Quantitatively adjustable suture length adjustment system

Abstract

The present invention provides a quantitatively adjustable suture length adjustment system, which includes an adjustment component. The adjustment component includes a first adjustment member and a second adjustment member that is axially movably connected to the first adjustment member. The first adjustment member is provided with a first positioning portion, and the second adjustment member is correspondingly provided with a second positioning portion for the first positioning portion. The suture is threaded between the first adjustment member and the second adjustment member. The second adjustment member moves axially relative to the first adjustment member towards the distal end to push against the suture, so that the length of the suture between the first adjustment member and the second adjustment member increases until the first positioning portion is adapted to the second positioning portion, thereby restricting the movement of the second adjustment member relative to the first adjustment member. This suture length adjustment system has a simple structure and convenient operation, can achieve quantitative adjustment of the suture length, and does not apply a fixed pressure to the suture during the adjustment process, which is beneficial to avoiding suture damage.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a suture length adjustment system with quantitative adjustment function. Background Art

[0002] Mitral insufficiency is one of the most common heart valve diseases nowadays. The main causes are rheumatic heart disease, mitral valve mucoid degeneration, cardiac ischemic disease, myocardial disease, etc., which lead to lesions in the mitral valve structure including the annulus, leaflets, chordae tendineae, and papillary muscles, and then cause the leaflets of the mitral valve to not fully close.

[0003] Surgical operation is an effective method for treating mitral insufficiency. However, due to the large trauma caused by the operation to the human body, for elderly patients and patients with multiple complications, there are more complications and a higher mortality rate.

[0004] Now, minimally invasive interventional surgery is a better choice for most heart diseases. The main interventional treatment methods include artificial chordae tendineae implantation, mitral annuloplasty, and mitral edge-to-edge repair. Among them, implanting artificial chordae tendineae on the leaflets can effectively treat mitral insufficiency caused by chordae tendineae rupture, leaflet prolapse, etc., while maintaining the physiological integrity of the mitral valve structure. However, after implanting artificial chordae tendineae for a period of time, due to changes in factors such as cardiac volume, the implanted artificial chordae tendineae will be in a relaxed state, and it is often necessary to adjust the length of the artificial chordae tendineae again to shorten the effective length of the artificial chordae tendineae to avoid abnormal heart valve function.

[0005] In the prior art, an artificial chordae tendineae length adjustment device is disclosed. First, a hook is used to capture the artificial chordae tendineae, the artificial chordae tendineae is stretched by an instrument, the adjustment length is determined by the stretching amount, and then the artificial chordae tendineae is fixed by two positioning clips to achieve the adjustment effect. The main defects of this technology are: 1. The adjustment instrument is too complex and the operation difficulty is large; 2. The squeezing force of the clips is likely to damage the artificial chordae tendineae; 3. Quantitative adjustment cannot be performed and the adjustment amount is unstable. These problems will all lead to the risk of surgical failure or ineffective adjustment in the adjustment of artificial chordae tendineae. Summary of the Invention

[0006] To solve the above technical problems, the present invention provides a suture length adjustment system with quantitative adjustment function, which has a simple structure and is easy to operate, can realize quantitative adjustment of the suture length, and can avoid damage to the suture during the adjustment process.

[0007] The quantitatively adjustable suture length adjustment system provided by the present invention includes an adjustment assembly. The adjustment assembly includes a first adjustment member and a second adjustment member axially movably connected to the first adjustment member. The first adjustment member is provided with a first positioning portion, and the second adjustment member is correspondingly provided with a second positioning portion corresponding to the first positioning portion. The suture is threaded between the first adjustment member and the second adjustment member. The second adjustment member moves axially towards the distal end relative to the first adjustment member to push against the suture, so that the length of the suture between the first adjustment member and the second adjustment member increases until the first positioning portion and the second positioning portion are adapted, thereby restricting the relative movement between the second adjustment member and the first adjustment member.

[0008] After the suture is threaded between the first adjustment member and the second adjustment member in the quantitatively adjustable suture length adjustment system provided by the present invention, the second adjustment member moves axially towards the distal end relative to the first adjustment member to push against the suture, thereby increasing the length of the suture between the first adjustment member and the second adjustment member to adjust the suture. By controlling the amount of movement of the second adjustment member relative to the first adjustment member, quantitative adjustment of the suture length can be achieved. The structure of the entire system is simple and the operation is convenient. Furthermore, during the process of adjusting the suture, the second adjustment member does not apply a fixed pressure to the suture, which is beneficial to avoiding suture damage. In addition, after the quantitative adjustment of the suture is completed, the cooperation of the first positioning portion and the second positioning portion can restrict the relative movement of the second adjustment member relative to the first adjustment member, thereby preventing the suture from loosening. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the implementation will be briefly introduced below. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0010] Figure 1 is an overall structural schematic diagram of a quantitatively adjustable suture length adjustment system provided by one embodiment of the present invention.

[0011] Figure 2 is Figure 1 a three-dimensional structural schematic diagram of the adjustment assembly and the delivery assembly shown.

[0012] Figure 3 is Figure 2 a partial axial sectional view of the adjustment assembly and the delivery assembly shown, wherein the second limiting member is received in the second receiving cavity and corresponds to the position of the second positioning portion.

[0013] Figure 4 is Figure 3Schematic diagram when the second adjusting member shown moves axially towards the distal end relative to the first adjusting member until the first positioning portion and the second positioning portion are engaged.

[0014] Figure 5 is Figure 4 Schematic diagram showing a suture being pushed through between the first adjusting member and the second adjusting member shown.

[0015] Figure 6 is Figure 4 Schematic perspective view of the adjusting assembly shown.

[0016] Figure 7 is Figure 6 Axial sectional view of the adjusting assembly shown.

[0017] Figure 8 is Figure 6 Schematic perspective view of the first adjusting member shown.

