An occluder with a clamp

Abstract

This invention relates to an occluder with a clamping element, belonging to the field of medical device technology. It includes an occluder body, a clamping element, and a choke membrane. The occluder body includes a left atrial disc, a left ventricular disc, and a waist section between the two discs. The clamping element is provided on the occluder body, and includes an elastic clamping segment located on the outer periphery of the waist section of the occluder body for clamping the valve. The choke membrane covers the surface of the occluder. This invention fixes the occluder to the left atrial disc of the mitral valve, and the waist section and clamping element capture and fix the mitral valve tissue, achieving stable placement of the occluder. The occluder body and the choke membrane prevent the reverse flow of blood from the left ventricle to the left atrium, achieving the purpose of treating mitral regurgitation and effectively avoiding postoperative complications such as hemolysis. This invention can more firmly fix the occluder, reducing the risk of postoperative displacement or even dislodgement, and improving surgical safety.

Description

Technical Field

[0001] This invention relates to an occluder with a clamping element, belonging to the field of medical device technology. Background Technology

[0002] Mitral regurgitation is one of the most common valvular heart diseases, and its incidence increases significantly with age, becoming a prominent medical challenge in an aging society. Moderate to severe mitral regurgitation increases the incidence of heart failure and hospitalization, and is a significant factor contributing to poor long-term prognosis. In recent years, the emergence of various new interventional techniques has provided treatment opportunities for many patients who cannot tolerate surgery. Among the many minimally invasive interventional procedures, transcatheter mitral valve edge-to-edge repair (TEER) is currently the most widely used, has the highest level of evidence, and is the only treatment method recommended by the latest guidelines.

[0003] Currently, TEER is most effective for mitral regurgitation located in the central region of the mitral valve orifice, i.e., central regurgitation, with the highest surgical success rate. For mitral regurgitation located outside the central region, i.e., eccentric mitral regurgitation, TEER is more difficult to perform, and the surgical success rate is lower than that of the former. As for regurgitation located at the outermost edge of the leaflet, i.e., the junction of the anterior and posterior leaflets of the mitral valve, the mitral commissure is prone to injury due to the abundance of chordae tendineae and the short leaflets in this area, which can easily lead to chordae tendineae injury and clamp dislodgement. The mitral commissure region was once considered a contraindication area for TEER surgery by the academic community, as it is the most difficult to treat and has a low success rate. To date, there have only been a few case reports. Currently, some foreign scholars are using TEER in combination with occluders for the treatment of congenital heart disease or for the treatment of mitral regurgitation. For example, the "I"-shaped occluder disclosed in Chinese patents CN103705274B, CN111000598B, and CN101687088B for congenital atrial septal defect occluders has a small connecting part between the two discs, resulting in a hollow center after clamping the mitral valve leaflets. Blood flow can easily pass through the occluder, and the rapid blood flow impact can easily cause blood cell rupture and hemolysis. For example, the vascular plug disclosed in Chinese patents CN109758199B and CN209899493U for closing blood vessels has a large deformation and tension after clamping the mitral valve leaflet tissue because the occluder has no obvious waist or the waist is close to the disc. Under the impact of heartbeat and blood flow, there is a risk of the occluder dislodging. Because the aforementioned occluders are not designed according to the structural features of the mitral regurgitation area, all of the above complications have been reported in case studies abroad. Furthermore, clinical practice has shown that patients with central regurgitation account for less than one-third of all cases, and a large number of patients with mitral regurgitation involving the commissural region lose treatment opportunities due to the limitations of current TEER technology. Therefore, this technical field urgently needs to develop an occluder that can stably clamp the valve leaflet tissue, reduce occluder displacement and dislodgement, and prevent the risk of postoperative hemolysis. Summary of the Invention

[0004] The purpose of this invention is to solve the technical problem of how to obtain an occluder that can stably clamp the valve leaflet tissue, reduce occluder displacement and dislodgement, and prevent the risk of postoperative hemolysis.

[0005] To address the aforementioned problems, the present invention provides an occluder with a clamping element, comprising an occluder body and a clamping element; the occluder body includes a left atrial disc, a left ventricular disc, and a waist portion; the waist portion is located between the left atrial disc and the left ventricular disc; the occluder body is provided with a clamping element for clamping the valve, the clamping element including an elastic clamping section located on the outer periphery of the waist portion of the occluder body, and a space for accommodating the valve is provided between the clamping section and the outer wall of the waist portion of the occluder body.

[0006] Preferably, the clamping member includes a fixed section disposed in the body of the occluder, the fixed section being connected to the clamping section; a variable included angle is provided between the fixed section and the clamping section.

