WO2013114782A1 - Substitute trachea - Google Patents

Substitute trachea Download PDF

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Publication number
WO2013114782A1
WO2013114782A1 PCT/JP2012/084084 JP2012084084W WO2013114782A1 WO 2013114782 A1 WO2013114782 A1 WO 2013114782A1 JP 2012084084 W JP2012084084 W JP 2012084084W WO 2013114782 A1 WO2013114782 A1 WO 2013114782A1
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Prior art keywords
coil
trachea
substitute
shape
wire
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PCT/JP2012/084084
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French (fr)
Japanese (ja)
Inventor
正幸 窪田
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国立大学法人新潟大学
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Priority to JP2013556226A priority Critical patent/JP6092789B2/en
Publication of WO2013114782A1 publication Critical patent/WO2013114782A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/046—Tracheae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the present invention relates to a substitute trachea used for the treatment of a tracheal defect.
  • Patent Document 1 discloses a shape memory alloy stent for expanding and holding a stenosis or occlusion of a trachea. Therefore, it is expected that the tracheal defect can be spontaneously healed without causing lumen stenosis by using the formation of the fibrous capsule and inserting the above stent as a temporary substitute trachea into the trachea. It was done.
  • a substitute trachea that is inserted into the trachea for use in the treatment of a tracheal defect portion, and can be reliably prevented from invading granulation into the inside.
  • the aim is to provide a trachea.
  • a substitute trachea according to claim 1 of the present invention is a substitute trachea that is inserted into a trachea for use in the treatment of a tracheal defect portion, and is formed by winding a wire in a coil shape without a gap, and has a spindle shape. It consists of the formed 1st coil and the 2nd coil provided without the clearance gap outside this 1st coil, It is characterized by the above-mentioned.
  • a substitute trachea according to the first aspect, wherein a double coil portion including the first coil and the second coil is formed in the center portion, and both ends of the double coil portion are formed. A single coil portion made of the first coil is formed.
  • the substitute trachea according to claim 3 of the present invention is characterized in that in claim 1 or 2, the wire is made of a shape memory alloy having superelasticity that maintains a memorized shape at room temperature and softens when cooled.
  • the substitute trachea of claim 1 of the present invention is formed by winding a wire in a coil shape without a gap, and there is no gap on the outside of the first coil and the first coil formed in a spindle shape. Since it consists of the provided 2nd coil, it can prevent reliably that granulation penetrate
  • a double coil portion comprising the first coil and the second coil is formed at the center, and the first coil is formed at both ends of the double coil portion. Since the single coil part consisting of the coils of the two is formed, the single coil part is inserted into the trachea, and the double coil part is positioned in the defect part to ensure that the granulation enters the inside by the double coil part.
  • the substitute trachea can be placed in the trachea in a state suitable for the defect, and the substitute trachea can be reliably prevented from moving.
  • the wire is made of a shape memory alloy having a superelasticity that maintains a memorized shape at room temperature and softens when cooled, so that the defect part is naturally healed. After that, the substitute trachea can be cooled and removed endoscopically.
  • the substitute trachea of the present invention can be used in fields such as pediatric surgery, respiratory surgery, and regenerative surgery.
  • reference numeral 1 denotes a substitute trachea inserted into the trachea for use in the treatment of a tracheal defect, and is formed by winding the wire 2 in a coil shape without any gaps.
  • the wire 2 is preferably made of a shape memory alloy having superelasticity that maintains a memorized shape at room temperature and softens when cooled.
  • a shape memory alloy for example, a titanium / nickel alloy that maintains a memorized shape at room temperature and softens when cooled to minus 10 ° C. can be used. Titanium / nickel alloys have the advantage that they will not deteriorate even if left in the body for a long period of time.
  • the substitute trachea 1 includes a first coil 3 formed by winding a wire 2 in a spindle shape, and a second coil 4 provided by winding the wire 2 around the outside of the first coil 3 without a gap. It consists of.
  • the second coil 4 is provided only at the central portion in the central axis direction of the first coil 3. That is, a double coil portion 5 including the first coil 3 and the second coil 4 is formed in the central portion in the central axis direction of the substitute trachea 1. Further, single coil portions 6 each formed of the first coil 3 are formed at both ends of the double coil portion 5.
