Valve repair fixture

Abstract

The present invention relates to the field of medical device technology, and in particular to a valve repair clamp comprising an inner clamp, an outer clamp, and a splint. The inner clamp and the outer clamp can be extended from a folded closed position to an inner and outer clamp open state. The splint comprises a fixed arm and a movable arm. The fixed arm is fixed to the inner clamp and moves with the inner clamp; the outer clamp comprises a base and an outer clamp braided arm on the base; the movable arm is also connected to a first control wire to control the clamping of the movable arm and the inner clamp outer plate. The valve repair clamp of the present invention reduces the overall weight of the clamp, and at the same time, the clamp is not easy to be damaged and lose its functionality. Its special structure is used to successfully repair damaged valve leaflet tissue, restore the physiological function of the valve, extend the functional life of the valve, improve the success rate of the operation and the convenience of the surgical operation, and reduce damage to the patient.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve repair clamp. Background Art

[0002] Regurgitation is a common valvular disease. Regurgitation occurs when the valve leaflets fail to close completely, causing blood to flow back into the pumping chamber. Annular dilatation, leaflet prolapse, and obstructed leaflet movement are the main causes of regurgitation. Many diseases, such as rheumatic heart disease and endocarditis, can cause valvular lesions and impair valvular function.

[0003] Currently, the main treatment options for valve leaflet problems include valve replacement and valve repair. Valve leaflet replacement uses an artificial valve to replace a diseased or abnormal heart valve. This surgery often requires a thoracotomy and is quite invasive. Valve repair involves using a delivery device to deliver a clip from the apex of the heart to the damaged valve, attempting to clamp the anterior leaflet together. However, this repair method makes the operation more difficult, and it is difficult to control the amount of overlap of the clamping. It also requires a hole to be opened at the apex of the heart. Prior art, such as patent document No. 2018800181249, discloses a heart valve sealing device and its delivery device. The exemplary implantable prosthetic device has an apposition element and at least one anchor. The apposition element is configured to be positioned within the natural heart valve orifice to assist in filling the natural valve regurgitant space and forming a more effective seal. The apposition element may have a structure that is impermeable to blood and allows the natural leaflets to close around the apposition element during ventricular contraction to prevent blood from flowing back from the left ventricle or right ventricle to the left atrium or right atrium, respectively. The apposition element can be connected to the leaflets of the natural valve via an anchor. The above-mentioned technologies will cause additional damage to the patient's body and heart. However, the above-mentioned technical solution has a complex structure and requires high processing and assembly precision. In addition, the clamp parts are easily damaged during the high-frequency movement of the valve, and the clamp itself is prone to causing great pressure on the valve operation.

[0004] In view of the above technical problems, it is necessary to improve them. Summary of the Invention

[0005] The purpose of the present invention is to provide a valve repair clamp to address the defects of the prior art.

[0006] In order to achieve the above objectives, the present invention adopts the following technical solutions:

[0007] A valve repair clamp, comprising an inner clamp, an outer clamp, and a splint; the outer clamp comprises a base and an outer clamp braided arm on the base, the outer clamp braided arm forming an outer clamp clamping surface; the inner clamp is W-shaped, comprising a top seat, an inner clamp inner plate under the top seat, and an inner clamp outer plate, the inner clamp inner plate and the inner clamp outer plate forming two inner clamp clamping surfaces, the inner clamp is connected to the outer clamp braided arm end through the inner clamp outer plate end; the splint comprises a fixed arm and a movable arm, the fixed arm end is elastically connected to the movable arm end, the clamp The plate is fixedly sleeved in the inner clamping surface through a fixed arm and the inner side of the inner clamping outer plate; the length of the movable arm is adapted to the length of the inner clamping outer plate to form a valve clamping surface between the movable arm and the inner clamping outer plate to clamp the valve, and the movable arm is also connected to a first control wire to control the clamping of the movable arm and the inner clamping outer plate; the top seat and the base are used to be connected to a conveying device, and the conveying device is used to drive the base and the top seat to move relative to each other, and the base and the top seat drive the clamping of the outer clamping surface and the inner clamping surface when they move relative to each other.

