Transcatheter heart tissue cutting and taking-out device and implementation method

Abstract

The invention relates to the field of medical instruments, and discloses a transcatheter heart tissue cutting and taking-out device and an implementation method. The cutting and taking-out device comprises a conveying catheter, a protective net basket, a cutting support and an anchor. The anchor is arranged in the cutting support, the cutting support is arranged in the protection net basket, the protection net basket, the cutting support and the anchor are all connected with cavity pipes, and the three cavity pipes are sequentially arranged in the conveying guide pipe in a sleeved mode and all slidably arranged in the conveying guide pipe. The protective net basket, the cutting stent and the anchor can be deformed, and the protective net basket, the overlapped cutting stent and the anchor are arranged in the conveying catheter in series in a conveying state, so that the whole device can realize a smaller conveying size and can be conveyed to a target area of a heart in a fine blood vessel; the protective net basket can prevent the tissue from falling off and being washed away by blood flow in the tissue taking-out process; the anchor sucks the tissue under negative pressure, the metal foot of the cutting support is inserted into the tissue, the tissue can be physically cut powerfully, and the tissue taking-out capacity is high.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and more specifically, to a transcatheter cardiac tissue cutting and removal device and an implementation method thereof. Background Art

[0002] Cardiac interventional surgery uses a catheter to deliver relevant instruments into the heart through the blood vessels to perform physical intervention on heart disease. Cardiac interventional surgery is becoming more and more popular in clinics because it does not require cardiac arrest, has small surgical wounds, low surgical risks, and high patient comfort, and is gradually replacing surgical operations.

[0003] Current cardiac interventional surgeries mainly involve implanting devices into the heart, such as implanting stents, valves, or occluders, or ablating or damaging cardiac tissue, such as radiofrequency ablation for atrial fibrillation or alcohol ablation for myocardial cells. However, sometimes it is necessary to cut cardiac tissue and remove foreign bodies, such as removing cardiac tumors or blood clots, or removing long valve tissue. Because there is blood flowing in the heart and the heart is beating, foreign bodies may be washed away by the blood flow during removal, causing organ embolism. In addition, the use of interventional methods to deliver devices from blood vessels requires that the devices have a very small delivery size, so the development of transcatheter cardiac tissue cutting and removal devices is quite challenging.

[0004] Currently, there is no safe and effective transcatheter cardiac tissue cutting and removal device in clinical practice. Summary of the invention

[0005] The purpose of the present invention is to provide a device and implementation method that has a relatively small delivery size and can safely and effectively cut and remove cardiac tissue via an intravascular route.

[0006] In order to achieve the above invention objectives, this application adopts the following technical solutions:

[0007] In the first aspect, the present application provides a transcatheter cardiac tissue cutting and removal device, comprising a delivery catheter, a protective mesh basket, a cutting stent and an anchor; the anchor is arranged in the cutting stent, the cutting stent is arranged in the protective mesh basket, the protective mesh basket, the cutting stent and the anchor are all connected with a hollow tube, and the three hollow tubes are overlapped in sequence and are all slidably arranged in the delivery catheter.

[0008] Furthermore, the protective mesh is a nickel-titanium wire braided conical mesh, and the proximal end of the protective mesh is connected to the cavity tube.

[0009] Furthermore, the cutting stent is a cylindrical grid stent that is laser cut and heat-formed by nickel-titanium tubing and has an inwardly folded distal stent leg. The proximal end of the cutting stent is conical and converges toward the center and is connected to the cavity tube.

[0010] Furthermore, the cutting support comprises a plurality of rhombus lattice units, and the apex of the rhombus lattice unit at the distal end of the cutting support extends the top and bottom toward the distal end in a strip shape to form a support foot structure.

[0011] Furthermore, the support foot at the distal end of the cutting support is concave, so that the sharp structure at the distal end of the cutting support is not facing the distal end or the outer end.

[0012] Furthermore, the anchor is a hollow polymer tube with a distal conical end and a proximal tubular end, including a distal conical small suction cup, and the proximal end of the distal conical small suction cup is connected to the hollow tube.