[0007] Preferably, the number of clamping members is greater than or equal to 2, and the fixing section of the clamping member is fixed to the waist of the occluder body.

[0008] Preferably, the blocker body is provided with a flow-blocking membrane.

[0009] Preferably, an elastic angle is provided between the clamping section and the outer wall of the waist of the plug body, and the angle is set to be variable from 0 to 180 degrees.

[0010] Preferably, the clamping section is provided with a control line for pulling the clamping section.

[0011] Preferably, the occluder body is integrally woven from shape memory metal wire and then heat-set; the projections of the two discs and waist of the occluder body onto a cross section perpendicular to the central axis of the occluder body are elliptical or circular.

[0012] Preferably, the clamping section is a hollow U-shaped structure; one end of the clamping section near the waist of the occluder body is connected to the fixing section, and the other end of the clamping section away from the occluder body is the bottom of a continuous U-shaped structure.

[0013] Preferably, the flow-blocking membrane is made of a polymer material and covers the surface of the plug.

[0014] Preferably, the control line is made of a polymer material, one end of which is connected to the end of the clamping section. By pulling the other end of the control line, the clamping section can be moved away from the waist of the blocker body.

[0015] Preferably, the outer diameter of the left atrial disc is larger than the outer diameter of the left ventricular disc.

[0016] Preferably, the outer diameter of the waist portion near the left atrial plate is larger than the outer diameter near the left ventricular plate; the outer diameter of the waist portion near the left atrial plate is smaller than the outer diameter of the left atrial plate, and the outer diameter of the waist portion near the left ventricular plate is smaller than the outer diameter of the left ventricular plate.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] The occluder provided by this invention has a left atrial disc surface that can be fixed to the left atrial surface of the mitral valve. Its waist section, wider at the top and narrower at the bottom, conforms to the anatomical shape of the mitral valve leaflets. The waist section, along with two clamping elements, captures and fixes the mitral valve tissue, thus achieving stable placement of the occluder. Simultaneously, the polymer flow-blocking membrane covering the ventricular surface of the mitral valve leaflets, the left ventricular disc surface, and the occluder surface works together to prevent retrograde blood flow from the left ventricle to the left atrium, achieving the purpose of treating junctional mitral regurgitation and effectively avoiding postoperative complications such as hemolysis. When the occluder is implanted via the apex, the clamping elements can be actively operated by a control line. Compared to existing technologies without clamping elements, this provides a more secure fixation of the occluder, reducing the risk of postoperative displacement or even dislodgement and improving surgical safety. The occluder can be implanted via a small apical incision or through a blood vessel, resulting in minimal trauma. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the structure of a plugging device with a clamping element in its natural state according to the present invention;

[0020] Figure 2 This is a schematic diagram of the structure of a occluder clamping member with a clamping element according to the present invention;

[0021] Figure 3 This is a schematic diagram of a closure device with a clamping member, wherein the clamping member fixing section is symmetrically fixed to the waist of the closure device according to the present invention;

[0022] Figure 4 This is a schematic diagram of the structure of the clamping section of the plugging device with clamping member after being pulled.

[0023] Figure 5 This is a schematic diagram of the surgical procedure for implanting an occluder with a clamping element according to the present invention;

[0024] The black area in the image is a schematic diagram of the valve.

[0025] Reference numerals in the attached diagram: 1. Occluder body; 2. Left atrial disc; 3. Waist; 4. Left ventricular disc; 5. Clamping element; 6. Fixing section; 7. Clamping section; 8. Bridging element; 9. Control line; 10. Fixing branch; 11. Clamping branch. Detailed Implementation

[0026] To make the present invention more apparent and understandable, preferred embodiments are described in detail below with reference to the accompanying drawings:

