being broken.

[0080] In some embodiments, the clamping assembly 100 further includes a left secondary thorn 206 connected to the left extension section 204 and a right secondary thorn 207 connected to the right extension section 205. The first clamping arm 1 is located between the left secondary thorn 206 and the right secondary thorn 207. As Figure 5 shown, the tip orientations of the left secondary thorn 206 and the right secondary thorn 207 are the same as the tip orientation of the main thorn 201. The provided left secondary thorn 206 and right secondary thorn 207 can further enhance the fixing effect of the clamping assembly 100, enable the high clamping force mitral valve clip to be firmly fixed to the mitral valve leaflet, and since the left secondary thorn 206 and the right secondary thorn 207 are indirectly connected to the second clamping arm 2 through the corresponding extension sections, it can effectively avoid the deformation of the second clamping arm 2 during bending, further ensuring that the product has a high qualification rate.

[0081] See Figure 3 shown, there is a certain angle α between the main thorn 201 and the secondary thorn and the second clamping arm 2. The tips of the main thorn 201 and the secondary thorn are inclined towards the connecting member 3, and the angle α between the main thorn 201 and the secondary thorn and the second clamping arm 2 is between 15 and 90 degrees. In a preferred embodiment, the angle α between the main thorn 201 and the secondary thorn and the second clamping arm 2 is 60 degrees.

[0082] In some embodiments, the connection positions of the left extension section 204 and the right extension section 205 with the second clamping arm 2 are close to or located at the middle of the second clamping arm 2. This can make the second clamping arm 2 have approximately the same length on both sides of the first clamping arm 1, ensuring that when the mitral valve is clamped between the first clamping arm 1 and the second clamping arm 2, the first clamping arm 1 and the second clamping arm 2 have sufficient length to closely fit the mitral valve.

[0083] In some embodiments, one end of the first clamping arm 1 away from the connecting member 3 and / or one end of the second clamping arm 2 away from the connecting member 3 are bent, and the bending direction increases the distance between one end of the first clamping arm 1 away from the connecting member 3 and one end of the second clamping arm 2 away from the connecting member 3. When the mitral valve is clamped between the first clamping arm 1 and the second clamping arm 2, the bent portions of the first clamping arm 1 and / or the second clamping arm 2 can tightly clamp the mitral valve, further improving the clamping effect of the high clamping force mitral valve clip. As Figure 3 shown, in this figure, one end of the second clamping arm 2 away from the connecting member 3 is bent downward. In other embodiments, one end of the first clamping arm 1 away from the connecting member 3 can also be bent upward.

[0084] To facilitate the connection between the first clamping arm 1 and the second clamping arm 2 and the connecting member 3, a rectangular slot 302 is provided on the connecting member 3. One end of the first clamping arm 1 has a plug-in portion 102. One ends of the plug-in portion 102 and the second clamping arm 2 are inserted into the slot 302. The width of the slot 302 is equal to the sum of the thicknesses of the plug-in portion 102 and the second clamping arm 2. A threaded hole 303 communicating with the slot 302 is provided on the connecting member 3. Pin holes 103 and 2012 are provided on the plug-in portion 102 and the second clamping arm 2. After one ends of the plug-in portion 102 and the second clamping arm 2 are inserted into the slot 302, a set screw 11 is screwed into the threaded hole 303 until the set screw 11 is inserted into the pin holes 103 and 2012 on the plug-in portion 102 and the second clamping arm 2.

[0085] See Figure 17 shown, a first cut groove 208 and a second cut groove 209 are provided on the edge of the second clamping arm 2, so as to form a buffer portion 2010 located between the first cut groove 208 and the second cut groove 209 on the edge of the second clamping arm 2. One end of the main thorn 201 is fixedly connected to the buffer portion 2010.

