CN113520671A - Transcatheter ring reduction system - Google Patents

Abstract

The invention provides a transcatheter ring-retracting system. The transcatheter ring-retracting system comprises a forming ring, at least two rivets and a rivet implanting device; the rivet implanting device comprises at least two nail feeding sutures; the far end of the folded nail feeding suture is hung on the outer surface of the forming ring in a penetrating way, and two free ends of the nail feeding suture extend out of the body; the shaping ring is substantially straight when delivered, the shaping ring is arc-shaped or ring-shaped when in a natural state, and when the shaping ring rebounds to be ring-shaped or arc-shaped and is attached to a predetermined treatment site, the rivet is delivered to the shaping ring along the staple delivering suture, and the shaping ring is fixed to the treatment site. The through-conduit ring-shrinking system can accurately set the fixing positions of a plurality of rivets, is convenient for realizing the uniform distribution of the rivets, improves the ring-shrinking effect and is simple to operate.

Description

Transcatheter ring reduction system

Technical Field

The invention belongs to the field of medical appliances, relates to an interventional therapy appliance for valvular diseases, and particularly relates to a transcatheter ring-contracting system.

Background

Mitral regurgitation is a common heart valve disease, and is caused by the organic or functional changes of the leaflets, annulus, papillary muscles, chordae tendinae, etc. of the mitral valve resulting in poor anastomosis of the anterior and posterior leaflets of the mitral valve. The traditional standard treatment is surgery, mainly involving valve repair or valve replacement, of which mitral annuloplasty is a common type of repair.

In recent years, a variety of interventional medical devices have emerged to treat mitral regurgitation. Prior art discloses an interventional annuloplasty ring that reduces annulus size and alleviates mitral regurgitation by progressively attaching the annuloplasty ring to the native annulus by implanting a plurality of rivets sequentially through a transcatheter pathway to tighten the annuloplasty ring and then tightening the annuloplasty ring. This technique has the following drawbacks: 1. the implantation of the rivets and the delivery of the annuloplasty ring are performed synchronously, the rivets are wrapped in the annuloplasty ring, the annuloplasty ring is gradually sent out by pushing out the rivets one by one, the position of the annuloplasty ring also changes correspondingly with the adjustment and uncertainty of the position of the rivets, the position accuracy and the treatment effect of the annuloplasty ring connected with the native valve ring are finally affected, and the surgical risk is increased; 2. the position of the rivet wrapped in the forming ring has a developing prompt in a corresponding area of the forming ring, but the rivet is not connected with the forming ring in other ways in the forming ring, and along with the beating of the heart, the accurate implantation position of the rivet is difficult to grasp, so that the rivet arrangement is uneven, and the ring shrinking effect is influenced; 3. in the operation process, in order to ensure that the rivets are uniformly arranged as much as possible, the requirements on professional literacy of doctors and the proficiency of instrument use are high, and the operation difficulty is high.

Disclosure of Invention

The invention provides a transcatheter ring-shrinking system, which can accurately set the implantation position of rivets, ensures uniform implantation distance of the rivets, ensures ring-shrinking effect and is simple to operate.

The invention provides a transcatheter ring-shrinking system, which comprises a forming ring, at least two rivets and a rivet implanting device, wherein the forming ring is provided with a plurality of rivets;

the rivet implanting device comprises at least two nail feeding sutures; the far end of the folded nail feeding suture is hung on the outer surface of the forming ring in a penetrating way, and two free ends of the nail feeding suture extend out of the body;

the shaping ring is substantially straight when delivered, the shaping ring is arc-shaped or ring-shaped when in a natural state, and when the shaping ring rebounds to be ring-shaped or arc-shaped and is attached to a predetermined treatment site, the rivet is delivered to the shaping ring along the staple delivering suture, and the shaping ring is fixed to the treatment site.

According to the transcatheter ring-retracting system provided by the embodiment of the invention, a plurality of nail-feeding sutures are threaded on the outer surface of the forming ring, the plurality of nail-feeding sutures are used as passages for conveying rivets, the rivets are conveyed to the forming ring along the nail-feeding sutures, and the rivets are used for fixing the forming ring and the mitral valve ring so as to adjust the shape and the circumference of the mitral valve ring and further treat the valve regurgitation.

Compared with the prior art, the invention at least has the following beneficial effects:

(1) the relative positions of the forming ring and the mitral valve ring can be adjusted firstly by conveying the forming ring and then conveying the rivet, the treatment effect is ensured, and the operation risk is reduced;

(2) the positions of the connecting points of the nail feeding sutures and the forming ring are fixed, and after the rivets fed by the nail feeding sutures are implanted, the positions of the connecting points are fixed and unique with the forming ring, so that the rivets are uniformly distributed after being implanted, and the ring shrinking effect is good;

(3) the forming ring is conveyed firstly and then the rivet is conveyed, so that the requirement on the proficiency of a doctor is low, the operation difficulty is reduced, and the operation is simple.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a schematic diagram of a transcatheter retraction system according to an embodiment of the present invention;

FIG. 2 is a schematic illustration of the construction of the forming ring transport apparatus of FIG. 1;