  • the substitute trachea 1 of this embodiment is installed in the trachea through the defect hole in the tracheal defect part, and if the tracheal defect part is left without being closed after the substitute trachea 1 is installed, the defect The part is completely closed with a fibrous cap. Therefore, the treatment using the substitute trachea 1 of the present embodiment brings about natural healing without tracheal stenosis, and there is no risk of infection as in the case of using a biomaterial. And by making the part corresponded to a tracheal defect part into the double coil part 5, it is prevented reliably that granulation penetrate
  • the substitute trachea of this embodiment is the substitute trachea 1 inserted into the trachea for use in the treatment of the tracheal defect, and is formed by winding the wire 2 in a coil shape without any gaps.
  • the first coil 3 is formed in a spindle shape, and the second coil 4 is provided outside the first coil 3 without a gap.
  • the coils are doubled, it is possible to reliably prevent the granulation from entering the inside. In addition, it can withstand long-term use. Furthermore, since the wire 2 is simply formed by winding it in a coil shape, various sizes can be easily and inexpensively manufactured.
  • a double coil portion 5 composed of the first coil 3 and the second coil 4 is formed in the center portion, and a single coil portion 6 composed of the first coil 3 is formed at both ends of the double coil portion 5. Is formed.
  • the double coil part 5 can surely prevent the granulation from entering inside, and substitute
  • the trachea 1 can be indwelled in the trachea in a state suitable for the defect portion, and it is possible to reliably prevent the substitute trachea from moving.
  • the wire 2 is made of a shape memory alloy having superelasticity that maintains a memorized shape at room temperature and softens when cooled.
  • the substitute trachea 1 can be cooled and endoscopically removed after the defect has healed naturally.
  • the substitute trachea 1 can be cooled by spraying cold spray or the like.
  • a substitute trachea was created by winding a wire 2 made of a titanium / nickel alloy having a diameter of 0.4 mm into a coil without any gaps. The photograph is shown in FIG.
  • the wire 2 was developed by Solv Co., Ltd. for curling nail correction, and has superelasticity that softens when it is cooled to minus 10 ° C. while maintaining a memorized shape at room temperature.
  • the first coil 3 was formed in a spindle shape with a total length of 24 mm, a diameter at both ends of 4 mm, and a diameter at the center of 6 mm.
  • the 2nd coil 4 was provided in the outer side of this 1st coil 3 without gap.
  • the total length of the second coil 4 was 12 mm.
  • the wire 2 ′ extending linearly from the end portions of the first coil 3 and the second coil 4 is cut when the substitute trachea 1 is used.
  • the sedation was added by intramuscular anesthetic injection, and the cervical trachea (diameter 6-7 mm) was exposed by a longitudinal cervical incision. Then, as shown in FIG. 3 (a), the front half B of the trachea A was excised across 6 cartilage rings and the tracheal wall B was excised, thereby sharply creating a defect C in the trachea A.
  • the substitute trachea 1 was inserted from the defect C. While bending the substitute trachea 1 from the defect hole C, the single coil portions 6 at both ends are inserted into the lumen of the trachea A and installed so that the double coil portion 5 is positioned in the defect portion C.
  • the defect portion C was closed by the coil portion 5.
  • the stump of the defect C and the substitute trachea 1 were fixed with several needles using 5-0 non-absorbing thread.
  • the incised front neck muscle group and subcutaneous tissue were closed with continuous sutures, and the operation was completed.
  • antibiotics were not used, and no particular treatment was performed.
  • normal rabbit feed was fed.
  • oral intake was poor, so drip was injected subcutaneously to replenish water.

Abstract

Provided is a novel substitute trachea capable of reliably preventing granulation from penetrating inside. A substitute trachea (1) for insertion inside a trachea for use in the treatment of a damaged section of trachea was formed by winding a wire (2) into a coil shape without gaps. The substitute trachea comprises a first coil (3) formed in a spindle shape, and a second coil (4) provided without gaps on the outside of this first coil (3). A double coil section (5) comprising the first coil (3) and the second coil (4) is formed in a center section, and a single coil section (6) comprising the first coil (3) is formed at both ends of the double coil section (5). The wire (2) comprises a shape-memory alloy having superelasticity whereby the wire maintains a remembered shape at normal temperature and softens when cooled.

