CN115770077A - Anchoring system and forming device thereof - Google Patents

Abstract

The present application relates to the field of medical devices, in particular to an anchoring system and its shaping device. In one embodiment of the present application, the anchoring device is provided with a limit rod, and the limit rod is centered on the connecting rod in a natural state. Extend outward so that after the anchoring needle is implanted, the stopper can prevent the anchoring needle from being over-screwed into the tissue, which allows the operator to easily judge the anchoring by operating the force of rotation even if it is not visible The implantation condition of the needle, and the stopper can press the anchoring area of the implantation device like a "spacer", providing lateral stability, and, when used for shrinkage ring forming, the stopper can be used during the contraction process Prevent the fabric layer from detaching from the anchor pins.

Description

An anchoring system and its forming device

technical field

The application belongs to the field of medical devices, and in particular relates to an anchoring system and a forming device thereof.

Background technique

With the development and progress of science and technology, people's living standards are also improving day by day, and the corresponding average life expectancy has also increased significantly. As the life expectancy of the human body increases, the load on the heart is also increasing, especially in the elderly, heart disease occurs frequently. Among them, valvular regurgitation is the majority, and when the heart valve regurgitates, it will cause fatigue, ascites, edema, pain in the liver area, indigestion, anorexia and other symptoms of right heart failure. Drug therapy for mild to severe reflux, and surgical methods with corresponding surgical indications. Among them, surgical methods also include valve replacement and valve repair. In recent years, with the report of the first case of aortic valve interventional replacement, many companies have done a lot of work in interventional aortic valve technology, and the technology is becoming more and more mature. However, there is still a big gap in the field of interventional treatment of the atrioventricular valve. Although at present, a few products for the interventional treatment of atrioventricular valves have been applied in transcatheter valvuloplasty and repair, and the fixation methods of atrioventricular valves mostly rely on anchoring needles, and the existing anchoring needles are There are some technical problems in practical application.

Patent CN202210431866.2 discloses an anchor device, which includes a nail body, an anchor seat connected to the nail body and capable of driving the nail body to rotate, set on the nail body or the anchor seat and can be positioned relative to the nail body The body rotates the thread guide, and the anchor base is provided with an anchor base connecting piece for detachable connection with the anchor feeder. In this patent solution, the nail body is in a helical shape, and the anchoring force is obtained by rotating and screwing into the tissue. Although the anchoring effect is good, it is difficult to observe the specific position during the operation because the anchoring needle is small. And shape, lead to easy overtightening when anchoring the needle body, the anchor seat is screwed into the tissue, causing damage to the tissue, and the limiting effect of the anchor seat is limited, the anchor needle and the anchored implant device are easily separated , causing the anchor to fail.

Therefore, those skilled in the art are devoting themselves to developing an anchoring system and its shaping device, mainly to solve the following problems: 1. Due to invisible reasons during the operation, it is impossible to determine the depth of the anchoring needle entering the tissue, and it is easy to place the anchor Screwing into the tissue causes damage to the tissue; 2. The anchor seat has a limited limiting effect, and the anchor needle is easily separated from the anchored implant device, resulting in anchor failure.

application content

The purpose of this application is to provide an anchoring system and its forming device. The new anchoring mechanism has the following advantages: 1. The blocking member can prevent the anchoring needle from being excessively screwed into the tissue, and effectively prevent the anchoring needle from interfering with the implanted instrument. 2. The blocking member can increase the fixing point between the anchoring device and the implanted device or heart tissue, so that the anchoring can be stabilized, and at the same time, it can also provide lateral force to facilitate the shrinkage of the ring.

In order to solve the above technical problems, the present application is solved through the following technical solutions: an anchoring system, including an anchoring device and a conveyor for delivering the anchoring device, the anchoring device includes an anchoring device in a helical structure Needle, connecting rod, connecting head, blocking member, the anchor needle is fixed on one end of the connecting rod, the connecting head is fixed on the other end of the connecting rod, the blocking member includes a collar and is arranged on the sleeve The limit rod on the ring, and the limit rod expands outwards centering on the connecting rod in a natural state.

