CN116350399B

CN116350399B - Tendon implantation instrument

Info

Publication number: CN116350399B
Application number: CN202310636514.5A
Authority: CN
Inventors: 张旭升; 杜家全; 谢琦宗
Original assignee: Hanxin Medical Technology Shenzhen Co ltd
Current assignee: Hanxin Medical Technology Shenzhen Co ltd
Priority date: 2023-06-01
Filing date: 2023-06-01
Publication date: 2023-08-25
Anticipated expiration: 2043-06-01
Also published as: CN116350399A

Abstract

The application relates to the technical field of medical instruments, and particularly provides a tendon implantation instrument which comprises a tendon traction unit, a puncture unit, a tissue clamping unit and an elastic piece, wherein a first connecting structure is arranged on the tendon traction unit; the puncture unit comprises a puncture tube, and a second connecting structure capable of being connected with the first connecting structure is arranged at the distal end of the puncture tube; the tissue clamping unit comprises a first clamping piece and a second clamping piece, wherein the first clamping piece is far away from the second clamping piece and is close to the second clamping piece to clamp body tissue; the elastic piece is abutted with the puncture tube or the elastic piece is abutted with the tendon traction unit, and the tendon implantation instrument is configured as follows: when the puncture tube is connected with the tendon traction unit, the deformation amount of the elastic piece is increased along the puncture direction of the puncture unit along with the increase of the acting force of the puncture tube on the tendon traction unit. The tendon implantation instrument provided by the application has the advantages of high connection success rate, safe and reliable use and the like.

Description

Tendon implantation instrument

Technical Field

The application belongs to the technical field of medical instruments, and particularly relates to a tendon implantation instrument.

Background

This section provides merely background information related to the present disclosure and is not necessarily prior art.

Mitral insufficiency is one of the most common heart valve diseases today, and the main causes are rheumatic heart disease, mitral valve myxomatosis, heart ischemic disease, cardiomyopathy, etc., resulting in lesions of the annulus, leaflets, chordae tendineae and papillary muscles in the mitral valve structure, resulting in incomplete closure of the leaflets of the mitral valve. Surgery is an effective method for treating mitral insufficiency, but is more complicated and has higher mortality rate for elderly patients and patients with more complications due to the great trauma caused by surgery. So the prior minimally invasive interventional operation treatment is a better choice for most heart diseases, and the main interventional treatment modes are artificial chordae tendineae implantation, mitral valve annuloplasty, mitral valve edge-to-edge repair and the like. Wherein implantation of artificial chordae tendineae on the leaflet can effectively treat mitral insufficiency caused by chordae tendineae fracture, leaflet prolapse, etc., while maintaining the physiological integrity of the mitral valve structure.

The existing tendon implantation instrument has no feedback function, and cannot determine whether the tendon implantation instrument is successfully connected with the tendon, so that a doctor cannot objectively judge the tendon implantation instrument, the operation difficulty of tendon connection is further increased, and even the success rate of tendon connection is affected. In addition, in the operation process, the puncture needle and the like are easy to deform due to improper operation, the operation process is also influenced, and even safety accidents are caused. In addition, the existing tendon implantation devices can generate a channel which cannot be closed with the outside, and the risk of blood leakage exists.

Disclosure of Invention

The application aims to improve the reliability, the safety and the like of a tendon implantation instrument. The aim is achieved by the following technical scheme:

the application provides a tendon implantation instrument, which comprises a tendon traction unit, a puncture unit, a tissue clamping unit and an elastic piece, wherein a first connecting structure is arranged on the tendon traction unit; the puncture unit comprises a puncture tube assembly, the puncture tube assembly comprises a puncture tube, a second connecting structure capable of being connected with the first connecting structure in an adapting way is arranged at the distal end of the puncture tube, and the puncture tube is in a state of moving towards the first connecting structure and in a state of pulling the tendon traction unit; the tissue clamping unit comprises a first clamping piece and a second clamping piece, wherein the first clamping piece is far away from the second clamping piece and is close to the second clamping piece to clamp body tissue; the elastic piece is abutted with the puncture tube or the elastic piece is abutted with the tendon traction unit, and the tendon implantation instrument is configured as follows: when the puncture tube is connected with the tendon traction unit, the deformation amount of the elastic piece is increased along the puncture direction of the puncture unit along with the increase of the acting force of the puncture tube on the tendon traction unit.

According to the application, the tendon implantation instrument comprises the elastic piece, and the elastic piece is abutted against the puncture tube or abutted against the tendon traction unit, so that the elastic piece has a buffer effect on the puncture tube, deformation of the puncture tube and the like caused by improper force application in the operation process is avoided, and the tendon implantation operation is safer. Further, after the puncture tube is connected with the tendon traction unit, the deformation amount of the elastic piece is increased along with the increase of acting force of the puncture tube on the tendon traction unit along the puncture direction of the puncture unit, and feedback information about whether the puncture tube is connected with the tendon traction unit successfully or not can be provided for a doctor through the action of the elastic piece, so that tendon implantation operation can be completed smoothly.

