WO1995003837A1 - Procede de traitement d'un materiau de suture synthetique resorbable - Google Patents

Procede de traitement d'un materiau de suture synthetique resorbable Download PDF

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Publication number
WO1995003837A1
WO1995003837A1 PCT/DE1994/000884 DE9400884W WO9503837A1 WO 1995003837 A1 WO1995003837 A1 WO 1995003837A1 DE 9400884 W DE9400884 W DE 9400884W WO 9503837 A1 WO9503837 A1 WO 9503837A1
Authority
WO
WIPO (PCT)
Prior art keywords
suture material
packaging
heat treatment
temperature
reducing agent
Prior art date
Application number
PCT/DE1994/000884
Other languages
German (de)
English (en)
Inventor
Rainer Kautz
Original Assignee
Deknatel Medizinische Produkte Gmbh
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 Deknatel Medizinische Produkte Gmbh filed Critical Deknatel Medizinische Produkte Gmbh
Publication of WO1995003837A1 publication Critical patent/WO1995003837A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06114—Packages or dispensers for needles or sutures
    • 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
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/206—Ethylene oxide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive

Definitions

  • the invention relates to a method for the treatment of synthetic resorbable suture material, in particular multifilament suture material made from polyglycolic acid, according to the features specified in the preamble of claim 1.
  • sutures are known to be used for medical, especially surgical, applications. It is therefore imperative that the sutures are reliably sterilized, which is done by the manufacturer today.
  • the suture material is sensitive to moisture.
  • the suturing material in the body is broken down by hydrolysis. Contact with moisture should therefore be avoided if possible during production, sterilization and storage.
  • it is placed in an aluminum packaging, which is inserted through an open side during sterilization
  • This object is achieved according to the invention in that a reducing agent is provided inside the packaging for the sterilization gas remaining in the suture material and possibly also in the packaging and only emerging after the packaging has been sealed, and in that the sealed packaging with the therein suture material present is accelerated to accelerate the degassing and / or reduction processes of a heat treatment.
  • the method according to the invention reliable degassing of the suture material and conversion of the sterilizing gas located in the packaging is achieved with little technical and economic effort.
  • the heat treatment is not problematic from a process engineering point of view, since the sealed packaging is fed to the heat treatment, so that no special procedural measures have to be taken.
  • the type and duration of the heat treatment depends on the one hand on the suture material in the packaging and on the other hand on the permissible residual content of sterilizing gas in the suture material and / or in the packaging.
  • a coating is usually applied to improve the lubricity, for example a polyglyd coating (a coating consisting of polycaprolactone and glycerol monostearate).
  • a polyglyd coating a coating consisting of polycaprolactone and glycerol monostearate.
  • Coating limited so is preferably just below this melting temperature. Otherwise, a melting of the coating within the packaging and subsequent re-solidification must be expected, which can lead to sticking together of the wound suture material and to undesired surface roughness.
  • the reducing agent inside the packaging is very important for the effectiveness of the heat treatment. Because only in this way can the ethylene oxide gas concentration within the packaging be reduced again after the sterilization gas has escaped from the suture material, so that further degassing of the suture material can take place.
  • Agents containing cellulose, in particular paper, cardboard and the like, have proven to be particularly suitable. These substances are cheap and easy to manufacture and dispose of and are available in almost any quality.
  • the reducing agent can form part of the packaging.
  • a thread carrier made of paper or cardboard is used, which must be provided for receiving the thread anyway and then also forms the reducing agent, which then with a sufficiently large surface area within the packaging.
  • a multifilament suture made from polyglycolic acid is packaged in the usual way, i.e. H. , arranged with or without a needle on a thread carrier and placed in a packaging made of coated aluminum foil that is open on one side.
  • This filled, but still open packaging is then exposed to ethylene oxide in a humid atmosphere.
  • the sterilization process is also carried out in a manner known per se.
  • an air stream is first passed over the sterilized material to remove the sterilization gas, which stream absorbs the gas removed by diffusion from the suture material and transports it further. This is followed by drying in a vacuum dryer, after which the packaging is sealed by sealing the remaining opening, the film coatings being welded to one another at the sealing points.
  • the filled and hermetically sealed package is then supplied to a heat treatment, namely at 50 ° C and a '
  • the temperature is selected so that neither the suture material itself nor its coating undergoes an undesired or uncontrolled change. During this heat treatment, the ethylene oxide still in the suture material escapes. It is due to the reducing agent in the packaging
  • the shape of the thread carrier made of paper converted into harmless substances. With the process described above The ethylene oxide remaining in the packaging or in the thread could be reduced to a value which is below 1 ppm.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Dentistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

