CN115770077B

CN115770077B - Anchoring system and forming device thereof

Info

Publication number: CN115770077B
Application number: CN202211431056.3A
Authority: CN
Inventors: 吕世文; 陈琼; 马振宇; 崔泽浩; 陈志�
Original assignee: Jenscare Scientific Co Ltd
Current assignee: Jenscare Scientific Co Ltd
Priority date: 2022-11-15
Filing date: 2022-11-15
Publication date: 2026-06-23
Anticipated expiration: 2042-11-15
Also published as: CN115770077A

Abstract

The application relates to the field of medical instruments, in particular to an anchoring system and a forming device thereof, wherein a limiting rod is arranged on the anchoring device, the limiting rod stretches outwards by taking a connecting rod as a center in a natural state, so that after an anchoring needle is implanted, the blocking piece can prevent the anchoring needle from being excessively screwed into tissues, an operator can easily judge the implantation condition of the anchoring needle through operating rotating force even under invisible condition, the blocking piece can press an anchoring area of the implantation instrument like a gasket to provide lateral stabilizing force, and the blocking piece can prevent a fabric layer from being separated from the anchoring needle in the shrinkage process when the anchoring system is used for shrinkage ring forming.

Description

Anchoring system and forming device thereof

Technical Field

The application belongs to the field of medical instruments, and particularly relates to an anchoring system and a forming device thereof.

Background

With the development and progress of technology, the living standard of people is increasingly improved, and the corresponding average life is greatly prolonged. With the increase of the life of the human body, the load on the heart is also increased, and especially for the elderly, heart diseases frequently occur. The heart valve regurgitation is mainly used, and after the heart valve is regurgitated, symptoms of heart failure such as hypodynamia, ascites, edema, liver pain, dyspepsia, anorexia and the like can be caused, and traditional treatment means comprise drug treatment applicable to mild-to-severe regurgitation and surgical operation methods with corresponding operation instructions. Among other surgical methods, valve replacement and valve repair are also included. In recent years, with the report of the first aortic valve interventional replacement, a great deal of work is done by a plurality of companies on the aspect of the aortic valve interventional technology, and the technology is mature day by day. But there is still a large gap in the industry in terms of intervention of atrioventricular valves. Although few products are currently used for interventional procedures for atrioventricular valves in transcatheter interventional valve shaping and repair procedures, the atrioventricular valves are fixed in a manner that is dependent on anchoring needles, and the existing anchoring needles have some technical problems in practical application.

Patent CN202210431866.2 discloses an anchor device, which comprises a nail body, an anchor seat connected to the nail body and capable of driving the nail body to rotate, and a wire guide device arranged on the nail body or the anchor seat and capable of rotating relative to the nail body, wherein the anchor seat is provided with an anchor seat connecting piece which is detachably connected with an anchor conveyer. In this patent scheme, the nail body is the heliciform, obtains anchoring force through rotating screwing into the tissue in, and although anchoring effect is better, but when the operation, because the anchoring needle is less, through influencing specific position and the form of hardly observing, lead to screwing down excessively easily when anchoring the needle body, screw into the tissue with the anchor pad, cause the damage to the tissue to, the spacing effect of anchor pad is limited, and the anchoring needle breaks away from easily by the implantation apparatus of anchoring, leads to the anchoring inefficacy.

Accordingly, those skilled in the art have focused on developing an anchoring system and its forming device that primarily address the problems of 1. Because of the inability to determine the depth of the anchor needle into the tissue during the surgical procedure, the anchor is easily threaded into the tissue, causing damage to the tissue, and 2. The limited restraining action of the anchor, the anchor needle is easily disengaged from the anchored implant device, resulting in anchor failure.

Content of the application

The application aims to provide an anchoring system and a forming device thereof, and the novel anchoring mechanism has the advantages that 1, a blocking piece can prevent an anchoring needle from being excessively screwed into tissues and effectively prevent the anchoring needle from being separated from an implantation instrument to cause anchoring failure, and 2, the blocking piece can increase the fixing point of the anchoring device and the implantation instrument or heart tissues to ensure anchoring stability, and can provide lateral force at the same time, so that the contraction ring is convenient.