In addition, the tendon implantation apparatus according to the present application may have the following additional technical features:

in some embodiments of the present application, the puncture unit further comprises a base, the puncture tube assembly is slidably fitted with the base, and in the sliding direction of the puncture tube assembly, the puncture tube assembly is abutted with the base via an elastic member; or, the second clamping piece is provided with a containing cavity opposite to the puncture tube, the tendon traction unit is arranged in the containing cavity, the first connecting structure is opposite to the movement direction of the puncture tube, and the tendon traction unit is abutted against the end wall of the containing cavity (namely the inner wall of the containing cavity opposite to the movement direction of the puncture tube) through the elastic piece.

In some embodiments of the present application, the base is provided with a first chute, the puncture tube assembly further comprises a sliding body, the sliding body is in sliding fit with the first chute, and the outer wall of the proximal end of the puncture tube is fixedly connected with the sliding body; the outer wall of the puncture tube is abutted with the base through the elastic piece or the sliding body is abutted with the base through the elastic piece.

In some embodiments of the present application, the elastic member is configured as a spring, and the puncture tube assembly further comprises a reinforcing sleeve, wherein the reinforcing sleeve is sleeved outside the puncture tube and fixedly connected with the puncture tube, and the proximal end of the reinforcing sleeve is abutted with the base through the spring; or the elastic piece is made to be a spring, a limit structure is arranged at the proximal end of the first chute, and the sliding body is abutted with the limit structure through the spring.

In some embodiments of the present application, the puncture unit further comprises a puncture needle assembly, the base is further provided with a second chute, and the proximal end of the puncture needle assembly is in sliding fit with the second chute; the lancet assembly includes a lancet such that a distal end of the lancet extends from a proximal end of the lancet tube and the distal end of the lancet has a state positioned within the lancet tube and a state extending from the distal end of the lancet tube.

In some embodiments of the present application, the second connection structure is selectively a clamping groove provided at a distal end of the puncture tube, the first connection structure is provided with a buckle adapted to the clamping groove, and the puncture tube can be connected with the tendon traction unit in a clamping manner through the clamping groove and the buckle; or, the second connecting structure is a buckle arranged at the far end of the puncture tube, the first connecting structure is a clamping groove matched with the buckle, and the puncture tube can be connected with the tendon traction unit in a clamping way through the clamping groove and the buckle.

In some embodiments of the application, the tube wall at the distal end of the puncture tube is provided with a plurality of notches communicated with two sides of the tube wall; and/or selectively enabling the first connecting structure to comprise a plurality of clamping bodies matched with the distal end of the puncture tube, wherein the clamping bodies extend towards the second connecting structure, and adjacent clamping bodies are arranged at intervals.

In some embodiments of the application, the chordae tendineae implantation instrument further comprises a resilient seal sealingly connected to the outer periphery of the proximal end of the penetration tube and the resilient seal sealingly connected to the outer periphery of the penetration needle at the proximal end of the penetration tube.

In some embodiments of the present application, the elastic seal is configured to provide a resistance to the needle that is greater than the penetration force required to penetrate the body tissue.

In some embodiments of the present application, the tendon implantation apparatus includes a plurality of puncture units, a plurality of puncture channels penetrating through two ends of the puncture units are provided on the first clamping member, each puncture channel corresponds to one puncture unit, and a puncture tube included in each puncture unit extends into a proximal end of the puncture channel corresponding to each puncture unit.

Drawings

Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the application. Also, like reference numerals are used to designate like parts throughout the figures. In the drawings:

FIG. 1 schematically illustrates a schematic view of a tendon implantation instrument in accordance with some embodiments of the present application;

FIG. 1.1 is an enlarged view of a portion of the structure at A in FIG. 1;

FIG. 2 schematically illustrates a schematic view of the components of a tendon implantation instrument in accordance with some embodiments of the present application;

FIG. 3 schematically illustrates an exploded view of a lancing unit, in which two lancing units are exploded views, according to some embodiments of the present application;

fig. 4.1 schematically illustrates a cross-sectional view of a lancing unit in some embodiments of the present application, with the spring in its natural state;

FIG. 4.2 schematically illustrates a cross-sectional view of a lancing unit in accordance with some embodiments of the present application, with a spring in a compressed state;

FIG. 5 schematically illustrates a cross-sectional view of a lancing unit in further embodiments of the present application;

FIG. 6 schematically illustrates a schematic structural view of a lancet assembly in some embodiments of the present application;

FIG. 7 schematically illustrates a schematic construction of a tendon traction unit in accordance with some embodiments of the present application, with tendon attached to a traction ring;

FIG. 8.1 schematically illustrates a cross-sectional view of a partial structure at the proximal end of a chorda implantation instrument in accordance with some embodiments of the present application, wherein the needle is shown in a distally slidable position relative to the base;

FIG. 8.2 schematically illustrates a cross-sectional view of a partial structure at the proximal end of a chorda implantation instrument in accordance with some embodiments of the present application, with the needle in a constrained state;

FIG. 9 schematically illustrates a cross-sectional view of a partial structure at the distal end of a chorda implantation instrument in accordance with some embodiments of the present application, with the penetration unit in a pre-penetration state;

FIG. 10 schematically illustrates a cross-sectional view of a partial structure at the distal end of a chorda implantation instrument in accordance with some embodiments of the present application, with the penetration unit in a state of passing through body tissue;

FIG. 11 schematically illustrates a cross-sectional view of a partial structure at the distal end of a tendon implantation instrument in accordance with some embodiments of the present application, with a penetration tube and tendon traction unit in a pre-connection state;

