Valve repair system with magnetic attraction positioning function

Abstract

The invention relates to the field of medical instruments, in particular to a magnetic suction positioning valve repairing system which comprises a conveying catheter, a pre-positioning device arranged in the conveying catheter, a guiding device, a positioning support and a contraction ring component. The guiding device comprises a guiding piece arranged corresponding to the pre-positioning piece, magnetic attraction force can be generated between the head end of the positioning piece and the head end of the guiding piece, and the positioning support is connected with the guiding piece in a matched mode so that the guiding device can limit the moving path of the positioning support; the pre-positioning device is matched with the guiding device so that the position of the autologous valve ring can be pre-determined, rapid positioning can be achieved, operation is convenient and fast, and precision is high.

Description

Technical Field

[0001] This application belongs to the field of medical devices, and particularly relates to a magnetic attraction positioning valve repair system. 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 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 variable internal cavity environments of the human body such as the cardiovascular system of patients, and send instruments 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 CN202111466800.9 discloses a precisely positionable repair system, including a guiding and positioning mechanism, with an active guiding device provided at the distal end of the guiding and positioning mechanism; an anchoring and repairing mechanism, with a passive positioning device provided at the distal end of the anchoring and repairing mechanism, and a magnetic suction force generated between the active guiding device and the passive positioning device; during positioning, the distal part of the guiding and positioning mechanism reaches the predetermined position in advance and remains stationary, the distal part of the anchoring and repairing mechanism enters the heart, and the active guiding device and the passive positioning device attract each other, causing the distal part of the anchoring and repairing mechanism to reach the target anchoring position; the defects of this patented technology are as follows: First, this repair system uses two sets of devices to complete the repair of the valve through different access paths, resulting in a long operation time and complex operation during the surgery; Second, in this solution, only a single point can be guided and positioned, and in the case of non-visualization during the surgery and the generally saddle-shaped morphology of the autologous valve annulus, it is very difficult to ensure that the guiding and positioning mechanism can be delivered to the ideal positioning position. Moreover, relying on imaging to find the position of each single positioning point for anchoring increases the operation time during the surgery significantly, and the operation difficulty rises linearly, which is neither conducive to the postoperative rehabilitation of the patient nor to the market promotion of the product.

[0004] Therefore, those skilled in the art are committed to developing a magnetically positioned valve repair system, mainly solving the following problems: how to shorten the operation time during the surgery and ensure precise guiding of the positioning at the same time. Summary of the Invention

[0005] The purpose of this application is to provide a magnetically positioned valve repair system. This new type of anchoring mechanism has the following advantages: 1. Both the pre-positioning device and the guiding device are integrated in the same delivery catheter, without the need to increase the access path, which simplifies the operation and reduces the intraoperative risk at the same time; 2. At least two groups of pre-positioning members can determine the height of the autologous valve annulus, enabling the positioning stent to move along the path of the guiding member to the autologous valve annulus, and rapid positioning can be achieved, saving the operation time during the surgery.

[0006] To solve the above technical problems, this application is solved through the following technical solutions: A magnetically positioned valve repair system, including a delivery catheter, a pre-positioning device, a guiding device, a positioning stent, and a ring constriction member provided in the delivery catheter. The pre-positioning device includes at least two groups of pre-positioning members. The guiding device includes guiding members corresponding to the pre-positioning members, and a magnetic suction force can be generated between the head ends of the positioning members and the head ends of the guiding members. The positioning stent is cooperatively connected with the guiding member so that the guiding device defines the movement path of the positioning stent.

[0007] As a further improvement of the present invention, the shrink ring component is detachably connected to the positioning bracket, and when the positioning bracket reaches the target position (the native valve ring) along the path of the guide, the shrink ring component is transported to the native valve ring.

[0008] As a further improvement of the present invention, the shrinking ring component can shrink the expanded native valve ring to repair the native valve.

[0009] As a further improvement of the present invention, after the pre-positioning device reaches the predetermined position in advance, the predetermined position is the root of the valve leaflet in the ventricle, the guiding device is moved, the head end of the positioning member and the head end of the guiding member attract each other and form a connection, at this time, the head end of the guide member is located at the root of the valve leaflet in the atrium, and the positioning bracket reaches the target position along the path of the guiding device.

