Anchoring system for anchoring an implantation device

Abstract

The application relates to the field of medical devices, in particular to an anchoring system for anchoring an implanted device, which comprises a delivery catheter, a positioning support, an anchoring device and an implanted device, the positioning support is detachably connected with the implanted device, the implanted device is provided with an anchored area, the positioning support comprises a plurality of positioning rods and a limiting sleeve arranged on the positioning rods, a distal end part of the anchoring device is preloaded in the limiting sleeve, and the anchoring device can be pushed to move along a channel in the limiting sleeve until a head end of the anchoring device abuts against the anchored area; in the application, the anchoring device is guided by the limiting sleeve, can be quickly and accurately guided to the anchored area, and the limiting sleeve does not occupy the loading space of the implanted device, so that the device is not only convenient to operate, but also has a high fault tolerance.

Description

Technical Field

[0001] This application belongs to the field of medical devices, and specifically relates to an anchoring system for anchoring implantable devices. Background Technology

[0002] Minimally invasive interventional medical technology is a highly efficient diagnostic and treatment method that has gradually emerged in recent years. It boasts significant advantages such as minimal trauma, ease of operation, precise intervention site selection, and fewer complications, and has become one of the most important diagnostic and treatment methods for cardiovascular and oncological diseases. In interventional procedures, specialists typically use manual manipulation of specific devices to deliver one or more slender, flexible catheters of different shapes or functions through the complex and variable internal cavities of the patient's cardiovascular system. Catheters, guidewires, stents, and other instruments are then advanced to the intended lesion site for minimally invasive treatment. Mitral valve disease has a high incidence rate among adult heart valve diseases. Mitral regurgitation (MR) in mitral valve disease has a particularly serious impact on patients. Normally, the mitral valve in the human heart acts as a hemostatic valve, preventing oxygen-rich blood from the lungs from flowing back into the left atrium. If the mitral valve malfunctions or becomes misaligned, MR will occur, which significantly reduces the heart's pumping efficiency and can even lead to heart failure. Mitral regurgitation is classified into functional and degenerative types. Functional mitral regurgitation (FMR) is characterized by mitral annular dilation, inadequate leaflet junction, and mitral valve leaflet tethering, which is caused by left ventricular dysfunction and remodeling. Driven by the unfavorable outcomes and high risks of surgical mitral valve repair, alternatives using catheters and minimally invasive techniques have been sought, such as percutaneous rim-to-rim repair, indirect annulation, and direct annulation. Mitral annulation is one of the most common surgical procedures for treating FMR.

[0003] Patent CN 202310567779.4 discloses a guideable anchoring system, including a delivery conduit, a positioning bracket disposed within the delivery conduit, an anchoring mechanism, a flexible kit, and a guiding mechanism. The positioning bracket is disposed at the distal end of the delivery conduit and has multiple circumferentially distributed anchoring points. The flexible kit has multiple connection points. The guiding mechanism includes multiple guide lines, which pass through the connection points and connect with the anchoring points. The distal portion of the anchoring mechanism is fitted within the flexible kit, and the flexible kit, in conjunction with the guide lines, allows the anchoring mechanism to be guided to each anchoring point along a predetermined route and complete anchoring. In this scheme, the anchoring mechanism uses multiple guide lines for guidance and positioning. However, due to the limited diameter of the delivery catheter, the multiple guide lines are prone to interference within the lumen. Secondly, using lines as guides can easily cause angular deviations, resulting in insufficient accuracy. Furthermore, the head of the anchoring mechanism can only guide to the end of the positioning stent's rod. When a part of the positioning stent cannot be against the heart tissue, the head of the anchoring mechanism cannot be against the heart tissue for anchoring. Therefore, using lines as guides limits the position of the guidance point.