[0027] like Figure 1-5As shown, the technical solution adopted by the present invention is to provide an occluder with a clamping element, including an occluder body 1 and a clamping element 5; the occluder body 1 includes a left atrial disc 2, a left ventricular disc 4, and a waist 3; the waist 3 is located between the left atrial disc 2 and the left ventricular disc 4; the occluder body 1 is provided with a clamping element 5 for clamping the valve, the clamping element 5 including an elastic clamping section 7 located on the outer periphery of the waist 3 of the occluder body 1, and a space for accommodating the valve is provided between the clamping section 7 and the outer wall of the waist 3 of the occluder body 1. The clamping element 5 includes a fixing section 6 located in the occluder body 1, the fixing section 6 being connected to the clamping section 7; a variable included angle is provided between the fixing section 6 and the clamping section 7. The number of clamping elements 5 is greater than or equal to 2, and the fixing section 6 of the clamping element 5 is fixed to the waist 3 of the occluder body 1. The occluder body 1 is provided with a flow-blocking membrane. An elastic angle is provided between the clamping section 7 and the outer wall of the waist 3 of the occluder body 1, and the angle is variable from 0 to 180 degrees. A control line 9 for pulling the clamping section 7 is provided. The occluder body 1 is integrally woven from shape memory metal wire and then heat-set; the projections of the two discs and the waist of the occluder body 1 onto a cross-section perpendicular to the central axis of the occluder body 1 are elliptical or circular. The clamping section 7 is a hollow U-shaped structure; one end of the clamping section 7 near the waist 3 of the occluder body 1 is connected to the fixing section 6, and the end of the clamping section 7 away from the occluder body 1 is the bottom of a continuous U-shaped structure. A flow-blocking membrane made of polymer material covers the surface of the occluder. The control line 9 is made of polymer material, one end of which is connected to the end of the clamping section 7; by pulling the other end of the control line 9, the clamping section 7 can be moved away from the waist 3 of the occluder body 1. The outer diameter of the left atrial disc 2 is larger than the outer diameter of the left ventricular disc 4. The outer diameter of the lumbar region 3 near the left atrial plate 2 is greater than the outer diameter of the lumbar region near the left ventricular plate 4; the outer diameter of the lumbar region 3 near the left atrial plate 2 is smaller than the outer diameter of the left atrial plate 2, and the outer diameter of the lumbar region 3 near the left ventricular plate 4 is smaller than the outer diameter of the left ventricular plate 4.

[0028] Example

[0029] This embodiment provides an occluder with a clamping element to solve the problems of unstable fixation, easy displacement or dislodgement, and postoperative hemolysis in the prior art.

[0030] This embodiment provides an occluder with a clamping component, comprising: an occluder body 1, a clamping component 5, a control line 9, and a polymer flow-blocking membrane. The polymer flow-blocking membrane covers the surface of the occluder. The clamping component 5 includes a fixing section 6 and a clamping section 7. The fixing section 6 is fixed to the occluder support. The clamping section 7 is connected to the fixing section 6 and adheres to the outer peripheral wall of the waist 3 of the occluder. The free end of the clamping section 7 is connected to the control line 9, and by pulling the control line 9, the clamping section 7 can be moved away from the occluder body 1, forming an angle of 0-180° with the fixing section 6. The occluder body 1 can be integrally woven from shape memory metal wire and then heat-set. Its shape includes a left atrial disc 2, a left ventricular disc 4, and a waist 3 connecting the two. Furthermore, the cross-section of the two discs and the waist of the occluder body 1 can be elliptical or circular depending on the size and model. The occluder body 1 is made of shape memory metal and has shape memory properties. In its delivery state, the composite structure can be straightened into a series of single-layer structures to reduce the stent delivery size, thus enabling transvascular delivery; under normal conditions, it returns to its unfolded working state. The cross-section of the waist portion 3 of the occluder is wider at the top and narrower at the bottom, meaning that the diameter of the upper cross-section near the left atrial disc 2 is larger than the diameter of the lower cross-section near the left ventricular disc 4, while the diameter of the upper cross-section of the waist portion 3 is smaller than the diameter of the left atrial disc 2, and the diameter of the lower cross-section of the waist portion 3 is smaller than the diameter of the left ventricular disc 4. The clamping member 5 includes a fixing section 6 and a clamping section 7. The fixing section 6 includes two fixing branches 10, and the clamping section 7 includes two clamping branches 11 and a bridging member 8. The clamping member 5 is composed of two fixing branches 10 and two clamping branches 11 forming a double V-shaped structure. The ends of the two clamping branches 11 that are away from the fixing branches 10 form an inverted U-shaped structure through the bridging member 8. Two fixed support sections 10 are parallel, and two clamping support sections 11 are parallel. The two fixed support sections 10 and the two clamping support sections 11 are connected to each other at a certain angle. The clamping members 5 are made of shape memory material, and there are at least two clamping members 5. The clamping members 5 are symmetrically distributed along the outer periphery of the waist 3 of the occluder relative to the waist of the occluder. The fixed sections 6 of the clamping members are symmetrically fixed to the waist 3 of the occluder by means of threading holes or other methods. The number of control lines 9 is the same as the number of clamping members 5. The control lines 9 can be made of polymer material. One end of the control line 9 is connected to the end of the clamping section 7 away from the fixed section 6. By pulling the other end of the control line 9, the clamping section 7 can be moved away from the waist 3 of the occluder body 1, and the clamping section 7 and the fixed section 6 can form an angle of 0-180°. The polymer flow-blocking membrane can be made of polymer materials such as PET and PTFE, and the polymer flow-blocking membrane covers the surface of the occluder.