FIG. 12 is an enlarged view of a portion of the structure at B in FIG. 11;

FIG. 13 schematically illustrates a cross-sectional view of a partial structure at the distal end of a tendon implantation instrument in accordance with some embodiments of the present application, with a penetration tube connected to a tendon traction unit;

FIG. 14 is an enlarged view of a portion of the structure at C in FIG. 13;

FIG. 15 schematically illustrates a schematic structural view of another first connection structure and a second connection structure according to some embodiments of the present application, the first connection structure and the second connection structure being in a pre-connection state;

fig. 16 is a schematic view schematically showing a structure in which the first connection structure and the second connection structure shown in fig. 15 are in a connected state;

FIG. 17.1 schematically illustrates a cross-sectional view of a partial structure at the distal end of a chorda tendineae implantation instrument in which the spring is in its natural state, in accordance with some embodiments of the present application;

FIG. 17.2 schematically illustrates a cross-sectional view of a partial structure at the distal end of a chorda tendineae implantation instrument in which the spring is in a compressed state, in accordance with some embodiments of the present application;

FIG. 18 schematically illustrates a schematic view of a chorda implantation instrument capturing a valve in accordance with some embodiments of the present application;

FIG. 19 schematically illustrates a state of the chordae tendineae implantation instrument capturing a valve in some embodiments of the application;

FIG. 20 schematically illustrates a schematic view of a chorda implantation instrument in a piercing state, in accordance with some embodiments of the present application;

FIG. 21 schematically illustrates a schematic view of a tendon implantation instrument in a post-puncture traction on tendons in some embodiments of the present application;

FIG. 22 is an enlarged view of a portion of the structure at D in FIG. 21;

FIG. 23 is an enlarged partial view of the structure at E in FIG. 21;

FIG. 24 schematically illustrates a schematic view of a chorda implantation instrument in a state of pulling chordae out of the heart in some embodiments of the application;

fig. 25 is a partially enlarged view of the structure at F in fig. 24.

Reference numerals illustrate:

1. a tendon traction unit; 11. a traction member body; 12. a traction ring; 13. a first connection structure; 131. a clamping body; 132. a gap;

2. a puncture unit; 21. a puncture tube assembly; 211. a puncture tube; 2111. a second connection structure; 2112. a clamping hole; 2113. a notch; 212. a sliding body; 22. a base; 221. a first chute; 222. a cover plate; 2221. a limit structure; 223. a second chute; 224. a through hole; 23. a lancet assembly; 231. a puncture needle; 232. a steering structure; 2321. a mounting hole; 24 reinforcing the sleeve;

3. a tissue clamping unit; 31. a first clamping member; 311. a puncture channel; 32. a second clamping member; 321. a receiving chamber;

4. a spring;

5. an elastic seal;

61. an upper housing; 62. a lower housing; 621. a limit groove;

x, chordae tendineae;

y, body tissue.

Detailed Description

Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless an order of performance is explicitly stated. It should also be appreciated that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.

It should be noted that "distal end" and "proximal end" are used as terms of orientation, which are terms commonly used in the field of interventional medical devices, where "distal end" refers to an end that is away from an operator during a surgical procedure and "proximal end" refers to an end that is near the operator during a surgical procedure. Axial, refers to a direction parallel to the line connecting the distal center and the proximal center of the medical instrument; radial refers to a direction perpendicular to the axial direction.

The application provides a tendon implantation instrument, which is shown in fig. 1 to 17.2, and comprises a tendon traction unit 1, a puncture unit 2, a tissue clamping unit 3 and an elastic piece, wherein a first connecting structure 13 is arranged on the tendon traction unit 1; the puncture unit 2 comprises a puncture tube assembly 21, the puncture tube assembly 21 comprises a puncture tube 211, a second connecting structure 2111 capable of being connected with the first connecting structure 13 in an adapting way is arranged at the distal end of the puncture tube 211, so that the puncture tube 211 has a state of moving towards the first connecting structure 13 and a state of pulling the tendon traction unit 1; the tissue clamping unit 3 includes a first clamping member 31 and a second clamping member 32, the first clamping member 31 having a state of being away from the second clamping member 32, and having a state of being close to the second clamping member 32 to clamp body tissue; the elastic member is abutted with the puncture tube 211 or the elastic member is abutted with the tendon traction unit 1, and the tendon implantation instrument is configured to: when the puncture tube 211 is connected to the tendon traction unit 1, the deformation amount of the elastic member increases with the increase of the acting force of the puncture tube 211 on the tendon traction unit 1 in the puncture direction of the puncture unit 2.

Note that the form of the first connection structure 13 and the second connection structure 2111 in the present application is not particularly limited. In a specific implementation, the first connection structure 13 and the second connection structure 2111 are preferably configured to be capable of achieving a snap connection, that is, the first connection structure 13 is moved toward the second connection structure 2111, so that the puncture tube 211 and the tendon traction unit 1 can be connected in a snap connection manner, and the puncture tube 211 and the tendon traction unit 1 can be connected more easily.

It should be noted that the tendon traction unit 1 in the present application is not particularly limited, and may be any structure, assembly or unit that can be used for traction of tendons. As shown in fig. 7, the tendon traction unit 1 includes a traction member body 11, a traction ring 12 is connected to a first end of the traction member body 11, and a first connection structure 13 capable of being connected to a second connection structure 2111 is connected to a second end of the traction member body 11. Wherein the traction ring 12 is used to pull the chordae X.

