WO1993023091A1 - Trachee artificielle - Google Patents

Trachee artificielle Download PDF

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Publication number
WO1993023091A1
WO1993023091A1 PCT/US1993/004829 US9304829W WO9323091A1 WO 1993023091 A1 WO1993023091 A1 WO 1993023091A1 US 9304829 W US9304829 W US 9304829W WO 9323091 A1 WO9323091 A1 WO 9323091A1
Authority
WO
WIPO (PCT)
Prior art keywords
artificial
windpipe
hydroxyapatite
organic polymer
groups
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US1993/004829
Other languages
English (en)
Inventor
Masaki Ogawa
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sherwood Medical Co
Original Assignee
Sherwood Medical Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sherwood Medical Co filed Critical Sherwood Medical Co
Publication of WO1993023091A1 publication Critical patent/WO1993023091A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/32—Phosphorus-containing materials, e.g. apatite
    • 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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Definitions

  • the present invention concerns an artificial windpipe to be used for reconstructing a part of or entire windpipe in case of diseases or accidents.
  • a sputtering method is disclosed in Japanese Patent Disclosure No. Tokkai Sho 58[1983]-109049; a flame melt-spray method in The Proceedings from the 1988 First Fall Symposium of the Japan Ceramic Society, pp. 401-402; and a glass frit baking method in The Proceedings from the 9th Biomaterial Society Convention (1987), p. 6.
  • An electrophoretic method is disclosed in Japan Ceramic Society, 1988, pp. 417-418.
  • Japanese Patent Application Publication No. Kokai Sho 63[1988]-27014 presented an attempt to provide an artificial windpipe for long-term or permanent uses, in which by coating collagen on a mesh/silicone composite is coated with collagen to improve the biocompatibility and to prevent unsatisfactory excessive granulation growths.
  • Japanese Patent Disclosure No. Tokkai Hei 1[1989]-291858 has disclosed an artificial windpipe which consists of a ceramic composite of porous and dense materials containing hydroxyapatite.
  • a terminal made from the sintered material are subjected to severe restrictions on the structure and shape because the strength of hydroxyapatite is low.
  • the electrophoretic method can be applied only to metal substrates with good electric conductivity because it uses the substrate itself as an electrode. Since a sintered apatite is used as a feed material, a coating of apatite different from the apatite inside the body is formed.
  • the objective of the present invention which has been proposed in order to resolve the aforementioned problems inherent in conventional artificial windpipes, is to provide an innovative light-weight artificial windpipe with an excellent biocompatibility.
  • the present invention concerns an artificial windpipe with the following characteristics: an artificial windpipe consisting of adapters at both ends and an elastomer tube in the middle, in which the adapter of said artificial windpipe is primarily made of an organic polymer selected from among organic polymers containing sulfone groups and/or carboxyl groups or organic polymers containing esters in the
  • the artificial windpipes satisfy the following conditions (1) - (10).
  • the said adapter is fitted over and fixed to the elastomer tube with an overlapping between them and at least two, preferably at least four, through holes are present on its circumferential surface.
  • the adhesive strength between the hydroxyapatite coating and the organic polymer material is at least 2 MPa.
  • the Shore hardness of said elastomer is 30A to 70D.
  • the said elastomer tube has thicker wall segments for reinforcement and/or is reinforced by a stent.
  • the said organic polymer containing sulfone group is selected from among polyethersulfone, polysulfone, and/or a compound containing organic polymers selected from between them.
  • the said organic polymer containing carboxyl group is a polymer while is obtained through a copolymerization of an olefin and carboxylic acid containing vinyl group and subsequent cross-linking with metal ions and/or a compound containing an organic polymer.
  • the said organic polymer containing esters in the principal-chain is allyl resin, oxybenzoyl polyester, polyacrylate, polybutylene terephthalate, polycarbonate, or polyethylene terephthalate.
  • the said organic polymer containing esters in side-chains is selected from among AAS resin (acrylic esteracrylonitrile-styrene copolymer), cellulosic plastics such as cellulose acetate, cellulose butyrate and ethyl
