A transcatheter heart valve annuloplasty system

Abstract

This invention belongs to the field of medical device technology and discloses a transcatheter cardiac valve annulus repair system, including a valve puncture needle, an adjustable guiding catheter, and annulus repair rivets. The valve puncture needle is placed inside the adjustable guiding catheter, and has an inner lumen in the middle through which a guidewire can pass. The annulus repair rivets include lockable male and female rivets, each with a central aperture for the guidewire to pass through. This invention allows for puncture under ultrasound guidance, greatly optimizing the procedure, ensuring safety, and reducing surgical time and difficulty. The annulus is reduced using the annulus repair rivets along the track established by the adjustable guiding catheter. Each rivet contains a shape memory alloy braided metal washer, reducing rivet-induced cutting damage to the valve and improving surgical safety and success rate.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to a transcatheter annulus repair system. Background Technology

[0002] Currently, functional valvular heart disease is usually secondary to ischemic or dilated cardiomyopathy. With the increasing aging of the population, senile valvular disease and functional valvular disorders caused by coronary heart disease and myocardial infarction are becoming increasingly common. These secondary changes are often irreversible and difficult to correct with existing surgical valve procedures. For example, in the United States, there are nearly 1.6 million patients with tricuspid regurgitation, but only 0.5% of them have received surgical valve replacement or repair.

[0003] According to epidemiological data from developed countries, functional / secondary tricuspid regurgitation accounts for up to 80% of cases. In these patients, the progression of right heart failure is associated with tricuspid annular enlargement and chordae tendineae traction due to right ventricular pressure overload. Currently, various minimally invasive treatment devices for functional valvular heart disease are in the clinical exploration stage. However, due to their complex procedures and applicability only to a limited number of patients, they have not been widely used clinically. Therefore, this invention patent addresses the etiology of annular enlargement in functional valvular heart disease by proposing a complete transcatheter annular angioplasty system. This system can reduce the enlarged annulus, increase valve edge apposition, and decrease valvular regurgitation.

[0004] Based on the above analysis, the problems and shortcomings of the existing technology are as follows: the operation steps of the existing minimally invasive treatment devices for functional valvular heart disease are too complicated, they are only suitable for a portion of patients, and they have not been widely used in clinical practice.

[0005] The difficulties in solving the above problems and shortcomings are as follows: 1. To date, there are no minimally invasive devices specifically for tricuspid valve repair that have been certified by the US FDA, and all devices are still in the research and development stage; 2. Due to its special anatomical structure and pathophysiological mechanism, the tricuspid valve is difficult to treat with minimally invasive intervention. Existing minimally invasive treatment devices have complicated operation procedures and limited applicability; 3. Such devices cannot be replaced by domestic alternatives at present. Even if they are launched in China, patients will face high costs and heavy burdens.

[0006] The significance of solving the above problems and defects is as follows: 1. This invention targets the most common cause of tricuspid regurgitation—tricuspid annular enlargement—and uses a minimally invasive approach to reduce part of the annulus to achieve the purpose of reducing valvular regurgitation; 2. This invention simplifies the operation steps of minimally invasive valvular interventional devices, improves surgical safety, and greatly reduces surgical trauma; 3. This invention can achieve domestic substitution as soon as possible, reduce the cost of such medical devices, and bring a brand-new minimally invasive treatment method to patients with heart valve disease. Summary of the Invention

[0007] To address the problems existing in the prior art, the present invention provides a transcatheter annulus repair system.

[0008] This invention is implemented as follows: a transcatheter cardiac valve annulus repair system includes:

[0009] Valve puncture needle, adjustable guide catheter, and annulus repair rivet;

[0010] The valve puncture needle is placed inside an adjustable guiding catheter, and the valve puncture needle has an inner cavity in the middle through which a guidewire can pass.

[0011] The valve-shaped rivet includes a lockable male rivet and a female rivet, both of which have holes in the middle for the guide wire to pass through.

[0012] Furthermore, the male rivet includes a pin structure and a shape memory alloy braided metal washer connected to the pin structure, and the female rivet includes a metal ring and a shape memory alloy braided metal washer connected to the metal ring.

[0013] Furthermore, the pin structure is made of nickel-titanium alloy.

[0014] Furthermore, the valve puncture needle is a hollow metal long needle with one end that can be connected to a syringe.

[0015] Combining all the above technical solutions, the advantages and positive effects of this invention are as follows:

[0016] This invention uses an adjustable guiding catheter to make the operation more direct and simple, and also reduces the occurrence of complications. The valve puncture needle can be used for puncture only under ultrasound guidance, which greatly optimizes the operation process, ensures the safety of puncture, and reduces the operation time and difficulty.

[0017] This invention establishes a track using an adjustable guide catheter and uses annulus shaping rivets to reduce the size of the valve annulus. All rivets are made of shape memory alloy woven metal gaskets, which reduces the cutting damage to the valve caused by the rivets and improves the safety and success rate of the operation.

[0018] The petal ring forming rivet in this invention adopts a self-locking rivet design. It is only necessary to pull the male rivet to the female rivet through the track to complete the self-locking, so as to complete the petal ring forming. After the self-locking operation is completed, the track guide wire can be removed. Attached Figure Description

[0019] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the embodiments of this application will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This is a schematic diagram illustrating the locking principle of the annulus forming rivet in the transcatheter annulus annuloplasty system provided in this embodiment of the invention.