[0018] Figure 9 is Figure 8 Front view of the proximal end of the first adjusting member shown.

[0019] Figure 10 is Figure 6 Schematic diagram of the second adjusting member shown.

[0020] Figure 11 is Figure 10 Right side view of the second adjusting member shown.

[0021] Figure 12 is Figure 3 Schematic diagram of the release member shown.

[0022] Figure 13 is Figure 12 Axial sectional view of the release member shown.

[0023] Figure 14 is Figure 12 Front view of the distal end of the release member shown.

[0024] Figure 15 is Figure 3 Schematic perspective view of the first limiting member shown.

[0025] Figure 16 is Figure 15 Axial sectional view of the first limiting member shown.

[0026] Figure 17 is Figure 15 Front view of the distal end of the first limiting member shown.

[0027] Figure 18 is Figure 3Schematic three-dimensional structure diagram of the connecting shaft shown

[0028] Figure 19 is Figure 3 Schematic three-dimensional structure diagram of the connecting shaft, release member, second limiting member and connecting piece shown

[0029] Figure 20 is Figure 19 Axial sectional view of the connecting shaft, release member, second limiting member and connecting piece shown

[0030] Figures 21 to 23 Schematic diagram of the usage process of the quantitatively adjustable suture length adjustment system provided by the present invention Specific embodiments

[0031] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention

[0032] In addition, the descriptions of the following embodiments refer to the attached drawings for illustrating specific embodiments in which the present invention can be implemented. The directional terms mentioned in the present invention, for example, "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., are only the directions of the attached drawings. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus cannot be construed as a limitation of the present invention

[0033] It should be noted that in order to more clearly describe the structure of the quantitatively adjustable suture length adjustment system, the defined terms "proximal end" and "distal end" in the description of the present invention are common terms in the field of interventional medicine. Specifically, the "distal end" represents the end far from the operator during the surgical operation, and the "proximal end" represents the end close to the operator during the surgical operation; the direction of the rotation central axis of objects such as cylinders and tubes is defined as the axial direction; the circumferential direction is the direction around the axis of objects such as cylinders and tubes (perpendicular to the axis and perpendicular to the section radius at the same time); the radial direction is the direction along the diameter or radius. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly understood by those skilled in the technical field to which the present invention belongs. The common terms used in the description of the present invention are only for the purpose of describing specific embodiments and cannot be construed as a limitation of the present invention

[0034] Please refer to together Figures 1 to 5, the present invention provides a quantitatively adjustable suture length adjustment system 1, which includes an adjustment assembly 20. The adjustment assembly 20 includes a first adjustment member 21 and a second adjustment member 22 movably connected to the first adjustment member 21 axially. Among them, the first adjustment member 21 is provided with a first positioning portion 211, and the second adjustment member 22 is correspondingly provided with a second positioning portion 221 opposite to the first positioning portion 211. The suture 2 is threaded between the first adjustment member 21 and the second adjustment member 22. The second adjustment member 22 moves axially distally relative to the first adjustment member 21 to push against the suture 2, so that the length of the suture 2 between the first adjustment member 21 and the second adjustment member 22 increases until the first positioning portion 211 and the second positioning portion 221 are adapted, thereby restricting the relative movement between the second adjustment member 22 and the first adjustment member 21. It can be understood that when the second adjustment member 22 moves axially distally relative to the first adjustment member 21 by different distances, the distance by which the suture 2 is pushed is also different, and thus the length of the suture 2 to be adjusted is different. Specifically, as Figure 5 shown, after the suture 2 is pushed by the second adjustment member 22, the suture 2 between the first adjustment member 21 and the second adjustment member 22 is bent into an inverted U shape or a "ji" shape. The adjusted length H of the suture 2 is approximately equal to twice the length h of the suture 2 on each side along the radial direction of the first adjustment member 21 of the second adjustment member 2. That is, H and h satisfy the relationship: H = 2h. Among them, the length h of the suture 2 on each side along the radial direction of the first adjustment member 21 of the second adjustment member 2 is the distance by which the second adjustment member 22 moves axially distally relative to the first adjustment member 21. Therefore, by controlling the moving amount of the second adjustment member 22 relative to the first adjustment member 21, the quantitative adjustment of the length of the suture 2 can be achieved.

[0035] For the quantitatively adjustable suture length adjustment system 1 provided by the present invention, after the suture 2 is threaded between the first adjustment member 21 and the second adjustment member 22, the second adjustment member 22 moves axially distally relative to the first adjustment member 21 to push against the suture 2, thereby increasing the length of the suture 2 between the first adjustment member 21 and the second adjustment member 22 to adjust the suture 2. And by controlling the moving amount of the second adjustment member 22 relative to the first adjustment member 21, the quantitative adjustment of the length of the suture 2 can be achieved. The structure of the whole system is simple and the operation is convenient. Moreover, during the process of adjusting the suture 2, the second adjustment member 22 does not apply a fixed pressure to the suture 2, which is beneficial to avoiding damage to the suture 2. In addition, after the quantitative adjustment of the suture 2 is completed, the cooperation of the first positioning portion 211 and the second positioning portion 221 can restrict the movement of the second adjustment member 22 relative to the first adjustment member 21, thereby preventing the suture 2 from loosening.

[0036] It should be noted that the suture 2 can be a suture serving as an artificial chordae tendineae, such as an e-PTFE suture or a PET suture. 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 chordae tendineae. After the quantitative adjustment of the suture 2 is completed, the adjusting assembly 20 is clamped on the suture 2 and left in the human body as an implant. To ensure implant safety, the first adjusting member 21 and the second adjusting member 22 can be made of a metal material or a polymer material with good biocompatibility, such as stainless steel or PEEK. The materials of the first adjusting member 21 and the second adjusting member 22 can be the same or different.