[0008] As a preferred solution, the inner clip is an integrated structure.

[0009] As a preferred solution, the braided layer of the outer braided arm is single-layer or multi-layer.

[0010] As a preferred solution, the outer clamping braided arm is connected to a second control wire to regulate the clamping of the outer clamping braided arm.

[0011] As a preferred solution, the material of the first control wire and the second control wire is any one of nickel-titanium alloy wire, stainless steel wire, carbon fiber, and glass fiber.

[0012] As a preferred solution, the end of the inner clamp outer plate is connected to the end of the outer clamp braided arm via a rotating shaft structure.

[0013] As a preferred solution, the movable arm and the inner and outer plates each have a microneedle structure at the valve clamping surface.

[0014] As a preferred embodiment, the microneedles of the microneedle structure are arranged in multiple rows and columns, and the length of the microneedles is 0.3-0.5 mm.

[0015] As a preferred solution, the fixed arm and the inner side of the inner clamp outer plate are fixed by any one of steel sleeve connection, welding, and rivet connection.

[0016] As a preferred solution, the surfaces of the inner clip, outer clip and splint are coated; the coating carries functional drugs for accelerating the endothelialization of the valve repair clamp.

[0017] As a preferred solution, the coating is a single-layer coating or a multi-layer coating, and the material of the coating is selected from any one of non-degradable polymer materials, degradable polymer materials, and natural polymers, or a combination of multiple thereof.

[0018] As a preferred solution, the inner plate of the inner clip has a supporting protrusion.

[0019] As a preferred solution, the top seat has connecting protrusions on both sides, the center of the top seat has a connecting through hole, and the center of the base has a connecting groove; the top seat has through holes for the first control wire and the second control wire to pass through, and the base has a through hole for the second control wire to pass through.

[0020] As a preferred solution, the maximum angle at which both sides of the outer clamping surface are opened is 160 degrees.

[0021] As a preferred solution, the outer braided arm is braided with nickel-titanium wire.

[0022] Compared with the existing technology, the valve repair clamp of the present invention utilizes its structure to successfully connect the damaged valve leaflet tissue, restore the physiological function of the valve, extend the functional life of the valve, improve the success rate of the operation and the convenience of the surgical operation, and the outer clamp adopts the form of a woven arm, which reduces the overall weight of the clamp, and at the same time the clamp is not easy to be damaged and lose its functionality; the preparation process is simple and can be achieved through a simple processing method; the fixing method has no special requirements for the valve shape structure, and can be implemented on the surface of valves with various complex shapes and structures; the operation of repairing the valve can be completed only through the femoral vein and then through the heart septum, which causes little damage to the patient; the surface of the clamp has a coating that has good compatibility with blood, which can effectively reduce thrombosis and effectively shorten the time required for endothelialization. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 This is a schematic structural diagram of the valve repair clamp in a partially opened state according to the first embodiment of the present invention;

[0024] Figure 2 This is a schematic structural diagram of the outer clamp of the valve repair clamp according to the first embodiment of the present invention;

[0025] Figure 3 This is a schematic structural diagram of the inner clip of the valve repair fixture according to the first embodiment of the present invention;

[0026] Figure 4 This is a schematic structural diagram of a splint of a valve repair fixture according to a first embodiment of the present invention;

[0027] Figure 5 This is a schematic structural diagram of the valve repair clamp in a closed state according to the first embodiment of the present invention;

[0028] Figure 6 This is a schematic structural diagram of the valve repair fixture in a fully opened state according to the first embodiment of the present invention;

[0029] Figure 7This is a schematic diagram of the valve repair clamp according to the first embodiment of the present invention when it begins to capture the valve;

[0030] Figure 8 This is a schematic diagram of the valve repair fixture according to the first embodiment of the present invention capturing a unilateral valve leaflet;

[0031] Figure 9 This is a schematic diagram of the valve repair clamp according to the first embodiment of the present invention after the captured leaflets are closed;

[0032] Figure 10 This is a schematic structural diagram of a valve repair fixture according to a fifth embodiment of the present invention;

