A transcatheter heart valve clamping system

Abstract

The present invention discloses a transcatheter heart valve clamping system, which includes a heart valve clamp part and a delivery system part. The heart valve clamp includes an upper clamping arm and a lower clamping arm, and the delivery system includes a delivery catheter and an operating handle. This system fixes the heart valve by the mutual clamping between the upper and lower clamping arms, and has the characteristics of simple structure, precise operation, and complete retrievability, and can treat heart valve diseases such as mitral regurgitation and tricuspid regurgitation.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a transcatheter heart valve clamping system. Background Art

[0002] With the development of society and the aging of the population, the incidence of mitral regurgitation (MR) has shown an obvious upward trend and has currently become a common heart valve disease. According to the pathogenesis, MR can be divided into primary (organic, 30%) and secondary (functional, 70%). According to the condition, MR can be divided into acute and chronic. Mild MR may not show clinical symptoms for a long time and has a good prognosis. Severe MR can cause symptoms such as palpitations, chest tightness, and shortness of breath. Patients with acute severe MR have poor tolerance and are prone to death. For chronic severe MR, the incidence of cardiovascular death and cardiovascular events within 5 years in asymptomatic patients is 14±3% and 33±3% respectively, while the annual mortality rate of those with severe heart failure (New York Heart Association (NYHA) cardiac function grade above 3) can reach 34%.

[0003] According to the investigation and research conducted by the Chinese Key Cardiovascular Disease Prevalence Investigation and Key Technology Research Group on nearly 30,000 people aged ≥35 years, the detection rates of mitral regurgitation in the natural population in China are relatively high for both men and women, both being 18.4%, and there is an increasing trend with age. Among them, the detection rate of severe mitral regurgitation in the 35 - 50 age group is 0.3%, in the 51 - 64 age group is 0.9%, and in the ≥65 age group is 2.2%. Generally, 1.2% of people have moderate to severe mitral regurgitation. According to statistics, and with the increase of age, it reaches 10% in people over 75 years old. Referring to some studies in the United States: only in the United States, there are 4.1 million cases of MR, of which 1.67 million need surgical treatment. The incidence rates of mild (+), mild (++), moderate (+++), and severe (++++) mitral regurgitation are 19.2%, 1.6%, 0.3%, and 0.2% respectively. In addition, in China, the specific incidence rate of MR is not clear, but according to the analysis of large - sample echocardiogram databases in Zhongshan Hospital Affiliated to Fudan University and the Second Affiliated Hospital of Zhejiang University School of Medicine, MR is the most common valve disease. The detection rates of MR (≥3 grades) in these two hospitals are 1.44% and 0.68% respectively. Based on this, it is estimated that there are approximately 10 million MR (≥3 grades) patients in China who need treatment. Therefore, the research and development of minimally invasive and low - risk mitral valve interventional treatment devices have great social benefits and market demands.

[0004] Mitral regurgitation treatment has evolved from traditional surgical median sternotomy to minimally invasive small-incision surgery, and is now entering the era of transcatheter interventional therapy. Minimally invasive interventional treatments for mitral regurgitation have become one of the hottest research areas in interventional cardiology, with significant progress in MRI interventional therapy, which offers minimal trauma, complications, and cost.

[0005] Mitral regurgitation interventional treatment techniques can be divided into two categories: one is transcatheter mitral valve repair, such as MitraClip, PASCAL, ValveClam, Cardioband, Mitralign, NeoChord, etc.; the other is transcatheter mitral valve implantation. Currently, repair is the main treatment method, but the technology still has some problems. For example, MitralClip clamps the anterior and posterior leaflets of the mitral valve, converting the large single hole into a small double hole to achieve the purpose of treatment. However, the implantation path is too long and the operation is too complicated, and needs to be improved. Therefore, it is necessary to design a minimally invasive interventional surgical method and device for mitral valve repair on a beating heart, which is convenient for production and can also reduce the intensity and difficulty of the operation for the surgeon.

