CN112137756A

CN112137756A - Tubular covered film structure, preparation method thereof and covered film stent

Info

Publication number: CN112137756A
Application number: CN201910578661.5A
Authority: CN
Inventors: 马晓曼; 胡冰清; 赵海娜
Original assignee: Maitong Medical Technology Jiaxing Co ltd
Current assignee: Maitong Medical Technology Jiaxing Co ltd
Priority date: 2019-06-28
Filing date: 2019-06-28
Publication date: 2020-12-29
Also published as: WO2020258983A1

Abstract

The invention discloses a tubular tectorial membrane structure, a preparation method thereof and a tectorial membrane stent. The tubular membrane-coated tube structure comprises a main tube body, a sealing part and two or more branch tube bodies, wherein the main tube body is connected with one end of each branch tube body respectively and communicated with the other end of each branch tube body, the sealing part is arranged between at least one pair of adjacent two branch tube bodies, the sealing part is arranged in a transition area of the at least one pair of adjacent two branch tube bodies, which is connected with the main tube body and the branch tube bodies respectively, so that blood is prevented from seeping out from the transition area. The stent graft comprises the tubular stent graft structure and a stent body, wherein the tubular stent graft structure is coated on the outer surface of the stent body. The tubular membrane-coated tube structure has small amount of blood seepage.

Description

Tubular covered film structure, preparation method thereof and covered film stent

Technical Field

The invention relates to the field of medical instruments for treating intravascular diseases, in particular to a tubular tectorial membrane structure, a preparation method thereof and a tectorial membrane stent.

Background

In recent years, in the medical field, a stent graft is gradually the mainstream product of an artificial blood vessel, and the stent graft is composed of a stent graft and a metal stent, wherein the stent graft mainly plays a role in blood blocking. The coating material is generally polyester, polyurethane, polytetrafluoroethylene, silk and the like, and the coating structure is plain weave, twill weave, satin weave and the change weave thereof. The diseased vessels are divided into a thoracic main vessel and an abdominal main vessel according to the difference of the diseased positions, and the stent graft used for the abdominal main vessel has a double-branch shape according to the characteristics of the diseased positions, so that the stent graft used for the stent graft also has a double-branch structure.

The film covering structure on the market at present is usually manufactured by two processing modes, the first mode is that a planar film covering is adopted to be sewn into a tubular film covering structure, but the sewing position of the film covering structure not only seeps blood, but also increases the release resistance of the film covering stent; the second is that a tubular covered structure is directly woven in an integrated forming mode, as shown in fig. 1, but when a main body 20 (a thicker tube) is transited to a branch tube 21 and a branch tube 22, a larger hole is left at the joint of the main body 20 and the branch tube 21, the branch tube 22, and the hole is shown as a structure shown in a position a in fig. 2, which is a structural defect caused by the existing integrated forming and weaving process, and this structural defect causes a large amount of blood seepage at the joint of the three tubes of the covered stent, and at present, the hole is usually repaired by sewing, but the blood seepage phenomenon still exists in the sewn area.

Therefore, the problem of blood leakage at the joint of the three tubes inevitably exists no matter what kind of tubular film structure is made, and the technical problem to be solved in the field is urgent.

Disclosure of Invention

Based on this, there is a need for a tubular cover film structure and a method for preparing the same, which can effectively solve the problem of the conventional cover film structure that the large blood seepage exists in the transition area between the main body and the branch.

The invention provides a tubular film coating structure which comprises a main pipe body, at least one sealing part and two or more than two branch pipe bodies, wherein the main pipe body is respectively connected and communicated with one end of each branch pipe body, the sealing part is arranged in a transition region where at least one pair of adjacent two branch pipe bodies are mutually connected, and the sealing part is respectively connected with the main pipe body and the at least one pair of adjacent two branch pipe bodies in a sealing manner so as to prevent blood from seeping out of the transition region.

The term "adjacent" in the above-mentioned "the closing portion is provided between at least one pair of adjacent two of the branch pipe bodies" means that no other branch pipe body or blocking member is provided between the two branch pipe bodies, and does not represent the closest branch pipe body selected in the case where there are a plurality of branch pipe bodies; the "closed connection" in the above "the closing part is in closed connection with the main tube and each of the branch tubes" means that when blood flows from the main tube or the branch tubes to the closing part, the blood is subjected to resistance and does not smoothly flow into the closing part and/or from the closing part, but does not mean that the blood flow must be completely blocked.