[0013] Furthermore, it also includes a negative pressure device, which is connected to the anchor and is used to suck the gas or liquid in the anchor so that the anchor can be adsorbed on the heart tissue.

[0014] In a second aspect, the present application provides an implementation method of the transcatheter cardiac tissue cutting and removal device described in the first aspect, comprising the following steps:

[0015] S1, initial state, the anchor and the cutting stent are stacked in sequence and put into the delivery catheter, the protection basket is put into the delivery catheter at the distal end of the anchor and the cutting stent, a guide wire is inserted along the cavity in the anchor, and the whole device is sent to the vicinity of the target position of the heart along the guide wire;

[0016] S2, withdraw the guidewire, push the protective basket out of the delivery catheter to cover the target area, push the cutting stent and anchor out of the delivery catheter, and operate the anchor to make it adhere to the target cardiac tissue;

[0017] S3, push the cutting stent forward and pull the anchor backward, pull the target tissue into the cutting stent cavity, push the delivery catheter forward to compress the cutting stent to deform it, and the distal stent foot of the cutting stent deflects and moves to insert into the target tissue, cutting the tissue, and the tissue, the cutting stent and the anchor are pulled into the delivery catheter together, and pulled into a deeper position of the catheter;

[0018] S4, withdraw the protection net and pull it into the delivery catheter. If there is any residual detached tissue, it will fall into the protection net basket and be collected into the delivery catheter together;

[0019] S5, withdraw the delivery catheter and remove the entire device and the removal device out of the body.

[0020] In summary, compared with the prior art, the present application has the following beneficial effects:

[0021] Since the protective mesh basket, cutting stent and anchor are all deformable, and the larger protective mesh basket and the overlapping cutting stent and anchor are arranged in series and installed in the delivery catheter in the delivery state, the overall device can achieve a smaller delivery size and be delivered to the target area of ​​the heart in small blood vessels; secondly, the protective mesh basket covers the target area and foreign objects in the mesh basket can be removed to prevent the tissue from falling off and being washed away by the blood flow during tissue removal; the anchor sucks the tissue with negative pressure, and the hard material of the metal foot of the cutting stent is inserted into the tissue, which can effectively physically cut the tissue and has a strong tissue removal capability. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 : A schematic diagram of one state of the transcatheter cardiac tissue cutting and removal device in an embodiment of the present application;

[0023] Figure 2 : A schematic diagram of another state of the transcatheter cardiac tissue cutting and removal device in an embodiment of the present application;

[0024] Figure 3 : Schematic diagram of cutting the stent in the embodiment of the present application;

[0025] Figure 4 : A schematic diagram of a protective basket in an embodiment of the present application;

[0026] Figure numerals: 1. delivery catheter; 2. protection basket; 3. cutting bracket; 4. anchor. DETAILED DESCRIPTION

[0027] The structure and effect of the present application are further described in detail below in conjunction with the embodiments. It is to be understood that the specific embodiments described herein are only used to explain the invention, rather than to limit the invention. It is also necessary to explain that, for ease of description, only the parts related to the invention rather than the entire structure are shown in the accompanying drawings.

[0028] It is worth noting that the proximal end mentioned in the present invention refers to the end close to the operator during the surgical operation, and the distal end refers to the opposite end away from the operator and toward the patient's heart.

[0029] This embodiment discloses a transcatheter cardiac tissue cutting and removal device, referring to Figure 1 The transcatheter cardiac tissue cutting and removal device comprises a delivery catheter 1, a protection basket 2, a cutting stent 3, an anchor 4 and a negative pressure device (not shown in the figure).

[0030] The proximal end of the delivery catheter 1 is a thin-walled hollow tube made of polymer material with a circular long cross-section. The tube wall has a high hardness requirement, so in a preferred embodiment, a metal braided wire can be included in the tube wall to enhance the hardness. The distal end of the delivery catheter 1 requires a stronger hardness. In a preferred embodiment, the distal end of the delivery catheter 1 is cut from a nickel-titanium tube. The polymer tube at the proximal end and the nickel-titanium tube at the distal end are physically connected, such as by hot melting.