[0006] To address the above-mentioned issues, the present invention provides a transcatheter heart valve clipping system. This system can be implanted transcatheter and secures the heart valve by interlocking upper and lower clipping arms, allowing for repair of the mitral or tricuspid valve. This device features a beating heart procedure, simple operation, and complete retraction, shortening operative time, minimizing trauma, and reducing both surgical difficulty and risk. Summary of the Invention

[0007] The object of the present invention is to provide a heart valve clamping system for treating mitral valve regurgitation or tricuspid valve regurgitation through transcatheter intervention.

[0008] The system shortens the operation time, simplifies the implantation process, facilitates the surgeon's operation, and reduces the difficulty and risk of the operation.

[0009] To achieve the above objectives, the present invention provides a transcatheter heart valve clamping system, comprising a heart valve clamp portion and a delivery system portion. The heart valve clamp comprises an upper clamping arm and a lower clamping arm, wherein the upper clamping arm has two symmetrical upper left and upper right clamping arms, and the lower clamping arm is an integrated structure having two symmetrical lower left and lower right clamping arms, with two symmetrical left and right traction arms positioned at the positions of the lower left and lower right clamping arms. The delivery system comprises a handle body, a fixing rod, a sheath tube holder, a sheath tube, a traction tail, and a traction wire. The delivery system is connected to the heart valve clamp via the hook, and the expansion, closing, and release steps of the clamping arms are controlled by operating the handle.

[0010] Preferably, the upper clamping arm has two symmetric left upper clamping arms and right upper clamping arms.

[0011] Preferably, the tops of the left upper clamping arm and the right upper clamping arm have round holes for passing the pulling wire, and the number can be one or more.

[0012] Preferably, the lower clamping arm has two symmetric left lower clamping arms and right lower clamping arms.

[0013] Preferably, the lower clamping arm has two symmetric left pulling arms and right pulling arms at the positions of the left lower clamping arm and the right lower clamping arm, and are respectively connected to the left lower clamping arm and the right lower clamping arm.

[0014] Preferably, the lower clamping arm is of an integral structure and is made of a whole pipe, and no additional assembly is required between the lower clamping arm and the pulling arm.

[0015] Preferably, the lower clamping arm has a positive connection hanging head, which is in an L shape or a T shape.

[0016] Preferably, the heart valve clip and the delivery system are fixed by a fixing rod connecting rod.

[0017] Preferably, the hanging head sheath has a reverse connection hanging head, which is in an L shape or a T shape.

[0018] Preferably, the lower clamping arm hanging head and the hanging head sheath are fixed by positive and reverse connection hanging heads.

[0019] Preferably, the pulling wire passes through the round hole at the top of the upper clamping arm, and passes through the fixing rod and the inner hole of the handle body, and is connected and fixed to the pulling tail end.

[0020] Preferably, the pulling tail end can move back and forth in the handle body.

[0021] Preferably, the hanging head sheath can move axially on the fixing rod, and the position of the pulling arm can be controlled by moving the displacement, thereby realizing the control of the angle of the lower clamping arm.

[0022] Preferably, the hanging head sheath can rotate circumferentially by a small angle on the fixing rod. When the positive and reverse connection hanging heads rotate to a certain angle, the release step of the heart valve clip can be realized.

[0023] Preferably, the hanging head sheath can control the locking and release of the heart valve clip. When the heart valve clip has not detached from the fixing rod, the clamped valve can be re-expanded and clamped again, which is completely reversible and recoverable.

[0024] Preferably, the upper clamping arm and the lower clamping arm in the heart valve clip applicator are made of shape memory alloy, such as NiTi, etc.

[0025] The advantages of the present invention are that it can be implanted through a catheter to treat mitral regurgitation or tricuspid regurgitation without stopping the heart. Through the transcatheter method, the fixing arm and the clamping arm of the cardiac valve clip are used to clamp the valve leaflets under the guidance of three-dimensional ultrasound and angiography, thereby reducing the regurgitation area and achieving transcatheter edge-to-edge repair. The structure of this system is simpler than other methods, which is convenient for the operator, shortens the operation time, reduces the degree of trauma, and reduces the operation difficulty and risk. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0027] FIG. 1 is a schematic diagram of the principle of surgical mitral edge-to-edge suture technique, where 1a is when the mitral valve is closed and 1b is when the mitral valve is open;

[0028] Figure 2 FIG. is a front view schematic diagram of the cardiac valve clip, where the cardiac valve clip is in a closed state;

