Valve repair system capable of guiding and positioning

Abstract

The invention relates to the field of medical instruments, in particular to a valve repair system capable of guiding positioning, which comprises a delivery catheter, a pre-positioning device arranged in the delivery catheter, a guiding device, a positioning support and a contraction ring component, the positioning support comprises a plurality of positioning rods, each positioning rod is provided with a detection element with a developing function, the positioning support is connected with the guiding device in a matched mode, magnetic attraction force can be generated between the pre-positioning device and the guiding device, the positioning support can move along the guiding device, and the positioning support determines whether the positioning support reaches a designated position or not by observing the detecting element. The pre-positioning device and the guiding device are matched to guide a path in advance, the relative position of the positioning support and the autologous valve ring can be determined through the detecting element, and the situation that an operator excessively moves the positioning support, and consequently heart tissue is damaged is avoided.

Description

Technical Field

[0001] This application belongs to the field of medical devices, and particularly relates to a valve repair system capable of guiding and positioning. 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, insufficient 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 is 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 to make the distal part of the anchoring and repairing mechanism reach the target anchoring position; the defects of this patented technology are as follows: First, when the anchoring and repairing mechanism enters along the path of the guiding and positioning mechanism, due to the invisibility of the autologous valve annulus in the image, the operator cannot judge whether the anchoring and repairing mechanism reaches the autologous valve annulus; Second, in this solution, only a single point can be guided and positioned. In the case of being invisible during the operation and the autologous valve annulus being generally saddle-shaped in morphology, it is very difficult to ensure that the guiding and positioning mechanism can be delivered to the ideal positioning position. Moreover, a single positioning point relies on the image to find the position one by one and then anchor, which greatly increases the operation time during the operation and the operation difficulty rises linearly, which is neither conducive to the postoperative rehabilitation of patients nor to the market promotion of products; Third, this repair system uses two sets of devices to complete the repair of the valve through different access paths, with a long operation time and complex operation during the operation.

[0004] Therefore, those skilled in the art are committed to developing a valve repair system that can be guided and positioned, mainly solving the following problems: how to intuitively judge the position of the repair system and the autologous valve annulus and how to ensure precise guidance of the positioning while shortening the operation time during the operation. Application content

[0005] The purpose of this application is to provide a valve repair system that can be guided and positioned. This new type of anchoring mechanism has the following advantages: 1. The guiding device determines the anchoring position through the pre-positioning device. The positioning bracket moves along the path of the guiding device, and the position with the autologous valve annulus is determined through the detection element, and the guiding and positioning method is precise; 2. The flexible detection element can not only be used to judge the position with the autologous valve annulus, but also avoid damage to the heart tissue caused by the positioning rod.

[0006] In order to solve the above technical problems, the present application solves the problems through the following technical solutions: a valve repair system that can be guided and positioned, comprising a delivery catheter, a pre-positioning device arranged in the delivery catheter, a guiding device, a positioning bracket and a shrinking ring component, the positioning bracket comprising a plurality of positioning rods, the positioning rods being provided with a detection element with a developing function, wherein the positioning bracket is cooperatively connected with the guiding device, a magnetic attraction force can be generated between the pre-positioning device and the guiding device, the positioning bracket can move along the guiding device, and the positioning bracket determines whether the positioning bracket has reached the specified position by observing the detection element.

[0007] As a further improvement of the present invention, after the pre-positioning device reaches the predetermined position in advance, 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, the positioning bracket moves along the path of the guiding device and determines whether the positioning bracket has reached the specified position by observing the detection element.

[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, the pre-positioning device includes at least two groups of pre-positioning parts, and the pre-positioning device is in an anchor-shaped structure in a working state. Moreover, when the pre-positioning parts are 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.

[0010] As a further improvement of the present invention, the detection element is a flexible member.

[0011] As a further improvement of the present invention, the detection element is a spring made of metal wire, and the detection element is threadedly connected to the positioning rod.

[0012] As a further improvement of the present invention, the predetermined position is located at the root of the valve leaflet in the ventricle, and the target position is located at the root of the valve leaflet in the atrium.

[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 guiding wire is non-circular, and the positioning wire / the guiding wire 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 / the head end of the guiding member, and can ensure the direction of the magnetic pole distribution at its head end.

