A magnetic positioning valve repair system

Abstract

The application relates to the field of medical devices, in particular to a magnetic positioning valve repair system, which comprises a delivery catheter, a pre-positioning device arranged in the delivery catheter, a guide device, a positioning support and a shrink ring component, the pre-positioning device comprises at least two groups of pre-positioning members, the guide device comprises guide members arranged in correspondence with the pre-positioning members, magnetic attraction force can be generated between the head ends of the pre-positioning members and the head ends of the guide members, and the positioning support is connected with the guide members in a matched mode so that the guide device defines the moving path of the positioning support; the pre-positioning device and the guide device in the application can pre-determine the position of the autologous valve ring, quick positioning can be realized, the operation is convenient and the precision is high.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to a magnetically positioned valve repair system. 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 CN202111466800.9 discloses a precise positioning repair system, including a guiding and positioning mechanism with an active guiding device at its distal end; and an anchoring repair mechanism with a passive positioning device at its distal end. The active guiding device and the passive positioning device generate a magnetic attraction. During positioning, the distal end of the guiding and positioning mechanism reaches a predetermined position and remains stationary, while the distal end of the anchoring repair mechanism enters the heart. Furthermore, the active guiding device and the passive positioning device attract each other, causing the distal end of the anchoring repair mechanism to... The end portion reaches the target anchoring position; the defects of this patented technology are as follows: First, the repair system requires two sets of devices to complete the valve repair through different access paths, which makes the operation time lengthy and the operation complex; Second, this solution can only guide and locate a single point. In cases where the valve is not visible during the operation and the autologous valve annulus is roughly saddle-shaped, it is difficult to ensure that the guiding and positioning mechanism can be delivered to the ideal positioning position. Furthermore, the single positioning point relies on images to find the position one by one and then anchor it, which greatly increases the operation time and the operation difficulty, which is not conducive to the postoperative recovery of patients, nor to the market promotion of the product.

[0004] Therefore, those skilled in the art are dedicated to developing a magnetically positioned valve repair system, mainly to address the following issues: how to shorten intraoperative time while ensuring accurate positioning guidance. Summary of the Invention

[0005] The purpose of this application is to provide a magnetically positioned valve repair system. This novel anchoring mechanism has the following advantages: 1. The prepositioning device and the guiding device are integrated into the same delivery catheter, eliminating the need for additional access paths, simplifying operation, and reducing intraoperative risks; 2. At least two sets of prepositioning components can determine the height of the autologous valve annulus, allowing the positioning stent to move along the path of the guiding components to the autologous valve annulus, enabling rapid positioning and saving intraoperative operation time.

[0006] To solve the above-mentioned technical problems, this application provides the following technical solution: a magnetically positioned valve repair system, comprising a delivery catheter, a prepositioning device disposed within the delivery catheter, a guiding device, a positioning bracket, and a retractable ring component. The prepositioning device includes at least two sets of prepositioning elements, the guiding device includes guiding elements corresponding to the prepositioning elements, and a magnetic attraction force is generated between the head end of the positioning element and the head end of the guiding element. The positioning bracket is connected to the guiding element so that the guiding device limits the movement path of the positioning bracket.

[0007] As a further improvement of the present invention, the shrinking ring member is detachably connected to the positioning bracket. When the positioning bracket reaches the target position (autologous valve annulus) along the path of the guide, the shrinking ring member is transported to the autologous valve annulus.

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

[0009] As a further improvement of the present invention, after the prepositioning device arrives at the predetermined position, namely the leaflet root in the ventricle, the guiding device is moved, and the head end of the positioning member attracts each other and forms a connection with the head end of the guiding member. At this time, the head end of the guiding member is located at the leaflet root in the atrium, and the positioning bracket arrives at the target position along the path of the guiding device.

[0010] As a further improvement of the present invention, the prepositioning device has an anchor-shaped structure in the working state. When there are two sets of prepositioning components, the prepositioning device will bring the autologous leaflets closer to the center of the valve, which acts like a valve clamp. It can shorten the distance between the original leaflets, so that during the operation, the valve can not only maintain normal operation, but also increase the contact area between the leaflets, thus 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 prepositioning member and the head end of the guide member are axially misaligned.

[0012] As a further improvement of the present invention, the prepositioning head end is located at the far end of the guide head end.