[0086] Figure 22 This is a planar development view of a second clamping arm 2 in the present invention. As shown in this figure, a plurality of groups of third cut grooves 2013 and fourth cut grooves 2014 are provided on the edge of the second clamping arm 2. The third cut grooves 2013 are substantially parallel to the length direction of the second clamping arm 2. The fourth cut grooves 2014 extend inward from the edge of the second clamping arm 2 and communicate with the third cut grooves 2013. The number of groups of the third cut grooves 2013 and the fourth cut grooves 2014 is equal to the number of main thorns 201. By providing the foregoing third cut grooves 2013 and fourth cut grooves 2014, buffer portions 2010 equal in number to the main thorns 201 can be formed on the edge of the second clamping arm 2. The extending direction of the buffer portion 2010 is substantially parallel to the length direction of the second clamping arm 2. Figure 22 The included angle between the main thorn 201 and the buffer portion 2010 in Figure 23The dashed line in [it] is the bending line. During the process of bending the main thorn 201, the provided buffer part 2010 can effectively prevent the second clamping arm 2 from deforming, which is beneficial to improving the qualified rate of the product.

[0087] See Figure 20 As shown, the flow blocking block 200 includes a support body 4 and a sealing film 5 wrapped around the outside of the support body 4. The support body 4 and / or the sealing film 5 are fixedly connected to the second clamping arm 2. The support body 4 among them can be made of memory alloy wire woven, and the support body 4 has a certain elastic deformation ability to facilitate being received into the delivery catheter. The sealing film 5 can be made of a biocompatible film (such as PET, PTFE or biological film, etc.). As Figure 9 shown, the shape of the flow blocking block 200 is approximately like a tortoise shell, and its specific shape can be optimized and designed in combination with the shape of the reflux hole.

[0088] In some embodiments, the flow blocking block 200 further includes a mesh cover 6 wrapped around the outside of the sealing film 5. The mesh cover 6 is densely covered with holes 9. The mesh cover 6 can be made of a knitted film. The planar structure of the knitted film is similar to the aforementioned wire mesh, and reference can be made to Figure 19 . By providing a layer of mesh cover 6 with holes 9 on the outside of the sealing film 5, it is beneficial to endothelialize the flow blocking block 200 faster.

[0089] In some embodiments, a riser plate 10 is provided at one end of the second clamping arm 2 away from the connecting member 3. A recovery hole 12 is provided on the riser plate 10. The recovery hole 12 and the main thorn 201 are respectively located on both sides of the second clamping arm 2.

[0090] Figure 12 、 Figure 13 and Figure 14 show three different second clamping arms 2 provided with the recovery hole 12.

[0091] In Figure 12 the shown second clamping arm 2, the number of riser plates 10 is two. The two riser plates 10 are respectively located on both sides of the second clamping arm 2 and perpendicular to the second clamping arm 2. Each riser plate 10 is provided with a recovery hole 12. A part of the recovery hole 12 and the main thorn 201 are respectively located on both sides of the second clamping arm 2. The riser plate 10 and the main thorn 201 are both bent from a whole piece of plate, and the bending directions of the riser plate 10 and the main thorn 201 are opposite.

[0092] In Figure 13 the shown second clamping arm 2, the number of riser plates 10 is one. The shape of the riser plate 10 is generally L-shaped. A part of the riser plate 10 is fixedly welded to the second clamping arm 2. The recovery hole 12 and the main thorn 201 are respectively located on both sides of the second clamping arm 2.

[0093] In Figure 14On the second clamping arm 2 shown, the number of vertical plates 10 is one. There are two mounting holes (not shown in the figure) on the second clamping arm 2. One end of the vertical plate 10 is provided with two insertion plates 1001. The two insertion plates 1001 are respectively inserted into the corresponding mounting holes, so that a part of the insertion plates 1001 passes through the second clamping arm 2, and then the insertion plates 1001 are bent, thus realizing the fixation of the vertical plate 10.