[0037] As Figure 1 shown, the suture length adjusting system 1 further includes a delivery assembly 40 connected to the proximal end of the adjusting assembly 20 and a handle assembly 60 connected to the proximal end of the delivery assembly 40. Among them, the delivery assembly 40 is used to deliver the adjusting assembly 20 into the human body and control the relative movement between the first adjusting member 21 and the second adjusting member 22, and the handle assembly 60 is used for the operator to control the delivery assembly 40 outside the body.

[0038] Specifically, please refer to Figures 6 to 8 together. The first adjusting member 21 is a hollow and generally cylindrical body, which is provided with a first receiving cavity 212 extending along the axial direction. The first receiving cavity 212 at least penetrates the proximal end face of the first adjusting member 21, so that the second adjusting member 22 can be slidably inserted into the first receiving cavity 212 along the axial direction from the proximal end of the first adjusting member 21. Preferably, in this embodiment, the first receiving cavity 212 penetrates the distal end face of the first adjusting member 21 together, which is beneficial to reducing the weight of the first adjusting member 21; furthermore, the first receiving cavity 212 penetrates the distal end face of the first adjusting member 21, so that the second adjusting member 22 can move axially relative to the first adjusting member 21 to the distal end 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 relative to the first adjusting member 21, and further increases the length H of the suture 2 to be adjusted. Of course, in other embodiments, the first receiving cavity 212 may not penetrate the distal end face 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.

[0039] It should be noted that the inner contour of the first receiving cavity 212 is substantially the same as the outer contour of the second adjusting member 22, so that the second adjusting member 22 can be movably received in the first receiving cavity 212.

[0040] Please refer to Figures 7 to 10, on the inner wall of the first receiving cavity 212, a pair of guiding surfaces 213 are oppositely arranged. The first positioning portion 211 includes at least one clamping groove opened on at least one guiding surface 213, and the clamping groove extends along the approximate 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 guiding surfaces 213 one by one, and the second positioning portion 221 includes elastic hooks arranged on at least one outer wall surface 222. The elastic hooks are snapped into the corresponding clamping grooves to stop the relative movement between the second adjusting member 22 and the first adjusting member 21. Preferably, in this embodiment, both the guiding surface 213 and its corresponding outer wall surface 222 are arc surfaces. When the second adjusting member 22 moves axially in the first receiving cavity 212, the sliding contact between the guiding surface 213 and the outer wall surface 222 is smoother. Of course, in other embodiments, both the guiding surface 213 and its corresponding outer wall surface 222 can also be flat surfaces.

[0041] In this embodiment, the pair of guiding surfaces 213 are both provided with the clamping grooves, and the pair of outer wall surfaces 222 are both provided with the elastic hooks. Thus, the relative movement between the first adjusting member 21 and the second adjusting member 22 can be restricted by the elastic hooks on the relative two sides of the second adjusting member 22 being snapped into the corresponding clamping grooves, and the reliability is higher.

[0042] Among them, in the pair of guiding surfaces 213, the clamping grooves on one guiding surface 213 may or may not correspond to the clamping grooves on the other guiding surface 213, that is, the position of the clamping groove on one guiding surface 213 in the axial direction of the first adjusting member 21 is the same as or different from the position of the clamping groove on the other guiding surface 213 in the axial direction of the first adjusting member 21. In this embodiment, the positions of the respective clamping grooves of the pair of guiding surfaces 213 correspond to each other.

[0043] In this embodiment, the card slot on each guiding sliding surface 213 is provided with one. It can be understood that when the card slot on each guiding sliding surface 213 is provided with one, the elastic hook on the outer wall surface 222 corresponding to the guiding sliding surface 213 can only be inserted into this one card slot to limit the relative movement between the first adjusting member 21 and the second adjusting member 22. That is to say, the distance that the second adjusting member 22 moves axially relative to the first adjusting member 21 towards the distal end is a fixed value, and the length H of the suture 2 that can be quantitatively adjusted is unique. Optionally, in other embodiments, the card slots on each guiding sliding surface 213 can be provided with multiple (i.e., two or more). The multiple card slots are distributed on the guiding sliding surface 213 along the axial direction of the first adjusting member 21. The elastic hook on the outer wall surface 212 corresponding to the guiding sliding surface 213 provided with the multiple card slots can be inserted into one of the card slots at different axial positions of the first adjusting member 21. Thus, there are multiple distance values for the second adjusting member 22 to move axially relative to the first adjusting member 21 towards the distal end, and further there are multiple values for the length H of the suture 2 that can be quantitatively adjusted, which is beneficial to enhancing the application range of the suture length adjustment system 1. Moreover, providing multiple card slots is also beneficial to reducing the weight of the first adjusting member 21.

[0044] Among them, each of the card slots can extend along the radial direction of the first adjusting member 21 to penetrate or not penetrate the outer wall of the first adjusting member 21. Preferably, it penetrates the outer wall of the first adjusting member 21, which is beneficial to further reducing the weight of the first adjusting member 21.

[0045] It should be noted that in this embodiment, the interval direction of the pair of guiding sliding surfaces 213 is defined as the first direction. A gap is provided between the inner wall of the first receiving cavity 212 and the second adjusting member 22 in a second direction that is substantially perpendicular to the first direction. The gap is used to receive the suture 2 located between the inner wall of the first receiving cavity 212 and the second adjusting member 22 to avoid squeezing and damaging the suture 2. Specifically, please refer to Figure 5 、 Figure 6 and Figure 9In this embodiment, the inner wall of each side of the first receiving cavity 212 in the second direction is respectively provided with a groove that axially penetrates the first adjusting member 21, and the depth of the groove (i.e., the dimension along the second direction) is not less than the diameter of the suture 2. When the second adjusting member 22 is received in the first receiving cavity 212 and pushes the suture 2, the suture 2 between the outer wall of the second adjusting member 22 and the inner wall of the first receiving cavity 212 is received in the groove, thereby avoiding squeezing and damaging the suture 2. In other embodiments, the groove may also be provided on the 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 receiving cavity 212 in the second direction and the outer wall of each side of the second adjusting member 22 in the second direction may be respectively provided with a groove to receive the suture 2 between the outer wall of the second adjusting member 22 and the inner wall of the first receiving cavity 212, thereby avoiding squeezing and damaging the suture 2.

