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WO2011109882A1 - Polymère réabsorbable, coloré et radio-opaque utilisé dans la fabrication de dispositifs chirurgicaux implantables - Google Patents

Polymère réabsorbable, coloré et radio-opaque utilisé dans la fabrication de dispositifs chirurgicaux implantables Download PDF

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Publication number
WO2011109882A1
WO2011109882A1 PCT/BR2011/000064 BR2011000064W WO2011109882A1 WO 2011109882 A1 WO2011109882 A1 WO 2011109882A1 BR 2011000064 W BR2011000064 W BR 2011000064W WO 2011109882 A1 WO2011109882 A1 WO 2011109882A1
Authority
WO
WIPO (PCT)
Prior art keywords
radiopaque
manufacture
surgical devices
polymer used
polymer
Prior art date
Application number
PCT/BR2011/000064
Other languages
English (en)
Portuguese (pt)
Inventor
Aguedo Aragones
Steferson Luiz Stares
Márcio Celso FREDEL
Lourival Boehs
Ricardo De Souza Magini
Cláudia Maria Oliveira SIMÕES
Eliana Aparecida De Rezende Duek
Original Assignee
Agal Consultoria E Assessoria Ltda
Universidade Federal De Santa Catarina
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 Agal Consultoria E Assessoria Ltda, Universidade Federal De Santa Catarina filed Critical Agal Consultoria E Assessoria Ltda
Publication of WO2011109882A1 publication Critical patent/WO2011109882A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/18Materials at least partially X-ray or laser opaque
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present report refers to the improvement made on bioabsorbable and biodegradable plastic components, used as surgical implants, more specifically as plates and screws, as they promote their easy visualization inside and outside the body.
  • Such improvement consists in the addition of a radiopaque element to the polymer used in the manufacture of said devices and also the addition of organic dyes.
  • bioabsorbable materials which are materials developed to be absorbed by the body without producing a strong immune response, ie without rejection by the body. They are usually composed of plastics and are often used in orthopedics and dentistry.
  • bioabsorbable and biodegradable materials are being used, which in addition to being absorbed by the body are decomposed over time within the body, widely used in situations where there would be a need to remove the implant after a certain time. This eliminates the need for a second surgery to remove the implant.
  • Implantable devices on the market are not colored. This makes it difficult to identify the necessary item during the surgery due to the presence of body fluids such as blood. There are different ways of presenting these devices, as they may vary in thickness, diameter, length, time to degradation, among other characteristics.
  • Radiopacity is the impermeability that the material presents against X-rays or other forms of radiant energy allowing its visualization or radiographic image.
  • bioabsorbable Marker Having Radiopaque Constituints describes an implant-use flag made from bioabsorbable material and including radiopaque material such as bismuth trioxide and barium sulfate and that the weight percent of the material Radiopaque tissue in bioabsorbable material may range from 1% to approximately 80%.
  • CA 2579477 entitled “Implantable Device Formed From Polymer and Plasticizer Blends” describes a biocompatible material configured for use in implantable device medical devices including the known “intra-luminal stents"; It consists of a polymeric blend which may include additives such as bioactive agents, and radiopaque elements; and that the radiopaque material consists of barium sulfate.
  • CA 2579324 entitled “Implantable Device Formed From Polymer Blends” describes a biocompatible material consisting of a polymeric blend and which also uses barium sulfate as a radiopaque material.
  • biocompatible polymer prepared from “Melt Processing” which comprises a barium sulfate-type radiopaque agent.
  • other patent documents describe materials and products that somehow adds radiopacity to the product.
  • the subject of this report relates to a differentiated form from documents and products known in the state of the art. It favors the surgical practice of the professional in its detection both inside the body after implantation (radiopaque), as well as outside the body before implantation, by the different color classification.
  • This document describes a material for the manufacture of Resorbable, Color and Radiopaque Polymer devices manufactured through various production processes such as injection, hot pressing, sintering, machining, etc.
  • the radiopaque element and the dye are added to the polymer to form a radiopaque colored composite.
  • the inventive idea is the creation of the so-called "RESERVABLE, COLORFUL AND RADIOPACY POLYMER USED IN THE MANUFACTURE OF IMPLANTABLE SURGICAL DEVICES" using a chemically modified polymeric material with a radiopaque chemical dye to impart different colors to the product.
  • the product is made from the addition to the differentiated polymer of the radiopaque element, without the formation of blends, which consists in the physical mixture of two or more polymers without chemical connection between them; with the addition of ceramic additives as radiopaque agents.
  • the product is manufactured from a differentiated polymer, with the addition of organic dye to the material used in the manufacture of the devices, enabling the creation of a color standardization methodology in relation to the characteristics of each type of devices, such as plates or screws of different sizes in different color scales; plates and screws for different applications in different colors, and so on. This feature favors the professional's working condition, minimizing medical errors, surgical procedure time, etc.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un polymère réabsorbable, coloré et radio-opaque utilisé dans la fabrication de dispositifs chirurgicaux implantables. Ce polymère réabsorbable et biodégradable, additionné d'un élément radio-opaque et de colorants organiques, est utilisé dans la fabrication d'implants chirurgicaux, tels que des plaques et des vis. L'addition d'un élément radio-opaque et d'un colorant organique au polymère facilite la visualisation et la détection de la matière plastique à l'intérieur et à l'extérieur du corps humain.
PCT/BR2011/000064 2010-03-09 2011-03-02 Polymère réabsorbable, coloré et radio-opaque utilisé dans la fabrication de dispositifs chirurgicaux implantables WO2011109882A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
BRPI1000625-7A BRPI1000625A2 (pt) 2010-03-09 2010-03-09 polìmero reabsorvìvel, colorido e radiopaco utilizado na fabricação de dispositivos cirúrgicos implantáveis
BRPI1000625-7 2010-03-09

