CN114681151B

CN114681151B - Adjustable suture length adjustment system

Info

Publication number: CN114681151B
Application number: CN202011639628.8A
Authority: CN
Inventors: 张庭超; 郭荣辉
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2020-12-31
Filing date: 2020-12-31
Publication date: 2025-07-11
Anticipated expiration: 2040-12-31
Also published as: CN114681151A

Abstract

The present invention provides a quantitatively adjustable suture length adjustment system, comprising an adjustment component, wherein the adjustment component comprises a first adjustment member and a second adjustment member axially movably connected to the first adjustment member, wherein the first adjustment member is provided with a first positioning portion, and the second adjustment member is provided with a second positioning portion corresponding to the first positioning portion. The suture is passed between the first adjustment member and the second adjustment member, and the second adjustment member moves axially distally relative to the first adjustment member to push the suture, thereby increasing the length of the suture between the first adjustment member and the second adjustment member until the first positioning portion is matched with the second positioning portion, thereby limiting the movement of the second adjustment member relative to the first adjustment member. The suture length adjustment system has a simple structure and is easy to operate, and can realize quantitative adjustment of the suture length. Moreover, no fixed pressure is applied to the suture during the adjustment process, which is conducive to avoiding suture damage.

Description

Suture length adjusting system capable of being quantitatively adjusted

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a suture length adjusting system capable of being quantitatively adjusted.

Background

Mitral insufficiency is one of the most common heart valve diseases at present, and the main causes are rheumatic heart disease, mitral valve myxomatosis, heart ischemic disease, cardiomyopathy and the like, which cause lesions of the annulus, valve leaflets, chordae tendineae and papillary muscles in the mitral valve structure, and further cause incomplete closure of the valve 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.

At present, the minimally invasive interventional operation treatment is a better choice for most heart diseases, and the main interventional treatment modes include artificial chordae tendineae implantation, mitral valve annuloplasty, mitral valve edge-to-edge repair and the like. Wherein, implantation of artificial chordae tendineae on the valve leaflet can effectively treat mitral insufficiency caused by chordae tendineae fracture, valve leaflet prolapse and the like, and simultaneously maintain the physiological integrity of the mitral valve structure. However, after the artificial chordae are implanted for a period of time, due to the change of factors such as heart capacity, the implanted artificial chordae are in a loose state, and the length of the artificial chordae is often required to be adjusted again, so that the effective length of the artificial chordae is shortened, and abnormal functions of heart valves are avoided.

In the prior art, an artificial tendon length adjusting device is disclosed, wherein an artificial tendon is captured by a hook, the artificial tendon is stretched by an instrument, the length is regulated and controlled according to the stretching amount, and the artificial tendon is fixed by two positioning clamps, so that the regulation and control effect is achieved. The technology has the main defects that 1, the regulating and controlling instrument is too complex, the operation difficulty is high, 2, the extrusion force of the clamp is easy to damage the artificial chordae tendineae, 3, the quantitative regulation and control cannot be carried out, and the regulating and controlling amount is unstable. These problems all lead to the risk of surgical failure or ineffective regulation in artificial chordae regulation.

Disclosure of Invention

In order to solve the technical problems, the invention provides a suture length adjusting system capable of being quantitatively adjusted, which has the advantages of simple structure and convenience in operation, can realize quantitative adjustment of the suture length, and can avoid suture damage in the adjusting process.

The invention provides a quantitatively adjustable suture length adjusting system, which comprises an adjusting assembly, wherein the adjusting assembly comprises a first adjusting piece and a second adjusting piece which is connected with the first adjusting piece in an axially movable mode, the first adjusting piece is provided with a first positioning part, the second adjusting piece is provided with a second positioning part corresponding to the first positioning part, a suture is penetrated between the first adjusting piece and the second adjusting piece, the second adjusting piece moves relative to the first adjusting piece in the axial and distal direction to push the suture, the length of the suture between the first adjusting piece and the second adjusting piece is increased until the first positioning part is matched with the second positioning part, and therefore relative movement between the second adjusting piece and the first adjusting piece is limited.

The quantitative adjustable suture length adjusting system provided by the invention has the advantages that after the suture passes through the space between the first adjusting piece and the second adjusting piece, the second adjusting piece moves towards the far end along the axial direction relative to the first adjusting piece so as to push the suture, the length of the suture between the first adjusting piece and the second adjusting piece is further increased so as to adjust the suture, the quantitative adjustment of the suture length can be realized by controlling the movement amount of the second adjusting piece relative to the first adjusting piece, the whole system is simple in structure and convenient to operate, in addition, the second adjusting piece does not apply fixed pressure to the suture in the suture adjusting process, so that the suture damage is avoided, in addition, after the quantitative adjustment of the suture is finished, the cooperation of the first positioning part and the second positioning part can limit the movement of the second adjusting piece relative to the first adjusting piece, so that the suture loosening is prevented.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic diagram of the overall structure of a quantitatively adjustable suture length adjustment system according to one embodiment of the present invention.

Fig. 2 is a schematic perspective view of the adjusting assembly and the conveying assembly shown in fig. 1.

Fig. 3 is a partial axial cross-sectional view of the adjustment assembly and the delivery assembly shown in fig. 2, wherein the second limiting member is received in the second receiving cavity and corresponds to the position of the second positioning portion.

Fig. 4 is a schematic view of the second adjustment member of fig. 3 moved axially distally relative to the first adjustment member to engage the first positioning portion with the second positioning portion.

FIG. 5 is a schematic view of the first and second adjustment members of FIG. 4 with an ejected suture threaded therebetween.

Fig. 6 is a schematic perspective view of the adjustment assembly shown in fig. 4.

Fig. 7 is an axial cross-sectional view of the adjustment assembly shown in fig. 6.

Fig. 8 is a schematic perspective view of the first regulating member shown in fig. 6.

Fig. 9 is a front view of the proximal end of the first adjustment member shown in fig. 8.

Fig. 10 is a schematic structural view of the second regulating member shown in fig. 6.

Fig. 11 is a right side view of the second adjustment member shown in fig. 10.