[0033] Among them: 100. Clamp; 101. Protective cover; 102. Inner clamp; 103. Outer clamp; 104. Clamp; 105. Top seat; 106. Inner plate of inner clamp; 107. Outer plate of inner clamp; 108. Connecting through hole; 109. Connecting protrusion; 110. Microneedle at the front end of the outer plate of inner clamp; 111. Braided arm of outer clamp; 112. Base; 113. Hinge; 114. Fixed arm; 115. Moving arm; 116. Microneedle at the front end of the moving arm; 117. First control wire; 118. Second control wire; 119. Push rod; 120. Leaflet; 121. Steel sleeve. DETAILED DESCRIPTION

[0034] The following describes the embodiments of the present invention through specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments. The details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the following embodiments and features in the embodiments can be combined with each other unless they conflict.

[0035] Example 1:

[0036] like Figure 1-9As shown, the valve repair clamp 100 of this embodiment is used to implant a damaged valve through a conveying device, and includes an inner clamp 102, an outer clamp 103, and a splint 104. The inner clamp 102 and the outer clamp 103 can be extended from a folded closed position to an open state of the inner and outer clamps 103, and the splint 104 includes a fixed arm 114 and a movable arm 115. The fixed arm 114 is fixed on the inner clamp 102 and moves with the inner clamp 102; the outer clamp 103 includes a base 112 and an outer clamp braided arm 111 on the base 112, and the outer clamp braided arm 111 forms a V-shaped clamping surface of the outer clamp 103; the inner clamp 102 is W-shaped, and includes a top seat 105, an inner clamp inner plate 106 under the top seat 105, and an inner clamp outer plate 107. The inner clamp inner plate 106 and the inner clamp outer plate 107 form two V-shaped clamping surfaces of the inner clamp 102. The clamp 102 is connected to the end of the inner clamp outer plate 107 and the end of the outer clamp braided arm 111 and is sleeved in the clamping surface of the outer clamp 103; the end of the fixed arm 114 is elastically connected to the end of the movable arm 115, and the clamp 104 is fixedly sleeved in the clamping surface of the inner clamp 102 through the fixed arm 114 and the inner side of the inner clamp outer plate 107; the arm length of the movable arm 115 is adapted to the length of the inner clamp outer plate 107 to form a valve clamping surface between the movable arm 115 and the inner clamp outer plate 107 to clamp the valve, and the movable arm 115 is also connected to a first control wire 117 to control the clamping of the movable arm 115 and the inner clamp outer plate 107; the top seat 105 and the base 112 are used to be connected to the conveying device to drive the base 112 and the top seat 105 to move relative to each other, and when the base 112 and the top seat 105 move relative to each other, they drive the clamping surface of the outer clamp 103 and the clamping surface of the inner clamp 102 to clamp.

[0037] Specifically, the outer clamp braided arm 111 can open and close relative to the base 112, and its maximum single-side opening angle is 80 degrees. At this angle, the outer clamps on both sides are not easy to open excessively and exceed 160 degrees, causing the outer clamp clamping surface to lose control. The outer clamp braided arm 111 is woven from nickel-titanium wire. The outer clamp braided arm 111 woven from multiple strands of nickel-titanium wire is not easy to break even after multiple opening and closing. Even if one or two strands of the outer clamp braided arm 111 break, it can still maintain its function. Preferably, other memory materials can be used as the braiding material; the braided layer of the outer clamp braided arm 111 can be single-layer or multi-layer, such as double-layer or triple-layer braided mesh. The use of a braided mesh structure can greatly reduce the overall weight of the bracket. The outer clamp 103 arm woven from nickel-titanium wire, a memory material, is After the force applied thereto is removed, it can restore its shape before deformation at a suitable temperature; the front end of the outer braided arm 111 is provided with a rotating shaft-type hinge 113 connected to the inner outer plate 107, and the outer braided arm 111 is hinged to the inner outer plate 107 through the hinge 113. Preferably, other connecting parts with rotating shaft structures can be selected, such as a rotating arm with a spring, a bearing, etc.; the rear part of the hinged end is provided with a connection structure with the second control wire 118, such as a connecting hole, a connecting ring, etc. for connecting with the second control wire 118; the tail end of the outer braided arm 111 is connected to the base 112, and the center position of the base 112 is provided with five holes, four holes with smaller diameters and one hole with larger diameters. The small hole is a through hole for the second control wire 118 to pass through, and the large hole is a connecting groove for fixing the top rod 119 of the conveying device. The preferred small hole can be omitted, and the second control wire 118 directly passes through the pipeline of the conveying device.

