Transcatheter shrink ring system

Abstract

The present invention provides a transcatheter ring shrinking system. The transcatheter ring shrinking system includes a forming ring, at least two rivets and a rivet implanting device; the rivet implanting device includes at least two rivet-feeding sutures; the distal end of the rivet-feeding suture is folded in half and hung on the outer surface of the forming ring, and the two free ends of the rivet-feeding suture extend outside the body; the forming ring is generally straight during transportation, and the forming ring is arc-shaped or ring-shaped in a natural state. When the forming ring rebounds to a ring or arc shape and fits a predetermined treatment site, the rivet is transported to the forming ring along the rivet-feeding suture, and the forming ring is fixed to the treatment site. The transcatheter ring shrinking system provided by the present invention can accurately set the fixed positions of multiple rivets, facilitate the uniform distribution of multiple rivets, improve the ring shrinking effect, and is simple to operate.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and relates to an interventional treatment device for valvular diseases, and in particular to a transcatheter shrink ring system. Background Art

[0002] Mitral regurgitation is a common heart valve disease caused by organic or functional changes in the mitral valve leaflets, valve ring, papillary muscles, chordae tendineae and other components, resulting in poor anastomosis between the anterior and posterior leaflets of the mitral valve. The traditional standard treatment method is surgery, mainly including valve repair or valve replacement, among which mitral annuloplasty is a common repair procedure.

[0003] In recent years, a variety of interventional medical devices for treating mitral regurgitation have emerged. The prior art discloses an interventional annuloplasty ring, which is implanted through a transcatheter path, with multiple rivets implanted in sequence to gradually fix the annuloplasty ring with the natural valve ring, and then tightens the annuloplasty ring, thereby reducing the size of the valve ring and alleviating mitral regurgitation. This technology has the following defects: 1. The implantation of rivets and the delivery of the valve forming ring are carried out simultaneously. The rivets are wrapped in the forming ring. The forming ring is gradually delivered by pushing out the rivets one by one. With the adjustment and uncertainty of the rivet position, the position of the forming ring will also change accordingly, which will eventually affect the position accuracy and treatment effect of the forming ring connected to the natural valve ring, and increase the risk of surgery; 2. The position of the rivet wrapped in the forming ring has a visual prompt in the corresponding area of ​​the forming ring, but the rivet itself has no other connection with the forming ring in the forming ring. With the beating of the heart, it is difficult to grasp the exact implantation position of the rivet, which will cause uneven rivet arrangement and affect the ring shrinking effect; 3. During the operation, in order to ensure the uniform arrangement of the rivets as much as possible, the doctor's professional quality and proficiency in the use of instruments are required to be high, and the operation is difficult. Summary of the invention

[0004] The invention provides a transcatheter ring shrinking system, which can accurately set the implantation position of the rivet so that the implantation spacing of the rivet is uniform to ensure the ring shrinking effect, and the operation is simple.

[0005] The present invention provides a transcatheter ring shrinking system, comprising a forming ring, at least two rivets and a rivet implanting device;

[0006] The rivet implantation device comprises at least two rivet-delivering sutures; the distal ends of the rivet-delivering sutures are folded in half and hung on the outer surface of the forming ring, and the two free ends of the rivet-delivering sutures extend outside the body;

[0007] The shaping ring is roughly straight during transportation, and is arc-shaped or ring-shaped in a natural state. When the shaping ring rebounds into a ring or arc shape and fits onto a predetermined treatment site, the rivet is delivered to the shaping ring along the rivet delivery suture and fixes the shaping ring to the treatment site.

[0008] The transcatheter ring shrinkage system provided in an embodiment of the present invention has multiple rivet delivery sutures hung on the outer surface of the shaping ring, and the multiple rivet delivery sutures serve as channels for delivering rivets. The rivets are delivered to the shaping ring along the rivet delivery sutures, and the rivets fix the shaping ring and the mitral valve ring to adjust the shape and circumference of the mitral valve ring, thereby treating valvular regurgitation.

[0009] Compared with the prior art, the present invention has at least the following beneficial effects:

[0010] (1) The shaping ring is delivered first and then the rivet is delivered. The relative position of the shaping ring and the mitral valve ring can be adjusted first, which ensures the treatment effect and reduces the surgical risk.

[0011] (2) The connection point between the rivet feeding suture and the forming ring is fixed. Each time the rivet is implanted, the connection point between the rivet feeding suture and the forming ring is fixed and unique, ensuring that the rivets are evenly arranged after implantation and the ring shrinking effect is good;

[0012] (3) The shaping ring is delivered first and then the rivet is delivered, which requires less proficiency of the doctor, reduces the difficulty of the operation, and is simple to operate. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0014] Figure 1 It is a structural schematic diagram of a transcatheter shrink ring system provided by an embodiment of the present invention;

[0015] Figure 2 yes Figure 1 A schematic structural diagram of a forming ring conveying device;

[0016] Figure 3 yes Figure 1 A schematic diagram of the structure in which the forming ring conveying device is installed on the adjustable bend guide device;

[0017] Figure 4 yes Figure 2 A schematic diagram of the structure in which a forming ring in a forming ring conveying device is inserted into an adjustable bending guide device;

[0018] Figure 5 yes Figure 2 A schematic diagram of a shaping ring in a shaping ring delivery device being attached to a mitral valve annulus;