Fig. 12 is a schematic view of the structure of the release member shown in fig. 3.

Fig. 13 is an axial cross-sectional view of the release member shown in fig. 12.

Fig. 14 is a distal elevation view of the release member of fig. 12.

Fig. 15 is a schematic perspective view of the first limiting member shown in fig. 3.

Fig. 16 is an axial cross-sectional view of the first stop member shown in fig. 15.

Fig. 17 is a distal end elevational view of the first stop member illustrated in fig. 15.

Fig. 18 is a schematic perspective view of the connecting shaft shown in fig. 3.

Fig. 19 is a schematic perspective view of the connecting shaft, the release member, the second limiting member and the connecting piece shown in fig. 3.

Fig. 20 is an axial cross-sectional view of the connecting shaft, the release member, the second stopper and the connecting piece shown in fig. 19.

Fig. 21-23 are schematic illustrations of the use of the quantitatively adjustable suture length adjustment system provided by the present invention.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without any inventive effort, are intended to be within the scope of the invention.

Furthermore, the following description of the embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. Directional terms, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., in the present invention are merely referring to the directions of the attached drawings, and thus, directional terms are used for better, more clear explanation and understanding of the present invention, rather than indicating or implying that the apparatus or element being referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention.

It should be noted that, in order to more clearly describe the structure of the quantitatively adjustable suture length adjustment system, the terms "proximal" and "distal" are defined in the specification as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end that is distal from the operator during a surgical procedure, and "proximal" refers to the end that is proximal to the operator during a surgical procedure, where the direction of the rotational center axis of an object such as a cylinder, a tube, etc., is defined as axial, and the circumferential direction is the direction (perpendicular to the axis and to the radius of the cross-section) about the axis of the object such as the cylinder, tube, etc., and the radial direction is the direction along the diameter or radius. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

Referring to fig. 1 to 5, the present invention provides a quantitatively adjustable suture length adjusting system 1, which includes an adjusting assembly 20, wherein the adjusting assembly 20 includes a first adjusting member 21 and a second adjusting member 22 axially movably connected to the first adjusting member 21, the first adjusting member 21 is provided with a first positioning portion 211, and the second adjusting member 22 is provided with a second positioning portion 221 corresponding to the first positioning portion 211. The suture 2 is threaded between the first and second adjustment members 21, 22, and the second adjustment member 22 is moved axially distally relative to the first adjustment member 21 to push the suture 2 such that the length of the suture 2 between the first and second adjustment members 21, 22 increases until the first and second positioning portions 211, 221 are mated, thereby restricting relative movement between the second and first adjustment members 22, 21. It will be appreciated that the second adjustment member 22 is moved axially distally relative to the first adjustment member 21 by different distances, i.e., by different distances, by which the suture 2 is pushed, thereby resulting in different lengths by which the suture 2 is adjusted. Specifically, as shown in fig. 5, after the suture 2 is pushed by the second adjusting member 22, the suture 2 between the first adjusting member 21 and the second adjusting member 22 is bent into an inverted U shape or a shape of a letter "n", the adjusted length H of the suture 2 is approximately equal to twice the length H of the suture 2 located on each side of the second adjusting member 2 along the radial direction of the first adjusting member 21, that is, the relationship H satisfies the relationship h=2h, where the length H of the suture 2 located on each side of the second adjusting member 2 along the radial direction of the first adjusting member 21 is the distance that the second adjusting member 22 moves distally along the axial direction relative to the first adjusting member 21, so that quantitative adjustment of the length of the suture 2 can be achieved by controlling the moving amount of the second adjusting member 22 relative to the first adjusting member 21.

The quantitatively adjustable suture length adjusting system 1 provided by the invention has the advantages that after the suture 2 is penetrated between the first adjusting piece 21 and the second adjusting piece 22, the second adjusting piece 22 moves relative to the first adjusting piece 21 along the axial direction and the distal direction so as to push the suture 2, the length of the suture 2 between the first adjusting piece 21 and the second adjusting piece 22 is further increased so as to adjust the suture 2, the quantitative adjustment of the length of the suture 2 can be realized by controlling the moving amount of the second adjusting piece 22 relative to the first adjusting piece 21, the whole system is simple in structure and convenient to operate, in addition, the second adjusting piece 22 does not apply fixed pressure on the suture 2 in the process of adjusting the suture 2, thereby being beneficial to avoiding the suture 2 from being damaged, and in addition, after the quantitative adjustment of the suture 2 is finished, the cooperation of the first positioning part 211 and the second positioning part 221 can limit the movement of the second adjusting piece 22 relative to the first adjusting piece 21, thereby preventing the suture 2 from loosening.

It should be noted that, the suture 2 may be a suture as an artificial tendon, such as an e-PTFE suture or a PET suture, and the second adjusting member 22 pushes the suture 2 to adjust the length of the suture 2, that is, to adjust the effective length of the artificial tendon, and after the quantitative adjustment of the suture 2 is completed, the adjusting assembly 20 is clamped on the suture 2 and is left as an implant in the human body. In order to ensure implantation safety, the first and second adjustment members 21 and 22 may be made of a metal material or a polymer material having good biocompatibility, such as stainless steel or PEEK, and the materials of the first and second adjustment members 21 and 22 may be the same or different.

As shown in fig. 1, the suture length adjustment system 1 further includes a delivery assembly 40 coupled to the proximal end of the adjustment assembly 20 and a handle assembly 60 coupled to the proximal end of the delivery assembly 40, wherein the delivery assembly 40 is configured to deliver the adjustment assembly 20 into the human body and to control the relative movement between the first adjustment member 21 and the second adjustment member 22, and the handle assembly 60 is configured to allow an operator to control the delivery assembly 40 outside the body.