[0021] Figure 2 This is a flowchart illustrating the usage method of the transcatheter annulus repair system provided in this embodiment of the invention. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0023] To address the problems existing in the prior art, the present invention provides a transcatheter cardiac valve annulus repair system, which will be described in detail below with reference to the accompanying drawings.

[0024] The transcatheter annulus repair system provided in this invention includes a valve puncture needle, an adjustable guide catheter, and annulus repair rivets.

[0025] The valve puncture needle is a long, hollow metal needle with a syringe attached to one end, through which a guidewire can pass. It is usually placed inside an adjustable guiding catheter, with the tip of the guiding catheter only exposed when puncturing the valve.

[0026] An adjustable guiding catheter is typically inserted after puncturing the internal jugular / subclavian vein. It passes through the atrioventricular valves and enters the ventricle. Under transesophageal echocardiography guidance, it is hooked towards the atrial surface, pointing towards the root of the tricuspid valve leaflets. A valve puncture needle can pass through the lumen of the adjustable guiding catheter.

[0027] The valve annulus reshaping rivet mainly consists of a male rivet and a female rivet. The male rivet is a pin-shaped structure made of nickel-titanium alloy that connects to a shape memory alloy braided metal washer. The female rivet is a metal ring that connects to the shape memory alloy braided metal washer. Both rivets have a hole between them for the guide wire to pass through. The shape memory alloy braided metal washer is pre-shaped into a flat disc in vitro. Before implantation, it can be compressed into a thin metal strip in cold saline solution, and after entering the body, it can return to its pre-shaped flat disc shape. After the flat disc-shaped shape memory alloy braided metal washer is placed in front of the two rivets, the guide wire is tightened, and the pin-shaped structure of the male rivet is inserted into the metal ring of the female rivet and locked. This tightens the two points of the valve annulus from the valve root to a single point, reducing the size of the valve annulus, increasing the apposition of the valve edges, and reducing valvular regurgitation.

[0028] This invention uses an adjustable guide catheter to puncture both ends of the valve annulus requiring narrowing from the ventricular to the atrial surface under ultrasound guidance. After establishing the track, a self-locking valve forming rivet is inserted. The male rivet is pushed into the female rivet by the knotted track to lock the device in place.

[0029] The specific method is as follows:

[0030] 1. Strict preoperative patient screening, thorough cardiac imaging assessment of the valve annulus structure to be annulated, selection of patients with valve annulus enlargement as the main cause of valvular regurgitation, exclusion of surgical contraindications, and full informed consent regarding the potential benefits and risks of transcatheter annulus annuloplasty;

[0031] 2. After anesthesia, the right internal jugular vein and subclavian vein are punctured and an adjustable guiding catheter is inserted to establish access. The adjustable guiding catheter is inserted through the right internal jugular vein, passes through the tricuspid valve, and is hooked up so that the guiding catheter is from the ventricular surface to the atrial surface. Under ultrasound guidance, the first puncture point at the valve root is located, and the puncture is completed using a valve puncture needle.

[0032] 3. Insert the guidewire into the atrium through the hollow part of the valve puncture needle. Use the catcher inserted into the atrium via the subclavian vein to pull out one end of the guidewire. Pass the second adjustable guide catheter through the first valve annulus puncture site along the guidewire into the ventricle. Withdraw the guidewire and the first adjustable guide catheter.

[0033] 4. Hook the second adjustable guide catheter from the ventricular side to the atrial side. Locate the second puncture point at the valve root under ultrasound guidance. Use the valve puncture needle to complete the puncture. Insert the guidewire into the atrium again along the hollow part of the valve puncture needle. Use the grabber inserted into the atrium via the internal jugular vein to pull out one end of the guidewire and establish a track.

[0034] 5. Feed the ring-forming male and female rivets along the established tracks. The guide wire on one side of the male rivet is knotted. After entering the device and allowing the shape memory alloy braided metal gasket to fully unfold, tighten the guide wire at one end of the female rivet. This allows the self-locking structure of the male rivet to insert into the metal ring at the center of the female rivet, completing the self-locking process. Once the device is locked, pull out the guide wire from the male rivet side to release the device.

[0035] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any modifications, equivalent substitutions, and improvements made by those skilled in the art within the scope of the technology disclosed in the present invention, and within the spirit and principles of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A transcatheter annulus repair system, characterized in that, The transcatheter annulus repair system includes: a valve puncture needle, an adjustable guide catheter, and annulus repair rivets. The valve puncture needle is placed inside an adjustable guiding catheter, and the valve puncture needle has an inner cavity in the middle through which a guidewire can pass. The valve-shaped rivet includes a self-locking male rivet and a female rivet. Both the male rivet and the female rivet have holes in the middle for the guide wire to pass through. After the head of the male rivet passes through the female rivet, it can be locked by the return of a metal pin. The male rivet includes a pin structure and a shape memory alloy braided metal washer connected to the pin structure, and the female rivet includes a metal ring and a shape memory alloy braided metal washer connected to the metal ring.

2. The transcatheter annulus repair system as described in claim 1, characterized in that, The pin structure is made of nickel-titanium alloy.

3. The transcatheter annulus repair system as described in claim 1, characterized in that, The valve puncture needle is a hollow metal long needle with one end that can be connected to a syringe.

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