FIG. 3 is a schematic view of the apparatus for transferring the forming ring of FIG. 1 mounted to an adjustable bend guide;

FIG. 4 is a schematic view of the configuration of the forming ring threading to the adjustable bend guide in the forming ring transport apparatus of FIG. 2;

FIG. 5 is a schematic illustration of the conforming of the annuloplasty ring to the mitral annulus in the annuloplasty ring delivery device of FIG. 2;

FIG. 6 is an enlarged schematic view of the layout of the forming rings in the forming ring transfer apparatus of FIG. 2;

FIG. 7 is a schematic structural view of the rivet implanting device of FIG. 1;

FIG. 8 is a schematic structural view of a rivet implanting device for implanting rivets into a mitral valve annulus and a forming ring by feeding a staple line according to an embodiment of the present invention;

FIG. 9 is a schematic view of the mitral annulus of FIG. 8 omitted;

FIG. 10 is a schematic view of a rivet implanting device according to an embodiment of the present invention implanting a rivet at each set position of a staple feeding suture;

FIG. 11 is a schematic view of the staple line removal configuration of FIG. 10;

FIG. 12 is a cross-sectional view of the shaped ring of FIG. 6 including a withdrawal suture;

FIG. 13 is a cross-sectional view of the forming ring of FIG. 6 including a withdrawal suture and a protective sheath;

FIG. 14 is a schematic view of the internal structure of the protective sheath of FIG. 13 after being set by a rivet;

FIG. 15 is a cross-sectional view of the forming ring of FIG. 6 including a shrink ring suture, an inner race support assembly, and an outer race support assembly;

FIG. 16 is a schematic view of the inner race support assembly and the outer race support assembly of FIG. 15;

FIG. 17 is a schematic illustration of the inner race support assembly and the outer race support assembly of FIG. 16 in a configuration that forms a closed loop upon rebound;

FIG. 18 is a schematic structural view of the formed ring of FIG. 15 having inner and outer race support assemblies forming a closed ring upon rebound;

FIG. 19 is a schematic view of the inner structure of the forming ring of FIG. 18 upon rebound to form a closed ring;

FIG. 20 is a cross-sectional structural view of the rivet of FIG. 7;

FIG. 21 is a schematic view of the rivet of FIG. 7 engaged with a connecting tube;

FIG. 22 is a schematic view of the adjustable bend guide of FIG. 1 entering the left atrium;

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. The embodiments of the present invention can be combined with each other as appropriate.

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

When an element is referred to as being "fixed" or "disposed" to another element, it can 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 can be directly connected to the other element or be connected to the other element through one or more connecting elements.

As shown in fig. 1, the transcatheter retraction system 1000 according to the present embodiment includes a guide device 100, an annuloplasty ring 400, at least two rivets 500, an annuloplasty ring delivery device 200 for delivering the annuloplasty ring 400 to the mitral annulus, and a rivet implanting device 300 for delivering the rivets 500.

As shown in fig. 1, the guiding device 100 includes an adjustable bending sheath 110 and a bending handle 120 connected to the proximal end of the adjustable bending sheath 110. The distal end of the bendable sheath 110 has an adjustable bending section, and the bendable 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 bendable sheath 110 can reach a predetermined treatment site through a bent path such as a blood vessel. The guide 100 may also be a pre-shaped sheath with different angles to facilitate delivery of the shaped ring delivery device 200 to a predetermined treatment site via a tortuous path. In this embodiment, the predetermined treatment site is the mitral valve annulus, which will not be described in detail later.

As shown in fig. 1, when the ring feeder 200 is used, the ring feeder 200 is movably inserted into the inner cavity of the guide 100. Specifically, the distal end of the annuloplasty ring delivery device 200 is received within the adjustable curved sheath 110. The proximal end of the annuloplasty ring delivery device 200 is located beyond the proximal end of the guide 100.

As shown in fig. 2, the ring feeder 200 is used to feed the rings 400, and the ring feeder 200 includes a push pipe 220 and a feed handle 230.

Forming ring 400 is arc-shaped or ring-shaped in its natural state. As shown in fig. 2 and 3, the forming ring 400 is substantially flat and fits through the flexible sheath 110 during transport. The shaped ring 400 springs back in a ring or arc shape as it extends from the distal end of the guide 100. The embodiment of the present invention is described by taking a state where the forming ring delivery device 200 is inserted into the inner cavity of the guiding device 100 as an example, and will not be described in detail later. For ease of description, the distal-to-proximal direction in fig. 2 is defined as the axial direction of the annuloplasty ring delivery device 200, hereinafter referred to as the axial direction.

As shown in fig. 2, the forming ring 400, the push tube 220, and the delivery handle 230 are arranged in order in the axial direction. The annular ring 400, the pusher tube 220, and the delivery handle 230 are all provided with a lumen extending proximally through the distal end. The inner cavity of the forming ring 400, the inner cavity of the pushing tube 220 and the inner cavity of the delivery handle 230 are sequentially communicated.

