A valve leaflet obstruction repair clip and repair system thereof

Abstract

The present invention discloses a leaflet flow obstruction repair clip and a repair system thereof, comprising a clamping component and a flow obstruction component, wherein the clamping component is integrally assembled with the flow obstruction component and clamped and fixed at the position of incomplete closure between leaflets, an upper clamping arm and a lower clamping arm are clamped together in a natural state, and the upper clamping arm performs unilateral movement in a stretched state. The present invention can realize edge-to-edge repair of leaflets and adopts unilateral clamping to effectively prevent the problem of leaflet stenosis caused by implantation of the repair device.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a valve leaflet flow obstruction repair clip and a repair system thereof. Background Art

[0002] In recent years, medical device manufacturers at home and abroad have developed many interventional devices for the treatment of mitral or tricuspid regurgitation. Specifically, the main methods for treating mitral or tricuspid regurgitation include edge-to-edge repair technology, valve ring shrinkage technology, annuloplasty, and chord repair technology. Among them, edge-to-edge repair technology has good safety. MitraClip (CN102395331B) launched by foreign manufacturers Abbott and PASCAL (US2019 / 0321166A1) launched by Edwards are typical representatives of edge-to-edge repair technology and have been well promoted in market applications. This type of device usually fixes the implant at the end of the interventional catheter and delivers it to the location where it needs to be implanted through a matching delivery sheath. In this process, the operator uses modern medical imaging technology to guide the device to be accurately implanted to the location where regurgitation needs to be blocked. Taking the mitral valve as an example, when the edge-to-edge repair device is implanted, the anterior and posterior leaflets of the mitral valve need to be clamped together separately, and the problem of mitral valve leakage and regurgitation is solved by mechanical clamping.

[0003] On the other hand, the edge-to-edge repair device may cause leaflet stenosis after implantation. After implantation, the clip clamps the free edge of the leaflet, making the leaflet closer at the end of contraction and reducing possible regurgitation. However, during diastole, when the leaflet needs to open to facilitate blood flow from the atrium to the ventricle, the clamping of the clip may limit the opening of the leaflet, causing leaflet stenosis. Summary of the invention

[0004] In view of the above technical problems, the present invention provides a leaflet flow obstruction repair clip and a repair system thereof, comprising:

[0005] A clamping component and a flow-blocking component, wherein the clamping component and the flow-blocking component are integrally assembled and clamped and fixed at the insufficiency between the leaflets;

[0006] The clamping component includes an upper clamping arm, a lower clamping arm, a fixing member, a supporting member and a connecting member;

[0007] The upper clamp arm and the lower clamp arm are clamped together in a natural state, and the upper clamp arm performs unilateral movement in a stretched state;

[0008] The connecting member is provided with a mounting groove, and the upper clamp arm, the lower clamp arm and the supporting member are overlapped and fixed in the mounting groove relative to the proximal end of the connecting member and extend from the bottom of the mounting groove;

[0009] The fixing member is arranged on the lower surface of the lower clamping arm and is used to fix the flow blocking component;

[0010] The lower portion of the support member is accommodated in the interior of the flow blocking component to support the flow blocking component.

[0011] After the clamping part and the flow-blocking part are assembled, they are clamped and fixed to fill the incomplete closure between the leaflets, which plays the function of preventing reflux. A clamping opening is formed between the upper clamp arm and the lower clamp arm. The repair clamp needs to cooperate with the driving mechanism to operate, and the driving mechanism is used to control the opening and closing of the clamping opening. In the natural state, the upper clamp arm and the lower clamp arm are clamped together, wherein the natural state refers to the state in which the upper clamp arm and the lower clamp arm are assembled and formed after the processing is completed. Relatively speaking, the repair clamp also has a recovery state, a stretched state and a folded state. In the recovery state, the natural state and the folded state, the upper clamp arm and the lower clamp arm are closed. In the stretched state, the upper clamp arm and the lower clamp arm are open, and the opening of the clamping opening is achieved by unilaterally controlling the rotation of the upper clamp arm. The closing of the clamping opening in the folded state is also achieved by controlling the unilateral rotation of the upper clamp arm. This unilateral clamp design effectively overcomes the problem of diastolic leaflet stenosis caused by implantation of the repair device.

[0012] Preferably, the main structure of the flow-blocking component is an expanded bluff body, and the surface of the bluff body is a bluff film.

[0013] The overall appearance of the blocking component is a flat pot shape. After the instrument is clamped as a whole, that is, when the upper and lower clamping arms are folded, the blocking component is almost erected, and the middle part of the blocking component corresponds to the joint surface of the leaflet, so as to obtain a better blocking effect.

