Rotating artificial chord adjustment system

Abstract

The present invention provides a rotary artificial chord adjustment system, comprising a wire locker, wherein the wire locker comprises a sheath for hooking an artificial chord and a rotating member rotatably arranged in the sheath; the rotating member rotates unidirectionally relative to the sheath, and the rotating member winds up the artificial chord hooked by the sheath to increase the length of the artificial chord contained in the sheath. The rotary artificial chord adjustment system provided by the present invention can increase the length of the artificial chord in the sheath by rotating the rotating member in the sheath to wind up the artificial chord after the sheath hooks up the artificial chord, thereby shortening the effective length of the artificial chord. The structure of the whole system is simple and easy to operate. Moreover, the adjustment degree of the artificial chord can be intuitively known through the rotation angle of the rotating member, and the quantitative adjustment of the artificial chord can be realized. Moreover, the artificial chord can be prevented from loosening again after winding by regulating through unidirectional rotation, thereby improving the stability of the instrument; and the chord can be fixed by squeezing, thereby causing less damage to the artificial chord.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a rotary artificial chord adjustment system. Background Art

[0002] Mitral regurgitation is one of the most common valvular diseases today. The main causes of the disease include rheumatic heart disease, myxomatous degeneration of the mitral valve, ischemic heart disease, myocardial disease, etc., which lead to lesions in the valve ring, leaflets, chordae tendineae and papillary muscles in the mitral valve structure, making the mitral valve unable to close completely.

[0003] Surgical operations, such as mitral valvuloplasty and artificial valve replacement, are effective methods for treating mitral regurgitation. However, since the operation requires extracorporeal circulation technical support, it causes great trauma to the human body. For elderly patients and patients with more comorbidities, there are more complications and a higher mortality rate.

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

[0005] In the prior art, an artificial chord length adjustment device is disclosed, which firstly uses a hook to capture the artificial chord, stretches the chord through an instrument, and the length is adjusted by the stretching amount, and then fixes the artificial chord through two positioning clips to achieve the adjustment effect; the main defects of this technology are: 1. The structure of the adjustment instrument is complex and difficult to operate; 2. The clip must be able to provide sufficient squeezing force to clamp the chord, but excessive squeezing force can easily cause damage to the chord; 3. The clip is easy to slip off the chord and has poor stability; 4. Quantitative adjustment cannot be performed, and the adjustment amount is unstable. These problems will lead to the risk of surgical failure or ineffective adjustment in the adjustment of artificial chords. Summary of the invention

[0006] In view of the deficiencies in the prior art, the present invention provides a rotary artificial chord adjustment system, which has a simple structure, is easy to operate, and can adjust the artificial chords reliably and stably with little damage.

[0007] In order to solve the above technical problems, the present invention provides a rotational artificial tendon chord adjustment system, including a wire locking device, the wire locking device including a sheath for hooking artificial tendon chords and a rotating member rotatably arranged in the sheath; the rotating member rotates unidirectionally relative to the sheath, and the rotating member winds around the artificial tendon chord hooked by the sheath to increase the length of the artificial tendon chord accommodated in the sheath.

[0008] The rotary artificial chord adjustment system provided by the present invention can increase the length of the artificial chord in the sheath by rotating the rotating part in the sheath to wind the artificial chord after the sheath hooks the artificial chord, thereby shortening the effective length of the artificial chord. The structure of the entire system is simple and easy to operate. The adjustment degree of the artificial chord can be intuitively known through the rotation angle of the rotating part, and quantitative adjustment of the artificial chord can be achieved. The artificial chord can be regulated by unidirectional rotation to avoid loosening of the wound artificial chord again, thereby improving the stability of the instrument; and the chord can be fixed by avoiding squeezing, which causes less damage to the artificial chord. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solution of the embodiment of the present invention, the drawings required for use in the implementation mode will be briefly introduced below. Obviously, the drawings described below are some implementation modes of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0010] Figure 1 It is a schematic diagram of the three-dimensional structure of the rotary artificial chord adjustment system provided in the first embodiment of the present invention.

[0011] Figure 2 yes Figure 1 Schematic diagram of the three-dimensional decomposition structure of the rotating artificial chord adjustment system.

[0012] Figure 3 yes Figure 1 Axial cross-section of the distal portion of the rotating artificial chord adjustment system.

[0013] Figure 4 yes Figure 1 A partial cross-sectional view of the distal portion of the rotational artificial chord adjustment system.

[0014] Figure 5 yes Figure 2 Schematic diagram of the three-dimensional exploded structure of the sheath.

[0015] Figure 6 yes Figure 2 Schematic diagram of the three-dimensional structure of the rotating part.

[0016] Figure 7 yes Figure 2Schematic diagram of the three-dimensional structure of the end bevel gear.

[0017] Figure 8 yes Figure 2 Schematic diagram of the three-dimensional structure of the limiting member.

[0018] Fig. 9 yes Figure 2 Schematic diagram of the three-dimensional structure of the first connecting member.

[0019] Fig.10 yes Figure 2 Schematic diagram of the three-dimensional structure of the second connecting member.

[0020] Figures 11 to 15 yes Figure 1 Schematic diagram of the use process of the rotary artificial chord adjustment system; wherein, Fig.12 and Fig.13 The states of the artificial tendon cord in the sheath when the rotating member rotates at different angles relative to the sheath are respectively shown.

[0021] Fig.16 It is an axial cross-sectional view of a wire locker of a rotary artificial chord adjustment system provided by a second embodiment of the present invention.

[0022] Fig.17 yes Fig.16 Sectional view along line AA. DETAILED DESCRIPTION

[0023] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0024] In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, 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 therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", etc., are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0025] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0026] In the description of the present invention, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device. The above definitions are only for the convenience of expression and cannot be understood as limitations of the present invention.