As shown in FIG. 2, the push tube 220 may be a composite tube with a distal end having some bending capability to facilitate delivery of the annuloplasty ring 400 to the mitral annulus. The composite tube may include an inner film, an intermediate mesh grid, and an outer film, formed by cladding and hot melt processing. Wherein the inner membrane can be made of Polytetrafluoroethylene (PTFE), the outer membrane can be made of polyether block Polyamide (PEBAX), and the middle woven mesh is made of metal materials such as stainless steel. The push tube 220 may also be a single layer tube with a distal end that is plastically deformed to a certain bend angle. The single-layer tube may be made of Polyethylene (PE).

As shown in fig. 2, the distal end of the pusher tube 220 is movably abutted against the proximal end of the annular ring 400. In other words, as the push tube 220 is moved distally, the distal end of the push tube 220 can push the forming ring 400 distally together. As the push tube 220 moves proximally, the distal end of the push tube 220 can separate from the proximal end of the forming ring 400. The distal end of the delivery handle 230 is connected to the proximal end of the push tube 220, and the push tube 220 is controlled to push the shaped ring 400 distally by operating the delivery handle 230. When the push tube 220 pushes the shaped ring 400 out of the distal end of the adjustable curved sheath 110, the shaped ring 400 springs back into a ring or arc shape. Preferably, in order to increase the strength of the forming ring 400 and improve the ring-collapsing effect, the forming ring 400 after springback is in a closed loop shape.

In this embodiment, as shown in fig. 4, the forming ring 400 has a flat, strip-like tubular shape. The outer surface of forming ring 400 includes first 411 and second 412 oppositely disposed surfaces. As shown in fig. 5, the first surface 411 is configured to conform to the mitral valve annulus 2000 (i.e., the treatment site) when the annuloplasty ring 400 springs back in an annular or arc shape. The second surface 412 is used to thread the staple line 310.

As shown in fig. 6 and 7, the rivet implanting device 300 is used for delivering and implanting at least two rivets 500, and includes at least two rivet-delivering sutures 310 and an implanting tube 320. The implant tube 320 is detachably connected to the proximal end of the rivet 500. When the annuloplasty ring 400 is rebounded in a ring or arc shape and fits against the mitral valve annulus 2000 (the intended treatment site), the implant 320 delivers the rivet 500 to the annuloplasty ring 400 along the staple delivering suture 310, and the rivet 500 fixes the annuloplasty ring 400 to the mitral valve annulus 2000. Because the annular or arc-shaped annuloplasty ring 400 is attached to and fixed to the mitral valve annulus 2000, the mitral valve annulus 2000 can be pulled to adjust the shape and size of the native valve annulus, thereby achieving the effects of ring shrinkage and molding.

As shown in FIG. 6, the staple delivering suture 310 is doubled over in a U-shape and disposed in an axial direction. The doubled distal end of the staple-delivering suture 310 is threaded through the outer surface (i.e., the second surface 412) of the forming ring 400. The portion of the staple line 310 between the distal and proximal ends extends axially beyond the outer surface of the forming ring 400 and is threaded into the lumen of the pusher tube 220 and the lumen of the delivery handle 230. Both ends of the staple feeding suture 310 are free ends, and both free ends extend to the outside of the body.

As shown in FIG. 6, the distal end of each staple-delivering suture 310 is U-shaped and movably threaded onto the outer surface of the forming ring 400. Specifically, each staple feed line 310 passes from the outer surface of the forming ring 400 into the wall of the forming ring 400, and exits the outer surface of the forming ring 400 after traveling a short distance into the wall of the forming ring 400.

Further, as shown in FIG. 6, the distal ends of the plurality of staple-delivering sutures 310 are sequentially axially offset and hung on the outer surface of the forming ring 400. The two staple-feeding stitches 310 are not axially coincident and twisted. In other words, the distal ends of the plurality of staple feeding sutures 310 are threaded differently on the outer surface of the forming ring 400. The plurality of staple-feeding stitches 310 are provided at a plurality of axially spaced positions on the outer surface of the forming ring 400. Further, the plurality of hanging positions can be distributed at equal intervals.

Specifically, as shown in fig. 8 and 9, each folded nail feeding seam 310 forms a channel for conveying the rivet 500, so that the rivet 500 can be conveyed through the nail feeding seams 310 in sequence in the subsequent operation. As shown in fig. 10, a rivet 500 is delivered to each of the staple-delivering sutures 310 and fixedly connected to the ring 400 and the mitral valve annulus 2000 by the rivet 500. As shown in fig. 11, the staple feed line 310 can be disengaged from the forming ring 400 by pulling any one of the staple feed lines 310 to facilitate removal of the staple feed line 310 from the forming ring 400 after the delivery of the rivet 500 is completed. The number of the nail feeding sewing lines 310 is in the range of 2-15, preferably 8. In this embodiment, the number of the staple feeding stitches 310 is 8. 8 rivets 500 are implanted. Of course, more or fewer rivets 500 may be implanted depending on the patient's physiological anatomy or clinical needs.