Specifically, referring to fig. 6 to 8, the first adjusting member 21 is a hollow substantially cylindrical body, and is provided with a first receiving cavity 212 extending along an axial direction, wherein the first receiving cavity 212 penetrates at least a proximal end surface of the first adjusting member 21, so that the second adjusting member 22 is slidably inserted into the first receiving cavity 212 along the axial direction from the proximal end of the first adjusting member 21. In this embodiment, the first receiving cavity 212 is formed through the distal end surface of the first adjusting member 21, which is beneficial to reducing the weight of the first adjusting member 21, and the first receiving cavity 212 is formed through the distal end surface of the first adjusting member 21, so that the second adjusting member 22 can move axially and distally relative to the first adjusting member 21 until the distal end of the second adjusting member 22 extends out of the distal end of the first adjusting member 21, which is beneficial to increasing the distance that the second adjusting member 22 moves axially and distally relative to the first adjusting member 21, and further increasing the adjusted length H of the suture 2. Of course, in other embodiments, the first receiving cavity 212 may not penetrate the distal end surface of the first adjusting member 21, as long as the depth of the first receiving cavity 212 along the axial direction of the first adjusting member 21 is sufficient to provide a moving space for the second adjusting member 22.

It should be noted that the inner contour of the first accommodating cavity 212 is substantially the same as the outer contour of the second adjusting member 22, so that the second adjusting member 22 is movably accommodated in the first accommodating cavity 212.

Referring to fig. 7 to 10, a pair of sliding guide surfaces 213 are disposed on opposite inner walls of the first accommodating cavity 212, the first positioning portion 211 includes at least one clamping groove disposed on at least one sliding guide surface 213, the clamping groove extends along a substantially radial direction of the first adjusting member 21, the second adjusting member 22 includes a pair of outer wall surfaces 222 corresponding to the pair of sliding guide surfaces 213, and the second positioning portion 221 includes an elastic hook disposed on at least one outer wall surface 222, and the elastic hook is clamped into a corresponding clamping groove to stop the relative movement between the second adjusting member 22 and the first adjusting member 21. Preferably, in the present embodiment, the sliding guide surface 213 and the corresponding outer wall surface 222 are both arc surfaces, and when the second adjusting member 22 moves in the axial direction in the first accommodating cavity 212, the sliding contact between the sliding guide surface 213 and the outer wall surface 222 is smoother. Of course, in other embodiments, the sliding guide surface 213 and the corresponding outer wall surface 222 may be planar.

In this embodiment, the clamping grooves are formed in the pair of sliding guide surfaces 213, the elastic hooks are disposed in the pair of outer wall surfaces 222, so that the elastic hooks on opposite sides of the second adjusting member 22 can be clamped into the corresponding clamping grooves to limit the relative movement between the first adjusting member 21 and the second adjusting member 22, and the reliability is higher.

The clamping groove on one of the pair of guide sliding surfaces 213 may or may not correspond to the clamping groove on the other guide sliding surface 213, that is, the clamping groove on one of the guide sliding surfaces 213 may or may not have the same position in the axial direction of the first adjusting member 21 as the clamping groove on the other guide sliding surface 213. In this embodiment, the positions of the clamping grooves of the pair of sliding guide surfaces 213 correspond to each other.

In this embodiment, the clamping groove on each sliding guide surface 213 is set to be one. It will be appreciated that when the number of the locking grooves on each sliding guide surface 213 is one, the elastic hook on the outer wall surface 222 corresponding to the sliding guide surface 213 can only be locked into the one locking groove to limit the relative movement between the first adjusting member 21 and the second adjusting member 22, that is, the distance that the second adjusting member 22 moves axially and distally relative to the first adjusting member 21 is a fixed value, and the length H of the suture 2 that can be quantitatively adjusted is unique. Alternatively, in other embodiments, the clamping grooves on each sliding guide surface 213 may be multiple (i.e. two or more), the multiple clamping grooves are distributed on the sliding guide surface 213 along the axial direction of the first adjusting member 21, the elastic hooks on the outer wall surface 212 corresponding to the sliding guide surface 213 provided with the multiple clamping grooves can be clamped into the clamping grooves at different axial positions of the first adjusting member 21, thereby, the distance of the second adjusting member 22 moving distally along the axial direction relative to the first adjusting member 21 is multiple, so that the length H of the suture 2 that can be quantitatively adjusted has multiple values, which is beneficial to enhancing the application range of the suture length adjusting system 1, and the provision of multiple clamping grooves is beneficial to reducing the weight of the first adjusting member 21.

Each of the clamping grooves may extend through the outer wall of the first adjusting member 21 or not through the outer wall of the first adjusting member 21 in the radial direction of the first adjusting member 21, preferably through the outer wall of the first adjusting member 21, so that the weight of the first adjusting member 21 is reduced more.

In this embodiment, the direction of the interval between the pair of sliding guide surfaces 213 is defined as a first direction, and a gap is provided between the inner wall of the first accommodating cavity 212 and the second adjusting member 22 in a second direction substantially perpendicular to the first direction, and the gap is used for accommodating the suture 2 between the inner wall of the first accommodating cavity 212 and the second adjusting member 22, so as to avoid the suture 2 from being damaged by extrusion. In detail, referring to fig. 5, 6 and 9, in the present embodiment, the inner wall of each side of the first accommodating cavity 212 in the second direction is provided with a groove penetrating the first adjusting member 21 along the axial direction, the depth of the groove (i.e. the dimension along the second direction) is not smaller than the diameter of the suture 2, and when the second adjusting member 22 is accommodated in the first accommodating cavity 212 and pushes against the suture 2, the suture 2 between the outer wall of the second adjusting member 22 and the inner wall of the first accommodating cavity 212 is accommodated in the groove, so as to avoid the extrusion damage to the suture 2. In other embodiments, the groove may be formed on an outer wall of each side of the second adjusting member 22 in the second direction, or the inner wall of each side of the first accommodating cavity 212 in the second direction and the outer wall of each side of the second adjusting member 22 in the second direction are respectively formed with grooves correspondingly, so as to accommodate the suture 2 between the outer wall of the second adjusting member 22 and the inner wall of the first accommodating cavity 212, which also can avoid damaging the suture 2 by extrusion.