It should be noted that the structure and composition of the puncture unit 2 in the present application are not particularly limited, and may be selectively set according to actual needs. In particular, it is preferable that the puncture unit 2 includes a puncture tube 211 and a puncture needle 231, the puncture tube 211 is fitted to the outside of the puncture needle 231, the puncture needle 231 is allowed to reciprocate in the puncture direction with respect to the puncture tube 211, and the distal end of the puncture needle 231 has a state of being positioned in the puncture tube 211 and a state of being extended out of the puncture tube 211.

It should be noted that, the structure of the tissue clamping unit 3 in the present application is not limited in particular, and may be selectively set according to actual needs. In practice, as shown in fig. 1 and 2, the tissue clamping unit 3 is preferably configured in a rod-like structure, and the first clamping member 31 can be moved closer to and away from the second clamping member 32 under the action of external force, so that the body tissue (for example, heart valve) can be clamped during the process that the first clamping member 31 is moved closer to the second clamping member 32. Further, a puncture channel 311 penetrating through both ends of the first clamping member 31 and adapted to the puncture tube 211 is provided in the length direction of the first clamping member 31, such that the puncture tube 211 extends from the proximal end of the puncture channel 311 and can extend from the distal end of the puncture channel 311; the second clamping member 32 includes a chuck opposite to the distal end of the first clamping member 31, and a receiving cavity 321 (as shown in fig. 1.1) for placing the tendon traction unit 1 is provided on the chuck, and in a specific implementation, the puncture tube 211 can extend from the puncture channel 311 and be connected with the tendon traction unit 1 in the receiving cavity 321, so as to realize connection and traction of the tendon X.

It should be noted that, the elastic member in the present application is not limited in particular, and in the specific implementation, as shown in fig. 3, 4.1, 4.2, 5, 17.1 and 17.2, the elastic member is preferably a spring. The setting position of the elastic member is not particularly limited, and it is only required to satisfy the condition that "when the puncture tube 211 is connected with the tendon traction unit 1, the deformation amount of the elastic member increases along the puncture direction of the puncture unit as the acting force of the puncture tube 211 on the tendon traction unit 1 increases".

As some preferred embodiments of the present application, the tendon implantation apparatus further includes a plurality of puncture units 2, the first clamping member 31 is provided with a plurality of puncture channels 311 penetrating through two ends thereof, and each puncture channel 311 corresponds to one puncture unit 2, and each puncture unit 2 includes a puncture tube 211 extending from a proximal end of the corresponding puncture channel 311. In a specific implementation, the tendon implantation apparatus is provided with a plurality of puncture units 2 and a plurality of tendon traction units 1 corresponding to the puncture units 2 one by one, preferably, two puncture channels 311 penetrating through two ends of the first clamping member 31 and adapted to the puncture tubes 211 are arranged in the length direction of the first clamping member 31, each puncture channel 311 is provided with one puncture unit 2, two accommodating cavities 321 corresponding to the puncture channels 311 one by one are arranged on the second clamping member 32, and one tendon traction unit 1 can be respectively placed in each accommodating cavity 321.

In particular embodiments, the chorda implantation apparatus further comprises a manipulation member, as shown in fig. 1 and 2, comprising a housing, one end of the tissue clamping unit 3 being located within the housing, and the other end of the tissue clamping unit 3 extending outside the housing.

As shown in fig. 2, a limit groove 621 adapted to the puncture unit 2 is provided in the housing, the puncture unit 2 is slidably adapted to the limit groove 621, the proximal end of the puncture unit 2 is located outside the housing, and the distal end of the puncture unit 2 extends into the first clamping member 31; the puncture unit 2 can slide relative to the stopper groove 621. In a specific implementation, the housing includes an upper housing 61 detachably connected to the lower housing 62 (as shown in fig. 8.1 and 8.2) and aligned and buckled with the upper housing 61, where the upper housing 61 and the lower housing 62 are covered to form a containing cavity, and a limiting slot 621 is disposed on the lower housing 62 along the length direction of the housing. The puncture unit 2 is made to comprise a base 22, with the base 22 being in sliding fit with a limit slot 621.

According to the application, the tendon implantation instrument comprises the elastic piece, and the elastic piece is abutted against the puncture tube 211 or abutted against the tendon traction unit 1, so that the elastic piece has a buffer effect on the puncture tube 211, deformation and the like of the puncture tube 211 due to improper force application in the operation process are avoided, and the tendon implantation operation is safer. Further, after the puncture tube 211 is connected with the tendon traction unit 1, the deformation of the elastic element is increased along with the increase of the acting force of the puncture tube 211 on the tendon traction unit 1 along the puncture direction of the puncture unit 2, and feedback information about whether the puncture tube 211 is successfully connected with the tendon traction unit 1 or not can be provided for a doctor through the action of the elastic element, so that the tendon implantation operation can be successfully completed.

As some preferred embodiments of the present application, as shown in fig. 3, 4.1, 4.2, 5, 8.1 and 8.2, the puncture unit 2 further optionally further comprises a base 22, the puncture tube assembly 21 being slidably fitted with the base 22, the puncture tube assembly 21 being in abutment with the base 22 via an elastic member in the sliding direction of the puncture tube assembly 21. In practice, the sliding of the puncture tube assembly 21 relative to the base 22 is limited by the elastic member, so that a better buffering effect is achieved, and feedback information can be provided for a doctor.

