Anchoring system and forming device therefor

Abstract

The present application relates to the field of medical devices, in particular to an anchoring system and a forming device thereof. In an embodiment of the present application, a limiting rod is arranged on the anchoring device, which limiting rod extends outwardly with the connecting rod as the center in a natural state, so that the blocking piece can prevent the anchoring needle from being screwed into the tissue excessively after implantation, which enables the operator to easily determine the implantation condition of the anchoring needle by operating the rotating force even in an invisible condition, and the blocking piece can press the anchoring area of the implanted device like a "washer" to provide a lateral stabilizing force, and when used for ring contraction, the blocking piece can prevent the fabric layer from being separated from the anchoring needle during the contraction process.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to an anchoring system and its forming device. Background Technology

[0002] With the development and progress of science and technology, people's living standards have improved significantly, and their average lifespan has also increased substantially. However, with increased lifespan, the burden on the heart has also increased, especially for the elderly, who frequently experience heart disease. Among these, valvular regurgitation is the most common. When heart valves regurgitate, it can lead to symptoms of right heart failure such as fatigue, ascites, edema, liver pain, indigestion, and loss of appetite. Traditional treatments include drug therapy for mild to severe regurgitation and surgical procedures when indicated. Surgical procedures include valve replacement and valve repair. In recent years, following the report of the first aortic valve replacement, many companies have done extensive work in interventional aortic valve technology, and the technology is becoming increasingly mature. However, there is still a significant gap in the interventional treatment of atrioventricular valves. Although a few products are currently used in transcatheter valve angioplasty and repair for atrioventricular valves, the fixation of atrioventricular valves often relies on anchoring pins, but existing anchoring pins have some technical problems in practical applications.

[0003] Patent CN202210431866.2 discloses an anchor device, including a nail body, an anchor seat connected to the nail body and capable of rotating the nail body, and a derrick disposed on the nail body or the anchor seat and rotatable relative to the nail body. The anchor seat is provided with an anchor seat connector for detachable connection with an anchor delivery device. In this patented solution, the nail body is spiral-shaped, and anchoring force is obtained by rotating and screwing it into the tissue. Although the anchoring effect is good, during surgery, because the anchor needle is small, it is difficult to observe its specific position and shape through the instrument, which can easily lead to over-tightening when anchoring the needle body, causing the anchor seat to be screwed into the tissue and damaging the tissue. Furthermore, the limiting effect of the anchor seat is limited, and the anchor needle can easily detach from the anchored implanted instrument, resulting in anchoring failure.

[0004] Therefore, those skilled in the art are dedicated to developing an anchoring system and its forming device, mainly to solve the following problems: 1. Due to the lack of visibility during surgery, the depth of the anchoring needle entering the tissue cannot be determined, which can easily lead to the anchor being screwed into the tissue and causing tissue damage; 2. The limiting effect of the anchor is limited, and the anchoring needle can easily detach from the anchored implanted device, resulting in anchoring failure.

[0005] Application content

[0006] The purpose of this application is to provide an anchoring system and its forming device. The novel anchoring mechanism has the following advantages: 1. The blocking element can prevent the anchoring needle from being excessively screwed into the tissue and effectively prevent the anchoring needle from detaching from the implanted device, resulting in anchoring failure; 2. The blocking element can increase the fixation points between the anchoring device and the implanted device or cardiac tissue, making its anchoring stable, and at the same time, it can provide lateral force to facilitate the contraction of the shrink ring.

[0007] To solve the above-mentioned technical problems, this application provides the following technical solution: an anchoring system, including an anchoring device and a conveyor for conveying the anchoring device, wherein the anchoring device includes an anchoring pin, a connecting rod, a connector, and a blocking member in a spiral 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, and the blocking member includes a collar and a limiting rod disposed on the collar, wherein the limiting rod extends outward from the connecting rod in its natural state.

[0008] As a further improvement of the present invention, the conveyor includes a control handle, a conveying conduit connected to the control handle, and a control rod disposed within 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 pin.

[0009] As a further improvement of the present invention, the limiting rod has an arc-shaped structure, and the bending direction of the limiting rod is the same as the spiral direction of the anchoring needle.

[0010] 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 portion of the limiting rod enters the tissue.

[0011] As a further improvement of the present invention, the connector head is provided with a connecting groove, and in its natural state, the two sides of the connecting groove expand outward.

[0012] As a further improvement of the present invention, the distal end of the control rod is provided with a connecting structure. During pre-installation, the connecting structure is detachably connected to the connecting groove. When the connecting groove is disengaged from the delivery conduit, the control rod is separated from the connector.

