CN111920549A - Clip body of mitral valve clamping device, mitral valve clamping device and repair equipment - Google Patents

Clip body of mitral valve clamping device, mitral valve clamping device and repair equipment Download PDF

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Publication number
CN111920549A
CN111920549A CN202010950172.0A CN202010950172A CN111920549A CN 111920549 A CN111920549 A CN 111920549A CN 202010950172 A CN202010950172 A CN 202010950172A CN 111920549 A CN111920549 A CN 111920549A
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CN
China
Prior art keywords
arm
clip
mitral valve
clamping
clamping arm
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Pending
Application number
CN202010950172.0A
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Chinese (zh)
Inventor
肖振昕
王海山
虞奇峰
秦涛
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Shanghai Newmed Medical Co Ltd
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Shanghai Newmed Medical Co Ltd
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Application filed by Shanghai Newmed Medical Co Ltd filed Critical Shanghai Newmed Medical Co Ltd
Priority to CN202010950172.0A priority Critical patent/CN111920549A/en
Publication of CN111920549A publication Critical patent/CN111920549A/en
Priority to PCT/CN2021/094985 priority patent/WO2022052506A1/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246Devices for obstructing a leak through a native valve in a closed condition
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

The application discloses a clamp main body of a mitral valve clamping device, the mitral valve clamping device and repair equipment, wherein the clamp main body of the mitral valve clamping device comprises a supporting part, a first inner clamping arm, a first outer clamping arm, a second inner clamping arm and a second outer clamping arm; one side of the supporting part is sequentially connected with the first inner clamping arm and the first outer clamping arm in a bendable manner, and the other side of the supporting part is sequentially connected with the second inner clamping arm and the second outer clamping arm in a bendable manner; the length of the first inner clamping arm is greater than that of the second inner clamping arm; the length of the first outer clamping arm is larger than that of the second outer clamping arm.

Description

Clip body of mitral valve clamping device, mitral valve clamping device and repair equipment
Technical Field
The application relates to the field of medical equipment, in particular to a clip main body of a mitral valve clamping device, the mitral valve clamping device and repair equipment.
Background
Valves are membranous structures that can be opened and closed inside the organs of humans or some animals. For example, each individual has four valves in the heart, namely the aortic, pulmonary, mitral and tricuspid valves. Taking the mitral valve as an example, the mitral valve is located between the left atrium and the left ventricle, and when the left ventricle contracts, the mitral valve functions as a check valve to tightly close the atrioventricular orifice and prevent blood from flowing backward from the left ventricle into the left atrium. However, when the mitral valve is diseased, it may happen that the left ventricle is difficult to close completely when contracting, resulting in the left atrium receiving a large amount of blood backflow, which may result in a sharp rise in left atrium and pulmonary venous pressure, an increase in left ventricle diastolic volume load, and further a series of pathological changes such as left ventricle enlargement and pulmonary hypertension, and finally clinical manifestations such as heart failure, arrhythmia, etc., which may endanger life in severe cases.
When repairing diseased mitral valves, this can be accomplished with mitral valve repair devices. For example, the opposite sides of the mitral valve can be clamped by the mitral valve clamping device, so that the valve of the mitral valve is changed from a big hole into two small holes, the backflow area is reduced, and the mitral valve backflow is effectively prevented. The clip body is one of the main components of the mitral valve clamping device used to clamp the mitral valve. Similarly, the mitral valve clamping device can also be suitable for repairing other valves such as the tricuspid valve of the heart, and the effect of reducing the backflow area is achieved by clamping the valve leaflets on two sides.
Disclosure of Invention
One of the embodiments of the present application provides a clip main body of a mitral valve clamping device, the clip main body includes a support portion, a first inner clip arm, a first outer clip arm, a second inner clip arm, and a second outer clip arm; one side of the supporting part is sequentially connected with the first inner clamping arm and the first outer clamping arm in a bendable manner, and the other side of the supporting part is sequentially connected with the second inner clamping arm and the second outer clamping arm in a bendable manner; the length of the first inner clamping arm is greater than that of the second inner clamping arm; the length of the first outer clamping arm is larger than that of the second outer clamping arm.
One of the embodiments of the present application provides a mitral valve clamping device, which includes the clip main body according to any one of the above technical solutions.
One of the embodiments of the present application provides a mitral valve repair device, which includes a control handle and the mitral valve clamping device according to any one of the above technical solutions; the control handle is used for conveying the mitral valve clamping device to the mitral valve via the left auricle and the left atrium, controlling the opening and closing of the first inner clamping arm and the first clamping piece of the mitral valve clamping device, and controlling the opening and closing of the second inner clamping arm and the second clamping piece.
Drawings
The present application will be further explained by way of exemplary embodiments, which will be described in detail by way of the accompanying drawings. These embodiments are not intended to be limiting, and in these embodiments like numerals are used to indicate like structures, wherein:
FIG. 1 is a perspective view of a clip body of a mitral valve clamping device according to some embodiments of the present application;
FIG. 2 is a front view of a clip body of a mitral valve clamping device according to some embodiments of the present application;
FIG. 3 is a schematic view of a clip body of a mitral valve clamping device shown in accordance with some embodiments of the present application in an unbent configuration;
FIG. 4 is a side view of the clip body according to the mitral valve clamping device shown in FIG. 3;
FIG. 5 is a schematic view of an S-rod bend configuration of a clip body of a mitral valve clamping device according to some embodiments of the present application;
FIG. 6 is a schematic view of a waisted bend configuration of a clip body of a mitral valve clamping device according to some embodiments of the present application;
FIG. 7 is a schematic view of the attachment of the clip body, the first connector and the second connector of the mitral valve clamping device according to some embodiments of the present application;
FIG. 8 is a schematic view of the connection of the clip body and clip of the mitral valve clamping device according to some embodiments of the present application;
FIG. 9 is a schematic diagram of a barbed clip of a mitral valve clamping device integrally formed with a clip body according to some embodiments of the present application;
FIG. 10 is a perspective view of an elastomeric stent of a mitral valve clamping device according to some embodiments of the present application;
FIG. 11 is a schematic view of the attachment of the clip body, the first connector, the second connector and the flexible holder of the mitral valve clamping device according to some embodiments of the present application;
FIG. 12 is a schematic structural view of a mitral valve repair device according to some embodiments of the present application;
FIG. 13 is a schematic illustration in partial cross-sectional view of an inner clamp arm control mechanism according to some embodiments of the present application;
FIG. 14 is a schematic structural view of a cannula according to some embodiments of the present application;
FIG. 15 is an exploded view of the glides and protective sleeves according to some embodiments of the present application;
FIG. 16 is a schematic structural diagram of an inner clamp arm control mechanism according to another embodiment of the present application;
FIG. 17 is a schematic diagram of the internal structure of an internal clamp arm control mechanism according to another embodiment of the present application;
FIG. 18 is a schematic structural view of a threaded engagement mechanism according to another embodiment of the present application;
figure 19 is a schematic diagram of a partial cross-sectional configuration of a clip control mechanism according to some embodiments of the present application;
FIG. 20 is a schematic view of a housing according to some embodiments of the present application;
FIG. 21 is a schematic structural diagram of a second control section according to some embodiments of the present application;
FIG. 22 is a schematic structural view of a second control and locking mechanism shown in a first perspective in accordance with some embodiments of the present application;
FIG. 23 is a schematic structural view of a second control and locking mechanism shown in a second perspective in accordance with some embodiments of the present application;
FIG. 24 is a front view schematic diagram of a curved tube according to some embodiments of the present application;
FIG. 25 is an exploded view of a curved tube according to some embodiments of the present application;
FIG. 26 is an exploded view of a bend tube control mechanism according to some embodiments of the present application.
