CN110786964A

CN110786964A - Novel anti-embolism protection device

Info

Publication number: CN110786964A
Application number: CN201911220148.5A
Authority: CN
Inventors: 胡登脉; 周而辰; 薛宗玉; 王震; 周剑杰; 王国辉
Original assignee: Shanghai Wei Wei Medical Technology Co Ltd
Current assignee: Shanghai Wei Wei Medical Technology Co Ltd
Priority date: 2019-12-03
Filing date: 2019-12-03
Publication date: 2020-02-14

Abstract

The invention discloses a novel embolism prevention protection device, and relates to the technical field of embolism prevention protection devices. The protection filter unit is composed of double-layer woven dense nets, the protection filter unit is connected with a push rod and one end of a stay wire, the push rod and the other end of the stay wire penetrate through a conveying sheath pipe to be connected with a push handle, the push rod and the stay wire can move axially in the conveying sheath pipe by pushing and pulling the push handle, the protection filter unit is converted between two states of shrinkage in the sheath pipe and relaxation outside the sheath pipe through the axial movement of the push rod, the lower-layer woven dense nets of the protection filter unit change mutual gaps with the upper-layer woven dense nets through the axial movement of the stay wire. The device has good flexibility, small pushing resistance of the pushing rod, good biocompatibility on the surface and good attaching effect with the inner wall of each branch vessel of the aortic arch.

Description

Novel anti-embolism protection device

Technical Field

The invention relates to the technical field of anti-embolism protection devices, in particular to a novel anti-embolism protection device.

Background

Cerebral embolism refers to the blockage of blood vessels by various emboli (such as mural thrombus in heart, atherosclerotic plaque, fat, tumor cells, fibrocartilage or air, etc.) in blood flowing into cerebral artery, when collateral circulation can not be compensated, ischemic necrosis of cerebral tissue in the region of artery supplying blood occurs, and focal neurological deficit appears. Cerebral embolism often occurs in the internal carotid artery system, and the vertebrobasilar artery system is relatively rare. Cerebral embolism accounts for about 15% -20% of ischemic stroke. About 75% of cardiogenic emboli are embolized into the brain, and common heart diseases causing cerebral embolism are atrial fibrillation, valvular heart disease, infectious endocarditis, cardiac surgery, cardiac myxoma, and the like. With the increasing level of medical care, more and more cardiac and vascular surgical problems can be accomplished by endovascular surgery. Stent implantation, valve replacement, and the like are all rapid endovascular procedures that have been developed in recent years. The Valve replacement is mainly a Transcatheter Aortic Valve Implantation (TAVI), and an interventional catheter is fed through the femoral artery to deliver a prosthetic heart Valve to an Aortic Valve area for opening, so that the prosthetic Valve is implanted and the Valve function is recovered. The operation does not need to be performed through thoracotomy, so that the wound is small, and the postoperative recovery is fast. The valve replacement is used in cooperation with an anti-embolism protection device, so that embolism is effectively prevented from entering the cranium, and the risk is further reduced.

At present, most of the existing anti-embolism protection devices are of a nickel-titanium alloy frame and filter membrane structure, the porosity is single, small emboli cannot be filtered, the small emboli are not well attached to the mouths of all branch vessels of an aortic arch, and the small emboli can easily enter the branch vessels to cause cerebral embolism and the like. In addition, the device has the problems that the biocompatibility of the surface of the device is poor, new emboli can not be generated while emboli can not be filtered, the pushing performance of a pushing rod in the device is poor, the resistance is large, the flexibility of the far end of a conveying system is poor, and the like, and the application of the anti-embolism protection device in the medical field of heart valve replacement is limited by the defects.

Therefore, those skilled in the art are dedicated to develop a novel anti-embolism protection device, which can effectively filter emboli of different sizes, and has good flexibility, small pushing resistance of the pushing rod, good biocompatibility on the surface, and good attaching effect with the inner wall of each branch vessel of the aortic arch.