[0094] In some embodiments, a raised portion 2011 is provided at one end of the second clamping arm 2 away from the connecting member 3. A recovery hole 12 is provided on the raised portion 2011. The recovery hole 12 and the main thorn 201 are respectively located on both sides of the second clamping arm 2. See Figure 16 As shown, the raised portion 2011 is formed by bending the second clamping arm 2, and the cross-sectional structure of the raised portion 2011 is generally V-shaped.

[0095] The high-gripping-force mitral valve clip is installed at the proximal end of the delivery catheter 15 through the dissociator 14. The shape of the high-gripping-force mitral valve clip when it is received in the delivery catheter 15 is shown in Figure 18 As shown, the first clamping arm 1 and the second clamping arm 2 are approximately in a "one" shape. A first pulling rope 16 is threaded through the first threading hole 202 and the second threading hole 203. A second pulling rope 17 is threaded through the recovery hole 12. One ends of the first pulling rope 16 and the second pulling rope 17 both extend to the outside of the body through the delivery catheter 15. The first pulling rope 16 is used to control the release of the second clamping arm 2, and the second pulling rope 17 is used to control the recovery of the second clamping arm 2. In the embodiments provided with the recovery hole 12, the high-gripping-force mitral valve clip can be recovered, and this function is beneficial to reducing the risk of failure of the high-gripping-force mitral valve clip, and avoiding the need for the patient to undergo further thoracotomy due to the failure of the clamping.

[0096] The working process of the present invention is as follows:

[0097] The high gripping force mitral valve clip is delivered into the body by using a cardiac implant instrument 300. After the high gripping force mitral valve clip is delivered to the target position, the second clip arm 2 is released by manipulating the first pull cord 16. The first clip arm 1 and the second clip arm 2 return to the pre-shaped form in the in-vivo environment. During this process, the first clip arm 1 and the second clip arm 2 approach each other, clamping the mitral valve between the first clip arm 1 and the second clip arm 2. Meanwhile, the main spines 201 and the secondary spines on the second clip arm 2 penetrate into the mitral valve. Subsequently, observe continuously for a period of time to confirm whether the clamping assembly 100 is firmly clamped to the mitral valve. If there is a situation where the clamping assembly 100 falls off and the high gripping force mitral valve clip needs to be removed as a whole, tighten the second pull cord 17 to drag the recovery hole 12, so that the second clip arm 2 is recovered into the delivery catheter 15 following the second pull cord 17, and then the first clip arm 1 can be recovered into the delivery catheter 15 by pulling the guide wire. In addition, a third pull cord (not shown in the figure) can also be tied to the first clip arm 1. The third pull cord extends to the outside of the body through the delivery catheter 15, and the first clip arm 1 can be manually controlled by manipulating the third pull cord.

[0098] So far, the embodiments of the present application have been described in detail. To avoid obscuring the concept of the present application, some details known in the art are not described. Those skilled in the art can fully understand how to implement the technical solutions disclosed here based on the above description.

[0099] Although some specific embodiments of the present application have been described in detail by way of examples, those skilled in the art should understand that the above examples are only for the purpose of illustration and not for the purpose of limiting the scope of the present application. Those skilled in the art should understand that the above embodiments can be modified or some technical features can be equivalently replaced without departing from the scope and spirit of the present application. In particular, as long as there is no structural conflict, the various technical features mentioned in each embodiment can be combined in any way.

Claims

1. A high clamping force mitral valve clip, comprising a clamping assembly and a baffle, wherein the clamping assembly is used to be fixed to a human valve, and the baffle is connected to the clamping assembly, characterized in that: Also includes: A first sleeve bag connected to the baffle block and extending toward the left side of the baffle block; as well as a second sleeve bag connected to the baffle block and extending toward the right side of the baffle block; Wherein, the first sleeve bag and the second sleeve bag are both made of flexible material, and are both provided with a cavity and an opening communicating with the cavity; The first sleeve bag comprises a flat plate portion and a curved portion, both of which are connected to the baffle block, and the middle portion of the curved portion protrudes in a direction away from the flat plate portion; the second sleeve bag is mirror-symmetrical to the first sleeve bag in structure.