In order to solve the technical problems, the application solves the technical problems by the following technical scheme that the anchoring system comprises an anchoring device and a conveyor for conveying the anchoring device, wherein the anchoring device comprises an anchoring needle with a spiral structure, a connecting rod, a connector and a blocking piece, the anchoring needle is fixed at one end of the connecting rod, the connector is fixed at the other end of the connecting rod, the blocking piece comprises a lantern ring and a limiting rod arranged on the lantern ring, and the limiting rod is outwards unfolded by taking the connecting rod as a center in a natural state.

As a further improvement of the invention, the conveyor comprises a control handle, a conveying catheter connected with the control handle, and a control rod arranged in the conveying catheter, wherein when the conveyor is preassembled, the connector is connected with the distal end of the control rod, and the limit rod is limited in a reserved space between the connector and the anchoring needle.

As a further improvement of the invention, the limit rod is of an arc-shaped structure, and the bending direction of the limit rod is the same as the spiral direction of the anchoring needle.

As a further development of the invention, the free end of the stop lever is sharp and the free end portion of the stop lever enters the tissue after implantation of the anchoring device.

As a further improvement of the invention, the connecting head is provided with a connecting groove, and both sides of the connecting groove are outwardly expanded in a natural state.

As a further improvement of the invention, the distal end of the control rod is provided with a connection structure, the connection structure is matched with the connecting groove to be detachably connected when the connection groove is preassembled, and the control rod is separated from the connector when the connection groove is separated from the conveying catheter.

As a further improvement of the present invention, a forming device for fixing by the above-mentioned anchoring device comprises an anchoring device, a ring shrinking member and a conveyor for conveying the anchoring device and the ring shrinking member, wherein the ring shrinking member comprises a shrinking skeleton, a fabric layer coated on the outer layer of the shrinking skeleton and a thread for controlling the shrinking of the shrinking skeleton, and the ring shrinking member is fixed on the tissue by the anchoring device after the ring shrinking member reaches a preset position.

As a further development of the invention, the ring-retracting member is provided with an anchoring hole through which the anchoring needle passes and penetrates the tissue when anchored.

As a further improvement of the invention, the free end of the stop bar pierces the fabric layer and enters the tissue when the stop bar protrudes from the delivery catheter and returns to a predetermined configuration.

As a further improvement of the present invention, the contracting skeleton comprises a first skeleton and a second skeleton, the first skeleton being disposed adjacent to the second skeleton in a contracting ring region defined by the native valve annulus or atrial tissue after implantation of the shaping device.

As a further improvement of the invention, the anchoring device and the ring shrinking member are preloaded into the conveyor, the anchoring device and the ring shrinking member are positioned at the target position by the conveyor, the control rod is rotated to enable the anchoring needle to rotate and penetrate through the anchoring hole to penetrate into heart tissue, the limit rod stretches out of the conveying conduit and returns to a preset shape, the free end of the limit rod pierces the fabric layer into the tissue until the connecting groove is separated from the conveying conduit, the control rod is separated from the connecting head to complete anchoring, then the shrinkage of the shrinkage skeleton is achieved by pulling wires to complete ring shrinking forming, and finally the conveyor is withdrawn from the body to complete implantation.

Compared with the prior art, the application has the advantages that:

1. In one embodiment of the application, the anchoring device is provided with a limiting rod which extends outwards by taking the connecting rod as a center in a natural state, so that after the anchoring needle is implanted, the blocking piece can prevent the anchoring needle from being excessively screwed into the tissue, the implantation condition of the anchoring needle can be easily judged by operating the rotating force even under the invisible condition, and the blocking piece can press the anchoring area of the implantation device like a gasket to provide lateral stabilizing force, and can prevent the fabric layer from being separated from the anchoring needle in the shrinkage process when the device is used for the shrinkage ring forming.

2. In one embodiment of the application, the free end of the limit rod pierces the fabric layer and enters the tissue after the anchoring device is implanted, so that the fixing point of the anchoring device and the tissue is increased, the anchoring needle is prevented from loosening, the implantation stability of the anchoring device is effectively improved, and the limit rod can provide lateral force during the ring shrinking operation, so that the shrinking force is transmitted more directly and effectively. 3. In one embodiment of the application, the stop bar is "hidden" in the space reserved between the connector and the anchor needle, which makes it easier to receive the anchor device into the sheath during preassembly, and also significantly reduces the loading diameter of the anchor needle.

