CA2350638A1 - Biologically active implants coated with a biodegradable polymer - Google Patents

Biologically active implants coated with a biodegradable polymer Download PDF

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Publication number
CA2350638A1
CA2350638A1 CA002350638A CA2350638A CA2350638A1 CA 2350638 A1 CA2350638 A1 CA 2350638A1 CA 002350638 A CA002350638 A CA 002350638A CA 2350638 A CA2350638 A CA 2350638A CA 2350638 A1 CA2350638 A1 CA 2350638A1
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CA
Canada
Prior art keywords
implant
solvent
polymer
coating
dispersion
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.)
Granted
Application number
CA002350638A
Other languages
French (fr)
Other versions
CA2350638C (en
Inventor
Gerhard Schmidmaier
Michael Raschke
Axel Stemberger
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2350638A1 publication Critical patent/CA2350638A1/en
Application granted granted Critical
Publication of CA2350638C publication Critical patent/CA2350638C/en
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61L27/34—Macromolecular materials
    • 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
    • A61L31/00—Materials 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L31/00—Materials 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
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings

Abstract

The invention relates to an implant for providing pathological modifications on the spinal column and/or locomotor system. According to the invention, th e implant comprises an enamel-type coating which has a thickness of 100 .mu.m or less and which is made of a biodegradable polymer such as polyactide. This coating has an osteoinductive effect and thus an effect which promotes the healing of fractures. Additional osteoinductive materials such as growth factors can be incorporated in the coating. The invention also relates to a method for producing such an implant using the follow steps: Producing a dispersion of biodegradable polymers in an organic solvent; applying the dispersion to the surface to be coated; evaporating the solvent off.

Claims (26)

1. Implant serving to compensate for pathological changes in the spinal column and/or locomotor system, characterized in that it is provided with a varnish-like biodegradable polymer coating with a thickness of 100 µm or less, which varnish-like coating is producible by a method consisting of the following steps:
- Preparing a dispersion of the biodegradable polymer in an organic solvent;
- Applying the dispersion on the surface to be coated;
- Allowing the solvent to evaporate in a gaseous atmosphere, essentially saturated with solvent vapor.
2. Implant as in claim 1, characterized in that it is selected from the group comprised of fracture-fixation and endoprosthetic devices.
3. Implant as in claim 2, characterized in that the fracture-fixation device is selected from the group comprised of plates, screws, nails, pins, wires, threads or cages, used for the spinal column and locomotor system.
4. Implant as in one of the claims 1 to 3, characterized in that the varnish-like coating has a thickness of 50 µm or less, preferably 30 µm or less, and more desirably, 20 µm or less.
5. Implant as in claim 4, characterized in that the varnish-like coating has a thickness of 10 to 30 µm, and preferably 10 to 20 µm.
6. Implant as in one of the claims 1 to 5, characterized in that the polymer has a glass transition temperature of 37°C (98.6°F) or higher.
7. Implant as in one of the claims 1 to 6, characterized in that the mean molecular weight of the polymer is 100 kDa or less.
8. Implant as in one of the claims 1 to 7, characterized in that the polymer is selected from the group comprised of poly-.alpha. hydroxy acids, polyglycols, polytyrosine carbonates, starch, gelatins and cellulose as well as blends and interpolymers thereof.
9. Implant as in claim 8, characterized in that the polymer includes poly-.alpha. hydroxy acids selected from the group comprised of polylactides, polyglycol acids and interpolymers thereof.
10. Implant as in one of the claims 1 to 7, characterized in that the varnish-like coating contains pharmaceutically active additives.
11. Implant as in claim 10, characterized in that the pharmaceutically active additives include osteoinductive substances.
12. Implant as in claim 11, characterized in that the osteoinductive substance contains one or more growth factors.
13. Implant as in claim 12, characterized in that the growth-factor percentage of the total weight of the coating is 0.1 to 10% by weight, preferably 0.5 to 8%
by weight, and more desirably, 1 to 5% by weight.
14. Implant as in claim 12, characterized in that the growth factors are selected from the group comprised of IGF, TGF, FGF, EGF, BMP, as well as PDGF.
15. Implant as in claim 12, characterized in that the varnish-like coating contains IGF-I and/or TGF-.beta..
16. Implant as in claim 12, characterized in that the varnish-like coating contains a combination of IGF-I and TGF-.beta..
17. Method for producing an implant per one of the claims 1 to 16, consisting of the following steps:
- Preparing a dispersion of the biodegradable polymer in an organic solvent;
- Applying the dispersion on the surface to be coated;
- Allowing the solvent to evaporate in a gaseous atmosphere, essentially saturated with solvent vapor.
18. Method as in claim 17, whereby the application and evaporation processes take place at a temperature of between 0 and 30°C (32 - 86°F) and preferably at about 22°C (72°F).
19. Method as in claim 17 to 18, whereby the application of the dispersion and the evaporation of the solvent are repeated two or more times.
20. Method as in one of the claims 17 to 19, whereby the dispersion is a colloidal solution of the polymer in the solvent.
21. Method as in claim 20, whereby the colloidal solution is produced by allowing a mixture of polymer and solvent to stand for 1 minute to 24 hours, preferably 2 to 24 hours, preferably 3 to 12 hours, preferably 4 to 8 hours, and most preferably, for about 6 hours.
22. Method as in claim 20 or 21, whereby the colloidal solution is filtered prior to its application.
23. Method as in claim 22, whereby the colloidal solution is filtered through a micropore filter with a pore size of 0.45 µm or smaller.
24. Method as in one of the claims 17 to 23, whereby ethyl acetate or chloroform is used as the solvent.
25. Method as in one of the claims 17 to 24, whereby the dispersion contains 20 to 300, and preferably, 50 to 150 mg of polymer per ml of solvent.
26. Implant as in one of the claims 1 to 16, producible by a method per one of the claims 17 to 25.
CA002350638A 1998-09-11 1999-09-10 Biologically active implants coated with a biodegradable polymer Expired - Lifetime CA2350638C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19843251 1998-09-11
DE19843251.8 1998-09-11
PCT/EP1999/006708 WO2000015273A1 (en) 1998-09-11 1999-09-10 Biologically active implants

Publications (2)

Publication Number Publication Date
CA2350638A1 true CA2350638A1 (en) 2000-03-23
CA2350638C CA2350638C (en) 2009-11-24

Family

ID=7881711

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002350638A Expired - Lifetime CA2350638C (en) 1998-09-11 1999-09-10 Biologically active implants coated with a biodegradable polymer

Country Status (13)

Country Link
US (4) US6998134B2 (en)
EP (1) EP1112095B1 (en)
JP (2) JP4854114B2 (en)
AT (1) ATE228021T1 (en)
AU (1) AU5862199A (en)
CA (1) CA2350638C (en)
DE (1) DE59903490D1 (en)
DK (1) DK1112095T3 (en)
ES (1) ES2187195T3 (en)
PT (1) PT1112095E (en)
SI (1) SI1112095T1 (en)
WO (1) WO2000015273A1 (en)
ZA (1) ZA200102764B (en)

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