It should be noted that the structure of the base in the present application is not particularly limited. In a specific implementation, the base 22 is provided with a first chute 221, the puncture tube assembly 21 further comprises a sliding body 212, the sliding body 212 is in sliding fit with the first chute 221, and the outer wall of the proximal end of the puncture tube 211 is fixedly connected with the sliding body 212; the outer wall of the puncture tube 211 is abutted against the base 22 via an elastic member. Specifically, as shown in fig. 3, 4.1, 4.2, 5, 8.1 and 8.2, the base 22 is made to be elongated, the first chute 221 is arranged on the side wall of the base body along the length direction of the base 22, a through hole 224 for communicating the first chute 221 and the distal end of the base 22 is further provided in the length direction of the base 22, the distal end of the puncture tube 211 is penetrated out of the through hole 224, and the puncture tube assembly 21 slides along the first chute 221. The application can well limit and guide the puncture tube 211 by arranging the through hole 224 on the base 22, has simple structure and can effectively improve the local stability of the puncture tube 211.

As some preferred embodiments of the present application, the elastic member is further selectively configured as a spring, as shown in fig. 3, 4.1 (the spring is in a natural state or in a slightly compressed state) and 4.2 (the spring is in a compressed state), the puncture tube assembly 21 further includes a reinforcing sleeve 24, the reinforcing sleeve 24 is sleeved outside the puncture tube 211 and fixedly connected with the puncture tube 211, and the proximal end of the reinforcing sleeve 24 is abutted against the distal end face of the base 22 via the spring 4; when the spring 4 is deformed, the spring 4 can generate a force that inhibits the puncture tube 211 from sliding toward the proximal end of the first runner 221. The puncture tube assembly 21 comprises the reinforcing sleeve 24, so that the strength of the puncture tube 211 can be effectively improved, and the puncture tube 211 is prevented from being bent due to improper force application, so that the smooth completion of the operation can be ensured. As further shown in fig. 4.1 and 4.2, the proximal end of the stiffening sleeve 24 is optionally thickened to enable the stiffening sleeve 24 to abut the spring 4, reducing the use of material while increasing the local strength and stability of the stiffening sleeve 24. It should be noted that the connection between the reinforcing sleeve 24 and the puncture tube 211 is not particularly limited, and may be selectively fixed by welding, cementing, or the like.

As some preferred embodiments of the present application, as shown in fig. 8.1 and 8.2, the chordae tendineae implant device may further optionally further comprise an elastic seal 5, the elastic seal 5 being sealingly connected to the outer periphery of the proximal end of the penetration tube 211, and the elastic seal 5 being sealingly connected to the outer periphery of the penetration needle 231 at the proximal end of the penetration tube 211.

The structure and material of the elastic seal 5 in the present application are not particularly limited, and the outer periphery of the proximal end of the puncture tube 211 and the outer periphery of the puncture needle 231 may be sealed. In particular, the elastic seal 5 is preferably made of silicone.

As some preferred embodiments of the present application, the elastic seal 5 is further selectively made to provide a resistance to the piercing needle 231 that is greater than the piercing force required for the piercing needle 231 to penetrate body tissue. In practice, for example, the force required for the puncture tube 211 and the puncture needle 231 to penetrate through the body tissue (such as a valve) is a n, and then the force of the elastic sealing member 5 on the puncture needle 231 in the puncture direction should be greater than a n, so as to ensure that the puncture needle 231 is not retracted under force. The application can ensure that the puncture needle 231 is not stressed to be withdrawn when in puncture by making the resistance of the elastic sealing element 5 on the puncture needle 231 larger than the puncture force required by the puncture needle 231 penetrating through organism tissues, and can prevent the puncture failure while achieving the purpose of preventing the blood from sealing from the assembly gap between the puncture tube 211 and the puncture needle 231.

As an alternative embodiment of the present application, the elastic member may be alternatively configured as a spring, the sliding body 212 may be abutted against the base 22 via the elastic member, the proximal end of the first chute 221 may be provided with a limit structure 2221, and the sliding body 212 may be abutted against the limit structure 2221 via the spring 4. As shown in fig. 3 and 5, the base 22 further includes a cover plate 222 adapted to the first sliding slot 221, and the limit structure 2221 is disposed on the lower surface of the cover plate 222 and extends toward the bottom of the first sliding slot 221. The proximal end of the puncture tube assembly 21 is in abutment with the limit structure 2221 via the elastic seal 5 and the spring 4. When the spring 4 is deformed, the spring 4 is also capable of generating a force that inhibits the puncture tube 211 from sliding toward the proximal end of the first runner 221, i.e., a force that enables the spring 4 to generate a force that inhibits the puncture tube 211 from sliding toward its proximal end relative to the base 22. Further, the cover plate 222 is located above the elastic sealing element 5, the cover plate 222 and the first chute 221 limit the elastic sealing element 5 in the space enclosed by the cover plate 222 and the first chute 221, so that the cover plate 222 and the first chute 221 can squeeze the elastic sealing element 5, thereby achieving a better sealing effect and preventing blood from flowing out from the gap between the puncture tube 211 and the puncture needle 231 in the operation process. According to the application, the proximal end of the puncture tube assembly 21 is abutted against the limit structure 2221 through the elastic sealing element 5 and the spring 4, so that in the operation process, as the deformation amount of the spring 4 is increased, the elastic sealing element 5 is extruded under the action of the cover plate 222, the limit structure 2221 and the first sliding groove 221, and the sealing effect between the elastic sealing element 5 and the puncture needle 231 and between the elastic sealing element 5 and the puncture needle 231 is improved.