Description of reference numerals: 100. a clip main body; 110. a support portion; 120. a first inner clamp arm; 130. a second inner clamp arm; 140. a first outer clamp arm; 150. a second outer clamp arm; 160. a first bending structure; 170. a second bending structure; 200. a clip; 210. a first clip piece; 220. a second clip; 230. a fixed part; 240. a clamping portion; 250. a barb; 300. a control handle; 400. an inner clamp arm control mechanism; 410. a sleeve; 412. a first chute; 420. a first control unit; 421. connecting grooves; 429. connecting blocks; 430. a sliding part; 440. a drive rod; 450. a thread engagement mechanism; 451. an operation button; 453. a first elastic member; 455. an engaging member; 460. a fixed block; 470. a protective sleeve; 500. a clip control mechanism; 510. a housing; 511. a second chute; 520. a second control unit; 521. a conduit; 523. an end cap; 530. a locking mechanism; 531. a second elastic member; 533. a lock button; 535. a locking stop block; 537. a toothed connecting portion; 600. a delivery pipe; 610. bending the tube; 612. an inner core; 614. an outer tube; 616. a notch; 620. a bent tube control mechanism; 621. a screw; 622. a rotating part; 623. a traction part; 625. a hauling rope; 627. a threaded traction block; 700. a conveying connecting piece; 800. a first connecting member; 900. a second connecting member; 1000. an elastic support; 1010. a first support bar; 1020. a second support bar; 1030. a first mounting portion; 1040. a second mounting portion; 1110. s, a rod bending structure; 1111. a straight rod; 1112. bending a rod; 1120. a waist-thinning bending structure.
Detailed Description
In order to make the objects, technical solutions and advantages of the present application more apparent, the present application is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present application and are not intended to limit the present application.
On the contrary, this application is intended to cover any alternatives, modifications, equivalents, and alternatives that may be included within the spirit and scope of the application as defined by the appended claims. Furthermore, in the following detailed description of the present application, certain specific details are set forth in order to provide a better understanding of the present application. It will be apparent to one skilled in the art that the present application may be practiced without these specific details.
Embodiments of the present application relate to a clip body of a mitral valve clamping device, and a repair apparatus. The first inner clamping arm and the second inner clamping arm of the clamp body of the mitral valve clamping device can be opened or closed relatively, and the mitral valve or other valves (such as a tricuspid valve) can be clamped after being matched with the clamping pieces. Meanwhile, the length of the first inner clamping arm of the clamp body is larger than that of the second inner clamping arm, and the length of the first outer clamping arm is larger than that of the second outer clamping arm. In some embodiments, taking clamping the mitral valve as an example, in the process of clamping the mitral valve, the longer first inner and first outer clamp arms may be used for clamping an anterior leaflet of the mitral valve, and the shorter second inner and second outer clamp arms may be used for clamping a posterior leaflet of the mitral valve, which may be beneficial to maintain dynamic balance of the mitral valve after being clamped, ensure stable operation of the repaired mitral valve, and thus improve the mitral valve repair effect. In addition. The mitral valve repair device may include a control handle that may be used to deliver and manipulate the mitral valve clamping device and the mitral valve clamping device. In some embodiments, the mitral valve clamping device can reach the predetermined location through multiple paths. For example, a mitral valve clamping device may be delivered to the mitral valve via the femoral vein, inferior vena cava, right atrium, and left atrium to repair the mitral valve. For another example, a mitral valve clamping device may be delivered to the mitral valve via the left atrial appendage and the left atrium to repair the mitral valve.
Fig. 1 is a perspective view illustrating a clip body of a mitral valve clamping device according to some embodiments of the present application, fig. 2 is a front view illustrating the clip body of the mitral valve clamping device according to some embodiments of the present application, fig. 3 is a view illustrating the clip body of the mitral valve clamping device according to some embodiments of the present application when it is not bent, and fig. 4 is a side view illustrating the clip body of the mitral valve clamping device according to fig. 3. Hereinafter, a clip body for a mitral valve clamping device according to an embodiment of the present application will be described in detail with reference to fig. 1 to 4. It should be noted that the following examples are only for explaining the present application and do not constitute a limitation to the present application.
As shown in fig. 1 to 4, the clip body 100 of the mitral valve clamping device may include a support portion 110, a first inner clip arm 120, a first outer clip arm 140, a second inner clip arm 130, and a second outer clip arm 150. One side of the support 110 is sequentially connected to the first inner and outer clamp arms 120 and 140 in a bendable manner, and the other side of the support 110 is sequentially connected to the second inner and outer clamp arms 130 and 150 in a bendable manner. The first inner clip arm 120 is longer than the second inner clip arm 130. The first outer clamp arm 140 is longer than the second outer clamp arm 150.
In this embodiment, the bendable connection between the support 110 and the first inner clip arm 120 and the bendable connection between the support 110 and the second inner clip arm 130 can be understood as follows: the connection between the first inner clip arm 120 and the support 110 and the connection between the second inner clip arm 130 and the support 110 may be bent, so that the first inner clip arm 120 and the second inner clip arm 130 can be bent toward the support 110 to be relatively folded, and the first inner clip arm 120 and the second inner clip arm 130 can also be bent away from the support 110 to be relatively opened. The bendable connection of the first inner clamping arm 120 and the first outer clamping arm 140 and the bendable connection of the second inner clamping arm 130 and the second outer clamping arm 150 can be understood as follows: the joint of the first inner clamping arm 120 and the first outer clamping arm 140 and the joint of the second inner clamping arm 130 and the second outer clamping arm 150 can be bent, the included angle between the first inner clamping arm 120 and the first outer clamping arm 140 can be changed, and the included angle between the second inner clamping arm 130 and the second outer clamping arm 150 can be changed. In some embodiments, the number of the inner and outer clamping arms may be increased as needed, for example, a third inner clamping arm, a fourth inner clamping arm, a third outer clamping arm and a fourth outer clamping arm may be further included, and the support portion 110 may be sequentially connected with the third inner clamping arm and the third outer clamping arm in a bendable manner, and the support portion 110 may be sequentially connected with the fourth inner clamping arm and the fourth outer clamping arm in a bendable manner.
In the present embodiment, the lengths of the first inner clip arm 120, the second inner clip arm 130, the first outer clip arm 140, and the second outer clip arm 150 can be understood in conjunction with the state of the clip body 100 when it is not bent. Specifically, as shown in fig. 3, the length of the first inner clip arm 120 can be understood as: the distance between the end of the first inner clamp arm 120 proximal to the support 110 and the end of the first inner clamp arm 120 distal from the support 110; the length of the second inner clip arm 130 can be understood as: the distance between the end of the second inner clip arm 130 that is proximal to the support 110 and the end of the second inner clip arm 130 that is distal from the support 110. The length of first inner clamp arm 120 may be 1.2 times, 1.5 times, 2 times, 2.2 times, etc. the length of second inner clamp arm 130. The length of the first outer clamp arm 140 can be understood as: the distance between the end of the first outer clamp arm 140 proximal to the first inner clamp arm 120 and the end of the first outer clamp arm 140 distal to the first inner clamp arm 120; the length of the second outer clip arm 150 can be understood as: the distance between the end of the second outer clip arm 150 that is proximal to the second inner clip arm 130 and the end of the second outer clip arm 150 that is distal from the second inner clip arm 130. The length of the first outer clamp arm 140 may be 1.2 times, 1.5 times, 2 times, 2.2 times, etc. the length of the second outer clamp arm 150. In addition, the length of the first inner clamp arm 120, the second inner clamp arm 130, the first outer clamp arm 140 and the second outer clamp arm 150 can be designed by those skilled in the art according to the structural characteristics and the dimensional characteristics of the valve to be clamped.