[0014] Preferably, a support ring is provided inside the baffle component, the upper end of the support ring is connected to the fixing member, the support ring and the support member constitute the skeleton of the baffle component, and the skeleton cooperates with the fixing member to pull and expand the baffle film to a desired shape.

[0015] The skeleton can play a supporting role after the blocking component is implanted, ensuring that it can stably fill the incomplete closure of the valve leaflets and achieve reliable blocking function, increase the overall toughness of the blocking membrane, prevent the blocking component from being deformed or displaced relative to the clamping component due to blood flow erosion, and also assist in the positioning of the lower clamp arm.

[0016] Preferably, the transverse cross-section of the bluff body is a bluff cross-section, and the bluff cross-section has the largest thickness and width in the entire bluff body.

[0017] The shape of the flow-blocking component can be diverse. In addition to the flat pot shape, it can also be square, round or a combination of multiple shapes. The flow-blocking cross-section can also be designed to be circular, elliptical or various shapes combined with multiple curves. There is also a fully wrapped flow-blocking component. Although the shapes of these flow-blocking components are different, flow-blocking components of different shapes need to ensure that they have the maximum thickness and width to ensure the best flow-blocking effect after implantation.

[0018] Preferably, a layer of braided membrane is sewn on the outside of the clamping component, and the braided membrane and the flow-blocking membrane are made of a biocompatible polymer material membrane.

[0019] Unmodified synthetic polymer materials will produce a strong immune rejection reaction after entering the human body, while polymer materials with good biocompatibility are highly compatible with human tissue cells, are non-carcinogenic, and have no other adverse reactions. The repair clip acts on the mitral valve or tricuspid valve. Therefore, more specifically, it is required that the polymer material membrane here is a polymer material membrane with good blood compatibility in the biocompatibility evaluation, which can effectively increase the endothelialization speed of the device after implantation in the body.

[0020] Preferably, the ratio of the length of the fixing piece from the distal edge of the lower clamping arm to the total length of the lower clamping arm is 0.5-0.75.

[0021] The position requirements of the fixings are intended to ensure the expansion effect and support stability of the bluff body. If the fixings are too low, the bluff body will not be able to be fully pulled open and the bluff effect will be greatly reduced. If the installation position is too high, the tension of the bluff body will be too large and the bluff membrane will lack toughness.

[0022] Preferably, the upper clamping arm, the lower clamping arm and the supporting member are all composed of a fixed section and a free section, and the fixed sections of the three are overlapped in sequence and fixed in the installation groove by crimping or welding.

[0023] The three fixed sections are fixed in a stacked manner, which can reduce the overall volume of the repair clamp on the one hand, and keep the free sections of the upper clamp arm and the lower clamp arm on the same symmetry plane on the other hand, so as to facilitate the alignment of the clamping surfaces of the two and achieve stable clamping.

[0024] Fixing by crimping or welding is a fixed connection. Both fixing methods can effectively reduce the use of redundant fixing parts.

[0025] Preferably, in a natural state, the angle between the fixed section of the upper clamp arm and the free section thereof is an acute angle, and in an extended state, the free section is pulled toward and abuts against the fixed section.

[0026] The stretched state is a preparatory state for repair clamping, in which the free section of the upper clamp arm changes from a state of abutting against the upper surface of the lower clamp arm to a state of abutting against the fixed section, while the lower clamp arm remains stationary throughout the entire process, and stretching is achieved only by unilateral movement of the upper clamp arm. In addition, the angles in the present invention all refer to inner angles.

[0027] Preferably, a pressing sheet is cut out at the bottom of the free section of the upper clamping arm, and the pressing sheet is bent toward the inside of the upper clamping arm to form the fixed section of the upper clamping arm, and the pressing sheet is hollowed out at the original position of the free section.

[0028] The fixed section of the upper clamp arm is formed by cutting and bending a part of the free section, which reduces processing consumables and makes full use of the plasticity of the material. The upper clamp arm produced under this processing method is subjected to a pulling force in the counterclockwise movement of the free section toward the fixed section in the same direction as its own elastic deformation direction. Stress fatigue at the bend will not occur due to frequent adjustments during the operation. The bending cycle of the upper clamp arm is increased, and the anti-fatigue effect of the structure is better.

[0029] Preferably, the fixed section and the free section of the lower clamp arm are V-shaped, and the fixed section of the lower clamp arm passes through the hollow on the free section of the upper clamp arm and is fixed in the installation groove.

