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Artificial Trachea and Method for Producing the Same

Foreign code F200010116
File No. 6015
Posted date May 18, 2020
Country United States of America
Application number 201816189138
Gazette No. 20190142569
Date of filing Nov 13, 2018
Gazette Date May 16, 2019
Priority data
  • P2017-220048 (Nov 15, 2017) JP
Title Artificial Trachea and Method for Producing the Same
Abstract Disclosed is an artificial trachea comprising: a hollow tubular base material whose cross-section in a direction orthogonal to the central axis of the tube has an approximately circular shape.
Outline of related art and contending technology BACKGROUND OF THE INVENTION
Field of the Invention
The present invention relates to an artificial trachea and a method for producing the same.
Description of the Related Art
In recent years, there have been increasing cases where reconstruction of a trachea and its bifurcation is needed, and there has been made a study on an artificially manufactured trachea (hereinafter also referred to as “artificial trachea”) that is used for reconstruction of the trachea and its bifurcation.
The artificial trachea is required to have properties that enable adequate supporting property to the lumen as well as rapid and reliable incorporation in a living body with little inflammatory reaction in the body tissues.
PCT International Publication WO01/024731 discloses an artificial trachea comprising a polypropylene mesh tube as a base material, around the outer periphery of which a polypropylene filamentous stent is wound in a spiral shape (or helically), an amorphous collagen thin layer on the surface of the base material, and fine fibrous collagen layers formed on the inner and outer surfaces of the amorphous collagen thin layer, the fibrous collagen layers being subjected to thermal crosslinking (see WO01/024731: claim 1, line 27 on page 3 to line 2 on page 4, FIG. 1).
JP 6-17715 U (utility model) discloses an artificial trachea comprising a polypropylene mesh tube as a base material, around the outer periphery of which a polypropylene monofilament is wound in a spiral shape, an amorphous collagen thin layer on the surface of the base material, and fine fibrous collagen layers on the inner and outer surfaces of the amorphous collagen thin layer, the fibrous collagen layers being subjected to thermal crosslinking (see JP 6-17715 U: paragraphs [0007] to [0008]).
The artificial trachea is inserted into a living body, and faces the outside at the inner surface of the airway. Therefore, the body makes an attempt to reject the artificial trachea out of the body as a foreign body (or foreign object). Thus, the artificial trachea is required to have higher biocompatibility and to be easily incorporated into the living body. To do this, the artificial trachea is first required to be scarcely recognized as a foreign body inside the living body, and thus it is preferred to have a structure as simple and uncomplicated as possible.
Meanwhile, the artificial trachea is used inside a living body over a long period of time, and is therefore required to have a frame part acting as a mechanical structure that is stable inside the living body over a longer period of time, and to have a mechanical strength capable of retaining the lumen of the artificial trachea over a longer period of time, even though it has a simple and uncomplicated structure.
The artificial trachea disclosed in WO01/024731 has an excellent biocompatibility and a mechanical strength, and the stent is further placed on the outer periphery of the tubular mesh base material. Therefore, the artificial trachea has a tubular double structure. The artificial trachea is entirely thickened by the stent as a support material, thus making it possible to give an artificial trachea having a larger size.
Therefore, when the artificial trachea disclosed in WO01/024731 is further used over a longer period of time, there is a higher possibility of giving mechanical stress to the living body. In today's increasing human life span, it is important that the artificial trachea can be used over a longer period of time. Since surgery performed on an older age person is associated with a higher risk on hid life, it is important that the artificial trachea can be used over a longer period of time.
With regard to the artificial trachea disclosed in JP 6-17715 U, the support material (or reinforcing material) of one monofilament is wound in a spiral shape on the outer periphery of the tubular base material. Comparing to the artificial trachea disclosed in WO01/024731, this artificial trachea is considered to be simpler and gives a smaller mechanical stress based on the support material. The artificial trachea of JP 6-17715 U also has a mechanical strength capable retaining the lumen therein.
However, the only single monofilament is used spirally as the support material for the entire tubular base material. Therefore, if this single monofilament is broken, the following problems can arise: the strength of the artificial trachea can totally decrease, and balance of the strength can be deteriorated.
Furthermore, the tubular base material, around the outer periphery of which the support material is wound spirally, may have drawbacks or cause problems as follows: The tubular base material lacks in extensibility in the longitudinal axis direction, and when a twisting force is applied in a spiral direction, the tubular base material is deformed into a collapsed shape, and thus the lumen is likely to be developed in a constriction form. To the contrary, when a twisting force is applied in a direction opposite to the spiral direction, the spiral support material is likely to be peeled from the tubular base material, etc.
In JP 6-17715 U, there is also a problem that it is not easy to treat (or deal) an artificial trachea having a complicated form such as a branching form or a form having a non-constant diameter of the trachea.
Scope of claims [claim1]
1. An artificial trachea comprising:
a hollow tubular base material whose cross-section in a direction orthogonal to the central axis of the tube has an approximately circular shape, the hollow tubular base material having meshes on the side of the tube;
a plurality of annular support materials that are placed apart from each other on the outer periphery of the tubular base material; and
porous collagen layers on both the outside and the inside of the tubular base material, wherein
the tubular base material is made of polyolefin,
the annular support material is made of at least one selected from polyolefin and polyamide, and
the tubular base material and the annular support materials are bonded to each other.