[0019] Figure 6 yes Figure 2An enlarged schematic diagram of the layout of the forming rings in the forming ring conveying device;

[0020] Figure 7 yes Figure 1 A schematic diagram of the structure of the rivet implantation device;

[0021] Figure 8 It is a schematic structural diagram of a rivet implantation device provided in an embodiment of the present invention implanting rivets into a shaping ring and a mitral valve ring by feeding sutures;

[0022] Fig. 9 yes Figure 8 The schematic diagram of the structure in which the mitral valve ring is omitted;

[0023] Fig.10 It is a structural schematic diagram of a rivet implanting device provided by an embodiment of the present invention implanting a rivet at each setting position of a rivet feeding suture;

[0024] Fig.11 yes Fig.10 A schematic diagram of the structure of removing the stapler and suture;

[0025] Fig.12 yes Figure 6 A cross-sectional view of a shaping ring including a shrinking ring suture;

[0026] Fig.13 yes Figure 6 A cross-sectional view of the shaping ring including the shrinking ring suture and the protective sleeve;

[0027] Fig.14 yes Fig.13 A schematic diagram of the internal structure of a forming ring with a protective sleeve after being fixed by rivets is provided;

[0028] Fig.15 yes Figure 6 A cross-sectional view of the forming ring including a shrink ring suture, an inner ring support assembly and an outer ring support assembly;

[0029] Fig.16 yes Fig.15 A schematic diagram of the structure of the inner ring support assembly and the outer ring support assembly;

[0030] Fig.17 yes Fig.16 A schematic diagram of the structure in which the inner ring support assembly and the outer ring support assembly form a closed loop during rebound;

[0031] Fig.18 yes Fig.15 A schematic diagram of the structure in which a forming ring having an inner ring support assembly and an outer ring support assembly forms a closed ring during springback;

[0032] Fig.19 yes Fig.18Schematic diagram of the internal structure of the forming ring forming a closed ring during springback;

[0033] Fig. 20 yes Figure 7 A schematic diagram of the cross-sectional structure of a rivet in FIG.

[0034] Fig.21 yes Figure 7 A schematic diagram of the structure in which the rivet in the figure is hooked with the connecting pipe;

[0035] Fig. 22 yes Figure 1 A schematic diagram of the structure of the adjustable curved guide device entering the left atrium; DETAILED DESCRIPTION

[0036] 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, rather than all the embodiments. The embodiments listed in the present invention can be appropriately combined with each other.

[0037] In the field of interventional medical device technology, the position close to the operator is generally defined as the proximal end, and the position far from the operator is defined as the distal end.

[0038] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, the element may be directly connected to the other element, or indirectly connected to the other element through one or more connecting elements. When an element is referred to as being "connected to" another element, it may be directly connected to the other element, or connected to the other element through one or more connecting elements.

[0039] like Figure 1 As shown, the transcatheter ring shrinkage system 1000 provided in an embodiment of the present invention includes a guiding device 100, a shaping ring 400, at least two rivets 500, a shaping ring delivery device 200 for delivering the shaping ring 400 to the mitral valve annulus, and a rivet implantation device 300 for delivering the rivets 500.

[0040] like Figure 1 As shown, the guide device 100 includes an adjustable sheath tube 110 and a bending handle 120 connected to the proximal end of the adjustable sheath tube 110. The distal end of the adjustable sheath tube 110 has an adjustable bending section, and the bending handle 120 can control the adjustable bending section and adjust the bending degree of the adjustable bending section, so that the distal end of the adjustable sheath tube 110 can reach a predetermined treatment site through a curved path such as a blood vessel. The guide device 100 can also be a pre-shaped sheath tube with different angles, so that the shaping ring delivery device 200 can be delivered to the predetermined treatment site through a curved path. In this embodiment, the predetermined treatment site is the mitral valve annulus, which will not be described in detail later.

[0041] like Figure 1 As shown, when the shaping ring delivery device 200 is used, the shaping ring delivery device 200 is movably installed in the inner cavity of the guide device 100. Specifically, the distal end of the shaping ring delivery device 200 is accommodated in the adjustable bending sheath tube 110. The proximal end of the shaping ring delivery device 200 is located outside the proximal end of the guide device 100.

[0042] like Figure 2 As shown, the shaping ring conveying device 200 is used to convey the shaping ring 400 , and the shaping ring conveying device 200 includes a pushing tube 220 and a conveying handle 230 .

[0043] The shaping ring 400 is arc-shaped or ring-shaped in a natural state. Figure 2 and Figure 3 As shown, the shaping ring 400 is generally straight during transportation and is installed in the adjustable bending sheath tube 110. When the shaping ring 400 is extended from the distal end of the guide device 100, it rebounds into a ring or arc shape. The embodiment of the present invention takes the state where the shaping ring delivery device 200 is installed in the inner cavity of the guide device 100 as an example for explanation, and will not be repeated in the following. For the convenience of description, the definition Figure 2 The direction from the mid-distal end to the proximal end is the axial direction of the forming ring delivery device 200, hereinafter referred to as the axial direction.

[0044] like Figure 2 As shown, the shaping ring 400, the pushing tube 220 and the delivery handle 230 are arranged in sequence along the axial direction. The shaping ring 400, the pushing tube 220 and the delivery handle 230 are all provided with an inner cavity extending from the proximal end to the distal end. The inner cavity of the shaping ring 400, the inner cavity of the pushing tube 220 and the inner cavity of the delivery handle 230 are connected in sequence.

