Anchoring system for anchoring implanted instrument

Abstract

The invention relates to the field of medical instruments, in particular to an anchoring system for anchoring an implantation instrument, which comprises a delivery catheter, a positioning support, an anchoring device and the implantation instrument, the positioning support is detachably connected with the implantation instrument, the implantation instrument is provided with an anchored area, and the anchoring device is arranged in the anchored area. The positioning support comprises a plurality of positioning rods and limiting sleeves arranged on the positioning rods, the far-end portion of the anchoring device is preassembled in the limiting sleeves, and the anchoring device can be pushed to move along channels in the limiting sleeves, so that the anchoring device can move along the channels in the limiting sleeves. The head end of the anchoring device abuts against the anchored area; the anchoring device is guided through the limiting sleeve, the anchoring device can be rapidly and accurately guided to an anchored area, the limiting sleeve does not occupy the loading space of the implanted instrument, and the instrument is convenient to operate and high in error-tolerant rate.

Description

Technical Field

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

[0002] Minimally invasive interventional medical technology is an efficient diagnosis and treatment method that has gradually emerged in recent years. It has prominent advantages such as small trauma, simple operation, accurate intervention site, and few complications, and has now become one of the most important diagnosis and treatment means for cardiovascular diseases and tumor diseases. In interventional medical surgeries, usually professional doctors need to manually operate specific devices to enable one or more slender flexible catheters with different shapes or functions to pass through the complex and changeable internal cavity environments of the human body such as the cardiovascular system of patients, and send devices such as catheters, guide wires, and stents to the predetermined diagnosis and treatment lesion sites for minimally invasive diagnosis and treatment. The incidence of mitral valve disease remains high among adult heart valve diseases. Mitral regurgitation (MR) in mitral valve disease has a very serious impact on patients. Normally, the mitral valve in the human heart acts as a hemostatic valve to prevent oxygen-rich blood from the lungs from flowing back into the left atrium. Once the mitral valve fails to close properly or is misaligned, MR will occur, which will significantly reduce the heart pumping efficiency and even cause heart failure. Mitral regurgitation is divided into functional and degenerative types. Functional mitral regurgitation (FMR) is characterized by mitral annulus dilation, inadequate leaflet coaptation, and mitral valve leaflet tethering, which is caused by left ventricular dysfunction and remodeling. Driven by the poor outcomes and high risks of surgical mitral valve repair, people have started to look for alternative solutions using catheters and minimally invasive methods, such as percutaneous edge-to-edge repair, indirect annuloplasty, direct annuloplasty, etc. Mitral annuloplasty is one of the most common surgical procedures for treating FMR.

[0003] Patent CN 202310567779.4 discloses an anchor system with guiding and positioning functions, which includes a delivery catheter, a positioning stent arranged inside the delivery catheter, an anchoring mechanism, a flexible kit, and a guiding mechanism. The positioning stent is arranged at the distal end of the delivery catheter. Moreover, the positioning stent is provided with a plurality of circumferentially distributed anchor point positions, the flexible kit is provided with a plurality of connection positions, the guiding mechanism includes a plurality of guide wires, and the guide wires respectively pass through the connection positions and are cooperatively connected with the anchor point positions. Among them, the distal part of the anchoring mechanism is sleeved inside the flexible kit, and the flexible kit cooperates with the guide wires so that the anchoring mechanism can be guided to each anchor point position along a predetermined route and complete anchoring. In this solution, the anchoring mechanism is respectively guided and positioned by a plurality of guide wires. However, due to the limited diameter of the delivery catheter, the plurality of guide wires are prone to interference with each other inside the lumen. Secondly, using wires for guiding is likely to cause angular deviation, and the accuracy is still not high enough. Moreover, the head end of the anchoring mechanism can only be guided to the end of the rod of the positioning stent. When a certain part of the positioning stent cannot be attached to the heart tissue, the head end of the anchoring mechanism cannot abut against the heart tissue to perform anchoring. Therefore, when using wires for guiding, the position of the guiding site will be restricted.