As some alternative embodiments of the present application, as shown in fig. 17.1 and 17.2, the second clamping member 32 may be optionally provided with a receiving cavity 321 opposite to the puncture tube 211, the tendon traction unit 1 is disposed in the receiving cavity 321, the first connection structure 13 is opposite to the movement direction of the puncture tube 211, and the tendon traction unit 1 abuts against an end wall of the receiving cavity 321 (an inner wall of the receiving cavity 321 opposite to the movement direction of the puncture tube 211) via an elastic member. As shown in fig. 9, 10, 11, 13, 17.1 and 17.2, the accommodating cavity 321 is adapted to the tendon traction unit 1, and the first connection structure 13 at one end of the tendon traction unit 1 is opposite to the second connection structure 2111 at the distal end of the puncture tube 211, and the other end of the tendon traction unit 1 abuts against the end wall of the accommodating cavity 321 via the spring 4. When the spring 4 is deformed, the spring 4 can also generate a force that inhibits the puncture tube 211 from sliding toward the proximal end of the first runner 221. According to the application, the tendon traction unit 1 is abutted against the inner wall of the accommodating cavity 321 opposite to the movement direction of the puncture tube 211 through the elastic piece, so that the puncture tube 211 can be buffered, and feedback information is sent to an operator.

As some preferred embodiments of the present application, the puncture unit 2 further optionally further comprises a puncture needle assembly 23, and the base 22 is further provided with a second sliding groove 223, and the proximal end of the puncture needle assembly 23 is slidably fitted with the second sliding groove 223. The second runner 223 is located on a side of the proximal end of the first runner 221. In particular, the first chute 221 and the second chute 223 may be integrally provided or separately provided. Specifically, as shown in fig. 4.1, 4.2 and 5, the first chute 221 and the second chute 223 are integrally provided, and the integrally provided chutes are blocked by a blocking member, which is preferably provided as a limit structure 2221 provided on the cover plate 222 in order to simplify the structure of the base 22.

As some preferred embodiments of the present application, the lancet assembly 23 is further optionally made to include a lancet 231 such that the distal end of the lancet 231 extends from the proximal end of the lancet tube 211, and the distal end of the lancet 231 has a state of being positioned within the lancet tube 211 (as shown in fig. 13) and a state of extending from the distal end of the lancet tube 211 (as shown in fig. 9 and 10).

The composition and structure of the puncture needle assembly 23 in the present application are not particularly limited. In particular, the needle assembly 23 may further optionally include a handling structure 232, with the proximal end of the needle 231 secured to the handling structure 232, and further with the handling structure 232 being capable of sliding fit with a second chute 223 provided on the base 22, whereby an operator may extend the needle 231 out of the tube 211 through the handling structure 232 to perforate body tissue. In the embodiment, as shown in fig. 6, the handling structure 232 is provided with a mounting hole 2321 penetrating through two ends thereof, the proximal end of the puncture needle 231 penetrates through the mounting hole 2321, and the puncture needles 231 of one fixing piece are respectively provided at two ends of the mounting hole 2321 to be fixedly connected (specifically, can be connected by welding, gluing or the like) so as to fix the puncture needles 231 on the handling structure 232 and form the puncture needle assembly 23.

It is further preferable that the proximal end of the manipulation structure 232 is provided as a manipulation portion, and the manipulation portion is protruded from one side of the second sliding groove 223 to facilitate manipulation at the time of puncturing. In addition, in order to avoid the puncture needle 231 from transiting the puncture, it is preferable to have the puncture needle 231 disposed in a restricted manner in the puncture direction; in particular, the manipulator is selectively constrained by a housing comprised by the chordae implantation instrument. In the specific implementation, as shown in fig. 8.1 and 8.2, the manipulation unit is located on the proximal side of the upper case 61, and the puncture needle 231 is movable in the puncture direction in the set space on the proximal side, even if the puncture needle 231 has a state in which it is capable of puncturing in the puncture direction (as shown in fig. 8.1) and a state in which it is restricted in the puncture direction (as shown in fig. 8.2).

As some preferred embodiments of the present application, the second connection structure 2111 is further optionally provided with a slot provided at the distal end of the puncture tube 211, and the first connection structure 13 is provided with a buckle adapted to the slot, so that the puncture tube 211 can be connected to the tendon traction unit 1 in a clamping manner via the slot and the buckle. In the specific embodiment, as shown in fig. 12, 14, 15 and 16, the locking groove is formed as a plurality of locking holes 2112 formed in the wall of the distal end of the puncture tube 211. It should be noted that the number of the clamping holes 2112 is not particularly limited, and the number of the clamping holes 2112 may be two, three, four, or five, and in practical implementation, it is preferable to make the number of the clamping holes 2112 two, and make the two clamping holes 2112 uniformly distributed in the circumferential direction of the puncture tube 211. According to the application, the second connection structure 2111 is the clamping groove arranged at the distal end of the puncture tube 211, and the first connection structure is the clamping buckle matched with the clamping groove, so that the puncture tube 211 can be clamped with the tendon traction unit 1 when the puncture tube 211 moves in the puncture direction, and the structure is simple in structure, convenient to process and convenient and simple in operation. In particular, it is further preferable that the second end of the retractor body 11 is tapered toward the extension direction thereof so that the tendon traction unit 1 can be smoothly docked with the puncture tube 211. As shown in fig. 7, 10 to 17.2, the end at the second end is chamfered in the direction of extension thereof.