[0038] The top seat 105, inner clamp inner plate 106 and inner clamp outer plate 107 of the inner clamp 102 are all integrally formed with each other as an integral structure, avoiding the complexity of manufacturing and assembly operations, and the influence of assembly accuracy on surgery; when subjected to force, the inner clamp outer plate 107 can be opened to a maximum of 170 degrees relative to the inner clamp inner plate 106. When the force is removed, the inner clamp outer plate 107 forms an angle of less than 10 degrees with the inner clamp inner plate 106. It should be noted that the inverted V-shaped and W-shaped finger structures are similar in overall shape. For example, the small elastic angle of the w-shape made at the lower end of the V-shape also belongs to a similar V-shape. Preferably, the inner clamp inner plate 106 has an arc-shaped supporting protrusion at a position close to the valve clamping surface; symmetrical connecting protrusions 109 are provided on both sides of the top seat 105, and a connecting through hole 108 is provided in the center of the top seat 105. The connecting protrusion 109 is connected to the conveying device to ensure that the clamp 100 can be stably fixed on the conveying system. The connecting through hole 108 is for the top rod 119 of the conveying device to pass through.

[0039] The fixed arm 114 and the movable arm 115 of the clamping plate 104 are thin-film structures. The end of the fixed arm 114 and the end of the movable arm 115 are elastically connected in an integral manner. In the natural state, a negative angle is formed between the fixed arm 114 and the movable arm 115. The existence of this angle forms a certain clamping force between the fixed arm 114 and the movable arm 115. The fixed arm 114 is shorter than the movable arm 115 and is fixed to the inner clamp outer plate 107 by riveting, welding, gluing, etc. Following the movement of the inner clamp 102, the length of the movable arm 115 is adapted to the length of the inner clamp outer plate 107, so as to form a valve clamping surface between the movable arm 115 and the inner clamp outer plate 107 to clamp the valve. The front end of the movable arm 115 has one or two round holes for connecting a first control wire 117 to control the clamping of the movable arm 115 and the inner clamp outer plate 107. The first control wire 117 can directly go through the conveying device pipeline or pass through the small hole of the top seat 105 to the operating end. The movable arm 115 The circular hole at the front end is connected to the first control wire 117. When the first control wire 117 is tightened, the movable arm 115 is subjected to tension, and the fixed arm 114 is fixed to the inner clamp outer plate 107. Therefore, the movable arm 115 will rotate relative to the fixed arm 114 around the connection part between the fixed arm 114 and the movable arm 115 under the tension of the first control wire 117. Preferably, the movable arm 115 and the inner clamp outer plate 107 are respectively provided with a micro-needle structure at the valve clamping surface, including the inner clamp The microneedles 110 at the front end of the outer plate and the microneedles 116 at the front end of the movable arm are arranged in multiple rows and columns. The length of the microneedles is 0.3-0.5mm, such as 0.3mm, 0.4mm, and 0.5mm. This microneedle structure can increase the friction between the leaflets 120, and the microneedle structure can reduce the damage to the leaflets 120. At the same time, the microneedle structure can inject therapeutic drugs internally and inject them into the leaflets 120 in the form of injection, which has a strong absorption and therapeutic effect.

[0040] Preferably, the surfaces of the inner clip 102, outer clip 103, and splint 104 are coated. The coating can be connected by suturing and mainly covers the inner clip inner plate 106, the inner clip outer plate 107, the outer clip braided arm 111, and the movable arm 115. The coating can be a single layer or a multi-layer coating. The coating material is a degradable polymer material or a natural polymer. In addition, the coating can carry functional drugs to accelerate the endothelialization of the valve repair clamp 100. The first and second control wires are made of high-strength control wires and can be made of any one of nickel-titanium alloy wire, stainless steel wire, carbon fiber, and glass fiber, preferably nickel-titanium alloy wire to reduce rejection reactions.