[0045] like Figure 2 As shown, the push tube 220 can be a composite tube, and its distal end has a certain bending function, which is convenient for delivering the forming ring 400 to the mitral valve ring. The composite tube can include an inner membrane, an intermediate braided mesh and an outer membrane, which are formed by coating and hot-melt treatment. Among them, the material of the inner membrane can be polytetrafluoroethylene (PTFE), the material of the outer membrane can be polyether block polyamide (PEBAX), and the intermediate braided mesh is a metal material such as stainless steel. The push tube 220 can also use a single-layer tube for distal plasticity so that its distal end has a certain bending angle. The material of the single-layer tube can be polyethylene plastic (PE).

[0046] like Figure 2As shown, the distal end of the push tube 220 movably abuts the proximal end of the shaping ring 400. In other words, when the push tube 220 moves toward the distal end, the distal end of the push tube 220 can push the shaping ring 400 to move toward the distal end together. When the push tube 220 moves toward the proximal end, the distal end of the push tube 220 can be separated from the proximal end of the shaping ring 400. The distal end of the delivery handle 230 is connected to the proximal end of the push tube 220, and the delivery handle 230 is operated to control the push tube 220 to push the shaping ring 400 to move toward the distal end. When the push tube 220 pushes the shaping ring 400 out of the distal end of the adjustable bending sheath tube 110, the shaping ring 400 rebounds in a ring or arc shape. Preferably, in order to increase the strength of the shaping ring 400 and improve the ring shrinking effect, the shaping ring 400 after rebounding is in a closed ring shape.

[0047] In this embodiment, Figure 4 As shown, the shaping ring 400 is in a flat strip-shaped tube shape. The outer surface of the shaping ring 400 includes a first surface 411 and a second surface 412 disposed opposite to each other. Figure 5 As shown, the first surface 411 is used to fit the mitral valve ring 2000 (ie, the treatment site) when the shaping ring 400 rebounds into a ring or arc shape. The second surface 412 is used to thread and hang the nail delivery suture 310 .

[0048] like Figure 6 and Figure 7 As shown, the rivet implantation device 300 is used to deliver and implant at least two rivets 500, including at least two rivet delivery sutures 310 and an implantation tube 320. The implantation tube 320 is detachably connected to the proximal end of the rivet 500. When the shaping ring 400 rebounds to be annular or arc-shaped and fits the mitral valve ring 2000 (predetermined treatment site), the implantation tube 320 delivers the rivet 500 to the shaping ring 400 along the rivet delivery suture 310, and the rivet 500 fixes the shaping ring 400 at the mitral valve ring 2000. Since the annular or arc-shaped shaping ring 400 fits and is fixed at the mitral valve ring 2000, the mitral valve ring 2000 can be pulled to adjust the shape and size of the natural valve ring, thereby achieving the effect of shrinking the ring and shaping.

[0049] like Figure 6 As shown, the nail delivery suture 310 is folded in a U shape and arranged in the axial direction. The distal end of the nail delivery suture 310 after being folded in half is hung on the outer surface (i.e., the second surface 412) of the shaping ring 400. The portion between the distal end and the proximal end of the nail delivery suture 310 extends axially outside the outer surface of the shaping ring 400 and then is installed in the inner cavity of the push tube 220 and the inner cavity of the delivery handle 230. Both ends of the nail delivery suture 310 are free ends, and the two free ends extend outside the body.

[0050] like Figure 6As shown, the distal end of each nail delivery suture 310 is U-shaped and movably hung on the outer surface of the shaping ring 400. Specifically, each nail delivery suture 310 passes through the tube wall of the shaping ring 400 from the outer surface of the shaping ring 400, advances a short distance in the tube wall of the shaping ring 400, and then passes out from the outer surface of the shaping ring 400.

[0051] Furthermore, if Figure 6 As shown, the distal ends of the plurality of nail-feeding sutures 310 are sequentially staggered and hung on the outer surface of the forming ring 400 along the axial direction. The two nail-feeding sutures 310 do not overlap and are not entangled in the axial direction. In other words, the distal ends of the plurality of nail-feeding sutures 310 have different hanging positions on the outer surface of the forming ring 400. The plurality of hanging positions formed by the plurality of nail-feeding sutures 310 on the outer surface of the forming ring 400 are arranged at intervals along the axial direction. Furthermore, the plurality of hanging positions can be distributed at equal intervals.

[0052] Specifically, Figure 8 and Fig. 9 As shown, each rivet feeding suture 310 is folded to form a channel for feeding rivets 500, so that the rivets 500 can be fed through the rivet feeding suture 310 in sequence during subsequent operations. Fig.10 As shown, a rivet 500 is delivered on each suture 310 and the shaping ring 400 and the mitral valve ring 2000 are fixedly connected by the rivet 500. Fig.11 As shown, by pulling any one of the nail delivery sutures 310, the nail delivery suture 310 can be separated from the shaping ring 400, so that after the delivery of the rivet 500 is completed, the nail delivery suture 310 can be removed from the shaping ring 400. The number of nail delivery sutures 310 ranges from 2 to 15, preferably 8. In this embodiment, the number of nail delivery sutures 310 is 8. 8 rivets 500 are implanted. Of course, more or fewer rivets 500 can also be implanted according to the patient's physiological anatomical structure or clinical needs.