In one embodiment, the closure portion is a planar structure.

In one embodiment, the closure portion is a single-layer planar structure.

In one embodiment, the closure portion has a length of 1mm to 10mm and a width of 1mm to 8 mm.

In one embodiment, the closure portion is a plain weave construction.

In one embodiment, the sealing portion is disposed at a transition region where each pair of adjacent two branch pipe bodies are connected with each other.

In one embodiment, the closing portion has a first closed end and a second closed end, at least one pair of adjacent two of the branch pipes includes a first branch pipe and a second branch pipe, and the first branch pipe and the second branch pipe are spaced apart by the closing portion in a radial direction of the first branch pipe, and the main pipe and the closing portion are connected at the first closed end, and at least one pair of adjacent two of the branch pipes are spaced apart at the second closed end.

In one embodiment, the first closed end has a rectangular edge, the second closed end has an arcuate edge, and the arcuate edge is concave toward the first closed end.

In one embodiment, the shape of the closure portion is a polygon.

In one embodiment, the sum of the inner diameters of the branch pipes is equal to the inner diameter of the main pipe.

In one embodiment, the closing portion is integrally woven with the main pipe body and each of the branch pipe bodies.

A preparation method of the tubular film covering structure comprises the following steps:

weaving the weft yarns with the upper layer warp yarns and the lower layer warp yarns respectively to form the main pipe body;

and in the process of forming each branch pipe body, combining the other part of the upper layer warp yarns and the other part of the lower layer warp yarns into the same layer of warp yarns, and weaving the closing part in a transition region where at least one pair of adjacent two branch pipe bodies are connected by using the same layer of warp yarns and weft yarns.

In one embodiment, the at least one pair of adjacent two branch pipes includes a first branch pipe and a second branch pipe, and the step of weaving the closure between the at least one pair of adjacent two branch pipes using the same layer of warp and weft yarns includes:

dividing part of the upper layer warp yarns into first upper layer warp yarns and second upper layer warp yarns, and dividing part of the lower layer warp yarns into first lower layer warp yarns and second lower layer warp yarns;

weaving the first upper layer warp yarns, the first lower layer warp yarns, the combined same layer warp yarns, the second upper layer warp yarns and the second lower layer warp yarns together by using weft yarns, forming part of the first branch pipe body, the closed part and part of the second branch pipe body, and enabling the closed part to be located in a transition region where part of the first branch pipe body is connected with part of the second branch pipe body;

restoring the same layer of warp yarns into another part of upper layer warp yarns and another part of lower layer warp yarns, dividing another part of the upper layer warp yarns into third upper layer warp yarns and fourth upper layer warp yarns, and dividing another part of the lower layer warp yarns into third lower layer warp yarns and fourth lower layer warp yarns;

and weaving the first upper layer warp yarns, the first lower layer warp yarns, the third upper layer warp yarns and the third lower layer warp yarns together by using weft yarns to form the rest of the first branch pipes, and weaving the second upper layer warp yarns, the second lower layer warp yarns, the fourth upper layer warp yarns and the fourth lower layer warp yarns by using the weft yarns to form the rest of the second branch pipes, so that the first branch pipes and the second branch pipes are completely obtained.

The tubular film covering structure not only can solve the problem that the traditional film covering of the abdominal main film covering stent has larger blood seepage amount in the transition area of the main body and the branches, but also is suitable for film covering structures of other branches, improves the safety and effectiveness of the film covering structure, reduces the blood seepage amount, and improves the product performance.

The invention also provides a covered stent.

The tectorial membrane stent comprises the tubular tectorial membrane structure and a stent main body, wherein the tubular tectorial membrane structure is coated on the outer surface of the stent main body.

Compared with the traditional manually sewed or integrally formed film covering structure, the tubular film covering structure has the advantages that the main body and the branch transition area are reliably sealed, the blood seepage amount is low or almost zero, the hole blood seepage phenomenon caused by the weaving process in the prior art is effectively avoided, the manufacturing process can effectively improve the processing efficiency, the later-stage manual sewing is not needed, the labor cost is saved, and the tubular film covering structure is suitable for wide popularization and application.

Drawings

FIG. 1 is a front view of a prior art tubular film structure;

FIG. 2 is a top view of a prior art tubular film structure;

FIG. 3 is a front view of a tubular film structure according to one embodiment of the present invention;

fig. 4 is an enlarged view of the structure at position B of the tubular coating structure shown in fig. 3.