[0046] like Figure 8 As shown, in this embodiment, the outer wall of the first adjusting member 21 is provided with a first slot 214 connected to the first receiving cavity 212 from the proximal end surface. The first slot 214 extends approximately along the axial direction of the first adjusting member 21, and the first slot 214 and the slot on the inner wall of the first receiving cavity 212 are staggered in the circumferential direction of the first adjusting member 21. The first slot 214 is used for the suture 2 to pass in and out. When the second adjusting member 22 pushes the suture 2, the first slot 214 can prevent the suture 2 from moving radially along the first adjusting member 21, thereby preventing the suture 2 from detaching from between the first adjusting member 21 and the second adjusting member 22. Optionally, as Figure 6 and Figure 7 As shown, in this embodiment, at least one hollow hole 216 is further provided on the outer wall of the first adjusting member 21 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 slot of the first adjusting member 21, and each hollow hole 216 may be connected to or not connected with the first receiving cavity 212. In this embodiment, each hollow hole 216 has the same extending direction as the clamping slot and is connected to the first receiving cavity 212, so that the hollow hole 216 can also play the role of the clamping slot.

[0047] For further information, please also refer to Figure 3 , Figure 7 and Figure 8, in this embodiment, at least one threaded hole extending axially is formed on one side of the first receiving cavity 212 from the proximal end surface of the first adjusting member 21 for detachably connecting to the distal end of the driving rod 45 in the conveying assembly 40. The driving rod 45 is used to convey the first adjusting member 21, and its axial movement can drive the first adjusting member 21 to move axially, thereby driving the relative axial movement between the first adjusting member 21 and the second adjusting member 22 to realize the hooking and pushing of the suture 2, and further realize the quantitative adjustment of the length of the suture 2; furthermore, after the quantitative adjustment of the length of the suture 2 is completed, the driving rod 45 can be detached and separated from the first adjusting member 21, so that the first adjusting member 21 remains in the human body.

[0048] Please refer to Figure 7 , Figure 10 and Figure 11 , the second adjusting member 22 is a hollow and generally block-shaped body, which is provided with a second receiving cavity 223 extending axially. The second receiving cavity 223 at least penetrates the proximal end surface of the second adjusting member 22, and at least one outer wall surface 222 of the second adjusting member 22 is provided with an opening 224 communicating with the second receiving cavity 223 at the proximal region, and the second positioning portion 221 (i.e., the elastic hook) is provided at the opening 224. In this embodiment, openings 224 are respectively formed on two outer wall surfaces 222 on opposite sides of the second adjusting member 22, and each opening 224 is provided with one of the elastic hooks.

[0049] Specifically, as Figure 11As shown, in this embodiment, the elastic hook includes a spring piece and a buckle connected to the proximal end of the spring piece. The distal end of the spring piece is connected to the distal edge of the opening 224. The buckle includes a stop surface facing the proximal end of the second adjusting member 22 and an inclined plane facing the outside of the second adjusting member 22 and also facing the distal end of the second adjusting member 22. Among them, the spring piece is made of an elastic material to ensure its ability of elastic deformation. 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 relative to the first adjusting member 21 towards the distal end, the elastic hook first abuts against the proximal end face of the first adjusting member 21. At this time, the inner wall of the proximal port edge of the first receiving cavity 212 will push against the inclined plane of the buckle, forcing the proximal end of the spring piece to bend towards the inside of the second receiving cavity 223, so that the second adjusting member 22 can move axially relative to the first adjusting member 21 towards the distal end until the elastic hook is received in the first receiving cavity 212; when the second adjusting member 22 continues to move axially relative to the first adjusting member 21 towards the distal end until the buckle corresponds to the position of the slot of the first adjusting member 21, the inner wall of the first receiving cavity 212 no longer pushes against the buckle, and the spring piece restores its deformation to make the buckle snap into the corresponding slot; it can be understood that under the reaction force of the pushed suture 2, the second adjusting member 22 has a tendency to move axially relative to the first adjusting member 21 towards the proximal end, and the stop surface of the buckle abuts against the slot surface of the slot, which can limit the axial movement of the second adjusting member 22 relative to the first adjusting member 21 towards the proximal end, thereby preventing the suture 2 from loosening.

[0050] As Figure 10 shown, in this embodiment, a radial groove 225 is provided on the distal end face of the second adjusting member 22 corresponding to the first slot 214 of the first adjusting member 21. Both ends of the radial groove 225 penetrate the outer wall of the second adjusting member 22. The radial groove 225 is used to accommodate and pass the suture 2 located at the distal end of the second adjusting member 22. Preferably, the radial groove 225 is rounded to ensure the smoothness of the radial groove 225 and avoid damaging the suture 2.

[0051] Furthermore, please refer to Figure 3 , Figure 6 and Figure 10, in this embodiment, a first connection portion 226 is provided at the proximal end of the second adjusting member 22 for detachably connecting to the distal end of a conveying member 43 in the conveying assembly 40. The conveying member 43 is used to convey the second adjusting member 22 and to fix the axial position of the second adjusting member 22 when the driving rod 45 drives the first adjusting member 21 to move axially, so that relative axial movement can occur between the first adjusting member 21 and the second adjusting member 22 to achieve hooking and pushing of the suture 2, thereby realizing quantitative adjustment of the length of the suture 2; furthermore, after the quantitative adjustment of the length of the suture 2 is completed, the conveying member 43 can be detachably separated from the second adjusting member 22, so that the second adjusting member 22 can be left in the human body together with the first adjusting member 21.