[0010] As a further improvement of the present invention, the pre-positioning device is in an anchor-shaped structure in a working state, and when the pre-positioning parts are in two groups, the pre-positioning device brings the native leaflets closer to the center of the valve, playing a role similar to a valve clamp, which can shorten the distance between the native leaflets, so that during the operation, it can not only allow the valve to maintain normal operation, but also increase the area of ​​​​coaptation between the leaflets, thereby achieving the effect of valve repair during the operation.

[0011] As a further improvement of the present invention, during pre-installation, the head end of the pre-positioning member and the head end of the guiding member are axially offset.

[0012] As a further improvement of the present invention, the head end of the pre-positioning member is located at the distal end of the head end of the guiding member.

[0013] As a further improvement of the present invention, the pre-positioning member includes a positioning wire and a magnet or magnetic material arranged at the head end of the positioning wire, and the guide member includes a guide wire and a magnet or magnetic material arranged at the head end of the guide wire, so that the head end of the pre-positioning member and the head end of the guide member can generate magnetic attraction force between each other, and when the pre-positioning member arrives at the predetermined position in advance, moving the guide member can make the guide member be attracted by the pre-positioning member and reach the specified position.

[0014] As a further improvement of the present invention, the cross-section of the positioning wire / the guide wire is non-circular.

[0015] As a further improvement of the present invention, the positioning wire / the guide wire is a flat wire. The advantage of such a design is that the direction of the pre-positioning member head end / the guide member head end can be circumferentially controlled to ensure the direction of the magnetic pole distribution of the head end.

[0016] As a further improvement of the present invention, the head end of the pre-positioning member and the head end of the guiding member have N poles and S poles in the axial direction, and when pre-installed, the head ends of the pre-positioning members are at the same height axially, and the head ends of the guiding members are at the same height axially; the purpose of such a design is to ensure that the pre-positioning members / guiding members do not attract each other.

[0017] As a further improvement of the present invention, when repairing the mitral valve, there are 2 groups of the pre-positioning members, and the head ends of the 2 groups of the pre-positioning members respectively abut against the root of the autologous anterior leaflet and the root of the autologous posterior leaflet.

[0018] As a further improvement of the present invention, when there are 2 groups of the pre-positioning members, the head ends of the pre-positioning members respectively abut against the A2 area and the P2 area of the autologous valve annulus; there is less chordal tissue in the A2 area and the P2 area of the autologous valve annulus, which can avoid the entanglement with the chordal tissue during the operation of the pre-positioning member.

[0019] As a further improvement of the present invention, when repairing the tricuspid valve, there are 3 groups of the pre-positioning members, and the head ends of the 3 groups of the pre-positioning members respectively abut against the root of the autologous anterior leaflet, the root of the autologous posterior leaflet and the root of the autologous septal leaflet.

[0020] As a further improvement of the present invention, the positioning bracket includes a plurality of positioning rods, and a limiting track is provided between adjacent positioning rods, wherein the distal part of the guiding wire passes through the limiting track, so that the guiding wire can guide the moving path of the positioning bracket.

[0021] As a further improvement of the present invention, the pre-positioning device further includes a bending adjustment tube and a bending adjustment wire connected to the bending adjustment tube, wherein a bending adjustment section is provided at the distal end of the bending adjustment tube, and the bending adjustment wire is arranged inside the bending adjustment tube.

[0022] Compared with the prior art, the advantages of the present application are as follows: 1. In the existing repair system, it is difficult to determine the specific position of the autologous valve annulus only through imaging. Therefore, it is also difficult to confirm the release position and release timing of the positioning bracket, resulting in a significant increase in the intraoperative time. In the existing system that uses magnetic attraction for positioning, two sets of systems need to intervene from different access paths for treatment, and only a single point can be positioned and anchored. Not only is the operation difficult, but the intraoperative treatment time is also long; in an embodiment of the present application, at least 2 groups of pre-positioning members can reach the position of the root of the autologous valve leaflet in advance, and then the guiding member can be attracted to the pre-positioning member by magnetic attraction to quickly determine the height of the autologous valve annulus. The positioning bracket can then reach the autologous valve annulus along the path of the guiding member. The positioning method is simple, fast, accurate, and only one set of system can complete functions such as positioning, guiding, and repair. It has a high degree of integration and is convenient to operate, can save a large amount of surgical time, and reduce the possibility of postoperative complications.