[0015] 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 of the same height in the axial direction, and the head ends of the guiding members are of the same height in the axial direction; the purpose of such a design is to ensure that the pre-positioning members / the guiding members do not attract each other.

[0016] As a further improvement of the present invention, a limiting track is provided on the positioning bracket, 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.

[0017] 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.

[0018] 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.

[0019] As a further improvement, 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 entanglement with the chordal tissue during the operation of the pre-positioning member.

[0020] 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.

[0021] As a further improvement of the present invention, the valve repair system further includes an anchoring device. After the positioning bracket reaches the autologous valve annulus, operating the anchoring device can anchor the ring constriction member on the autologous valve annulus.

[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 native valve ring only through images. Therefore, the position and release timing of the positioning stent are also difficult to confirm, resulting in a significant increase in the intraoperative time. The existing system that uses magnetic attraction for positioning requires two systems to intervene in the treatment from different access paths, and can only position and anchor a single point. Not only is the operation difficult, but the intraoperative treatment time is also long. In one embodiment of the present application, the pre-positioning device can reach the root position of the native valve leaflet in advance, and then use the magnetic attraction to enable the guide device to attract the pre-positioning device and quickly determine the guide path. The positioning stent moves toward the native valve ring along the path of the guide device, and the relative position of the positioning stent and the native valve ring is determined by a detection element with a developing function, so that the positioning stent is accurately attached to the native valve ring. The guiding and positioning method not only uses the magnetic attraction to establish a precise guide path in advance, but also further uses the detection element to determine the relative position between the positioning stent and the native valve ring, so as to avoid the operator from moving the positioning stent excessively, thereby causing damage to the heart tissue.

[0023] 2. Different from the prior art, in one embodiment of the present application, the detection element is a flexible spring element, which enables the detection element to bend in accordance with the atrial wall after touching the atrial wall during the release and movement of the positioning stent, thereby preventing the positioning rod from puncturing the atrial tissue. In addition, when the positioning stent reaches the position of the native valve ring, the swing of the native valve leaflets will cause the detection element to jump. When the operator can clearly see the jumping of the detection element through the image, it can be determined that the positioning stent has reached the position of the native valve ring, thereby avoiding excessive movement of the positioning stent and damaging the heart tissue.

[0024] 3. 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 there are two groups of pre-positioning parts, 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.

[0025] 4. 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

[0026] Figure 1 It is a schematic diagram of the overall structure of the valve repair system of the present invention.

[0027] Figure 2 It is a structural schematic diagram of the positioning bracket of the present invention.

[0028] Figure 3 This is a schematic structural diagram of the bending tube of the present invention.

[0029] Figure 4 This is a schematic structural diagram of the pre-positioning device during pre-installation of the present invention.

[0030] Figures 5 to 9 This is a schematic diagram of the operation process of the valve repair system of the present invention.

[0031] The names of the parts referred to by each number in the 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 - guiding member, 311 - guiding wire, 4 - positioning bracket, 41 - positioning rod, 42 - detecting element, 5 - constriction ring member. Embodiment

[0032] The present application will be further described in detail below in conjunction with the drawings and embodiments.

[0033] In the present application, the proximal end refers to the end close to the surgeon, and the distal end refers to the end far from the surgeon. Specific Embodiment

[0034] As Figure 1 and Figure 2 shown, when the anchoring system is used for mitral valve constriction annuloplasty treatment, a steerable positioning valve repair system includes a delivery catheter 1, a pre-positioning device 2 disposed in the delivery catheter 1, a guiding device 3, a positioning bracket 4, and a constriction ring member 5. The constriction ring member 5 can contract and expand the autologous valve annulus to repair the autologous valve. The positioning bracket 4 includes a plurality of positioning rods 41, and a detecting element 42 with imaging function is provided on the positioning rods 41. The detecting element 42 is a flexible member. Among them, the positioning bracket 4 is cooperatively connected with the guiding device 3, and a magnetic attraction force can be generated between the pre-positioning device 2 and the guiding device 3. After the pre-positioning device 2 reaches the predetermined position in advance, the guiding device 3 is moved, and the head end of the positioning member and the head end of the guiding member 31 attract each other and form a connection. As Figure 7 shown, the positioning bracket 4 moves along the path of the guiding device 3 and determines whether the positioning bracket 4 reaches the designated position by observing the detecting element 42. The state of the detecting element 42 is observed through imaging. When the detecting element 42 swings greatly, it can be determined that the positioning bracket 4 has reached the autologous valve annulus, as Figure 8 shown.