In the transcatheter annuloplasty ring system 1000 according to an embodiment of the present invention, a plurality of nail feeding sutures 310 are threaded through an outer surface of the annuloplasty ring 400, the plurality of nail feeding sutures 310 serve as passages for feeding rivets 500, the rivets 500 are fed to the annuloplasty ring 400 along the nail feeding sutures 310, and the rivets 500 fix the annuloplasty ring 400 and the mitral valve annulus 2000, so as to adjust the shape of the mitral valve annulus 2000 to the same or similar shape as the annuloplasty ring 400, thereby performing a function of annuloplasty on the mitral valve annulus 2000; through setting up a plurality of positions of sending the nail seam line 310, can accurately set up the fixed position of a plurality of rivets 500, be convenient for realize the evenly distributed of a plurality of rivets 500, improve the ring effect that contracts, and easy operation.

As shown in fig. 2 and 12, the transcatheter retraction system 1000 further comprises at least one retraction suture 600, the retraction suture 600 being U-folded in half and disposed in an axial direction. The shrink loop suture 600 is removably threaded into the shaped ring 400 and is bent out of the shaped ring 400 at the distal end of the shaped ring 400 and extends proximally. The free ends of the staple feeding suture 310 and the shrink-ring suture 600 penetrate out of the proximal end of the pushing tube 220 and extend to the outside of the body. Specifically, half of the two folded contracted loop sutures 600 are sequentially and movably arranged 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 a penetrating manner, penetrate out of the far end of the forming ring 400 and then are bent to wind outside the forming ring 400; the other half of the doubled-over shrink ring sutures 600 extend axially toward the proximal end of the forming ring 400, enter the lumen of the pusher tube 220 from the distal end of the pusher tube 220, pass through the lumen of the delivery handle 230, and exit the proximal end of the delivery handle 230. Both free ends of the contraction ring suture 600 extend through the push tube 220 to the outside of the proximal end of the delivery handle 230 and thus outside the patient, and the operator may pull the contraction ring suture 600 outside the patient to pull the shaping ring 400 to further cause the shaping ring 400 to bend to shape for subsequent manipulation to adjust the circumference of the mitral valve annulus 2000 (treatment site) for further contraction of the mitral valve annulus 2000. In this way, the ring-reducing effect on the mitral valve annulus 2000 is improved.

Further, as shown in fig. 13 and 14, the transcatheter retraction system 1000 further comprises a plurality of protective sheaths 4700 secured within the annuloplasty ring 400. Protective casing 4700 can be sewn inside of the forming ring 400. The shrink-ring suture 600 is movably arranged in a plurality of protective sleeves 4700 in a penetrating way, and the shrink-ring suture 600 can freely move in the protective sleeves 4700. The number of protective casings 4700 is consistent with the number of rivets 500 that need to be implanted. The protective casing 4700 is disposed adjacent to the staple feed line 310. Each of the protective casings 4700 is positioned to correspond to the threading of one of the staple lines 310 on the outer surface of the forming ring 400. The length of the protective casing 4700 in the axial direction of the shrink ring seam 600 is greater than or equal to the outer diameter of the rivet 500. By providing the protective sleeve 4700 on the shrink-ring suture 600, the rivet 500 can be prevented from interfering with the shrink-ring suture 600 when implanted, and subsequent pulling and tightening of the shrink-ring suture 600 is prevented from being affected.

The structure of forming ring 400 is further described below in conjunction with the figures.

As shown in fig. 15, the annuloplasty ring 400 may be pre-shaped to a specific shape similar to the shape of the native annulus, such as a D-shaped ring or a C-shaped ring, preferably a D-shaped ring, to provide more uniform and comprehensive contraction of the mitral annulus 2000, resulting in better surgical effect. The forming ring 400 includes a flexible body 413 and at least one support member (see inner ring support member 460, outer ring support member 470 in fig. 15). The support member is threaded through the flexible body 413 parallel to the shrink-ring suture 600, the support member is at least partially made of a shape memory material and is heat-set, and the support member is in a ring shape or an arc shape in a natural state.

In this embodiment, the at least one support assembly includes an inner race support assembly 460 and an outer race support assembly 470. An inner ring support member 460 and an outer ring support member 470 are threaded into the flexible body 413 generally parallel to the shrink ring seam 600. The shrink ring seam line 600 is located between the inner race support assembly 460 and the outer race support assembly 470. The length of inner race support assembly 460 is less than the length of outer race support assembly 470.

The flexible body 413 has flexibility. The flexible body 413 may be made of a biocompatible polymer material, for example, Polyethylene terephthalate (PET). The flexible body 413 is in the form of a sleeve with two open ends and may take the form of a gasket.

As shown in fig. 15 and 16, inner and outer race support assemblies 460 and 470 are positioned against and secured to the inner wall of the interior cavity of flexible body 413. Inner and outer race support assemblies 460, 470 are axially movable relative to flexible body 413. Inner race support assembly 460 and outer race support assembly 470 are symmetrically disposed about a central axis of flexible body 413. The inner and outer ring support assemblies 460, 470 may be secured to the flexible body 413 by stitching, which may be an implant grade stitching, in any manner that does not interfere with the axial movement of the inner and outer ring support assemblies 460, 470 within the flexible body 413.