Description

代用気管Substitute trachea
　本発明は、気管欠損部の治療に用いられる代用気管に関する。 The present invention relates to a substitute trachea used for the treatment of a tracheal defect.
　従来、巨大な気管欠損部の治療は、欠損部を肋軟骨や人工被覆材などの被覆材を用いて被覆することで行なわれてきた。しかし、現在まで、理想的な被覆材は見出されていない。その理由は、気管は呼吸サイクルに合わせて内圧が変化するが、被覆材にはその内圧の変化に耐えることのできる恒常的な強度が要求され、さらに、生体反応による肉芽形成や感染などを惹起しないことが要求されるからである。なお、工業的に作成された非生体素材を被覆材に用いた場合は、感染や肉芽形成による内腔狭窄が問題となる。一方、医用工学を用いて産生された素材を用いた場合は、培養過程で牛のアルブミンなどが用いられるため、狂牛病などに対する安全性が問題となる。 Conventionally, treatment of a huge tracheal defect has been performed by covering the defect with a covering material such as costal cartilage or an artificial covering material. However, until now, no ideal coating has been found. The reason for this is that the trachea changes its internal pressure in accordance with the respiratory cycle, but the covering material is required to have a constant strength that can withstand the change in internal pressure, and it causes granulation and infection due to biological reactions. This is because it is required not to. In addition, when an industrially prepared non-living material is used as a covering material, lumen narrowing due to infection or granulation is a problem. On the other hand, when materials produced using medical engineering are used, bovine albumin or the like is used in the culturing process, and thus safety against mad cow disease is a problem.
　ところで、気管欠損部を放置した場合は、薄いながらも気道の内圧の変化に耐えることのできる線維性被膜が形成されるが、長期的には気管欠損部のサイズに比例した内腔狭窄をきたす。一方、特許文献１には、気管の狭窄部や閉塞を拡張保持するための形状記憶合金製ステントが開示されている。そこで、この線維性被膜の形成を利用し、上記のステントを一時的な代用気管として気管内に挿入することで、内腔狭窄をきたさずに気管欠損部を自然治癒させることができるものと期待された。 By the way, if the tracheal defect is left untreated, a fibrous coating that can withstand changes in the internal pressure of the airway is formed although it is thin. . On the other hand, Patent Document 1 discloses a shape memory alloy stent for expanding and holding a stenosis or occlusion of a trachea. Therefore, it is expected that the tracheal defect can be spontaneously healed without causing lumen stenosis by using the formation of the fibrous capsule and inserting the above stent as a temporary substitute trachea into the trachea. It was done.
　しかし、特許文献１に開示されたようなコイル状のステントを気管内に挿入してみたところ、異物に対する生体反応として旺盛な肉芽形成を惹起してしまい、結局、肉芽の一部がステントの内側に侵入し、内腔狭窄をきたしてしまうことが判明した。 However, when a coiled stent as disclosed in Patent Document 1 is inserted into the trachea, vigorous granulation is induced as a biological reaction against foreign substances, and eventually a part of the granulation is inside the stent. It has been found that the stenosis of the lumen occurs.
特開平１１－９９２０７号公報JP 11-99207 A
　そこで本発明では上記問題点に鑑み、気管欠損部の治療に用いるために気管内に挿入される代用気管であって、肉芽が内側に侵入することを確実に防止することのできる、新規の代用気管を提供することを目的とする。 Therefore, in the present invention, in view of the above-mentioned problems, it is a substitute trachea that is inserted into the trachea for use in the treatment of a tracheal defect portion, and can be reliably prevented from invading granulation into the inside. The aim is to provide a trachea.
　本発明の請求項１記載の代用気管は、気管欠損部の治療に用いるために気管内に挿入される代用気管であって、ワイヤーを隙間なくコイル状に巻くことで形成されるとともに、紡錘形に形成された第１のコイルと、この第１のコイルの外側に隙間なく設けられた第２のコイルとからなることを特徴とする。 A substitute trachea according to claim 1 of the present invention is a substitute trachea that is inserted into a trachea for use in the treatment of a tracheal defect portion, and is formed by winding a wire in a coil shape without a gap, and has a spindle shape. It consists of the formed 1st coil and the 2nd coil provided without the clearance gap outside this 1st coil, It is characterized by the above-mentioned.