[0041] like Figure 6As shown, the valve repair clamp 100 is in a fully open state, which is the state just coming out of the conveyor protective cover 101. When the clamp 100 is in a fully open state, its maximum diameter is relatively small, so a smaller catheter can be used. The smaller the catheter, the less damage it will cause to the human body.

[0042] The valve repair clamp 100 is opened in the following manner: the delivery device's top rod 119 passes through the connecting through-hole 108 at the top of the inner clamp 102. The end of the top rod 119 is fixed to the connecting groove of the base 112, which can be fixed by thread or mechanical latch. Because the clamp 100 is fixed to the delivery device via the connecting protrusion 109, the position of the top seat 105 of the inner clamp 102 is fixed. The top rod 119 can slide relatively within the connecting through-hole 108 of the top seat 105. When the top rod 119 moves forward, it drives the base 112 downward. The base 112 drives the outer clamp braided arms 111 downward through the connecting portion. The outer clamp 103 arms drive the inner clamp outer plate 107 outward and downward through the front connection portion. As the top rod 119 moves downward, the clamp 100 continues to open and stretch until it reaches its limit position. When the top rod 119119 moves backward, under the elastic action of the connection between the inner clamp outer plate 107 and the inner clamp inner plate 106, the inner clamp outer plate 107 moves upward toward the center, driving the outer clamp weaving arm 111 to open and move upward and then close; when the top rod 119 retreats into place, the clamp 100 is in a completely closed state.

[0043] like Figure 7-9 As shown, the clamp 100 that comes out of the conveyor protective cover 101 that passes through the diaphragm is in a partially open state ready for capture. At this time, adjusting the first control wire 117 can control the opening and closing of the movable arm 115 and the valve clamping surface of the inner clamp outer plate 107, thereby capturing the leaflet 120. The movable arm 115 can repeat the opening and closing action multiple times to adjust the capture state. The two movable arms 115 can be regulated individually or at the same time. At this time, the outer clamp braided arm 111 can also be fine-tuned by the second control wire 118 to reach the ideal capture state. After the two movable arms 115 capture the leaflet 120, the top rod 119 can be moved backward to make the clamp 100 reach the closed state. This closed state can be maintained by a mechanical lock, or it can be maintained by an elastic material or shape memory alloy such as nickel titanium alloy. Since the outer clamp braided arm 111, the inner clamp inner plate 106, and the inner clamp outer plate 107 of the clamp 100 are all sutured with a membrane, when the valve is captured and closed, the entire clamp 100 and most of the clamped leaflets 120 are wrapped in the membrane, reducing the possibility of thrombosis and shortening the time required for endothelialization.

[0044] This embodiment utilizes its special structure to successfully connect damaged valve leaflet tissue, restore the valve's physiological function, extend the valve's functional life, improve the success rate of the operation and the convenience of the surgical operation, and reduce damage to the patient.

[0045] Example 2:

[0046] The valve repair fixture of this embodiment differs from that of the first embodiment in that:

[0047] In this embodiment, the outer braided arm and the inner outer plate are an integral structure, formed by integrally cutting and forming the elastic metal. The connection part is relatively thin, making it easy to deform. Compared with the first embodiment, the integral cutting and forming operation is more convenient and eliminates the cumbersome process of using hinges for connection.

[0048] For other structures, please refer to Example 1.

[0049] Example 3:

[0050] The valve repair fixture of this embodiment differs from that of the first embodiment in that:

[0051] The clamp's fixed arm in this embodiment is fixed to the inner plate of the inner clamp, while its movable arm has an elastic force that clamps the outer plate inward, thereby also clamping the leaflets. To overcome the elastic force of the movable arm, which would otherwise cause the clamp to have a larger radial dimension, the outer clamp arm is wider and more flexible than the outer clamp arm in the first embodiment. Compared to the first embodiment, securing the clamp's fixed arm to the inner plate of the inner clamp is much easier to operate.