In the operation process, the puncture tube 211 is moved towards the chorda tendineae traction unit 1, the buckle and the clamping groove are close to each other along with the movement of the puncture tube 211, the buckle is radially pressed and stretches into the distal end of the puncture tube 211, and when the buckle and the clamping groove are in a right-facing position, the buckle is deformed in a restoration mode and is clamped with the clamping groove.

As some preferred embodiments of the present application, the second connection structure may be a buckle provided at the distal end of the puncture tube 211, and the first connection structure may be a slot adapted to the buckle, so that the puncture tube 211 may be connected to the tendon traction unit 1 in a clamping manner (not shown) through the slot and the buckle.

As some preferred embodiments of the present application, the wall of the tube at the distal end of the puncture tube 211 is further optionally provided with a plurality of notches 2113 communicating with both sides of the tube wall. Notch 2113 extends a set depth from the end surface of the distal end of the puncture tube 211 in the proximal direction of the puncture tube 211. The number of the notches 2113 provided at the distal end of the puncture tube 211 is not particularly limited, and in practice, the number of the notches 2113 may be selectively set to two, three, four, five, or the like. As shown in fig. 12, two notches 2113 are provided at the distal end of the puncture tube 211, and the two notches 2113 are uniformly provided in the circumferential direction of the puncture tube 211. According to the application, the plurality of notches 2113 are formed in the pipe wall at the distal end of the puncture pipe 211, so that the distal end of the puncture pipe 211 is convenient to deform in the connection process of the buckle and the clamping groove, the buckle and the clamping groove are smoothly connected, and the success rate of the connection of the puncture pipe 211 and the chordae traction unit 1 is effectively improved. Besides, by arranging the notch 2113 on the tube wall, when the puncture tube 211 and the chorda tendineae traction unit 1 are connected in a matched manner through the buckle and the clamping groove, the required acting force is smaller, so that the deformation amount of the spring 4 is controlled when the buckle and the clamping groove are clamped, and the puncture tube has a better protection effect on heart tissues (such as valves) and prevents damage to the heart tissues caused by overlarge force.

As some alternative embodiments of the present application, the first connecting structure 13 may further optionally include a plurality of clamping bodies 131 adapted to the distal end of the puncture tube 211, where the clamping bodies 131 extend toward the second connecting structure 2111, and adjacent clamping bodies 131 are spaced apart. It should be noted that the number of the clamping bodies 131 is not particularly limited, and may be selectively set according to the number of the clamping grooves. In specific implementation, the number of the fastening bodies 131 may be selectively set to two, three, four, five, or the like. As shown in fig. 15 and 16, the first connection structure 13 includes two clamping bodies 131, and a gap 132 (as shown in fig. 16) is provided between the two clamping bodies 131. The first connecting structure 13 comprises the plurality of clamping bodies 131, and the clamping bodies 131 are structurally arranged, so that when the puncture tube 211 is connected with the tendon traction unit 1, the plurality of clamping bodies 131 are easy to fold and deform, and the puncture tube 211 is connected with the tendon traction unit 1, and the success rate of the connection of the puncture tube 211 and the tendon traction unit 1 can be effectively improved.

As some alternative embodiments of the present application, the tube wall at the distal end of the puncture tube 211 may be optionally provided with a plurality of notches 2113 communicating with two sides of the tube wall, and the first connection structure 13 may include a plurality of fastening bodies adapted to the distal end of the puncture tube 211, where the fastening bodies extend toward the second connection structure 2111, and adjacent fastening bodies are spaced apart.

To facilitate an understanding of the tendon implantation instrument, the following description of the procedure of using the tendon implantation instrument is provided with reference to fig. 18 to 25:

as shown in fig. 18, the tissue holding unit 3 of the chorda tendineae implantation instrument is extended to the vicinity of the valve in the heart, and the holding portion of the first holding member 31 and the holding portion of the second holding member 32 are further brought into a state of being away from each other by controlling the tissue holding unit 3. As shown in fig. 19, the tissue holding unit 3 is then caused to hold the valve by controlling the first holding member 31 and the second holding member 32. When the valve is clamped, the puncture unit 2 punctures, and as shown in fig. 9 and 10, the puncture unit 2 is controlled to move towards the clamped valve; specifically, the puncture needle 231 is extended out of the puncture tube 211 from the state of being positioned in the puncture tube 211, the puncture needle 231 and the puncture tube 211 are further extended out of the puncture channel 311 and passed through the valve, and then the puncture tube 211 is connected to the chordae traction unit 1 (as shown in fig. 13). When it is determined that the puncture tube 211 is successfully connected with the chorda tendineae traction unit 1, the tissue clamping unit 3 is controlled to make the clamping portions of the first clamping member 31 and the second clamping member 32 in a state of being far away from each other so as to release the valve (as shown in fig. 21 and 22); under traction of the puncture tube 211 and traction chorda traction unit 1, chorda are passed through the valve and extracted from the chorda implantation instrument (as shown in fig. 23), and the extraction traction ring 12 is sheared. The tissue holding unit 3 is further removed from the heart (as shown in fig. 24), the other end of the tendon is cut off (as shown in fig. 25), and finally the implanted tendon is fixed, and the implantation operation of the tendon is completed.

