CA2347331A1 - Freeze-dried composite materials and processes for the production thereof - Google Patents

Freeze-dried composite materials and processes for the production thereof Download PDF

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Publication number
CA2347331A1
CA2347331A1 CA002347331A CA2347331A CA2347331A1 CA 2347331 A1 CA2347331 A1 CA 2347331A1 CA 002347331 A CA002347331 A CA 002347331A CA 2347331 A CA2347331 A CA 2347331A CA 2347331 A1 CA2347331 A1 CA 2347331A1
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CA
Canada
Prior art keywords
sponge
collagen
freeze
regenerated cellulose
oxidized regenerated
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
CA002347331A
Other languages
French (fr)
Other versions
CA2347331C (en
Inventor
Wil Harvey
Peter Van Leeuwen
Tom Hyland
Will Aitken
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.)
Johnson and Johnson Medical Ltd
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Johnson and Johnson Medical Ltd
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 Johnson and Johnson Medical Ltd filed Critical Johnson and Johnson Medical Ltd
Publication of CA2347331A1 publication Critical patent/CA2347331A1/en
Application granted granted Critical
Publication of CA2347331C publication Critical patent/CA2347331C/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
    • 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
    • A61L31/04—Macromolecular materials
    • A61L31/043—Proteins; Polypeptides; Degradation products thereof
    • A61L31/044—Collagen
    • 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
    • A61L31/04—Macromolecular materials
    • A61L31/042—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/91—Suction aspects of the dressing
    • A61M1/915—Constructional details of the pressure distribution manifold
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/02—Equipment for testing the apparatus

Abstract

The invention provides a sterile freeze-dried sponge, wherein at least 80% by weight of the sponge consists of collagen and oxidized regenerated cellulose in the weight ratio 60:40 to 40:60, wherein the sponge has a dry tensile strength of more than 3N and/or a wet tensile strength of more than 1 N. Preferably, the collagen has a degree of denaturation less than 20% and the sponge is substantially free of chemical cross-links. The invention also provides methods for the manufacture of sponges according to the invention

Claims (22)