Un procédé sert à traiter un matériau de suture résorbable synthétique, notamment un matériau de suture constitué de multifilaments d'acide polyglycolique. Afin de décomposer le gaz stérilisant qui reste dans le matériau de suture et dans son emballage après la stérilisation, un agent réducteur est introduit dans l'emballage. L'emballage fermé est soumis avec le matériau de suture et l'agent réducteur qu'il contient à un traitement thermique qui accélère les processus de dégazage et/ou de réduction.
PCT/DE1994/000884 1993-07-31 1994-07-28 Procede de traitement d'un materiau de suture synthetique resorbable WO1995003837A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19934325766 DE4325766C1 (de) 1993-07-31 1993-07-31 Verfahren zur Behandlung von synthetischem resorbierbaren Nahtmaterial
DEP4325766.6 1993-07-31

Publications (1)

Publication Number Publication Date
WO1995003837A1 true WO1995003837A1 (fr) 1995-02-09

Family

ID=6494181

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DE1994/000884 WO1995003837A1 (fr) 1993-07-31 1994-07-28 Procede de traitement d'un materiau de suture synthetique resorbable

Country Status (2)

Country Link
DE (1) DE4325766C1 (fr)
WO (1) WO1995003837A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1040840A1 (fr) * 1999-02-16 2000-10-04 Ethicon, Inc. Procédé pour le dégazage de produits de suture absorbables
US9968350B2 (en) 2007-08-31 2018-05-15 Avent, Inc. Blunted safety needle
US10098628B2 (en) 2014-07-22 2018-10-16 Cook Medical Technologies Llc Anchor deployment system, device, and method of treatment

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE752755A (fr) * 1969-01-02 1970-12-30 American Cyanamid Co Emballage assurant une bonne conservation des sutures resorbables a base d'acide polyglycolique et son procede de fabrication
US3815315A (en) * 1971-04-29 1974-06-11 American Cyanamid Co Ethylene oxide sterilization of moisture sensitive surgical elements
EP0182553A1 (fr) * 1984-11-15 1986-05-28 Pfizer Hospital Products Group, Inc. Emballage stérile double

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4470941A (en) * 1982-06-02 1984-09-11 Bioresearch Inc. Preparation of composite surgical sutures
DE3901835A1 (de) * 1988-01-28 1989-08-10 Claus M Hiltner Verpackung, insbesondere sterile verpackung fuer steril zu haltende gegenstaende

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE752755A (fr) * 1969-01-02 1970-12-30 American Cyanamid Co Emballage assurant une bonne conservation des sutures resorbables a base d'acide polyglycolique et son procede de fabrication
US3815315A (en) * 1971-04-29 1974-06-11 American Cyanamid Co Ethylene oxide sterilization of moisture sensitive surgical elements
EP0182553A1 (fr) * 1984-11-15 1986-05-28 Pfizer Hospital Products Group, Inc. Emballage stérile double

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1040840A1 (fr) * 1999-02-16 2000-10-04 Ethicon, Inc. Procédé pour le dégazage de produits de suture absorbables
US9968350B2 (en) 2007-08-31 2018-05-15 Avent, Inc. Blunted safety needle
US10098628B2 (en) 2014-07-22 2018-10-16 Cook Medical Technologies Llc Anchor deployment system, device, and method of treatment

Also Published As

Publication number Publication date
DE4325766C1 (de) 1995-05-11

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