Publications (1)

Publication Number Publication Date
WO2011109882A1 true WO2011109882A1 (fr) 2011-09-15

Family

ID=44562755

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/BR2011/000064 WO2011109882A1 (fr) 2010-03-09 2011-03-02 Polymère réabsorbable, coloré et radio-opaque utilisé dans la fabrication de dispositifs chirurgicaux implantables

Country Status (2)

Country Link
BR (1) BRPI1000625A2 (fr)
WO (1) WO2011109882A1 (fr)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS60100527A (ja) * 1983-11-04 1985-06-04 Haruyuki Kawahara 手術野組織・骨表面専用の印象材組成物
US4689424A (en) * 1981-08-06 1987-08-25 Ethicon, Inc. Radiation sterilizable absorbable polymeric materials and methods for manufacturing the same
WO1998018408A1 (fr) * 1996-10-25 1998-05-07 Bionix Implants Oy Implant chirurgical
US5997568A (en) * 1996-01-19 1999-12-07 United States Surgical Corporation Absorbable polymer blends and surgical articles fabricated therefrom
US6165202A (en) * 1998-07-06 2000-12-26 United States Surgical Corporation Absorbable polymers and surgical articles fabricated therefrom
WO2005034726A2 (fr) * 2003-09-23 2005-04-21 Ortho Therapeutics, Llc Implants absorbables et leurs procedes d'utilisation pour une hemostase et pour traiter des defauts osseux
US7135025B2 (en) * 2002-04-22 2006-11-14 Inion Ltd. Surgical implant
CA2699660A1 (fr) * 2007-09-17 2009-03-26 Synergy Biosurgical Ag Implant medical ii

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4689424A (en) * 1981-08-06 1987-08-25 Ethicon, Inc. Radiation sterilizable absorbable polymeric materials and methods for manufacturing the same
JPS60100527A (ja) * 1983-11-04 1985-06-04 Haruyuki Kawahara 手術野組織・骨表面専用の印象材組成物
US5997568A (en) * 1996-01-19 1999-12-07 United States Surgical Corporation Absorbable polymer blends and surgical articles fabricated therefrom
WO1998018408A1 (fr) * 1996-10-25 1998-05-07 Bionix Implants Oy Implant chirurgical
US6165202A (en) * 1998-07-06 2000-12-26 United States Surgical Corporation Absorbable polymers and surgical articles fabricated therefrom
US7135025B2 (en) * 2002-04-22 2006-11-14 Inion Ltd. Surgical implant
WO2005034726A2 (fr) * 2003-09-23 2005-04-21 Ortho Therapeutics, Llc Implants absorbables et leurs procedes d'utilisation pour une hemostase et pour traiter des defauts osseux
CA2699660A1 (fr) * 2007-09-17 2009-03-26 Synergy Biosurgical Ag Implant medical ii

Also Published As

Publication number Publication date
BRPI1000625A2 (pt) 2011-11-01

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