[0052] Specifically, as Figure 6 shown, in this embodiment, the first connection portion 226 is a pair of first barbs provided 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 connection portion 226 is located outside the distal end of the first adjusting member 21.

[0053] Please refer to Figure 3 , the conveying assembly 40 includes the aforementioned conveying member 43 and driving member 45. The conveying member 43 and the driving member 45 are flexible rods or flexible tubes or flexible steel cables having a certain axial length, certain supportability and bendability, and are both made of metal materials or polymer materials with good biocompatibility, preferably metal materials 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, and an external thread adapted to the internal thread of the threaded hole of the first adjusting member 21 is provided at the distal end of the driving rod 45. The driving rod 45 is threadedly connected to the first adjusting member 21.

[0054] Among them, the number of driving rods 45 is equal to the number of the threaded holes. In this embodiment, a pair of the threaded holes are provided in the first adjusting member 21, and the driving rods 45 are correspondingly provided as two. Driving the first adjusting member 21 to move axially by a pair of driving rods 45 is beneficial to improving the smoothness of the axial movement of the first adjusting member 21 and can prevent the first adjusting member 21 from rotating during the movement.

[0055] Please refer to Figure 3 , Figures 12 to 14 , in this embodiment, the conveying assembly 40 further includes a release member 47 detachably connected to the distal end of the conveying member 43. The release member 47 is used to detachably connect to the second adjusting member 22. That is to say, in this embodiment, the distal end of the conveying member 43 is detachably connected to the second adjusting member 22 through the release member 47.

[0056] Specifically, asFigures 12 to 14 As shown, in this embodiment, the release member 47 is generally a block-shaped structure, which includes a stopper 472 at the distal end, an embedded portion 474 connected to the distal end of the stopper 472, and a pair of second barbs arranged at the distal end of the stopper 472, the pair of second barbs are respectively located on opposite sides of the embedded portion 474, and the pair of second barbs are used to be detachably connected with the pair of first barbs at the proximal end of the second adjustment member 22. Among them, each of the second barbs has a second bonding surface adapted to the first bonding surface of the first barb, and the first bonding surface and the second bonding surface are both S-shaped surfaces with a certain curvature, and the curvatures of the two are adapted. It can be understood that the axial movement of the conveying member 43 can drive the release member 47 to move axially relative to the second adjustment member 22, so that the second connection portion 476 and the first connection portion 226 can be detachably connected or separated. 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. It should be noted that, in this embodiment, when the first barb and the second barb are in a connected state, the stopper 472 of the release member 47 stops at the proximal end of the first barb, and the embedding portion 474 of the release member 47 is embedded between the pair of first barbs.

[0057] The release member 47 is also made of metal material or polymer material with good biocompatibility, preferably metal material such as stainless steel.

[0058] For further information, please also refer to Figure 2 , Figure 3 and Figures 15 to 17 In this embodiment, the delivery assembly 40 further includes an outer sheath 49 and a first stopper 41 connected to the 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. The first stopper 41 is used to limit the separation of the first connection portion 226 of the second adjustment member 22 and the second connection portion 476 of the release member 47. The outer sheath 49 and the first stopper 41 can be made of metal materials or polymer materials with good biocompatibility, preferably metal materials such as stainless steel.

[0059] Specifically, Figure 2 and Figure 3 As shown, in this embodiment, the first stopper 41 includes a main body 414 of a columnar structure and a sleeve portion 415 connected to the proximal end of the main body 414, the sleeve portion 415 is a hollow cylindrical body, and the distal end of the outer sheath 49 is fixedly connected to the sleeve portion 415 of the first stopper 41 by any means such as snap-fitting, bonding or welding. Among them, the main body 414 and the sleeve portion 415 can be integrally formed, or they can be separately formed and fixedly connected by any means such as laser welding, bonding, snap-fitting, etc., preferably laser welding.

[0060] Please refer to Figure 3 , Figure 16 and Figure 17 , a limiting groove 410 is formed in the distal end surface of the main body portion 414. A first through hole 411 extending axially is formed in the bottom surface of the limiting groove 410 for the distal end of the conveying member 43 to pass through. At least one second through hole 412 extending axially is further formed in one side of the limiting groove 410 of the main body portion 414 for the distal end of at least one driving member 45 to pass through. In this embodiment, the number of the second through holes 412 and the number of the driving members 45 are both set to two.

[0061] Wherein, there is a radial distance between the axis of the limiting groove 410 and the axis of the first limiting member 41, that is, the limiting groove 410 is eccentrically arranged at the distal end of the main body portion 414 of the first limiting member 41. It should be noted that in this embodiment, the shape of the limiting groove 410 is adapted to the shape of the releasing member 47. When the axial movement of the outer sheath 49 drives the first limiting member 41 to move axially, so that the connecting portion of the first connecting portion 226 of the second adjusting member 22 and the second connecting portion 476 of the releasing member 47 is received in or removed from the limiting groove 410, the connection or separation of the first connecting portion 226 and the second connecting portion 476 can be realized, that is, the connection or separation of the second adjusting member 22 and the releasing member 47 can be realized.

[0062] As Figure 16 shown, in this embodiment, a convex rib 416 is further protruded at the edge of the distal end surface of the main body portion 414. The convex rib 416 extends along the circumferential direction of the first limiting member 41. Preferably, the convex rib 416 extends around the circumferential direction of the first limiting member 41. As Figure 3As shown, in this embodiment, under the drive of the drive rod 45, the first adjusting member 21 moves proximally along the axis relative to the second adjusting member 22 until it abuts against the distal end surface of the main body portion 414 of the first limiting member 41. It can be understood that the convex rib 416 has a certain height along the axis of the first limiting member 41. After the suture 2 is passed through the first slot 14 of the first adjusting member 21, during the process of the first adjusting member 21 moving proximally along the axis relative to the second adjusting member 22, the proximal end portion of the first adjusting member 21 will gradually penetrate into the space formed by the surrounding of the convex rib 416 until the proximal end surface of the first adjusting member 21 abuts against the distal end surface of the main body portion 414, which also means that the convex rib 416 can gradually surround the proximal end portion of the first adjusting member 21 extending a certain distance from the proximal end surface to the distal end surface. Thus, the gap between the proximal end surface of the first adjusting member 21 and the distal end surface of the main body portion 414 before the first adjusting member 21 abuts against the main body portion 414 can be enclosed, preventing the gap from catching human tissues and avoiding damage to human tissues. Preferably, in this embodiment, the convex rib 416 is provided with a second slot 417 corresponding to the first slot 214 of the first adjusting member 21. Thus, when the first adjusting member 21 abuts against the distal end surface of the main body portion 414, the first slot 214 and the second slot 417 together form a through hole to accommodate the suture 2 hooked by the first adjusting member 21.

