An introducible positioning valve repair system

Abstract

The application relates to the field of medical devices, in particular to a valve repair system capable of guided positioning, 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 positioning support comprises a plurality of positioning rods, the positioning rods are provided with detection elements with developing functions, the positioning support is connected with the guide device in a matched mode, magnetic attraction force can be generated between the pre-positioning device and the guide device, the positioning support can move along the guide device, and whether the positioning support reaches a specified position can be determined by observing the detection elements; the pre-positioning device and the guide device in the application can pre-guide a path, the relative position of the positioning support and the autologous valve ring can be determined through the detection elements, and the operator is prevented from excessively moving the positioning support, so that the heart tissue is prevented from being damaged.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to a guided and 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 repair system capable of precise positioning, 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. The active guiding device and the passive positioning device attract each other, causing the distal end of the anchoring repair mechanism to reach the target anchoring position. The drawback of this patented technology is that: firstly, the anchoring repair mechanism... Firstly, when the guided positioning mechanism enters the system, the surgeon cannot determine whether the anchoring and repair mechanism has reached the autologous valve annulus because the annulus is not visible in the image. Secondly, this approach can only guide and position a single point. However, since the annulus is not visible during the operation and is generally saddle-shaped, it is difficult to ensure that the guided positioning mechanism can be delivered to the ideal positioning position. Furthermore, each positioning point is located and anchored one by one based on the image, which significantly increases the operation time and the difficulty of the operation, which is not conducive to the postoperative recovery of patients or the market promotion of the product. Thirdly, this repair system requires two sets of devices to complete the valve repair through different access paths, resulting in a lengthy operation time and complex operation.

[0004] Therefore, those skilled in the art are dedicated to developing a guided positioning valve repair system, mainly to solve the following problems: how to intuitively determine the position of the repair system and the autologous valve annulus, and how to ensure accurate positioning guidance while shortening the intraoperative time.

[0005] Application content

[0006] The purpose of this application is to provide a guided positioning valve repair system. This novel anchoring mechanism has the following advantages: 1. The guiding device determines the anchoring position through a pre-positioning device, the positioning bracket moves along the path of the guiding device, and the position with the autologous valve annulus is determined by the detection element, resulting in precise guidance and positioning; 2. The flexible detection element can not only be used to determine the position with the autologous valve annulus, but also avoid damage to the heart tissue caused by the positioning rod.

[0007] To solve the above-mentioned technical problems, this application provides the following technical solution: a guided valve repair system, comprising a delivery catheter, a pre-positioning device disposed within the delivery catheter, a guiding device, a positioning bracket, and a constriction ring component. The positioning bracket includes multiple positioning rods, each equipped with a detection element having imaging function. The positioning bracket is connected to the guiding device, and a magnetic attraction is 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 has reached the designated position by observing the detection element.

[0008] As a further improvement of the present invention, after the pre-positioning device arrives at the predetermined position in advance, the guiding device is moved, the head end of the positioning member attracts the head end of the guiding member and forms a connection, the positioning bracket moves along the path of the guiding device and the positioning bracket is determined to have arrived at the designated position by observing the detection element.

[0009] As a further improvement of the present invention, the shrinking ring member can shrink the expanded autologous valve ring to repair the autologous valve.

[0010] As a further improvement of the present invention, the prepositioning device includes at least two sets of prepositioning components. In the working state, the prepositioning device has an anchor-shaped structure. When there are two sets of prepositioning components, the prepositioning device moves the autologous leaflets toward the center of the valve, acting as a valve clamp. This 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 occlusion area between the leaflets, thus achieving the effect of valve repair during the operation.

[0011] As a further improvement of the present invention, the detection element is a flexible component.

[0012] 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.

[0013] As a further improvement of the present invention, the predetermined position is located at the leaflet root in the ventricle, and the target position is located at the leaflet root in the atrium.

[0014] 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.