[0027] Please also read Figures 1 to 3 The first embodiment of the present invention provides a rotary artificial chord adjustment system 1000, including a wire locker 100, which can be implanted in the patient's heart to hook and accommodate artificial chords and adjust the effective length of artificial chords. Specifically, the wire locker 100 includes a sheath 10 for hooking artificial chords, a rotating member 20 rotatably arranged in the sheath 10, and the rotating member 20 rotates unidirectionally relative to the sheath 10. The rotating member 20 winds the artificial chords hooked by the sheath 10 to increase the length of the artificial chords accommodated in the sheath 10, thereby shortening the effective length of the artificial chords and improving the overall tension of the artificial chords. The structure of the whole system is simple and easy to operate. Moreover, the adjustment degree of the artificial chords can be intuitively known through the rotation angle of the rotating member 20, and the quantitative adjustment of the artificial chords can be achieved. Moreover, the artificial chords can be regulated by unidirectional rotation to avoid loosening again after winding, thereby improving the stability of the device; and the chords can be fixed by squeezing, which is less damaged.

[0028] Among them, in order to ensure the safety of implantation, the sheath 10 and the rotating part 20 can be made of metal materials, preferably stainless steel, or other materials with good biocompatibility and certain rigidity, such as PEEK, etc. The materials of the sheath 10 and the rotating part 20 can be different or the same.

[0029] For details, please refer to Figures 3 to 5 The sheath 10 is roughly cylindrical, and includes a hollow main body 11 with open ends and a cover body 13 covering the distal end of the main body 11, and the cover body 13 and the main body 11 are covered to form a receiving cavity 15 extending along the axial direction of the sheath 10; the outer wall of the distal end of the main body 11 is provided with a first hook groove 111 penetrating to the receiving cavity 15; the proximal surface of the cover body 13 is convexly provided with an annular convex 131, and the annular convex 131 is received in the distal inner cavity of the main body 11.

[0030] The main body 11 and the cover body 13 are formed separately and connected by laser welding, bonding, clamping, interference fit, etc., preferably laser welding.

[0031] like Figure 3 and Figure 6 As shown, the rotating member 20 is roughly in the shape of a hollow cylinder. The rotating member 20 is accommodated in the receiving cavity 15. The distal end of the rotating member 20 is accommodated in a groove surrounded by the annular convex 131. The distal end surface of the rotating member 20 abuts against the bottom of the groove, so that the distal axial position of the rotating member 20 is fixed; a radial gap is provided between the rotating member 20 and the main body 11 of the sheath 10, so that the rotating member 20 can rotate in the sheath 10; the proximal end of the rotating member 20 is provided with an axially extending threaded hole 21, and the threaded hole 21 is used to connect with the conveying device 200, so that the operator can remotely control the rotation of the rotating member 20 relative to the sheath 10 in vitro; the distal end of the rotating member 20 is provided with a second hook groove 22 corresponding to the first hook groove 111 at the distal end of the main body 11, and the first hook groove 111 is connected to the second hook groove 22 to hook the artificial tendon cord. For details, please refer to Figures 3 to 5The first hook groove 111 includes a straight groove 1111 extending in the radial direction of the sheath 10 and a U-shaped groove 1113 connected to the straight groove 1111 and extending in the axial direction of the sheath 10. The second hook groove 22 includes a receiving groove 223 corresponding to the U-shaped groove 1113. After the sheath 10 hooks the artificial tendon cord, the artificial tendon cord is received in the receiving groove 223 in the radial direction. When the rotating member 20 rotates relative to the sheath 10, the artificial tendon cord is wound around the portion of the outer circumference of the rotating member 20 corresponding to the receiving groove 223. The artificial tendon cord is gradually rolled into the tendon cord receiving space between the rotating member 20 and the main body 11 of the sheath 10, and twisted to form an S shape, thereby increasing the length of the artificial tendon cord in the sheath 10. It should be noted that artificial chordae are usually made of e-PTFE sutures or PET sutures, and their outer diameter is generally 0.2-0.5mm, and the number is usually two. After the artificial chordae are implanted in the heart, endothelial cells will crawl on the sutures, thereby increasing the outer diameter of the artificial chordae. In this embodiment, in order to ensure that the sheath 10 can smoothly hook the endothelialized artificial chordae and enter the chordae accommodating space, the width of the linear groove 1111 along the axial direction of the sheath 10 is greater than 2mm, the width of the U-shaped groove 1113 along the radial direction of the sheath 10 and the depth along the axial direction of the sheath 10 are both greater than 2mm, and the size of the accommodating groove 223 corresponding to the U-shaped groove 1113 is not less than the size of the U-shaped groove 1113; furthermore, in order to avoid damaging the artificial chordae, the inner surfaces of the linear groove 1111, the U-shaped groove 1113 and the accommodating groove 223 are preferably smooth surfaces, and the junctions are all rounded.

[0032] Preferably, please also refer to Figure 5 and Figure 6 In this embodiment, at least one clamping platform 24 is protruded from the outer wall of the rotating member 20 at the notch position corresponding to the receiving groove 223, and the outer side surface of the clamping platform 24 is clearance-matched with the inner circumference of the main body 11, and an axial clearance is provided between the proximal end surface of the clamping platform 24 and the bottom of the receiving groove 223. Figure 6 As shown, when the artificial tendon cord is twisted into an S shape and wound on the portion of the outer circumferential surface of the rotating member 20 corresponding to the receiving groove 223, the axial gap between the proximal end surface of the clamping platform 24 and the bottom of the receiving groove 223 can clamp the artificial tendon cord to prevent the artificial tendon cord from slipping out of the receiving groove 223, thereby ensuring the stability of adjusting the artificial tendon cord. In this embodiment, a pair of truncated cone-shaped clamping platforms 24 are symmetrically protruded on the outer wall of the rotating member 20, and the symmetrically arranged pair of clamping platforms 24 have better clamping performance and better stability for the artificial tendon cord.