[0053] The transcatheter ring shrinkage system 1000 provided in an embodiment of the present invention has a plurality of rivet delivery sutures 310 pierced through the outer surface of the forming ring 400, and the plurality of rivet delivery sutures 310 are used as channels for delivering rivets 500. The push rivets 500 are delivered to the forming ring 400 along the rivet delivery sutures 310, and the rivets 500 fix the forming ring 400 and the mitral valve ring 2000, so as to adjust the shape of the mitral valve ring 2000 to be the same or similar to the shape of the forming ring 400, thereby shrinking the mitral valve ring 2000. By setting the positions of the plurality of rivet delivery sutures 310, the fixed positions of the plurality of rivets 500 can be accurately set, which facilitates the uniform distribution of the plurality of rivets 500, improves the ring shrinkage effect, and is simple to operate.

[0054] like Figure 2 and Fig.12As shown, the transcatheter ring shrinking system 1000 further includes at least one ring shrinking suture 600, which is folded in a U shape and arranged in the axial direction. The ring shrinking suture 600 is movably installed in the shaping ring 400 and is bent at the distal end of the shaping ring 400 to the outside of the shaping ring 400 and extends toward the proximal end. The free ends of the nail delivery suture 310 and the ring shrinking suture 600 are both passed through the proximal end of the push tube 220 and extend outside the body. Specifically, half of the folded shrink ring suture 600 is movably installed in the inner cavity of the delivery handle 230, the inner cavity of the push tube 220 and the inner cavity of the forming ring 400 in turn, and passes through the distal end of the forming ring 400, and then bends to go around the outside of the forming ring 400; the other half of the folded shrink ring suture 600 extends axially toward the proximal end of the forming ring 400, enters the inner cavity of the push tube 220 from the distal end of the push tube 220, passes through the inner cavity of the delivery handle 230 and then passes through the proximal end of the delivery handle 230. Both free ends of the ring shrinking suture 600 pass through the push tube 220 and extend to the proximal end of the delivery handle 230, thereby extending outside the patient's body. The operator can pull the ring shrinking suture 600 outside the patient's body to pull the shaping ring 400, so as to further cause the shaping ring 400 to bend and shape during subsequent operations, so as to adjust the circumference of the mitral valve ring 2000 (treatment site) and further shrink the mitral valve ring 2000. In this way, the shrinking effect of the mitral valve ring 2000 is improved.

[0055] Furthermore, if Fig.13 and Fig.14 As shown, the transcatheter shrink ring system 1000 also includes a plurality of protective sleeves 4700 fixed in the shaping ring 400. The protective sleeves 4700 can be sutured inside the shaping ring 400. The shrink ring suture 600 is movably installed in the plurality of protective sleeves 4700, and the shrink ring suture 600 can move freely inside the protective sleeves 4700. The number of protective sleeves 4700 is consistent with the number of rivets 500 to be implanted. The protective sleeves 4700 are arranged near the nail delivery suture 310. The position of each protective sleeve 4700 corresponds to the hanging position of one nail delivery suture 310 on the outer surface of the shaping ring 400. The length of the protective sleeve 4700 along the axial direction of the shrink ring suture 600 is greater than or equal to the outer diameter of the rivet 500. By arranging the protective sleeve 4700 on the shrink ring suture 600, it is possible to avoid the rivet 500 from interfering with the shrink ring suture 600 during implantation, and avoid affecting the subsequent pulling and tightening of the shrink ring suture 600.

[0056] The structure of the forming ring 400 is further described below in conjunction with the accompanying drawings.

[0057] like Fig.15As shown, the shaping ring 400 can be pre-shaped into a specific shape similar to the natural valve ring shape, such as a D-shaped ring or a C-shaped ring, preferably a D-shaped ring, which can shrink the mitral valve ring 2000 more evenly and comprehensively, and achieve better surgical results. The shaping ring 400 includes a flexible body 413 and at least one supporting component (see the attached Fig.15 The inner ring support assembly 460 and the outer ring support assembly 470 are installed in parallel with the shrink ring suture 600 in the flexible body 413. The support assembly is at least partially made of shape memory material and is heat-set. The support assembly is ring-shaped or arc-shaped in a natural state.

[0058] In this embodiment, at least one support assembly includes an inner ring support assembly 460 and an outer ring support assembly 470. The inner ring support assembly 460, the outer ring support assembly 470 and the shrink ring suture 600 are installed in the flexible body 413 substantially in parallel. The shrink ring suture 600 is located between the inner ring support assembly 460 and the outer ring support assembly 470. The length of the inner ring support assembly 460 is less than the length of the outer ring support assembly 470.

[0059] The flexible body 413 is flexible and can be made of a biocompatible polymer material, such as polyethylene terephthalate (PET). The flexible body 413 is in the shape of a bag with two ends open, and can be in the form of a gasket.

[0060] like Fig.15 and Fig.16 As shown, the inner ring support assembly 460 and the outer ring support assembly 470 are attached to and fixed on the inner wall of the inner cavity of the flexible body 413. The inner ring support assembly 460 and the outer ring support assembly 470 can move axially relative to the flexible body 413. The inner ring support assembly 460 and the outer ring support assembly 470 are symmetrically arranged about the central axis of the flexible body 413. The inner ring support assembly 460, the outer ring support assembly 470 and the flexible body 413 can be fixed by suture, and the suture is an implant-grade suture. The suture can be sutured in any way as long as it does not affect the axial movement of the inner ring support assembly 460 and the outer ring support assembly 470 in the flexible body 413.