[0004] Therefore, those skilled in the art are committed to developing an anchor system for anchoring implantable devices, mainly to solve the following problems: 1. Solve the problem of interference between guide wires inside the lumen; 2. Solve the problem of angular deviation caused by using guide wires for guiding; 3. Solve the problem of restricted guiding sites. Summary of the Invention

[0005] The purpose of this application is to provide an anchor system for anchoring implantable devices. This new type of anchoring mechanism has the following advantages: 1. The limit sleeve can not only accurately guide the anchoring device to the target anchoring position without mutual interference; 2. After the anchoring device abuts against the area to be anchored, it can continue to be pushed to ensure that the area to be anchored fits the heart tissue, its guiding site is not restricted, and the error tolerance rate is high; 3. The limit sleeve can be compressed during loading so that it does not occupy the loading space of the implantable device inside the delivery catheter; 4. The anchoring device is designed with a rigid and flexible segmented structure, so that it is not affected when bending in blood vessels; 5. The hollow tube and the anchoring needle are designed separately and are detachably connected through guide wires, enabling it to have the function of secondary anchoring, and the error tolerance rate of the device is higher.

[0006] To solve the above technical problems, the present application is solved by the following technical solutions: An anchoring system for anchoring an implant device, comprising a delivery catheter, a positioning stent, an anchoring device and an implant device. The positioning stent is detachably connected to the implant device. The implant device has an area to be anchored. The positioning stent includes a plurality of positioning rods and a limiting sleeve disposed on the positioning rods. The distal portion of the anchoring device is pre-mounted in the limiting sleeve. And by pushing the anchoring device, the anchoring device can be moved along the channel in the limiting sleeve until the head end of the anchoring device abuts against the area to be anchored.

[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, for example: PTFE material.

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

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

[0012] As a further improvement of the present invention, during preloading, the distal portion of the limiting sleeve is compressed and deformed to avoid occupying the loading space of the implant device. When the positioning stent is deployed and the anchoring device is pushed along the channel in the limiting sleeve, the distal portion of the limiting sleeve is expanded and the channel is restored so that the head end of the anchoring device can abut against the area to be anchored along the path of the limiting sleeve.

[0013] As a further improvement of the present 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 area to be anchored.

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

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

[0016] As a further improvement of the present invention, the anchoring device includes a needle hiding tube and an anchoring assembly arranged in the needle hiding tube. The needle hiding tube includes a rigid section and a flexible section, and the rigid section is arranged 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 limit sleeve.

[0018] As a further improvement of the present invention, the anchoring assembly includes an anchoring needle, a hollow tube and a guiding wire. The anchoring needle is a spiral needle. Among them, the guiding wire is detachably connected to the anchoring needle. The guiding wire is arranged in the hollow tube. And pushing the hollow tube can make the hollow tube move along the guiding wire and form a detachable connection with the anchoring needle. And rotating the hollow tube can make the hollow tube 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 card slot, and the distal end of the hollow tube is provided with a protrusion that cooperates with the card slot. Among them, the hollow tube moves along the guiding wire, so that the protrusion is inserted into the card slot to form a connection.

[0020] As a further improvement of the present invention, the hollow tube is cooperatively connected with the anchoring needle through the guiding wire, and the anchoring needle can be anchored multiple times and repeatedly.

[0021] As a further improvement of the present invention, during pre-installation, the anchoring needle is arranged in the rigid section, the hollow tube is arranged in the flexible section, and the hollow tube is pre-installed in the proximal part of the needle hiding tube. The advantage of such a design is that: the needle hiding tube is designed with a rigid and flexible section. The rigid section is used for pre-installing the anchoring needle, and the flexible section is used for bending in the blood vessel. And the hollow tube is pre-installed in the proximal part of the needle hiding tube, which will not affect the bending of the flexible section, and at the same time can be cooperatively connected with the anchoring needle through the guiding wire to complete the anchoring operation.