As shown in fig. 3 and 4, the cross-sectional shape of the support part 110 may be a circle or an ellipse, and the cross-sectional area of the middle part of the support part 110 may be larger than the cross-sectional areas of both ends thereof. By such a design, possible benefits include, but are not limited to: so that the supporting part 110 does not easily damage the tissue; can form effective support for the clamped tissue. In some embodiments, the support 110 may also be pear-shaped, cylindrical, etc. Those skilled in the art can determine the shape of the support portion 110 of the clip body 100 to be different according to the specific condition of the tissue to be clipped (such as the shape of the coaptation edge of the mitral valve leaflet), so that the shape of the support portion 110 can be more suitable for the shape of the tissue (such as the coaptation edge of the mitral valve leaflet), and the clipping effect is better.
As shown in fig. 3, in some embodiments, the support 110 may be a mesh structure. The mesh structure may include one or more of a diamond mesh, a circular mesh, a rectangular mesh, a square mesh, a triangular mesh, or a regular polygonal mesh. The supporting portion 110 of the mesh structure can effectively fill the space between the first inner clamping arm 120 and the second inner clamping arm 130, and can prevent the formation of thrombus after the mitral valve clamping device clamps a valve (such as a mitral valve and a tricuspid valve).
In some embodiments, the clip body 100 can be a one-piece structure. Specifically, in the production manufacturing process of the clip body 100, the clip body 100 may be made by cutting (e.g., laser cutting) using a metal tube. In alternative embodiments, the clip body 100 may also be made using a woven wire. In some embodiments, the clip body 100 can be a one-piece structure made of a shape memory alloy tube that is cut and heat set. The shape memory alloy may include nickel titanium alloy or cobalt chromium alloy, etc.
The length of the first inner clamp arm 120 may be greater than, equal to, or less than the length of the first outer clamp arm 140, and the length of the second inner clamp arm 130 may be greater than, equal to, or less than the length of the second outer clamp arm 150. In some embodiments, the ratio of the lengths of the first inner and outer clamp arms 120, 140 may be equal to the ratio of the lengths of the second inner and outer clamp arms 130, 150. For example, when the length ratio of the first inner and outer clamp arms 120 and 140 is 0.9, the length ratio of the second inner and outer clamp arms 130 and 150 may also be 0.9. Through such setting, the structure of clip main part 100 is more reasonable, and after the centre gripping valve (like mitral valve, tricuspid valve), the atress of valve can be more even.
In some embodiments, one side of the support 110 is connected to the first inner clip arm 120 via a first bending structure 160; the other side of the supporting portion 110 is connected to the second inner clip arm 130 through the first bending structure 160. The first bending structure 160 may be an S-bar bending structure 1110 or a waist-reducing bending structure 1120. The first inner clamping arm 120 is connected with the first outer clamping arm 140 through a second bending structure 170; the second inner clamping arm 130 is connected to the second outer clamping arm 150 via a second bending structure 170. The second bending structure 170 may be an S-bar bending structure 1110 or a waist-reducing bending structure 1120. The first bending structure 160 and the second bending structure 170 enable both to realize bending by themselves due to their own structural characteristics and/or material characteristics. The specific structures of the first bending structure 160 and the second bending structure 170 may be the same or different. For example, when the first bending structure 160 is an S-bar bending structure 1110, the second bending structure 170 may be the S-bar bending structure 1110 or a waist-reducing bending structure 1120. Both the S-bar bending structure 1110 and the waist-reducing bending structure 1120 may be heat treated. The S-bar bending structure 1110 and the waist-thinning bending structure 1120 are easy to be deformed by heat treatment, and can enable stress at the bending part to be shared uniformly, and are not easy to break after being bent for multiple times, so that the service life of the clip main body 100 can be prolonged.
Specifically, fig. 5 is a schematic view of an S-bar bending structure of a clip body of a mitral valve clamping device according to some embodiments of the present application, and as shown in fig. 5, the S-bar bending structure 1110 can be understood as a bendable bar body structure resembling an "S" shape. In some embodiments, the S-bar bending structure 1110 may comprise at least three straight bars 1111 and two bent bars 1112, wherein the three straight bars 1111 are parallel to each other and the three straight bars 1111 are connected end to end by the two bent bars 1112. Fig. 6 is a schematic view of a waist-reducing bending structure of a clip body of a mitral valve clamping device according to some embodiments of the present application, and as shown in fig. 6, the waist-reducing bending structure 1120 can be understood as a bendable rod-shaped structure having a central portion with a width smaller than that of both ends. The middle width through setting up thin waist structure 1120 of buckling is less than both ends width, can make the middle part of thin waist structure 1120 of buckling change in buckling.
The benefits that may be brought about by the clip body of the mitral valve clamping device of the embodiments of the present application include, but are not limited to: (1) through the design that the length of the first inner clamping arm is greater than that of the second inner clamping arm and the length of the first outer clamping arm is greater than that of the second outer clamping arm, the dynamic balance of valves (such as a mitral valve and a tricuspid valve) can be kept after the valves are clamped, the valves after being repaired can be guaranteed to work stably, and therefore the repairing effect of the valves is improved; (2) the integrally formed structure of the clamp main body can ensure that the clamp main body has stable structure, reliable connection and simple and convenient production and manufacture; (3) the inner clamping arm of the clamp main body can be flexibly folded or unfolded through the bendable connection of the inner clamping arm and the supporting part and the bendable connection of the inner clamping arm and the outer clamping arm, so that the tissue capturing and clamping work can be better completed; (4) through the ingenious design of the bending structure, the related parts can be easily subjected to heat treatment and deform, and the stable bending effect between the parts can be realized. It is to be noted that different embodiments may produce different advantages, and in different embodiments, any one or combination of the above advantages may be produced, or any other advantages may be obtained.
In another aspect, one of the embodiments of the present application provides a mitral valve clamping device. The mitral valve clamping device includes the clip body 100 of any of the above-described aspects. Fig. 7 is a schematic view of the connection of the clip body, the first connector and the second connector of the mitral valve clamping device according to some embodiments of the present application, and fig. 8 is a schematic view of the connection of the clip body and the clip of the mitral valve clamping device according to some embodiments of the present application. As shown in fig. 7 and 8, the mitral valve clamping device may further include a first connector 800, a second connector 900, and a clip 200. The clip body 100 is connected between the first connector 800 and the second connector 900, and the relative movement of the first connector 800 and the second connector 900 can drive the first inner clip arm 120 and the second inner clip arm 130 to open or close relatively. The clip 200 includes a first clip 210 disposed on the first inner clip arm 120 and a second clip 220 disposed on the second inner clip arm 130, the first clip 210 and the second clip 220 being capable of opening and closing relative to the first inner clip arm 120 and the second inner clip arm 130, respectively, and enabling a mitral valve to be clamped between the first clip 210 and the first inner clip arm 120 and between the second clip 220 and the second inner clip arm 130.