[0013] As a further improvement of the present invention, a forming device using the above-described anchoring device for fixation includes an anchoring device, a shrinking ring member, and a conveyor for conveying the anchoring device and the shrinking ring member. The shrinking ring member includes a shrinking skeleton, a fabric layer covering the outer layer of the shrinking skeleton, and a thread for controlling the shrinking of the shrinking skeleton. When the shrinking ring member reaches a predetermined position, the shrinking ring member is fixed to the tissue by the anchoring device.

[0014] As a further improvement of the present invention, the shrink ring member is provided with an anchoring hole, and during anchoring, the anchoring needle passes through the anchoring hole and pierces the tissue.

[0015] As a further improvement of the present invention, 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.

[0016] As a further improvement of the present invention, the shrinkage skeleton includes a first skeleton and a second skeleton. 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.

[0017] As a further improvement of the present invention, the anchoring device and the shrinking ring component are pre-installed in the delivery device. The control rod is rotated at the target position of the anchoring device and the shrinking ring component through the delivery device, causing the anchoring needle to rotate and pass through the anchoring hole into the heart tissue. The limiting rod extends out of the delivery catheter and returns to the preset shape. The free end of the limiting rod pierces the fabric layer and enters the tissue until the connecting groove disengages from the delivery catheter. At this point, the control rod separates from the connecting head, completing the anchoring. Subsequently, the shrinking skeleton is contracted by pulling the line to complete the shrinking ring formation. Finally, the delivery device is withdrawn from the body to complete the implantation.

[0018] Compared with the prior art, the advantages of this application are:

[0019] 1. Unlike existing technologies where spiral needles lack a good limiting structure, making them prone to excessive screwing into tissue and causing severe damage to cardiac tissue, and also prone to detachment from the implanted device, resulting in anchoring failure, in one embodiment of this application, the anchoring device is provided with a limiting rod. In its natural state, the limiting rod extends outward from the connecting rod, preventing the anchor needle from being excessively screwed into the tissue after implantation. This allows the surgeon to easily determine the implantation status of the anchor needle even without visual inspection by manipulating the rotational force. Furthermore, the blocking member acts like a "shim" to press down on the anchoring area of ​​the implanted device, providing lateral stability. Moreover, when used for ring shrinking, the blocking member prevents the fabric layer from detaching from the anchor needle during shrinkage.

[0020] 2. Unlike existing technologies, in one embodiment of this application, after implantation, the free end of the limiting rod pierces the fabric layer and enters the tissue, increasing the fixation points between the anchoring device and the tissue, preventing the anchoring needle from loosening, and effectively improving the stability of the anchoring device implantation. Furthermore, during the retraction ring operation, the limiting rod provides lateral force, making the transmission of its contraction force more direct and effective. 3. Unlike existing technologies, in one embodiment of this application, during pre-installation, the limiting rod is "hidden" within the space reserved between the connector and the anchoring needle, making it easier for the anchoring device to retract into the sheath during pre-installation and significantly reducing the loading diameter of the anchoring needle.

[0021] 4. Unlike the prior art, in one embodiment of this application, the connecting groove on the connector head and the connecting groove on the control rod are detachable structures. When the connector head is removed from the delivery conduit, the two sides of the connecting groove will spring outward, so that the connector head and the control rod can be disassembled and separated without adding separation operation steps and complex structures. At the same time, the outward opening of the two sides of the connecting groove also has a limiting effect, further preventing the fabric layer from detaching from the anchoring needle.

[0022] 5. In a different embodiment of this application, there are two contractile skeletons. The first skeleton and the second skeleton are arranged adjacent to each other in the contractile annulus region set by the autologous valve annulus or atrial tissue. When the contractile line is manipulated to contract the contractile annulus component, the two endpoints of the contractile skeleton contract / move the maximum distance, causing the set contractile annulus region to move significantly towards the valve center. This reduces the distance between adjacent leaflets and increases the mating area between adjacent leaflets, which can effectively repair the valve and prevent regurgitation. Attached Figure Description

[0023] Figures la-d This is a schematic diagram of the anchoring device of the present invention, wherein... Figure lc This is a schematic diagram of the blocking component structure. Figure Id This is a schematic diagram of the anchoring pin structure.