[0022] As a further improvement of the present invention, the implanting device is a ring reducing member for treating the autologous valve annulus.

[0023] Compared with the prior art, the advantages of the present application are as follows: 1. In the existing repair system, the guiding and positioning of the anchoring device is achieved through wires. However, due to the large number of guiding positions, the guiding wires are prone to interference with each other in the narrow and limited space of the sheath tube. During the guiding process, because of the long and tortuous access path, the wires cannot be fully straightened, which may cause the anchored pipe fittings to deflect easily and the guiding accuracy is insufficient. In an embodiment of the present application, a limiting sleeve is provided on the positioning rod. The limiting sleeve forms a movable channel, and the anchoring device can slide along this channel and abut against the anchored area of the implanting instrument. By using the channel of the limiting sleeve to guide the moving path of the anchoring device, it is not only possible to avoid interference between the guiding components (the wires used for guiding in the prior art), save the loading space inside the sheath tube, but also the anchoring device will not deflect in terms of path or angle during movement in the channel, improving the guiding and positioning accuracy, which has great clinical significance.

[0024] 2. Different from the prior art, in an embodiment of the present application, the limiting sleeve is made of a flexible material. And during loading, the distal part of the limiting sleeve is compressed, and after pushing the anchoring device, the limiting sleeve can restore the channel again, which makes the limiting sleeve not occupy the loading space of the implanting instrument.

[0025] 3. Different from the prior art, in an embodiment of the present application, when the anchored area does not fit the heart tissue, continue to push the anchoring device so that the head end of the anchoring device abuts against the anchored area until the anchored area fits the heart tissue. This enables the anchoring device to ensure that the anchoring needle penetrates into the heart tissue, guaranteeing its anchoring effect. Moreover, this also eliminates the influence of the irregularity of the valve annulus shape caused by the lesion on the anchoring device, further improving the fault tolerance rate of the instrument.

[0026] 4. Different from the prior art, in an embodiment of the present application, the needle hiding tube has a rigid-flexible segmented design. The rigid segment is used for preloading the anchoring needle, and the flexible segment is used for bending in the blood vessel. And the hollow tube is preloaded in the proximal part of the needle hiding tube, which will not affect the bending of the flexible segment, and at the same time can be connected with the anchoring needle through the guiding wire to complete the anchoring operation.

[0027] 5. Different from the prior art, in an embodiment of the present application, the anchoring needle and the hollow tube are separately designed and form a detachable connection through the guiding wire, enabling the anchoring device to have the function of secondary or multiple anchoring. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

[0030] Figure 4Schematic diagram of the movement of the anchoring device of the present invention along the limiting sleeve.

[0031] Figure 5 and Figure 6 Schematic diagram of the structure of the anchoring device of the present invention.

[0032] Figure 7 Schematic diagram of the structure of the anchoring component of the present invention.

[0033] Figure 8 Schematic diagram of the implant device of the present invention anchored in the heart.

[0034] The names of the parts referred to by the numbers in the drawings are as follows: 1 - delivery catheter, 2 - positioning stent, 21 - positioning rod, 211 - serrated structure, 22 - limiting sleeve, 3 - anchoring device, 31 - needle hiding tube, 311 - rigid section, 312 - flexible section, 32 - anchoring component, 321 - anchoring needle, 3211 - needle tip, 3212 - connecting part, 3213 - card slot, 322 - hollow tube, 3221 - protrusion, 323 - guiding wire, 4 - implant device, 41 - anchored area. Embodiment

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

[0036] The proximal end referred to in the present application means the end close to the surgeon, and the distal end means the end far from the surgeon. Specific embodiment