[0063] Further, please refer to Figure 3 , to prevent the second adjusting member 22 from moving distally along the axis relative to the first adjusting member 21 and being received in the first receiving cavity 212 prematurely when there is no suture 2 in the first slot 214 (i.e., the first adjusting member 21 does not hook the suture 2) and the elastic hook is caught in the corresponding card slot, in this embodiment, the conveying assembly 40 further includes a second limiting member 42 connected to the distal end of the conveying member 43. The conveying member 43 is further configured to drive the second limiting member 42 to move distally along the axis 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 towards the inside of the second receiving cavity 223, so that when the second adjusting member 22 moves distally along the axis relative to the first adjusting member 21, the elastic hook can be blocked at the proximal port of the first receiving cavity 212, thereby preventing the second adjusting member 22 from being received in the first receiving cavity 212 prematurely.

[0064] Specifically, please refer to Figure 3 , Figure 13 and Figures 18 to 20 , in this embodiment, a connecting shaft 46 is fixedly provided at the distal end of the conveying member 43. The releasing member 47 is further provided with a third through hole 478 that penetrates axially and is provided with internal threads corresponding to the first through hole 411 of the first limiting member 41 (as Figure 13As shown), the distal end of the conveying member 43 is threadedly connected to the release member 47 through the connecting shaft 46, and the distal end of the connecting shaft 46 extends out from the distal end of the release member 47, and the second limiting member 42 is fixedly disposed at the distal end of the connecting shaft 46.

[0065] like Figure 18 As shown, in this embodiment, the connecting shaft 46 includes a proximal shaft section 462, an intermediate shaft section 464 and a distal shaft section 466 which are sequentially connected from the proximal end to the distal end, and the diameters of the three are successively reduced, wherein the proximal shaft section 462 is provided with a through hole along the axial direction from the proximal end surface for connecting the distal end of the conveying member 43, and the intermediate shaft section 464 is provided with an external thread adapted to the internal thread of the third through hole 478 of the release member 47. Figure 19 and Figure 20 As shown in , in this embodiment, the second stopper 42 is a block-shaped gasket with a connection hole, the second stopper 42 is sleeved on the distal shaft section 466 of the connecting shaft 46, and the proximal surface of the second stopper 42 abuts against the shoulder between the intermediate shaft section 464 and the distal shaft section 466 of the connecting shaft 46, the outer contour of the second stopper 42 is adapted to the inner contour of the second receiving cavity 223, and is convenient for being inserted into the proximal end of the second receiving cavity 223 to stop the elastic hook. In this embodiment, a connecting piece 48 is further provided at the distal end of the second stopper 42, 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 stopper 42, and the connecting piece 48 is fixedly connected to the connecting shaft 46, thereby fixing the second stopper 42 on the connecting shaft 46. In other embodiments, the second stopper 42 can be directly fixedly connected to the connecting shaft 46, and the connecting shaft 46 can be integrated with the conveying member 43. Among them, the second stopper 42, the connecting shaft 46 and the connecting piece 48 can be made of metal materials or polymer materials with good biocompatibility, preferably metal materials 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 can be connected by any method such as laser welding, bonding, clamping, interference, etc., preferably laser welding.

[0066] Please also read Figure 3 and Figure 4, in this embodiment, after the second connecting portion 476 of the release member 47 is adapted to the first connecting portion 226 of the second adjusting member 22, it is placed in the limiting groove 410 of the first limiting member 41. When the rotating conveying member 43 rotates, the rotation of the conveying member 43 drives the connecting shaft 46 to rotate. Under the limiting action of the limiting groove 410, the release member 47 does not rotate, causing the connecting shaft 46 and the release member 47 to perform a threaded movement, and the connecting shaft 46 moves axially relative to the release member 47 and drives the second limiting member 42 to perform an axial movement. Thus, when the second limiting member 42 moves distally to be received in the proximal end of the second receiving 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 the side of the elastic hook facing the second receiving cavity 223, restricting the elastic hook from bending and deforming towards the second receiving cavity 223. When the first adjusting member 21 moves proximally driven by the driving member 45, the proximal end opening of the first receiving cavity 212 of the first adjusting member 21 presses the inclined plane of the elastic hook. At this time, since the elastic hook is abutted by the second limiting member 42 and cannot elastically deform, the elastic hook cannot be inserted into the card slot of the first adjusting member 21, and the second adjusting member 22 cannot be completely received in the first receiving cavity 212; when the control conveying member 43 drives the second limiting member 42 to move proximally to leave the inner cavity of the second receiving cavity 223 of the second adjusting member 22, then the elastic hook of the second adjusting member 22 resumes the ability of elastic deformation. At this time, if the first adjusting member 21 continues to move proximally, the proximal end opening portion of the first receiving cavity 2122 of the first adjusting member 21 presses the inclined plane of the elastic hook, and the elastic hook bends towards the second receiving cavity 223. The first adjusting member 21 can move proximally relative to the second adjusting member 22, so that the second adjusting member 22 is completely received in the first receiving cavity 212 until the elastic hook is inserted into the corresponding card slot, thereby restricting the axial movement between the first adjusting member 21 and the second adjusting member 22, and locking the first adjusting member 21 and the second adjusting member 22 together.