[0024] Figures 2a-c This is a schematic diagram of the release process of the anchoring device of the present invention, wherein... Figure 2a This is a schematic diagram of the anchoring device in its pre-installed state. Figure 2b This is a schematic diagram showing the limit rod extending from inside the delivery conduit and returning to its natural state. Figure 2c This is a schematic diagram showing the connector detaching from the delivery tube and returning to its natural state.

[0025] Figure 3a and Figure 3b This is a schematic diagram of the shrink ring component of the present invention.

[0026] Figures 4a-g This is a schematic diagram illustrating the working process of an anchoring system and its forming device according to the present invention, wherein... Figures 4a-dThis is a schematic diagram of the anchoring device's operation. Figures 4b-d for Figure 4a A partially enlarged schematic diagram, Figures 4e-g This is a schematic diagram of the working process of the shrink ring component after the anchoring device is installed.

[0027] The parts referred to by the numbers in the attached diagram are as follows: 1-Anchoring device, 11-Anchoring pin, 12-Connecting rod, 13-Connecting head, 131-Connecting groove, 14-Blocking component, 141-Loop, 142-Limiting rod, 2-Conveyor, 21-Control handle, 22-Conveying conduit, 23-Control rod, 231-Connecting structure, 3-Contraction ring component, 31-Contraction skeleton, 311-First skeleton, 312-Second skeleton, 32-Fabric layer, 33-Thread, 34-Anchoring hole. Detailed Implementation

[0028] The present application will now be described in further detail with reference to the accompanying drawings and embodiments.

[0029] The proximal end, as described in this application, refers to the end closer to the surgical operator, while the distal end refers to the end farther away from the surgical operator. Specific Implementation Example 1:

[0031] In the prior art, although the spiral needle can provide a large anchoring force, it is easy to over-twist the spiral needle into the tissue due to the lack of visibility during the operation, which can lead to tissue damage and easy detachment from the implanted device. Especially when used for anchoring and shrinking the shrinking ring, the spiral needle is very easy to detach from the shrinking ring, resulting in shrinkage failure. This application proposes a new anchoring system to address the above-mentioned technical pain points and cleverly solves the pain points existing in the prior art.

[0032] like Figures la-d As shown, an anchoring system includes an anchoring device 1 and a conveyor 2 for conveying the anchoring device 1. The conveyor 2 includes a control handle 21, a conveying conduit 22 connected to the control handle 21, and a control rod 23 disposed within the conveying conduit 22. The anchoring device 1 includes an anchoring pin 11 with a spiral structure, a connecting rod 12, a connector 13, and a blocking member 14. The anchoring pin 11 is fixed to one end of the connecting rod 12, and the connector 13 is fixed to the other end of the connecting rod 12. The blocking member 14 includes a collar 141 and a limiting rod 142 disposed on the collar 141. In its natural state, the limiting rod 142 extends outward from the connecting rod 12. During pre-installation, the connector 13 is connected to the distal end of the control rod 23, and the limiting rod 142 is confined within the space reserved between the connector 13 and the anchoring pin 11. Figure 2aAs shown, when the anchoring device 1 reaches the area to be anchored, the control rod 23 can be rotated to drive the connector 13 to rotate the anchoring needle 11. When the anchoring needle 11 partially enters the tissue, the control rod 23 is rotated further, and the limiting rod 142 extends out of the delivery conduit 22 and returns to the preset shape, as shown. Figure 2b As shown, the limiting rod 142 has an arc-shaped structure, and the free end of the limiting rod 142 is sharp. Furthermore, the bending direction of the limiting rod 142 is the same as the spiral direction of the anchoring needle 11. This allows the free end of the limiting rod 142 to enter the tissue, thereby drastically increasing the force of the control rod 23's rotation. The surgeon can clearly perceive that the anchoring device 1 has been fixed in place through the force of rotation. Moreover, the free end of the limiting rod 142 entering the tissue increases the fixation points between the anchoring device 1 and the tissue, preventing the anchoring needle 11 from loosening and effectively improving the stability of the anchoring device 1's implantation. In addition, during the ring tightening operation, the limiting rod 142 can provide lateral force, making the transmission of its contraction force more direct and effective.

[0033] In this embodiment, the connector 13 is provided with a connecting groove 131, and in its natural state, the two sides of the connecting groove 131 expand outwards. The distal end of the control rod 23 is provided with a connecting structure 231. During pre-installation, the connecting structure 231 and the connecting groove 131 are detachably connected. Figure 2a As shown, when the connecting groove 131 disengages from the delivery conduit 22, the two sides of the connecting groove 131 will spring outwards, allowing the connector 13 to be disassembled from the control rod 23. Figure 2c As shown, there is no need to add separation operation steps and complex structure. At the same time, the outward opening of the two sides of the connecting groove 131 also has a limiting effect, further preventing the fabric layer 32 from detaching from the anchor needle 11.