4. In an embodiment of the application, the connecting groove on the connecting head and the connecting groove of the control rod are of detachable structures, and when the connecting head is separated from the conveying guide pipe, two sides of the connecting groove can be outwards sprung, so that the connecting head and the control rod can be detached and separated, the operation steps and the complex structure of separation are not required to be added, and simultaneously, two sides of the connecting groove are outwards splayed to have a limiting effect, so that the separation of a fabric layer and an anchoring needle is further avoided.

5. In one embodiment of the present application, the number of the contraction frames is 2, and the first frame and the second frame are adjacently arranged in the set contraction ring area of the self-body valve ring or the atrial tissue, when the contraction wire is operated to contract the contraction ring component, the set contraction ring area can obviously move towards the center of the valve due to the maximum contraction/movement distance of the 2 end points of the contraction frames, so that the distance between the adjacent valve leaflets is reduced, the involution area between the adjacent valve leaflets is increased, the valve can be effectively repaired, and the regurgitation of the valve is prevented.

Drawings

FIGS. 1a to 1d are schematic views of an anchoring device according to the present invention, wherein FIG. 1c is a schematic view of a blocking member, and FIG. 1d is a schematic view of an anchoring needle.

Fig. 2a to 2c are schematic views illustrating a process of releasing the anchoring device according to the present invention, wherein fig. 2a is a schematic structural view of the anchoring device in a pre-assembled state, fig. 2b is a schematic view of the restraining bar extending from the delivery catheter and returning to a natural state, and fig. 2c is a schematic view of the connector separating from the delivery catheter and returning to a natural state.

Fig. 3a and 3b are schematic structural views of the ring-shrinking member according to the present invention.

Fig. 4a to 4g are schematic diagrams of the working process of an anchoring system and a forming device thereof according to the present invention, wherein fig. 4a to 4d are schematic diagrams of the working process of the anchoring device, fig. 4b to 4d are enlarged partial schematic diagrams of fig. 4a, and fig. 4e to 4g are schematic diagrams of the working process of the ring shrinking member after the anchoring device is implanted.

The parts of the drawing are named as 1-anchoring device, 11-anchoring needle, 12-connecting rod, 13-connector, 131-connecting groove, 14-blocking piece, 141-collar, 142-limit rod, 2-conveyor, 21-control handle, 22-conveying conduit, 23-control rod, 231-connecting structure, 3-shrinking ring component, 31-shrinking framework, 311-first framework, 312-second framework, 32-fabric layer, 33-line and 34-anchoring hole.

Detailed Description

The present application will be described in further detail with reference to the accompanying drawings and examples.

The proximal end refers to an end near an operator, and the distal end refers to an end far away from the operator.

First embodiment:

In the prior art, although the spiral needle can provide larger anchoring force, the spiral needle is easy to excessively screw into tissue due to invisible reasons in operation, so that the tissue is damaged and is easy to separate from an implantation instrument, and particularly when the spiral needle is used for anchoring and shrinking a ring shrinking piece, the spiral needle is extremely easy to separate from the ring shrinking piece, so that shrinkage failure is caused.

