CN212415988U

CN212415988U - Valve repair clamp

Info

Publication number: CN212415988U
Application number: CN202020467778.4U
Authority: CN
Inventors: 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2020-04-02
Filing date: 2020-04-02
Publication date: 2021-01-29
Anticipated expiration: 2030-04-02

Abstract

The utility model relates to the technical field of medical equipment, in particular to a valve repair clamp, which comprises an inner clamp, an outer clamp and a clamping plate, wherein the inner clamp and the outer clamp can extend to an opening state of the inner clamp and the outer clamp from a folding closing position; the outer clamp comprises a base and an outer clamp weaving arm on the base; the movable arm is also connected with a first control wire to control the movable arm to be clamped with the inner clamp outer plate. The utility model discloses a valve repair anchor clamps has alleviateed the whole weight of anchor clamps, and anchor clamps should not damage its functionality simultaneously, utilizes its special construction to successfully repair impaired valve blade tissue, resumes valve physiology, prolongs the functional life of valve, has improved the success rate of operation and the convenience of operation, has reduced the damage to the patient.

Description

Valve repair clamp

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to a valve repair anchor clamps.

Background

Regurgitation is a common valvular disease. Regurgitation is caused by the failure of the leaflets to close completely, causing blood to flow back into the chamber where the blood is pumped, and is caused by the main reasons for regurgitation, such as annular dilation, leaflet prolapse, and obstruction of leaflet movement, and is impaired by the lesions of the valve caused by many diseases, such as rheumatic heart disease and endocarditis.

The main current methods for leaflet treatment are valve replacement techniques and valve repair techniques. Leaflet replacement techniques replace an original diseased or abnormal heart valve with a prosthetic valve. Such replacement surgery often requires an open chest procedure, which is a major trauma to the patient. Valve repair treatments, i.e. delivery of clips from the apex of the heart to the damaged valve using a transporter, attempt to clamp the anterior leaflet edges of the leaflets together using the clips. However, this repair makes the procedure more difficult, does not control the amount of overlap of the pinch, and requires an opening at the apex, and prior art such as patent application No. 2018800181249 discloses a heart valve sealing device and delivery device therefor, an exemplary implantable prosthetic device having a coaptation element configured to be positioned within the native heart valve orifice to assist in filling the native valve commissure regurgitation space and creating a more effective seal, and at least one anchor, the coaptation element may be impermeable to blood and allow the native leaflets to close around the coaptation element during ventricular systole to prevent backflow of blood from the left ventricle or right ventricle, respectively, to the left atrium in the right atrium, and the above-described technique of the leaflets being connectable to the native valve via the anchor can all cause additional damage to the patient's body, heart. However, the technical scheme has a complex structure and high requirements on machining and assembling precision, and the clamp parts are easily damaged in the high-frequency valve movement process, so that the clamp easily generates large pressure on valve work.

In view of the above technical problems, it is desirable to improve.

SUMMERY OF THE UTILITY MODEL

The utility model aims at providing a valve repair clamp aiming at the defects of the prior art.

In order to realize the above purpose, the utility model adopts the following technical scheme:

a valve repair clamp comprises an inner clamp, an outer clamp and a clamping plate; the outer clamp comprises a base and an outer clamp weaving arm on the base, and the outer clamp weaving arm forms an outer clamp surface; the inner clamp is W-shaped and comprises a top seat, an inner clamp inner plate and an inner clamp outer plate, wherein the inner clamp inner plate and the inner clamp outer plate form two inner clamp surfaces; the clamping plate comprises a fixed arm and a movable arm, the end part of the fixed arm is elastically connected with the end part of the movable arm, and the clamping plate is fixedly sleeved in the inner clamping surface through the fixed arm and the inner side of the inner clamping outer plate; the length of the moving arm is matched with the length of the inner clamp outer plate so as to form a valve clamping surface clamping valve between the moving arm and the inner clamp outer plate, and the moving arm is also connected with a first control wire so as to control the clamping of the moving arm and the inner clamp outer plate; the top seat and the base are used for being connected with a conveying device, the conveying device drives the base and the top seat to move relatively, and the base and the top seat drive the clamping of the outer clamping surface and the inner clamping surface when moving relatively.

