WO2009149645A1

WO2009149645A1 - A coated tuber for the bifurcated stent and the method for cutting membrane

Info

Publication number: WO2009149645A1
Application number: PCT/CN2009/072139
Authority: WO
Inventors: 朱清; 罗七一; 叶伟; 孟德娟
Original assignee: 微创医疗器械(上海)有限公司
Priority date: 2008-06-10
Filing date: 2009-06-05
Publication date: 2009-12-17
Also published as: CN101601615B; CN101601615A

Abstract

A coated tube for the bifurcated stent comprises a trunk coated tube (1) and at least one branch coated tube (2), wherein there is a tapered transition coated tube (3) between the trunk coated tube (1) and the branch coated tube (2). A method for making the coated tube for the bifurcated stent comprises the following steps: cutting a rectangular coated membrane to create the trunk coated membrane (6) and the branch coated membrane (8) according to the anticipated size of the trunk coated tube and the branch coated tube of the bifurcated stent; cutting the edge of the transition of the trunk coated membrane (6) and the branch coated membrane (8) to create bevel edges (7); folding up the trunk coated membrane (6) and the branch coated membrane (8) respectively, and sewing them to form the coated tube with tapered transition portion.

Description

Laminating tube for bifurcated blood vessel stent and film cutting method thereof

Technical field

The present invention relates to a microtrauma interventional medical device product, and in particular to a laminating tube for a bifurcated vascular stent. Background technique

With the development of modern medicine, artificial blood vessel stents, as a new type of interventional vascular treatment technology, are being continuously applied to the treatment of diseases such as aortic stenosis, valve abnormalities, aortic dissection, and aneurysms. Among them, the vascular stent with a membrane (referred to as a stent graft) is very common in the treatment of aneurysms.

An aneurysm is a very dangerous vascular disease in the clinic. Once an aneurysm is found, it should be treated as soon as possible. At present, the microinvasive interventional technique using the principle of intracavitary isolation has been widely used. It uses a small-diameter delivery system to deliver a compressed stent-covered stent to the vascular lesion site. After accurate positioning, it releases and covers the diseased blood vessels, isolating the vascular lesions and forming a new blood flow channel. When the stent graft is used for the treatment of the aneurysm, it is sent to the position of the aneurysm by the corresponding delivery system and released, so that the two ends of the stent graft are supported on the normal blood vessels at both ends of the aneurysm, so that the aneurysm is isolated from the blood. After the aneurysm loses blood supply, the residual blood in the tumor cavity gradually forms a thrombus and muscles into vascular tissue. The expanded tumor wall shrinks due to negative pressure and gradually recovers to near the original form, thereby achieving the purpose of treating an aneurysm.

At present, the intracavitary artificial blood vessel stent has been commercialized, and is mainly divided into a straight type and a bifurcated type. It is made of a nickel-titanium memory alloy intravascular stent or an inner porous PTFE expanded or polyester film.

The bifurcated vascular stent is suitable for the treatment of aortic abnormalities with branch vessels. The structure of the bifurcated vascular stent is composed of a main body stent graft and a branch stent graft. For the laminating tube with a large difference in the diameter of the main body and the branch, the cutting process is difficult, and even if it can barely be cut out, the laminating tube made by this method is difficult to exhibit a good shape. Furthermore, the existing bifurcated stents of the bifurcated stent are often designed in one piece, and the proximal bifurcation of the bifurcated stent is combined by a "point" (see Figure 2), in the bloodstream. Easy to deform under impact, and blood flow is not smooth, It even leads to thrombosis. Summary of the invention

SUMMARY OF THE INVENTION An object of the present invention is to provide a laminating tube for a bifurcated blood vessel stent, which makes it easy to process a tube of this type having a large difference in body diameter from a branch diameter, and the morphology of the laminating tube is expressed. good.

Another object of the present invention is to provide a film cutting method for realizing the above-described laminating tube for a bifurcated blood vessel stent.

For convenience of description, the proximal end referred to below refers to one end near the heart, and the distal end refers to one end away from the heart.

The technical solution provided by the present invention for achieving the above object of the invention is:

A coated tube for a bifurcated vascular stent, comprising a main body laminating tube and at least one branched laminating tube, wherein a tapered transition laminating tube is provided between the main body laminating tube and the branch laminating tube.

Among them, the diameter of the main laminating tube and the branch laminating tube are different. A tapered transitional laminating tube can be disposed between any of the branch laminating tubes and the main body laminating tube as needed, that is, the conical transition laminating tube can be set according to the number of branch laminating tubes, and the commonly used bifurcated blood vessel stent is used. In terms of the most common, a tapered transitional laminating tube is placed on each of the two branch brackets.

Wherein, the tapered transition tube has a cone angle ranging from 0 to 80 degrees. Among them, the preferred cone angle ranges from 5 to 60 degrees.