  • cellulose ethylene-vinyl acetate-vinyl chloride copolymer
  • ethylene-acrylic ester copolymer ethylene-acrylic ester copolymer
  • acrylic ester-butadienestyrene copolymer methacrylic resin
  • vinyl acetate resin ethylene-vinyl acetate-vinyl chloride copolymer
  • ethylene-acrylic ester copolymer ethylene-acrylic ester copolymer
  • acrylic ester-butadienestyrene copolymer acrylic ester-butadienestyrene copolymer
  • methacrylic resin methyl methacrylic resin
  • vinyl acetate resin vinyl acetate resin
  • a part of phosphate groups, or hydroxyl groups of hydroxyapatite is substituted by carbonate groups.
  • Figure 1 shows a partial sectional view of one
  • Figure 2 shows a partial sectional view of another embodiment of an artificial windpipe according to the present invention.
  • Figure 3 shows a partial sectional view of still another embodiment of an artificial windpipe according to the present invention.
  • the scope of the present invention is limited to an artificial windpipe which consists of adapters at both ends and an elastomer tube in the middle for the following reasons: the gist of the present invention lies in the fact that an excellent biocompatibility which has not been achieved in conventional techniques is attained by coating an organic polymer with a relatively low specific weight hydroxyapatite having a composition virtually identical to that of human body, and materials which can be coated by said hydroxyapatite with sufficient adhesive strengths are limited to materials with relatively large elastic
  • Elastomers are selected as tubes connecting said adapters to obtain the overall compliance of the artificial windpipe similar to that of an actual artificial windpipe.
  • the primary material of the adapter is limited to an organic polymer selected from among organic polymers
  • polypropylene selected as an organic polymer receives a plasma treatment at 0.1 Torr, 8 cc/min., and 150 mA for 3 minutes, carboxyl groups are introduced into approximately 7% of carbon atoms on the surface and sufficient adhesive strength with hydroxyapatite is attained.
  • organic polymers containing sulfone groups or carboxyl groups include polyethersulfone, polysulfone, ionomer, carboxylic acid-modified polyolefins (e.g., brand name: Mitsui Lonply), etc.
  • other polymers may be used as long as sulfone groups or carboxyl groups are present on the surface in contact with hydroxyapatite.
  • organic polymers containing esters in the principal-chain include allyl resin, oxybenzoyl polyester, polyacrylate, polybutylene terephthalate, polycarbonate, and polyethylene terephthalate.
  • organic polymers containing esters in sidechains include AAS resin (acrylic ester-acrylonitrilestyrene copolymer), cellulosic plastics such as cellulose acetate, cellulose butyrate and ethyl cellulose, ethylene- vinyl acetate-vinyl chloride copolymer, ethylene-acrylic ester copolymer, acrylic ester-butadiene-styrene copolymer, methacrylic resin, and vinyl acetate resin.
  • AAS resin acrylic ester-acrylonitrilestyrene copolymer
  • cellulosic plastics such as cellulose acetate, cellulose butyrate and ethyl cellulose, ethylene- vinyl acetate-vinyl chloride copolymer, ethylene-acrylic ester copolymer, acrylic ester-butadiene-styrene copolymer, methacrylic resin, and vinyl acetate resin.
  • hydroxyapatite film be 3-100 ⁇ m. If the thickness is less than 3 ⁇ m, it may be eroded and disappear while it remains inside the body. If the thickness exceeds 100 ⁇ m, a
  • hydroxyapatite in response to temperature and humidity variations.
  • the hydroxyapatite layer becomes more easily cracked, and the film separation may result from such cracks.
  • the prolonged time required for forming such thick hydroxyapatite layer inflates the
  • An ionomer obtained by cross-linking an ethylene-methacrylic acid copolymer with metal ions is desirable in the present invention since the highest adhesive strength with hydroxyapatite is attained.
  • adapters are locked with and fixed to the elastomer tube in an overlapping fashion, and at least two, preferably at least four, through holes are present on the circumferential surface. There is no need, however, to open holes on the tube. If holes are present on hard adapters, which needles go through, then even if no holes are present in the tube, which needles can easily go through, the needles can easily penetrate when the
  • the number of holes be at least 2, preferably at least four, since it is desirable that four or more holes be present to obtain an air tight suture between an artificial windpipe-real windpipe.