[0004] Therefore, those skilled in the art are dedicated to developing an anchoring system for anchoring implantable devices, mainly to solve the following problems: 1. Solving the problem of mutual interference between guide wires within the lumen; 2. Solving the problem of angular deviation caused by guide wires; 3. Solving the problem of limited guide points. Summary of the Invention

[0005] The purpose of this application is to provide an anchoring system for anchoring implantable devices. This novel anchoring mechanism has the following advantages: 1. The limiting sleeve can accurately guide the anchoring device to the target anchoring position without interference; 2. After the anchoring device is against the anchored area, it can continue to be pushed to ensure that the anchored area conforms to the heart tissue, and its guidance point is unrestricted with a high fault tolerance rate; 3. The limiting sleeve can be compressed during loading, so that it will not encroach on the loading space of the implantable device in the delivery catheter; 4. The rigid and flexible segmented design of the anchoring device makes it unaffected when it bends in the blood vessel; 5. The hollow tube and the anchoring needle are designed separately and can be detachably connected through the guide wire, so that it has a secondary anchoring function and a higher device fault tolerance rate.

[0006] To solve the above-mentioned technical problems, this application provides the following technical solution: an anchoring system for anchoring implantable devices, comprising a delivery catheter, a positioning bracket, an anchoring device, and an implantable device, wherein the positioning bracket is detachably connected to the implantable device, the implantable device has an anchored area, the positioning bracket includes multiple positioning rods and a limiting sleeve disposed on the positioning rods, the distal portion of the anchoring device is pre-installed in the limiting sleeve, and pushing the anchoring device allows the anchoring device to move along a channel within the limiting sleeve until the head end of the anchoring device abuts against the anchored area.

[0007] As a further improvement of the present invention, the limiting sleeve is made of a flexible material.

[0008] As a further improvement of the present invention, the limiting sleeve has deformability.

[0009] As a further improvement of the present invention, the limiting sleeve is made of a polymer material, such as PTFE.

[0010] As a further improvement of the present invention, the channel of the limiting sleeve is located inside the positioning bracket.

[0011] As a further improvement of the present invention, the inner wall of the limiting sleeve is smooth, which means that the limiting sleeve will not generate resistance to the anchoring device during the pushing process.

[0012] As a further improvement of the present invention, during pre-installation, the distal portion of the limiting sleeve is compressed and deformed to avoid encroaching on the loading space of the implantable device. When the positioning bracket is deployed and pushes the anchoring device to move along the channel inside the limiting sleeve, the distal portion of the limiting sleeve is stretched open and the channel is restored, so that the head end of the anchoring device can abut against the anchored area along the path of the limiting sleeve.

[0013] As a further improvement of the invention, the anchoring device can slide along the channel of the limiting sleeve so that the distal end of the anchoring device abuts against the anchored area.

[0014] As a further improvement of the present invention, the shape of the positioning stent after deployment is similar to that of the treated autologous valve annulus, and the anchored area of ​​the positioning stent conforms to the heart tissue after deployment; however, due to the differences in physiological and anatomical structures among different patients, when the anchored area does not conform to the heart tissue, the anchoring device is pushed further, so that the head end of the anchoring device presses against the anchored area until the anchored area conforms to the heart tissue.

[0015] As a further improvement of the present invention, the positioning rod is provided with a serrated structure, which is used to fix the limiting sleeve and can prevent the limiting sleeve from sliding.

[0016] As a further improvement of the present invention, the anchoring device includes a needle tube and an anchoring component disposed within the needle tube. The needle tube includes a rigid section and a flexible section, and the rigid section is disposed at the distal end of the flexible section.

[0017] As a further improvement of the present invention, the rigid section is pre-installed in the limiting sleeve.

[0018] As a further improvement of the present invention, the anchoring assembly includes an anchoring needle, a hollow tube, and a guide wire. The anchoring needle is a spiral needle. The guide wire is detachably connected to the anchoring needle. The guide wire is disposed inside the hollow tube. Pushing the hollow tube allows it to move along the guide wire and form a detachable connection with the anchoring needle. Rotating the hollow tube allows it to drive the anchoring needle to rotate for anchoring.

[0019] As a further improvement of the present invention, the anchoring needle includes a needle head and a connecting part, the connecting part is provided with a groove, and the distal end of the hollow tube is provided with a protrusion that engages with the groove, wherein the hollow tube moves along the guide line so that the protrusion is inserted into the groove to form a connection.

[0020] As a further improvement of the present invention, the hollow tube is connected to the anchoring needle through the guide wire, which can achieve multiple and repeated anchoring of the anchoring needle.