[0037] As Figure 1 shown, when the anchoring system is used for mitral valve annuloplasty treatment, an anchoring system for anchoring the implant device 4 includes a delivery catheter 1, a positioning stent 2, an anchoring device 3 and an implant device 4. Among them, the implant device 4 is a ring constriction member for treating the autologous valve annulus. The positioning stent 2 is detachably connected to the implant device 4. The implant device 4 is provided with an anchored area 41. The positioning stent 2 includes a plurality of positioning rods 21 and a limiting sleeve 22 arranged on the positioning rods 21. The distal part of the anchoring device 3 is pre-installed in the limiting sleeve 22. As Figure 2 and Figure 3 shown, and by pushing the anchoring device 3, the anchoring device 3 can be moved along the channel in the limiting sleeve 22 until the head end of the anchoring device 3 abuts against the anchored area 41. As Figure 4 shown, when the anchoring device 3 abuts against the anchored area 41, operating the anchoring device 3 can anchor the implant device 4 in the heart. As Figure 8 shown, after the annuloplasty operation is completed, the delivery system is withdrawn from the body to complete the operation.

[0038] In this embodiment, the limiting sleeve 22 is made of a flexible material, which endows the limiting sleeve 22 with deformability. Moreover, 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 occupying the loading space of the implanting instrument 4. When the positioning bracket 2 is deployed and the anchoring device 3 is pushed to move along the channel in the limiting sleeve 22, the distal part of the limiting sleeve 22 is expanded and the channel is restored, so that the head end of the anchoring device 3 can abut against the area to be anchored 41 along the path of the limiting sleeve 22.

[0039] In this embodiment, the limiting sleeve 22 is made of PTFE material. Due to the characteristics of the PTFE material, the inner wall of the limiting sleeve 22 is smooth, which enables the limiting sleeve 22 not to generate resistance to the anchoring device 3 during the pushing process.

[0040] 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 area to be anchored 41. By means of the limiting sleeve 22, the anchoring device 3 can be guided to move quickly and accurately to the area to be anchored 41, avoiding the problem of mutual interference caused by using a wire as a guide in the prior art. At the same time, the anchoring device 3 will not deflect in terms of path or angle during movement in the channel, improving the accuracy of guiding and positioning, which has great clinical significance.

[0041] In this embodiment, the shape of the positioning bracket 2 after deployment is similar to the shape of the autologous valve annulus to be treated. Moreover, after the positioning bracket 2 is deployed, most of the area to be anchored 41 fits against the heart tissue. However, due to the differences in physiological and anatomical structures among different patients, when a local area to be anchored 41 does not fit against the heart tissue, the anchoring device 3 is further pushed so that the head end of the anchoring device 3 presses against the area to be anchored 41 until the area to be anchored 41 fits against the heart tissue.

[0042] In this embodiment, a serrated structure 211 is provided on the positioning rod 21, and the serrated structure 211 is used to fix the limiting sleeve 22. The serrated structure 211 can prevent the limiting sleeve 22 from sliding, as Figure 2 and Figure 3 shown.

[0043] In this embodiment, the anchoring device 3 includes a needle hiding tube 31 and an anchoring assembly 32 arranged in the needle hiding tube 31. The needle hiding tube 31 includes a rigid section 311 and a flexible section 312. Moreover, the rigid section 311 is arranged at the distal end of the flexible section 312, as Figure 5 and Figure 6 shown.

[0044] In this embodiment, the rigid section 311 is pre-installed in the limit sleeve 22.

[0045] In this embodiment, the anchoring assembly 32 includes an anchoring needle 321, a hollow tube 322, and a guiding wire 323. The anchoring needle 321 is a spiral needle. Among them, the guiding wire 323 is detachably connected to the anchoring needle 321, and the guiding wire 323 is arranged inside the hollow tube 322. As Figure 7 shown, and by pushing the hollow tube 322, the hollow tube 322 can move along the guiding wire 323 and form a detachable connection with the anchoring needle 321. Moreover, by rotating the hollow tube 322, the hollow tube 322 can drive the anchoring needle 321 to rotate for anchoring.