  • the holes do not have to be circular and may be elliptical and hyperelliptical.
  • elastomer used for the artificial windpipe of the present invention be 30A to 70D since the artificial windpipe must have a flexibility comparable to those of real windpipes. If the hardness is lower than 30A, the size of the inner cavity may locally decrease. If the hardness exceeds 70D, an excessive load is exerted on a real windpipe at the suture, prolonging the healing of the wound.
  • said elastomer tube prefferably has locally thicker wall segments for reinforcement and/or be reinforced by a stent. This is to prevent the narrowing of the inner cavity under an external pressure. If the thickness of the entire tube is increased, the flexibility of the artificial windpipe decreases, and the load is concentrated at the suture, consequently, the healing of the wound may be delayed, or in an extreme case, the artificial windpipe may come off.
  • Tables I and II show data obtained corresponding to the following examples, in which the thickness of hydroxyapatite coating and the adapter material were varied.
  • Figure 1 shows a partially sectioned view of an
  • Figures 2 and 3 show partially sectioned views of other embodiments of an artificial windpipe.
  • (1), (2), and (3) are an adapter, a tube, and through holes, respectively.
  • the artificial windpipe of the present invention is prepared as follows.
  • the adapter (1) at both ends of the artificial windpipe is composed of polyethersulfone (PE S4100G, manufactured by ICI Japan). Two of such artificial windpipe adapters are buried into a glass powder with particle diameters 100-600 ⁇ m (this technique is disclosed in Japanese Patent Disclosure No. Tokkai Hei 2[1990]-25515). In said glass powder, the ranges of CaO and SiO 2
  • compositions are: CaO: 20-60 mol%; SiO 2 : 40-80 mol%.
  • the sum of CaO and SiO 2 is at least 70 mol%.
  • At least 80% of the glass powder has particle diameters 100-600 ⁇ m.
  • the glass composition was as follows: CaO: 49.87 mol%; SiO 2 : 35.46 mol%; P 2 O 5 : 7.153 mol%; MgO: 7.111 mol%; CaF:
  • the composition of the artificial body fluid was as follows (with respect to 1 L of water): artificial body fluid A: 7.996 g of NaCl, 0.350 g of NaHCO 3 , 0.224 g of KCl, 0.228 g of K 2 HPO 4 ⁇ 3H 2 O, 0.305 g of MgCl 2 , 0.071 g of Na 2 SO 4 , approximately 45 mL of 1 N HCl, and 6.057 g of
  • artificial body fluid B 11.99 g of NaCl, 0.525 g of NaHCO 3 , 0.336 g of KCl, 0.324 g of K 2 HPO 4 ⁇ 3H 2 O, 0.458 g of MgCl 2 , 0.107 g of Na 2 SO 4 ,
  • NaHCO 3 has also been added to the present artificial body fluid as a carbonate. It has been confirmed that the phosphate groups or hydroxyl groups of the hydroxyapatite layer derived from said artificial body fluid are partially substituted with carbonate groups. It is also known that the phosphate groups or hydroxyl groups of hydroxyapatite existing in the human body are partially substituted with carbonate groups as well.
  • the artificial windpipe was retrieved 48 hours later, and subsequently, it was immersed in artificial body fluid B for 1 week.
  • the adapter was retrieved from the artificial body fluid B, washed with water and dried, it was then fitted over and glued to a tube of medical
  • the thickness of the hydroxyapatite coating was
  • hydroxyapatite coating and physical appearances were measured or observed by using a scanning electron microscope.
  • hydroxyapatite a plate (length: 5 mm; width: 5 mm;
  • An artificial windpipe adapter with the shape identical to that in Application Example 1 was prepared by using polybutylene terephthalate (PBT1401-X06, manufactured by Toray, Inc.), and hydroxyapatite was coated under conditions identical to those in Application Example 2.
  • PBT1401-X06 polybutylene terephthalate
  • An artificial windpipe adapter with the shape identical to that in Application Example 1 was prepared by using a polyacrylic resin (Delpet 60N, manufactured by Asahi Kasei Co.), and hydroxyapatite was coated under conditions
  • a medicalgrade soft polyvinyl chloride resin (RS3090, manufactured by Riken-Vinyl Industries Co.; Shore hardness: 60A) was used for the tube.
  • both the inner and outer surfaces of the tube may be coated with hydroxyapatite.
  • the artificial windpipe of the present invention has the aforementioned characteristics, a light-weight artificial windpipe with an excellent biocompatibility was successfully obtained.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