Both the inner ring support assembly 460 and the outer ring support assembly 470 are subjected to a heat setting process to adapt the forming ring 200 to the physiological anatomy of the native valve annulus. During shaping, the inner ring support assembly 460 and the outer ring support assembly 470 are placed in a shaping tool mold, heat shaping treatment is carried out at the preferred shaping temperature of 500 +/-20 ℃ for 15-25 min, shaping is carried out to be similar to the shape of the natural valve ring, and then the inner ring support assembly 460 and the outer ring support assembly 470 are arranged in the flexible main body 413 in a penetrating mode and are sewn and fixed with the flexible main body.

In this embodiment, the inner ring support assembly 460 and the outer ring support assembly 470 are in a closed ring shape after being subjected to a heat setting process, so that the flexible body 413 forms a ring shape. Wherein the inner ring support assembly 460 is located on the inner ring, and the outer ring support assembly 470 surrounds the outer periphery of the inner ring support assembly 460.

As shown in fig. 15 and 16, the proximal end of the support member has a cavity, and when the support member rebounds in a natural state, the distal end of the support member is received in the cavity to form a ring shape. Specifically, the inner ring support assembly 460 includes an inner ring rod 461 and an inner ring tube 462, a proximal portion of the inner ring rod 461 is threaded into a distal end of the inner ring tube 462; outer ring support assembly 470 includes an outer ring rod 471 and an outer ring tube 472, with a proximal portion of outer ring rod 471 fitting within outer ring tube 472, thereby allowing forming ring 400 to spring back into a stable closed loop configuration.

The inner and outer rods 461, 471 are each a solid rod or a hollow tube made at least in part of a shape memory material. Preferably, the inner ring rod 461 and the outer ring rod 471 are integrally made of an alloy having a shape memory function, such as a nickel titanium alloy, a cobalt chromium alloy, or the like. The inner tube 462 and the outer tube 472 are hollow tubes and are also made of shape memory material, and preferably, the inner tube 462 and the outer tube 472 are made of shape memory alloy.

As shown in FIG. 17, the proximal end of the inner coil tube 462 is reserved with a cavity for receiving the distal end of the inner coil rod 461, so that the distal end of the inner coil rod 461 is threaded into the proximal cavity of the inner coil tube 462 to form a closed ring-shaped structure when the inner coil rod 461 rebounds. A cavity is reserved in the proximal end of the outer ring tube 472 for receiving the distal end of the outer ring rod 471, so that the distal end of the outer ring rod 471 penetrates into the cavity of the proximal end of the outer ring tube 472 to form a closed ring structure when the outer ring rod 471 rebounds.

Further, as shown in fig. 18 and 19, a shrink ring suture 600 is threaded between the inner and outer ring support members 460, 470, adjacent to either the inner ring support member 460 or the outer ring support member 470, so as not to interfere with the implantation of the rivet 500. By pulling on the free ends of the contraction ring suture 600, the outer ring rod 471 is threaded into the outer ring tube 472 and the inner ring rod 461 is threaded into the inner ring tube 462 to an increased depth, and the annuloplasty ring 400 is gradually contracted to further adjust the circumference of the mitral annulus 2000.

It will be appreciated that in other embodiments, the distal end of the support member is adjacent the proximal end of the support member when the support member springs back in its natural state to form an arc with an opening. That is, the inner ring support assembly 460 may only include the inner ring rod 461, the outer ring support assembly 470 only includes the outer ring rod 471, the inner ring rod 461 and the outer ring rod 471 respectively rebound to the arc shape in the natural state after being pushed out from the delivery sheath, the distal end of the inner ring rod 461 is close to the proximal end of the inner ring rod 461, and the distal end of the outer ring rod 471 is close to the proximal end of the outer ring rod 471, so that the shaping ring 400 forms the arc shape to fit the mitral annulus. As the withdrawal string 600 is pulled, the distal end of the support assembly is further proximal to the proximal end of the support assembly, i.e., the distal end of the inner loop bar 461 is further proximal to the proximal end of the inner loop bar 461, and the distal end of the outer loop bar 471 is further proximal to the proximal end of the outer loop bar 471; depending on clinical requirements, in some embodiments, the two ends of the inner rod 461 and the two ends of the outer rod 471 may overlap to form a closed ring structure, and the forming ring 400 forms a ring structure.