In this embodiment, the relative opening angle of the first inner clip arm 120 and the second inner clip arm 130 may be any angle, such as 40 °, 90 °, 120 °, 180 °, 270 °, 350 °, 360 °, and so on. As shown in fig. 7, one end (shown upper end) of the support portion 110 is connected (e.g., fixedly connected) to the first connector 800, and one end (shown lower end) of the first outer clamp arm 140 and one end (shown lower end) of the second outer clamp arm 150 are respectively connected (e.g., fixedly connected) to the second connector 900. With this arrangement, when the second link 900 moves relative to the first link 800, the second link 900 can move relative to the support 110. When the second connector 900 is far away from the support portion 110, the first outer clamping arm 140 and the second outer clamping arm 150 can respectively pull the first inner clamping arm 120 and the second inner clamping arm 130 to be relatively opened under the driving of the second connector 900. In some embodiments, in order to allow a greater angular range of opening of the first and second inner clamp arms 120 and 130, an end of the first outer clamp arm 140 and an end of the second outer clamp arm 150 may be flexibly connected to the second connector 900. In addition, regarding how to further control the relative opening or closing of the first inner clamping arm 120 and the second inner clamping arm 130, reference may be made to the related description about the inner clamping arm control mechanism, and regarding how to further control the opening or closing of the first clamping jaw 210 and the second clamping jaw 220 relative to the first inner clamping arm 120 and the second inner clamping arm 130, respectively, reference may be made to the related description about the clamping jaw 200 control mechanism.
In some embodiments, first inner clip arm 120 and first clip 210 are for gripping an anterior leaflet of a mitral valve, and second inner clip arm 130 and second clip 220 are for gripping a posterior leaflet of the mitral valve. The anterior leaflet of the mitral valve, which is located relatively anterior to the anterior side and has a large area, is also called a large valve and is a boundary marker of the inflow and outflow tracts of the left ventricle. The posterior leaflet of the mitral valve is relatively located on the posterior side and has a small area, also called a small valve. Since the area of the anterior leaflet is large and the area of the posterior leaflet is small, the anterior leaflet is clamped by the first clamping piece 210 and the first inner clamping arm 120, and the posterior leaflet is clamped by the second clamping piece 220 and the second inner clamping arm 130, which can be beneficial to maintaining dynamic balance after the mitral valve is clamped. In other embodiments, when the mitral valve clamping device is used to clamp a tricuspid valve, the first inner clamping arm 120 and the first clamping piece 210 can be used to clamp leaflets with a larger tricuspid valve area (or longer length), and the second inner clamping arm 130 and the second clamping piece 220 can be used to clamp leaflets with a smaller tricuspid valve area (or shorter length), which can also facilitate dynamic balance of the clamped tricuspid valve.
In some embodiments, the length of the first clip 210 is greater than the length of the second clip 220. The length of the first clip 210 can be understood as: the distance between the end of the first clip 210 that is closer to the first inner clip arm 120 and the end that is farther from the first inner clip arm 120 when open; the length of the second clip 220 can be understood as: second clip 220, when expanded, is the distance between an end proximate to second inner clip arm 130 and an end distal to second inner clip arm 130. Through such an arrangement, the first clip 210 and the first inner clip arm 120 can more conveniently cooperate to clamp a leaflet with a large area (such as an anterior leaflet of a mitral valve), the second clip 220 and the second inner clip arm 130 can also more conveniently cooperate to clamp a leaflet with a small area (such as a posterior leaflet of a mitral valve), and dynamic balance of the clamped leaflet can be further maintained.
In some embodiments, to make the leaflets of a valve (e.g., mitral valve, tricuspid valve) more uniformly stressed and easier to clamp, the ratio of the lengths of first clip 210 and first inner clip arm 120 is equal to the ratio of the lengths of second clip 220 and second inner clip arm 130. For example, when the length ratio of the first clip 210 to the first inner clip arm 120 is 0.6, the length ratio of the second clip 220 to the second inner clip arm 130 may also be 0.6. Through such setting, mitral valve clamping device's structure is more reasonable, and the atress of the leaflet of being held is more even.
In some embodiments, as shown in fig. 8, the clip 200 may be a barbed clip. The barb clip may include a retainer portion 230, a grip portion 240, and barbs 250. One end of the clamping portion 240 may be connected to one end of the fixing portion 230 by a bending portion, and the other end of the clamping portion 240 may be provided with a barb 250. The barb 250 may be located on a side of the clamping portion 240 of the clip 200 (e.g., the first clip 210 or the second clip 220) that faces the inner clip arm (e.g., the first inner clip arm 120 or the second inner clip arm 130). The fixing portion 230 may be used to fix the clip 200 (e.g., the first clip 210 or the second clip 220) to the inner clip arm (e.g., the first inner clip arm 120 or the second inner clip arm 130). Clamping portion 240 may be configured to cooperate with an inner clamp arm (e.g., first inner clamp arm 120 or second inner clamp arm 130) to clamp tissue. One end of the fixing portion 230 and one end of the clamping portion 240 may be connected by a bending portion, so that the clip 200 (e.g., the first clip 210 or the second clip 220) can be opened and closed relative to the inner clip arm (e.g., the first inner clip arm 120 or the second inner clip arm 130). The bending portion can be an S-bar bending structure 1110 or a waist bending structure 1120, and the two bending structures of the clamping piece 200 are similar to those of the clamp body 100, as described above in connection with fig. 5 and 6. The barbs 250 can effectively prevent the valve from falling out from the clamping piece 200 and the inner clamping arms, so that the clamping of the mitral valve clamping device on the valve is more stable. In some alternative embodiments, the clip 200 may be other types of clips 200. For example, the side of the clip 200 facing the inner clip arm (e.g., the first inner clip arm 120 or the second inner clip arm 130) may be provided with barbs and/or protrusions, etc.
Fig. 9 is a schematic view of a barb clip of a mitral valve clamping device integrally formed with a clip body according to some embodiments of the present application. As shown in fig. 9, the first clip 210 and the first inner clip arm 120 may be integrally formed, and the second clip 220 and the second inner clip arm 130 may be integrally formed. Specifically, the retention portion 230, the gripping portion 240, and the barb 250 of the barb clip may all be integrally formed with the clip body 100. Specifically, when the clip body 100 is cut, the shapes of the clamping portion 240 and the barb 250 of the barb clip may be cut on the inner clip arms (the first inner clip arm 120 and the second inner clip arm 130) of the clip body 100, and one end of the cut clamping portion 240 is still connected to the inner clip arm (at this time, one end of the fixing portion 230 of the barb clip is also still connected to the inner clip arm). In some embodiments, after the grip portion 240 and the barb 250 are integrally cut, the barb 250 may be bent by heat treatment. In some alternative embodiments, the retainer portion 230 and the clamping portion 240 of the barbed clip may be integrally formed with the clip body 100. The clamping piece 200 and the inner clamping arm are integrally formed, so that the connection between the clamping piece 200 and the inner clamping arm is more reliable, and the clamping stability of the mitral valve clamping device is improved; meanwhile, the assembling process of the mitral valve clamping device can be simplified, and the production efficiency is improved.
In some embodiments, the mitral valve clamping device may include an elastic stent 1000. Fig. 10 is a perspective view illustrating an elastic support of a mitral valve clamping device according to some embodiments of the present disclosure, and fig. 11 is a view illustrating connection of a clip main body, a first connector, a second connector, and the elastic support of the mitral valve clamping device according to some embodiments of the present disclosure. As shown in fig. 10, the elastic bracket 1000 may include a first bar 1010, a second bar 1020, a first mounting portion 1030, and a second mounting portion 1040. One end of the first and second struts 1010, 1020 may be connected to the first mounting portion 1030 and the other end of the first and second struts 1010, 1020 may be connected to the second mounting portion 1040. In the embodiment of the present application, the elastic bracket 1000 is an integrally formed structure. That is, the first bar 1010, the second bar 1020, the first mounting portion 1030, and the second mounting portion 1040 are integrally formed. The elastic support 1000 is stable in structure, reliable in connection of all parts and simple and convenient to produce and manufacture through integral forming.