Une trachée artificielle d'un poids léger présentant une excellente biocompatibilité comporte des adaptateurs à ses deux extrémités ainsi qu'un tube élastomère central. L'adaptateur de la trachée artificielle est essentiellement composé d'un polymère organique choisi parmi des polymères organiques contenant des groupes sufone et/ou des groupes carboxyle, ou des polymères organiques contenant des esters dans la chaîne principale et/ou les chaînes latérales, et il est enduit d'hydroxyapatite d'une épaisseur comprise entre 3 et 10 νm.
PCT/US1993/004829 1992-05-20 1993-05-20 Trachee artificielle Ceased WO1993023091A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP4127156A JPH05317409A (ja) 1992-05-20 1992-05-20 人工気管
JP4/127156 1992-05-20

Publications (1)

Publication Number Publication Date
WO1993023091A1 true WO1993023091A1 (fr) 1993-11-25

Family

ID=14953024

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1993/004829 Ceased WO1993023091A1 (fr) 1992-05-20 1993-05-20 Trachee artificielle

Country Status (3)

Country Link
JP (1) JPH05317409A (fr)
AU (1) AU4253393A (fr)
WO (1) WO1993023091A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100428919C (zh) * 2006-07-31 2008-10-29 中南大学湘雅二医院 一种人工气管
CN107596442A (zh) * 2017-10-31 2018-01-19 上海纳米技术及应用国家工程研究中心有限公司 Pet材料表面的梯度生物涂层的制备方法及其产品和应用

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002263183A (ja) * 2001-03-09 2002-09-17 Asahi Kasei Corp 生体適合性材料
KR20020094074A (ko) * 2001-06-07 2002-12-18 (주)에이치비메디컬스 체내 이식관
JP4149897B2 (ja) * 2002-11-07 2008-09-17 学校法人 聖マリアンナ医科大学 気管移植片の調製方法および気管移植片
US9592117B2 (en) * 2006-05-25 2017-03-14 E. Benson Hood Laboratories Coated tracheostomy tube and stoma stent or cannula

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0389713A1 (fr) * 1989-03-29 1990-10-03 Kyoto University Procédé de revêtement avec une pellicule d'hydroxyapatite bioactive
EP0437975A1 (fr) * 1990-01-08 1991-07-24 Sumitomo Chemical Company, Limited Méthode pour la formation d'un revêtement d'hydroxyapatite
WO1993007916A2 (fr) * 1991-10-15 1993-04-29 Sherwood Medical Company Element d'implant corporel bioactif, recouvert d'une couche d'apatite

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0389713A1 (fr) * 1989-03-29 1990-10-03 Kyoto University Procédé de revêtement avec une pellicule d'hydroxyapatite bioactive
EP0437975A1 (fr) * 1990-01-08 1991-07-24 Sumitomo Chemical Company, Limited Méthode pour la formation d'un revêtement d'hydroxyapatite
WO1993007916A2 (fr) * 1991-10-15 1993-04-29 Sherwood Medical Company Element d'implant corporel bioactif, recouvert d'une couche d'apatite

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPIL Week 8606, Derwent Publications Ltd., London, GB; AN 86-039159 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100428919C (zh) * 2006-07-31 2008-10-29 中南大学湘雅二医院 一种人工气管
CN107596442A (zh) * 2017-10-31 2018-01-19 上海纳米技术及应用国家工程研究中心有限公司 Pet材料表面的梯度生物涂层的制备方法及其产品和应用
CN107596442B (zh) * 2017-10-31 2020-10-27 上海纳米技术及应用国家工程研究中心有限公司 Pet材料表面的梯度生物涂层的制备方法及其产品和应用

Also Published As

Publication number Publication date
AU4253393A (en) 1993-12-13
JPH05317409A (ja) 1993-12-03

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