As shown in fig. 1a to 1d, an anchoring system comprises an anchoring device 1 and a conveyor 2 for conveying the anchoring device 1, wherein the conveyor 2 comprises a control handle 21, a conveying conduit 22 connected with the control handle 21, and a control rod 23 arranged in the conveying conduit 22, the anchoring device 1 comprises an anchoring needle 11 with a spiral structure, a connecting rod 12, a connector 13 and a blocking piece 14, the anchoring needle 11 is fixed at one end of the connecting rod 12, the connector 13 is fixed at the other end of the connecting rod 12, the blocking piece 14 comprises a collar 141 and a limiting rod 142 arranged on the collar 141, and the limiting rod 142 is outwards unfolded in a natural state by taking the connecting rod 12 as a center; when the head 13 is pre-assembled with the distal end of the control rod 23 and the limit rod 142 is limited in the space reserved between the head 13 and the anchoring needle 11, as shown in fig. 2a, when the anchoring device 1 reaches the area to be anchored, the head 13 can be driven to rotate the anchoring needle 11 by rotating the control rod 23, when the anchoring needle 11 is partially inserted into the tissue, the control rod 23 is further rotated, the limit rod 142 protrudes from the delivery catheter 22 and returns to the preset shape, as shown in fig. 2b, and the limit rod 142 is in an arc-shaped structure, the free end of the limit rod 142 is sharp, and the bending direction of the limit rod 142 is the same as the spiral direction of the anchoring needle 11, which enables the free end portion of the limit rod 142 to enter the tissue, whereby the force of rotation of the control rod 23 is greatly increased, the operator can obviously perceive that the anchoring device 1 is already fixed in place by the rotating force, and the free end portion of the limit rod 142 enters the tissue, the fixing point of the anchoring device 1 and the tissue is increased, the anchoring needle 11 is prevented from loosening, the implantation stability of the anchoring device 1 is effectively improved, and the limiting rod 142 can provide lateral force during the ring shrinking operation, so that the shrinking force is transmitted more directly and effectively.

In this embodiment, the connecting groove 131 is disposed on the connecting head 13, and in a natural state, two sides of the connecting groove 131 expand outwards, the distal end of the control rod 23 is provided with the engagement structure 231, and when the connecting groove 131 is pre-assembled, the engagement structure 231 is detachably connected with the connecting groove 131 in a matching manner, as shown in fig. 2a, when the connecting groove 131 is separated from the conveying conduit 22, two sides of the connecting groove 131 can spring outwards, so that the connecting head 13 and the control rod 23 can be detached and separated, as shown in fig. 2c, an additional operation step and a complicated structure are not required, and meanwhile, two sides of the connecting groove 131 expand outwards to have a limiting effect, so that the fabric layer 32 and the anchoring needle 11 are further prevented from being separated.

As shown in fig. 3a and 3b, the anchoring system provided by the present invention may be used for fixing a shaping device for treating mitral regurgitation, comprising an anchoring device 1, a ring-shrinking member 3 and a conveyor 2 for conveying the anchoring device 1 and the ring-shrinking member 3, the ring-shrinking member 3 comprising a shrinking skeleton 31, a fabric layer 32 covering the outer layer of the shrinking skeleton 31 and threads 33 for controlling the shrinking of the shrinking skeleton 31, wherein the ring-shrinking member 3 is fixed on tissue by the anchoring device 1 after the ring-shrinking member 3 reaches a predetermined position.

In this embodiment, the ring-shrinking member 3 is provided with an anchoring hole 34, and the anchoring needle 11 passes through the anchoring hole 34 and penetrates into the tissue when anchored, as shown in fig. 3b and 4 b.

In this embodiment, when the stop bar 142 is extended from the delivery catheter 22 and returns to its predetermined configuration, the free end of the stop bar 142 pierces the fabric layer 32 and enters the tissue, as shown in fig. 4b and 4 c.

In this embodiment, the contracting skeleton 31 includes a first skeleton 311 and a second skeleton 312, after the forming device is implanted, the first skeleton 311 and the second skeleton 312 are disposed adjacent to each other in the P2 region of the mitral valve posterior annulus, when the anchoring device 1 is fixed, the contracting wire 33 is pulled to control the contraction of the first skeleton 311 and the second skeleton 312 to achieve the contraction of the contraction ring, as shown in fig. 4 e-4 g, in this process, the limiting rod 142 can effectively provide a lateral force, so that the transmission of the contraction force is more direct, the contraction ring effect is better, and in addition, the limiting rod 142 can effectively prevent the fabric layer 32 from being separated from the anchoring device 1 due to the lateral tension when the contraction ring member 3 is contracted, and after the contraction, the P2 region of the posterior annulus is obviously close to the anterior leaflet region due to the maximum distance moved by the end point of the contracting skeleton 31, as shown in fig. 4f and 4g, so that the coaptation area of the anterior leaflet and the posterior leaflet is significantly increased, and the regurgitation area is effectively improved.