In some embodiments, as shown in fig. 11, the first and second mounting portions 1030 and 1040 of the elastic bracket 1000 may be fixedly coupled to the second connector 900. That is, both ends of the first and second struts 1010 and 1020 are fixed to the second connector 900. The first rod 1010 of the elastic bracket 1000 can be abutted against the joint of the first inner clamping arm 120 and the first outer clamping arm 140; the second supporting rod 1020 of the elastic bracket 1000 can be abutted against the joint of the second inner clamping arm 130 and the second outer clamping arm 150. For example, as shown in fig. 11, the first strut 1010 may be supported internally between the first inner and outer clamp arms 120, 140, and the second strut 1020 may be supported internally between the second inner and outer clamp arms 130, 150. In some embodiments, when the first strut 1010 or the second strut 1020 is abutted between the inner clamping arm and the outer clamping arm, the first strut 1010 or the second strut 1020 may be further fixedly connected to the joint of the inner clamping arm and the outer clamping arm by means of gluing, laser welding, or wire-wound connection. The length of the first strut 1010 may be greater than the length of the second strut 1020 such that the first strut 1010 is fittingly held between the first inner and outer clamp arms 120, 140 and the second strut 1020 is fittingly held between the second inner and outer clamp arms 130, 150.
In some alternative embodiments, the first strut 1010 may abut against the outside of the first outer clamp arm 140, and the second strut 1020 may abut against the outside of the second outer clamp arm 150. For example, a middle portion of the first strut 1010 may be fixedly attached to an outer side of the first outer clamp arm 140 (e.g., by gluing, laser welding, or wire wrapping, etc.), and the second strut 1020 may be fixedly attached to an outer side of the second outer clamp arm 150.
In this embodiment, by providing the elastic stent 1000, the area of the mitral valve clamping device for capturing the valve can be increased, and the elastic stent 1000 has a better supporting effect on the tissue, thereby improving the stability of the mitral valve clamping device. Meanwhile, the elastic support 1000 has a good tightening effect, so that the elastic force of the elastic support 1000 can make the clamping force on the tissue greater after the first inner clamping arm 120 and the second inner clamping arm 130 are folded. In addition, the amount of spring force provided by the resilient mount 1000 to the mitral valve clamping device can be adjusted (e.g., by adjusting the width of the first strut 1010 and/or the second strut 1020) based on the clamping requirements of different tissues or different patients, such that the mitral valve clamping device using the resilient mount 1000 can be adapted to different tissues or different patients.
The mitral valve clamping device of the embodiments of the present application may have benefits including, but not limited to: (1) the clip body is characterized in that the length of the first inner clip arm is greater than that of the second inner clip arm, and the length of the first outer clip arm is greater than that of the second outer clip arm, so that the dynamic balance of the mitral valve can be kept after the mitral valve is clamped, the stable work of the repaired mitral valve can be ensured, and the repair effect of the mitral valve can be improved; (2) the clip main body and the barb clip of the mitral valve clamping device can be integrally formed, so that the mitral valve clamping device has stable structure, reliable connection and simple and convenient production and manufacture; (3) by arranging the barb clamping piece, the tissue can be prevented from falling out between the clamping piece and the inner clamping arm, so that the clamping stability of the mitral valve clamping device is improved; (4) through setting up the elastic support, not only can make the tissue more easily catch by first interior arm lock and second interior arm lock, can also protect the tissue to improve the stability of mitral valve clamping device centre gripping. It is to be noted that different embodiments may produce different advantages, and in different embodiments, any one or combination of the above advantages may be produced, or any other advantages may be obtained.
In yet another aspect, one of the embodiments of the present application provides a mitral valve repair device. Fig. 12 is a schematic diagram of a mitral valve repair device according to some embodiments of the present application. As shown in fig. 12, the mitral valve repair device comprises a control handle and a mitral valve holding device according to any of the above-mentioned technical solutions. The control handle can be used to convey the mitral valve clamping device to the mitral valve, and control the opening and closing of the first inner clamping arm 120 and the first clamping piece 210 of the mitral valve clamping device, and the opening and closing of the second inner clamping arm 130 and the second clamping piece 220.
In some embodiments, the mitral valve repair device includes a delivery tube 600. The first connector 800 of the mitral valve clamping device is connected to the control handle 300 via the delivery tube 600. In some embodiments, the delivery tube 600 may include a curved tube 610, in which case the control handle 300 may include a curved tube control mechanism 620, the curved tube control mechanism 620 being operable to control the bending of the curved tube 610. In some embodiments, delivery tube 600 may be removably coupled to the mitral valve holding device via delivery connector 700. In some embodiments, the control handle 300 may be free of the bent tube control mechanism 620 when the bent tube 610 is not included on the delivery tube 600 (e.g., when the delivery tube 600 is in a non-bendable configuration).
FIG. 13 is a schematic illustration in partial cross-sectional view of an inner clamp arm control mechanism according to some embodiments of the present application; FIG. 14 is a schematic structural view of a cannula according to some embodiments of the present application; FIG. 15 is an exploded view of the glides and protective sleeves according to some embodiments of the present application; FIG. 16 is a schematic structural diagram of an inner clamp arm control mechanism according to another embodiment of the present application; FIG. 17 is a schematic diagram of the internal structure of an internal clamp arm control mechanism according to another embodiment of the present application; fig. 18 is a schematic structural view of a threaded engagement mechanism according to another embodiment of the present application. As shown in fig. 13-18, in some embodiments, control handle 300 includes an inner clamp arm control mechanism 400 and a clip control mechanism 500. The inner clamping arm control mechanism 400 is used for controlling the movement of the first inner clamping arm 120 and the second inner clamping arm 130 of the mitral valve clamping device; the clip control mechanism 500 is used to control the movement of the clips 200 (first clip 210 and second clip 220) of the mitral valve clamping device.
In some embodiments, as shown in fig. 13-18, the inner clamp arm control mechanism 400 can include a sleeve 410, a first control portion 420, and a slide portion 430, the slide portion 430 being disposed within the sleeve 410; the first control part 420 can drive the sliding part 430 to move in the sleeve 410 along the length direction of the sleeve 410 by rotating to control the opening and closing of the first inner clamping arm 120 and the second inner clamping arm 130. If one end of control handle 300 near the mitral valve clamping device is defined as the front end and the opposite end of control handle 300 is the rear end, then movement of slider 430 toward the front end within sleeve 410 can be used to control the opening of the inner clamping arms (e.g., relative opening of first inner clamping arm 120 and second inner clamping arm 130) and movement of slider 430 toward the rear end can be used to control the closing of the inner clamping arms (e.g., relative closing of first inner clamping arm 120 and second inner clamping arm 130).
In some embodiments, the casing 410 may have one or more interlayers, the sliding portion 430 is disposed in the interlayer of the casing 410, and the first control portion 420 can drive the sliding portion 430 to move along the length direction of the casing 410 in the casing 410. For example, the socket 410 may have a hollow cylindrical shape, which may be formed by connecting two semi-cylindrical housings, and the sliding part 430 has a cylindrical shape, and the sliding part 430 may be snapped between the two semi-cylindrical housings of the socket 410.
In some embodiments, referring to fig. 13-14, the outer circumference of the sleeve 410 may be externally threaded; the inner circumferential surface of the first control part 420 is provided with internal threads; the sleeve 410 is screw-coupled to the first control portion 420. The sleeve 410 may be provided with a first sliding groove 412 along the length direction; the sliding portion 430 passes through the first sliding groove 412 and is connected to the first control portion 420. Specifically, the sliding portion 430 may include a protruding connection block 429, the inner circumferential surface of the first control portion 420 may include a connection groove 421, and the connection block 429 may extend from the first sliding groove 412 and be clamped with the connection groove 421, so that the first control portion 420 may drive the sliding portion 430 to move along the first sliding groove 412 when rotating. In the embodiment of the present application, the sleeve 410 may include two first sliding grooves 412 respectively disposed on two sides of the sleeve 410, and two protruding connecting blocks 429 correspondingly disposed on the sliding portion 430; therefore, the stability of the first control part 420 driving the sliding part 430 to move can be ensured. In some alternative embodiments, the number of the first sliding grooves 412 may be one, three, five, or the like.