Preferably, the inner clip is of an integral structure.

Preferably, the braided layer of the outer clamping braided arm is a single layer or a plurality of layers.

Preferably, the outer clamping braiding arm is connected with a second wire control to regulate clamping of the outer clamping braiding arm.

Preferably, the first wire control and the second wire control are made of any one of nickel-titanium alloy wires, stainless steel wires, carbon fibers and glass fibers.

Preferably, the end part of the inner-clamp outer plate and the end part of the outer-clamp weaving arm are connected through a rotating shaft structure.

Preferably, the moving arm and the inner clamp outer plate are respectively provided with a microneedle structure at the valve clamping surface.

Preferably, the microneedles of the microneedle structure are arranged in a plurality of rows and columns, and the length of the microneedles is 0.3-0.5 mm.

Preferably, the fixed arm and the inner side of the inner clamp outer plate are fixed in any one of a steel sleeve sleeving mode, a welding mode and a rivet riveting mode.

Preferably, the surfaces of the inner clamp, the outer clamp and the splint are provided with a coating film; the covering film carries functional medicine and is used for accelerating endothelialization of the valve repair clamp.

Preferably, the coating is a single-layer coating or a multi-layer coating, and the material of the coating is selected from one or a combination of more of a non-degradable high polymer material, a degradable high polymer material and a natural polymer.

Preferably, the inner clip inner panel has a support protrusion.

Preferably, the two sides of the top seat are provided with connecting bulges, the center of the top seat is provided with a connecting through hole, and the center of the base is provided with a connecting groove; the top seat is provided with a through hole for the first wire control and the second wire control to pass through, and the base is provided with a through hole for the second wire control to pass through.

Preferably, the maximum angle of opening of both sides of the outer clamping face is 160 degrees.

Preferably, the outer clamping braided arm is braided by nickel-titanium wires.

Compared with the prior art, the valve repair clamp of the utility model successfully connects the damaged valve leaflet tissue by utilizing the structure, recovers the valve physiological function, prolongs the functional life of the valve, improves the success rate of the operation and the convenience of the operation, and the outer clamp adopts the form of the weaving arm, thereby reducing the whole weight of the clamp, and simultaneously the clamp is not easy to damage and lose the functionality; the preparation process is simple and can be realized by a simple processing method; the fixing method has no special requirements on the valve shape and structure, and can be realized on the surfaces of valves with various complex shape and structure; the operation of repairing the valve can be completed only by passing through the femoral vein and then through the heart septum, so that the damage to a patient is small; the surface of the clamp is provided with a film which has good compatibility with blood, so that thrombosis can be effectively reduced, and the time required by endothelialization can be effectively shortened.

Drawings

Fig. 1 is a schematic structural view of a valve repair clamp according to a first embodiment of the present invention in a partially opened state;

fig. 2 is a schematic structural view of an outer clip of a valve repair clip according to a first embodiment of the present invention;

fig. 3 is a schematic structural view of an inner clip of a valve repair clip according to a first embodiment of the present invention;

fig. 4 is a schematic structural view of a clamping plate of a valve repair clamp according to a first embodiment of the present invention;

fig. 5 is a schematic structural view of a valve repair clamp according to a first embodiment of the present invention in a closed state;

fig. 6 is a schematic structural view of a valve repair clamp according to a first embodiment of the present invention in a fully opened state;

fig. 7 is a schematic view of a valve repair clamp according to a first embodiment of the present invention at the beginning of capturing a valve;

fig. 8 is a schematic view of a valve repair clamp according to a first embodiment of the present invention when capturing a single-sided leaflet;

fig. 9 is a schematic view of a valve repair clamp according to a first embodiment of the present invention after closing of the captured leaflets;

fig. 10 is a schematic structural view of a valve repair clamp according to a fifth embodiment of the present invention;

wherein: 100. a clamp; 101. a protective sleeve; 102. internal clamping; 103. an outer clamp; 104. a splint; 105. a top seat; 106. an inner plate is clamped; 107. an outer plate is clamped in the inner part; 108. connecting the through holes; 109. a connecting projection; 110. microneedle at the front end of the inner-clamping outer plate; 111. an outer clamping braiding arm; 112. a base; 113. an articulation member; 114. a fixed arm; 115. a moving arm; 116. moving the microneedle at the front end of the arm; 117. first wire control; 118. second wire control; 119. a top rod; 120. a leaflet; 121. and (5) steel sleeve.