In use, as shown in fig. 3, the forming ring 400 is straightened and installed in the adjustable curved sheath 110 of the guiding device 100, as shown in fig. 15, since the materials of the components of the forming ring 400 are flexible materials or semi-rigid materials, and the inner ring support component 460 and the outer ring support component 470 are constrained by external force after being installed in the adjustable curved sheath 110, and are in a straight line or an arc shape, the forming ring 400 can be smoothly straightened and installed in the adjustable curved sheath 110, and is adaptive along the inner cavity of the adjustable curved sheath 110 for transportation; delivering the distal end of the adjustable curved sheath 110 into the vicinity of the mitral valve annulus 2000 of the patient by interventional means, the adjustable curved sheath 110 delivering the distal end of the annuloplasty ring delivery device 200 to the mitral valve annulus 2000, controlling the annuloplasty ring delivery device 200 to release the annuloplasty ring 400; as shown in fig. 18, after the forming ring 400 is pushed out of the adjustable curved sheath 110 by the pushing tube 220, the inner ring support assembly 460 and the outer ring support assembly 470 are rapidly rebounded due to their shape memory properties, the distal end of the outer ring rod 471 is automatically rebounded and penetrates into the inner cavity of the proximal end of the outer ring tube 472 to form a closed ring, the distal end of the inner ring rod 461 is automatically rebounded and penetrates into the inner cavity of the proximal end of the inner ring tube 462 to form a closed ring, and then the flexible body 413 is driven to deform according to the shaped shape to form a closed forming ring 400, so that the forming ring 400 is similar to the mitral valve annulus 2000 in shape; as shown in fig. 5, the pusher tube 220 is withdrawn by adjusting the pusher tube 220 to fit the first surface 411 of the forming ring 400 to the mitral valve annulus 2000, while the staple feed suture 310 and the ring-retraction suture 600 remain installed in the guide device 100, and the free ends of the staple feed suture 310 and the ring-retraction suture 600 pass out of the bending handle 120 and extend out of the patient; as shown in fig. 8, the implantation tube 320 of the rivet implantation device 300 is then advanced distally through the lumen of the introducer 100 to the released forming ring 400; as shown in fig. 10, the plurality of rivets 500 are sequentially implanted into the annuloplasty ring 400 and the mitral valve annulus 2000 by controlling the rivet implanting device 300, so that the annuloplasty ring 400 is fixedly connected to the mitral valve annulus 2000 to achieve a first annuloplasty of the mitral valve annulus 2000; further reduction of the annular ring of the annuloplasty ring 400 may be achieved by pulling on the constricting ring sutures 600, as shown in fig. 11, to provide a secondary reduction of the mitral valve annulus 2000.

As shown in fig. 7, the implantation tube 320 includes a delivery sheath 321, a release tube 322, and a connection tube 323. As shown in fig. 20, the connection pipe 323 is inserted into the release pipe 322. The releasing pipe 322 is arranged in the conveying sheath pipe 321 in a penetrating way. The distal end of the delivery sheath 321 is adapted to receive the proximal end of the rivet 500. The distal end of the connecting tube 323 is detachably coupled to the proximal end of the rivet 500. The distal end of the releasing tube 322 is sleeved on the connection position of the connecting tube 323 and the rivet 500 to restrain the connection position of the connecting tube 323 and the rivet 500.

As shown in fig. 20 and 21, the rivet 500 takes the form of a screw. The rivet 500 includes a spiral structure 501 at a distal end and a rivet seat 502 at a proximal end, with a fixed connection therebetween.

As shown in fig. 21, the distal end of the helix 501 has a sharp tip. The proximal end of the rivet seat 502 is detachably connected to the connecting tube 323. The connector tube 323 rotates the rivet seat 502 to cause the sharp tip of the spiral structure 501 to pierce the annuloplasty ring 400 and screw into the treatment site to secure the annuloplasty ring 400 to the mitral annulus 2000.

As shown in fig. 20 and 21, the rivet holder 502 includes a base 503 and a first hook portion 504 integrally formed with the base 503. The first hook portion 504 is provided at the proximal end of the base 503. The first hook portion 504 has a curvature and is hook-shaped. The distal end of the connection pipe 323 is provided with a second hook portion 324 that matches the curvature of the first hook portion 504. The portion where the first hook portion 504 and the second hook portion 324 are hooked is inserted into the releasing tube 322, so that the rivet 500 and the connecting tube 323 form a detachable fixed connection by being bound by the releasing tube 322 (as shown in fig. 11).

After the rivet 500 fixes the annuloplasty ring 400 and the mitral valve annulus 2000, the release tube 322 is withdrawn a distance towards the proximal end, the portion where the first hook 504 and the second hook 324 are hooked is exposed from the release tube 322, and the rivet 500 and the connection tube 323 are not released by the restraining force of the release tube 322. At this point, the connecting tube 323 can be removed, leaving the rivet 500 on the forming ring 400.

As shown in fig. 20, 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 the step 505 so that the rivet 500 can be carried through the delivery sheath 321.

As shown in fig. 10, a through cavity is provided inside the assembly formed by the spiral structure 501, the rivet seat 502 and the connecting tube 323 of the rivet 500. The two free ends of the staple-feeding suture 310 may be passed from the proximal end of the rivet 500 through the lumen to the proximal exterior of the connecting tube 323. by rotating the connecting tube 323, the rivet 500 may be driven to rotate so that the rivet 500 pierces the ring 400 and threads into the tissue to fixedly attach the ring 400 to the mitral annulus 2000.

To facilitate penetration, the helix 501 is made of a metallic material, such as implant grade stainless steel. The rivet seat 502 may be made of an implant-grade polymer material or a metal material, such as Polyetheretherketone (PEEK), Polycarbonate (PC), stainless steel, and preferably stainless steel, and may be laser welded or integrally formed with the spiral structure 501.

The delivery sheath 321 and the detachment tube 322 may be a single-layer flexible tube or a multi-layer composite tube, such as a nitinol tube, a composite catheter, a nylon tube, or the like.