As shown in fig. 8, in the present embodiment, a first slot 214 communicating with the first accommodating cavity 212 is formed in the outer wall of the first adjusting member 21 from the proximal end surface, the first slot 214 extends substantially along the axial direction of the first adjusting member 21, and the positions of the first slot 214 and the clamping groove on the inner wall of the first accommodating cavity 212 in the circumferential direction of the first adjusting member 21 are staggered. The first slot 214 is used for allowing the suture 2 to be inserted into and pulled out of, and when the second adjusting member 22 pushes against the suture 2, the first slot 214 can prevent the suture 2 from moving along the radial direction of the first adjusting member 21, so as to prevent the suture 2 from being separated from the first adjusting member 21 and the second adjusting member 22. Optionally, as shown in fig. 6 and 7, in this embodiment, the outer wall of the first adjusting member 21 is further provided with at least one hollow hole 216 to further reduce the weight of the first adjusting member 21. The extending direction of each hollow hole 216 may be the same as or different from the extending direction of the clamping groove of the first adjusting member 21, and each hollow hole 216 may be communicated with or not communicated with the first accommodating cavity 212. In this embodiment, each hollow hole 216 and the extending direction of the slot are the same and are communicated with the first accommodating cavity 212, so that the hollow hole 216 can also function as the slot.

Further, referring to fig. 3, 7 and 8, in the present embodiment, at least one threaded hole extending along the axial direction is formed in the first adjusting member 21 from the proximal end surface at one side of the first receiving cavity 212, for detachable connection with the distal end of the driving rod 45 in the conveying assembly 40. The driving rod 45 is used for conveying the first adjusting piece 21, and the axial movement of the driving rod can drive the first adjusting piece 21 to move axially, so that the relative movement between the first adjusting piece 21 and the second adjusting piece 22 is driven in the axial direction, the hooking and pushing of the suture 2 are realized, the quantitative adjustment of the length of the suture 2 is realized, and furthermore, after the quantitative adjustment of the length of the suture 2 is completed, the driving rod 45 can be detached from the first adjusting piece 21, so that the first adjusting piece 21 is left in a human body.

Referring to fig. 7, 10 and 11, the second adjusting member 22 is a hollow substantially block, and is provided with a second accommodating cavity 223 extending along an axial direction, the second accommodating cavity 223 at least penetrates through a proximal end surface of the second adjusting member 22, at least one outer wall surface 222 of the second adjusting member 22 is provided with an opening 224 in a proximal end region, which communicates with the second accommodating cavity 223, and the second positioning portion 221 (i.e. the elastic hook) is disposed at the opening 224. In this embodiment, two outer wall surfaces 222 on opposite sides of the second adjusting member 22 are respectively provided with an opening 224, and each opening 224 is provided with the elastic hook.

Specifically, as shown in fig. 11, in this embodiment, the elastic hook includes a spring and a buckle connected to a proximal end of the spring, a distal end of the spring is connected to a distal edge of the opening 224, and the buckle includes a stop surface facing the proximal end of the second adjusting member 22 and an inclined plane facing the outer side of the second adjusting member 22 and simultaneously facing the distal end of the second adjusting member 22. Wherein the elastic sheet is made of elastic material to ensure the elastic deformation capability. It should be noted that, in this embodiment, in the initial state, the elastic hook of the second adjusting member 22 is located outside the distal end of the first adjusting member 21, when the second adjusting member 22 moves axially and distally relative to the first adjusting member 21, the elastic hook first abuts against the proximal end surface of the first adjusting member 21, at this time, the inner wall of the proximal end edge of the first accommodating member 212 abuts against the inclined plane of the buckle, so that the proximal end of the elastic sheet is forced to bend toward the inside of the second accommodating member 223, so that the second adjusting member 22 can move axially and distally relative to the first adjusting member 21 until the elastic hook is accommodated in the first accommodating member 212, and when the second adjusting member 22 continues to move axially and distally relative to the first adjusting member 21 until the buckle corresponds to the clamping groove position of the first adjusting member 21, the inner wall of the first accommodating member 212 no longer abuts against the buckle, and the restoring deformation makes the buckle enter the corresponding clamping groove, and it can be understood that the second adjusting member 22 moves axially and proximally relative to the first adjusting member 21, so as to prevent the second adjusting member 22 from moving axially and approaching the second adjusting member 21, thereby, the second adjusting member 22 moves axially and the corresponding to the clamping groove 21.

As shown in fig. 10, in this embodiment, the distal end of the second adjusting member 22 corresponds to the first slot 214 of the first adjusting member 21, and radial slots 225 are formed in the distal end of the second adjusting member 22, and two ends of each radial slot 225 are respectively penetrated through the outer wall of the second adjusting member 22, and the radial slots 225 are used for accommodating and passing the suture 2 located at the distal end of the second adjusting member 22. Preferably, the radial slots 225 are rounded to ensure that the radial slots 225 are smooth and avoid damaging the suture 2.

Further, referring to fig. 3, 6 and 10, in the present embodiment, a first connection portion 226 is provided at a proximal end of the second adjusting member 22 for detachably connecting with a distal end of the conveying member 43 in the conveying assembly 40. The conveying member 43 is used for conveying the second adjusting member 22, and limiting the axial position of the second adjusting member 22 to be fixed when the driving rod 45 drives the first adjusting member 21 to move axially, so that the first adjusting member 21 and the second adjusting member 22 can move relatively in the axial direction to achieve hooking and pushing of the suture 2 and further achieve quantitative adjustment of the length of the suture 2, and the conveying member 43 can be detached from the second adjusting member 22 after the quantitative adjustment of the length of the suture 2 is completed, so that the second adjusting member 22 and the first adjusting member 21 can be placed in a human body together.

Specifically, as shown in fig. 6, in the present embodiment, the first connection portion 226 is a pair of first barbs disposed at the proximal end of the second adjusting member 22, the pair of first barbs are integrally connected to the outer wall surface 222 on one side of the second adjusting member 22, and each of the first barbs has a first engaging surface. It should be noted that, when the second adjusting member 22 is received in the first receiving cavity 212, the first connecting portion 226 is located outside the distal end of the first adjusting member 21.