[0031] The protective mesh is a conical cavity structure formed by braiding and heat-setting nickel-titanium wires, and the apex of the cone is connected to the cavity and the long round tube (cavity tube). The nickel-titanium wire has shape memory. The protective mesh is conical in its natural shape, but this shape can be compressed into a thin strip. The protective mesh can be put into the delivery catheter 1 by pulling back the cavity tube of the protective mesh. The protective mesh can be covered in a certain area to prevent the ectopic part in the area from being washed away by the blood flow.

[0032] The cutting stent 3 is a hollow, cylindrical body made of nickel-titanium tubing through laser cutting and heat setting. A plurality of rhombus-shaped cells form a grid-like stent structure with morphological memory. In the natural working state, it is a hollow cylindrical grid stent. When compressed, it can become a thin strip, which is collected in the protective mesh basket 2 and loaded into the delivery catheter 1 together. The proximal end of the cutting stent 3 is tapered and converges toward the center, connected to a long tube (hollow tube), so that the long tube can be operated at the proximal end to push and pull back the cutting stent 3. The cutting stent 3 is composed of rhombus-shaped cell units, and the apex of the rhombus at the distal end of the stent extends the top and bottom to the distal end in a strip shape, forming a stent foot. The bracket foot at the distal end of the cutting bracket 3 is concave, so that the sharp structure at the distal end of the cutting bracket 3 does not face the distal end or the outer end and does not injure human tissue. At the same time, when the cutting bracket 3 is gradually compressed and retracted from the proximal end by the delivery catheter 1 and the cutting bracket 3 changes from a cone shape to a thin strip, the bracket foot is deflected from facing downward and inward to facing upward and inward, thereby inserting into the target tissue in the cutting bracket 3 to achieve the cutting effect on the tissue, and finally pulling the cut tissue into the delivery catheter 1 together.

[0033] The anchor 4 comprises a distal conical small suction cup and a proximal long tube, which are made of polymer materials. The small suction cup is made of soft material such as latex and can be deformed and compressed into a strip; the proximal long tube is a long tube (cavity tube) with a small cavity.

[0034] The negative pressure device is a device that can suck gas or liquid under negative pressure. It can be an electric or manual device. It is connected to the proximal lumen of the anchor 4 and sucks the gas or liquid in the lumen so that the distal cone of the anchor 4 can be adsorbed on the heart tissue.

[0035] The anchor 4 is arranged in the cutting bracket 3, and the cutting bracket 3 is arranged in the protective mesh basket 2. The protective mesh basket, the cutting bracket 3 and the anchor 4 are all connected with a cavity tube, and the three cavity tubes are overlapped in sequence and are all slidably arranged in the delivery catheter 1, so that the three cavity tubes can independently drive the protective mesh basket, the cutting bracket 3 and the anchor 4 to move relative to each other in the axial direction, and finally be released or collected into the delivery catheter 1.

[0036] This embodiment also discloses an implementation method of the above-mentioned transcatheter cardiac tissue cutting and removal device, comprising the following steps:

[0037] S1, initial state, the anchor 4 and the cutting stent 3 are stacked and put into the delivery catheter 1 in sequence, the protection basket 2 is put into the delivery catheter 1 at the distal end of the anchor 4 and the cutting stent 3, a guide wire is sent along the cavity in the anchor 4, and the whole device is sent to the vicinity of the target position of the heart along the guide wire;

[0038] S2, withdraw the guide wire, push the protection basket 2 out of the delivery catheter 1 to cover the target area, push the cutting stent 3 and the anchor 4 out of the delivery catheter 1, and operate the anchor 4 to adsorb it on the target cardiac tissue;

[0039] S3, push the cutting stent 3 forward and pull the anchor 4 backward, pull the target tissue into the cavity of the cutting stent 3, push the delivery catheter 1 forward to compress the cutting stent 3 to deform it, and the distal stent foot of the cutting stent 3 deflects and moves to insert into the target tissue, cutting the tissue, and the tissue, the cutting stent 3 and the anchor 4 are pulled into the delivery catheter 1 together, and pulled into a deeper position of the catheter;

[0040] S4, withdraw the protection net and pull it into the delivery catheter 1. If there is any residual detached tissue, it will fall into the protection net basket 2 and be collected into the delivery catheter 1 together;

[0041] S5, withdraw the delivery catheter 1, and remove the entire device and the removal device out of the body.