[0061] The inner ring support assembly 460 and the outer ring support assembly 470 are both subjected to a heat setting process to adapt the shaping ring 200 to the physiological and anatomical structure of the natural valve ring. During the setting process, the inner ring support assembly 460 and the outer ring support assembly 470 are placed in a setting tooling mold, preferably at a setting temperature of 500±20°C and a setting time of 15min-25min for heat setting treatment, and are set to a shape similar to the natural valve ring, and then the inner ring support assembly 460 and the outer ring support assembly 470 are installed in the flexible body 413 and sutured and fixed thereto.

[0062] In this embodiment, the inner ring support assembly 460 and the outer ring support assembly 470 are shaped into a closed ring after being heat-set, so that the flexible body 413 forms a ring. The inner ring support assembly 460 is located in the inner ring, and the outer ring support assembly 470 surrounds the outer periphery of the inner ring support assembly 460.

[0063] like Fig.15 and Fig.16 As shown, the proximal end of the support assembly has a cavity, and when the support assembly rebounds in a natural state, the distal end of the support assembly is received in the cavity to form a ring. Specifically, the inner ring support assembly 460 includes an inner ring rod 461 and an inner ring tube 462, and the proximal end of the inner ring rod 461 is installed in the distal end of the inner ring tube 462; the outer ring support assembly 470 includes an outer ring rod 471 and an outer ring tube 472, and the proximal end of the outer ring rod 471 is installed in the outer ring tube 472, so that the forming ring 400 forms a stable closed ring structure after rebounding.

[0064] The inner ring rod 461 and the outer ring rod 471 are both solid rods or hollow tubes at least partially made of shape memory materials. Preferably, the inner ring rod 461 and the outer ring rod 471 are made of alloys with shape memory function, such as nickel titanium alloy, cobalt chromium alloy, etc. The inner ring tube 462 and the outer ring tube 472 are both hollow tubes, also made of shape memory materials, preferably the inner ring tube 462 and the outer ring tube 472 are made of shape memory alloys.

[0065] like Fig.17 As shown, a cavity is reserved at the proximal end of the inner ring tube 462 for accommodating the distal end of the inner ring rod 461, so that when the inner ring rod 461 rebounds, the distal end of the inner ring rod 461 is inserted into the proximal cavity of the inner ring tube 462 to form a closed ring structure. A cavity is reserved at the proximal end of the outer ring tube 472 for accommodating the distal end of the outer ring rod 471, so that when the outer ring rod 471 rebounds, the distal end of the outer ring rod 471 is inserted into the proximal cavity of the outer ring tube 472 to form a closed ring structure.

[0066] Furthermore, if Fig.18 and Fig.19 As shown, the shrink ring suture 600 is inserted between the inner ring support assembly 460 and the outer ring support assembly 470, and is close to the inner ring support assembly 460 or the outer ring support assembly 470, so as not to interfere with the implantation process of the rivet 500. By pulling the free end of the shrink ring suture 600, the depth to which the outer ring rod 471 is inserted in the outer ring tube 472 and the inner ring rod 461 is inserted in the inner ring tube 462 increases, and the shaping ring 400 gradually shrinks to further adjust the circumference of the mitral valve ring 2000.

[0067] It is understandable that in other embodiments, when the support assembly rebounds in a natural state, the distal end of the support assembly is close to the proximal end of the support assembly to form an arc with an opening. That is, the inner ring support assembly 460 may only include the inner ring rod 461, and the outer ring support assembly 470 may only include the outer ring rod 471. After being pushed out of the delivery sheath, the inner ring rod 461 and the outer ring rod 471 rebound to an arc in a natural state, respectively, with the distal end of the inner ring rod 461 close to the proximal end of the inner ring rod 461, and the distal end of the outer ring rod 471 close to the proximal end of the outer ring rod 471, so that the shaping ring 400 forms an arc and fits the mitral valve annulus. When the shrink ring suture 600 is pulled, the distal end of the support assembly is further approached to the proximal end of the support assembly, that is, the distal end of the inner circle rod 461 is further approached to the proximal end of the inner circle rod 461, and the distal end of the outer circle rod 471 is further approached to the proximal end of the outer circle rod 471; depending on clinical needs, in some embodiments, the two ends of the inner circle rod 461 can be partially overlapped, and the two ends of the outer circle rod 471 can also be partially overlapped to form closed annular structures respectively. At this time, the forming ring 400 forms an annular structure.