[0030] The V-shaped structure of the lower clamp arm, with its fixed section passing through the free section of the upper clamp arm, makes the upper clamp arm and the lower clamp arm present a cross, i.e., X-shaped fixed state. Compared with the parallel fixing method of the upper clamp arm and the lower clamp arm, the X-shaped fixing method can make the clamping surfaces of the upper and lower clamp arms fit more closely, thereby improving the clamping force on the target tissue during clamping and the stability of capturing the valve leaflets during surgery.

[0031] Preferably, the upper clamping arm is provided with a barb facing the lower clamping arm.

[0032] The provision of the barbs can enhance the stability of the upper and lower clamping arms in clamping the leaflets, and the role played by the barbs is exactly what the aforementioned V-shaped structure of the lower clamping arm pursues.

[0033] Preferably, the upper clamp arm, the lower clamp arm and the support member are formed by cutting and processing a nickel-titanium alloy sheet with shape memory.

[0034] The shape memory nickel-titanium alloy sheet has good plasticity, and also has the advantages of wear resistance, corrosion resistance, high damping and superelasticity. Its corrosion resistance is better than the best medical stainless steel currently available, and can effectively achieve the action requirement of unilateral clamping of the upper clamp arm in the present invention.

[0035] Preferably, the braided coating and the flow-blocking membrane are made of PET or PTFE.

[0036] In addition to polytetrafluoroethylene (PTFE) and polyethylene terephthalate (PET), i.e. polyester resin, the above-mentioned materials may also include polylactic acid (PLA) and other materials. After implantation, the above-mentioned materials are inert in the body, will not cause serious physiological reactions, are not easily degraded, and are non-toxic and harmless.

[0037] The present invention also provides a leaflet obstruction repair clip repair system, comprising the leaflet obstruction repair clip or conventional leaflet clip and a driving mechanism thereof, wherein the conventional leaflet clip is a conventional device in the prior art that is clamped on the leaflet by a clamping force, the leaflet obstruction repair clip or conventional leaflet clip is an implanted part of the system, and the driving mechanism delivers the implanted part to a target position;

[0038] The driving mechanism comprises a dissociation device, a dissociation rod and a pull wire;

[0039] The dissociation device comprises a connecting section, a receiving groove for receiving the implanted part and a dissociation groove in sequence; the tail of the connecting section is connected to the lumen of the delivery system; a dissociation rod hole is provided in the connecting section, and the dissociation rod is input from the lumen through the dissociation rod hole to cooperate and fix the implanted part and the distal end of the pull wire;

[0040] The distal end of the pull line is arranged on the disengagement device, and the other end passes through and connects to the control point of the clamping component and then is connected to the control point of the disengagement rod, and the clamping component is opened and clamped by pulling and releasing at the control point;

[0041] The dissociation groove is arranged below the receiving groove, and holes are arranged on both side walls of the dissociation groove. The dissociation rod is inserted into the holes to realize positioning in the dissociation groove, and the distal end of the pull line is wound around the dissociation rod in the dissociation groove.

[0042] The driving mechanism delivers the repair clip to the target position of the mitral valve or tricuspid valve through the femoral vein in a minimally invasive manner. The dissociation device controls the opening and closing of the upper clamp arm, and retracts and releases it by adjusting the pull wire. The repair clip is delivered into the body through an external sheath. The storage groove can effectively reduce the volume of the repair clip. During delivery, the repair clip is recovered in the storage groove, reducing the delivery size and facilitating the system to adapt to smaller delivery sheaths.

[0043] Preferably, a groove is provided below the dissociation groove, a boss is provided at the side end of the connecting piece of the leaflet flow obstruction repair clip, a through hole is opened on the boss, the groove is adapted to the boss, the boss is accommodated in the groove, and the dissociation rod passes through the through hole and the groove to fix the boss in the groove.

[0044] The purpose of the dissociation rod passing through the through hole of the boss is to fix the implant part on the dissociation device. When the implant part completes the implantation operation, the dissociation rod is pulled upward out of the through hole on the boss to separate the dissociation device from the implant part. This design is easy to operate and facilitates the separation operation of the implant part.

[0045] Preferably, the control point of the implant part is located on the upper clamp arm, and a pull ring is provided on the upper clamp arm. The pull ring referred to here can be a pull wire threading position in the upper clamp arm, and the distal end of the pull wire is a loop, and the loop passes through the pull ring and is connected to the dissociation rod in the dissociation groove.

[0046] During the clamping adjustment process, the rotation of the free section of the upper clamping arm is controlled by the pull wire loop. After the implantation is completed, the dissociation rod is withdrawn to separate the dissociation device from the clamping component. The dissociation rod is continued to be withdrawn, and the distal end of the pull wire is released from the dissociation rod. After the pull wire is retrieved from the upper control point, the implanted part is released as a whole.