[0035] In this embodiment, the pre-positioning device 2 includes at least two groups of pre-positioning members 21. Moreover, the pre-positioning device 2 has an anchor-shaped structure in the working state. And when there are two groups of pre-positioning members 21, the pre-positioning device 2 moves the autologous leaflets towards the center of the valve, playing a role similar to a valve clip, which can shorten the distance between the native leaflets, enabling the valve to not only maintain normal operation during the operation, but also increase the coaptation area between the leaflets, achieving the effect of valve repair during the operation.

[0036] In this embodiment, the valve repair system further includes an anchoring device. After the positioning stent 4 reaches the autologous valve annulus, operating the anchoring device can anchor the constricting ring member 5 on the autologous valve annulus.

[0037] In this embodiment, the detection element 42 is a spring made of nitinol wire, and the detection element 42 is threadedly connected to the positioning rod 41. This connection method can strengthen the connection between the detection element 42 and the positioning rod 41.

[0038] In this embodiment, the predetermined position is at the root of the leaflet in the ventricle, and the target position is at the root of the leaflet in the atrium.

[0039] 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. 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, such 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. 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.

[0040] In this embodiment, the cross-section of the positioning wire 211 / the guiding wire 311 is non-circular, and 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.

[0041] 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 / the guiding members 31 do not attract each other, as Figure 4 shown.

[0042] In this embodiment, a limiting track is provided on the positioning bracket 4. Among them, the distal portion of the guide wire 311 passes through the limiting track, so that the guide wire 311 can guide the moving path of the positioning bracket 4, as Figure 1 shown.

[0043] 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. Among them, a bending adjustment section 221 is provided at the distal end of the bending adjustment tube 22, and the bending adjustment wire 23 is arranged inside the bending adjustment tube 22, as Figure 3 shown.

[0044] In this embodiment, when repairing the mitral valve, there are 2 groups of the pre-positioning members 21. 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, and 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 when the pre-positioning member 21 is operated.

[0045] The operation process of the valve repair system includes the following steps.

[0046] 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 Figure 5 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 6 and Figure 7 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. At this time, the state of the detection element 42 is observed through imaging. When the detection element 42 swings greatly, the positioning bracket 4 has reached the autologous valve annulus, as Figure 8 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 9 shown.

[0047] 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 valve repair system capable of guiding and positioning, comprising a delivery catheter, a pre-positioning device arranged in the delivery catheter, a guiding device, a positioning stent, and a constriction ring member, characterized in that: The positioning bracket includes a plurality of positioning rods, and a detection element with a developing function is provided on the positioning rods. Among them, the positioning bracket is cooperatively connected with the guiding device, a magnetic attraction force can be generated between the pre-positioning device and the guiding device, the positioning bracket can move along the guiding device, and the positioning bracket determines whether it reaches the designated position by observing the detection element.

2. The guided positioning valve repair system according to claim 1, wherein: After the pre-positioning device reaches the predetermined position in advance, 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, and the positioning bracket moves along the path of the guiding device and determines whether the positioning bracket reaches the designated position by observing the detection element.

3. The guided positioning valve repair system according to claim 1, wherein: The pre-positioning device includes at least two groups of pre-positioning members, and the pre-positioning device has an anchor-shaped structure in the working state.

4. A valve repair system capable of guiding and positioning according to claim 1, characterized in that: The detection element is a flexible member.

5. The guided positioning valve repair system according to claim 1, wherein: The detection element is a spring made of a metal wire, and the detection element is threadedly connected to the positioning rod.

6. The guided positioning valve repair system according to claim 2, wherein: 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.

7. The guided positioning valve repair system according to claim 1, wherein: During pre-installation, the head end of the pre-positioning member and the head end of the guiding member are axially offset, and 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.

8. The guided positioning valve repair system according to claim 7, wherein: The cross-section of the positioning wire / the guiding wire is non-circular.

9. The guided positioning valve repair system according to claim 1, characterized in that: The head end of the pre-positioning member and the head end of the guiding member have an N pole and an S pole in the axial direction. During pre-installation, 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.

10. The guided 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.

11. A valve repair system capable of guiding and positioning according to claim 2, characterized in that: 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.

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