　また、本発明の請求項２記載の代用気管は、請求項１において、中央部に前記第１のコイル及び第２のコイルからなる２重コイル部が形成され、この２重コイル部の両端に前記第１のコイルからなる１重コイル部が形成されたことを特徴とする。 According to a second aspect of the present invention, there is provided a substitute trachea according to the first aspect, wherein a double coil portion including the first coil and the second coil is formed in the center portion, and both ends of the double coil portion are formed. A single coil portion made of the first coil is formed.
　また、本発明の請求項３記載の代用気管は、請求項１又は２において、前記ワイヤーは、常温では記憶された形状を維持し冷却すると軟化する超弾性を有する形状記憶合金からなることを特徴とする。 Further, the substitute trachea according to claim 3 of the present invention is characterized in that in claim 1 or 2, the wire is made of a shape memory alloy having superelasticity that maintains a memorized shape at room temperature and softens when cooled. And
　本発明の請求項１記載の代用気管によれば、ワイヤーを隙間なくコイル状に巻くことで形成されるとともに、紡錘形に形成された第１のコイルと、この第１のコイルの外側に隙間なく設けられた第２のコイルとからなるので、コイルが２重になっていることにより、肉芽が内側に侵入することを確実に防止することができる。 According to the substitute trachea of claim 1 of the present invention, it is formed by winding a wire in a coil shape without a gap, and there is no gap on the outside of the first coil and the first coil formed in a spindle shape. Since it consists of the provided 2nd coil, it can prevent reliably that granulation penetrate | invades inside because the coil is doubled.
　また、本発明の請求項２記載の代用気管によれば、中央部に前記第１のコイル及び第２のコイルからなる２重コイル部が形成され、この２重コイル部の両端に前記第１のコイルからなる１重コイル部が形成されたので、１重コイル部を気管に挿入し欠損部に２重コイル部を位置させることにより、２重コイル部により肉芽が内側に侵入することを確実に防止することができるとともに、代用気管を欠損部に適合した状態で気管内に留置させることができ、代用気管が移動することを確実に防止することができる。 According to the substitute trachea of claim 2 of the present invention, a double coil portion comprising the first coil and the second coil is formed at the center, and the first coil is formed at both ends of the double coil portion. Since the single coil part consisting of the coils of the two is formed, the single coil part is inserted into the trachea, and the double coil part is positioned in the defect part to ensure that the granulation enters the inside by the double coil part. In addition, the substitute trachea can be placed in the trachea in a state suitable for the defect, and the substitute trachea can be reliably prevented from moving.
　また、本発明の請求項３記載の代用気管によれば、前記ワイヤーは、常温では記憶された形状を維持し冷却すると軟化する超弾性を有する形状記憶合金からなることにより、欠損部が自然治癒した後に代用気管を冷却して内視鏡的に抜去することができる。 According to the substitute trachea of claim 3 of the present invention, the wire is made of a shape memory alloy having a superelasticity that maintains a memorized shape at room temperature and softens when cooled, so that the defect part is naturally healed. After that, the substitute trachea can be cooled and removed endoscopically.
本発明の代用気管の一実施例を示す正面図である。It is a front view which shows one Example of the substitute trachea of this invention. 本発明の代用気管の一実施例を示す写真である。It is a photograph which shows one Example of the substitute trachea of this invention. 本発明の代用気管を使用した動物実験を示す説明図である。It is explanatory drawing which shows the animal experiment using the substitute trachea of this invention.
　以下、本発明の代用気管の実施例について、添付した図面を参照しながら説明する。なお、本発明の代用気管は、小児外科、呼吸器外科、再生外科などの分野で用いることができるものである。 Hereinafter, embodiments of the substitute trachea of the present invention will be described with reference to the attached drawings. The substitute trachea of the present invention can be used in fields such as pediatric surgery, respiratory surgery, and regenerative surgery.