[0046] In this embodiment, the anchoring needle 321 includes a needle head 3211 and a connecting portion 3212. The connecting portion 3212 is provided with a card slot 3213. The distal end of the hollow tube 322 is provided with a protrusion 3221 that cooperates with the card slot 3213. Among them, the hollow tube 322 moves along the guiding wire 323, so that the protrusion 3221 is inserted into the card slot 3213 to form a connection.

[0047] In this embodiment, the hollow tube 322 is cooperatively connected to the anchoring needle 321 through the guiding wire 323, and the anchoring needle 321 can be anchored multiple times and repeatedly.

[0048] In this embodiment, during pre-installation, the anchoring needle 321 is arranged inside the rigid section 311, the hollow tube 322 is arranged inside the flexible section 312, and the hollow tube 322 is pre-installed in the proximal part of the needle hiding tube 31. The advantage of such a design is that the needle hiding tube 31 has a rigid and flexible segmented design. The rigid section 311 is used for pre-installing the anchoring needle 321, and the flexible section 312 is used for bending in the blood vessel. Moreover, the hollow tube 322 is pre-installed in the proximal part of the needle hiding tube 31, which will not affect the bending of the flexible section 312. At the same time, it can be cooperatively connected to the anchoring needle 321 through the guiding wire 323 to complete the anchoring operation.

[0049] The foregoing description of several embodiments of the present application is presented for purposes of illustration. The foregoing description is not intended to be exhaustive nor to limit the present application to the precise configurations, structures, and / or steps disclosed. Obviously, many modifications and variations are possible in light of the above teachings. The scope of the invention and all equivalents are intended to be defined by the appended claims.

Claims

1. An anchoring system for anchoring an implant device, comprising a delivery catheter, a positioning stent, an anchoring device and an implant device, wherein the positioning stent is detachably connected to the implant device, and the implant device is provided with an area to be anchored, and is characterized in that: The positioning bracket includes multiple positioning rods and limiting sleeves arranged on the positioning rods. The distal end portion of the anchoring device is pre-installed in the limiting sleeve, and pushing the anchoring device can make the anchoring device move along the channel in the limiting sleeve until the head end of the anchoring device abuts against the anchored area.

2. The positioning system for anchoring an implantable device according to claim 1, wherein: The limiting sleeve is made of flexible material.

3. The positioning system for anchoring an implantable device according to claim 1, characterized in that: The channel of the limiting sleeve is located on the inner side of the positioning bracket.

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

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

6. The positioning system for anchoring an implantable device according to claim 1, wherein: 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 does not fit the heart tissue, the anchoring device continues to be pushed so that the head end of the anchoring device presses against the anchored area until the anchored area fits the heart tissue.

7. The positioning system for anchoring an implantable device according to claim 1, wherein: The positioning rod is provided with a sawtooth structure, and the sawtooth structure is used to fix the limiting sleeve.

8. The positioning system for anchoring an implant device according to claim 1, characterized in that: The anchoring device comprises a needle-hiding tube and an anchoring assembly arranged in the needle-hiding tube. The needle-hiding tube comprises a rigid section and a flexible section, and the rigid section is arranged at the distal end of the flexible section.

9. The positioning system for anchoring an implantable device according to claim 8, characterized in that: The anchoring assembly includes an anchoring needle, a hollow tube and a guide wire, wherein the guide wire is detachably connected to the anchoring needle, the guide wire is arranged in the hollow tube, and pushing the hollow tube can make the hollow tube move along the guide wire and form a detachable connection with the anchoring needle.

10. The positioning system for anchoring an implantable device 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, and the distal end of the hollow tube is provided with a protrusion that cooperates with the slot, wherein the hollow tube moves along the guide wire so that the protrusion is inserted into the slot to form a connection.

11. The positioning system for anchoring an implant device according to claim 9, wherein: When pre-installed, the anchoring needle is disposed in the rigid section, and the hollow tube is disposed in the flexible section.

12. The positioning system for anchoring an implantable device according to claim 1, characterized in that: The implantation device is a shrink ring member used for treating an autologous valve ring.

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