In some embodiments, the first control part 420 may have a circular ring-shaped outer contour, and a rubber layer may be disposed on a surface of the outer contour. When an operator controls the inner clamping arms (the first inner clamping arm 120 and the second inner clamping arm 130) by rotating the first control part 420, the rubber layer can increase the friction between the first control part 420 and the palm or fingers, so that the operator can realize accurate control. In other embodiments, the outer contour surface of the first control portion 420 may be made of a hard material such as plastic, metal, etc. without a rubber layer, and the surface thereof is provided with anti-slip patterns to increase the surface friction.
In some embodiments, as shown in fig. 13-15, the inner clamp arm control mechanism 400 may include a drive rod 440, a securing block 460, and a protective sleeve 470; the sliding portion 430 can control the opening and closing of the inner clamping arms (the first inner clamping arm 120 and the second inner clamping arm 130) through the driving rod 440, the rear end of the driving rod 440 is fixedly connected with the fixing block 460, and the front end of the driving rod 440 can be detachably connected with the second connector 900 (e.g., in threaded connection or clamping connection). Specifically, the fixing block 460 may be cylindrical, the cross-sectional diameter of the fixing block may be greater than that of the driving rod 440, and the driving rod 440 may be inserted into the fixing block 460 and fixedly connected to the fixing block 460 by means of glue joint, welding, interference connection, or the like. The protective sleeve 470 may be detachably coupled with the sliding part 430 by a screw; when the protective sleeve 470 is coupled to the sliding part 430, the protective sleeve 470 can limit the relative movement between the fixing block 460 and the sliding part 430. In some embodiments, the drive rod 440 may be made of a memory alloy (e.g., nitinol), thereby allowing the drive rod 440 to have superior tensile and compressive properties as well as superior bending properties; further, the inner clamp arm control mechanism 400 can effectively control the opening and closing of the inner clamp arms (the first inner clamp arm 120 and the second inner clamp arm 130) through the driving rod 440 even if the conveying pipe 600 is bent.
In some embodiments, after clamping of the mitral valve holding device is completed, the drive rod 440 needs to be separated from the mitral valve holding device and withdrawn from the control handle 300 (e.g., completely or some distance). As shown in fig. 11 to 13, the protective sleeve 470 is detachably coupled to the sliding part 430 by means of screw threads. When it is desired to disengage the driving rod 440, the operator may rotate the protective sheath 470 to disengage from the sliding portion 430, and then the operator may rotate the fixing block 460 (i.e., rotate the driving rod 440) to separate the driving rod 440 from the second connector 900 of the mitral valve clamping device, and then the operator may pull the fixing block 460 to withdraw the driving rod 440 from the control handle 300.
In some embodiments, as shown in fig. 16-18, the first control portion 420 can include a threaded engagement mechanism 450. The screw engagement mechanism 450 includes a manipulation button 451, a first elastic member 453, and a pair of engagement members 455; the engaging members 455 are symmetrically arranged (e.g., centrosymmetrically) and configured to engage with the external threads of the sleeve 410 by the elastic force of the first elastic member 453; the manipulation button 451 is annularly provided outside the engaging member 455 for controlling the engaging member 455 to be disengaged from the external thread of the sleeve 410 against the elastic force of the first elastic member 453.
In operation, an operator presses the two control buttons 451, the control buttons 451 drive the pair of engaging members 455 to move relatively and compress the first elastic member 453 to disengage the tooth-shaped structure inside the engaging members 455 from the external thread of the sleeve 410, so that the first control portion 420 and the sleeve 410 can slide relatively in the longitudinal direction. At this time, the operator can directly drag the first control part 420 to slide on the sleeve 410, so as to realize the rapid opening and closing of the inner clamping arms (the first inner clamping arm 120 and the second inner clamping arm 130). By controlling the rapid opening and closing of the inner clamping arm, an operator can operate more flexibly during operations (such as mitral valve repair) so as to adapt to different operation conditions. When the operator releases the control button, the engaging member 455 is engaged with the outer thread of the casing 410 again under the driving of the elastic force of the first elastic member 453, and the operator can rotate the first control portion 420 as required to perform the fine adjustment of the opening and closing angle of the inner clamping arm or perform the next operation. Through setting up two relative operating button 451, can make the operator comparatively convenient when carrying out the control that opens and shuts fast to the inside arm lock, can effectively avoid the operator again because the mistake touches and leads to the maloperation.
Figure 19 is a schematic diagram of a partial cross-sectional configuration of a clip control mechanism according to some embodiments of the present application; FIG. 20 is a schematic view of a housing according to some embodiments of the present application; FIG. 21 is a schematic structural diagram of a second control section according to some embodiments of the present application; FIG. 22 is a schematic structural view of a second control and locking mechanism shown in a first perspective in accordance with some embodiments of the present application; FIG. 23 is a schematic structural view of a second control and locking mechanism shown in a second perspective according to some embodiments of the present application. In some embodiments, as shown in fig. 19-23, the clip control mechanism 500 can include a housing 510 and a second control 520; the housing 510 is provided with a second chute 511; the second control portion 520 passes through the second sliding slot 511 and can move along the second sliding slot 511 to control the opening and closing of the jaws (the first jaw 210 and the second jaw 220) relative to the inner jaws (the first inner jaw 120 and the second inner jaw 130).
In some embodiments, as shown in fig. 21, the second control portion 520 may include an L-shaped conduit 521 and an end cap 523; one end of the guide pipe 521 may pass through the second sliding groove 511 and be detachably connected to the cover 523. In operation, the L-shaped conduit 521 is more easily controlled by the operator by pushing and pulling the conduit 521 at the end cap so that the second control portion 520 slides within the second chute 511. In this embodiment, the second control part 520 may be in transmission connection with the clips (the first clip 210 and the second clip 220) through a traction cable. In some embodiments, the pulling cable may pass through the through holes of the free ends of the clips (the first clip 210 and the second clip 220), and both ends of the pulling cable may be fixed at the end cap 523. When the mitral valve clamping device needs to be separated from the control handle 300, the end cover 523 can be separated from the guide pipe 521, then the fixation of the two ends of the traction cable is released, and the traction cable is pulled out, so that the control handle 300 can be separated from the clamping piece. In some embodiments, releasing the securing of the two ends of the pull cable may include: releasing the clamping connection between the two ends of the traction rope and the end covers, releasing knots formed at the two ends of the traction rope, cutting off the traction rope and the like. In some embodiments, the pull cable may not be completely withdrawn from the control handle 300, but rather, the pull cable may be disengaged from the clip.
In some embodiments, as shown in fig. 20, the second chute 511 may be an elongated configuration. When the end cap 523 of the second control portion 520 (or the portion of the conduit 521 extending out of the second chute) moves to the rear end of the second chute 511 (the end away from the mitral valve clamping device), the clip may be in a folded state. In some alternative embodiments, the second chute 511 may be provided with an L-shaped profile. Specifically, a channel may be formed at the rear end of the second sliding slot 511 along a direction that is at an angle (e.g., perpendicular) to the second sliding slot 511. When the end cover 523 of the second control part 520 (or the portion of the guide pipe 521 extending out of the second sliding slot) moves to the rear end of the second sliding slot 511, the second control part 520 can be pushed and pulled laterally to enable the portion of the guide pipe 521 extending out of the second sliding slot to be clamped into the channel, so that the clip can be kept in a folded state to prevent misoperation in an operation.