[0015] As a further improvement of the present invention, the cross-section of the positioning wire / the guide wire is non-circular, and the positioning wire / the guide wire is a flat wire. The advantage of this design is that the direction of the pre-positioning part head end / guide part head end can be controlled circumferentially, which 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, the positioning bracket is provided with a limiting track, wherein the distal portion of the guide wire passes through the limiting track, so that the guide wire can guide the movement path of the positioning bracket.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] As a further improvement of the present invention, the valve repair system further includes an anchoring device, which, when the positioning bracket reaches the autologous valve annulus, can be operated to anchor the annulus retraction member onto the autologous valve annulus.

[0023] 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, a pre-positioning device can pre-arrive at the root of the autologous valve leaflet. Magnetic attraction then allows the guiding device to be attracted to the pre-positioning device, quickly determining the guiding path. The positioning stent moves along the path of the guiding device towards the autologous valve annulus, and a detection element with imaging capabilities determines the relative position of the positioning stent to the autologous valve annulus, ensuring precise placement of the stent. This guided positioning method utilizes magnetic attraction to pre-establish a precise guiding path and further uses detection elements to determine the relative position between the positioning stent and the autologous valve annulus, preventing excessive stent movement by the surgeon and potential damage to cardiac tissue.

[0024] 2. Unlike existing technologies, in one embodiment of this application, the detection element is a flexible spring. This allows the detection element to bend in accordance with the atrial wall after contacting it during the release and movement of the positioning stent, avoiding damage to the atrial tissue caused by the positioning rod. Furthermore, when the positioning stent reaches the position of the autologous valve annulus, the swing of the autologous valve leaflet will cause the detection element to jump. When the surgeon can clearly and intuitively see the jumping of the detection element through the image, he can determine that the positioning stent has reached the position of the autologous valve annulus, avoiding excessive movement of the positioning stent and damage to the heart tissue.

[0025] 3. 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.

[0026] 4. In a different 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

[0027] Figure 1 This is a schematic diagram of the overall structure of the valve repair system of the present invention.

[0028] Figure 2 This is a schematic diagram of the positioning bracket of the present invention.

[0029] Figure 3 This is a schematic diagram of the bending pipe of the present invention.

[0030] Figure 4 This is a schematic diagram of the pre-installed positioning device of the present invention.

[0031] Figures 5-9 This is a schematic diagram illustrating the operation process of the valve repair system of the present invention.

[0032] 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, 42-Detection element, 5-Contraction ring component. Implementation

[0033] The present application will now be described in further detail with reference to the accompanying drawings and embodiments.

[0034] 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

[0035] like Figure 1 and Figure 2 As shown, when this anchoring system is used for mitral valve annulus retraction angioplasty, a guided and positioned valve repair system includes a delivery catheter 1, a pre-positioning device 2 disposed within the delivery catheter 1, a guiding device 3, a positioning support 4, and an annulus retraction member 5. The annulus retraction member 5 can retract the dilated autologous valve annulus to repair the autologous valve. The positioning support 4 includes multiple positioning rods 41, each with a detection element 42 having imaging function. The detection element 42 is a flexible component. The positioning support 4 is connected to the guiding device 3. A magnetic attraction force is generated between the pre-positioning device 2 and the guiding device 3. After the pre-positioning device 2 reaches a predetermined position, the guiding device 3 is moved. The head end of the positioning member and the head end of the guiding member 31 attract each other and form a connection. Figure 7 As shown, the positioning bracket 4 moves along the path of the guiding device 3, and the position is determined by observing the detection element 42 to see if the positioning bracket 4 has reached the designated position. The state of the detection element 42 is observed via image monitoring. When the detection element 42 swings significantly, it can be determined that the positioning bracket 4 has reached the autologous valve annulus. Figure 8 As shown.

[0036] In this embodiment, the prepositioning device 2 includes at least two sets of prepositioning elements 21. In the working state, the prepositioning device 2 has an anchor-shaped structure. When there are two sets of prepositioning elements 21, the prepositioning device 2 moves the autologous leaflets toward the center of the valve, acting 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 occlusion area between the leaflets, thus achieving the effect of valve repair during the operation.