As a further improvement of the present invention, the delivery device includes a control handle, a delivery catheter connected to the control handle, and a control rod arranged in the delivery catheter. When pre-installed, the connecting head is connected to the distal end of the control rod, Moreover, the limiting rod is limited in the space reserved between the connecting head and the anchoring needle.

As a further improvement of the present invention, the limiting rod has an arc-shaped structure, and the bending direction of the anchoring needle is the same as the helical direction of the anchoring needle.

As a further improvement of the present invention, the free end of the limiting rod is sharp, and after the anchoring device is implanted, the free end of the limiting rod partially enters the tissue.

As a further improvement of the present invention, the connecting head is provided with a connecting groove, and, in a natural state, both sides of the connecting groove expand outward.

As a further improvement of the present invention, the distal end of the control rod is provided with an engaging structure. When pre-installed, the engaging structure cooperates with the connecting groove for detachable connection. When the connecting groove is separated from the delivery catheter, the connecting structure The control rod is separated from the connecting head.

As a further improvement of the present invention, a shaping device fixed by the above-mentioned anchoring device includes an anchoring device, a shrinking ring member, and a conveyor for delivering the anchoring device and the shrinking ring member, and the shrinking ring member includes Shrinkable skeleton, fabric layer covering the outer layer of the shrinkable skeleton, and wires for controlling the shrinkage of the shrinkable skeleton, wherein, when the shrinkage ring member reaches a predetermined position, the shrinkage ring member is fixed to the tissue through the anchoring device superior.

As a further improvement of the present invention, the shrink ring member is provided with an anchoring hole, and when anchoring, the anchoring needle passes through the anchoring hole and penetrates into the tissue.

As a further improvement of the present invention, when the limiting rod protrudes from the delivery catheter and returns to a preset shape, the free end of the limiting rod pierces through the fabric layer and enters the tissue.

As a further improvement of the present invention, the shrinkable framework includes a first framework and a second framework, and after the shaping device is implanted, the first framework and the second framework are arranged adjacent to the native valve annulus or atrial tissue The set shrink ring area.

As a further improvement of the present invention, the anchoring device and the shrinking ring member are pre-installed into the conveyor, and the anchoring device and the shrinking ring member are placed at the target position by the conveyor, and the control rod is rotated so that the anchor The fixed needle rotates and penetrates the heart tissue through the anchor hole, the limiting rod protrudes from the delivery catheter and restores a preset shape, and the free end of the limiting rod pierces the The fabric layer enters the tissue until the connection groove is separated from the delivery catheter, the control rod is separated from the connection head to complete the anchoring, and then the contraction of the contraction skeleton is achieved by pulling the wire to complete the contraction ring forming, and finally the delivery The device is withdrawn from the body to complete the implantation.

Compared with the prior art, the advantages of the present application are:

1. Different from the spiral needle in the prior art, because there is no better limiting structure, it is easy to over-screw the spiral needle into the tissue, resulting in serious damage to the heart tissue, and at the same time, it is easy to separate from the implanted device, making its anchoring invalid; In one embodiment of the present application, the anchoring device is provided with a limit rod, and the limit rod extends outward centered on the connecting rod in a natural state, so that after the anchor needle is implanted, the stopper can prevent the anchor The anchor needle is over-screwed into the tissue, which allows the operator to easily judge the implantation status of the anchor needle by operating the rotation force even if it is not visible, and the stopper can be pressed like a "spacer" The anchoring area of the implant device provides lateral stabilizing force, and when used for shrink ring forming, the stopper can prevent the fabric layer from detaching from the anchor pin during shrinkage.