Description of the reference numerals

10: a tubular membrane-coated tube structure; 100: a primary tube; 200: a first branch pipe body; 300: a second branch pipe body; 400: a closing part; 40 a: a first closed end; 400 b: a second closed end; 20: a main pipe; 21. 22: and (4) branch pipes.

Detailed Description

To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

An embodiment of the present invention provides a stent graft. The covered stent comprises a tubular covered structure and a stent main body, wherein the tubular covered structure is covered on the outer surface of the stent main body.

Referring to fig. 3, the tubular film structure 10 includes a main pipe 100, a first branch pipe 200, a second branch pipe 300, and a sealing part 400.

In one embodiment, the first branch pipe 200 and the second branch pipe 300 are disposed in parallel, one end of the main pipe 100 is a blood inlet end, the other end of the main pipe is connected and communicated with one end of the first branch pipe 200 and one end of the second branch pipe 300, respectively, and the other end of the first branch pipe 200 and the other end of the second branch pipe 300 are blood outlet ends. The sealing part 400 is respectively connected to the main tube 100, the first branch tube 200 and the second branch tube 300, and further, the sealing part 400 is respectively connected to the main tube 100, the first branch tube 200 and the second branch tube 300 in a sealing manner, and the sealing part 400 is located in a transition region where the first branch tube 200 and the second branch tube 300 are connected to prevent blood from leaking out of the transition region.

Preferably, the closing part 400 is integrally woven with the main pipe body 100, the first branch pipe body 200, and the second branch pipe body 300, and the closing part 400 has a planar structure, and further preferably has a single-layer structure and/or a plain-weave structure. The single-layer plane structure can provide better flexibility and foldability for the closed part, the tubular film-coated structure 10 is coated on the stent body, the film-coated stent is loaded on the conveying device, and the plain structure has the characteristic of high compactness and can further provide good anti-seepage performance. Of course, in other embodiments, the closing portion 400 may also have a twill, satin, or multi-layer structure, which is not limited by the present invention.

As shown in fig. 4, the closing part 400 is substantially rectangular and has a first closed end 400a and a second closed end 400b, the first branch pipe body 200 and the second branch pipe body 300 are spaced apart by the closing part 400 in a radial direction of the first branch pipe body 200, and the main pipe body 100 and the closing part 400 are connected at the first closed end 400a, and the first branch pipe body 200 and the second branch pipe body 300 are separated at the second closed end 400 b.

Compared with the mode that the first branch pipe body 200 is connected with the second branch pipe body 300 through sewing in the prior art, the sealing part provided in the embodiment can not only avoid the blood seepage condition of small holes caused by sewing, but also strengthen the strength of the connection area of the first branch pipe body 200 and the second branch pipe body 300, and further improve the sealing reliability.

With further reference to fig. 4, preferably, the first closed end 400a of the closed portion 400 has a rectangular edge, and the second closed end 400b of the closed portion 400 has an arc-shaped edge, and the arc-shaped edge is recessed toward the first closed end 400a, so that the first branch pipe body 200 and the second branch pipe body 300 have more flexibility, and the tearing at the second closed end 400b caused by the relative movement between the first branch pipe body 200 and the second branch pipe body 300 is effectively prevented.

It will be understood by those skilled in the art that the structure and shape of the sealing portion 400 are not limited thereto in other embodiments, the structure and shape of the sealing portion 400 may also be designed according to the shape and relative position relationship of the first branch pipe body 200 and the second branch pipe body 300, for example, the sealing portion 400 may also be polygonal such as triangle, trapezoid, etc., and the present invention is not limited thereto, and is also applicable to a film structure having three or more branch pipe bodies as well as a film structure having two branch pipe bodies.

In one embodiment, the length of the closure portion 400 along the axial direction of the main tube 100 is 1mm to 10mm, for example, the length of the closure portion 400 is 1mm, 2mm, 5mm, 10mm or other non-integer value. The width of the closure portion 400 in the radial direction of the main tube 100 is 1mm-8mm, for example the width of the closure portion 400 is 1mm, 2mm, 5mm, 8mm or other non-integer value.

In one embodiment, the main pipe body 100 is smoothly transitionally connected with the outer circumferential surface of the first branch pipe body 200 and the outer circumferential surface of the second branch pipe body 300.