In this embodiment, the fabric layer 32 material includes a metal material, polytetrafluoroethylene, polyethylene, polypropylene, polyester or animal-derived material.

The working process of the application comprises the following steps:

1. preassembling the anchoring device 1 and the ring shrinking member 3 into the conveyor 2, and placing the anchoring device 1 and the ring shrinking member 3 at target positions through the conveyor 2, as shown in fig. 4 a;

2. Rotating the control rod 23 so that the anchoring needle 11 rotates and penetrates the anchoring hole 34 to penetrate into heart tissue, the limit rod 142 protrudes from the delivery catheter 22 and returns to the preset shape as shown in fig. 4b and 4c, and the free end of the limit rod 142 pierces the fabric layer 32 into the tissue until the connecting groove 131 is separated from the delivery catheter 22, the control rod 23 is separated from the connecting head 13, and anchoring is completed as shown in fig. 4 d;

3. The shrinkage of the shrinkage skeleton 31 is then completed by pulling the wire 33, as shown in fig. 4e to 4g, and finally the delivery device 2 is withdrawn from the body to complete implantation.

The foregoing description of several embodiments of the application has been presented for the purposes of illustration. It is not intended to be exhaustive or to limit the application to the precise configuration, construction and/or steps disclosed, and obviously many modifications and variations are possible in light of the above teaching. The scope of the application and all equivalents are intended to be defined by the appended claims.

Claims

1. An anchoring system, comprising an anchoring device and a conveyor for conveying the anchoring device, characterized in that: the anchoring device comprises an anchoring pin, a connecting rod, a connector, and a blocking member in a helical structure; the anchoring pin is fixed to one end of the connecting rod, the connector is fixed to the other end of the connecting rod, the blocking member comprises a collar and a limiting rod disposed on the collar, and the limiting rod is an arc-shaped structure, the bending direction of the limiting rod is the same as the helical direction of the anchoring pin, and the limiting rod extends outward from the connecting rod as the center in its natural state.

2. An anchoring system according to claim 1, characterized in that: the conveyor includes a control handle, a conveying conduit connected to the control handle, and a control rod disposed in the conveying conduit; during pre-installation, the connector is connected to the distal end of the control rod, and the limiting rod is restricted within the space reserved between the connector and the anchoring needle.

3. An anchoring system according to claim 1, characterized in that: the free end of the limiting rod is sharp, and after the anchoring device is implanted, the free end portion of the limiting rod enters the tissue.

4. An anchoring system according to claim 2, characterized in that: the connector head is provided with a connecting groove, and in its natural state, the two sides of the connecting groove expand outward.

5. An anchoring system according to claim 4, wherein the anchoring device is made of shape memory metal material.

6. An anchoring system according to claim 4, characterized in that: the distal end of the control rod is provided with a connecting structure, which is detachably connected to the connecting groove during pre-installation, and the control rod separates from the connector when the connecting groove is disengaged from the delivery conduit.

7. A forming apparatus comprising an anchoring system according to any one of claims 1-6, comprising an anchoring device, a shrink ring member, and a conveyor for conveying the anchoring device and the shrink ring member, the conveyor comprising a conveying conduit, characterized in that: the shrink ring member comprises a shrink skeleton, a fabric layer covering the shrink skeleton, and a thread for controlling the shrinking of the shrink skeleton, wherein, when the shrink ring member reaches a predetermined position, the shrink ring member is fixed to the tissue by the anchoring device.

8. A forming device according to claim 7, characterized in that: the shrinking ring member is provided with an anchoring hole, and during anchoring, the anchoring needle passes through the anchoring hole and pierces the tissue.

9. A forming device according to claim 8, characterized in that: when the limiting rod extends out of the delivery conduit and returns to a preset shape, the free end of the limiting rod pierces the fabric layer and enters the tissue.

10. A shaping device according to claim 8, characterized in that: the shrinkage skeleton includes a first skeleton and a second skeleton, and after the shaping device is implanted, the first skeleton and the second skeleton are disposed adjacent to each other in the shrinkage ring region defined by the autologous valve annulus or atrial tissue.