　本実施例の代用気管を示す図１において、１は気管欠損部の治療に用いるために気管内に挿入される代用気管であって、ワイヤー２を隙間なくコイル状に巻くことで形成されている。ワイヤー２は、好ましくは、常温では記憶された形状を維持し冷却すると軟化する超弾性を有する形状記憶合金からなる。このような形状記憶合金としては、例えば、常温では記憶された形状を維持しマイナス１０℃に冷却すると軟化するチタン・ニッケル合金を用いることができる。なお、チタン・ニッケル合金は、長期間体内に留置しても劣化がないという利点を有する。 In FIG. 1 showing the substitute trachea of this embodiment, reference numeral 1 denotes a substitute trachea inserted into the trachea for use in the treatment of a tracheal defect, and is formed by winding the wire 2 in a coil shape without any gaps. . The wire 2 is preferably made of a shape memory alloy having superelasticity that maintains a memorized shape at room temperature and softens when cooled. As such a shape memory alloy, for example, a titanium / nickel alloy that maintains a memorized shape at room temperature and softens when cooled to minus 10 ° C. can be used. Titanium / nickel alloys have the advantage that they will not deteriorate even if left in the body for a long period of time.
　また、代用気管１は、紡錘形にワイヤー２を巻くことで形成された第１のコイル３と、この第１のコイル３の外側に隙間なくワイヤー２を巻くことで設けられた第２のコイル４とからなる。第２のコイル４は、第１のコイル３の中心軸方向における中央部にのみ設けられている。すなわち、代用気管１の中心軸方向における中央部に第１のコイル３及び第２のコイル４からなる２重コイル部５が形成されている。また、この２重コイル部５の両端には、それぞれ第１のコイル３からなる１重コイル部６が形成されている。 The substitute trachea 1 includes a first coil 3 formed by winding a wire 2 in a spindle shape, and a second coil 4 provided by winding the wire 2 around the outside of the first coil 3 without a gap. It consists of. The second coil 4 is provided only at the central portion in the central axis direction of the first coil 3. That is, a double coil portion 5 including the first coil 3 and the second coil 4 is formed in the central portion in the central axis direction of the substitute trachea 1. Further, single coil portions 6 each formed of the first coil 3 are formed at both ends of the double coil portion 5.
　本実施例の代用気管１は、気管欠損部に欠損孔を通して気管内に設置されるものであり、代用気管１を設置した後に気管欠損部を閉鎖することなく放置したままにしておくと、欠損部は線維性被膜で完全に閉鎖される。したがって、本実施例の代用気管１を用いた治療は、気管狭窄のない自然治癒を来すものであり、生体材料を用いた場合のような感染の虞がない。そして、気管欠損部に相当する部分を２重コイル部５とすることで、肉芽が内側に侵入することが確実に防止され、欠損部に２重コイル部５をフィットさせることで、代用気管１の移動が防止される。 The substitute trachea 1 of this embodiment is installed in the trachea through the defect hole in the tracheal defect part, and if the tracheal defect part is left without being closed after the substitute trachea 1 is installed, the defect The part is completely closed with a fibrous cap. Therefore, the treatment using the substitute trachea 1 of the present embodiment brings about natural healing without tracheal stenosis, and there is no risk of infection as in the case of using a biomaterial. And by making the part corresponded to a tracheal defect part into the double coil part 5, it is prevented reliably that granulation penetrate | invades inside, and the substitute trachea 1 is made by fitting the double coil part 5 to a defect part. Movement is prevented.
　以上のように、本実施例の代用気管は、気管欠損部の治療に用いるために気管内に挿入される代用気管１であって、ワイヤー２を隙間なくコイル状に巻くことで形成されるとともに、紡錘形に形成された第１のコイル３と、この第１のコイル３の外側に隙間なく設けられた第２のコイル４とからなる。 As described above, the substitute trachea of this embodiment is the substitute trachea 1 inserted into the trachea for use in the treatment of the tracheal defect, and is formed by winding the wire 2 in a coil shape without any gaps. The first coil 3 is formed in a spindle shape, and the second coil 4 is provided outside the first coil 3 without a gap.
　したがって、コイルが２重になっていることにより、肉芽が内側に侵入することを確実に防止することができる。また、これにより、長期間の使用にも耐えることができる。さらに、ワイヤー２をコイル状に巻くだけで簡単に形成されるので、種々のサイズのものを容易かつ安価に製造することが可能である。 Therefore, since the coils are doubled, it is possible to reliably prevent the granulation from entering the inside. In addition, it can withstand long-term use. Furthermore, since the wire 2 is simply formed by winding it in a coil shape, various sizes can be easily and inexpensively manufactured.