The present application is not limited to the above-mentioned embodiments, and any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present application are intended to be included in the scope of the present application. Therefore, the protection scope of the application is subject to the protection scope of the claims.

Claims

1. A tendon implantation instrument, comprising:

the tendon traction unit is provided with a first connecting structure;

the puncture unit comprises a puncture tube assembly, the puncture tube assembly comprises a puncture tube, a second connecting structure capable of being connected with the first connecting structure in an adaptive mode is arranged at the distal end of the puncture tube, and the puncture tube is in a state of moving towards the first connecting structure and in a state of pulling the tendon traction unit;

a tissue clamping unit including a first clamping member and a second clamping member, the first clamping member having a state of being away from the second clamping member and having a state of being close to the second clamping member to clamp body tissue;

the elastic piece is abutted with the puncture tube or the tendon traction unit, and the tendon implantation instrument is configured to: when the puncture tube is connected with the tendon traction unit, the deformation amount of the elastic piece is increased along the puncture direction of the puncture unit along with the increase of the acting force of the puncture tube on the tendon traction unit;

the puncture unit further comprises a base, the puncture tube assembly is in sliding fit with the base, and in the sliding direction of the puncture tube assembly, the puncture tube assembly is abutted with the base through the elastic piece; or alternatively, the process may be performed,

the second clamping piece is provided with a containing cavity opposite to the puncture tube, the tendon traction unit is arranged in the containing cavity, the first connecting structure is opposite to the movement direction of the puncture tube, and the tendon traction unit is abutted to the end wall of the containing cavity through the elastic piece.

2. The tendon implantation instrument of claim 1 in which,

the puncture tube assembly comprises a base, a puncture tube and a puncture tube, wherein the base is provided with a first chute, the puncture tube assembly further comprises a sliding body which is in sliding fit with the first chute, and the outer wall of the proximal end of the puncture tube is fixedly connected with the sliding body; the outer wall of the puncture tube is abutted with the base through the elastic piece or the sliding body is abutted with the base through the elastic piece.

3. The tendon implantation instrument as claimed in claim 2, wherein,

the elastic piece is arranged as a spring, the puncture tube assembly further comprises a reinforcing sleeve, the reinforcing sleeve is sleeved on the outer side of the puncture tube and fixedly connected with the puncture tube, and the proximal end of the reinforcing sleeve is abutted against the base through the spring; or alternatively, the process may be performed,

the elastic piece is arranged to be a spring, a limiting structure is arranged at the proximal end of the first sliding groove, and the sliding body is abutted to the limiting structure through the spring.

4. The tendon implantation instrument of claim 1 in which,

the puncture unit further comprises a puncture needle assembly, a second chute is further arranged on the base, and the proximal end of the puncture needle assembly is in sliding fit with the second chute;

the lancet assembly includes a lancet, the distal end of which extends from the proximal end of the lance, and the distal end of which has a state positioned within the lance and a state extending from the distal end of the lance.

5. The tendon implantation instrument of claim 1 in which,

the second connecting structure is a clamping groove arranged at the far end of the puncture tube, the first connecting structure is a buckle matched with the clamping groove, and the puncture tube can be connected with the tendon traction unit in a clamping way through the clamping groove and the buckle; or alternatively, the process may be performed,

the second connection structure is a buckle arranged at the far end of the puncture tube, the first connection structure is a clamping groove matched with the buckle, and the puncture tube can be connected with the tendon traction unit in a clamping way through the clamping groove and the buckle.

6. The tendon implantation instrument as claimed in claim 5, wherein,

a plurality of notches communicated with two sides of the tube wall are arranged on the tube wall at the far end of the puncture tube; and/or, the first connecting structure comprises a plurality of clamping bodies matched with the distal end of the puncture tube, the clamping bodies extend towards the second connecting structure, and the adjacent clamping bodies are arranged at intervals.

7. The apparatus according to claim 4, wherein,

the chorda tendineae implantation instrument further comprises an elastic sealing element, wherein the elastic sealing element is in sealing connection with the periphery of the proximal end of the puncture tube, and the elastic sealing element is in sealing connection with the periphery of the puncture needle at the proximal end of the puncture tube.

8. The tendon implantation instrument as claimed in claim 7, wherein,

the elastic sealing element generates a resistance to the puncture needle greater than a puncture force required by the puncture needle to penetrate through body tissue.

9. The tendon implantation device of any one of claims 1 to 8,

the tendon implantation instrument comprises a plurality of puncture units, a plurality of puncture channels penetrating through two ends of the first clamping piece are arranged on the first clamping piece, each puncture channel corresponds to one puncture unit, and each puncture unit comprises a puncture tube which extends into the corresponding puncture channel from the proximal end of the corresponding puncture channel.