[0047] In the present invention, the pull wire is not directly passed through the upper clamping arm, but a pull ring is used as a medium. Compared with the control method of direct contact with the upper clamping arm, this structure makes the withdrawal of the pull wire smoother and smoother, and the pull wire will not directly touch the clamped leaflet, and the clamping effect of the leaflet will not be affected by the withdrawal action of the pull wire.

[0048] Beneficial effects:

[0049] 1. The present invention can achieve edge-to-edge repair of valve leaflets and adopts unilateral clamping to effectively prevent the problem of valve leaflet stenosis caused by implantation of the repair device.

[0050] 2. The flow-blocking structure of the present invention can reliably reduce the problems of valve leaflet insufficiency and regurgitation in patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] The present invention will be further described below in conjunction with the accompanying drawings.

[0052] Figure 1 This is a schematic diagram of the structure of the leaflet flow-blocking repair clip of the present invention;

[0053] Figure 2-3 This is a schematic diagram of the valve leaflet flow obstruction repair clip clamping in the present invention;

[0054] Figure 4 It is a schematic diagram of the structure of the clamping parts in the present invention;

[0055] Figure 5 for Figure 4 The enlarged schematic diagram at A in the middle;

[0056] Figure 6 It is a schematic diagram of the structure of the flow blocking component in the present invention;

[0057] Figure 7 This is a schematic diagram of the structure of the valve leaflet flow obstruction repair clip repair system of the present invention;

[0058] Figure 8 It is a schematic diagram of the driving mechanism structure in the present invention.

[0059] The numbers in the figure represent:

[0060] 1. Clamping component 11, lower clamping arm 12, upper clamping arm 121, fixed section 122, free section 123, barb 13, fixing member 14, supporting member 15, connecting member 151, mounting groove 152, boss 153, through hole 2, flow blocking component 3, dissociation device 31, connecting section 32, receiving groove 33, dissociation rod hole 34, dissociation groove 35, groove 4, dissociation rod 5, pull wire 51, pull ring. DETAILED DESCRIPTION

[0061] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0062] In the description of the present invention, it is necessary to understand that the directions or positional relationships indicated by the terms "front", "rear", "left", "right", "up", "down", etc. are based on the directions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as a limitation on the present invention.

[0063] like Figure 1-6 As shown, the present invention provides a leaflet flow obstruction repair clip and a repair system thereof, comprising a clamping component 1 and a flow obstruction component 2, wherein the clamping component 1 and the flow obstruction component 2 are integrally assembled and clamped and fixed at the incomplete closure between the leaflets; the clamping component 1 comprises an upper clamping arm 12, a lower clamping arm 11, a fixing member 13, a supporting member 14 and a connecting member 15; the upper clamping arm 12 and the lower clamping arm 11 are clamped together in a natural state, and the upper clamping arm 12 performs unilateral movement in a stretched state;

[0064] The connecting member 15 is provided with a mounting groove 151, and the upper clamping arm 12, the lower clamping arm 11 and the supporting member 14 are overlapped and fixed in the mounting groove 151 relative to the proximal end of the connecting member 15 and extend from the bottom of the mounting groove 151; the fixing member 13 is provided on the lower surface of the lower clamping arm 11, and is used to fix the flow blocking component 2; the lower part of the supporting member 14 is accommodated inside the flow blocking component 2, and is used to support the flow blocking component 2.

[0065] After the clamping part 1 and the flow-blocking part 2 are assembled, they are clamped and fixed behind the leaflets to fill the incomplete closure between the leaflets, and play the role of preventing reflux. A clamping opening is formed between the upper clamp arm 12 and the lower clamp arm 11. The repair clamp needs to cooperate with the driving mechanism to operate, and the driving mechanism is used to control the opening and closing of the clamping opening. In the natural state, the upper clamp arm 12 and the lower clamp arm 11 are clamped together, wherein the natural state refers to the state in which the upper clamp arm 12 and the lower clamp arm 11 are assembled and formed after the processing is completed. Relatively, the repair clamp also has a recovery state, a stretching state and a folded state. In the recovery state, the natural state and the folded state, the upper clamp arm 12 and the lower clamp arm 11 are closed. In the stretching state, the upper clamp arm 12 and the lower clamp arm 11 are opened, and the opening of the clamping opening is achieved by unilaterally controlling the rotation of the upper clamp arm 12, and the closing of the clamping opening in the folded state is also achieved by controlling the unilateral rotation of the upper clamp arm 12. This unilateral clamp design effectively overcomes the problem of diastolic leaflet stenosis caused by implantation of the repair device.