Referring to fig. 3, the conveying assembly 40 includes the conveying member 43 and the driving member 45. The conveying member 43 and the driving member 45 are flexible rods, flexible pipes, or flexible steel cables having a certain axial length, a certain supporting property, and a certain bending property, and are made of a metal material or a polymer material having good biocompatibility, preferably a metal material such as stainless steel. In this embodiment, the conveying member 43 is a stainless steel cable, the driving rod 45 is a rod body made of stainless steel, the distal end of the driving rod 45 is provided with an external thread adapted to the internal thread of the threaded hole of the first adjusting member 21, and the driving rod 45 is in threaded connection with the first adjusting member 21.

Wherein the number of driving rods 45 is equal to the number of threaded holes. In this embodiment, the first adjusting member 21 is provided with a pair of threaded holes, two driving rods 45 are correspondingly provided, and the first adjusting member 21 is driven to move along the axial direction by the pair of driving rods 45, so that the stability of the first adjusting member 21 moving along the axial direction is improved, and the first adjusting member 21 can be prevented from rotating in the moving process.

Referring to fig. 3 and 12-14, in the present embodiment, the conveying assembly 40 further includes a release member 47 detachably connected to the distal end of the conveying member 43, and the release member 47 is configured to detachably connect with the second adjusting member 22. That is, in the present embodiment, the distal end of the conveying member 43 is detachably connected to the second regulating member 22 via the release member 47.

Specifically, as shown in fig. 12 to 14, in this embodiment, the release member 47 has a substantially block-shaped structure, which includes a stop portion 472 having a waist shape at a distal end, an insertion portion 474 connected to the distal end of the stop portion 472, and a pair of second barbs disposed at the distal end of the stop portion 472, the pair of second barbs being located on opposite sides of the insertion portion 474, respectively, and being adapted to be detachably connected to the pair of first barbs at the proximal end of the second adjustment member 22. Each second barb is provided with a second combining surface matched with the first combining surface of the first barb, the first combining surface and the second combining surface are both S-shaped curved surfaces with certain curvature, and the curvature of the first combining surface and the second combining surface are matched. It will be appreciated that axial movement of the transport member 43 may move the release member 47 axially relative to the second adjustment member 22 such that the second connection portion 476 is detachably connected or disconnected from the first connection portion 226. When the first barb of the first connecting portion 226 and the second barb of the second connecting portion 476 are in a connected state, the conveying member 43 can be used to convey the second adjusting member 22 and to limit the axial position of the second adjusting member 22. In this embodiment, when the first barb and the second barb are in the connected state, the stop portion 472 of the release member 47 is stopped at the proximal end of the first barb, and the insertion portion 474 of the release member 47 is inserted between the pair of first barbs.

The release member 47 is also made of a metal material or a polymer material having good biocompatibility, preferably a metal material such as stainless steel.

Further, referring to fig. 2, 3 and 15-17, in the present embodiment, the delivery assembly 40 further includes an outer sheath 49 and a first limiting member 41 connected to a distal end of the outer sheath 49, the outer sheath 49 is a hollow tube for the delivery member 43 and the driving member 45 to move through, and the first limiting member 41 is used for limiting the detachment of the first connecting portion 226 of the second adjusting member 22 from the second connecting portion 476 of the releasing member 47. The sheath tube 49 and the first stopper 41 may be made of a metal material or a polymer material having good biocompatibility, and preferably a metal material such as stainless steel.

Specifically, as shown in fig. 2 and 3, in the present embodiment, the first limiting member 41 includes a main body portion 414 with a columnar structure and a socket portion 415 connected to a proximal end of the main body portion 414, the socket portion 415 is a hollow substantially cylindrical body, and a distal end of the outer sheath 49 is fixedly connected to the socket portion 415 of the first limiting member 41 by any means such as engagement, adhesion or welding. The main body 414 and the socket 415 may be integrally formed, or may be formed separately and fixedly connected by any means such as laser welding, adhesion, or clamping, and preferably laser welding.

Referring to fig. 3, 16 and 17, the main body 414 has a limiting slot 410 formed on a distal surface thereof, a first through hole 411 extending along an axial direction is formed on a bottom surface of the limiting slot 410 for the distal end of the conveying member 43 to pass through, and at least one second through hole 412 extending along an axial direction is formed on one side of the limiting slot 410 for the distal end of the at least one driving member 45 to pass through. In the present embodiment, the number of the second through holes 412 and the number of the driving members 45 are two.

The axial line of the limiting groove 410 and the axial line of the first limiting member 41 have a radial distance, that is, the limiting groove 410 is eccentrically disposed at the distal end of the main body portion 414 of the first limiting member 41. It should be noted that, in the present embodiment, the shape of the limiting groove 410 is adapted to the shape of the release member 47, and when the sheath tube 49 moves in the axial direction to drive the first limiting member 41 to move in the axial direction, the connection portion between the first connection portion 226 of the second adjusting member 22 and the second connection portion 476 of the release member 47 is accommodated in or moved out of the limiting groove 410, so that the connection or separation between the first connection portion 226 and the second connection portion 476, that is, the connection or separation between the second adjusting member 22 and the release member 47, is achieved.

As shown in fig. 16, in this embodiment, the edge of the distal end surface of the main body 414 is further provided with a protrusion 416, and the protrusion 416 extends along the circumference of the first limiting member 41, preferably, the protrusion 416 extends one turn along the circumference of the first limiting member 41. As shown in fig. 3, in this embodiment, the first adjusting member 21 is driven by the driving rod 45 to move axially and proximally relative to the second adjusting member 22 to abut against the distal end surface of the main body portion 414 of the first limiting member 41. It can be understood that, after the suture 2 is threaded into the first slot 14 of the first adjusting member 21 along the axial direction of the first limiting member 41, the proximal end portion of the first adjusting member 21 gradually goes deep into the space formed by the rounded-up of the first adjusting member 21 until the proximal end surface of the first adjusting member 21 abuts against the distal end surface of the main body 414 in the process that the second adjusting member 22 moves proximally along the axial direction, that is, the rounded-up of the first adjusting member 21 gradually surrounds the proximal end portion of the first adjusting member 21 extending a certain distance from the proximal end surface to the distal end, so that a gap between the proximal end surface of the first adjusting member 21 and the distal end surface of the main body 414 before the first adjusting member 21 abuts against the main body 414 can be enclosed, and human tissues can be prevented from being hung in the gap, thereby avoiding injury to human tissues. Preferably, in the present embodiment, the protrusion 416 has a second slot 417 corresponding to the first slot 214 of the first adjusting member 21, so that when the first adjusting member 21 abuts against the distal end surface of the main body 414, the first slot 214 and the second slot 417 together form a through hole for accommodating the suture 2 hooked by the first adjusting member 21.