As a preferred technical solution, the branch film tube and the bifurcation of the main body film tube are connected with a patch. Further, the tapered transition laminating tube is connected with a bifurcation at a bifurcation of the main body laminating tube.

Among them, the shape of the patch is preferably elongated or tapered, and may be designed into other suitable shapes as needed.

Among them, the width of the strip is 4-20 mm. Specifically, the main body laminating tube and the branch laminating tube of different specifications can be designed to be matched with different specifications.

Wherein, the patch is connected to the main body laminating tube and the branch laminating tube by suturing. The bifurcated stent of the bifurcated vascular stent with the patch is designed in a split manner, and the laminating tube is sutured in two parts, that is, one part is a patch and the other part is a main body laminating tube and a branch laminating tube. The presence of the strip makes the morphology of the entire laminating tube perform better, and the main body membrane and the two branches are coated under the impact of blood flow. The patch at the bifurcation forms a "linear" force, so it is more reasonable than the "point" in the prior art, and is not easily deformed.

The same material is used for the main body covered tube, the branch coated tube and the strip, and the same biocompatible polymer material such as polytetrafluoroethylene, polyester fiber textile, polyamide textile is used. , polypropylene textiles, etc.

The method for cutting a film-coated tube for a bifurcated blood vessel stent of the present invention comprises the following steps:

1), the rectangular film and the branch film are cut according to the size of the main body covering tube and the branching tube of the predetermined bifurcated blood vessel stent;

2) cutting the edge of the transition between the main body film and the branch film into a bevel;

3), the main body film and the branch film are folded in half, and the film is wrapped to form a film tube with a tapered transition.

Wherein, step 2) specifically cuts the transition edge of the main body film and the branch film into symmetrical oblique sides.

Wherein, the step 3) is specifically: respectively, the main body film and the branching film are folded in half, and the outer side of the strip is stitched and integrated with the outer side of the tapered transition film and the outer side of the branch film, that is, the strip can be formed. And a tapered transition tube.

The above-mentioned film cutting method forms a source of the taper of the film tube by cutting the bevel at the transition edge of the main body film and the branch film, and the method is novel, unique, simple, feasible, and easy to operate.

The bifurcated vascular stent coated tube of the invention has a tapered transitional laminating tube between the main body laminating tube and the branch laminating tube, and the presence of the "tapered" transitional laminating tube improves the main laminating tube The processability of such a coated tube with a large difference in the diameter of the branch-coated tube, and the morphology of the coated tube is good; in addition, the design of the "conical" transition increases the bifurcation of the stent tube Specifications, especially those with larger diameters and smaller branch diameters.

In the improved technical solution of the present invention, the laminating tube with the supplementary strip has a patch formed by the bifurcation of the main laminating tube and the branch laminating tube, so that the shape of the laminating tube is improved, especially the branch laminating tube is near The roundness of the end is significantly improved, thereby improving the patency of the blood flow after the stent graft is implanted into the blood vessel. DRAWINGS

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a schematic view showing the structure of a coated tube for a bifurcated vascular stent with a tapered transitional lamellar tube of the present invention.

Fig. 2 is a laminar tube of a bifurcated blood vessel stent without a supplement in the prior art.

3 is a schematic view showing the structure of a laminating tube of a bifurcated blood vessel stent with a patch according to the present invention.

Figure 4 is a schematic view of a patch in the present invention.

FIG. 5 is a schematic view showing a film cutting method for a laminating tube of a bifurcated blood vessel stent according to the present invention.

Legend: 1, the main film tube; 2, branch film tube; 3, tapered transition film tube; 4, two branches bifurcation; 5, patch. 6, the main body film; 7, oblique side; 8 branch film. detailed description

For this type of bifurcated vascular stent-coated tube with a large difference in body diameter and branch diameter, the processing difficulty is often large, and it is even difficult to process, and even if it is processed, it is difficult to exhibit a good shape. The present invention provides a laminating tube for a bifurcated vascular stent, which facilitates processing of a bifurcated vascular stent laminating tube of a type having a large difference in body diameter from a branch diameter, and a laminating tube The form performed well. The invention will be described in detail below with reference to the accompanying drawings.

1 is a schematic view showing the structure of a stent tube for a bifurcated vascular stent with a tapered transitional lamellar tube according to the present invention; the laminating tube of the bifurcated vascular stent comprises a main body laminating tube 1 and a branch laminating tube 2 Wherein the conical transition laminating tube 3 is between the main body laminating tube 1 and the branch laminating tube 2. The tapered transition tube has a cone angle g ranging from 0 to 80 degrees, with a preferred cone angle ranging from 5 to 60 degrees. The presence of the "tapered" transitional lamination tube 3 enhances the machinability of such bifurcated vascular stent-coated tube having a large difference in diameter between the main laminar tube 1 and the branch-coated tube 2, and enables the laminating tube The morphology is good; in addition, the design of the "conical" transition increases the size of the bifurcated stent graft, especially for larger diameters and smaller branch diameters.