2. Different from the prior art, in one embodiment of the present application, after the anchoring device is implanted, the free end of the limiting rod pierces the fabric layer and enters the tissue, increasing the anchoring device and tissue fixing point position, prevent the anchor pin from loosening, effectively improve the stability of the anchoring device implantation, and, when the shrink ring is operated, the limit rod can provide lateral force, so that the transmission of the contraction force is more direct and effective . 3. Different from the prior art, in one embodiment of the present application, during pre-installation, the limit rod is "hidden" in the space reserved between the connector and the anchor pin, making it easier for the anchor device to be pre-installed It is retracted into the sheath and also significantly reduces the loading diameter of the anchor needle.

4. Different from the prior art, in one embodiment of the present application, the connecting groove on the connecting head and the connecting groove of the control rod are detachable structures, and when the connecting head is separated from the delivery catheter, both sides of the connecting groove will be It springs outwards, so that the connecting head and the control rod can be disassembled and separated, without additional separation steps and complicated structures. At the same time, the outward expansion of the two sides of the connecting groove also has a limit effect, further preventing the fabric layer from being anchored. Needle disengages.

5. Different from the prior art, in one embodiment of the present application, there are two contraction frameworks, and the first framework and the second framework are adjacently arranged in the constriction zone set by the native valve annulus or atrial tissue, When the contraction line is manipulated to contract the contraction ring member, since the two endpoints of the contraction skeleton shrink/move the most, the contraction ring area set by it will obviously move to the center of the valve, which makes the gap between the adjacent valve leaflets The distance between the valves is reduced, and the coaptation area between adjacent valve leaflets is increased, which can effectively repair the valve and prevent its regurgitation.

Description of drawings

Figures 1a-1d are structural schematic diagrams of the anchoring device of the present invention, wherein Figure 1c is a schematic structural diagram of a blocking member, and Figure 1d is a schematic structural diagram of an anchoring needle.

Figures 2a-2c are schematic diagrams of the release process of the anchoring device of the present invention, wherein Figure 2a is a schematic diagram of the structure of the anchoring device when it is in a pre-installed state, and Figure 2b is a schematic diagram of the limit rod protruding from the delivery catheter and returning to its natural state , FIG. 2c is a schematic diagram of the connector detaching from the delivery catheter and returning to its natural state.

Fig. 3a and Fig. 3b are structural schematic diagrams of the shrink ring member of the present invention.

Figures 4a to 4g are schematic diagrams of the working process of an anchoring system and its forming device of the present invention, wherein Figures 4a to 4d are schematic diagrams of the working process of the anchoring device, Figures 4b to 4d are partially enlarged schematic diagrams of Figure 4a, and Figures 4e to 4g It is a schematic diagram of the working process of the retractable ring member after the anchoring device is implanted.

The names of the parts indicated by the numbers in the accompanying drawings are as follows: 1-anchor device, 11-anchor needle, 12-connecting rod, 13-connecting head, 131-connecting groove, 14-stopper, 141-collar, 142-Limiting rod, 2-Conveyor, 21-Control handle, 22-Conveying catheter, 23-Control rod, 231-Engagement structure, 3-Contraction ring member, 31-Contraction skeleton, 311-First skeleton, 312- The second skeleton, 32-fabric layer, 33-wire, 34-anchor hole.

Detailed ways

The application will be further described in detail below in conjunction with the accompanying drawings and embodiments.

The proximal end mentioned in this application refers to the end close to the operator, and the distal end refers to the end away from the operator.

Specific embodiment one:

In the prior art, although the helical needle can provide a large anchoring force, it is easy to over-screw the helical needle into the tissue due to invisible reasons during the operation, resulting in tissue damage and easy separation from the implanted device, especially when used for When the shrink ring is anchored and shrunk, the helical needle is easily separated from the shrink ring piece, resulting in shrinkage failure; and this application proposes a new type of anchoring system for the above-mentioned technical pain points, which skillfully solves the pain points existing in the prior art .