[0013] As a further improvement of the present invention, the prepositioning member includes a positioning wire and a magnet or magnetic material disposed at the head end of the positioning wire, and the guide includes a guide wire and a magnet or magnetic material disposed at the head end of the guide wire, so that the head end of the prepositioning member and the head end of the guide can generate a magnetic attraction force between them. When the prepositioning member arrives at the predetermined position in advance, moving the guide can cause the guide to be attracted by the prepositioning member and reach the designated 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 this design is that it can control the direction of the pre-positioning part head end / guide part head end in the circumferential direction, and can ensure the direction of the magnetic pole distribution at its head end.

[0016] As a further improvement of the present invention, the head end of the prepositioning member and the head end of the guide member have N poles and S poles in the axial direction, and during pre-assembly, the head ends of each prepositioning member are at the same height in the axial direction, and the head ends of each guide member are at the same height in the axial direction; the purpose of this design is to ensure that the prepositioning members and guide members do not attract each other.

[0017] As a further improvement of the present invention, when repairing the mitral valve, the prepositioning member is in two sets, and the head ends of the two sets of prepositioning members respectively abut against the root of the anterior leaflet and the root of the posterior leaflet.

[0018] As a further improvement of the present invention, when there are two sets of prepositioning members, the head ends of the prepositioning members respectively abut against the A2 and P2 regions of the autologous valve annulus; the A2 and P2 regions of the autologous valve annulus have less chordae tendineae tissue, which can prevent the prepositioning members from getting entangled with the chordae tendineae tissue during operation.

[0019] As a further improvement of the present invention, when repairing the tricuspid valve, the prepositioning member is in three sets, and the head ends of the three sets of prepositioning members respectively abut against the root of the anterior leaflet, the root of the posterior leaflet, and the root of the septal leaflet.

[0020] As a further improvement of the present invention, the positioning bracket includes multiple positioning rods, and a limiting rail is provided between adjacent positioning rods, wherein the distal end of the guide wire passes through the limiting rail, so that the guide wire can guide the movement path of the positioning bracket.

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

[0022] Compared with the prior art, the advantages of this application are: 1. Existing repair systems struggle to pinpoint the exact location of the autologous valve annulus using imaging alone. Consequently, determining the location and timing of stent placement is difficult, significantly increasing intraoperative time. Current magnetic positioning systems require two separate systems with different access routes, and can only perform single-point positioning and anchoring, resulting in high operational difficulty and extended treatment time. In one embodiment of this application, at least two pre-positioning elements can pre-arrive at the root of the autologous valve leaflet. Magnetic attraction then allows the guide element to be attracted to the pre-positioning elements, quickly determining the height of the autologous valve annulus. The stent can then reach the annulus along the guide element's path. This positioning method is simple, fast, and precise, requiring only one system to complete positioning, guidance, and repair functions. It boasts high integration and ease of operation, saving considerable surgical time and reducing the possibility of postoperative complications.

[0023] 2. Unlike the prior art, in one embodiment of this application, the prepositioning device has an anchor-shaped structure in the working state. When there are two sets of prepositioning components, the prepositioning device moves the autologous leaflets toward the center of the valve, which acts like a valve clamp. This can bring the distance between the original leaflets closer, so that during the operation, the valve can not only maintain normal operation, but also increase the contact area between the leaflets, thus achieving the effect of valve repair during the operation.

[0024] 3. Unlike the prior art, in one embodiment of this application, the positioning wire / guide wire is a flat wire. The advantage of this design is that it can control the direction of the prepositioning part head / guide part head in the circumferential direction, and can ensure the direction of the magnetic pole distribution at its head. Attached Figure Description

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

[0026] Figure 2 This is a schematic diagram of the pre-installed positioning device of the present invention.

[0027] Figure 3 This is a schematic diagram of the prepositioning device of the present invention.

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

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

[0030] The parts referred to by the numbers in the attached diagram are as follows: 1-Conveying conduit, 2-Pre-positioning device, 21-Pre-positioning component, 211-Positioning wire, 22-Adjusting pipe, 221-Adjusting section, 23-Adjusting wire, 3-Guiding device, 31-Guiding component, 311-Guiding wire, 4-Positioning bracket, 41-Positioning rod, 5-Contraction ring component. Implementation

[0031] The present application will now be described in further detail with reference to the accompanying drawings and embodiments.