[0066] The main structure of the baffle component 2 is an expanded baffle body, and the surface of the baffle body is a baffle film.

[0067] The overall appearance of the blocking component 2 is a flat pot shape. After the instrument is clamped as a whole, that is, when the upper and lower clamping arms are folded, the blocking component 2 is almost erected, and the middle part of the blocking component 2 corresponds to the joint surface of the leaflet, so as to obtain a better blocking effect.

[0068] A support ring (not shown in the figure) is provided inside the baffle component 2, and the upper end of the support ring is connected to the fixing member 13. The support ring and the support member 14 constitute the skeleton of the baffle component 2, and the skeleton cooperates with the fixing member 13 to pull and expand the baffle membrane to the expected shape.

[0069] The skeleton can play a supporting role after the blocking component 2 is implanted, ensuring that it can stably fill the incomplete closure of the valve leaflets and realize a reliable blocking function, thereby increasing the overall toughness of the blocking membrane and preventing the blocking component 2 from being deformed or displaced relative to the clamping component 1 due to blood flow erosion. At the same time, it can also assist in the positioning of the lower clamping arm 11.

[0070] The transverse cross section of the bluff body is a bluff cross section, and the bluff cross section has the largest thickness and width in the entire bluff body.

[0071] The shape of the flow-blocking component 2 can be diverse. In addition to the flat pot shape, it can also be square, round or a combination of multiple shapes. The flow-blocking cross-section can also be designed to be circular, elliptical or various shapes formed by a combination of multiple curves. There is also a fully wrapped flow-blocking component 2. Although the shapes of these flow-blocking components 2 are different, the flow-blocking components 2 of different shapes need to ensure that they have the maximum thickness and width to ensure the best flow-blocking effect after implantation.

[0072] A layer of braided membrane is sewn on the outside of the clamping component 1, and the braided membrane and the flow-blocking membrane are made of a polymer material membrane with good biocompatibility.

[0073] Unmodified synthetic polymer materials will produce a strong immune rejection reaction after entering the human body, while polymer materials with good biocompatibility are highly compatible with human tissue cells, are non-carcinogenic, and have no other adverse reactions. The repair clip acts on the mitral valve or tricuspid valve. Therefore, more specifically, it is required that the polymer material membrane here is a polymer material membrane with good blood compatibility in the biocompatibility evaluation, which can effectively increase the endothelialization speed of the device after implantation in the body.

[0074] The ratio of the length of the fixing member 13 from the distal end edge of the lower clamping arm 11 to the total length of the lower clamping arm 11 is 0.5-0.75.

[0075] The position requirement of the fixing part 13 is intended to ensure the expansion effect and support stability of the bluff body. If the fixing part 13 is positioned too low, the bluff body cannot be fully pulled open and the bluff effect will be greatly reduced. If the installation position is too high, the tension of the bluff body will be too large and the bluff membrane will lack toughness.

[0076] The upper clamping arm 12 , the lower clamping arm 11 and the supporting member 14 are all composed of a fixed section 121 and a free section 122 . The fixed sections of the three are overlapped in sequence and fixed in the installation groove 151 by crimping or welding.

[0077] The three fixed segments 121 are fixed in a stacked manner, which can reduce the overall volume of the repair clamp on the one hand, and keep the free segments of the upper clamp arm 12 and the lower clamp arm 11 on the same symmetrical plane on the other hand, so as to facilitate the alignment of the clamping surfaces of the two and achieve stable clamping.

[0078] Fixing by crimping or welding is a fixed connection. Both fixing methods can effectively reduce the use of redundant fixing parts.

[0079] The upper clamping arm 12 includes a fixed section 121 and a free section 122 . In a natural state, the angle between the fixed section 121 and the free section 122 is an acute angle. In a stretched state, the free section 122 is pulled toward and abuts against the fixed section 121 .

[0080] The stretched state is a preparatory state for repair clamping, and the free section 122 of the upper clamp arm 12 changes from a state of abutting against the upper surface of the lower clamp arm 11 to a state of abutting against the fixed section 121, while the lower clamp arm 11 remains stationary throughout the entire process, and stretching is achieved only by the unilateral movement of the upper clamp arm 12. In addition, the angles in the present invention all refer to internal angles.

[0081] The fixed section and the free section of the lower clamp arm 11 are in a V shape. The fixed section of the lower clamp arm passes through the hollow portion of the free section of the upper clamp arm 12 and is fixed in the mounting groove 151 .