Further, referring to fig. 3, in order to prevent the second adjusting member 22 from moving relative to the first adjusting member 21 in the axial distal direction to be received in the first receiving cavity 212 when the suture 2 is not inserted into the first slot 214 (i.e. the first adjusting member 21 does not hook the suture 2), the conveying assembly 40 further includes a second limiting member 42 connected to the distal end of the conveying member 43, and the conveying member 43 is further configured to drive the second limiting member 42 to move in the axial distal direction until the second limiting member 42 is received in the second receiving cavity 223 and corresponds to the position of the elastic hook, so as to stop the elastic hook from bending toward the second receiving cavity 223, such that the elastic hook can stop at the proximal end of the first receiving cavity 212 when the second adjusting member 22 moves relative to the first adjusting member 21 in the axial distal direction, thereby preventing the second adjusting member 22 from being received in the first receiving cavity 212 in the axial distal direction.

Specifically, referring to fig. 3, 13 and 18 to 20, in the present embodiment, the distal end of the conveying member 43 is fixedly provided with a connecting shaft 46, the releasing member 47 is further provided with a third through hole 478 (as shown in fig. 13) corresponding to the first through hole 411 of the first limiting member 41, the third through hole is axially penetrated and provided with an internal thread, the distal end of the conveying member 43 is in threaded connection with the releasing member 47 through the connecting shaft 46, and the distal end of the connecting shaft 46 extends from the distal end of the releasing member 47, and the second limiting member 42 is fixedly disposed at the distal end of the connecting shaft 46.

As shown in fig. 18, in this embodiment, the connecting shaft 46 includes a proximal shaft section 462, an intermediate shaft section 464 and a distal shaft section 466 that are sequentially connected from the proximal end to the distal end, and the diameters of the three are sequentially reduced, wherein the proximal shaft section 462 is provided with a through hole from the proximal end face in the axial direction for connecting the distal end of the conveying member 43, and the intermediate shaft section 464 is provided with an external thread that is adapted to the internal thread of the third through hole 478 of the disengaging member 47. As shown in fig. 19 and 20, in the present embodiment, the second limiting member 42 is a block-shaped spacer with a connecting hole, the second limiting member 42 is sleeved on the distal shaft section 466 of the connecting shaft 46, and the proximal end surface of the second limiting member 42 abuts against the shaft shoulder between the middle shaft section 464 and the distal shaft section 466 of the connecting shaft 46, and the outer contour of the second limiting member 42 is adapted to the inner contour of the second accommodating cavity 223, so as to be conveniently inserted into the proximal end of the second accommodating cavity 223 to stop the elastic hook. In this embodiment, the distal end of the second limiting member 42 is further provided with a connecting piece 48, the connecting piece 48 is provided with a through hole along the axial direction, the connecting piece 48 is sleeved on the distal shaft section 466 of the connecting shaft 46 and is located at the distal end of the second limiting member 42, and the connecting piece 48 is fixedly connected with the connecting shaft 46, so that the second limiting member 42 is fixed on the connecting shaft 46. In other embodiments, the second limiting member 42 may be directly fixedly connected to the connecting shaft 46, and the connecting shaft 46 may be integrated with the conveying member 43. The second limiting member 42, the connecting shaft 46 and the connecting piece 48 may be made of a metal material or a polymer material with good biocompatibility, preferably a metal material such as stainless steel. The connection between the connecting shaft 46 and the conveying member 43, and the connection between the connecting piece 48 and the connecting shaft 46 may be made by any means such as laser welding, adhesion, snap-fit, interference, and the like, and preferably laser welding.

Referring to fig. 3 and 4 together, in the present embodiment, the second connecting portion 476 of the release member 47 is adapted to the first connecting portion 226 of the second adjusting member 22 and then placed in the limiting groove 410 of the first limiting member 41, when the conveying member 43 is rotated, the rotation of the conveying member 43 drives the connecting shaft 46 to rotate, and under the limiting effect of the limiting groove 410, the release member 47 will not rotate, so that the connecting shaft 46 and the release member 47 move in a threaded manner, and the connecting shaft 46 moves axially relative to the release member 47 and drives the second limiting member 42 to move axially. Therefore, when the second limiting member 42 moves to the proximal end of the second accommodating cavity 223 of the second adjusting member 22 and corresponds to the position of the elastic hook, the outer side surface of the second limiting member 42 abuts against one side of the elastic hook facing the second accommodating cavity 223, bending deformation of the elastic hook facing the second accommodating cavity 223 is limited, when the first adjusting member 21 moves to the proximal end under the driving of the driving member 45, the proximal end opening of the first accommodating cavity 212 of the first adjusting member 21 presses the inclined plane of the elastic hook, at this time, the elastic hook is abutted by the second limiting member 42 and cannot be elastically deformed, the elastic hook cannot be clamped in the clamping groove of the first adjusting member 21, the second adjusting member 22 cannot be completely accommodated in the first accommodating cavity 212, when the control conveying member 43 drives the second limiting member 42 to move to the inner cavity of the second accommodating cavity 223 of the second adjusting member 22, the elastic hook of the second limiting member 22 returns to the elastic deformation capacity, and when the first clamping member 21 moves to the proximal end opening of the first adjusting member 21, the first clamping member 2122 continues to move to the second clamping member 21 corresponding to the second clamping member 21, and the second clamping member 21 moves to the first clamping member 22 is completely in the second accommodating cavity 212, and the second clamping member 22 can be completely accommodated in the second accommodating cavity 212, and the second clamping member 21 can be completely clamped in the clamping groove, and the second clamping member 22 can be completely clamped in the second clamping cavity 21 is completely corresponding to the second clamping cavity 21.