[claim2]
2. The artificial trachea according to claim 1, wherein the polyolefin comprises at least one selected from polypropylene, polyethylene and ethylene-propylene copolymer.

[claim3]
3. The artificial trachea according to claim 1, wherein the polyamide comprises at least one selected from 6,6-nylon and 6-nylon.

[claim4]
4. The artificial trachea according to claim 1, wherein the bonding of the tubular base material to the annular support materials is at least one selected from fusion bonding by heating and fixing with a suture.

[claim5]
5. The artificial trachea according to claim 4, wherein the suture comprises a suture made of at least one selected from polyolefin and polyamide.

[claim6]
6. The artificial trachea according to claim 1, wherein the porous collagen comprises at least one selected from sponge collagen, thin film multilocular collagen and fine fiber collagen.

[claim7]
7. The artificial trachea according to claim 1, wherein joint portions of three continuous annular support materials are placed so as not to be linearly aligned.

[claim8]
8. The artificial trachea according to claim 1, which has at least one form selected from a linear form, a curved form, a form having a constant diameter, a form having a non-constant diameter, a non-branching form, and a branching form.

[claim9]
9. A method for producing an artificial trachea, which comprises:
forming a mesh made of polyolefin in a hollow tubular shape to prepare a hollow tubular base material whose cross-section in a direction orthogonal to the central axis of the tube has an approximately circular shape, the hollow tubular base material having meshes on the side of the tube;
placing a plurality of annular support materials apart from each other on the outer periphery of the tubular base material using a monofilament made of at least one selected from polyolefin and polyamide;
bonding the annular support materials to the tubular base material; and
placing porous collagen layers on both the outside and the inside of the tubular base material.

[claim10]
10. The artificial trachea according to claim 2, wherein the polyamide comprises at least one selected from 6,6-nylon and 6-nylon.

[claim11]
11. The artificial trachea according to claim 2, wherein the bonding of the tubular base material to the annular support materials is at least one selected from fusion bonding by heating and fixing with a suture.

[claim12]
12. The artificial trachea according to claim 3, wherein the bonding of the tubular base material to the annular support materials is at least one selected from fusion bonding by heating and fixing with a suture.

[claim13]
13. The artificial trachea according to claim 2, wherein the porous collagen comprises at least one selected from sponge collagen, thin film multilocular collagen and fine fiber collagen.

[claim14]
14. The artificial trachea according to claim 3, wherein the porous collagen comprises at least one selected from sponge collagen, thin film multilocular collagen and fine fiber collagen.

[claim15]
15. The artificial trachea according to claim 4, wherein the porous collagen comprises at least one selected from sponge collagen, thin film multilocular collagen and fine fiber collagen.

[claim16]
16. The artificial trachea according to claim 5, wherein the porous collagen comprises at least one selected from sponge collagen, thin film multilocular collagen and fine fiber collagen.
  • Inventor, and Inventor/Applicant
  • Nakamura Tatsuo
  • Inada Yuji
  • Shigeno Keiji
  • KYOTO UNIVERSITY
IPC(International Patent Classification)
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