[0031] like Figures 1-5As shown, the present invention provides an occluder with a clamping element, comprising: an occluder body 1, a clamping element 5, a control line 9, and a polymer flow-blocking membrane, the polymer flow-blocking membrane covering the surface of the occluder body 1; the clamping element 5 includes a fixing section 6 and a clamping section 7, the fixing section 6 is fixed to the occluder, the clamping section 7 is connected to the fixing section 6 and forms an angle, the fixing section 6 is fixed to the outer peripheral wall of the waist 3 of the occluder, the end of the clamping section 7 away from the fixing section 6 is connected to the control line 9, and by pulling the control line 9, the clamping section 7 can be moved away from the waist 3 of the occluder, and the clamping section 7 and the fixing section 6 form an angle of 0-180°.

[0032] In the above technical solution, the clamping member 5 is in its natural state, such as Figure 1 , Figure 2 , Figure 3 As shown, the angle between the clamping section 7 and the fixed section 6 is small, and can be pulled by the control line 9 to make the angle between the clamping section 7 and the fixed section 6 larger. In this technical solution, the control line 9 is connected to the end of the clamping section 7 away from the fixed section 6.

[0033] The main body 1 of the occluder is made of shape-memory metal wire woven and shaped, possessing shape-memory properties. For example... Figure 5 As shown, in the delivery state, this structure can be straightened into a series of single-layer structures to reduce the delivery size of the stent, thereby enabling transvascular delivery; and in its natural state, it returns to its original shape. Figures 1-4 The work status.

[0034] After molding, the occluder body 1 includes: left atrial disc 2, occluder waist 3 and left ventricular disc 4; the cross-sections of the left atrial disc 2, occluder waist 3 and left ventricular disc 4 can be elliptical or circular according to size and specifications.

[0035] As a preferred embodiment of the above technical solution, the occluder body 1 and the clamping fixing section 6 can be made by stitching, hinge, or welding.

[0036] In the above technical solution, the polymer flow-blocking membrane covering the surface of the occluder can be made of materials such as PET and PTEF, or other polymer materials can be selected, which can effectively improve the efficacy of the occluder in treating mitral regurgitation.

[0037] As a preferred embodiment of the above technical solution, the control line 9 is preferably made of wire or rope.

[0038] In the above technical solution, control line 9 is connected at one end to the clamping section 7 of clamping member 5, and the other end extends to the outside of the body through a delivery tube. During normal release, control line 9 does not need to be pulled. When the occluder needs to unfold clamping member 5 for position adjustment or retrieval, pulling control line 9 causes the clamping section 7 of clamping member 5 to swing downwards and outwards, increasing the angle with the fixed section 6, thereby causing clamping member 5 to detach from the valve or even be retracted into the sheath. Figure 4 As shown.

[0039] The implementation principle of this invention is as follows:

[0040] Clamping member 5 in its natural state, such as Figure 1 As shown, the fixing section 6 of the clamping member 5 is symmetrically fixed to the outer peripheral wall of the waist 3 of the occluder. The clamping section 7 of the clamping member 5 can be pulled away from the waist of the occluder by the control line 9, thereby increasing the angle between the clamping section 7 and the fixing section 6. In this technical solution, the control line 9 is connected to the free end of the clamping section 7 of the clamping member 5. By pulling the control line 9, the clamping section 7 in the clamping member 5 can swing. The clamping member 5 can be actively operated by the operator via the control line 9, which is convenient for adjusting the position of the occluder or retrieving it as a whole. Compared with the prior art, the present invention can more easily fix the occluder, avoid complications such as displacement and dislodgement of the occluder, and improve the safety of the operation.

[0041] Additionally, the clamping member 5 is connected to the fixing section 6 of the waist part 3 of the occluder. In its natural state, it forms a V-shape with the clamping section 7 and is made of shape memory metal heat-set. Figure 2 It includes a fixing section 6 and a clamping section 7. The clamping section 7 is connected to the control line 9 by a bridging element 8. In its natural state, the fixing section 6 and the clamping section 7 have a small angle between them. During the operation, the clamping section 7 can be pulled and swayed by the control line 9, and the angle between it and the fixing section 6 becomes larger. In addition, there are at least two clamping elements 5, which are symmetrically distributed along the outer periphery of the waist of the occluder.

[0042] Furthermore, the control line 9, which drives the clamping section 7 of the manipulating clamping member 5 to swing, is preferably a rope. One end of it is connected to the free end of the clamping section 7 of the clamping member 5, and the other end passes through the delivery tube and extends to the outside of the body. Through the control line 9, the clamping section 7 of the clamping member can swing downwards and outwards, increasing the angle with the fixed section 6, such as... Figure 4 As shown.