Detailed Description

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The present invention can also be implemented or applied through other different specific embodiments, and various details in the present specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It is to be noted that the features in the following embodiments and examples may be combined with each other without conflict.

The first embodiment is as follows:

as shown in fig. 1-9, the valve repair clamp 100 of the present embodiment is used for implanting a damaged valve by a delivery device, and comprises an inner clamp 102, an outer clamp 103, and a clamping plate 104, wherein the inner clamp 102 and the outer clamp 103 can extend from a folded closed position to an opened state of the inner clamp 103 and the outer clamp 103, the clamping plate 104 comprises a fixed arm 114 and a movable arm 115, and the fixed arm 114 is fixed on the inner clamp 102 and moves together with the inner clamp 102; the outer clamp 103 comprises a base 112 and an outer clamp weaving arm 111 on the base 112, and the outer clamp weaving arm 111 forms a V-shaped outer clamp 103 clamping surface; the inner clamp 102 is W-shaped and comprises a top seat 105, an inner clamp inner plate 106 and an inner clamp outer plate 107, wherein the whole part below the top seat 105 is inverted V-shaped, the inner clamp inner plate 106 and the inner clamp outer plate 107 form two V-shaped clamping surfaces of the inner clamp 102, and the inner clamp 102 is connected with the end part of an outer clamp weaving arm 111 through the end part of the inner clamp outer plate 107 in a connecting way and is arranged in the clamping surface of the outer clamp 103; the end of the fixed arm 114 is elastically connected with the end of the movable arm 115, and the clamping plate 104 is fixedly sleeved in the clamping surface of the inner clamp 102 through the fixed arm 114 and the inner side of the outer plate 107 of the inner clamp; the arm length of the moving arm 115 is matched with the length of the inner clamp outer plate 107 so as to form a valve clamping surface clamping valve between the moving arm 115 and the inner clamp outer plate 107, and the moving arm 115 is further connected with a first wire control 117 so as to control the clamping of the moving arm 115 and the inner clamp outer plate 107; the top seat 105 and the base seat 112 are used for being connected with a conveying device so as to drive the base seat 112 and the top seat 105 to move relatively, and when the base seat 112 and the top seat 105 move relatively, the outer clamp 103 clamping surface and the inner clamp 102 clamping surface are driven to clamp.

Specifically, the outer clip weaving arm 111 can perform opening and closing movement relative to the base 112, the maximum opening angle of one side of the outer clip is 80 degrees, the outer clips on two sides are not easy to excessively open under the angle and exceed 160 degrees, so that the outer clip clamping surface is not controlled, the outer clip weaving arm 111 is woven by nickel-titanium wires, the outer clip weaving arm 111 formed by weaving multiple strands of nickel-titanium wires is not easy to break even under the condition of multiple opening and closing, the outer clip weaving arm 111 can still maintain the function even if one or two outer clip weaving arms 111 break, and preferably, other memory materials can be selected as weaving materials; the braided layer of the outer clip braided arm 111 can be a single layer or a plurality of layers, such as a double-layer braided mesh or a three-layer braided mesh, the whole weight of the bracket can be greatly reduced by using the braided mesh structure, and the outer clip 103 arm braided by the memory material nickel-titanium wire can recover the shape before deformation at a proper temperature after the force applied to the outer clip 103 arm is removed; the front end of the outer clamping weaving arm 111 is provided with a rotary shaft type hinge element 113 connected with the inner clamping outer plate 107, the outer clamping weaving arm 111 is hinged with the inner clamping outer plate 107 through the hinge element 113, preferably, a connecting piece with other rotary shaft structures can be selected, such as a rotary arm with a spring, a bearing and the like; the rear part of the hinged end is provided with a connecting structure with the second wire control 118, such as a connecting hole, a connecting ring and the like, for connecting with the second wire control 118; the tail end of the outer clamping weaving arm 111 is connected with a base 112, five holes are formed in the center of the base 112, four holes with smaller diameters and one hole with larger diameter are formed in the center of the base 112, the small holes are through holes for the second wire control 118 to pass through, and the large holes are connecting grooves for fixing a push rod 119 of a conveying device. The preferred orifice may be omitted and the second wire control 118 routed directly through the tubing of the delivery device.