[0042] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make modifications to the present embodiment without any creative contribution as needed, but such modifications are protected by the patent law as long as they are within the scope of the claims of the present application.

Claims

1. A transcatheter cardiac tissue cutting and removal device, characterized in that: The invention comprises a delivery catheter (1), a protective mesh basket (2), a cutting stent (3) and an anchor (4); the anchor (4) is arranged in the cutting stent (3), the cutting stent (3) is arranged in the protective mesh basket (2), the protective mesh basket, the cutting stent (3) and the anchor (4) are all connected with a cavity tube, and the three cavity tubes are overlapped in sequence and are all slidably arranged in the delivery catheter (1).

2. The transcatheter cardiac tissue cutting and removal device according to claim 1, characterized in that: The protective mesh is a conical mesh woven with nickel-titanium wires, and the proximal end of the protective mesh is connected to the cavity tube.

3. The transcatheter cardiac tissue cutting and removal device according to claim 1, characterized in that: The cutting stent (3) is a cylindrical grid stent made of nickel-titanium tubing laser cut and heat-set, with the distal stent legs folded inward. The proximal end of the cutting stent (3) is conical and converges toward the center and is connected to the cavity tube.

4. The transcatheter cardiac tissue cutting and removal device according to claim 3, characterized in that: The cutting support (3) comprises a plurality of rhombus lattice units, and the apex of the rhombus lattice units at the distal end of the cutting support (3) extends the top and bottom toward the distal end in a strip shape to form a support foot structure.

5. The transcatheter cardiac tissue cutting and removal device according to claim 4, characterized in that: The support foot at the distal end of the cutting support (3) is concave, so that the sharp structure at the distal end of the cutting support (3) does not face the distal end or the outer end.

6. The transcatheter cardiac tissue cutting and removal device according to claim 1, characterized in that: The anchor (4) is a hollow polymer tube with a distal conical end and a proximal tubular end, comprising a distal conical small suction cup, the proximal end of which is connected to the hollow tube.

7. The transcatheter cardiac tissue cutting and removal device according to claim 6, characterized in that: It also includes a negative pressure device, which is connected to the anchor (4) and is used to suck the gas or liquid in the anchor (4) so ​​that the anchor (4) can be adsorbed on the heart tissue.

8. The implementation method of the transcatheter cardiac tissue cutting and removal device according to any one of claims 1 to 7, characterized in that: The following steps are involved: S1, initial state, the anchor (4) and the cutting stent (3) are stacked in sequence and put into the delivery catheter (1), the protection basket (2) is put into the delivery catheter (1) at the distal end of the anchor (4) and the cutting stent (3), a guide wire is inserted along the cavity in the anchor (4), and the whole device is sent to the vicinity of the target position of the heart along the guide wire; S2, withdraw the guide wire, push the protective basket (2) out of the delivery catheter (1) to cover the target area, push the cutting stent (3) and the anchor (4) out of the delivery catheter (1), and operate the anchor (4) to make it adsorbed on the target cardiac tissue; S3, push the cutting stent (3) forward and pull the anchor (4) backward, pull the target tissue into the cavity of the cutting stent (3), push the delivery catheter (1) forward to compress the cutting stent (3) to deform it, and the distal stent foot of the cutting stent (3) deflects and inserts into the target tissue, cutting the tissue, and the tissue, the cutting stent (3) and the anchor (4) are pulled into the delivery catheter (1) together, and pulled into a deeper position of the catheter; S4, withdraw the protection net and pull it into the delivery catheter (1). If there is any residual detached tissue, it will fall into the protection net basket (2) and be collected into the delivery catheter (1); S5, withdraw the delivery catheter (1) and remove the entire device and the removal device out of the body.

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