As shown in Figures 1a to 1d, an anchoring system includes an anchoring device 1 and a delivery device 2 for delivering the anchoring device 1, and the delivery device 2 includes a control handle 21 and a delivery catheter connected to the control handle 21 22. The control rod 23 arranged in the delivery catheter 22, the anchoring device 1 includes an anchoring needle 11 in a helical structure, a connecting rod 12, a connecting head 13, and a blocking member 14, and the anchoring needle 11 is fixed on One end of the connecting rod 12, the connecting head 13 is fixed on the other end of the connecting rod 12, the blocking member 14 includes a collar 141 and a limit rod 142 arranged on the collar 141, and, the The limiting rod 142 expands outwards centering on the connecting rod 12 in a natural state; during pre-installation, the connecting head 13 is connected to the distal end of the control rod 23, and the limiting rod 142 is limited In the space reserved between the connecting head 13 and the anchoring needle 11, as shown in FIG. Drive the connecting head 13 to rotate the anchor needle 11, when the anchor needle 11 partially enters the tissue, continue to rotate the control rod 23, the limit rod 142 protrudes from the delivery catheter 22 and returns to the preset shape , as shown in Figure 2b, and, the stop rod 142 is an arc structure, the free end of the stop rod 142 is sharp, and the bending direction of the anchor needle 11 is the same as that of the anchor needle 11. The helical direction of the control rod 142 is the same, which allows the free end part of the limit rod 142 to enter the tissue, so that the force of the rotation of the control rod 23 increases sharply, and the operator can clearly perceive that the anchoring device 1 has been fixed in place through the force of rotation. , and the free end part of the limiting rod 142 enters the tissue, which increases the fixing point between the anchoring device 1 and the tissue, prevents the anchoring needle 11 from loosening, and effectively improves the stability of the anchoring device 1 implanted, and When the contraction ring is operated, the limit rod 142 can provide lateral force, so that the transmission of contraction force is more direct and effective.

In this embodiment, the connecting head 13 is provided with a connecting groove 131, and, in a natural state, both sides of the connecting groove 131 expand outward, and the distal end of the control rod 23 is provided with an engaging structure 231, When pre-installed, the connecting structure 231 is detachably connected with the connecting groove 131, as shown in FIG. open, so that the connecting head 13 and the control rod 23 can be disassembled and separated, as shown in Figure 2c, there is no need to increase the separation operation steps and complicated structure, and at the same time, the outward opening of the two sides of the connecting groove 131 also has a limiting effect, further Prevent the fabric layer 32 from detaching from the anchor pins 11 .

As shown in Figure 3a and Figure 3b, the anchoring system provided by the present invention can be used to fix the shaping device, which is used for the treatment of mitral valve regurgitation, including the anchoring device 1, the contraction ring member 3 and the anchoring device for delivery. The conveyor 2 of the device 1 and the ring-shrinking member 3, the ring-shrinking member 3 includes a shrinking skeleton 31, a fabric layer 32 covering the outer layer of the shrinking skeleton 31, and a wire 33 for controlling the shrinkage of the shrinking skeleton 31, wherein, when After the ring-shrinking member 3 reaches a predetermined position, the ring-shrinking member 3 is fixed on the tissue through the anchoring device 1 .

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

In this embodiment, when the stop rod 142 protrudes from the delivery catheter 22 and returns to the preset shape, the free end of the stop rod 142 pierces the fabric layer 32 and enters the tissue, as shown in the figure 4b and 4c are shown.

In this embodiment, the shrinkable skeleton 31 includes a first skeleton 311 and a second skeleton 312. After the shaping device is implanted, the first skeleton 311 and the second skeleton 312 are adjacently arranged on the mitral valve. In the P2 region of the posterior valve annulus, when the anchoring device 1 is fixed, the wire 33 for controlling contraction is pulled to make the first framework 311 and the second framework 312 contract to realize ring contraction, as shown in Figures 4e-4g, during this process Among them, the limit rod 142 can effectively provide lateral force, so that the transmission of the contraction force is more direct, and the effect of the shrink ring is better, and the limit rod 142 can effectively prevent the shrink ring member 3 from being caused by the side when shrinking. The pulling force in the direction causes the fabric layer 32 to separate from the anchoring device 1. After contraction, because the end point of the contraction skeleton 31 moves the largest distance, the P2 area of the posterior valve annulus will obviously move closer to the anterior valve area, as shown in Figures 4f and 4g As shown, the apposition area of the anterior leaflet and the posterior leaflet is significantly increased, effectively improving regurgitation.