[0082] The V-shaped structure of the lower clamp arm 11, with its fixed section passing through the free section 122 of the upper clamp arm, makes the upper clamp arm 12 and the lower clamp arm 11 present a cross or X-shaped fixed state. Compared with the parallel fixing method of the upper clamp arm 12 and the lower clamp arm 11, the X-shaped fixing method can make the clamping surfaces of the upper and lower clamp arms fit more closely, thereby improving the clamping force on the target tissue during clamping and the stability of capturing the valve leaflets during surgery.

[0083] The upper clamp arm 12 , the lower clamp arm 11 and the support member 14 are formed by cutting and processing a nickel-titanium alloy sheet having shape memory.

[0084] The shape memory nickel-titanium alloy sheet has good plasticity, and also has the advantages of wear resistance, corrosion resistance, high damping and super elasticity. Its corrosion resistance is better than the best medical stainless steel currently available. The fixed section 121 in the present invention adopts a fixed connection method (crimping or welding) relying on the material properties of the nickel-titanium alloy sheet. The rotation of the free section 122 of the upper clamping arm 12 can be achieved without a movable rotating part, effectively realizing the action requirement of unilateral clamping of the upper clamping arm 12 in the present invention.

[0085] A pressing sheet is cut out at the bottom of the free section 122 of the upper clamping arm 12 , and the pressing sheet is bent toward the inner side of the upper clamping arm 12 to form the fixed section 121 of the upper clamping arm 12 , and the pressing sheet forms the hollow at the original position of the free section.

[0086] The fixed section of the upper clamp arm 12 is formed by cutting and bending a part of the free section 122, which reduces processing consumables and makes full use of the plasticity of the nickel-titanium alloy sheet. The upper clamp arm 12 produced under this processing method, the direction of the pulling force exerted on the free section during the counterclockwise movement toward the fixed section is the same as the direction of its own elastic deformation, and stress fatigue at the bend will not occur due to frequent adjustments during the operation. The cycle of frequent bending is longer and the anti-fatigue effect is better.

[0087] The upper clamping arm 12 is provided with a barb 123 facing the lower clamping arm 11 .

[0088] The provision of the barbs 123 can enhance the stability of the upper and lower clamping arms in clamping the leaflets, and the role played by the barbs 123 is exactly what the aforementioned V-shaped structure of the lower clamping arm 11 pursues.

[0089] The braided coating and the flow-blocking film are made of PET or PTFE.

[0090] In addition to polytetrafluoroethylene (PTFE) and polyethylene terephthalate (PET), i.e. polyester resin, the above-mentioned materials may also include polylactic acid (PLA) and other materials. After implantation, the above-mentioned materials are inert in the body, will not cause serious physiological reactions, are not easily degraded, and are non-toxic and harmless.

[0091] like Figure 7-8 As shown, the present invention also provides a leaflet obstruction repair clip repair system, including the above-mentioned leaflet obstruction repair clip or conventional leaflet clip and its driving mechanism, the conventional leaflet clip is a conventional instrument in the prior art that clamps on the leaflet by clamping force, the leaflet obstruction repair clip or conventional leaflet clip is the implanted part of the system, and the driving mechanism delivers the implanted part to the target position.

[0092] The driving mechanism includes a dissociation device 3, a dissociation rod 4 and a pull wire 5; the dissociation device 3 includes a connecting section 31, a receiving groove 32 for receiving the implanted part and a dissociation groove 34 in sequence; the tail end of the connecting section 31 is connected to the lumen of the conveying system; a dissociation rod hole 33 is provided in the connecting section 31, and the dissociation rod 4 is input from the lumen through the dissociation rod hole 33 and then cooperates to fix the implanted part and the distal end of the pull wire 5; the distal end of the pull wire 5 is connected to the dissociation groove 34 in cooperation with the dissociation rod 4, and the other end of the pull wire 5 passes through and connects the control point of the implanted part and then guides to the force control point of the pull wire 5, and the implanted part is opened and clamped by pulling and releasing at the control point; holes are provided on both side walls of the dissociation groove 34, and the dissociation rod 4 is inserted into the holes to realize positioning in the dissociation groove 34, and the distal end of the pull wire 5 is wound around the dissociation rod 4 in the dissociation groove 34.

[0093] The driving mechanism delivers the repair clip to the target position of the mitral valve or tricuspid valve through the femoral vein in a minimally invasive manner. The dissociation device 3 controls the opening and closing of the upper clamp arm 12, and retracts and releases it by adjusting the pull wire 5. The repair clip is delivered to the body through an external sheath. The storage groove 32 can effectively reduce the volume of the repair clip. During delivery, the repair clip is recovered in the storage groove 32 to reduce the delivery size, which facilitates the system to adapt to a smaller delivery sheath.