In this embodiment, the two sides of the housing 510 may be respectively provided with a second sliding slot 511, and the second control portion 520 includes a first sub-control portion for controlling the first clip 210 and a second sub-control portion for controlling the second clip 220. The first sub-control part and the second sub-control part may correspond to separate traction ropes, respectively. In some embodiments, the second control portion 520 can be configured to be linked or separated according to actual needs, so as to accurately control the clip 200 according to experimental or surgical needs. For example, during a mitral valve repair procedure, the first clip 210 can be controlled to clamp one side of the mitral valve before the second clip 220 is controlled to clamp the other side of the mitral valve. For another example, the second control portion 520 may control the first clip 210 and the second clip 220 to clamp the mitral valve at the same time.
In some embodiments, one end of the housing 510 may be connected to (or integrally formed with) the cannula 410, and the central axes of the housing 510 and the cannula 410 coincide, making the control handle 300 more compact and easier to manipulate. For example, the housing 510 may be provided at an end of the sleeve 410 near the mitral valve clamping device, and the inner clamp arms (the first inner clamp arm 120 and the second inner clamp arm 130) may be configured in a maximally open state when the first control portion 420 abuts against the rear end of the housing 510. In some alternative embodiments, the housing 510 may also be provided at the end of the cannula 410 remote from the mitral valve clamping device.
In some embodiments, as shown in fig. 19-23, the clip control mechanism 500 can include a locking mechanism 530; the locking mechanism 530 includes a second elastic member 531, a locking button 533, and a locking stopper 535. The second control portion 520 may further include a tooth shaped connection portion 537. The locking button 533 serves to control the locking stopper 535 to move against the elastic force of the second elastic member 531 to release the locking stopper 535 from restraining the tooth-shaped connection portion 537.
As shown in fig. 19-23, in the present embodiment, the locking mechanism 530 includes a set of oppositely disposed locking stops 535, and the first and second sub-controls may each include a corresponding tooth attachment 537. Specifically, the tooth shape connection portion 537 may be connected to or integrally formed with the conduit 521 of the first sub-control portion or the second sub-control portion. A set of oppositely disposed locking stops 535 may be used to limit the movement of the first and second sub-control parts, respectively, under the elastic force of the second elastic member 531. For example, the locking stopper 535 corresponding to the first sub-control portion may be caught in the tooth-shaped connection portion 537 corresponding to the first sub-control portion by the elastic force of the second elastic member 531. The locking stopper 535 corresponding to the second sub-control portion can be engaged with the tooth-shaped connection portion 537 corresponding to the second sub-control portion by the elastic force of the second elastic member 531. The second elastic member 531 may be two springs in this embodiment. The locking button 533 may include two, which are respectively connected to the two locking stoppers 535. The locking button 533 may be exposed from the housing 510. Taking the operation of the first sub-control portion as an example, when the locking button 533 corresponding to the first sub-control portion is pressed, the locking button 533 drives the locking stopper 535 to overcome the elastic force of the second elastic member 531 so as to disengage from the tooth-shaped connection portion 537, and the operator can push and pull the first sub-control portion (e.g. the conduit 521 of the first sub-control portion) to slide in the second sliding slot 511 to control the opening and closing of the first clamping piece 210. When the operator releases the locking button 533, the locking stopper 535 may be re-inserted into the tooth-shaped connection portion 537 by the elastic force of the second elastic member 531, so as to limit the movement of the tooth-shaped connection portion 537 (i.e., the movement of the guide pipe 521). The operation of the second sub-control part is similar to that of the first sub-control part, and is not described in detail herein.
Figure 24 is a front view and an exploded view of a curved tube according to some embodiments of the present application, and figure 25 is a front view and an exploded view of a curved tube according to some embodiments of the present application. As shown in fig. 24 and 25, a curved tube 610 may be attached to the forward end of the delivery tube 600 (i.e., the end near the mitral valve clamping device). For example, the curved tube 610 may be coupled (e.g., laser welded) or integrally formed with the body of the delivery tube 600. The front end of the bent tube 610 may be connected to the first connector 800 by the delivery connector 700. The conveying connector 700 is provided with through holes for the driving rod 440 and the pulling cable for controlling the opening and closing of the clamping pieces to pass through. In some embodiments, the curved tube 610 may include an inner core 612 and an outer tube 614. The outer tube 614 fits over the inner core 612. In some embodiments, one or more through holes may be formed in the inner core 612 to allow passage of the actuation rod 440 and a cable that controls the opening and closing of the clip.
In the embodiment shown in fig. 24 and 25, the curved tube 610 is provided with a plurality of notches 616 along the length direction. Specifically, the outer tube 614 of the bending tube 610 is provided with a plurality of notches 616. By providing a plurality of notches 616, the bending tube 610 can be made to bend easily, and can be made to bend in a particular direction. In the present embodiment, a plurality of notches 616 are opened at one side of the bending tube 610, so that the bending tube can be bent toward the opening direction of the notches. In other embodiments, the plurality of notches 616 may also be spaced on different sides of the curved tube 610, thereby enabling the curved tube 610 to bend in multiple directions. In some embodiments, the outer tube 614 of the curved tube 610 may be cut from a stainless steel tube (e.g., 316 tubing) or a resilient metal (e.g., nitinol). The inner core 612 of the curved tube 610 may be made of an elastomeric material, such as nylon, silicone, heat-shrinkable polyether block polyamide (Pebax), Polytetrafluoroethylene (PTFE) material, and the like. In some embodiments, the curved tube 610 is elastic; when no external force is applied, the bent tube 610 can maintain a cylindrical shape. Further, a polymer material layer (such as a heat-shrinkable polyether block polyamide (Pebax) material) can be further arranged on the outer surface of the bending tube 610, so that the contact of blood with the tube can be effectively reduced. In some embodiments, a plurality of notches 616 are opened at one side of the bending tube 610, and a groove may be provided at one side of the inner core 612 facing the opening direction of the notches 616, and the pulling rope 625 may be disposed in the groove. Specifically, the front end of the pull string 625 may be fixedly coupled (e.g., welded, glued, etc.) to the inner core 612 and/or the outer tube 614. The curved tube control mechanism 620 is capable of controlling the bending of the curved tube 610 via the pull line 625.
FIG. 26 is an exploded view of a bend tube control mechanism according to some embodiments of the present application. In some embodiments, as shown in fig. 26, the bent tube control mechanism 620 may include a screw 621, a rotating portion 622, and a pulling portion 623; the screw 621 is in threaded connection with the traction part 623; the rotating part 622 can drive the screw 621 to rotate so as to drive the traction part 623 to move; the movement of the pulling portion 623 can control the bending of the bending tube 610. In some embodiments, the pull 623 may include a pull cord 625 and a threaded pull block 627; one end (like the tail end) of the pulling rope 625 is connected with the threaded pulling block 627, the other end (like the front end) of the pulling rope 625 is fixedly connected with the front end of the bent pipe 610, an internal thread is arranged inside the screw 621, and the threaded pulling block 627 is movably arranged inside the screw 621 and is matched with the internal thread of the screw 621. When the rotating portion 622 drives the screw 621 to rotate, the screw 621 drives the threaded traction block 627 to move in the screw 621 along the length direction, so as to realize traction or release of the traction rope 625, thereby controlling the bending of the bending tube 610. Specifically, pulling of the pull string 625 against the curved tube 610 may cause the plurality of notches 616 in the curved tube 610 to close together, thereby bending the curved tube 610. The bent tube 610 may remain bent while the threaded traction block 627 stops moving. When the threaded pull block 627 releases the pull cord 625, the curved tube 610 may relax back under its own spring force until it returns to its natural state (e.g., remains cylindrical).