[0067] Please refer to Figure 1 , in this embodiment, to facilitate the operator to manipulate the conveying assembly 40 outside the body, the suture length adjusting system 1 that can be quantitatively adjusted further includes a handle assembly 60 connected to the proximal end of the conveying assembly 40. Specifically, as Figure 1 shown, 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 outer sheath tube 49. The first knob 61 is arranged at the proximal end of the housing 64, the second knob 62 is arranged in the middle of the housing 64, and the third housing 63 is arranged at the distal end of the housing 64.

[0068] As Figure 2As shown, in this embodiment, the proximal ends of the conveying member 43 and the driving member 45 respectively extend out from the proximal end of the outer sheath tube 49 and extend into the housing 64, and then are connected to the corresponding knobs. Specifically, in this embodiment, the first knob 61 is connected to the proximal end of the driving member 45 and is used to control the axial movement of the driving member 45, 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 and is used to control the rotation of the driving member 45, so as to realize the separation of the driving member 45 from the first adjusting member 21; the third knob 63 is connected to the proximal end of the conveying member 43 and is used to control the axial movement of the conveying member 43 and to control the rotation of the conveying member 43 to drive the second limiting member 42 to move axially. It should be noted that the connections 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 realized by existing technical means, which will not be elaborated here.

[0069] Please refer to Figure 3 , Figure 4 and Figures 21 to 23 below. Taking the suture 2 as an artificial chordae tendineae implanted into the human body as an example, the usage process of the suture length adjustment system 1 provided in this embodiment will be described in conjunction with the accompanying drawings.

[0070] The first step: As Figure 21 shown, the adjustment assembly 20 at the distal end of the suture length adjustment system 1 is conveyed to the vicinity of the suture 2 serving as an artificial chordae tendineae through a guiding device such as an adjustable bending sheath tube or a pre-shaped catheter (not shown in the figure).

[0071] The second step: As Figure 22 shown, the first knob 61 of the handle assembly 60 is used to control the driving member 45 to move axially towards the distal end, and the driving member 45 drives the first adjusting member 21 to move towards the distal end, so that the first adjusting member 21 opens relative to the second adjusting member 22 and hooks the suture 2. At this time, the suture 2 is threaded through the first slot 214 of the first adjusting member 2.

[0072] The third step: Observe whether the first adjusting member 21 successfully hooks the suture 2 through a medical imaging device. After observing that the suture 2 is successfully hooked, the third knob 63 of the handle assembly 60 is used to control the rotation of the conveying member 43. The conveying member 43 rotates relative to the release member 47 to drive the second limiting member 42 to move proximally until it moves out of the proximal end of the second receiving cavity 223 of the second adjusting member 22, so that the second limiting member 42 does not limit the deformation ability of the elastic hook.

[0073] The fourth step: As Figure 4 and Figure 23As shown, the first knob 61 is further used to control the driving member 45 to move proximally along the axis to drive the first adjusting member 21 to move proximally, so that the second adjusting member 22 is received in the first receiving cavity 212. The distal end of the second adjusting member 22 pushes against the suture 2, causing the suture 2 to bend into an inverted U shape, completing the adjustment of the suture 2, that is, reducing the effective length of the artificial chordae tendineae, so that the originally loose artificial chordae tendineae are tensioned again after adjustment. At this time, the elastic hook of the second adjusting member 22 snaps into the card slot of the first adjusting member 21, thereby restricting the axial movement between the first adjusting member 21 and the second adjusting member 22 and preventing the adjusted suture 2 from loosening.

[0074] Step 5: The second knob 62 of the handle assembly 60 is used to control the driving member 45 to rotate to release the connection between the driving member 45 and the first adjusting member 21, so that the first adjusting member 21 is separated from the driving member 45; then the third knob 63 is used to control the conveying member 43 to move distally along the axis, and the conveying member 43 drives the releasing member 47 to move distally until it moves out of the limiting groove 410 of the first limiting member 41 to release the connection between the first connecting portion 216 of the second adjusting member 22 and the second connecting portion 476 of the releasing member 47, so that the second adjusting member 22 is separated from the releasing member 47. At this time, the adjusting assembly 20 is completely released from the conveying assembly 60.

[0075] Step 6: The conveying assembly 60 and the guiding device are withdrawn from the human body, and the adjusting assembly 20 is left in the patient's body as an implant and connected to the suture 2, completing the adjustment of the suture 2.

[0076] During the adjustment process of the suture 2, only the corresponding knob needs to be rotated to adjust the effective length of the suture 2, which is convenient to operate and saves time; furthermore, the second adjusting member 22 adjusts the suture 2 through a pushing action, with almost no damage to the suture 2, and the instrument has high safety; in addition, by controlling the moving amount of the second adjusting member 22 relative to the first adjusting member 21, and then controlling the moving distance of the second adjusting member 22 pushing against the suture 2, quantitative adjustment of the length of the suture 2 can be achieved.

[0077] The above is the implementation manner of the embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the embodiments of the present invention, several improvements and refinements can be made, and these improvements and refinements are also regarded as the protection scope of the present invention.

Claims

1. A quantitatively adjustable suture length adjustment system, characterized in that, Comprising an adjusting assembly, the adjusting assembly includes: A first adjusting member provided with a first positioning portion, the first adjusting member being used for hooking a suture; and A second adjusting member movably connected to the first adjusting member axially, and having a second positioning portion corresponding to the first positioning portion; The suture is threaded between the first adjusting member and the second adjusting member. The second adjusting member moves axially relative to the first adjusting member towards the distal end to push against the suture, so that the length of the suture between the first adjusting member and the second adjusting member increases until the first positioning portion is adapted to the second positioning portion, thereby restricting the relative movement between the second adjusting member and the first adjusting member.