[0068] When using, Figure 3 As shown, the shaping ring 400 is straightened and installed in the adjustable bending sheath tube 110 of the guide device 100, as shown in FIG. Fig.15 As shown, since the components of the shaping ring 400 are made of flexible or semi-rigid materials, the inner ring support component 460 and the outer ring support component 470 are constrained by external force after being installed in the adjustable bending sheath tube 110, and are in a straight line or arc shape. Therefore, the shaping ring 400 can be smoothly straightened and installed in the adjustable bending sheath tube 110, and adapt along the inner cavity of the adjustable bending sheath tube 110 for transportation; the distal end of the adjustable bending sheath tube 110 is delivered to the vicinity of the patient's mitral valve ring 2000 by intervention, and the adjustable bending sheath tube 110 can deliver the distal end of the shaping ring delivery device 200 to the mitral valve ring 2000, and control the shaping ring delivery device 200 to release the shaping ring 400; as shown in FIG. Fig.18 As shown, after the shaping ring 400 is pushed out of the adjustable bending sheath tube 110 by the pushing tube 220, the inner ring support assembly 460 and the outer ring support assembly 470 rebound quickly due to their own shape memory properties. When the distal end of the outer ring rod 471 rebounds automatically, it is installed into the inner cavity of the proximal end of the outer ring tube 472 to form a closed ring. When the distal end of the inner ring rod 461 rebounds automatically, it is installed into the inner cavity of the proximal end of the inner ring tube 462 to form a closed ring, thereby driving the flexible body 413 to deform according to the fixed shape to form a closed shaping ring 400, so that the shaping ring 400 is similar in shape to the mitral valve ring 2000; Figure 5 As shown, by adjusting the push tube 220, the first surface 411 of the shaping ring 400 is fitted with the mitral valve ring 2000, and the push tube 220 is withdrawn. At this time, the nail delivery suture 310 and the ring shrinking suture 600 are still installed in the guide device 100, and the free ends of the nail delivery suture 310 and the ring shrinking suture 600 pass through the bending adjustment handle 120 and extend outside the patient's body; Figure 8 As shown, the implant tube 320 of the rivet implantation device 300 is then sent to the distal end through the inner cavity of the guide device 100 to reach the released shaping ring 400; Fig.10 As shown, by controlling the rivet implantation device 300 to implant multiple rivets 500 into the shaping ring 400 and the mitral valve ring 2000 in sequence, the shaping ring 400 and the mitral valve ring 2000 are fixedly connected to achieve the first shrinkage of the mitral valve ring 2000; Fig.11 As shown, by tightening the ring shrinking suture 600, the ring opening of the shaping ring 400 can be further shrunk, thereby performing a secondary ring shrinkage on the mitral valve ring 2000.

[0069] like Figure 7 As shown, the implant tube 320 includes a delivery sheath tube 321, a release tube 322 and a connecting tube 323. Fig. 20 As shown, the connecting tube 323 is installed in the release tube 322. The release tube 322 is installed in the delivery sheath 321. The distal end of the delivery sheath 321 is used to accommodate the proximal end of the rivet 500. The distal end of the connecting tube 323 is detachably connected to the proximal end of the rivet 500. The distal end of the release tube 322 is sleeved at the connection between the connecting tube 323 and the rivet 500 to constrain the connection between the connecting tube 323 and the rivet 500.

[0070] like Fig. 20 and Fig.21 As shown, the rivet 500 is in the form of a spiral rivet. The rivet 500 includes a spiral structure 501 located at the distal end and a rivet seat 502 located at the proximal end, and the two are fixedly connected.

[0071] like Fig.21 As shown, the distal end of the spiral structure 501 has a sharp tip. The proximal end of the rivet seat 502 is detachably connected to the connecting tube 323. The connecting tube 323 drives the rivet seat 502 to rotate, so that the sharp tip of the spiral structure 501 pierces the shaping ring 400 and rotates into the treatment site to fix the shaping ring 400 on the mitral valve annulus 2000.

[0072] like Fig. 20 and Fig.21 As shown, the rivet seat 502 includes a base 503 and a first hook portion 504 integrally formed with the base 503. The first hook portion 504 is arranged at the proximal end of the base 503. The first hook portion 504 has a certain curvature and is hook-shaped. A second hook portion 324 that matches the curvature of the first hook portion 504 is arranged at the distal end of the connecting tube 323. The portion where the first hook portion 504 and the second hook portion 324 are hooked is inserted into the release tube 322, so that a detachable fixed connection is formed between the rivet 500 and the connecting tube 323 by the restraint of the release tube 322 (such as Fig.11 shown).

[0073] After the rivet 500 fixes the shaping ring 400 and the mitral valve ring 2000, the release tube 322 is withdrawn for a distance toward the proximal end, and the part where the first hook portion 504 and the second hook portion 324 are hooked is exposed from the release tube 322, and the rivet 500 and the connecting tube 323 are no longer bound by the release tube 322 and are released. At this time, the connecting tube 323 can be removed, and the rivet 500 is left on the shaping ring 400.

[0074] like Fig. 20 As shown, the radial dimension of the first hook portion 504 is smaller than the radial dimension of the base 503, and a step 505 is formed between the base 503 and the first hook portion 504. The distal end of the delivery sheath 321 abuts against the step 505, so that the delivery sheath 321 can carry the rivet 500 to move.

[0075] like Fig.10 As shown, a through cavity is provided inside the assembly formed by the spiral structure 501 of the rivet 500, the rivet seat 502 and the connecting tube 323. The two free ends of the suture 310 can pass through the through cavity from the proximal end of the rivet 500 to the proximal end of the connecting tube 323. The rivet 500 can be driven to rotate by rotating the connecting tube 323, so that the rivet 500 pierces the shaping ring 400 and screws into the tissue, thereby fixing the shaping ring 400 to the mitral valve ring 2000.

[0076] To facilitate puncture, the spiral structure 501 is made of metal material, such as implant grade stainless steel. The rivet seat 502 can be made of implant grade polymer material or metal material, such as polyetheretherketone (PEEK), polycarbonate (PC), stainless steel, etc., preferably stainless steel, and can be laser welded or integrally formed with the spiral structure 501.