The top seat 105, the inner clamp inner plate 106 and the inner clamp outer plate 107 of the inner clamp 102 are of an integrally formed integrated structure, so that the complexity operation of manufacturing and assembling and the influence of assembling precision on an operation are avoided; the inner clamp outer plate 107 can be maximally expanded by 170 degrees relative to the inner clamp inner plate 106 under the condition of stress, and after the stress is removed, the inner clamp outer plate 107 and the inner clamp inner plate 106 form an included angle smaller than 10 degrees; symmetrical connecting protrusions 109 are arranged on two sides of the top seat 105, a connecting through hole 108 is formed in the center of the top seat 105, the connecting protrusions 109 are connected with the conveying device, the clamp 100 can be stably fixed on a conveying system, and a mandril 119 of the conveying device penetrates through the connecting through hole 108.

The fixing arm 114 and the moving arm 115 of the clamping plate 104 are of thin-sheet structures, the end of the fixing arm 114 and the end of the moving arm 115 are in integral elastic connection, a negative angle is formed between the fixing arm 114 and the moving arm 115 which are integrally formed in a natural state, a certain clamping force is formed between the fixing arm 114 and the moving arm 115 due to the angle, the fixing arm 114 is shorter than the moving arm 115 and is fixed on the inner clamp outer plate 107 in a riveting, welding, adhering and other modes to move along with the inner clamp 102, the arm length of the moving arm 115 is matched with that of the inner clamp outer plate 107 so as to form a valve clamping surface clamping valve between the moving arm 115 and the inner clamp outer plate 107, one or two round holes are formed at the front end of the moving arm 115 and used for being connected with a first control wire 117 so as to control the clamping between the moving arm 115 and the inner clamp outer plate 107, the first control wire 117 can directly walk a device pipeline or pass through a small hole of the top seat 105, the round hole at the front end of the movable arm 115 is connected with the first wire control 117, when the first wire control 117 is tightened, the movable arm 115 is under tension, and the fixed arm 114 is fixed on the inner clamp outer plate 107, so that the movable arm 115 can rotate around the connection part of the fixed arm 114 and the movable arm 115 relative to the fixed arm 114 under the tension of the first wire control 117; preferably, microneedle structures are respectively arranged at the moving arm 115 and the inner clamp outer plate 107 at the valve clamping plane, and comprise inner clamp outer plate front-end microneedles 110 and moving arm front-end microneedles 116, the microneedles 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, the microneedle structures can increase the friction force between the microneedles and the valve leaflet 120, and the microneedle structures can reduce the damage to the valve leaflet 120, and meanwhile, the microneedle structures can be internally injected with therapeutic drugs and injected into the valve leaflet 120 in an injection mode, so that the microneedle structures have strong absorption and treatment effects.

Preferably, the surfaces of the inner clip 102, the outer clip 103, and the clamp plate 104 have a coating, and the coating may be connected by sewing and mainly covers the inner clip inner plate 106, the inner clip outer plate 107, the outer clip woven arm 111, and the moving arm 115, and may be a single-layer coating or a multi-layer coating. The coating material is degradable high molecular material and natural polymer, and the coating can carry functional medicine and is used for accelerating endothelialization of the valve repair clamp 100; the first wire control and the second wire control are high-strength wires, the material of the first wire control and the second wire control can be any one of nickel-titanium alloy wires, stainless steel wires, carbon fibers and glass fibers, and the first wire control and the second wire control are preferably nickel-titanium alloy wires, so that rejection reaction is reduced.

As shown in fig. 6, valve repair clip 100 is in a fully open position just after it exits from carrier protective sheath 101, and when clip 100 is in the fully open position it has a smaller diameter at its maximum, thus allowing for a smaller catheter, which reduces trauma to the body.