[0023] 2. Different from the prior art, in one embodiment of the present application, the pre-positioning device is in the shape of an anchor in the working state, and when the pre-positioning parts are in two groups, the pre-positioning device moves the native leaflets closer to the center of the valve, playing a role similar to that of a valve clamp, which can shorten the distance between the native leaflets, so that during the operation, it can not only maintain the normal operation of the valve, but also increase the area of ​​​​coaptation between the leaflets, thereby achieving the effect of valve repair during the operation.

[0024] 3. Different from the prior art, in one embodiment of the present application, the positioning wire / guide wire is a flat wire. The advantage of such a design is that the direction of the pre-positioning member head end / guide member head end can be circumferentially controlled to ensure the direction of the magnetic pole distribution of the head end. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a schematic diagram of the overall structure of the valve repair system of the present invention.

[0026] Figure 2 It is a schematic diagram of the structure of the pre-positioning device of the present invention when it is pre-installed.

[0027] Figure 3 It is a schematic structural diagram of the pre-positioning device of the present invention.

[0028] Figure 4 It is a structural schematic diagram of the positioning bracket of the present invention.

[0029] Figures 5 to 11 It is a schematic diagram of the operation process of the valve repair system of the present invention.

[0030] The names of the parts indicated by the numbers in the accompanying drawings are as follows: 1-delivery catheter, 2-pre-positioning device, 21-pre-positioning member, 211-positioning wire, 22-bending tube, 221-bending section, 23-bending wire, 3-guiding device, 31-guide member, 311-guide wire, 4-positioning bracket, 41-positioning rod, 5-shrinking ring component. Implementation

[0031] The present application is further described in detail below in conjunction with the accompanying drawings and embodiments.

[0032] The proximal end mentioned in the present application refers to the end close to the surgical operator, and the distal end refers to the end far away from the surgical operator. Specific embodiments

[0033] like Figure 1As shown, when the anchoring system is used for mitral valve reduction ring plasty treatment, a magnetically positioned valve repair system includes a delivery catheter 1, a pre-positioning device 2 arranged in the delivery catheter 1, a guiding device 3, a positioning bracket 4 and a reduction ring component 5, the pre-positioning device 2 includes at least two groups of pre-positioning parts 21, the guiding device 3 includes a guiding part 31 arranged corresponding to the pre-positioning part 21, and a magnetic attraction force can be generated between the head end of the positioning part and the head end of the guiding part 31, the positioning bracket 4 is cooperatively connected with the guiding part 31 so that the guiding device 3 limits the moving path of the positioning bracket 4.

[0034] In this embodiment, the shrink ring component is detachably connected to the positioning bracket 4. When the positioning bracket 4 reaches the target position (the native valve ring) along the path of the guide member 31, the shrink ring component 5 is transported to the native valve ring.

[0035] In this embodiment, the shrinking ring component 5 can shrink the expanded native valve ring to repair the native valve.

[0036] In this embodiment, an anchoring mechanism connected to the positioning bracket 4 is provided in the delivery catheter 1. The anchoring mechanism is consistent with the anchoring mechanism structure disclosed in Patent 202310567779.4, and is used to anchor the shrinking ring member 5 on the autologous valve ring. Since the existing Patent 202310567779.4 has disclosed the specific structure of the anchoring mechanism, it will not be repeated in this article.

[0037] In this embodiment, after the pre-positioning device 2 reaches the predetermined position in advance, the predetermined position is the root of the valve leaflet in the ventricle. Figure 6 and Figure 7 As shown, the guiding device 3 is moved, the head end of the pre-positioning member 21 and the head end of the guiding member 31 attract each other and form a connection. At this time, the head end of the guiding member 31 is located at the root of the valve leaflet in the atrium, as shown in FIG. Figure 8 and Figure 9 As shown, the positioning bracket 4 reaches the target position along the path of the guiding device 3, as shown in FIG. Figure 10 shown.