[0021] As a further improvement of the present invention, during pre-installation, the anchoring needle is placed in the rigid section, the hollow tube is placed in the flexible section, and the hollow tube is pre-installed in the proximal part of the needle tube. The advantage of this design is that the needle tube is designed with rigid and flexible sections. The rigid section is used for pre-installing the anchoring needle, and the flexible section is used for bending within the blood vessel. Furthermore, the hollow tube is pre-installed in the proximal part of the needle tube, which will not affect the bending of the flexible section. At the same time, it can be connected to the anchoring needle through the guide wire to complete the anchoring operation.

[0022] As a further improvement of the present invention, the implantable device is a shrinking annulus for treating autologous valves.

[0023] Compared with the prior art, the advantages of this application are: 1. Existing repair systems use wires to guide and position the anchoring device. However, due to the numerous guiding points, the wires are prone to interference within the narrow and limited space of the sheath. During guidance, the long and tortuous entry path prevents the wires from being fully taut, leading to deflection of the anchoring device and insufficient guidance accuracy. In one embodiment of this application, a limiting sleeve is provided on the positioning rod, forming a movable channel. The anchoring device can slide along this channel and abut against the anchored area of ​​the implanted device. By guiding the movement path of the anchoring device through the limiting sleeve channel, interference between guiding components (wires used as guides in the prior art) can be avoided, saving loading space inside the sheath. Furthermore, the anchoring device does not deflect in path or angle during movement within the channel, improving the accuracy of guidance and positioning, which has significant clinical implications.

[0024] 2. Unlike the prior art, in one embodiment of this application, the limiting sleeve is made of a flexible material, and during loading, the distal part of the limiting sleeve is compressed, while after the anchoring device is pushed, the limiting sleeve can restore the channel, which makes the limiting sleeve not encroach on the loading space of the implanted device.

[0025] 3. Unlike the prior art, in one embodiment of this application, when the anchored area does not adhere to the heart tissue, the anchoring device is continued to be pushed so that the head of the anchoring device presses against the anchored area until the anchored area adheres to the heart tissue. This ensures that the anchoring device can ensure that the anchoring needle penetrates into the heart tissue and guarantees its anchoring effect. In addition, this also eliminates the influence of the irregularity of the valve annulus shape caused by lesions on the anchoring device, further improving the fault tolerance of the device.

[0026] 4. Unlike the prior art, in one embodiment of this application, the needle tube is designed with rigid and flexible sections. The rigid section is used to pre-install the anchoring needle, and the flexible section is used for bending within the blood vessel. Furthermore, the hollow tube is pre-installed in the proximal part of the needle tube, which will not affect the bending of the flexible section. At the same time, it can be connected to the anchoring needle through the guide wire to complete the anchoring operation.

[0027] 5. Unlike the prior art, in one embodiment of this application, the anchoring pin and the hollow tube are designed separately and guided by a guide line to form a detachable connection, so that the anchoring device has the function of secondary or multiple anchoring. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the overall structure of the positioning system of the present invention.

[0029] Figure 2 and Figure 3 This is a schematic diagram of the positioning bracket of the present invention.

[0030] Figure 4This is a schematic diagram of the anchoring device of the present invention moving along the limiting sleeve.

[0031] Figure 5 and Figure 6 This is a schematic diagram of the anchoring device of the present invention.

[0032] Figure 7 This is a schematic diagram of the anchoring component of the present invention.

[0033] Figure 8 This is a schematic diagram of the implantable device of the present invention anchored in the heart.

[0034] The parts referred to by the numbers in the attached diagram are as follows: 1-Delivery catheter, 2-Positioning bracket, 21-Positioning rod, 211-Serrated structure, 22-Limiting sleeve, 3-Anchoring device, 31-Needle tube, 311-Rigid section, 312-Flexible section, 32-Anchoring component, 321-Anchoring needle, 3211-Needle tip, 3212-Connecting part, 3213-Slot, 322-Hollow tube, 3221-Protrusion, 323-Guide wire, 4-Implantable instrument, 41-Anchored area. Detailed Implementation

[0035] The present application will now be described in further detail with reference to the accompanying drawings and embodiments.