[0033] Please also refer to Figure 2 and Figure 4In the present invention, in order to ensure the stability and reliability of the adjustment process and to ensure the firmness of the wire locker 100 implanted on the artificial chord, the wire locker 100 also includes a limiting mechanism 30 arranged at the proximal end of the rotating member 20. The limiting mechanism 30 allows the rotating member 20 to rotate forward relative to the sheath 10 to wind the artificial chord, and stops the rotating member 20 from rotating backward relative to the sheath 10 to prevent the artificial chord from loosening. In other words, the sheath 10 and the rotating member 20 are in a one-way rotation fit.

[0034] Specifically, Figure 2 As shown, the limiting mechanism 30 includes a first limiting member 31 and a second limiting member 32 cooperating with the first limiting member 31, the first limiting member 31 is fixedly arranged at the proximal end of the rotating member 20, the second limiting member 32 is arranged opposite to the first limiting member and is fixed in a circumferential position relative to the sheath 10, thereby, when the rotating member 20 rotates forwardly relative to the sheath 10, the rotating member 20 drives the first limiting member 31 to rotate forwardly relative to the second limiting member 32; after the rotating member 20 and the first limiting member 31 stop rotating forwardly, the second limiting member 32 stops the first limiting member 31 and the rotating member 20 connected thereto.

[0035] More specifically, if Figure 4 and Figure 7 As shown, in this embodiment, the first limiting member 31 and the second limiting member 32 are a pair of end face bevel gears meshing with each other, and the pair of end face bevel gears include a first end face bevel gear located at the proximal end and a second end face bevel gear located at the distal end. Each of the end face bevel gears includes an annular base 33 and a plurality of meshing teeth 34 convexly arranged at one end of the annular base 33 close to the other end face bevel gear and continuously arranged along the circumference of the annular base 33; each of the meshing teeth 34 includes an oblique tooth surface 341 extending along the circumference of the annular base 33 and gradually moving away from the annular base 33 along the extension direction, and a stop surface 342 connected to the end of the oblique tooth surface 341 and extending approximately along the axial direction of the annular base 33. In this embodiment, the bevel tooth surface 341 of each meshing tooth 34 extends clockwise along the circumference of the annular base 33; the stop surface 342 of each meshing tooth 34 extends along the axial direction of the annular base 33, that is, the stop surface 342 is perpendicular to the end surface of the annular base 33 close to the other end face bevel gear. Preferably, the angle between the bevel tooth surface 341 and the end surface of the annular base 33 away from the other end face bevel gear is in the range of 15 degrees to 45 degrees.

[0036] Obviously, in other embodiments, the bevel tooth surface 341 of each meshing tooth 34 can extend counterclockwise along the circumference of the annular base 33; the stop surface 342 of each meshing tooth 34 can extend in a direction close to the axial direction of the annular base 33, that is, the stop surface 342 and the end surface of the annular base 33 close to the other end face bevel gear form an angle slightly less than 90 degrees.

[0037] It should be noted that the stop surface 342 of each meshing tooth 34 is smoothly transitionally connected to the end of the bevel surface 341 of the meshing tooth 34, and is also smoothly transitionally connected to the beginning of the bevel surface 341 of the adjacent meshing tooth 34. The beginning and the end of the bevel surface 341 are defined according to the extension direction, the beginning refers to the end where the bevel surface 341 starts to extend (or the end close to the annular base 33), and the end refers to the end where the bevel surface 341 ends to extend (or the end away from the annular base 33).

[0038] It can be understood that the rotation direction of the rotating member 20 relative to the sleeve 10 is related to the extension direction of the oblique tooth surface 341 of the meshing teeth 34 of the first limiting member 31 and the second limiting member 32. As mentioned above, in this embodiment, the oblique tooth surface 341 of each meshing tooth 34 extends clockwise along the circumference of the annular base 33, so that the first limiting member 31 can only rotate clockwise relative to the second limiting member 32, and the rotating member 20 can also only rotate clockwise relative to the sleeve 10. When the rotating member 20 is rotated counterclockwise, the rotating member 20 will not rotate under the stopper effect of the second limiting member 32. That is to say, in this embodiment, the clockwise rotation of the rotating member 20 relative to the sleeve 10 is positive rotation, and conversely, the counterclockwise rotation is reverse rotation.

[0039] In other embodiments, when the bevel tooth surface 341 of each meshing tooth 34 extends counterclockwise along the circumference of the annular base 33, the first limiting member 31 can only rotate counterclockwise relative to the second limiting member 32, and the rotating member 20 can only rotate counterclockwise relative to the sleeve 10. When the rotating member 20 is rotated clockwise, the rotating member 20 will not be able to rotate under the stopping action of the second limiting member 32. At this time, the counterclockwise rotation of the rotating member 20 relative to the sleeve 10 is positive rotation, and the clockwise rotation is reverse rotation.

[0040] In this embodiment, the first limiting member 31 is a first end face bevel gear located at the proximal end, and the end face of the annular base 33 of the first end face bevel gear facing away from the multiple meshing teeth 34 is fixed to the proximal end face of the rotating member 20 by bonding or welding.