[0034] like Figure 3a and Figure 3b As shown, the anchoring system provided by the present invention can be used to fix a shaping device for treating mitral regurgitation. The shaping device includes an anchoring device 1, a constricting ring member 3, and a conveyor 2 for conveying the anchoring device 1 and the constricting ring member 3. The constricting ring member 3 includes a constricting skeleton 31, a fabric layer 32 covering the outer layer of the constricting skeleton 31, and a thread 33 for controlling the constriction of the constricting skeleton 31. When the constricting ring member 3 reaches a predetermined position, the constricting ring member 3 is fixed to the tissue by the anchoring device 1.

[0035] In this embodiment, the shrinking ring member 3 is provided with an anchoring hole 34. During anchoring, the anchoring needle 11 passes through the anchoring hole 34 and pierces the tissue, such as... Figure 3b and Figure 4b As shown.

[0036] In this embodiment, when the limiting rod 142 extends out of the delivery conduit 22 and returns to its preset shape, the free end of the limiting rod 142 pierces the fabric layer 32 and enters the tissue, such as... Figure 4b and 4c As shown.

[0037] In this embodiment, the shrinkage 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 disposed adjacent to each other in the P2 region of the posterior mitral valve annulus. When the anchoring device 1 is fixed, pulling the control shrinkage line 33 causes the first skeleton 311 and the second skeleton 312 to shrink, thus achieving annulus shrinkage. Figures 4e-g As shown, during this process, the limiting rod 142 can effectively provide lateral force, making the transmission of its contraction force more direct and the ring-shrinking effect better. Furthermore, the limiting rod 142 can effectively prevent the fabric layer 32 from detaching from the anchoring device 1 due to lateral tension during contraction of the ring-shrinking component 3. After contraction, because the endpoint of the contraction skeleton 31 moves the greatest distance, the P2 region of the rear lobe ring will significantly move closer to the front lobe region, such as... Figure 4f and 4g As shown, this significantly increases the contact area between the anterior and posterior leaflets, effectively improving regurgitation.

[0038] In this embodiment, the fabric layer 32 is made of metal, polytetrafluoroethylene, polyethylene, polypropylene, polyester, or animal-derived materials.

[0039] The steps involved in this application process are as follows:

[0040] 1. The anchoring device 1 and the shrinking ring component 3 are pre-installed into the conveyor 2, and the conveyor 2 is used to move the anchoring device 1 and the shrinking ring component 3 to the target position, such as... Figure 4a As shown;

[0041] 2. Rotating the control lever 23 causes the anchoring needle 11 to rotate and pass through the anchoring hole 34 into the heart tissue. The limiting rod 142 extends out of the delivery catheter 22 and returns to its preset shape, as shown. Figure 4b and Figure 4c As shown, the free end of the limiting rod 142 pierces the fabric layer 32 and enters the tissue until the connecting groove 131 disengages from the delivery conduit 22. At this point, the control rod 23 separates from the connector 13, completing the anchoring. Figure 4d As shown;

[0042] 3. Subsequently, the shrinking frame 31 is shrunk by pulling line 33 to complete the ring forming, as shown. Figures 4e-g As shown, the delivery device 2 is finally removed from the body to complete the implantation.

[0043] The foregoing description of several embodiments of this application has been provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed; obviously, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its 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 includes an anchoring pin with a spiral structure, a connecting rod, a connector, and a blocking member. The anchoring pin is fixed to one end of the connecting rod, and the connector is fixed to the other end of the connecting rod. The blocking member includes a collar and a limiting rod disposed on the collar. The limiting rod has an arc-shaped structure, and the bending direction of the limiting rod is the same as the spiral direction of the anchoring pin. In its natural state, the limiting rod extends outward from the connecting rod as the center.

2. The 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 within 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 pin.

3. The 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 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, characterized in that: The anchoring device is made of shape memory metal material.

6. An anchoring system according to claim 4, characterized in that: The control rod has a connecting structure at its distal end. During pre-installation, the connecting structure is detachably connected to the connecting groove. When the connecting groove is disengaged from the delivery conduit, the control rod separates from the connector.

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

8. A forming apparatus according to claim 7, characterized in that: The shrink ring component is provided with an anchoring hole. When anchoring, the anchoring needle passes through the anchoring hole and pierces the tissue.

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

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

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