　また、中央部に前記第１のコイル３及び第２のコイル４からなる２重コイル部５が形成され、この２重コイル部５の両端に前記第１のコイル３からなる１重コイル部６が形成されたものである。 In addition, a double coil portion 5 composed of the first coil 3 and the second coil 4 is formed in the center portion, and a single coil portion 6 composed of the first coil 3 is formed at both ends of the double coil portion 5. Is formed.
　したがって、１重コイル部６を気管に挿入し欠損部に２重コイル部５を位置させることにより、２重コイル部５により肉芽が内側に侵入することを確実に防止することができるとともに、代用気管１を欠損部に適合した状態で気管内に留置させることができ、代用気管が移動することを確実に防止することができる。 Therefore, by inserting the single coil part 6 into the trachea and positioning the double coil part 5 in the defect part, the double coil part 5 can surely prevent the granulation from entering inside, and substitute The trachea 1 can be indwelled in the trachea in a state suitable for the defect portion, and it is possible to reliably prevent the substitute trachea from moving.
　また、前記ワイヤー２は、常温では記憶された形状を維持し冷却すると軟化する超弾性を有する形状記憶合金からなるものである。 The wire 2 is made of a shape memory alloy having superelasticity that maintains a memorized shape at room temperature and softens when cooled.
　したがって、欠損部が自然治癒した後に代用気管１を冷却して内視鏡的に抜去することができる。なお、代用気管１は、コールドスプレーなどを吹きつけることにより冷却することができる。 Therefore, the substitute trachea 1 can be cooled and endoscopically removed after the defect has healed naturally. The substitute trachea 1 can be cooled by spraying cold spray or the like.
　なお、本発明は上記の実施形態に限定されるものではなく、種々の変形実施が可能である。 In addition, this invention is not limited to said embodiment, A various deformation | transformation implementation is possible.
　０．４ｍｍ径のチタン・ニッケル合金からなるワイヤー２を隙間なくコイル状に巻いて代用気管を作成した。その写真を図２に示す。なお、ワイヤー２は、ソルブ株式会社が巻き爪矯正用に開発したもので、常温では記憶された形状を維持しマイナス１０℃に冷却すると軟化する超弾性を有している。 A substitute trachea was created by winding a wire 2 made of a titanium / nickel alloy having a diameter of 0.4 mm into a coil without any gaps. The photograph is shown in FIG. In addition, the wire 2 was developed by Solv Co., Ltd. for curling nail correction, and has superelasticity that softens when it is cooled to minus 10 ° C. while maintaining a memorized shape at room temperature.
　ここで、第１のコイル３は、全長を２４ｍｍ、両端部における径を４ｍｍ、中央部における径を６ｍｍとして、紡錘形に形成した。そして、この第１のコイル３の外側に第２のコイル４を隙間なく設けた。第２のコイル４の全長は１２ｍｍとした。なお、第１のコイル３と第２のコイル４の端部から直線状に伸びるワイヤー２’は、代用気管１の使用時に切断されるものである。 Here, the first coil 3 was formed in a spindle shape with a total length of 24 mm, a diameter at both ends of 4 mm, and a diameter at the center of 6 mm. And the 2nd coil 4 was provided in the outer side of this 1st coil 3 without gap. The total length of the second coil 4 was 12 mm. The wire 2 ′ extending linearly from the end portions of the first coil 3 and the second coil 4 is cut when the substitute trachea 1 is used.
　そして、この代用気管１を用いて、家兎を用いた動物実験を行った。 Then, using this surrogate trachea 1, an animal experiment using rabbits was conducted.