[0041] In this embodiment, the second limiting member 32 is a second end face bevel gear located at the distal end, and the second end face bevel gear is arranged opposite to the first end face bevel gear and is fixed relative to the circumferential position of the sheath 10. Figure 2 As shown, in this embodiment, the distal end of the second end face bevel gear is meshed with the first end face bevel gear, and the proximal end of the second end face bevel gear is fixedly connected to a limit member 40 by bonding or welding, and the limiting mechanism 30 also includes an elastic member 35 arranged in the sheath 10 and the distal end portion of which is sleeved outside the proximal end of the limit member 40, and the proximal end of the elastic member 35 abuts against the proximal end surface of a first connecting member 50 fixedly arranged at the proximal end of the sheath 10, thereby making the second end face bevel gear located at the proximal end of the sheath 10, wherein the limiting member 40 is also used to fix the circumferential position of the second end face bevel gear relative to the sheath 10, and the first connecting member 50 is also used to be detachably connected to the conveying device 200 to limit the circumferential position of the sheath 10.

[0042] For details, please refer to Figure 1 , Figure 2 and Figure 8 In this embodiment, the stopper 40 includes a first circular base 41 and a truncated cone 43 convexly arranged in the middle of the proximal end surface of the first circular base 41; at least one stopper block 415 is convexly arranged on the outer circumferential surface of the first circular base 41, and the proximal end of the main body 11 of the sheath 10 is correspondingly provided with at least one stopper groove 115 extending along the axial direction of the sheath 10, and the stopper block 415 is adapted to be inserted into the stopper groove 115, so that the second end face bevel gear fixedly connected to the stopper 40 is fixed relative to the circumferential position of the sheath 10; the distal end portion of the elastic member 35 is sleeved outside the truncated cone 43, and the distal end of the elastic member 35 abuts against the proximal end surface of the first circular base 41. In this embodiment, a group of stopper blocks 415 are symmetrically arranged on the outer circumferential surface of the first circular base 41, and a group of stopper grooves 115 are correspondingly provided on the main body 11; the elastic member 35 is preferably a spring.

[0043] Please also read Figure 2 , Figure 3 and Fig. 9 In this embodiment, the first connecting member 50 is a generally cylindrical structure with a barb at the proximal end. The first connecting member 50 includes a second circular base 52, a ring 54 protruding from the middle of the distal end surface of the second circular base 52, and a semi-circular first barb 56 protruding from the proximal end surface of the second circular base 52. The first barb 56 has a first coupling surface for detachably connecting with the delivery device 200, and the first coupling surface is an S-shaped curved surface. Figure 3As shown, when the first connecting member 50 is fixedly connected to the proximal end of the sheath 10, the proximal surface of the main body 11 of the sheath 10 is fitted to the distal surface of the second circular base 52, the ring 54 is accommodated in the proximal inner cavity of the main body 11, and the distal end of the elastic member 35 is accommodated in the ring 54 and abuts against the distal surface of the first connecting member 50.

[0044] In this embodiment, the sheath 10, the first limiting member 31 (i.e., the first end face bevel gear), the second limiting member 31 (i.e., the second end face bevel gear) and the limiting member 40 are all made of metal materials, such as stainless steel, so the fixed connection between the components is preferably laser welding. Of course, in other embodiments, the components can be made of other biocompatible materials, such as PEEK, and the components can be bonded and fixed by medical glue.

[0045] It should be noted that, in the present embodiment, the first connecting member 50, the limiting member 40, the second end face bevel gear and the first end face bevel gear are respectively provided with through holes along the axial direction, and the through holes of the first end face bevel gear, the second end face bevel gear and the limiting member 40 are connected to form a first channel connected to the proximal threaded hole 21 of the rotating member 20, so that the distal end of the conveying device 200 can pass through and be threadedly connected to the rotating member 20.

[0046] In this embodiment, the elastic member 35 abuts between the limiting member 40 and the first connecting member 50, and the elastic member 35 can generate an elastic thrust to make the second end face bevel gear and the first end face bevel gear engage with each other; furthermore, under the action of the elastic thrust of the elastic member 35, the rotating member 20, the first end face bevel gear (i.e., the first limiting member 31), the second end face bevel gear (i.e., the second limiting member 32) and the first connecting member 50, which are arranged in sequence from the distal end to the proximal end in the sheath 10, are fixed in the axial position relative to the sheath 10 when not subject to external force.

[0047] When the rotating member 20 rotates forwardly relative to the sleeve 10, the rotating member 20 drives the first end face bevel gear to rotate, and the second end face bevel gear is fixed relative to the circumferential position of the sleeve 10 under the action of the limiting member 40, so that the first end face bevel gear rotates forwardly relative to the second end face bevel gear. At this time, the bevel tooth surfaces 341 of the multiple meshing teeth 34 of the first end face bevel gear and the bevel tooth surfaces 341 of the multiple meshing teeth 34 of the second end face bevel gear slide alternately, and the distal end of the rotating member 20 connected to the first end face bevel gear abuts against the cover body 13 of the sleeve 10, so that the first end face bevel gear pushes the second end face bevel gear and the gear connected to the first end face bevel gear toward the proximal end. The limiting member 40 at the far end of the second end face bevel gear squeezes the elastic member 35, and the elastic member 35 is deformed to provide axial movement space for the second end face bevel gear, so that the second end face bevel gear can float axially, and the elastic thrust generated by the deformation of the elastic member 35 will keep the first end face bevel gear and the second end face bevel gear always in meshing. That is to say, in this embodiment, the elastic member 35 makes the first end face bevel gear (that is, the first limiting member 31) rotate forwardly relative to the second end face bevel gear (that is, the second limiting member 32), and the second limiting member 32 floats axially relative to the first limiting member 31 and maintains sliding contact with the first limiting member 31. When the rotating member 20 and the first limiting member 31 stop rotating in the forward direction, the elastic member 35 recovers its deformation and generates an elastic thrust to push the limiting member 40 and the second limiting member 32 toward the distal end, so that the first limiting member 31 and the second limiting member 32 return to the initial state of full engagement. At this time, the stop surface 342 of the multiple meshing teeth 34 of the second limiting member 32 contacts the stop surface 342 of the multiple meshing teeth 34 of the first limiting member 31. If the rotating member 20 and the first limiting member 31 have a tendency to rotate in the opposite direction, under the action of the stop surface 342, the second limiting member 32 can stop the first limiting member 31, thereby preventing the rotating member 20 from rotating and resetting relative to the sheath 10, causing the artificial tendon wound on the rotating member 20 to loosen. Therefore, with the cooperation of the first limiting member 31 and the second limiting member 32, the rotating member 20 can only rotate forward relative to the sheath 10 to wind the artificial chordae tendineae, so that the artificial chordae tendineae can only be locked but not loosened, and the implanted locking wire device 100 can be prevented from falling off the artificial chordae tendineae.