The connection tube 323 may be 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 has a certain torsion control property so as to drive the rivet 500 to rotate.

The rivet implanting device 300 can be sequentially attached to and detached from the plurality of rivets 500, respectively, and thus, the plurality of rivets 500 can be sequentially implanted through one set of the rivet implanting device 300.

The following briefly describes the application of the transcatheter annuloplasty system 1000 according to an embodiment of the present invention to mitral valve annuloplasty, the procedure being: the transfemoral vein-inferior vena cava-right atrium-interatrial septum-left atrium-mitral valve annulus 2000.

The first step is as follows: the femoral vein puncture is performed, and a trajectory of the femoral vein-inferior vena cava-right atrium-interatrial septum-left atrium-mitral annulus 2000 is established by a guide wire (not shown) and an instrument (not shown) such as an interatrial puncture device.

In a second step, as shown in fig. 22, the guide device 100 is advanced over the guide wire until the distal end of the adjustable curved sheath 110 passes through the foramen ovale to the left atrium, and the guide wire is withdrawn.

Third, as shown in fig. 3, the annuloplasty ring delivery device 200 is inserted into the adjustable curved sheath 110 of the guiding device 100, and the distal end of the adjustable curved sheath 110 is delivered to the vicinity of the mitral valve annulus 2000. The shaped ring 400 is pushed out of the distal end of the adjustable bending sheath 110. As shown in fig. 18, since the forming ring 400 is provided with the inner ring support assembly 460 and the outer ring support assembly 470 with the 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 the shape, so as to form the forming ring 400 in a closed ring shape.

Fourthly, as shown in fig. 5, the push tube 220 is withdrawn by adjusting the push tube 220 to fit the annuloplasty ring 400 to the mitral valve annulus 2000, while the staple feeding suture 310 is still hung on the outer surface of the annuloplasty ring 400 and the ring-contracting suture 600 is still installed in the annuloplasty ring 400, and the free ends of the staple feeding suture 310 and the ring-contracting suture 600 are extended out of the bending adjustment handle 120 through the bending adjustable sheath 110 and extended out of the patient.

In a fifth step, as shown in fig. 8 and 9, a set of staple-delivering sutures 310 is selected to be passed through the inner lumen of the rivet implanting device 300, and then the rivet implanting device 300 is passed through the guiding device 100 along the staple-delivering sutures 310 to the surface of the annuloplasty ring 400, and the distal rivet 500 is driven to rotate by twisting the connecting tube 323 until the rivet 500 pierces the annuloplasty ring 400 and is screwed into the mitral annulus 2000, thereby fixedly connecting the annuloplasty ring 400 to the mitral annulus 2000.

Sixth, as shown in fig. 10, the rivet implanting device 300 is withdrawn, another rivet 500 is assembled with the rivet implanting device 300, and the fifth step is repeated, a plurality of rivets 500 are sequentially implanted into the mitral valve annulus 2000 along each set of the staple delivering sutures 310, respectively, and the rivet implanting device 300 is withdrawn.

Seventh, as shown in FIG. 11, each set of staple-delivering sutures 310 has two free ends outside the handle and is pulled out of the body by pulling one of the free ends, the other free end through the lumen of the guide 100, over the forming ring 400, and thereby sequentially withdrawing each set of staple-delivering sutures 310 out of the guide 100.

Eighthly, as shown in fig. 11, the annuloplasty ring 400 is already fixedly connected to the mitral valve annulus 2000 by 8 rivets 500, two free ends of a shrink ring suture 600 penetrating the annuloplasty ring 400 extend out of the body, the annuloplasty ring 400 can be shrunk by pulling the shrink ring suture 600, and the mitral valve annulus 2000 is further shrunk, so as to achieve the effect of ring shrinkage, and meanwhile, the mitral valve regurgitation condition is observed by a medical imaging device, and when the regurgitation disappears or reaches the slightest state, the shrink ring suture 600 is knotted or locked, thereby completing the operation.

Compared with the prior art, the invention at least has the following beneficial effects:

(1) the forming ring 400 is fed firstly, then the rivet 500 is fed, the relative positions of the forming ring 400 and the mitral valve annulus 2000 are adjusted firstly, and the rivet 500 is riveted subsequently, so that the relative positions of the forming ring 400 and the mitral valve annulus 2000 are relatively ideal, the treatment effect is ensured, and the operation risk is reduced;

(2) the position of the connecting point of the nail feeding suture 310 and the forming ring 400 is fixed, and after the rivet 500 fed by the nail feeding suture 310 is implanted, the position of the rivet 500 is fixed and unique with the forming ring 400, so that the uniform implantation arrangement and good ring shrinking effect of the rivet 500 are ensured;

(3) the requirement on the proficiency of doctors is low, the operation difficulty is reduced, and the operation is simple;

(4) when the rivet 500 is implanted, the annuloplasty ring 400 is fixedly attached to the mitral valve annulus 2000, achieving a first ring-retraction, and then further securing the ring-retraction effect by pulling the ring-retraction suture 600.