[0029] Figure 3 FIG. is a front view schematic diagram of the cardiac valve clip, where the cardiac valve clip is in an unfolded state;

[0030] Figure 4 FIG. is a front view schematic diagram of the clamping arm on the cardiac valve clip, where the upper clamping arm is in a closed state;

[0031] Figure 5 FIG. is a front view schematic diagram of the clamping arm on the cardiac valve clip, where the upper clamping arm is in an unfolded state;

[0032] Figure 6 FIG. is a front view schematic diagram of the lower clamping arm on the cardiac valve clip, where the upper clamping arm is in a closed state;

[0033] Figure 7 FIG. is a front view schematic diagram of the lower clamping arm on the cardiac valve clip, where the upper clamping arm is in an unfolded state;

[0034] Figure 8 FIG. is an axonometric schematic diagram of the fixing rod of the cardiac valve clip;

[0035] Figure 9 FIG. is an axonometric schematic diagram of the hanging head sheath tube of the cardiac valve clip;

[0036] Figure 10 FIG. is a front view schematic diagram of the cardiac valve clip system, where the cardiac valve clip is in a closed state;

[0037] Figure 11 Front view schematic diagram of a heart valve clamping system, in which the heart valve clamp is in a semi-expanded state;

[0038] Figure 12 Front view schematic diagram of a heart valve clamping system, in which the heart valve clamp is in a fully-expanded state;

[0039] Figure 13 Release schematic diagram of the hanging head of the heart valve clamping system;

[0040] Figure 14 Schematic diagram during the implantation of the heart valve clamping system;

[0041] Figure 15 Front view schematic diagram of the heart valve clamp after the implantation is completed;

[0042] The markings in the attached drawings are as follows: 1. Heart valve clamp; 2. Pulling tail end; 3. Handle body; 4. Hanging head sheath tube base; 5. Leaflet; 6. Delivery system; 10. Upper clamping arm; 11. Left and right upper clamping arms; 12. Upper clamping arm base; 20. Lower clamping arm; 21. Left and right lower clamping arms; 22. Lower clamping arm base; 23. Left and right pulling arms; 24. Positive connection hanging head; 30. Fixed rod; 31. Inner hole; 32. Fixed step; 33. Fixed rod body; 40. Hanging head sheath tube; 41. Reverse connection hanging head; 42. Hanging head sheath tube body; 50. Pulling wire Detailed implementation manners

[0043] The embodiments of the present invention will be described in detail below. The examples of the embodiments are shown in the attached drawings. The embodiments described below by referring to the attached drawings are exemplary and are intended to explain the present invention, and should not be construed as a limitation to the present invention.

[0044] In the description of the present invention, it should be understood that "distal end" and "proximal end" are relative to the perspective of the operator during the operation. The direction close to the operator is the proximal end, and the direction away from the operator is the distal end.

[0045] As shown in Figure 2 , the heart valve clamp is in a closed state. At the proximal end, the positive connection hanging head 24 of the lower clamping arm 20 is connected to the reverse connection hanging head 41 of the hanging head sheath tube 40, and in this state, it can axially move within the delivery sheath tube. After reaching the designated position in the left atrium, the upper clamping arm 10 and the lower clamping arm 20 of the heart valve clamp are respectively expanded. The expansion effect is shown in Figure 3 , in which the expansion of the upper clamping arm 10 is achieved by tightening and loosening the pulling wire 50, and the expansion of the lower clamping arm 20 is achieved by the relative displacement of the pulling arm 23.

[0046] Figure 4-5Figure 0 is a schematic structural view of the upper clamping arm 10. The upper clamping arm 10 is processed from a whole pipe, including two symmetric left upper clamping arms and right upper clamping arms 11 and an upper clamping arm base 12. There are pulling wire round holes on the left and right upper clamping arms 11. The left and right upper clamping arms 11 need to be pre-shaped and unfolded at a certain angle, about 120° - 240°, and this angle is greater than the maximum unfolding angle of the lower clamping arm to ensure that the valve leaflets can still be normally fixed when unfolded at the maximum angle. When in the delivery sheath, the left and right upper clamping arms 11 are kept in a closed state under the tightening action of the pulling wire 50. After reaching the designated position, the left and right upper clamping arms are unfolded at a certain angle by relaxing the pulling wire 50, as shown in Figure 5 shown.