[0077] The delivery sheath 321 and the release tube 322 can be a single-layer flexible tube or a multi-layer composite tube, such as a nickel-titanium tube, a composite catheter, a nylon tube, etc.

[0078] The connecting tube 323 can be made of a metal tube or a polymer material tube, such as a nickel-titanium tube or a PEEK tube, so as to pass through the curved guide device 100 and have a certain degree of torsion control to drive the rivet 500 to rotate.

[0079] The rivet implanting device 300 can be assembled, disassembled and connected with a plurality of rivets 500 in sequence. Therefore, a plurality of rivets 500 can be implanted in sequence using a set of rivet implanting devices 300.

[0080] The following briefly describes the application process of the transcatheter shrink ring system 1000 according to an embodiment of the present invention in mitral annuloplasty, and the surgical path is: via the femoral vein-inferior vena cava-right atrium-atrial septum-left atrium-mitral valve ring 2000.

[0081] Step 1: Puncture through the femoral vein and establish a track of femoral vein-inferior vena cava-right atrium-atrial septum-left atrium-mitral valve ring 2000 through a guide wire (not shown) and an atrial septal puncture device (not shown).

[0082] The second step is, Fig. 22 As shown, the guide device 100 is advanced along the guide wire until the distal end of the adjustable curved sheath tube 110 passes through the oval foramen to reach the left atrium, and the guide wire is withdrawn.

[0083] The third step is Figure 3 As shown, the shaping ring delivery device 200 is installed in the adjustable bending sheath tube 110 of the guide device 100, and the distal end of the adjustable bending sheath tube 110 is delivered to the vicinity of the mitral valve ring 2000. The shaping ring 400 is pushed out from the distal end of the adjustable bending sheath tube 110. Fig.18 As shown, since the forming ring 400 is provided with an inner ring support assembly 460 and an outer ring support assembly 470 with shape memory function, the inner ring support assembly 460 and the outer ring support assembly 470 drive the flexible body 413 of the forming ring 400 to deform according to a fixed shape to form a closed ring-shaped forming ring 400.

[0084] The fourth step is Figure 5 As shown, the shaping ring 400 is fitted to the mitral valve ring 2000 by adjusting the push tube 220, and the push tube 220 is withdrawn. At this time, the nail delivery suture 310 is still hung on the outer surface of the shaping ring 400, and the ring shrinking suture 600 is still installed in the shaping ring 400. The free ends of the nail delivery suture 310 and the ring shrinking suture 600 are passed through the adjustable bending sheath tube 110, out of the bending handle 120 and extend to the patient's body.

[0085] Step 5: Figure 8 and Fig. 9 As shown, one group of the sutures 310 is selected to pass through the inner cavity of the rivet implantation device 300, and then the rivet implantation device 300 passes through the guide device 100 along the sutures 310 to reach the surface of the shaping ring 400, and drives the rivet 500 at the distal end to rotate by twisting the connecting tube 323 until the rivet 500 pierces the shaping ring 400 and screws into the mitral valve ring 2000, thereby fixing the shaping ring 400 to the mitral valve ring 2000.

[0086] Step 6: Fig.10As shown, the rivet implantation device 300 is withdrawn, another rivet 500 is assembled with the rivet implantation device 300, and step five is repeated to implant multiple rivets 500 into the mitral valve annulus 2000 along each group of rivet delivery sutures 310 in sequence, and the rivet implantation device 300 is withdrawn.

[0087] Step 7: Fig.11 As shown, each group of staple delivery sutures 310 has two free ends outside the handle. By pulling one of the free ends, the other free end passes through the inner cavity of the guide device 100, passes over the forming ring 400, and is pulled out of the body, thereby withdrawing each group of staple delivery sutures 310 from the guide device 100 in turn.

[0088] Step 8: Fig.11 As shown, the shaping ring 400 has been fixedly connected with the mitral valve ring 2000 by means of eight rivets 500, and the two free ends of the shrinking ring suture 600 installed inside the shaping ring 400 extend out of the body. By pulling the shrinking ring suture 600, the shaping ring 400 can be driven to shrink, thereby driving the mitral valve ring 2000 to shrink, thereby achieving a shrinking ring effect. At the same time, the mitral valve regurgitation can be observed by means of a medical imaging device. When the regurgitation disappears or reaches the mildest state, the shrinking ring suture 600 is knotted or locked to complete the operation.

[0089] Compared with the prior art, the present invention has at least the following beneficial effects:

[0090] (1) The shaping ring 400 is delivered first and then the rivet 500 is delivered. The relative position of the shaping ring 400 and the mitral valve ring 2000 is adjusted first, and the position of the rivet 500 is then more accurate, which can ensure that the relative position of the shaping ring 400 and the mitral valve ring 2000 is more ideal, the treatment effect is guaranteed, and the surgical risk is also reduced;

[0091] (2) The connection point between the rivet-feeding suture 310 and the forming ring 400 is fixed. Each time the rivet 500 fed by the rivet-feeding suture 310 is implanted, the connection point between the rivet 500 and the forming ring 400 is fixed and unique, ensuring that the rivet 500 is evenly arranged and the ring shrinking effect is good;

[0092] (3) The doctor's proficiency requirements are low, the operation difficulty is reduced, and the operation is simple;

[0093] (4) When the rivet 500 is implanted, the shaping ring 400 is fixedly connected to the mitral valve ring 2000 to achieve the first ring contraction, and then the ring contraction suture 600 is pulled to further ensure the ring contraction effect.