[0048] When the second limiting member 32 (i.e., the second end face bevel gear) moves axially under the push of the first limiting member 31 (i.e., the first end face bevel gear), the limiting block 415 of the limiting member 40 fixedly connected to the distal end of the second limiting member 32 moves axially in the limiting groove 115 at the distal end of the sheath 10.

[0049] It can be understood that, in the present embodiment, the stop surface 342 of any meshing tooth 34 on the second end face bevel gear can form a stop pair with the stop surface 342 of any meshing tooth 34 on the first end face bevel gear to prevent the rotating member 20 from rotating and resetting relative to the sheath 10, causing the artificial tendon cord wound on the rotating member 20 to loosen. Therefore, the rotating member 20 can drive the first end face bevel gear to rotate different numbers of teeth or different numbers of circles relative to the second end face bevel gear, so that the length of the artificial tendon cord wound on the rotating member 20 is different, thereby adjusting the length of the artificial tendon cord accommodated in the sheath 10. That is to say, by controlling the rotation amount of the rotating member 20 relative to the sheath 10, the winding length of the artificial tendon cord can be regulated by an equivalent amount, which is conducive to flexible and real-time quantitative adjustment of the effective length of the artificial tendon cord according to the actual clinical needs of the patient.

[0050] Please also refer to Figures 1 to 3 The rotary artificial chord adjustment system 1000 also includes a delivery device 200, and the distal end of the delivery device 200 is detachably connected to the wire locking device 100. When using the rotary artificial chord adjustment system 1000, the operator delivers the distal end of the delivery device 200 and the connected wire locking device 100 to a predetermined treatment site in an interventional manner through a hollow guide device such as an adjustable bending sheath or a pre-shaped catheter, and then controls the proximal end of the delivery device 200 outside the patient's body to control the wire locking device 100 to adjust the effective length of the artificial chord, and releases the wire locking device 100 after the adjustment is completed and leaves it in the patient's body.

[0051] Specifically, Figure 2 and Figure 3 As shown, the delivery device 200 includes a driving rod 210 for detachably connecting with the rotating member 20, and the rotation of the driving rod 210 drives the rotating member 20 to rotate unidirectionally relative to the sheath 10. In this embodiment, the proximal end of the driving rod 210 extends outside the patient's body, and the distal end of the driving rod 210 is fixedly provided with a threaded joint 211, and the threaded joint 211 is adapted to the threaded hole 21 of the rotating member 20, so that the driving rod 210 is threadedly connected with the rotating member 20. By controlling the proximal end rotation of the driving rod 210, it can be transmitted to the threaded joint 211, thereby controlling the rotation of the rotating member 20 relative to the sheath 10.

[0052] Among them, the spiral direction of the internal thread of the threaded hole 21 is opposite to the rotation direction of the rotating part 20 relative to the sleeve 10. When the driving rod 210 rotates in the tightening direction, the threaded connection between the driving rod 210 and the rotating part 20 becomes tighter, and the rotating part 20 rotates forward relative to the sleeve 10; when the driving rod 210 rotates in the release direction, the threaded connection between the driving rod 210 and the rotating part 20 is loosened to the final release, and the rotating part 20 cannot rotate in the opposite direction relative to the sleeve 10, so as to prevent the adjusted artificial tendon from loosening again.

[0053] It is understandable that the threaded joint 211 and the driving rod 210 may be an integral structure or a non-integrated structure. Preferably, in this embodiment, the threaded joint 212 and the driving rod 210 are integral, which is conducive to reducing costs, saving assembly time, and improving assembly accuracy.

[0054] Among them, the driving rod 210 is a flexible rod or flexible tube with a certain axial length, certain support and bendability. For example, the driving rod 210 can adopt an endoscope tube body such as a snake tube; the driving rod 210 and the threaded joint 211 are preferably made of metal materials such as stainless steel.

[0055] like Figure 2 As shown, the delivery device 200 further includes a connecting tube 220 sleeved on the outside of the driving rod 210, the proximal end of the connecting tube 220 extends outside the patient's body, and the distal end of the connecting tube 220 is fixedly provided with a second connecting member 221 by means of snap-fitting, bonding or welding, and the second connecting member 221 is detachably connected to the first connecting member 50 to define the circumferential position of the sheath 10, so that the sheath 10 can remain relatively still, so that the rotation of the driving rod 210 can drive the rotating member 20 to rotate in the positive direction relative to the sheath 10. Specifically, as Fig.10As shown, in this embodiment, the second connecting member 221 is generally hollow cylindrical, and the second connecting member 221 is provided with a through hole 225 for the driving rod 210 to pass through in the axial direction. The distal end of the second connecting member 221 is provided with a second barb 226 that matches the first barb 56 at the proximal end of the first connecting member 50. The second barb 226 has a second bonding surface that matches the first bonding surface of the first barb 56. The second bonding surface and the first bonding surface are both S-shaped surfaces with a certain curvature, and the curvatures of the two are matched. By controlling the proximal end of the connecting tube 220 to move in the axial direction, the second connecting member 221 can be driven to move in the axial direction relative to the first connecting member 50, so that the second connecting member 221 and the first connecting member 50 can be detachably connected or separated. When the first barb 56 of the first connector 50 and the second barb 226 of the second connector 221 are in a detachable connection state, the sheath 10 fixedly connected to the first connector 50 is circumferentially fixed, and the wire locker 100 can be moved by moving the connecting tube 220 .