[0052] For other structures, please refer to Example 1.

[0053] Example 4:

[0054] The valve repair fixture of this embodiment differs from that of the first embodiment in that:

[0055] In this embodiment, an external skeleton is woven onto the braided layer of the outer clamp arms, or an additional structure is added to increase the contact area between the clamp and the valve leaflets. A film is applied to the skeleton or the additional structure. The inner clamp plates on both sides are wrapped with a film, so that the valve leaflets no longer contact the metal at this location, but instead contact the drug-loaded film. Compared to the first embodiment, this embodiment can accelerate the endothelialization of the clamp and improve the success rate of the procedure.

[0056] For other structures, please refer to Example 1.

[0057] Embodiment 5:

[0058] The valve repair fixture of this embodiment differs from the first embodiment in that:

[0059] like Figure 10As shown, in this embodiment, the clamp plate fixing arm is fixed to the inner clamp outer plate by means of a steel sleeve 121. The steel sleeve 121 has an opening at one end, through which the two plates can be inserted into the steel sleeve, and then the steel sleeve 121 is completely fixed to the plates by welding. Compared with the first embodiment, the fixing method of this embodiment is simpler and the fixing effect is better.

[0060] For other structures, please refer to Example 1.

[0061] The specific embodiments described herein are merely illustrative of the spirit of the present invention. Persons skilled in the art may make various modifications, additions, or substitutions to the described specific embodiments without departing from the spirit of the present invention or exceeding the scope of the appended claims.

Claims

1. A valve repair fixture, characterized in that: The cam is secured to the chassis and has a W-shaped base, the inner clamp being adapted to engage the outer clamping plate and the outer clamping plate, and the outer clamping plate being adapted to engage the chassis and the outer clamping plate. The inner clip is an integrated structure; The outer clamping braided arm is connected to a second control thread to regulate the clamping of the outer clamping braided arm; The movable arm and the inner clamp outer plate each have a microneedle structure at the valve clamping surface; The surfaces of the inner clip, the outer clip and the clamp are coated; The membrane carries functional drugs for accelerating endothelialization of the valve repair clip; The microneedle structure is internally injected with therapeutic drugs, which are injected into the valve leaflet in the form of an injection; The microneedles of the microneedle structure are arranged in multiple rows and columns, and the length of the microneedles is 0.3-0.5 mm.

2. The valve repair fixture according to claim 1, characterized in that: The braided layer of the outer braided arm is single-layer or multi-layer.

3. The valve repair fixture according to claim 2, characterized in that: The material of the first control wire and the second control wire is any one of nickel-titanium alloy wire, stainless steel wire, carbon fiber, glass fiber, and polymer material.

4. The valve repair fixture according to claim 3, characterized in that: The end portion of the inner clamp outer plate is connected to the end portion of the outer clamp braided arm via a rotating shaft structure.

5. The valve repair fixture according to claim 1, characterized in that: The fixed arm and the inner side of the inner clamp outer plate are fixed by any one of steel sleeve connection, welding and rivet connection.

6. The valve repair fixture according to claim 5, characterized in that: The coating is a single-layer coating or a multi-layer coating, and the material of the coating is selected from any one of non-degradable polymer materials and degradable polymer materials or a combination of multiple ones.

7. The valve repair fixture according to claim 6, characterized in that: The inner clip inner plate has a supporting protrusion.

8. The valve repair fixture according to claim 7, characterized in that: The top seat has connecting protrusions on both sides, the center of the top seat has a connecting through hole, and the center of the base has a connecting groove; the top seat has through holes for the first control wire and the second control wire to pass through, and the base has a through hole for the second control wire to pass through.

9. The valve repair fixture according to claim 8, characterized in that: The maximum angle at which both sides of the outer clamping surface are opened is 160 degrees.

10. The valve repair fixture according to any one of claims 1 to 9, characterized in that: The outer braided arm is braided with nickel-titanium wire.

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