[0047] Figure 6-7 Figure 6 is a schematic structural view of the lower clamping arm 20. The lower clamping arm 20 is processed from a whole pipe, including two symmetric left lower clamping arms and right lower clamping arms 21, left and right pulling arms 23 respectively fixed on the left and right upper clamping arms 21, a positive connection hanging head 24 at the bottom of the lower clamping arm 20, and a lower clamping arm base 22. The upper clamping arm 10 and the lower clamping arm 20 are fixedly connected through the upper clamping arm base 12 and the lower clamping arm base 22. When the positive connection hanging head moves proximally, it will drive the left and right pulling arms 23 and the left and right lower clamping arms to unfold at a certain angle, as shown in Figure 7 shown.

[0048] Figure 8 Figure 12 is an axonometric schematic view of the fixing rod 30. The heart valve clip 1 is connected to the delivery system through a fixing step 32. The pulling wire 50 passes through the inner hole 31. There should be a chamfer at the distal end of the inner hole 31 to prevent scratching the pulling wire.

[0049] Figure 9 Figure 16 is an axonometric schematic view of the hanging head sheath tube 40. The hanging head sheath tube 40 includes a hanging head sheath tube main body 42 and a reverse connection hanging head 41. The reverse connection hanging head 41 is L-shaped and matches the positive connection hanging head 24.

[0050] Figure 10-12 Figure 20 is a front view schematic view of the heart valve clamping system. The heart valve clamping system includes parts such as the heart valve clip 1, the pulling tail end 2, the handle main body 3, the hanging head sheath tube socket 4, the fixing rod 30, the hanging head sheath tube 40, the pulling wire 50, etc.; the heart valve clip 1 is connected to the delivery system through the fixing rod 30 and the pulling wire 50. The fixing rod 30 controls the fixing and final release of the heart valve clip 1. The proximal end of the pulling wire 50 is connected to the pulling wire tail end 2, and the distal end is connected to the upper clamping arm 10. The unfolding and closing of the upper clamping arm are controlled by its axial forward and backward movement in the handle main body 3; the proximal end of the hanging head sheath tube 40 is connected to the hanging head sheath tube socket 4, and the reverse connection hanging head 41 at the distal end is connected to the positive connection hanging head 24 of the lower clamping arm 20. The unfolding and closing of the lower clamping arm are controlled by its axial forward and backward movement in the handle main body 3.Figure 10 The cardiac valve clip 1 is in the closed state. Figure 11 The lower clamping arm 20 of the cardiac valve clip 1 is in the deployed state. Figure 12 The upper clamping arm 10 of the cardiac valve clip 1 is in the deployed state.

[0051] Figure 13 It is a release schematic diagram of the hanging head of the cardiac valve clamping system; when the cardiac valve clip 1 has completed the operation of clamping the valve leaf, the hanging head sheath tube socket 4 can be rotated circumferentially by a small angle, so that the reverse connecting hanging head 41 and the positive connecting hanging head 24 generate relative rotation, and then the hanging head sheath tube socket 4 is moved proximally, so that the reverse connecting hanging head 41 and the positive connecting hanging head 24 complete the disconnection step, thereby realizing the release step of the cardiac valve clip.

[0052] Embodiment

[0053] This embodiment provides a transcatheter cardiac valve clamping system, which is described in detail taking the treatment of mitral regurgitation as an example. The surgical path is a transcatheter method, and the delivery system is sent to the left atrium and left ventricle positions, and subsequent operations are based on this.