[0038] In this embodiment, the pre-positioning device 2 is in an anchor-shaped structure when in operation, and when the pre-positioning parts 21 are in two groups, the pre-positioning device 2 brings the native leaflets closer to the center of the valve, playing a role similar to a valve clamp, which can shorten the distance between the native leaflets, so that during the operation, it can not only maintain the normal operation of the valve, but also increase the area of ​​​​coaptation between the leaflets, thereby achieving the effect of valve repair during the operation.

[0039] In this embodiment, during pre-installation, the head end of the pre-positioning member 21 is axially offset from the head end of the guiding member 31, and the head end of the pre-positioning member 21 is located at the distal end of the head end of the guiding member 31, as Figure 2 shown.

[0040] In this embodiment, the pre-positioning member 21 includes a positioning wire 211 and a magnet or magnetic material provided at the head end of the positioning wire 211, and the guiding member 31 includes a guiding wire 311 and a magnet or magnetic material provided at the head end of the guiding wire 311, so that a magnetic attraction force can be generated between the head end of the pre-positioning member 21 and the head end of the guiding member 31, as Figure 1 shown. After the pre-positioning member 21 reaches the predetermined position in advance, moving the guiding member 31 can cause the guiding member 31 to be attracted by the pre-positioning member 21 and reach the designated position.

[0041] In this embodiment, the positioning wire 211 / the guiding wire 311 is a flat wire. The advantage of such a design is that it can circumferentially control the direction of the head end of the pre-positioning member 21 / the guiding member 31, and can ensure the direction of the magnetic pole distribution at its head end.

[0042] In this embodiment, the distal part of the positioning wire 211 is flexible, which can ensure that the head end of the pre-positioning member 21 will not damage the tissue when contacting the tissue.

[0043] In this embodiment, the head end of the pre-positioning member 21 and the head end of the guiding member 31 have N poles and S poles in the axial direction, and during pre-installation, the head ends of the pre-positioning members 21 are at the same height axially, and the head ends of the guiding members 31 are at the same height axially; the purpose of such a design is to ensure that the pre-positioning members 21 / guiding members 31 will not attract each other.

[0044] In this embodiment, when repairing the mitral valve, there are 2 groups of the pre-positioning members 21, and the head ends of the 2 groups of the pre-positioning members 21 respectively abut against the root of the autologous anterior leaflet and the root of the autologous posterior leaflet.

[0045] In this embodiment, when there are 2 groups of the pre-positioning members 21, the head ends of the pre-positioning members 21 respectively abut against the A2 area and the P2 area of the autologous valve annulus; there is less chordal tissue in the A2 area and the P2 area of the autologous valve annulus, which can avoid entanglement with the chordal tissue during the operation of the pre-positioning member 21.

[0046] In this embodiment, the positioning bracket 4 includes a plurality of positioning rods 41, and a limiting track is provided between adjacent positioning rods 41, as Figure 1 and Figure 4 shown, wherein the distal part of the guiding wire 311 passes through the limiting track, so that the guiding wire 311 can guide the moving path of the positioning bracket 4.

[0047] In this embodiment, the pre-positioning device 2 further includes a bending adjustment tube 22 and a bending adjustment wire 23 connected to the bending adjustment tube 22. Wherein, a bending adjustment section 221 is provided at the distal end of the bending adjustment tube 22, and the bending adjustment wire 23 is disposed inside the bending adjustment tube 22, as Figure 3 shown.

[0048] In this embodiment, a limiting catheter is sleeved outside the bending adjustment tube 22. During pre-installation, the pre-positioning device 2 and the bending adjustment tube 22 are restricted inside the limiting catheter, as Figure 2 shown. When reaching the designated position, pushing the bending adjustment tube 22 distally can make the distal part of the bending adjustment tube 22 return to a preset bent shape, as Figure 6 shown. Then, pushing the positioning wire 211 makes the pre-positioning member 21 extend out of the bending adjustment tube 22 and reach the root position of the autologous valve leaflet, as Figure 7 shown.

[0049] In another embodiment, when the valve repair system is used to repair the tricuspid valve, there are 3 groups of the pre-positioning members 21, and the head ends of the 3 groups of the pre-positioning members 21 respectively abut against the root of the autologous anterior valve leaflet, the root of the autologous posterior valve leaflet, and the root of the autologous septal valve leaflet.