Disclosure of Invention

In view of the above defects of the prior art, the technical problem to be solved by the invention is how to adjust the porosity of the double-layer woven dense net to realize the filtration of emboli with different sizes.

In order to achieve the purpose, the invention provides a novel anti-embolism protection device, which comprises a protection filter unit, a pushing rod, a conveying sheath tube, a pull wire and a pushing handle; the protection filtering unit consists of a double-layer woven dense net, the protection filtering unit is connected with the pushing rod and one end of the pull wire, and the other ends of the pushing rod and the pull wire penetrate through the conveying sheath tube to be connected with the pushing handle; the push rod and the pull wire can axially move in the conveying sheath by pushing and pulling the push handle, and the protective filtering unit is switched between a contraction state and a relaxation state by the axial movement of the push rod; the protective filtering unit is in a contraction state when being pulled into the conveying sheath, and is in a relaxation state when being pushed out of the conveying sheath; and the double-layer woven dense nets of the protection filtering unit are mutually subjected to position translation through the axial movement of the stay wires, so that the mutual gaps of the double-layer woven dense nets are changed.

Further, the double-layer woven dense net of the protection filter unit is formed by weaving wires made of shape memory materials, and a stable structural unit made of the shape memory materials is arranged around the double-layer woven dense net.

Furthermore, the pushing handle comprises a sliding guide rail and a sliding push button, the sliding push button is connected with the pull wire, and the other end of the pull wire is connected with the lower-layer woven dense net of the double-layer woven dense net of the protection filtering unit.

Further, the protective filter unit is fixedly connected with a support structure unit composed of shape memory materials, and the number of the support structure units is 1, 2 or 3.

Further, the surfaces of the protective filter unit and the stable structure unit are coated with heparinized coating with good biocompatibility.

Further, the near end of the protection filtering unit is fixedly connected with the far end of the pushing rod, and the surface of the pushing rod is coated with a film or a smooth coating.

Further, the surface of the pushing rod is coated with FEP or PTFE heat-shrinkable film.

Further, the smooth coating on the surface of the pushing rod is a PTFE coating.

Further, the pipe diameter of the conveying sheath pipe is 6F small pipe diameter, and the conveying sheath pipe is composed of one section or multiple sections of parts.

Further, the stabilizing structure unit is annular in shape.

Compared with the prior art, the implementation of the invention achieves the following obvious technical effects:

1. the invention uses the double-layer woven dense net as a protective filtering unit of the anti-embolism protection device, adjusts the stay wires connected with the lower-layer woven dense net to enable the position of the double-layer woven dense net to move horizontally relatively, changes the self gap and the relative gap of the dense net, and enables the porosity to be adjustable. And in the operation process, the shape is subjected to compliance fine adjustment according to individual blood vessel difference, the porosity is further changed, and emboli with different sizes can be effectively filtered.

2. Aiming at the aortic arch structure, the anti-embolism protection device is provided with one, two or three support structure units which are attached to the inner walls of three branch vessels of the aortic arch, so that the problem of infirm attachment of the device is solved.

3. The surfaces of the double-layer woven dense net and the stable structure unit are treated by the heparinized coating, so that the biocompatibility is improved.

The conception, the specific structure and the technical effects of the present invention will be further described with reference to the accompanying drawings to fully understand the objects, the features and the effects of the present invention.

Drawings

FIG. 1 is a schematic view of the novel embolic protection device protecting a filter unit in a diastolic state outside a push-out sheath according to a preferred embodiment of the present invention;

FIG. 2 is a schematic view of the protection filter unit of the new embolic protection device in a retracted state inside the sheath according to a preferred embodiment of the present invention;

FIG. 3 is a top plan view of the distal end of the novel anti-embolic protection device in a relaxed state in accordance with a preferred embodiment of the present invention;

FIG. 4 is a schematic illustration of the in vivo release of the novel embolic protection device in accordance with a preferred embodiment of the present invention;

FIG. 5 is a top plan view of the intravascular release of the novel embolic protection device according to a preferred embodiment of the present invention;

fig. 6 is a schematic view of different support structures of the novel anti-embolism protection device according to another preferred embodiment of the invention.