Referring to fig. 1, in this embodiment, to facilitate the manipulation of the delivery assembly 40 by the operator outside the body, the quantitatively adjustable suture length adjustment system 1 further includes a handle assembly 60 coupled to the proximal end of the delivery assembly 40. Specifically, as shown in fig. 1, the handle assembly 60 includes a first knob 61, a second knob 62, a third knob 63, and a housing 64, the housing 64 is fixedly connected to the proximal end of the sheath 49, the first knob 61 is disposed at the proximal end of the housing 64, the second knob 62 is disposed in the middle of the housing 64, and the third housing 63 is disposed at the distal end of the housing 64.

In the present embodiment, as shown in fig. 2, the proximal ends of the delivery member 43 and the driving member 45 extend from the proximal end of the outer sheath 49 and into the housing 64, respectively, for connection to corresponding knobs. Specifically, in this embodiment, the first knob 61 is connected to the proximal end of the driving member 45 for controlling the driving member 45 to move in the axial direction, so as to drive the first adjusting member 21 to open and close relative to the second adjusting member 22, the second knob 62 is connected to the proximal end of the driving member 45 for controlling the rotation of the driving member 45, so as to separate the driving member 45 from the first adjusting member 21, and the third knob 63 is connected to the proximal end of the conveying member 43 for controlling the conveying member 43 to move in the axial direction, and for controlling the rotation of the conveying member 43 to drive the second limiting member 42 to move in the axial direction. It should be noted that, the connection between the first knob 61 and the second knob 62 and the driving member 45, and the connection between the third knob 63 and the conveying member 43 are all implemented in the prior art, and are not described herein.

Referring to fig. 3, fig. 4, and fig. 21 to fig. 23, the use of the suture length adjustment system 1 according to the present embodiment will be described with reference to the drawings by taking the suture 2 as an example of an artificial tendon implanted in a human body.

In a first step, as shown in FIG. 21, the adjustment assembly 20 at the distal end of the suture length adjustment system 1 is delivered to the vicinity of the suture 2 as an artificial tendon by means of an adjustable curved sheath or a guide device (not shown) such as a pre-shaped catheter.

In a second step, as shown in fig. 22, the first knob 61 of the handle assembly 60 controls the driving member 45 to move axially and distally, and the driving member 45 drives the first adjusting member 21 to move distally, so that the first adjusting member 21 is opened relative to the second adjusting member 22 and the suture 2 is hooked, and at this time, the suture 2 is threaded into the first slot 214 of the first adjusting member 2.

And thirdly, observing whether the first adjusting piece 21 successfully hooks the suture 2 through the medical imaging equipment, and controlling the conveying piece 43 to rotate through the third knob 63 of the handle assembly 60 after observing that the suture 2 is successfully hooked, wherein the conveying piece 43 rotates relative to the releasing piece 47 to drive the second limiting piece 42 to move proximally to move out of the proximal end of the second accommodating cavity 223 of the second adjusting piece 22, so that the second limiting piece 42 does not limit the deformation capacity of the elastic clamping hook.

Fourth, as shown in fig. 4 and 23, the driving member 45 is controlled by the first knob 61 to move axially and proximally to drive the first adjusting member 21 to move proximally, so that the second adjusting member 22 is accommodated in the first accommodating cavity 212, the distal end of the second adjusting member 22 pushes the suture 2, so that the suture 2 is bent to form an inverted U shape, and the adjustment of the suture 2 is completed, i.e. the effective length of the artificial tendon is reduced, so that the original loose artificial tendon is tensioned again after being adjusted. At this time, the elastic hook of the second adjusting member 22 is clamped into the clamping groove of the first adjusting member 21, so that the axial movement between the first adjusting member 21 and the second adjusting member 22 is limited, and the adjusted suture 2 is prevented from loosening.

And a fifth step of controlling the rotation of the driving member 45 through the second knob 62 of the handle assembly 60 to release the connection between the driving member 45 and the first adjusting member 21 so as to separate the first adjusting member 21 from the driving member 45, and controlling the movement of the conveying member 43 in the axial direction and distally through the third knob 63, wherein the conveying member 43 drives the releasing member 47 to move distally to move out of the limiting groove 410 of the first limiting member 41 so as to release the connection between the first connection portion 216 of the second adjusting member 22 and the second connection portion 476 of the releasing member 47, so that the second adjusting member 22 is separated from the releasing member 47, and at this time, the adjusting assembly 20 is completely released from the conveying assembly 60.

Sixth, the delivery assembly 60 and the guide device are withdrawn from the body, and the adjustment assembly 20 is placed as an implant in the patient and connected to the suture 2, completing the adjustment of the suture 2.

In the process of adjusting the suture 2, the effective length of the suture 2 can be adjusted by controlling the corresponding knob to rotate, the operation is convenient, the time is saved, in addition, the second adjusting piece 22 can adjust the suture 2 through the pushing action, almost no damage is caused to the suture 2, the safety of the instrument is high, in addition, the quantitative adjustment of the length of the suture 2 can be realized by controlling the moving distance of the second adjusting piece 22 relative to the first adjusting piece 21 and further controlling the moving distance of the second adjusting piece 22 pushing the suture 2.

The foregoing is a description of embodiments of the present invention, and it should be noted that, for those skilled in the art, modifications and variations can be made without departing from the principles of the embodiments of the present invention, and such modifications and variations are also considered to be within the scope of the present invention.

Claims

1. A quantitatively adjustable suture length adjustment system, characterized in that it comprises an adjustment component, wherein the adjustment component comprises:

A first adjusting member, provided with a first positioning portion, the first adjusting member being used to hook the suture; and

A second adjusting member is axially movably connected to the first adjusting member and is provided with a second positioning portion corresponding to the first positioning portion;

The suture is passed through the first adjusting member and the second adjusting member, and the second adjusting member moves axially toward the distal end relative to the first adjusting member to push the suture, thereby increasing the length of the suture between the first adjusting member and the second adjusting member until the first positioning portion is adapted to the second positioning portion, thereby limiting the relative movement between the second adjusting member and the first adjusting member.