　筋肉内麻酔薬注入にて鎮静を加え、頚部縦切開にて頚部気管（直径６～７ｍｍ）を露出した。そして、図３（ａ）に示すように、気管Ａの前半周を６軟骨輪にわたって切除して気管前壁Ｂを摘出することで、鋭的に気管Ａに欠損部Ｃを作成した。つぎに、図３（ｂ）～（ｃ）に示すように、欠損部Ｃから代用気管１を挿入した。欠損孔Ｃより代用気管１を曲げながら両端の１重コイル部６を気管Ａの内腔に差し込み、欠損部Ｃに２重コイル部５が位置するように設置することにより、中央部の２重コイル部５により欠損部Ｃを閉塞した。欠損部Ｃの断端と代用気管１を５－０非吸収糸にて数針固定した。切開した前頚筋群や皮下組織を連続縫合閉鎖し、手術を終了した。術後数日抗生剤を使用したほかは特に処置をせず、麻酔覚醒後は通常の家兎飼料を摂食させた。術直後の数日には経口摂取が不良のため、皮下に点滴液を注入して水分補給を適宜行った。 The sedation was added by intramuscular anesthetic injection, and the cervical trachea (diameter 6-7 mm) was exposed by a longitudinal cervical incision. Then, as shown in FIG. 3 (a), the front half B of the trachea A was excised across 6 cartilage rings and the tracheal wall B was excised, thereby sharply creating a defect C in the trachea A. Next, as shown in FIGS. 3B to 3C, the substitute trachea 1 was inserted from the defect C. While bending the substitute trachea 1 from the defect hole C, the single coil portions 6 at both ends are inserted into the lumen of the trachea A and installed so that the double coil portion 5 is positioned in the defect portion C. The defect portion C was closed by the coil portion 5. The stump of the defect C and the substitute trachea 1 were fixed with several needles using 5-0 non-absorbing thread. The incised front neck muscle group and subcutaneous tissue were closed with continuous sutures, and the operation was completed. A few days after the operation, antibiotics were not used, and no particular treatment was performed. After anesthesia awakening, normal rabbit feed was fed. In the few days immediately after the operation, oral intake was poor, so drip was injected subcutaneously to replenish water.
　体重２．５ｋｇの家兎５羽を用いて実験を行ったところ、５羽とも２ヶ月以上の長期生存が確認された。気管内視鏡検査を行ったところ、代用気管１に軽度の浸出液の付着はあるものの、内腔は保たれていた。 When an experiment was conducted using 5 rabbits weighing 2.5 kg, all 5 birds were confirmed to survive for more than 2 months. When tracheoscopy was performed, the luminal cavity was maintained, although a slight exudate adhered to the substitute trachea 1.
１　代用気管
２　ワイヤー
３　第１のコイル
４　第２のコイル
５　２重コイル部
６　１重コイル部 1 substitute trachea 2 wire 3 first coil 4 second coil 5 double coil part 6 single coil part

Claims (3)

  1. 気管欠損部の治療に用いるために気管内に挿入される代用気管であって、ワイヤーを隙間なくコイル状に巻くことで形成されるとともに、紡錘形に形成された第１のコイルと、この第１のコイルの外側に隙間なく設けられた第２のコイルとからなることを特徴とする代用気管。 A substitute trachea inserted into the trachea for use in the treatment of a tracheal defect, formed by winding a wire in a coil shape without a gap, and a first coil formed in a spindle shape, and the first coil A substitute trachea comprising a second coil provided outside the coil without any gap.
  2. 中央部に前記第１のコイル及び第２のコイルからなる２重コイル部が形成され、この２重コイル部の両端に前記第１のコイルからなる１重コイル部が形成されたことを特徴とする請求項１記載の代用気管。 A double coil part composed of the first coil and the second coil is formed in the center part, and a single coil part composed of the first coil is formed at both ends of the double coil part. The substitute trachea according to claim 1.
  3. 前記ワイヤーは、常温では記憶された形状を維持し冷却すると軟化する超弾性を有する形状記憶合金からなることを特徴とする請求項１又は２記載の代用気管。 The substitute trachea according to claim 1 or 2, wherein the wire is made of a shape memory alloy having superelasticity that maintains a memorized shape at room temperature and softens when cooled.
PCT/JP2012/084084 2012-01-30 2012-12-28 Substitute trachea WO2013114782A1 (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3245156B2 (en) * 1990-04-19 2002-01-07 インステント インコーポレイテッド Apparatus for the treatment of compressed tubes
JP2011010866A (en) * 2009-07-02 2011-01-20 Olympus Corp Stent

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3245156B2 (en) * 1990-04-19 2002-01-07 インステント インコーポレイテッド Apparatus for the treatment of compressed tubes
JP2011010866A (en) * 2009-07-02 2011-01-20 Olympus Corp Stent

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