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

The steps in the application process are as follows:

1. The anchoring device 1 and the shrinking ring member 3 are pre-installed into the conveyor 2, and the anchoring device 1 and the shrinking ring member 3 are placed at the target position through the conveyor 2, as shown in Figure 4a;

2. Turn the control rod 23 so that the anchor needle 11 rotates and penetrates into the heart tissue through the anchor hole 34, and the limit rod 142 protrudes from the delivery catheter 22 and restores the preset 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 breaks away from the delivery catheter 22, the control The rod 23 is separated from the connector 13 to complete the anchoring, as shown in Figure 4d;

3. Then pull the wire 33 to shrink the shrinking skeleton 31 to complete the ring shrinkage, as shown in Figures 4e-4g, and finally withdraw the conveyor 2 from the body to complete the implantation.

The foregoing description of several embodiments of the present application have been presented for purposes of illustration. The foregoing description is not intended to be exhaustive, nor 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. It is intended that the scope of the invention and all equivalents be defined by the claims appended hereto.

Claims (11)

1. An anchoring system, comprising an anchoring device and a conveyor for delivering the anchoring device, characterized in that: the anchoring device includes an anchoring needle in a helical structure, a connecting rod, a connecting head, and a stopper , the anchor pin is fixed at one end of the connecting rod, the connecting head is fixed at the other end of the connecting rod, the blocking member includes a collar and a limit rod arranged on the collar, and, the The limiting rod expands outwards centering on the connecting rod in a natural state. 2. An anchoring system according to claim 1, characterized in that: the delivery device comprises a control handle, a delivery catheter connected to the control handle, and a control rod arranged in the delivery catheter, and when pre-installed, the The connecting head is connected to the distal end of the control rod, and the limiting rod is limited in the space reserved between the connecting head and the anchor needle. 3 . The anchoring system according to claim 1 , wherein the limiting rod is in an arc shape, and the bending direction of the anchoring needle is the same as the helical direction of the anchoring needle. 4 . 4. 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 of the limiting rod The end part enters the tissue. 5. An anchoring system according to claim 2, characterized in that: the connecting head is provided with a connecting groove, and, in a natural state, both sides of the connecting groove expand outward. 6. An anchoring system according to claim 5, wherein the anchoring device is made of memory metal material. 7. An anchoring system according to claim 5, characterized in that: the distal end of the control rod is provided with an engaging structure, and when pre-installed, the engaging structure cooperates with the connecting groove to detachably connect, When the connection slot is disengaged from the delivery catheter, the control rod is separated from the connection head. 8. A forming device according to any one of claims 1-7, comprising an anchoring device, a shrinking ring member and a conveyor for delivering the anchoring device and the shrinking ring member, wherein the shrinking ring The ring member includes a contraction frame, a fabric layer covering the outer layer of the contraction frame, and a thread for controlling the shrinkage of the contraction frame, wherein, when the contraction ring member reaches a predetermined position, the contraction ring member passes through the anchoring device fixed on tissue. 9. A forming device according to claim 8, characterized in that: said shrink ring member is provided with an anchor hole, and when anchoring, said anchor needle passes through said anchor hole and penetrates into organize. 10. A forming device according to claim 9, characterized in that: when the limiting rod protrudes from the delivery catheter and returns to a preset shape, the free end of the limiting rod pierces Break through layers of fabric and gain access to tissue. 11. A shaping device according to claim 9, characterized in that: the shrinkable skeleton comprises a first skeleton and a second skeleton, and after the shaping device is implanted, the first skeleton and the second skeleton Adjacently arranged in the constricted ring area set by native valve ring or atrial tissue.

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