[0037] In this embodiment, the valve repair system further includes an anchoring device. When the positioning bracket 4 reaches the autologous valve annulus, operating the anchoring device can anchor the constricting ring member 5 onto the autologous valve annulus.

[0038] In this embodiment, the detection element 42 is a spring made of nickel-titanium metal 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.

[0039] In this embodiment, the predetermined position is located at the leaflet root in the ventricle, and the target position is located at the leaflet root in the atrium.

[0040] In this embodiment, the prepositioning member 21 includes a positioning wire 211 and a magnet or magnetic material disposed at the head end of the positioning wire 211. 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 prepositioning member 21 and the head end of the guide member 31 can generate a magnetic attraction force between them. 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 cross-section of the positioning wire 211 / guide wire 311 is non-circular, and 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 wire 31 in the circumferential direction, and can ensure the direction of the magnetic pole distribution at its head end.

[0042] In this embodiment, the head ends of the prepositioning member 21 and the guide member 31 have N and S poles in the axial direction, respectively. Furthermore, during pre-assembly, the head ends of all the prepositioning members 21 and the head ends of all the guide members 31 are at the same axial height. This design aims to ensure that the prepositioning members 21 and the guide members 31 do not attract each other. Figure 4 As shown.

[0043] In this embodiment, the positioning bracket 4 is provided with a limiting track, wherein 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, such as... Figure 1 As shown.

[0044] 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.

[0045] In this embodiment, when repairing the mitral valve, the prepositioning element 21 is in two sets. The tips of the two sets of prepositioning elements 21 abut against the root of the anterior leaflet and the root of the posterior leaflet, respectively. Furthermore, the tips of the prepositioning elements 21 abut against the A2 and P2 regions of the autologous valve annulus, respectively. The A2 and P2 regions of the autologous valve annulus have less chordae tendineae tissue, which can prevent the prepositioning element 21 from becoming entangled with the chordae tendineae tissue during operation.

[0046] The operation of this valve repair system includes the following steps.

[0047] 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... Figure 5 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 6 and Figure 7 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. At this time, observe the state of the detection element 42 through imaging. When the detection element 42 swings significantly, the positioning bracket 4 has reached the autologous valve annulus. Figure 8 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 9 As shown.

[0048] 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 guided and positioned valve repair system, comprising a delivery catheter, a pre-positioning device, a guiding device, a positioning support, and a retractable annulus component, wherein the pre-positioning device, the guiding device, the positioning support, and the retractable annulus component are disposed within the delivery catheter, and the retractable annulus component is detachably connected to the positioning support, characterized in that: The pre-positioning device includes a pre-positioning element, the guiding device includes a guiding element, and the positioning bracket includes multiple positioning rods. Each positioning rod is equipped with a detection element having imaging function. The positioning bracket is connected to the guiding device, and a magnetic attraction is generated between the pre-positioning device and the guiding device. The positioning bracket can move along the guiding device. The positioning bracket determines whether it has reached a designated position by observing the detection element. After the pre-positioning device reaches the predetermined position, it moves the guiding device. The head end of the positioning element and the head end of the guiding element attract each other and form a connection. The positioning bracket moves along the path of the guiding device and determines whether it has reached the designated position by observing the detection element. The predetermined position is located at the leaflet root in the ventricle, and the designated position is located at the leaflet root in the atrium.

2. The guided and positioned valve repair system according to claim 1, characterized in that: The pre-positioning device includes at least two sets of pre-positioning components, and the pre-positioning device has an anchor-shaped structure in the working state.

3. The guided and positioned valve repair system according to claim 1, characterized in that: The detection element is a flexible component.

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

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

6. The guided and positioned valve repair system according to claim 5, characterized in that: The cross-section of the positioning wire / guide wire is non-circular.

7. The guided valve repair system according to claim 1, 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.

8. The guided and positioned valve repair system according to claim 5, 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.

9. The guided and positioned valve repair system according to claim 1, 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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