[0036] 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

[0038] like Figure 1 As shown, when this anchoring system is used for mitral valve annulus reduction surgery, an anchoring system for anchoring an implantable device 4 includes a delivery catheter 1, a positioning bracket 2, an anchoring device 3, and an implantable device 4. The implantable device 4 is an annulus reduction component for treating autologous valve annulus. The positioning bracket 2 is detachably connected to the implantable device 4. The implantable device 4 has an anchored area 41. The positioning bracket 2 includes multiple positioning rods 21 and a limiting sleeve 22 disposed on the positioning rods 21. The distal portion of the anchoring device 3 is pre-installed within the limiting sleeve 22. Figure 2 and Figure 3 As shown, pushing the anchoring device 3 allows it to move along the channel within the limiting sleeve 22 until the head end of the anchoring device 3 abuts against the anchored area 41, as shown. Figure 4 As shown, when the anchoring device 3 abuts against the anchored area 41, operating the anchoring device 3 can anchor the implanted device 4 in the heart, as... Figure 8 As shown, after the ring-shrinking operation is completed, the delivery system is removed from the body, and the surgery is completed.

[0039] In this embodiment, the limiting sleeve 22 is made of a flexible material, which makes the limiting sleeve 22 deformable. Furthermore, the channel of the limiting sleeve 22 is located inside the positioning bracket 2. During pre-installation, the distal part of the limiting sleeve 22 is compressed and deformed to avoid encroaching on the loading space of the implantable device 4. When the positioning bracket 2 is unfolded, it pushes the anchoring device 3 to move along the channel inside the limiting sleeve 22. The distal part of the limiting sleeve 22 is stretched open and the channel is restored, so that the head end of the anchoring device 3 can abut against the anchored area 41 along the path of the limiting sleeve 22.

[0040] In this embodiment, the limiting sleeve 22 is made of PTFE material. Due to the properties of PTFE material, the inner wall of the limiting sleeve 22 is smooth, which means that the limiting sleeve 22 will not generate resistance to the anchoring device 3 during the pushing process.

[0041] In this embodiment, the anchoring device 3 can slide along the channel of the limiting sleeve 22 so that the distal end of the anchoring device 3 abuts against the anchored area 41. The limiting sleeve 22 guides the anchoring device 3 to move quickly and accurately to the anchored area 41, avoiding the problem of mutual interference caused by using a line as a guide in the prior art. At the same time, the anchoring device 3 will not deviate in path or angle when moving in the channel, improving the accuracy of guidance and positioning, which has great clinical significance.

[0042] In this embodiment, the shape of the positioning stent 2 after unfolding is similar to that of the treated autologous valve annulus. After unfolding, most of the anchored area 41 of the positioning stent 2 is attached to the heart tissue. However, due to the differences in physiological and anatomical structures among different patients, when the anchored area 41 in a localized area is not attached to the heart tissue, the anchoring device 3 is pushed further, so that the head end of the anchoring device 3 presses against the anchored area 41 until the anchored area 41 is attached to the heart tissue.

[0043] In this embodiment, the positioning rod 21 is provided with a serrated structure 211. The serrated structure 211 is used to fix the limiting sleeve 22, and the serrated structure 211 can prevent the limiting sleeve 22 from sliding. Figure 2 and Figure 3 As shown.

[0044] In this embodiment, the anchoring device 3 includes a needle tube 31 and an anchoring assembly 32 disposed within the needle tube 31. The needle tube 31 includes a rigid section 311 and a flexible section 312, and the rigid section 311 is disposed at the distal end of the flexible section 312, such as... Figure 5 and Figure 6 As shown.

[0045] In this embodiment, the rigid segment 311 is pre-installed inside the limiting sleeve 22.

[0046] In this embodiment, the anchoring assembly 32 includes an anchoring needle 321, a hollow tube 322, and a guide wire 323. The anchoring needle 321 is a spiral needle. The guide wire 323 is detachably connected to the anchoring needle 321 and is disposed within the hollow tube 322. Figure 7 As shown, pushing the hollow tube 322 allows it to move along the guide line 323 and form a detachable connection with the anchoring pin 321. Rotating the hollow tube 322 allows it to drive the anchoring pin 321 to rotate for anchoring.