[0032] 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

[0033] like Figure 1As shown, when this anchoring system is used for mitral valve annulus retraction repair, a magnetically positioned valve repair system includes a delivery catheter 1, a prepositioning device 2 disposed within the delivery catheter 1, a guiding device 3, a positioning bracket 4, and an annulus retraction member 5. The prepositioning device 2 includes at least two sets of prepositioning elements 21, and the guiding device 3 includes a guiding element 31 corresponding to the prepositioning element 21. Magnetic attraction can be generated between the head end of the positioning element and the head end of the guiding element 31. The positioning bracket 4 is connected to the guiding element 31 so that the guiding device 3 limits the movement path of the positioning bracket 4.

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

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

[0036] In this embodiment, the delivery conduit 1 is provided with an anchoring mechanism connected to the positioning bracket 4. The anchoring mechanism has the same structure as the anchoring mechanism disclosed in patent 202310567779.4, both of which are used to anchor the shrinking ring member 5 onto the autologous valve annulus. Since the specific structure of the anchoring mechanism has been disclosed in the existing patent 202310567779.4, it will not be described again in this article.

[0037] In this embodiment, after the pre-positioning device 2 arrives at the predetermined position, which is the leaflet root in the ventricle, as shown... Figure 6 and Figure 7 As shown, when the guiding device 3 is moved, the head end of the prepositioning 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 leaflet in the atrium, as shown. Figure 8 and Figure 9 As shown, the positioning bracket 4 reaches the target position along the path of the guide device 3, as... Figure 10 As shown.

[0038] In this embodiment, the prepositioning device 2 has an anchor-shaped structure in the working state. When there are two sets of prepositioning components 21, the prepositioning device 2 moves the autologous leaflets toward the center of the valve, which acts like a valve clamp. This can bring the distance between the original leaflets closer, so that during the operation, the valve can not only maintain normal operation, but also increase the contact area between the leaflets, thus 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 guide member 31, and the head end of the pre-positioning member 21 is located at the distal end of the head end of the guide member 31, such as... Figure 2 As shown.

[0040] In this embodiment, the pre-positioning member 21 includes a positioning wire 211 and a magnet or magnetic material disposed at the head end of the positioning wire 211, and the guide member 31 includes a guide wire 311 and a magnet or magnetic material disposed at the head end of the guide wire 311, so that the head end of the pre-positioning member 21 and the head end of the guide member 31 can generate a magnetic attraction force between them. Figure 1 As shown, when the prepositioning member 21 arrives at the predetermined position in advance, moving the guide member 31 can cause the guide member 31 to be attracted by the prepositioning member 21 and reach the designated position.

[0041] In this embodiment, the positioning wire 211 / guide wire 311 is a flat wire. The advantage of this design is that it can control the direction of the head end of the prepositioning member 21 / guide member 31 in the circumferential direction, and can ensure the direction of the magnetic pole distribution at the head end.

[0042] In this embodiment, the distal end of the positioning wire 211 is flexible, which ensures that the head end of the prepositioning member 21 will not damage the tissue when it comes into contact with the tissue.

[0043] In this embodiment, the head end of the prepositioning member 21 and the head end of the guide member 31 have N and S poles in the axial direction. Furthermore, during pre-assembly, the head ends of each prepositioning member 21 are at the same height in the axial direction, and the head ends of each guide member 31 are at the same height in the axial direction. The purpose of this design is to ensure that the prepositioning members 21 and the guide members 31 do not attract each other.

[0044] In this embodiment, when repairing the mitral valve, the prepositioning member 21 is in two sets, with the head ends of the two sets of prepositioning members 21 respectively abutting against the root of the anterior leaflet and the root of the posterior leaflet.

[0045] In this embodiment, when there are two sets of prepositioning members 21, the head ends of the prepositioning members 21 respectively abut against the A2 and P2 regions of the autologous valve ring; the A2 and P2 regions of the autologous valve ring have less chordae tendineae tissue, which can prevent the prepositioning members 21 from getting tangled with the chordae tendineae tissue during operation.

[0046] In this embodiment, the positioning bracket 4 includes multiple positioning rods 41, and a limiting track is provided between adjacent positioning rods 41, such as... Figure 1 and Figure 4 As shown, the distal portion of the guide wire 311 passes through the limiting track, so that the guide wire 311 can guide the movement path of the positioning bracket 4.

[0047] In this embodiment, the pre-positioning device 2 further includes a bending tube 22 and a bending wire 23 connected to the bending tube 22. The bending tube 22 has a bending section 221 at its distal end, and the bending wire 23 is disposed within the bending tube 22. Figure 3 As shown.