The tubular tectorial membrane structure 10 of the invention can solve the problem that the traditional peritoneal main tectorial membrane stent has large blood seepage in the transition area of the main body and the branch, the closed part 400 can effectively prevent the tectorial membrane from generating holes at the branch of the main tube body 100, the first branch tube body 200 and the second branch tube body 300, reduce the blood seepage amount of the tectorial membrane, and effectively improve the safety and the effectiveness of the tectorial membrane stent artificial blood vessel.

The present embodiment also relates to a method of manufacturing the tubular film structure 10.

In this embodiment, the loom needs to use two shuttles, each shuttle drives one weft yarn, and the warp yarn is divided into an upper layer warp yarn and a lower layer warp yarn. The tubular film structure 10 is integrally woven from weft yarns and upper and lower warp yarns.

Specifically, firstly, a first shuttle is adopted to drive weft yarns to respectively weave with upper-layer warp yarns and lower-layer warp yarns to form an upper surface and a lower surface of a partial main pipe body, the upper surface and the lower surface are used for forming an upper-layer half pipe and a lower-layer half pipe of the main pipe body, the upper-layer half pipe and the lower-layer half pipe are connected to form the main pipe body in the weaving process, and the main pipe body has a first preset width.

Then, dividing part of the upper layer warp yarns into a first upper layer warp yarn and a second upper layer warp yarn, dividing part of the lower layer warp yarn into a first lower layer warp yarn and a second lower layer warp yarn, merging the rest part of the upper layer warp yarn and the lower layer warp yarn into the same layer warp yarn, preferably, the width of the same layer warp yarn is 0.5cm-3cm, and continuously using the first shuttle to drive the weft yarn to weave with the first upper layer warp yarn, the first lower layer warp yarn, the merged same layer warp yarn, the second upper layer warp yarn and the second lower layer warp yarn respectively to form part of the first branch pipe body 200, the closed part 400 and part of the second branch pipe body 300, that is, the first upper layer warp yarn, the first lower layer warp yarn and the weft yarn are woven into part of the first branch pipe body 200, and the merged same layer warp yarn and weft yarn form the closed part 400, the second upper layer warp, the second lower layer warp, and the weft are woven to form a part of the second branch pipe body 300. The closure 400 is located at a transition region where a portion of the first branch pipe body 200 is connected with a portion of the second branch pipe body 300, and more specifically, the closure 400 is located between a portion of the first branch pipe body 200 and a portion of the second branch pipe body 300. The closure 400 has a second predetermined width, the width of the closure being 0.5cm-3cm, i.e. corresponding to the width of the warp yarns of the same layer.

The same-layer warp yarns are restored to the upper-layer warp yarns and the lower-layer warp yarns in the predetermined number, the upper-layer warp yarns are divided into third upper-layer warp yarns and fourth upper-layer warp yarns, the lower-layer warp yarns are divided into third lower-layer warp yarns and fourth lower-layer warp yarns, the third upper-layer warp yarns and the third lower-layer warp yarns are used for weaving the remaining first branch pipe body 200, and the fourth upper-layer warp yarns and the fourth lower-layer warp yarns are used for weaving the second branch pipe body 300.

And continuously driving the weft yarns and the first upper-layer warp yarns, the first lower-layer warp yarns, the third upper-layer warp yarns and the third lower-layer warp yarns to weave the remaining first branch pipe body 200 by adopting a first shuttle, so as to weave a complete first branch pipe body 200, and simultaneously introducing a second shuttle to drive the weft yarns and the second upper-layer warp yarns, the second lower-layer warp yarns, the fourth upper-layer warp yarns and the fourth lower-layer warp yarns to weave a remaining second branch pipe body 300, so as to weave a complete second branch pipe body 300. The first branch body 200 has a third predetermined width and the second branch body 300 has a fourth predetermined width.

It is to be understood that, in the weaving process of the first and

second branch pipes

200 and 300, the first and third upper warp yarns are used to weave the upper half pipe of the first branch pipe 200 with the weft yarns, and the first and third lower warp yarns are used to weave the lower half pipe of the first branch pipe 200 with the weft yarns; the second upper layer warp and the fourth upper layer warp are used for weaving the upper half pipe of the second branch pipe 300 with the weft, and the second lower layer warp and the fourth lower layer warp are used for weaving the lower half pipe of the second branch pipe 300 with the weft; the upper half pipe of the first branch pipe body 200 is connected with the lower half pipe of the first branch pipe body 200 to form a complete first branch pipe body 200, and the upper half pipe of the second branch pipe body 300 is connected with the lower half pipe of the second branch pipe body 300 to form a complete second branch pipe body 300.