[0094] The above are some embodiments of the present invention. It should be pointed out that a person skilled in the art can make several improvements and modifications without departing from the principles 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 transcatheter ring shrinkage system, characterized in that: It includes a forming ring, at least two rivets and a rivet implanting device; The rivet implantation device comprises at least two rivet-delivering sutures; the distal ends of the rivet-delivering sutures are folded in half and hung on the outer surface of the forming ring, and the two free ends of the rivet-delivering sutures extend outside the body; The shaping ring is in a flat strip-shaped tube shape. The shaping ring is substantially straight when being transported. The shaping ring is in an arc shape or a ring shape in a natural state. When the shaping ring rebounds into a ring shape or an arc shape and fits a predetermined treatment site, the rivet is transported to the shaping ring along the rivet delivery suture and fixes the shaping ring to the treatment site. The transcatheter shrink ring system also includes at least one shrink ring suture, a shaping ring delivery device and a guide device; the shrink ring suture is movably installed in the shaping ring and is bent at the distal end of the shaping ring to the outside of the shaping ring and extends toward the proximal end, and the two free ends of the shrink ring suture extend outside the body; the shaping ring delivery device includes a push tube movably abutted against the proximal end of the shaping ring, and the free ends of the nail delivery suture and the shrink ring suture both pass through the proximal end of the push tube and extend outside the body; the shaping ring is installed in the guide device during delivery, and the shaping ring rebounds in a ring or arc shape when extending from the distal end of the guide device.

2. The transcatheter shrink ring system according to claim 1, characterized in that: The shaping ring comprises a first surface and a second surface which are arranged opposite to each other, wherein the first surface is used to fit the treatment site, and the distal ends of the at least two staple delivery sutures are sequentially staggered and hung on the second surface.

3. The transcatheter shrink ring system according to claim 1, characterized in that: The transcatheter shrink ring system also includes a plurality of protective sleeves fixed in the forming ring, and the shrink ring suture is movably inserted into the plurality of protective sleeves. The position of each protective sleeve corresponds to a hanging position of a rivet delivery suture on the outer surface of the forming ring, and the length of the protective sleeve along the axial direction of the shrink ring suture is greater than or equal to the outer diameter of the rivet.

4. The transcatheter shrink ring system according to claim 1, characterized in that: The forming ring includes a flexible body and at least one supporting component. The supporting component is installed in parallel with the shrinking ring suture in the flexible body. The supporting component is at least partially made of shape memory material and is heat-set. The supporting component is ring-shaped or arc-shaped in a natural state.

5. The transcatheter shrink ring system according to claim 4, characterized in that: When the support component rebounds in a natural state, the distal end of the support component approaches the proximal end of the support component to form the arc shape; When the shrink ring suture is pulled, the distal end of the support component moves further toward the proximal end of the support component.

6. The transcatheter shrink ring system according to claim 4, characterized in that: The proximal end of the support component has a cavity, and when the support component rebounds in a natural state, the distal end of the support component is received in the cavity to form the ring shape.

7. The transcatheter shrink ring system according to claim 6, characterized in that: The support assembly includes a ring rod and a ring tube, the proximal end of the ring rod is inserted into the distal end inner cavity of the ring tube, and the distal end of the ring rod is inserted into the proximal end inner cavity of the ring tube when the support assembly rebounds; When the shrink ring suture is pulled, the depth to which the distal end of the coil rod is inserted into the proximal inner cavity of the coil tube increases.

8. The transcatheter shrink ring system according to claim 4, characterized in that: The at least one support assembly includes an inner ring support assembly and an outer ring support assembly, the inner ring support assembly and the outer ring support assembly are arranged in parallel, the axial length of the inner ring support assembly is smaller than the axial length of the outer ring support assembly, and the shrink ring suture is arranged between the inner ring support assembly and the outer ring support assembly.

9. The transcatheter shrink ring system according to claim 1, characterized in that: The rivet implantation device also includes an implantation tube, which includes a connecting tube and a release tube. The distal end of the connecting tube is detachably connected to the proximal end of the rivet. The release tube is coaxially arranged with the connecting tube, and the distal end of the release tube is sleeved on the connection between the connecting tube and the rivet.

10. The transcatheter shrink ring system according to claim 9, characterized in that: The rivet includes a spiral structure and a rivet seat connected to the proximal end of the spiral structure. The distal end of the spiral structure is a pointed tip. The proximal end of the rivet seat is detachably connected to the connecting tube. The connecting tube drives the rivet seat to rotate so that the distal end of the spiral structure pierces the shaping ring and is screwed into the treatment site.

11. The transcatheter shrink ring system according to claim 10, wherein: The rivet seat includes a base and a first hook portion connected to the proximal end of the base. The distal end of the connecting tube is provided with a second hook portion that is hooked with the first hook portion. The portion where the first hook portion and the second hook portion are hooked is inserted into the release tube. When the portion where the first hook portion and the second hook portion are hooked is exposed from the release tube, the rivet is released from the connecting tube.

12. The transcatheter shrink ring system according to claim 11, characterized in that: The implant tube further comprises a delivery sheath tube, which is sleeved on the outside of the release tube. A step is formed between the base and the first hook portion, and the distal end of the delivery sheath tube abuts against the step.

Images