The valve repair clip 100 is opened by: a top rod 119 of the conveying device penetrates through a connecting through hole 108 at the top of the inner clamp 102, and the end part of the top rod 119 is fixed on a connecting groove of the base 112 in a threaded fixing mode or a mechanical latching mode; since the clamp 100 is fixed to the carrier by the coupling projection 109, the top seat 105 of the inner clamp 102 is fixed in position; the rod 119 is relatively slidable in the coupling through-hole 108 of the head base 105. When the top rod 119 moves forward, the base 112 is driven to move downward, the base 112 drives the outer clamp weaving arm 111 to move downward through the connecting part, and the outer clamp 103 drives the inner clamp outer plate 107 to open outward and move downward through the connecting part at the front end. The clamp 100 is continuously opened and elongated to its extreme position with the downward movement of the ram 119. When the ejector rod 119119 moves backwards, under the elastic action of the connecting part of the inner-clamp outer plate 107 and the inner-clamp inner plate 106, the inner-clamp outer plate 107 moves upwards to the center, and drives the outer-clamp weaving arm 111 to open and move upwards and then close; when the ejector 119 is retracted to the position, the clamp 100 is in a fully closed state.

As shown in fig. 7-9, the clamp 100 from the delivery device protective sheath 101 passing through the septum is in a state of partial opening for capture, and at this time, adjusting the first control wire 117 can control the opening and closing of the valve clamping surface of the moving arm 115 and the inner clamp outer plate 107, so as to capture the leaflet 120, and the moving arm 115 can repeat the opening and closing actions for multiple times to adjust the capture state, and can independently adjust and control the two moving arms 115, or can simultaneously adjust and control the two moving arms 115; the outer clamping braid arm 111 can also be fine-tuned at this time by the second wire control 118 to achieve the desired capture state. After the two moving arms 115 capture the leaflets 120, the lift pins 119 can be moved back to bring the clip 100 to a closed state. The closed state may be maintained by means of a mechanical lock, or may be maintained by a resilient material or a shape memory alloy such as nitinol. Because the outer-clamp woven arm 111, the inner-clamp inner plate 106 and the inner-clamp outer plate 107 of the clamp 100 are all sewed with the covering film, after the valve is captured and closed, the whole clamp 100 and most of the clamped valve leaflets 120 are wrapped by the covering film, so that the possibility of forming thrombus is reduced, and the time required by endothelialization is shortened.

The embodiment utilizes the special structure to successfully connect the damaged valve leaflet tissue, recovers the physiological function of the valve, prolongs the functional life of the valve, improves the success rate of the operation and the convenience of the operation, and reduces the damage to the patient.

Example two:

the valve repair clamp of the present embodiment differs from the first embodiment in that:

the outer clamp woven arm and the inner clamp outer plate in the embodiment are of an integral structure, and the elastic metal is integrally cut and formed, so that the connecting part is relatively thin, and the elastic metal can be easily deformed. Compared with the first embodiment, the integral cutting and forming operation is more convenient, and the tedious process of using the hinge for connection is omitted.

Other structures refer to the first embodiment.

Example three:

the fixing arm of the clamping plate in the embodiment is fixed on the inner clamping plate, the moving arm has elastic force towards the inner clamping plate, so that the effect of clamping the valve leaflets can be achieved, the radial size of the clamp is enlarged to overcome the movable outward elastic force, and therefore the outer clamping arm is wider and has larger elasticity than the outer clamping arm in the first embodiment. Compared with the first embodiment, the clamping plate fixing arm is easier to fix on the inner clamp inner plate.

Other structures refer to the first embodiment.

Example four:

in the embodiment, an outer framework is woven on the woven layer of the outer clamp weaving arm, or an auxiliary structure is added, so that the contact area between the clamp and the valve leaflet can be increased; and (3) performing film coating operation on the framework or the accessory structure. The inner splints on both sides are wrapped with a film so that the leaflets no longer contact the metal here but the drug loaded film. Compared with the first embodiment, the embodiment can accelerate endothelialization of the clamp and improve the success rate of the operation.

Other structures refer to the first embodiment.