[0094] A groove 35 is provided below the dissociation groove 34, and a boss 152 is provided at the side end of the connecting piece 13 of the leaflet flow repair clip. A through hole 153 is opened on the boss 152, and the groove 35 is adapted to the boss 152. The boss 152 is accommodated in the groove 35, and the dissociation rod 4 passes through the through hole 153 and the groove 35 to fix the boss 152 in the groove 35.

[0095] The purpose of the dissociation rod 4 passing through the through hole 153 of the boss 152 is to fix the implanted part on the dissociation device 3. When the implanted part completes the implantation operation, the dissociation rod 4 is pulled upward out of the through hole on the boss 152 to separate the dissociation device 3 from the implanted part. The operation is convenient and the separation operation of the implanted part is easy.

[0096] The control point of the implanted part is located on the upper clamp arm 12 , and a pull ring 51 is provided on the upper clamp arm 12 . The distal end of the pull wire 5 is a loop, and the loop passes through the pull ring 51 and is connected to the dissociation rod 4 in the dissociation groove 34 .

[0097] During the adjustment and clamping process, the rotation of the free section 122 of the upper clamping arm 12 is controlled by the pull wire 5 loop. After the implantation is completed, the dissociation rod 4 is withdrawn to disengage the dissociation device 3 from the clamping component 1. The dissociation rod 4 is continued to be withdrawn, and the distal end of the pull wire 5 is released from the dissociation rod 4. After the pull wire 5 is retrieved from the upper control point, the implanted part is released as a whole.

[0098] In the present invention, the pull wire 5 is not directly passed through the upper clamping arm 12, but a pull ring 51 is used as a medium. Compared with the control method of directly contacting the upper clamping arm 12, this structure makes the withdrawal of the pull wire 5 smoother, and the pull wire 5 will not directly touch the clamped leaflet, and the clamping effect of the leaflet will not be affected by the withdrawal action of the pull wire 5.

[0099] The operation steps of the repair system of the present invention are as follows:

[0100] 1. During preparation, the upper clamp arm 12 is retracted into the receiving groove 32 of the dissociation device 3, and the lower clamp arm 11 is folded toward the distal end (i.e., the end away from the handle of the delivery system) so that it can be accommodated in the delivery sheath. The implanted part of the device and the dissociation device 3 are connected and fixed by the dissociation rod 4, and the implanted part of the device is retracted into the delivery sheath.

[0101] 2. Use the delivery system to deliver the repair system to the corresponding atrium (mitral valve repair needs to be delivered to the left atrium; tricuspid valve repair needs to be delivered to the right atrium).

[0102] 3. Push the implanted part of the device out of the delivery sheath, control the retraction state of the upper clamp arm 12 through the pull wire 5, and adjust the posture of the dissociation device 3, i.e., the repair clamp, through the adjustable bending sheath to ensure that its longitudinal axis is aligned with the leaflet apposition position. Rotate the clamp to ensure that the opening direction of the clamp arm is aligned with the target leaflet.

[0103] 4. Further deliver the repair clip into the ventricle (mitral valve repair needs to be delivered to the left ventricle; tricuspid valve repair needs to be delivered to the right ventricle).

[0104] 5. Adjust the position of the repair clip so that the target leaflet rests on the lower clip arm 11.

[0105] 6. Release the upper clamp arm 12 to capture the valve leaflet.

[0106] 7. Retract the dissociation rod 4 to release the implanted part, and the upper and lower clamping arms clamp the valve leaflets, and the blocking component 2 blocks the position where the valve leaflets are not fully closed.

[0107] 8. Confirm the reflux occlusion status through ultrasound and other imaging methods. If the expected goal is not achieved, pull back the upper clamp arm 12, adjust the position, and capture the leaflet again. If the occlusion is ideal, release and withdraw the corresponding pull wire 5, and implant the repair clip at the target position.

[0108] Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention.

Claims

1. A valve leaflet flow-blocking repair clip, Features: It comprises a clamping component and a flow-blocking component, wherein the clamping component and the flow-blocking component are assembled as one piece; The clamping component includes an upper clamping arm, a lower clamping arm, a fixing member, a supporting member and a connecting member; The upper clamp arm and the lower clamp arm are clamped together in a natural state, and the upper clamp arm performs unilateral movement in a stretched state; The connecting member is provided with a mounting groove, and the upper clamp arm, the lower clamp arm and the supporting member are overlapped and fixed in the mounting groove relative to the proximal end of the connecting member and extend from the bottom of the mounting groove; The fixing member is arranged on the lower surface of the lower clamping arm and is used to fix the flow blocking component; The lower portion of the support member is accommodated in the interior of the flow blocking component and is used to support the flow blocking component; A support ring is provided inside the flow-blocking component, the upper end of which is connected to the fixing member, and the support ring and the support member constitute the skeleton of the flow-blocking component, and the skeleton cooperates with the fixing member to pull and expand the flow-blocking component to a desired shape.