[0054] See Figure 14 As shown, first, after placing the cardiac valve clip 1 at the left ventricle position through the delivery system, the cardiac valve clip 1 is pushed above the valve. After the lower clamping arm 20 is deployed at a certain angle through the hanging head sheath tube socket 4, the cardiac valve clip 1 is pushed upward so that the clamping arm 20 holds the valve leaf from the ventricular surface. Then, the pulling wire 50 is released by pulling the end of the pulling wire 2, so that the upper clamping arm is deployed and the valve leaf is firmly pressed on the lower clamping arm 20. After determining that the clamping position of the valve leaf is appropriate and the treatment effect of regurgitation is achieved, the lower clamping arm 20 is closed through the hanging head sheath tube socket 4 to complete the clamping step of the cardiac valve clip 1. The clamping effect is determined again. If the regurgitation is reduced to an acceptable level, the hanging head sheath tube socket 4 can be rotated and retracted, so that the reverse connecting hanging head 41 and the positive connecting hanging head 24 complete the disconnection step to complete the release step of the cardiac valve clip 1. See Figure 15 As shown. If necessary, the above steps can be repeated to implant the cardiac valve clip 1 again until the ideal effect is achieved.

[0055] It should be particularly noted that when the reverse connecting hanging head 41 and the positive connecting hanging head 24 are completely disconnected, the cardiac valve clip can be deployed again to release the fixed valve, and the above steps can be repeated to achieve a completely retrievable operation, so the implantation risk can be greatly reduced.

[0056] The preferred specific embodiments of the present invention have been described in detail above. It should be understood that those of ordinary skill in the art can make many modifications and variations based on the concept of the present invention without creative efforts. Therefore, all technical solutions that can be obtained by those skilled in the art in the technical field according to the concept of the present invention through logical analysis, reasoning, or limited experiments on the basis of the prior art shall fall within the protection scope determined by the claims.

Claims

1. A transcatheter heart valve clamping system, characterized in that, The system includes a heart valve clip part and a delivery system part. The heart valve clip includes an upper clamping arm and a lower clamping arm. The upper clamping arm is processed from a whole piece of pipe material and includes two symmetric left upper clamping arms and right upper clamping arms and an upper clamping arm base. There are pulling wire round holes on the left and right upper clamping arms, and the left and right upper clamping arms need to be pre-shaped and unfolded at a certain angle; the lower clamping arm is an integral structure and has two symmetric left lower clamping arms and right lower clamping arms. There are two symmetric left pulling arms and right pulling arms at the positions of the left lower clamping arm and the right lower clamping arm; The bottom of the lower clamping arm has a positive connection hook head and a lower clamping arm base. The upper clamping arm and the lower clamping arm are fixedly connected through the upper clamping arm base and the lower clamping arm base. When the positive connection hook head moves proximally, it will drive the left and right pulling arms and the left and right lower clamping arms to unfold at a certain angle respectively; The delivery system includes a handle body, a fixing rod, a hook head sheath tube seat, a hook head sheath tube, a pulling tail end, and a pulling wire. The delivery system is connected to the heart valve clip through the hook head and controls the unfolding, closing, and releasing steps of the clamping arms by operating the handle; The hook head sheath tube includes a hook head sheath tube body and a reverse connection hook head, and the reverse connection hook head matches the positive connection hook head; The hook head sheath tube and the hook head sheath tube seat are fixedly connected and can axially move and rotate circumferentially at a small angle on the fixing rod.

2. The transcatheter heart valve clamping system according to claim 1, characterized in that The pre-shaped unfolding angle of the upper clamping arm is greater than the maximum unfolding angle of the fixing arm.

3. The transcatheter heart valve clamping system according to claim 1, wherein The upper clamping arm is made of shape memory alloy.

4. The transcatheter heart valve clamping system according to claim 1, wherein, The hook head at the bottom of the lower clamping arm connected to the delivery system is L-shaped or T-shaped.

5. The transcatheter heart valve clamping system according to claim 1, characterized in that, The lower clamping arm is made of shape memory alloy.

6. The transcatheter heart valve clamping system according to claim 1, wherein The handle body has an inner hole for the pulling wire.

7. The transcatheter heart valve clamping system according to claim 1, characterized in that, The fixing rod has an inner hole for the pulling wire and has chamfering treatment.

8. The transcatheter heart valve clamping system according to claim 1, wherein, The handle body and the fixing rod are fixedly connected as a whole.

9. The transcatheter heart valve clamping system according to claim 1, wherein The handle body cooperates with the pulling tail end, and the pulling tail end can move back and forth in the handle body.

10. The transcatheter heart valve clamping system according to claim 1, wherein The heart valve clip can be repositioned and the operation is reversible.

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