[0047] In this embodiment, the anchoring needle 321 includes a needle tip 3211 and a connecting portion 3212. The connecting portion 3212 is provided with a slot 3213. The distal end of the hollow tube 322 is provided with a protrusion 3221 that engages with the slot 3213. The hollow tube 322 moves along the guide line 323, so that the protrusion 3221 is inserted into the slot 3213 to form a connection.

[0048] In this embodiment, the hollow tube 322 is connected to the anchoring needle 321 through the guide line 323, which can achieve multiple and repeated anchoring of the anchoring needle 321.

[0049] In this embodiment, during pre-installation, the anchoring needle 321 is placed within the rigid section 311, and the hollow tube 322 is placed within the flexible section 312. Furthermore, the hollow tube 322 is pre-installed in the proximal portion of the needle tube 31. The advantage of this design is that the needle tube 31 is designed with rigid and flexible sections. The rigid section 311 is used for pre-installing the anchoring needle 321, and the flexible section 312 is used for bending within the blood vessel. Moreover, the hollow tube 322 is pre-installed in the proximal portion of the needle tube 31, which will not affect the bending of the flexible section 312. At the same time, it can be connected to the anchoring needle 321 through the guide wire 323 to complete the anchoring operation.

[0050] 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 for anchoring implantable devices, comprising a delivery catheter, a positioning bracket, an anchoring device, and an implantable device, wherein the positioning bracket is detachably connected to the implantable device, and the implantable device has an anchoring area, characterized in that: The positioning bracket includes multiple positioning rods and a limiting sleeve disposed on each positioning rod. The distal part of the anchoring device is pre-installed in the limiting sleeve. Pushing the anchoring device allows it to move along the channel within the limiting sleeve until the head end of the anchoring device abuts against the anchored area.

2. The anchoring system for anchoring implantable devices according to claim 1, characterized in that: The limiting sleeve is made of flexible material.

3. The anchoring system for anchoring implantable devices according to claim 1, characterized in that: The channel of the limiting sleeve is located inside the positioning bracket.

4. The anchoring system for anchoring implantable devices according to claim 1, characterized in that: The inner wall of the limiting sleeve is smooth.

5. The anchoring system for anchoring implantable devices according to claim 1, characterized in that: During pre-installation, the distal portion of the limiting sleeve is compressed and deformed. When the positioning bracket is unfolded, it pushes the anchoring device to move along the channel inside the limiting sleeve, and the distal portion of the limiting sleeve is stretched open.

6. The anchoring system for anchoring implantable devices according to claim 1, characterized in that: The anchoring device can slide along the channel of the limiting sleeve so that the distal end of the anchoring device abuts against the anchored area, and when the anchored area is not in contact with the heart tissue, the anchoring device is pushed further so that the head end of the anchoring device presses against the anchored area until the anchored area is in contact with the heart tissue.

7. The anchoring system for anchoring implantable devices according to claim 1, characterized in that: The positioning rod has a serrated structure, which is used to fix the limiting sleeve.

8. The anchoring system for anchoring implantable devices according to claim 1, characterized in that: The anchoring device includes a needle tube and an anchoring component disposed within the needle tube. The needle tube includes a rigid section and a flexible section, and the rigid section is disposed at the distal end of the flexible section.

9. The anchoring system for anchoring implantable devices according to claim 8, characterized in that: The anchoring assembly includes an anchoring pin, a hollow tube, and a guide wire. The guide wire is detachably connected to the anchoring pin. The guide wire is disposed inside the hollow tube. Pushing the hollow tube allows it to move along the guide wire and form a detachable connection with the anchoring pin.

10. The anchoring system for anchoring implantable devices according to claim 9, characterized in that: The anchoring needle includes a needle head and a connecting part. The connecting part is provided with a slot. The distal end of the hollow tube is provided with a protrusion that engages with the slot. The hollow tube moves along the guide line so that the protrusion is inserted into the slot to form a connection.

11. The anchoring system for anchoring implantable devices according to claim 9, characterized in that: During pre-installation, the anchoring pin is placed within the rigid section, and the hollow tube is placed within the flexible section.

12. The anchoring system for anchoring implantable devices according to claim 1, characterized in that: The implantable device is a shrinking annulus for treating autologous valves.

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