2. The quantitatively adjustable suture length adjustment system as described in claim 1 is characterized in that the first adjusting member is hollow and has a first receiving cavity axially provided therein, and the first receiving cavity at least passes through the proximal surface of the first adjusting member; the second adjusting member is axially slidably inserted into the first receiving cavity from the proximal end of the first adjusting member.

3. The quantitatively adjustable suture length adjustment system according to claim 2, characterized in that the inner wall of the first receiving cavity is provided with a pair of guide sliding surfaces opposite to each other, the first positioning portion comprises at least one slot opened in at least one of the guide sliding surfaces, and the slot extends along the radial direction of the first adjusting member;

The second adjusting member includes a pair of outer wall surfaces corresponding one-to-one to the pair of guide sliding surfaces, and the second positioning portion includes an elastic hook arranged on at least one of the outer wall surfaces, and the elastic hook is inserted into a corresponding one of the slots to stop the relative movement between the second adjusting member and the first adjusting member.

4. The quantitatively adjustable suture length adjustment system as described in claim 3 is characterized in that the spacing direction of the pair of guide sliding surfaces is a first direction, a gap is provided between the inner wall of the first receiving cavity and the second adjusting member in a second direction, and the second direction is roughly perpendicular to the first direction.

5. The quantitatively adjustable suture length adjustment system as described in claim 3 is characterized in that the second adjusting member is hollow and has a second receiving cavity axially arranged therein, the second receiving cavity at least passes through the proximal surface of the second adjusting member, at least one of the outer wall surfaces of the second adjusting member has an opening in the proximal region that is connected to the second receiving cavity, and the elastic hook is arranged at the opening.

6. The quantitatively adjustable suture length adjustment system according to any one of claims 1 to 5 is characterized in that the suture length adjustment system also includes a conveying component, the distal end of the conveying component is detachably connected to the adjustment component, and the conveying component is used to convey the adjustment component and control the relative movement between the first adjustment member and the second adjustment member.

7. The quantitatively adjustable suture length adjustment system as described in claim 6 is characterized in that the conveying assembly includes a conveying member and at least one driving member; the distal end of the conveying member is detachably connected to the second adjusting member, for conveying the second adjusting member and limiting the axial position of the second adjusting member; the distal end of the driving member is detachably connected to the first adjusting member, for conveying the first adjusting member and driving the relative movement of the first adjusting member and the second adjusting member.

8. The quantitatively adjustable suture length adjustment system as described in claim 7 is characterized in that the conveying assembly also includes a release member detachably connected to the distal end of the conveying member, a first connecting portion is arranged at the proximal end of the second adjusting member, and a second connecting portion is arranged at the distal end of the release member, and the first connecting portion and the second connecting portion are detachably connected.

9. The quantitatively adjustable suture length adjustment system according to claim 8, characterized in that the conveying assembly further comprises an outer sheath and a first stopper connected to the distal end of the outer sheath, the first stopper has a stopper groove formed on the distal end surface, a first through hole extending axially is formed on the bottom surface of the stopper groove for the distal end of the conveying member to pass through, and the first stopper also has at least one second through hole extending axially on one side of the stopper groove for the distal end of at least one of the driving members to pass through;

The conveying member and at least one driving member are movably installed in the outer sheath tube;

The outer sheath drives the first limiting member to move axially, so that the connecting portion of the first connecting portion and the second connecting portion is accommodated in or moved out of the limiting groove, so as to realize the connection or separation of the second adjusting member and the releasing member.

10. The quantitatively adjustable suture length adjustment system according to claim 9 is characterized in that a radial gap is provided between the axis of the limiting groove and the axis of the first limiting member, and the limiting groove is eccentrically arranged at the distal end of the first limiting member.

11. The quantitatively adjustable suture length adjustment system as described in claim 10 is characterized in that the first limiting member is provided with a protrusion on the edge of the distal surface, and the protrusion extends circumferentially along the first limiting member; the first adjusting member moves axially proximally relative to the second adjusting member until it abuts against the distal surface of the first limiting member, and the protrusion surrounds the proximal end of the first adjusting member.

12. The quantitatively adjustable suture length adjustment system according to claim 11, characterized in that the outer wall of the first adjustment member is provided with a first slot connected to the first receiving cavity from the proximal end surface, and the convex rib is provided with a second slot corresponding to the first slot;

When the first adjusting member abuts against the distal end surface of the first limiting member, the first slot and the second slot together form a through hole.

13. The quantitatively adjustable suture length adjustment system according to claim 9, characterized in that the release member is provided with a third through hole axially penetrating and provided with an internal thread corresponding to the first through hole, the conveying member is threadedly connected to the release member and its distal end extends from the distal end of the release member;

The conveying assembly also includes a second limit member connected to the distal end of the conveying member, and the conveying member is also used to drive the second limit member to move axially toward the distal end until the second limit member is received in the second receiving cavity and corresponds to the position of the elastic hook to stop the elastic hook from bending toward the second receiving cavity.

14. The quantitatively adjustable suture length adjustment system as described in claim 7 is characterized in that the distal end of the driving member is provided with an external thread; the first adjusting member opens a threaded hole extending axially from the proximal surface on one side of the first receiving cavity, the number of the threaded holes corresponds to the number of the driving members, and the internal thread of the threaded hole is adapted to the external thread of the driving member.

15. The quantitatively adjustable suture length adjustment system according to claim 3, characterized in that the outer wall of the first adjustment member is provided with a first slot communicating with the first receiving cavity from the proximal end surface, and the first slot extends substantially along the axial direction of the first adjustment member;

The first slot and the locking slot are staggered in positions in the circumferential direction of the first adjusting member.

16. The quantitatively adjustable suture length adjustment system according to claim 15 is characterized in that a radial groove is formed on the distal end surface of the second adjustment member corresponding to the first groove, and two ends of the radial groove respectively pass through the outer wall of the second adjustment member.

17. The quantitatively adjustable suture length adjustment system according to claim 3 is characterized in that at least one hollow hole is formed on the outer wall of the first adjustment member, and an extension direction of the hollow hole is the same as or different from an extension direction of the slot.