Fig. 3 is a schematic view showing the structure of a laminating tube of a bifurcated blood vessel stent with a patch according to the present invention, and Fig. 4 is a schematic view of a patch in the present invention. At any two branch bifurcations of the branch laminating tube and the main body laminating tube, a replenishing strip may be connected; for a laminating tube with a conical transition, the conical transition laminating tube and the main laminating tube may be divided into A patch is attached to the fork.

The covered tube of the bifurcated stent graft with the patch is not stitched by one piece, but is designed with a split type: the tube is stitched from two parts, that is, the part is the patch 5 and the other part It is a main body laminating tube 1 and a branch laminating tube 2. The strips can be designed into various specifications and shapes according to different specifications of the main body covered tube and the branch coated tube, and the width ranges from 4 to 20 mm. Due to the presence of the strip, the shape of the laminating tube is improved, especially the roundness of the proximal end of the bifurcated tube is significantly improved, and the main laminating tube and the bifurcation of the bifurcation are under the impact of blood flow. The patch forms a "linear" force, which is more reasonable than the "point" force in the prior art, and is not easily deformed, thereby improving the patency of blood flow after implantation of a blood vessel.

The main body covered tube, the branch coated tube and the strip are all made of the same biocompatible polymer material, such as polytetrafluoroethylene, polyester fiber textile, polyamide textile, polypropylene textile, etc. .

Fig. 5 is a schematic view showing a method of film-forming a film-coated tube for a bifurcated blood vessel stent of the present invention. The film cutting method comprises the following steps:

1), a rectangular film is cut according to the size of the main body of the bifurcated blood vessel stent and the branching membrane tube; the main body coating 6 and the branching membrane 8;

2) cutting the transition edge of the main body film 6 and the branch film 8 into a beveled edge 7;

3), the main body film 6 and the branch film 8 are respectively folded in half and stitched, that is, a tapered transition film tube can be formed.

Step 2) Preferably, the transition edge of the main body film 6 and the branch film 8 is cut into a symmetrical oblique side 7.

Step 3) The patch can also be sutured at the bifurcation of the tapered transitional laminating tube and the main laminating tube, specifically: the main body coating 6 and the branching coating 8 are folded in half, and then the outer side of the supplementary strip 5 is The tapered transition film bevel 7 and the outer edge of the branch film 8 are stitched and integrated into one body, that is, a film tube with a patch and a tapered transition can be formed.

It should be noted that the bifurcated vascular stent described in the Detailed Description section is a preferred embodiment for better implementing the present invention, and the scope of protection of the present invention is not limited to the technical solution described in the above embodiments, but should be The substance of the claims is subject to the invention, and any possible structural changes are within the scope of the invention as long as they do not depart from the spirit of the invention.

Claims

Claim

A coated tube for a bifurcated vascular stent, comprising a main body laminating tube and at least one branch laminating tube, characterized in that: a conical transition between the main laminating tube and the branch laminating tube Membrane tube.

2. A coated tube according to claim 1 wherein the tapered transition tube has a cone angle in the range of 0 to 80 degrees.

3. A coated tube according to claim 2, wherein the tapered transition tube has a cone angle in the range of 5 - 60 degrees.

The film-coated tube according to claim 1, wherein the branching film tube and the branch portion of the main body coating tube are connected with a filler.

The coated tube according to claim 1, wherein the tapered transition tube is connected to the bifurcation of the main body tube to have a patch.

6. A coated tube according to claim 4 - 5, characterized in that the shape of the strip is elongated or tapered.

The coated tube according to claim 4 - 5, characterized in that the width of the strip is in the range of 4 to 20 mm.

The coated tube according to any one of claims 4 to 5, characterized in that the supplementary strip is connected to the main body tube and the branching tube by suture.

9. A coated tube according to claim 4 - 5, wherein the main coated tube, the divided coated tube and the strip are made of the same material.

The coated tube according to claim 9, wherein the material is a biocompatible polymer material.

The coated tube according to claim 10, wherein the polymer material comprises polytetrafluoroethylene, polyester fiber woven fabric, polyamide woven fabric or polypropylene woven fabric.

12. The method of cutting a film-coated tube according to claim 1, comprising the steps of:

1) cutting a rectangular coating film according to the size of the main body coating tube and the branching tube of the predetermined bifurcated blood vessel stent; and cutting the main body coating and the branching film;

2) cutting the edge of the transition between the main body film and the branch film into a bevel; 3), the main body film and the branch film are folded in half and stitched, that is, a film tube with a tapered transition can be formed.

13. The film-cutting method of a film-coated tube according to claim 11, wherein the step 2) specifically cuts a transition edge of the main body film and the branch film into a symmetrical oblique side.

The film cutting method according to claim 12, wherein the step 3) is: folding the main body film and the branching film in half, respectively, and then trimming the outer edge of the strip and the tapered transition film and branching The outer edges of the membrane are stitched together to form a laminating tube with a patch and a tapered transition.