Wherein: 1-protective filtration unit, 2-stable structure unit, 3-support structure unit, 4-pushing rod, 5-conveying sheath, 6-pushing rod coating, 7-conveying sheath joint, 8-pushing handle, 9-sliding pushing button, 10-pulling wire, 11-sliding guide rail, 12-left subclavian artery, 13-left common carotid artery and 14-brachiocephalic artery.

Detailed Description

The technical contents of the preferred embodiments of the present invention will be more clearly and easily understood by referring to the drawings attached to the specification. The present invention may be embodied in many different forms of embodiments and the scope of the invention is not limited to the embodiments set forth herein.

In the drawings, structurally identical elements are represented by like reference numerals, and structurally or functionally similar elements are represented by like reference numerals throughout the several views. The size and thickness of each component shown in the drawings are arbitrarily illustrated, and the present invention is not limited to the size and thickness of each component. The thickness of the components may be exaggerated where appropriate in the figures to improve clarity. In order to ensure clarity and conciseness of the attached images, some devices are not shown in the drawings, but do not affect the understanding of the invention by those of ordinary skill in the relevant art.

Example 1:

for ease of description, the following description uses the terms "proximal" and "distal", where "proximal" refers to the end proximal to the operative end and "distal" refers to the end distal to the operative end.

As shown in fig. 1 and 2, the present embodiment provides a novel anti-embolism protection device, which includes a protection filtering unit 1, a pushing rod 4, a delivery sheath 5, a pull wire 10 and a pushing handle 8, where the pushing handle 8 includes a sliding guide rail 11 and a sliding push button 9. The protection filter unit 1 is composed of a double-layer woven dense net, a stable structure unit 2 composed of a shape memory material is arranged around the double-layer woven dense net, the protection filter unit 1 is fixedly connected with a support structure unit 3 composed of the shape memory material, and the shape and the direction of the support structure unit 3 can be changed according to specific conditions. The near end of the protection filter unit 1 is connected with the push rod 4 and the far end of the pull wire 10, and the near ends of the push rod 4 and the pull wire 10 penetrate through the conveying sheath 5 to be connected with the sliding push button 9 of the push handle 8; the pushing rod 4 and the pull wire 10 can be moved axially in the conveying sheath 5 by pushing and pulling the pushing handle 8 to move along the sliding guide rail 11, and the protective filter unit 1 is switched between a contraction state and a relaxation state by the axial movement of the pushing rod 4. The protective filter unit 1 is in a contracted state when being drawn into the transporting sheath 5, and the protective filter unit 1 is in a relaxed state when being pushed out of the transporting sheath 5. And the double-layer woven dense nets of the protection filtering unit 1 are mutually subjected to position translation through the axial movement of the stay wires 10, so that the mutual gaps of the double-layer woven dense nets are changed.

The surface of the push rod 4 is treated by a coating film 6(FEP or PTFE heat-shrinkable film) or a smooth coating (such as PTFE coating) so as to increase the smoothness of the surface of the push rod 4 and reduce the push resistance.

The near end of the conveying sheath pipe 5 is provided with a conveying sheath pipe joint 7, and the conveying sheath pipe 5 can be composed of one section, two sections or multiple sections, so that the near end of the conveying sheath pipe 5 is sufficiently supported, the far end is well supported, the flexibility of the conveying sheath pipe is improved, and the operation is convenient to place.

As shown in fig. 3, this embodiment provides a top view of the distal end of the novel anti-embolism protection device in a relaxed state, and when the protection filter unit 1 is pushed out of the delivery sheath 5 by the pushing rod 4, it is in a relaxed state under the elastic action of the shape memory material. The position of the double-layer woven dense net is enabled to move horizontally relatively by adjusting the stay wires 10 connected to the lower layer woven dense net, so that the self gap and the relative gap of the dense net are changed, and the porosity is changed. And in the operation process, the shape is subjected to compliance fine adjustment according to individual blood vessel difference, the porosity is further changed, and emboli with different sizes can be effectively filtered.