2. A valve leaflet flow obstruction repair clip as claimed in claim 1, Features: The main structure of the flow-blocking component is an expanded bluff body, and the surface of the bluff body is a bluff film.

3. A valve leaflet flow obstruction repair clip as claimed in claim 2, Features: The transverse cross section of the bluff body is a bluff cross section, and the bluff cross section has the largest thickness and width in the entire bluff body.

4. A valve leaflet flow obstruction repair clip as claimed in claim 2, Features: A layer of braided membrane is sewn on the outside of the clamping component, and the braided membrane and the flow-blocking membrane are made of biocompatible polymer material membranes.

5. A valve leaflet flow obstruction repair clip as claimed in claim 4, Features: The braided coating and the flow-blocking film are made of PET or PTFE.

6. The valve leaflet flow obstruction repair clip according to claim 1, Features: The upper clamping arm, the lower clamping arm and the supporting member are composed of a fixed section and a free section, and the fixed sections of the three are overlapped in sequence and fixed in the installation groove in a crimping or welding manner.

7. A valve leaflet flow obstruction repair clip as claimed in claim 6, Features: In a natural state, the angle between the fixed section of the upper clamp arm and the free section thereof is an acute angle, and in an extended state, the free section is pulled close to the fixed section.

8. A valve leaflet flow obstruction repair clip as claimed in claim 7, Features: A pressing sheet is cut out at the bottom of the free section of the upper clamping arm, and the pressing sheet is bent toward the inner side of the upper clamping arm to form the fixed section of the upper clamping arm, and the pressing sheet is hollowed out at the original position of the free section.

9. A valve leaflet flow obstruction repair clip as claimed in claim 8, Features: The fixed section of the lower clamp arm and its free section are in a V shape, and the fixed section of the lower clamp arm passes through the hollow on the free section of the upper clamp arm and is fixed in the installation groove.

10. The valve leaflet flow obstruction repair clip according to claim 9, Features: The upper clamping arm is provided with a barb facing the lower clamping arm.

11. A valve leaflet flow obstruction repair clip according to any one of claims 1 to 10, Features: The upper clamp arm, the lower clamp arm and the support member are formed by cutting and processing a nickel-titanium alloy sheet with shape memory.

12. A valve leaflet flow obstruction repair clip repair system, Features: The valve leaflet obstruction repair clip comprises the valve leaflet obstruction repair clip according to any one of claims 1 to 11, wherein the valve leaflet obstruction repair clip is an implanted part of the system, and a driving mechanism delivers the implanted part to a target position; The driving mechanism comprises a dissociation device, a dissociation rod and a pull wire; The dissociation device sequentially comprises a connecting section, a receiving groove for receiving the implanted part, and a dissociation groove; The tail of the connecting section is connected to the lumen of the delivery system; A dissociation rod hole is provided in the connecting section, and the dissociation rod is input from the cavity tube through the dissociation rod hole to cooperate and fix the implantation part and the distal end of the pull wire; The distal end of the pull wire cooperates with the dissociation rod to be connected in the dissociation groove, and the other end of the pull wire passes through and connects to the control point of the implanted part and then guides to the pull wire force control point, so that the implanted part can be opened and clamped by pulling and releasing the control point; Holes are arranged on both side walls of the dissociation tank, and the dissociation rod is inserted into the holes to realize positioning in the dissociation tank, and the distal end of the pull wire is wound around the dissociation rod in the dissociation tank.

13. A valve leaflet flow obstruction repair clip repair system as claimed in claim 12, Features: A groove is provided below the dissociation groove, and a boss is provided on the side end of the connecting piece of the leaflet flow blocking repair clip. A through hole is opened on the boss, and the groove is adapted to the boss. The boss is accommodated in the groove, and the dissociation rod passes through the through hole and the groove to fix the boss in the groove.

14. A valve leaflet flow obstruction repair clip repair system as claimed in claim 12, Features: The control point of the implanted part is located on the upper clamp arm, and a pull ring is provided on the upper clamp arm. The distal end of the pull wire is a loop, and the loop passes through the pull ring and is connected to the dissociation rod in the dissociation groove.

Images