2. The quantitatively adjustable suture length adjustment system according to claim 1, wherein The first adjusting member is hollow and has a first receiving cavity axially provided therein, and the first receiving cavity at least penetrates the proximal end surface of the first adjusting member; the second adjusting member is slidably inserted into the first receiving cavity axially from the proximal end of the first adjusting member.

3. The quantifiable adjustable suture length adjustment system according to claim 2, wherein A pair of guiding surfaces are oppositely provided on the inner wall of the first receiving cavity, and the first positioning portion includes at least one clamping groove opened on at least one of the guiding surfaces, and the clamping groove extends radially along the first adjusting member; The second adjusting member includes a pair of outer wall surfaces corresponding to the pair of guiding surfaces one by one, and the second positioning portion includes elastic hooks provided on at least one of the outer wall surfaces, and the elastic hooks are snapped into the corresponding one of the clamping grooves to stop the relative movement between the second adjusting member and the first adjusting member.

4. The quantifiable adjustable suture length adjustment system according to claim 3, wherein, The spacing direction of the pair of guiding surfaces is the first direction, and there is a gap between the inner wall of the first receiving cavity and the second adjusting member in the second direction, and the second direction is substantially perpendicular to the first direction.

5. The quantifiable adjustable suture length adjustment system according to claim 3, wherein The second adjusting member is hollow and has a second receiving cavity axially provided therein, and the second receiving cavity at least penetrates the proximal end surface of the second adjusting member. At least one of the outer wall surfaces of the second adjusting member is provided with an opening communicating with the second receiving cavity at the proximal region, and the elastic hook is provided at the opening.

6. The quantifiable adjustable suture length adjustment system according to any one of claims 1 to 5, characterized in that, The suture length adjusting system further includes a conveying assembly, the distal end of the conveying assembly is detachably connected to the adjusting assembly, and the conveying assembly is used for conveying the adjusting assembly and controlling the relative movement between the first adjusting member and the second adjusting member.

7. The quantifiable adjustable suture length adjustment system according to claim 6, wherein 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, and is used for conveying the second adjusting member and restricting the axial position of the second adjusting member; the distal end of the driving member is detachably connected to the first adjusting member, and is used for conveying the first adjusting member and driving the relative movement between the first adjusting member and the second adjusting member.

8. The quantifiable adjustable suture length adjustment system according to claim 7, characterized in that, The conveying assembly further includes a releasing member detachably connected to the distal end of the conveying member. A first connecting portion is provided at the proximal end of the second adjusting member, and a second connecting portion is provided at the distal end of the releasing member. The first connecting portion and the second connecting portion are detachably connected.

9. The quantifiable adjustable suture length adjustment system according to claim 8, wherein The conveying assembly further includes an outer sheath tube and a first limiting member connected to the distal end of the outer sheath tube. The first limiting member defines a limiting groove on its distal end face. A first through hole extending axially is defined in the bottom surface of the limiting groove for the distal end of the conveying member to pass through. At least one second through hole extending axially is further defined on one side of the limiting groove of the first limiting member for the distal ends of at least one of the driving members to pass through; The conveying member and at least one of the driving members are movably inserted into the outer sheath tube; The outer sheath tube drives the first limiting member to move axially, so that the connecting portion between the first connecting portion and the second connecting portion is received in or removed from the limiting groove, so as to realize the connection or separation between the second adjusting member and the releasing member.

10. The quantifiable adjustable suture length adjustment system according to claim 9, 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 quantifiable adjustable suture length adjustment system according to claim 10, characterized in that, The first limiting member is provided with a convex edge at the edge of its distal end face, and the convex edge extends along the circumferential direction of the first limiting member; the first adjusting member moves axially toward the proximal end relative to the second adjusting member until it abuts against the distal end face of the first limiting member, and the convex edge surrounds the proximal end portion of the first adjusting member.

12. The quantifiable adjustable suture length adjustment system according to claim 11, characterized in that, A first slot communicating with the first receiving cavity is defined on the outer wall of the first adjusting member from its proximal end face, and the second slot corresponding to the first slot is defined on the convex edge; When the first adjusting member abuts against the distal end face of the first limiting member, the first slot and the second slot together form a through hole.

13. The quantifiable adjustable suture length adjustment system according to claim 9, characterized in that, The releasing member defines a third through hole extending axially and having internal threads corresponding to the first through hole. The conveying member is threadedly connected to the releasing member and its distal end extends out from the distal end of the releasing member; The conveying assembly further includes a second limiting member connected to the distal end of the conveying member. The conveying member is further configured to drive the second limiting member to move axially toward the distal end until the second limiting member is received in the second receiving cavity and corresponds to the position of the elastic hook, so as to stop the elastic hook from bending toward the second receiving cavity.

14. The quantifiable adjustable suture length adjustment system according to claim 7, wherein The distal end portion of the driving member is provided with external threads; the first adjusting member defines a threaded hole extending axially on one side of the first receiving cavity from its proximal end face. The number of the threaded holes corresponds to the number of the driving members, and the internal threads of the threaded holes are adapted to the external threads of the driving members.

15. The quantifiable adjustable suture length adjustment system according to claim 3, wherein A first slot communicating with the first receiving cavity is defined on the outer wall of the first adjusting member from its proximal end face, and the first slot extends substantially along the axial direction of the first adjusting member; The positions of the first slot and the card slot in the circumferential direction of the first adjusting member are staggered from each other.

16. The quantifiable adjustable suture length adjustment system according to claim 15, wherein, A radial slot corresponding to the first slot is defined on the distal end face of the second adjusting member, and both ends of the radial slot penetrate through the outer wall of the second adjusting member respectively.

17. The quantifiable adjustable suture length adjustment system according to claim 3, wherein At least one hollow hole is defined on the outer wall of the first adjusting member, and the extending direction of the hollow hole is the same as or different from the extending direction of the card slot.

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