[0048] In this embodiment, a limiting guide tube is sleeved around the outer periphery of the bending pipe 22. During pre-installation, the pre-positioning device 2 and the bending pipe 22 are confined within the limiting guide tube, such as... Figure 2 As shown, when the designated position is reached, pushing the bending tube 22 to the distal end can restore the distal portion of the bending tube 22 to a preset bending shape, such as... Figure 6 As shown, the positioning wire 211 is then pushed so that the prepositioning member 21 extends out of the bending tube 22 and reaches the root position of the autologous leaflet, as shown. Figure 7 As shown.

[0049] In another embodiment, when the valve repair system is used to repair the tricuspid valve, the prepositioning member 21 is in three groups, with the head ends of the three groups of prepositioning members 21 respectively abutting against the root of the autologous anterior leaflet, the root of the autologous posterior leaflet, and the root of the autologous septal leaflet.

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

[0051] 1) The delivery catheter 1 enters the heart along the guidewire's path within the blood vessel, pushing the prepositioning device 2 to extend it from the limiting catheter and reach the root of the autologous valve leaflet, as... Figures 5-7 As shown; 2) When the head end of the prepositioning member 21 abuts against the root of the autologous leaflet, the guide member 31 is pushed, causing the guide member 31 and the corresponding prepositioning member 21 to attract each other and form a connection, such as... Figure 8 and Figure 9 As shown; 3) Push the positioning bracket 4 so that it reaches the autologous valve annulus along the preset path of the guide 31, completing the guidance and positioning. Figure 10 As shown; 4) Operate the anchoring mechanism to anchor the constricting ring member 5 onto the autologous valve annulus, and operate the constricting ring member 5 to complete the valve repair. Finally, remove the repair system from the body. Figure 11 As shown.

[0052] 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. A magnetically positioned valve repair system, comprising a delivery catheter, a pre-positioning device, a guiding device, a positioning bracket, and a retractable annulus component, wherein the pre-positioning device, the guiding device, the positioning bracket, and the retractable annulus component are disposed within the delivery catheter, and the retractable annulus component is detachably connected to the positioning bracket, characterized in that: The prepositioning device includes at least two sets of prepositioning elements, and the guiding device includes a guide element corresponding to the prepositioning elements. A magnetic attraction force can be generated between the head end of the prepositioning element and the head end of the guide element. The magnetic attraction force enables the guide element to attract the prepositioning element and quickly determine the height of the autologous valve annulus. The positioning bracket is connected to the guide element so that the guiding device limits the movement path of the positioning bracket.

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

3. The valve repair system with magnetic positioning according to claim 2, characterized in that: The predetermined location is at the leaflet root in the ventricle, and the target location is at the leaflet root in the atrium.

4. The valve repair system with magnetic positioning according to claim 1, characterized in that: The pre-positioning device has an anchor-shaped structure when in operation.

5. The valve repair system with magnetic positioning according to claim 1, characterized in that: During pre-installation, the head end of the pre-positioning component and the head end of the guide component are offset axially.

6. The valve repair system with magnetic positioning according to claim 1, characterized in that: The pre-positioning component includes a positioning wire and a magnetic material disposed at the head end of the positioning wire, and the guide component includes a guide wire and a magnetic material disposed at the head end of the guide wire.

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

8. The valve repair system with magnetic positioning according to claim 6, characterized in that: The head end of the prepositioning member and the head end of the guide member have N and S poles in the axial direction. Furthermore, during pre-assembly, the head ends of each prepositioning member and the head ends of each guide member are at the same axial height.

9. The valve repair system with magnetic positioning according to claim 1, characterized in that: When there are 2 or 3 sets of prepositioning elements, the head end of each prepositioning element abuts against the root of a different autologous leaflet.

10. A magnetically positioned valve repair system according to claim 9, characterized in that: When there are two sets of prepositioning elements, the head ends of the prepositioning elements abut against the A2 and P2 regions of the autologous valve ring, respectively.

11. A magnetically positioned valve repair system according to claim 6, characterized in that: The positioning bracket is provided with a limiting rail, wherein the distal end of the guide wire passes through the limiting rail, so that the guide wire can guide the movement path of the positioning bracket.

12. The valve repair system with magnetic positioning according to claim 6, characterized in that: The pre-positioning device further includes a bending tube and a bending wire connected to the bending tube, wherein the bending tube has a bending section at its distal end, and the bending wire is disposed inside the bending tube.

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