While the foregoing is directed to embodiments of the present invention, it will be appreciated by those skilled in the art that various changes may be made in the embodiments without departing from the principles of the invention, and that such changes and modifications are intended to be included within the scope of the invention.

Claims (15)

1. A transcatheter retraction system comprising a forming ring, at least two rivets and a rivet implanting device;

the rivet implanting device comprises at least two nail feeding sutures; the far end of the folded nail feeding suture is hung on the outer surface of the forming ring in a penetrating way, and two free ends of the nail feeding suture extend out of the body;

the shaping ring is substantially straight when delivered, the shaping ring is arc-shaped or ring-shaped when in a natural state, and when the shaping ring rebounds to be ring-shaped or arc-shaped and is attached to a predetermined treatment site, the rivet is delivered to the shaping ring along the staple delivering suture, and the shaping ring is fixed to the treatment site.

2. The transcatheter retraction system according to claim 1, wherein the forming ring comprises first and second oppositely disposed surfaces, the first surface for engaging the treatment site, and the distal ends of the at least two staple-delivering sutures being sequentially offset and suspended from the second surface.

3. The transcatheter retraction system according to claim 1, further comprising at least one retraction suture movably threaded within the shaping ring and bent out of the shaping ring at a distal end of the shaping ring and extending proximally, both free ends of the retraction suture extending out of the body.

4. The transcatheter looper system of claim 3, further comprising a plurality of protective sheaths secured within the forming ring, wherein the looper thread is movably threaded within the plurality of protective sheaths, wherein each of the protective sheaths is positioned to correspond to a threading position of one of the feed stitches on the outer surface of the forming ring, and wherein the length of the protective sheaths in an axial direction along the looper thread axis is greater than or equal to the outer diameter of the rivets.

5. The transcatheter retraction system according to claim 3, wherein the shaped ring comprises a flexible body and at least one support member, the support member being threaded into the flexible body in parallel with the retraction suture, the support member being at least partially made of a shape memory material and heat set, the support member being in a natural loop or arc shape.

6. The transcatheter retraction ring system according to claim 5, wherein when the support member is in a natural state of recoil, the distal end of the support member is adjacent the proximal end of the support member to form the arc;

the distal end of the buttress assembly is further proximal to the proximal end of the buttress assembly when the withdrawal suture is pulled.

7. The transcatheter retraction system according to claim 5, wherein the proximal end of the support member has a cavity, and wherein the distal end of the support member is received in the cavity to form the loop shape when the support member is allowed to spring back in its natural state.

8. The transcatheter retraction ring system according to claim 7, wherein the support assembly comprises a ring rod and a ring tube, wherein a proximal end of the ring rod is threaded into a distal lumen of the ring tube, and wherein a distal end of the ring rod is threaded into a proximal lumen of the ring tube upon recoil of the support assembly;

as the purse string suture is pulled, the depth to which the distal end of the loop bar is threaded into the proximal lumen of the loop tube increases.

9. The transcatheter ring reduction system of claim 5, wherein the at least one support assembly comprises an inner ring support assembly and an outer ring support assembly, the inner ring support assembly and the outer ring support assembly being disposed in parallel, the inner ring support assembly having an axial length that is less than an axial length of the outer ring support assembly, the ring reduction seam being disposed between the inner ring support assembly and the outer ring support assembly.

10. The transcatheter retraction system according to claim 1, wherein the rivet insertion device further comprises an insertion tube, the insertion tube comprises a connection tube and a release tube, the distal end of the connection tube is detachably connected to the proximal end of the rivet, the release tube is coaxially disposed with the connection tube, and the distal end of the release tube is sleeved at the connection of the connection tube and the rivet.

11. The transcatheter retraction system according to claim 10, wherein the rivet comprises a screw structure and a rivet seat connected to a proximal end of the screw structure, a distal end of the screw structure being pointed, the proximal end of the rivet seat being detachably connected to the connection tube, the connection tube rotating the rivet seat to cause the distal end of the screw structure to pierce the forming ring and to be screwed into the treatment site.

12. The transcatheter retraction system according to claim 11, wherein the rivet holder comprises a base and a first hook portion connected to a proximal end of the base, wherein a distal end of the connection tube is provided with a second hook portion engaged with the first hook portion, wherein a portion of the first hook portion engaged with the second hook portion is inserted into the release tube, and wherein the rivet is released from the connection tube when the portion of the first hook portion engaged with the second hook portion is exposed from the release tube.

13. The transcatheter retraction system according to claim 12, wherein the implantation tube further comprises a delivery sheath, the delivery sheath being sleeved outside the release tube, a step being formed between the base and the first hook portion, a distal end of the delivery sheath abutting the step.

14. The transcatheter retraction system according to claim 3, further comprising an annuloplasty ring delivery device comprising a pusher tube movably abutting a proximal end of the annuloplasty ring, wherein the staple and free ends of the retraction suture are each passed out of the proximal end of the pusher tube and extend outside the body.

15. The transcatheter retraction system according to any one of claims 1 to 14, further comprising a guide means within which the shaped ring passes during delivery, the shaped ring springing back into an annular or arcuate shape as it extends distally from the guide means.

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