2. The high clamping force mitral valve clip according to claim 1, characterized in that: The surfaces of the first sleeve bag and the second sleeve bag are densely covered with holes.

3. The high clamping force mitral valve clip according to claim 1, characterized in that: The flat portion and the curved portion are both biocompatible gauze, and a portion of the edge of the flat portion is connected to a portion of the edge of the curved portion, so that a cavity is formed between the flat portion and the curved portion, and an opening connected to the cavity is formed at one end of the first cuff.

4. The high clamping force mitral valve clip according to claim 3, characterized in that: The first sleeve bag further includes a limiting member located at the opening position, one end of the limiting member is connected to the flat plate portion, and the other end of the limiting member is connected to the curved surface portion.

5. The high clamping force mitral valve clip according to claim 1, characterized in that: The clamping assembly comprises: A first clamping arm having a first through hole formed therein; A second clamp arm, on which a plurality of main thorns for piercing a human valve are provided, and the second clamp arm obliquely penetrates the first through hole; A connecting member, wherein the connecting member is provided with a second through hole, the first clamp arm and the second clamp arm are both connected to the connecting member, and the connecting parts of the first clamp arm and the second clamp arm and the connecting member are elastically deformable; Wherein, the first clamp arm and the second clamp arm are both made of memory alloy, and a first threading hole and a second threading hole are provided at one end of the second clamp arm away from the connecting piece.

6. The high clamping force mitral valve clip according to claim 5, characterized in that: The clamping assembly also includes a left extension section and a right extension section connected to the second clamping arm and respectively located on both sides of the second clamping arm, and the projections of the left extension section and the right extension section on the first clamping arm are at least partially located outside the first through hole.

7. The high clamping force mitral valve clip according to claim 6, characterized in that: The clamping assembly also includes a left auxiliary thorn connected to the left extension section and a right auxiliary thorn connected to the right extension section, and the first clamping arm is located between the left auxiliary thorn and the right auxiliary thorn.

8. The high clamping force mitral valve clip according to claim 7, characterized in that: The connection positions of the left extension section and the right extension section with the second clamping arm are adjacent to or located in the middle of the second clamping arm.

9. The high clamping force mitral valve clip according to claim 5, characterized in that: The end of the first clamp arm away from the connecting member and / or the end of the second clamp arm away from the connecting member are bent, and the bending direction increases the distance between the end of the first clamp arm away from the connecting member and the end of the second clamp arm away from the connecting member.

10. The high clamping force mitral valve clip according to claim 5, characterized in that: The edge of the second clamp arm has a buffer portion, the number of the buffer portions is equal to the number of the main thorns, and one end of the main thorn is connected to the corresponding buffer portion.

11. The high clamping force mitral valve clip according to any one of claims 5 to 10, characterized in that: A vertical plate is provided at one end of the second clamp arm away from the connecting piece, and a recovery hole is provided on the vertical plate. The recovery hole and the main thorn are respectively located on two sides of the second clamp arm.

12. The high clamping force mitral valve clip according to any one of claims 5 to 10, characterized in that: A bulge is provided at one end of the second clamp arm away from the connecting piece, a recovery hole is provided on the bulge, and the recovery hole and the main thorn are respectively located on two sides of the second clamp arm.

13. The high clamping force mitral valve clip according to any one of claims 5 to 10, characterized in that: The baffle block comprises a support body and a sealing film coated on the outside of the support body, and the support body and / or the sealing film are fixedly connected to the second clamping arm.

14. The high clamping force mitral valve clip according to claim 13, characterized in that: The baffle block also includes a mesh cover covering the outer side of the sealing film, and the mesh cover is densely covered with holes.

Images