Example five:

the valve repair clamp of the present embodiment is different from the first embodiment in that:

as shown in fig. 10, the splint fixing arm in the embodiment fixes the splint fixing arm on the inner splint outer plate by means of a steel sleeve 121, an opening is formed at one end of the steel sleeve 121, two plates can be inserted into the steel sleeve from the opening, and then the steel sleeve 121 is completely fixed on the plates by means of welding. Compared with the first embodiment, the fixing mode of the embodiment is simpler, and the fixing effect is better.

Other structures refer to the first embodiment.

The specific embodiments described herein are merely illustrative of the spirit of the invention. Various modifications, additions and substitutions for the specific embodiments described herein may be made by those skilled in the art without departing from the spirit of the invention or exceeding the scope of the invention as defined in the accompanying claims.

Claims

1. A valve repair clamp is characterized by comprising an inner clamp, an outer clamp and a clamping plate; the outer clamp comprises a base and an outer clamp weaving arm on the base, and the outer clamp weaving arm forms an outer clamp surface; the inner clamp is W-shaped and comprises a top seat, an inner clamp inner plate and an inner clamp outer plate, wherein the inner clamp inner plate and the inner clamp outer plate form two inner clamp surfaces; the clamping plate comprises a fixed arm and a movable arm, the end part of the fixed arm is elastically connected with the end part of the movable arm, and the clamping plate is fixedly sleeved in the inner clamping surface through the fixed arm and the inner side of the inner clamping outer plate; the length of the moving arm is matched with the length of the inner clamp outer plate so as to form a valve clamping surface clamping valve between the moving arm and the inner clamp outer plate, and the moving arm is also connected with a first control wire so as to control the clamping of the moving arm and the inner clamp outer plate; the top seat and the base are used for being connected with a conveying device, the conveying device drives the base and the top seat to move relatively, and the base and the top seat drive the clamping of the outer clamping surface and the inner clamping surface when moving relatively.

2. The valve repair clip of claim 1, wherein the inner clip is a unitary structure.

3. The valve repair clip of claim 2, wherein the braided layer of the outer clip braided arm is a single layer or a plurality of layers.

4. The valve repair clamp of claim 3, wherein the outer clamp braiding arm is connected to a second wire control to regulate clamping of the outer clamp braiding arm.

5. The valve repair clamp of claim 4, wherein the first wire and the second wire are made of any one of nitinol wires, stainless steel wires, glass fibers, and polymer materials.

6. The valve repair clamp of claim 5, wherein the inner clamp outer plate end and the outer clamp woven arm end are connected by a rotating shaft structure.

7. The valve repair clamp of claim 6, wherein the transfer arm and the inner clamp outer plate each have a microneedle structure at the valve clamping face.

8. The valve repair clip of claim 7, wherein the microneedles of the microneedle array are arranged in a plurality of rows and columns, and the microneedles are 0.3-0.5mm in length.

9. The clamp of claim 8, wherein the fixing arms are fixed to the inner side of the outer plate of the inner clamp by one of steel sleeve, welding and rivet riveting.

10. The valve repair clamp of claim 9, wherein the inner clamp, the outer clamp and the clamping plate have a coating on their surfaces; the covering film carries functional medicine and is used for accelerating endothelialization of the valve repair clamp.

11. The clamp of claim 10, wherein the covering membrane is a single-layer covering membrane or a multi-layer covering membrane, and the material of the covering membrane is selected from any one of a non-degradable high polymer material, a degradable high polymer material and a natural polymer.

12. The valve repair clip of claim 11, wherein the inner clip inner plate has support protrusions.

13. The valve repair clamp of claim 12, wherein the top seat has coupling protrusions at both sides thereof, the top seat has a coupling through hole at the center thereof, and the base seat has a coupling groove at the center thereof; the top seat is provided with a through hole for the first wire control and the second wire control to pass through, and the base is provided with a through hole for the second wire control to pass through.

14. The valve repair clip of claim 13, wherein the maximum angle of opening on either side of the outer clip gripping surface is 160 degrees.

15. The valve repair clip of any one of claims 1-14, wherein the outer clip braiding arms are braided from nickel titanium wire.