[0056] The connecting pipe 220 and the second connecting member 221 are preferably made of metal materials, such as stainless steel; similarly, the connecting pipe 220 and the second connecting member 221 are preferably an integrated structure.

[0057] Furthermore, if Figure 2 As shown, the delivery device 200 further includes an outer tube 230 sleeved on the outside of the connecting tube 220, and the outer tube 230 limits the separation of the first connecting member 50 and the second connecting member 221. Specifically, the proximal end of the outer tube 230 extends outside the patient's body, and the distal end of the outer tube 230 is fixedly provided with a hollow sleeve 231 by means of snap-fitting, bonding or welding. The sleeve 231 is hollow and its inner diameter is slightly larger than the outer diameter of the second connecting member 221. By controlling the proximal end of the outer tube 230 to move axially, the sleeve 231 is driven to move axially, so that the detachably connected second connecting member 221 and the first connecting member 50 are accommodated in the sleeve 231 or removed from the sleeve 231. When the sleeve 231 moves axially toward the distal end until the distal surface of the sleeve 231 abuts against the proximal surface of the second circular base 52 of the first connecting member 50, the sleeve 231 stops moving. When the detachably connected second connecting member 221 and the first connecting member 50 are accommodated in the sleeve 231, the sleeve 231 can limit the separation of the first connecting member 50 and the second connecting member 221.

[0058] The outer tube 230 may be a commonly used medical sheath tube; the sleeve 231 is preferably made of metal materials such as stainless steel, or may be made of a polymer material with a certain strength, such as POM; the sleeve 231 is engaged with the distal end of the outer tube 230 .

[0059] Please refer again Figure 1 and Figure 2 For ease of operation, in this embodiment, the rotary artificial chord adjustment system 1000 also includes a control handle 300 connected to the proximal end of the delivery device 200, and the control handle 300 includes a shell 310 and a first knob 311, a second knob 312 and a third knob 313 arranged on the shell 310.

[0060] Among them, the first knob 311 is fixedly connected to the proximal end of the driving rod 210, and the driving rod 210 is controlled by rotating the first knob 311 to drive the rotating member 20 to rotate forward relative to the sheath 10 to wind the artificial tendon cord and adjust the artificial tendon cord, and the driving rod 210 is controlled to rotate in the reverse direction so that the threaded connection between the driving rod 210 and the rotating member 20 can be released; the second knob 312 is fixedly connected to the proximal end of the connecting tube 220, and the connecting tube 220 is controlled by rotating the second knob 312 to drive the wire locker 100 to move axially, so that the sheath 10 can hook the artificial tendon cord; the third knob 313 is fixedly connected to the proximal end of the outer tube 230, and the outer tube 230 is controlled by rotating the third knob 313 to drive the sleeve 231 to move axially to accommodate or expose the connection between the first connecting member 50 and the second connecting member 221, so that the two can be separated.

[0061] The control handle 300 is preferably made of a polymer material, such as ABS, PP, etc.

[0062] It should be noted that the proximal end of the delivery device 200 is connected to a control handle 300, and the distal end of the delivery device 200 and the wire locker 100 connected thereto are movably mounted in a guide device such as an adjustable bending sheath or a pre-shaped catheter, and can extend from the distal end of the guide device. The distal end of the guide device has at least one adjustable bending section, and by controlling the adjustable bending section of the guide device, the distal end of the delivery device 200 can be bent, so that the distal end of the delivery device 200 and the wire locker 100 connected thereto can pass through the complex tubular cavity structure of the human body and reach the vicinity of the predetermined treatment site. The structure of the guide device is substantially the same as that of the guide device in the prior art, and will not be described in detail here.

[0063] Please also read Figure 4 , Figures 11 to 15The following will describe the use process of the rotary artificial chord adjustment system 1000 provided in this embodiment in conjunction with the accompanying drawings.

[0064] Step 1: Instrumental approach, preferably via the femoral artery - abdominal aorta - thoracic aorta - aortic valve orifice - left ventricle, the wire locker 100 at the distal end of the rotary artificial chord adjustment system 1000 is delivered to the vicinity of the artificial chord X through an adjustable curved sheath tube and other guiding devices, and the sheath 10 is controlled by the second knob 312 of the control handle 300 to move and hook the artificial chord X, as shown in FIG. Fig.11 As shown, the artificial tendon cord X falls into the U-shaped groove 1113 of the first hook groove 111 . At this time, the artificial tendon cord X is also located in the receiving groove 223 (not shown) of the second hook groove 22 of the rotating member 20 .

[0065] Step 2: If Figure 4 As shown, after hooking the artificial tendon chord X, the first knob 311 of the control handle 300 is used to control the rotating member 20 to rotate forward relative to the sheath 10, and the rotating member 20 winds the artificial tendon chord X, thereby increasing the length of the artificial tendon chord X accommodated in the sheath 10 to adjust the effective length of the artificial tendon chord X.

[0066] Step 3: If Fig.12 and Fig.13 As shown, according to the regurgitation state of the mitral valve observed by medical imaging equipment such as ultrasound, the rotation angle of the rotating member 20 relative to the sheath 10 is controlled to slowly increase the length of the artificial chordae X in the sheath 10 until the regurgitation disappears or reaches the mildest state, and the rotation is stopped, and the effective length of the artificial chordae X is reasonably shortened.