[0043] This invention uses a polymer material flow-blocking membrane to cover the surface, and the clamping member 5 can wrap the mitral valve leaflet itself around the occluder, minimizing the blood flow from the left ventricle to the left atrium, thereby reducing the risk of hemolysis in patients after surgery and improving surgical safety.

[0044] This invention can be performed via either the transapical or transvascular approach. The following describes only the steps of the transapical approach, such as... Figure 5 As shown:

[0045] (1) The occluder delivery sheath is passed across the mitral valve junction regurgitation orifice and into the left atrium via a transvalvular device (which avoids chordae tendineae entanglement);

[0046] (2) Deliver the plugging device out of the sheath;

[0047] (3) The left atrial disc 2 can be released and withdrawn as a whole, so that the left atrial disc 2 of the occluder fits against the left atrial surface of the mitral valve leaflet;

[0048] (4) Continue to retract the sheath and release the waist 3 of the plugger. At this time, the clamping section 7 of the plugger clamping part 5 is still inside the delivery sheath.

[0049] (5) Continue to retract the conveyor sheath so that the clamping section 7 of the clamping member 5 is released and moves to the fixing section 6 of the clamping member 5 through metal memory. This step can be adjusted by the control line 9 to adjust the clamping movement of the clamping section 7.

[0050] (6) The clamping section 7 and the fixing section 6 of the clamping member 5 clamp the mitral valve leaflet, so that the mitral valve leaflet wraps around the waist 3 of the occluder, while the left ventricular disc 4 of the occluder is released.

[0051] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any form or substance. It should be noted that those skilled in the art can make various improvements and additions without departing from the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention. Any modifications, alterations, and equivalent changes made by those skilled in the art based on the above-disclosed technical content without departing from the spirit and scope of the present invention are equivalent embodiments of the present invention. Furthermore, any modifications, alterations, and evolutions made to the above embodiments based on the essential technology of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. An occluder with a clamping member, characterized in that, The device includes an occluder body and a clamping component. The occluder body includes a left atrial disc, a left ventricular disc, and a waist. The waist is located between the left atrial disc and the left ventricular disc. The occluder body is provided with a clamping component for clamping the valve. The clamping component includes an elastic clamping section located on the outer periphery of the waist of the occluder body. A space for accommodating the valve is provided between the clamping section and the outer wall of the waist of the occluder body. The clamping member includes a fixing section disposed in the body of the occluder, the fixing section being connected to the clamping section; a variable included angle is provided between the fixing section and the clamping section; An elastic angle is provided between the clamping section and the outer wall of the waist of the occluder body, and the angle is variable from 0 to 180 degrees; a control line for pulling the clamping section is provided on the clamping section; By pulling the control line, the clamping section is moved away from the main body of the plugger, and the clamping section forms an angle of 0-180° with the fixed section. The number of clamping components is greater than or equal to 2, and the fixing section of the clamping component is fixed to the waist of the occluder body.

2. The occluder with a clamping member according to claim 1, characterized in that, The plugging device is equipped with a flow-blocking membrane.

3. The occluder with a clamping member according to claim 1, characterized in that, The occluder body is integrally woven from shape memory metal wire and then heat-set; the projections of the two discs and waist of the occluder body onto the cross-section perpendicular to the central axis of the occluder body are elliptical or circular.

4. The occluder with a clamping member according to claim 1, characterized in that, The clamping section is designed as a hollow U-shaped structure; the end of the clamping section near the waist of the occluder body is connected to the fixing section, and the end of the clamping section away from the occluder body is the bottom of a continuous U-shaped structure.

5. The occluder with a clamping member according to claim 2, characterized in that, The flow-blocking membrane is made of polymer material and covers the surface of the plug.

6. The occluder with a clamping member according to claim 1, characterized in that, The control line is made of polymer material. One end of the control line is connected to the end of the clamping section. By pulling the other end of the control line, the clamping section can be moved away from the waist of the blocker body.

7. The occluder with a clamping member according to claim 1, characterized in that, The outer diameter of the left atrial disc is larger than the outer diameter of the left ventricular disc.

8. The occluder with a clamp according to claim 1, characterized in that The outer diameter of the waist portion near the left atrial plate is greater than the outer diameter near the left ventricular plate; the outer diameter of the waist portion near the left atrial plate is smaller than the outer diameter of the left atrial plate, and the outer diameter of the waist portion near the left ventricular plate is smaller than the outer diameter of the left ventricular plate.

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