As shown in fig. 4 and 5, the present embodiment provides a release schematic diagram of a novel anti-embolism protection device respectively located in a body and a blood vessel, and for an aortic arch structure, three major branches of the anti-embolism protection device are a left subclavian artery 12, a left common carotid artery 13 and a brachiocephalic artery 14. In combination with the specific case, the embolic protection device can be provided with one, two or three support structure units 3, and the shape and orientation thereof can be adjusted to ensure that the filter unit 1 is protected against the inner wall of each branch vessel of the aortic arch.

Example 2:

on the basis of example 1, the direction of the supporting structural unit 3 was changed, and the shape thereof was not changed.

As shown in FIG. 6, this embodiment provides another schematic design of the support structure unit of the new anti-embolic protection device. Depending on the case, the direction of the central support structure unit 3 is changed so that it is rotated 180 ° in the plane, while its shape, the shape and the direction of the left and right support structure units 3 remain unchanged. By changing the direction of the intermediate support structure unit 3, it is ensured that the protective filter unit 1 is attached to the inner wall of each branch vessel of the aortic arch. At the same time, the remaining instruments are prevented from passing through the blood vessel during the operation.

The foregoing detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, the technical solutions available to those skilled in the art through logic analysis, reasoning and limited experiments based on the prior art according to the concept of the present invention should be within the scope of protection defined by the claims.

Claims

1. A novel anti-embolism protection device is characterized by comprising a protection filtering unit, a pushing rod, a conveying sheath tube, a pull wire and a pushing handle; the protection filtering unit consists of a double-layer woven dense net, the protection filtering unit is connected with the pushing rod and one end of the pull wire, and the other ends of the pushing rod and the pull wire penetrate through the conveying sheath tube to be connected with the pushing handle; the push rod and the pull wire can axially move in the conveying sheath by pushing and pulling the push handle, and the protective filtering unit is switched between a contraction state and a relaxation state by the axial movement of the push rod; the protective filtering unit is in a contraction state when being pulled into the conveying sheath, and is in a relaxation state when being pushed out of the conveying sheath; and the double-layer woven dense nets of the protection filtering unit are subjected to mutual position translation through the axial movement of the stay wires, so that the mutual gaps of the double-layer woven dense nets are changed.

2. The novel embolic protection device of claim 1, wherein said double woven dense mesh of said protective filter element is woven from a silk material of shape memory material, and said double woven dense mesh is surrounded by a stable structural element of shape memory material.

3. The novel embolic protection device of claim 1, wherein said push handle comprises a sliding guide, a sliding push button, said sliding push button is connected to said pull wire, and the other end of said pull wire is connected to the lower woven dense mesh of said double woven dense mesh of said protective filter unit.

4. The novel embolic protection device of claim 1, wherein said protective filter unit is fixedly attached to a support structure unit comprising a shape memory material, said support structure unit being 1, 2 or 3 in number.

5. The novel anti-embolic protection device of claim 1 or 2, wherein the protective filter unit and the stabilizing structural unit are coated with heparinized coating with good biocompatibility.

6. The novel embolic protection device of claim 1, wherein the proximal end of the protective filter unit is fixedly connected to the distal end of the push rod, and a coating or a smooth coating is applied to the surface of the push rod.

7. The novel embolic protection device of claim 6, wherein the push rod surface coating is FEP or PTFE heat shrink.

8. The novel embolic protection device of claim 6, wherein the push rod surface slip coating is a PTFE coating.

9. The novel embolic protection device of claim 1, wherein said delivery sheath is of a 6F small diameter and said delivery sheath is comprised of one or more sections.

10. The novel embolic protection device of claim 2, wherein said stabilizing structural unit is annular in shape.