[0067] Step 4: If Fig.14 As shown, after the adjustment state is determined, the first knob 311 is rotated in the reverse direction to release the threaded connection between the driving rod 210 and the rotating member 20, and then the third knob 313 is controlled to make the outer tube 230 drive the sleeve 231 to retreat, so that the S-shaped surface matching part of the second connecting member 221 and the first connecting member 50 is exposed outside the sleeve 231 and separated. At this time, the wire locker 100 and the conveying device 200 are released.

[0068] Step 5: If Fig.15 As shown, the guide device and the delivery device 200 are withdrawn, and the wire locking device 100 is left in the patient's body as an implant and connected to the artificial chord X, thereby completing the adjustment of the artificial chord X.

[0069] During the entire adjustment process, the effective length of the artificial chords can be adjusted by controlling the corresponding rotation, which is easy to operate and saves time. Furthermore, the artificial chords are wound on the smooth rotating part 20, which causes almost no damage to the artificial chords and provides high safety for the device. In addition, by controlling the rotation angle of the rotating part 20, the artificial chords can be regulated in an equal amount, and the length of the artificial chords can be flexibly and quantitatively adjusted in real time according to the actual clinical needs of the patient. Moreover, the rotating part 20 can only rotate in one direction relative to the sheath 10 to prevent the adjusted artificial chords from loosening again and to prevent the wire locker 100 from falling off after implantation.

[0070] Please also read Fig.16 and Fig.17 The structure of the rotary artificial chord adjustment system provided in the second embodiment of the present invention is similar to the structure of the rotary artificial chord adjustment system 1000 of the first embodiment, except that: in the second embodiment, the proximal end of the rotating member 20 of the wire lock 100b is directly fixedly connected to the first connecting member 50, and the first limiting member 31 is a toothed ring arranged on the proximal outer circumference of the rotating member 20b, and the toothed ring includes a plurality of tooth openings 36 continuously arranged around the circumference of the rotating member 20, each of the tooth openings 36 includes a guide sliding surface 361 extending around the circumference of the rotating member 20 and gradually away from the outer circumference of the rotating member 20 along the extension direction, and a stop surface 362 connected to the end of the guide sliding surface 361 and extending approximately radially of the rotating member 20; the second limiting member 32 is at least a pair of spring plates arranged on the proximal inner circumference of the sheath 10, and each of the spring plates extends toward the inner cavity of the sheath and the extension direction is opposite to the extension direction of the guide sliding surface 361. Specifically, in this embodiment, the gear ring includes a plurality of ratchet teeth 37 protruding from the proximal outer peripheral surface of the rotating member 20 and continuously arranged around the circumference thereof, and a tooth opening 36 is formed between each two adjacent ratchet teeth 37; two pairs of spring plates are correspondingly arranged at the proximal end of the sleeve 10, and the two pairs of spring plates are symmetrically arranged about the circumference of the sleeve 10; the free end of each of the spring plates is accommodated in a tooth opening 36 of the gear ring, and when the rotating member 20 drives the gear ring to rotate forwardly relative to the spring plate, the free end of the spring plate alternately slides and contacts with the guide surfaces 361 of the plurality of tooth openings 36 of the gear ring; after the rotating member 20 and the gear ring stop rotating forwardly, the free end of the spring plate abuts against the anti-rotation surface 362 of a tooth opening 36 of the gear ring, thereby preventing the rotating member 20 from rotating in the opposite direction relative to the sleeve 10, causing the artificial tendon wound on the rotating member 20 to loosen.

[0071] In other embodiments, the gear ring may include a plurality of tooth grooves opened on the proximal outer peripheral surface of the rotating member 20 and continuously arranged around the circumference thereof, each of the tooth grooves forming a tooth opening 36, and the free end of the spring in the proximal inner cavity of the sheath 10 is obliquely inserted into the tooth groove, which can achieve the same effect, which is not elaborated here.

[0072] Compared with the first embodiment, the rotary artificial chord adjustment system provided in this embodiment omits the elastic member 35 and the limit member 40, so that the overall structure of the wire locking device 100b is simpler and lighter. When the wire locking device 100b is connected to the artificial chord and placed in the patient's body as an implant, the effect of the wire locking device 100b on the artificial chord under the action of gravity is also weaker.

[0073] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A rotary artificial chord adjustment system, characterized in that: The invention comprises a wire locker, the wire locker comprises a sheath for hooking an artificial tendon cord and a rotating member rotatably arranged in the sheath, the sheath is provided with a receiving cavity extending in the axial direction, the rotating member is accommodated in the receiving cavity and a radial gap is arranged between the rotating member and the sheath; the rotating member rotates unidirectionally relative to the sheath, and the rotating member winds the artificial tendon cord hooked by the sheath to increase the length of the artificial tendon cord accommodated in the sheath; The wire locker further comprises a limiting mechanism disposed at the proximal end of the rotating member, wherein the limiting mechanism allows the rotating member to rotate in a positive direction relative to the sheath to wind the artificial tendon cord, and stops the rotating member from rotating in a reverse direction relative to the sheath to prevent the artificial tendon cord from loosening; Wherein, the limiting mechanism includes a first limiting member and a second limiting member cooperating with the first limiting member, the first limiting member is fixedly arranged at the proximal end of the rotating member, and the second limiting member is arranged opposite to the first limiting member and is relatively fixed to the circumferential position of the sheath.

2. The rotary artificial chord adjustment system according to claim 1, characterized in that: The first limiting member and the second limiting member are a pair of end bevel gears meshing with each other, each of the end bevel gears includes an annular base and a plurality of meshing teeth protruding from one end of the annular base close to the other end bevel gear, and the plurality of meshing teeth are continuously arranged along the circumference of the annular base.