[0050] The operation process of the valve repair system includes the following steps.

[0051] 1) The delivery catheter 1 enters the heart along the path of the guide wire in the blood vessel, and the pre-positioning device 2 is pushed to extend out of the limiting catheter and reach the root of the autologous valve leaflet, as Figures 5 to 7 shown; 2) After the head end of the pre-positioning member 21 abuts against the root of the autologous valve leaflet, the guiding member 31 is pushed so that the guiding member 31 and the corresponding pre-positioning member 21 attract each other and form a connection, as Figure 8 and Figure 9 shown; 3) The positioning bracket 4 is pushed so that the positioning bracket 4 reaches the autologous valve annulus according to the preset path of the guiding member 31 to complete the guiding and positioning, as Figure 10 shown; 4) The anchoring mechanism is operated so that the ring shrinking member 5 is anchored on the autologous valve annulus, and the ring shrinking member 5 is operated to complete the valve repair. Finally, the repair system is withdrawn from the body, as Figure 11 shown.

[0052] 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. A magnetic attraction positioning valve repair system, comprising a delivery catheter, a pre-positioning device, a guiding device, a positioning stent and a constriction ring member arranged in the delivery catheter, characterized in that: The pre-positioning device includes at least two sets of pre-positioning members. The guiding device includes guiding members corresponding to the pre-positioning members. Moreover, a magnetic attraction force can be generated between the head ends of the positioning members and the head ends of the guiding members, and the positioning bracket is cooperatively connected with the guiding members so that the guiding device defines the moving path of the positioning bracket.

2. The magnetic attraction positioning valve repair system according to claim 1, characterized in that: After the pre-positioning device reaches the predetermined position in advance, the guiding device is moved, the head ends of the positioning members and the head ends of the guiding members attract each other and form a connection, and the positioning bracket reaches the target position along the path of the guiding device.

3. The valve repair system with magnetic attraction positioning according to claim 1, characterized in that: The predetermined position is located at the root of the valve leaf in the ventricle, and the target position is located at the root of the valve leaf in the atrium.

4. A magnetic positioning valve repair system according to claim 1, characterized in that: The pre-positioning device has an anchor-shaped structure in the working state.

5. The magnetic attraction positioning valve repair system according to claim 1, characterized in that: During pre-installation, the head ends of the pre-positioning members and the head ends of the guiding members are axially offset.

6. The magnetic attraction positioning valve repair system according to claim 1, wherein: The pre-positioning member includes a positioning wire and a magnet or magnetic material provided at the head end of the positioning wire, and the guiding member includes a guiding wire and a magnet or magnetic material provided at the head end of the guiding wire.

7. A magnetic positioning valve repair system according to claim 6, characterized in that: The cross-section of the positioning wire / the guiding wire is non-circular.

8. A magnetic positioning valve repair system according to claim 6, characterized in that: The head ends of the pre-positioning members and the head ends of the guiding members have N poles and S poles in the axial direction. Moreover, during pre-installation, the head ends of the pre-positioning members are of the same height axially, and the head ends of the guiding members are of the same height axially.

9. A magnetic positioning valve repair system according to claim 1, characterized in that: When there are two or three sets of pre-positioning members, the head ends of the pre-positioning members respectively abut against the roots of different native valve leafs.

10. A magnetic positioning valve repair system according to claim 9, characterized in that: When there are two sets of pre-positioning members, the head ends of the pre-positioning members respectively abut against the A2 area and the P2 area of the native valve annulus.

11. A magnetic positioning valve repair system according to claim 1, characterized in that: A limiting track is provided on the positioning bracket. Among them, the distal part of the guiding wire passes through the limiting track so that the guiding wire can guide the moving path of the positioning bracket.

12. A magnetic positioning valve repair system according to claim 6, wherein: The pre-positioning device further includes a bending adjustment tube and a bending adjustment wire connected to the bending adjustment tube. Among them, a bending adjustment section is provided at the distal end of the bending adjustment tube, and the bending adjustment wire is arranged inside the bending adjustment tube.

Images