In the present embodiment, the third predetermined width coincides with the fourth predetermined width. The first predetermined width is the sum of the second predetermined width, the third predetermined width and the fourth predetermined width, however, in other embodiments, the widths of the respective portions may also be designed according to the branching characteristics of the tubular film structure 10, the upper layer yarn and the lower layer yarn may also be divided into more parts for knitting more branch tubes, and during knitting, the branch tubes may be knitted first and then the main tube may be knitted, which is not limited by the present invention.

The preparation method of the tubular film covering structure is simple in process, saves time and labor compared with the traditional manual sewing mode, and the prepared tubular film covering structure is better in plugging effect and remarkably reduces the amount of blood seepage.

Compared with the tubular membrane covered stent in the prior art, the tube of the inventionThe laminated film tube structure can greatly reduce the amount of blood seepage, the inventor adopts water flow to replace blood flow in a laboratory according to an industry standard test method, tests a laminated film structure a with holes in a transition area connected between two adjacent branch tube bodies in the prior art, a laminated film structure c with a closed part (with the length of 8mm and the width of 1mm) arranged in a transition area connected between two adjacent branch tube bodies in the embodiment of the invention and a laminated film structure c with the holes in the transition area connected between two adjacent branch tube bodies, and the number of the laminated film structures a, the laminated film structures b and the laminated film structures c is 3 respectively, so that the following data can be obtained: the average water seepage amount of the transition region of the film covering structure a is 360ml/min/cm²And the average water seepage amount of the transition area of the film covering structure b is as follows: 240ml/min/cm²And the average water seepage amount of the transition area of the film covering structure c is as follows: 58ml/min/cm². In the best case, the average water penetration in the transition region of the film structure c is almost zero. As can be seen from the comparison, the tubular cover film structure in the above embodiment of the present invention can effectively reduce the amount of blood seepage when used in the stent operation.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. The tubular film covering structure is characterized by comprising a main pipe body, at least one sealing part and two or more than two branch pipe bodies, wherein the main pipe body is connected and communicated with one end of each branch pipe body, the sealing part is arranged in a transition region where at least one pair of adjacent two branch pipe bodies are connected with each other, and the sealing part is respectively connected with the main pipe body and the at least one pair of adjacent two branch pipe bodies in a sealing manner so as to prevent blood from seeping out of the transition region.

2. The tubular film-coated tube structure of claim 1, wherein the closed portion is a planar structure.

3. The tubular film-coated tube structure of claim 2, wherein the closed portion has a single-layer planar structure.

4. The tubular film-coated tube structure of claim 2, wherein the closed portion has a length of 1mm to 10mm and a width of 1mm to 8 mm.

5. The tubular film-coated tube structure according to any one of claims 1 to 4, wherein the closure portion is a plain weave structure.

6. The tubular film-coated tube structure of any one of claims 1 to 4, wherein the sealing portion is provided at a transition region where each pair of adjacent branch tube bodies are connected to each other.

7. The tubular lamination structure according to any one of claims 1 to 4, wherein the closed portion has a first closed end and a second closed end, at least one pair of adjacent two of the branch pipes comprises a first branch pipe and a second branch pipe, and the first branch pipe and the second branch pipe are spaced apart by the closed portion in a radial direction of the first branch pipe, and the main pipe and the closed portion are connected at the first closed end, and at least one pair of adjacent two of the branch pipes are spaced apart at the second closed end.

8. The tubular film structure of claim 7, wherein the first closed end has a rectangular edge, the second closed end has an arcuate edge, and the arcuate edge is a structure that is concave toward the first closed end.

9. The tubular film-coating structure of any one of claims 1 to 4, wherein said closed portion is polygonal in shape.

10. The tubular film-coating structure of any one of claims 1 to 4, wherein the sum of the inner diameters of the respective branch pipe bodies is equal to the inner diameter of the main pipe body.

11. The tubular film-covering structure according to any one of claims 1 to 4, wherein the closing portion is integrally formed by weaving with the main pipe body and each of the branch pipe bodies.

12. A method of preparing a tubular film structure according to any one of claims 1 to 11, comprising:

13. The method of claim 12, wherein the at least one pair of adjacent branch tubes includes a first branch tube and a second branch tube, and the step of using the same layer of warp and weft yarns to weave the closure portion between the at least one pair of adjacent branch tubes includes:

14. A stent graft comprising the tubular stent graft structure of any one of claims 1-11 and a stent body, wherein the tubular stent graft structure is coated on the outer surface of the stent body.