3. The rotary artificial chord adjustment system according to claim 2, characterized in that: The limiting mechanism also includes an elastic member arranged in the sleeve, and the elastic member enables the second limiting member to float axially relative to the first limiting member and maintain sliding contact with the first limiting member when the first limiting member rotates forwardly relative to the second limiting member, and enables the second limiting member to stop the first limiting member after the first limiting member stops rotating forwardly.

4. The rotary artificial chord adjustment system according to claim 3, characterized in that: The proximal end of the second limiting member is fixedly connected to a limiting member, and the elastic member abuts between the limiting member and the proximal end of the sheath.

5. The rotary artificial chord adjustment system according to claim 4, characterized in that: The first limiting member, the second limiting member and the limiting member are provided with a first through passage along the axial direction.

6. The rotary artificial chord adjustment system according to claim 1, characterized in that: The first limiting member is a toothed ring arranged on the proximal outer circumference of the rotating member, the toothed ring includes a plurality of tooth openings continuously arranged around the circumference of the rotating member, each of the tooth openings includes a guide sliding surface extending around the circumference of the rotating member and gradually away from the outer circumference of the rotating member along the extension direction, and a stop surface connected to the end of the guide sliding surface and extending along the approximately radial direction of the rotating member; the second limiting member is at least a pair of spring plates arranged on the proximal inner circumference of the sheath, each of the spring plates extends toward the inner cavity of the sheath and the extension direction is opposite to the extension direction of the guide sliding surface.

7. The rotary artificial chord adjustment system according to claim 6, characterized in that: The free end of each of the spring sheets is accommodated in a tooth opening of the gear ring; when the rotating member drives the gear ring to rotate forwardly relative to the spring sheet, the free end of the spring sheet alternately slides in contact with the guide surfaces of multiple tooth openings of the gear ring; after the rotating member and the gear ring stop rotating forwardly, the free end of the spring sheet abuts against the anti-rotation surface of a tooth opening of the gear ring.

8. The rotary artificial chord adjustment system according to claim 7, characterized in that: The gear ring includes a plurality of ratchet teeth protruding from the proximal outer circumference of the rotating member and continuously arranged around its circumference, and a tooth opening is formed between each two adjacent ratchet teeth; or, the gear ring includes a plurality of tooth grooves opened on the proximal outer circumference of the rotating member and continuously arranged around its circumference, and each tooth groove forms a tooth opening.

9. The rotary artificial chord adjustment system according to claim 1, characterized in that: The outer wall of the distal end of the sheath is provided with a first hook groove penetrating to the receiving cavity, and the distal end of the rotating member is correspondingly provided with a second hook groove, and the first hook groove is connected with the second hook groove to hook the artificial tendon cord.

10. The rotary artificial chord adjustment system according to claim 9, characterized in that: The sheath comprises a hollow main body with two open ends and a cover body covering the distal end of the main body, wherein the cover body and the main body are covered to form the receiving cavity.

11. The rotary artificial chord adjustment system according to claim 10, characterized in that: The proximal surface of the cover body is convexly provided with an annular convex rafter, and the annular convex rafter is accommodated in the distal inner cavity of the main body; when the rotating member is accommodated in the accommodating cavity, the distal end of the rotating member is accommodated in the groove surrounded by the annular convex rafter, and the distal end surface of the rotating member abuts against the bottom of the groove.

12. The rotary artificial chord adjustment system according to claim 9, characterized in that: The first hook groove includes a straight groove extending along the radial direction of the sheath, and a U-shaped groove connected to the straight groove and extending along the axial direction of the sheath; the width of the straight groove along the axial direction of the sheath is greater than 2 mm, and the width of the U-shaped groove along the radial direction of the sheath and the depth along the axial direction of the sheath are both greater than 2 mm.

13. The rotary artificial chord adjustment system according to claim 12, characterized in that: The second hook groove includes a receiving groove corresponding to the U-shaped groove of the first hook groove, and the artificial tendon cord hooked by the sheath is radially received in the receiving groove; when the rotating member rotates forward relative to the sheath, the artificial tendon cord is wound around the portion of the outer circumferential surface of the rotating member corresponding to the receiving groove.

14. The rotary artificial chord adjustment system according to claim 13, characterized in that: The outer wall of the rotating member is provided with at least one clamping platform at a notch position corresponding to the receiving groove, the outer side surface of the clamping platform is clearance-matched with the inner circumference of the sleeve, and an axial clearance is provided between the proximal end surface of the clamping platform and the bottom of the receiving groove.

15. The rotary artificial chord adjustment system according to any one of claims 1 to 14, characterized in that: The rotary artificial chord adjustment system also includes a delivery device, which includes a driving rod detachably connected to the rotating member, and the rotation of the driving rod drives the rotating member to rotate in a positive direction relative to the sheath.

16. The rotational artificial chord adjustment system according to claim 15, characterized in that: A threaded hole is arranged at the proximal end of the rotating member, the distal end of the driving rod is threadedly connected to the rotating member, and the spiral direction of the internal thread of the threaded hole is opposite to the rotation direction of the rotating member relative to the positive rotation of the sheath.

17. The rotational artificial chord adjustment system according to claim 15, characterized in that: The conveying device also includes a connecting tube that is sleeved on the outside of the driving rod, a first connecting piece is provided at the proximal end of the sheath, and a second connecting piece is provided at the distal end of the connecting tube, and the first connecting piece and the second connecting piece are detachably connected to limit the circumferential position of the sheath, so that the rotation of the driving rod drives the rotating piece to rotate in a positive direction relative to the sheath.

18. The rotational artificial chord adjustment system according to claim 17, characterized in that: The conveying device further comprises an outer tube sleeved on the outside of the connecting tube, and the outer tube restricts the separation of the first connecting member and the second connecting member.

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