1. A sterile freeze-dried sponge, wherein at least 80% by weight of the sponge consists of a mixture of collagen and oxidized regenerated cellulose in the weight ratio 60:40 to 40:60, and wherein the sponge has a dry tensile strength as herein defined of more than 3N.
2. A sterile freeze-dried sponge, wherein at least 80% by weight of the sponge consists of a mixture of collagen and oxidized regenerated cellulose in the weight ratio 60:40 to 40:60, wherein the sponge has a wet tensile strength as herein defined greater than 1 N.
3. A sterile freeze-dried sponge according to claim 1, wherein the sponge is substantially free of chemical cross-links.
4. A sterile freeze-dried sponge according to claim 1, wherein the collagen has a degree of denaturation less than 20%.
5. A sterile freeze-dried sponge according to claim 5, wherein the collagen has a degree of denaturation less than 10%.
6. A sterile freeze-dried sponge according to claim 4, wherein 80% of the oxidized regenerated cellulose fibers by volume are between 20µm and 1000µm in length.
7. A sterile freeze-dried sponge according to claim 6, wherein the mean length of the oxidized regenerated cellulose fibers is from 250 to 450µm.
8. A sterile freeze-dried sponge according to claim 1, wherein the oxidized regenerated cellulose is in the form of fibers, and at least 90% of the fibers by volume are less than 1 mm in length.
9. A sterile freeze-dried sponge according to claim 1, wherein the ratio of collagen to oxidized regenerated cellulose is from 50:50 to 55:45.
10. A sterile freeze-dried sponge according to claim 1, wherein the bioburden (TVC) of the sponge is less than 100 cfu/g, preferably less-than 10 cfu/g, more preferably less than 1 cfu/g.
11. A sterile freeze-dried sponge according to claim 1, wherein the sponge contains from 5 to 15% by weight of water.
12. A sterile freeze-dried sponge according to claim 1, wherein a layer of the sponge of thickness 3mm has an uncompressed absorption capacity of 0.9%
saline of from 15 to 20g/100cm2.
13. A sterile freeze-dried sponge according to claim 1, wherein the sponge has a resorption time under simulated physiological conditions of more than 48 hours.
14. A method of manufacture of a freeze-dried sponge pad comprising the steps of:
providing an acidified paste of purified collagen fibers, wherein the collagen is less than 10% denatured;
providing oxidized regenerated cellulose fibers, wherein at least 80% of said fibers have lengths in the range of 20µm to 1000µm;
combining said collagen and said ORC fibers in a homogeneous aqueous dispersion in a weight ratio of 60:40 to 40:60 collagen:ORC, said aqueous dispersion being acidified to a pH in the range of 2.8 to 3.2 and having a total solids concentration of 0.8 to 1.2% by weight;
pouring said aqueous dispersion into trays to a depth greater than 1 cm;
freezing the dispersion to a temperature below -30°C, followed by a temperature programmed freeze drying and dehydrothermal cross-linking to a final moisture content of 5-15% by weight;
splitting the freeze-dried dispersion to remove surface layers and leave one or more pads; and sterilizing the one or more pads by gamma-irradiation.
15. A method according to claim 14 carried out substantially without the use of any chemical cross-linking agents.
16. A method according to claim 14, wherein the step of providing collagen comprises the following steps:
providing fresh and unswollen splits of bovine corium;
treating the splits with a hypochloride solution to inhibit microbial activity;
treating the corium with a solution containing sodium hydroxide and hydrogen peroxide to swell and sterilize the corium; then treating the corium with a aqueous alkali solution at a pH greater than 12 and temperature less than 50°C for a period of ten-fourteen days; then treating the corium with a aqueous acid solution at a pH of 0.8-1.2 and temperature less than 50°C; then washing the corium, and comminuting the corium with sufficient water to form a paste.
17. A method according to claim 14, wherein the step of providing oxidized regenerated cellulose fibers comprising milling an oxidized regenerated cellulose cloth and screening the milled particles to remove particles having size less than 20µm or greater than 1000µm.
18. A method according to claim 14, wherein the step of dispersing the collagen and the ORC comprises the steps of:
adding an acid-swollen collagen/water paste to acidified water;
adding oxidized regenerated cellulose fibers to the acidified water; and homogenizing the resulting mixture.
19. A method according to claim 14, wherein the step of freezing is carried out by placing the trays containing the aqueous dispersion onto chilled shelves in a freezer followed by holding the trays at a temperature below -30°C
until the freezing is complete.
20. A method according to claim 14, wherein the step of freeze drying is carried out with dehydrothermal cross-linking.
21. A method according to claim 14, wherein the step of sterilizing is carried out by gamma-irradiation at a dose of 18-29 KGy.
22. A method according to claim 14, wherein the weight ratio of collagen to oxidized regenerated cellulose is from 50:50 to 55:45 and the pH of the aqueous dispersion is from 2.9 to 3.1.
CA2347331A 2000-05-12 2001-05-10 Freeze-dried composite materials and processes for the production thereof Expired - Lifetime CA2347331C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/570,105 2000-05-12
US09/570,105 US6309454B1 (en) 2000-05-12 2000-05-12 Freeze-dried composite materials and processes for the production thereof

Publications (2)

Publication Number Publication Date
CA2347331A1 true CA2347331A1 (en) 2001-11-12
CA2347331C CA2347331C (en) 2010-07-13

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2347331A Expired - Lifetime CA2347331C (en) 2000-05-12 2001-05-10 Freeze-dried composite materials and processes for the production thereof

Country Status (7)

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US (2) US6309454B1 (en)
EP (1) EP1153622B1 (en)
JP (1) JP4799758B2 (en)
AU (1) AU783184B2 (en)
CA (1) CA2347331C (en)
DE (1) DE60106322T2 (en)
GB (1) GB2362466B (en)

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JP2002058733A (en) 2002-02-26
EP1153622B1 (en) 2004-10-13
GB2362466B (en) 2003-10-08
AU4380601A (en) 2001-11-15
AU783184B2 (en) 2005-09-29
US6309454B1 (en) 2001-10-30
GB2362466A (en) 2001-11-21
US20010045177A1 (en) 2001-11-29
EP1153622A1 (en) 2001-11-14
DE60106322T2 (en) 2005-10-27
JP4799758B2 (en) 2011-10-26
CA2347331C (en) 2010-07-13
DE60106322D1 (en) 2004-11-18
GB0107400D0 (en) 2001-05-16

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