Benefits that may be brought about by the mitral valve repair device of embodiments of the present application include, but are not limited to: (1) the length of the first inner clamping arm of the clamp body is larger than that of the second inner clamping arm, and the length of the first outer clamping arm is larger than that of the first outer clamping arm, so that after mitral valve repair equipment repairs mitral valves, dynamic balance of valves (such as mitral valves and tricuspid valves) can be kept favorably after the valves are clamped, the repaired valves can work stably, and the repair effect of the valves is improved; (2) the control can quickly and accurately control the inner clamping arm and/or the clamping piece of the mitral valve clamping device, and the accuracy of repairing the mitral valve by the mitral valve repairing equipment is higher; (3) the inner clamping arm of the clamping device can be quickly controlled, so that the operation time can be shortened; (4) the mitral valve repair operation can be more convenient, and the repair efficiency and success rate are higher; (5) it is possible to prevent the occurrence of erroneous operation in a plurality of links. It is to be noted that different embodiments may produce different advantages, and in different embodiments, any one or combination of the above advantages may be produced, or any other advantages may be obtained.
The present invention is not intended to be limited to the particular embodiments shown and described, but is to be accorded the widest scope consistent with the principles and novel features herein disclosed.

Claims (17)

1. The clamp body of the mitral valve clamping device is characterized by comprising a supporting part, a first inner clamping arm, a first outer clamping arm, a second inner clamping arm and a second outer clamping arm;
one side of the supporting part is sequentially connected with the first inner clamping arm and the first outer clamping arm in a bendable manner, and the other side of the supporting part is sequentially connected with the second inner clamping arm and the second outer clamping arm in a bendable manner;
the length of the first inner clamping arm is greater than that of the second inner clamping arm;
the length of the first outer clamping arm is larger than that of the second outer clamping arm.
2. The clip body of claim 1 wherein said clip body is of unitary construction.
3. The clip body of claim 1, wherein a ratio of lengths of the first inner clip arm to the first outer clip arm is equal to a ratio of lengths of the second inner clip arm to the second outer clip arm.
4. The clip body of claim 1 wherein one side of said support portion is connected to said first inner clip arm by a first bend; the other side of the supporting part is connected with the second inner clamping arm through a first bending structure;
the first inner clamping arm is connected with the first outer clamping arm through a second bending structure; the second inner clamping arm is connected with the second outer clamping arm through a second bending structure.
5. The clip body of claim 4 wherein the first bend feature is an S-bar bend feature or a waisted bend feature;
the second bending structure is an S-rod bending structure or a waist-thinning bending structure.
6. A mitral valve clamping device comprising the clip body according to any one of claims 1-5.
7. The mitral valve clamping device of claim 6, further comprising a first connector, a second connector, and a clip;
the clamp body is connected between the first connecting piece and the second connecting piece, and the relative movement of the first connecting piece and the second connecting piece can drive the first inner clamping arm and the second inner clamping arm to be relatively opened or closed;
the clamping piece is including setting up first clamping piece on the first interior arm of holding and setting up and being in second clamping piece on the second interior arm of holding, first clamping piece with the second clamping piece can be respectively for first interior arm of holding with the arm opens and shuts in the second to make the mitral valve can be held in first clamping piece with between the first interior arm of holding, and by the centre gripping in the second clamping piece with between the second interior arm of holding.
8. The mitral valve clamping device of claim 7, wherein the first inner clamp arm and the first clip are configured to clamp an anterior leaflet of the mitral valve, and the second inner clamp arm and the second clip are configured to clamp a posterior leaflet of the mitral valve.
9. The mitral valve clamping device of claim 7, wherein the first clip has a length that is greater than a length of the second clip.
10. The mitral valve clamping device of claim 9, wherein a ratio of the length of the first clip to the first inner clip arm is equal to a ratio of the length of the second clip to the second inner clip arm.
11. The mitral valve clamping device of claim 7, wherein the clip is a barbed clip including a fixation portion, a clamping portion, and a barb;
one end of the fixing part is connected with one end of the clamping part through a bending part;
the other end of the clamping part is provided with the barb.
12. The mitral valve clamping device of claim 7, wherein the first clip piece is integrally cut from the first inner clip arm and the second clip piece is integrally cut from the second inner clip arm.
13. The mitral valve clamping device of claim 7, further comprising a resilient support including a first strut, a second strut, a first mounting portion, and a second mounting portion;
one end of the first supporting rod and one end of the second supporting rod are connected with the first mounting part; the other ends of the first supporting rod and the second supporting rod are connected with the second mounting part; the first support rod, the second support rod, the first mounting part and the second mounting part are of an integrally formed structure; the length of the first strut is greater than that of the second strut;
the first mounting part and the second mounting part of the elastic bracket are fixedly connected with the second connecting piece; the first supporting rod of the elastic support abuts against the joint of the first inner clamping arm and the first outer clamping arm; and a second supporting rod of the elastic support is abutted against the joint of the second inner clamping arm and the second outer clamping arm.
14. A mitral valve repair device comprising a control handle and a mitral valve clamping device according to any one of claims 7-13; the control handle is used for conveying the mitral valve clamping device to the mitral valve via the left auricle and the left atrium, controlling the opening and closing of the first inner clamping arm and the first clamping piece of the mitral valve clamping device, and controlling the opening and closing of the second inner clamping arm and the second clamping piece.
15. The mitral valve repair device of claim 14, wherein the control handle comprises:
the inner clamping arm control mechanism is used for controlling the movement of a first inner clamping arm and a second inner clamping arm of the mitral valve clamping device; the inner clamping arm control mechanism comprises a sleeve, a first control part and a sliding part, and the sliding part is arranged in the sleeve; the first control part can drive the sliding part to move in the sleeve along the length direction of the sleeve through rotation so as to control the first inner clamping arm and the second inner clamping arm to open and close;
a clip control mechanism for controlling movement of a clip of the mitral valve clamping device; the clamping piece control mechanism comprises a shell and a second control part; the shell is provided with a second sliding chute; the second control part penetrates through the second sliding groove and can move along the second sliding groove to control the first clamping piece to open and close relative to the first inner clamping arm and control the second clamping piece to open and close relative to the second inner clamping arm.
16. The mitral valve repair device of claim 14, further comprising a delivery tube; the first connecting piece of the mitral valve clamping device is connected with the control handle through the delivery pipe.
17. The mitral valve repair device of claim 16, wherein the delivery tube comprises a curved tube, the control handle further comprising a curved tube control mechanism; the bending pipe control mechanism is used for controlling the bending of the bending pipe.
CN202010950172.0A 2020-09-10 2020-09-10 Clip body of mitral valve clamping device, mitral valve clamping device and repair equipment Pending CN111920549A (en)

Priority Applications (2)

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CN202010950172.0A CN111920549A (en) 2020-09-10 2020-09-10 Clip body of mitral valve clamping device, mitral valve clamping device and repair equipment
PCT/CN2021/094985 WO2022052506A1 (en) 2020-09-10 2021-05-20 Mitral valve clamping device, clamp body of mitral valve clamping device, and mitral valve repair device

Applications Claiming Priority (1)

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CN202010950172.0A CN111920549A (en) 2020-09-10 2020-09-10 Clip body of mitral valve clamping device, mitral valve clamping device and repair equipment

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