CA2480839A1 - Bone graft substitute composition - Google Patents

Bone graft substitute composition Download PDF

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Publication number
CA2480839A1
CA2480839A1 CA002480839A CA2480839A CA2480839A1 CA 2480839 A1 CA2480839 A1 CA 2480839A1 CA 002480839 A CA002480839 A CA 002480839A CA 2480839 A CA2480839 A CA 2480839A CA 2480839 A1 CA2480839 A1 CA 2480839A1
Authority
CA
Canada
Prior art keywords
calcium sulfate
composition
kit
binder
stearic acid
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
CA002480839A
Other languages
French (fr)
Other versions
CA2480839C (en
Inventor
Jantzen Cole
Timothy Smith
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.)
Wright Medical Technology Inc
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA2480839A1 publication Critical patent/CA2480839A1/en
Application granted granted Critical
Publication of CA2480839C publication Critical patent/CA2480839C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

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
    • A61L27/02—Inorganic materials
    • A61L27/025—Other specific inorganic materials not covered by A61L27/04 - A61L27/12
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/02—Surgical adhesives or cements; Adhesives for colostomy devices containing inorganic 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/505—Stabilizers
    • 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
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/06—Flowable or injectable implant compositions
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Abstract

A composition includes calcium sulfate hemihydrate, stearic acid, an accelerant, and a mixing solution. The composition can be injected, e.g., through a needle, and is capable of setting, e.g., in vivo, in a relatively short period of time to a relatively high hardness.

Claims (20)

1. A kit, comprising:
a mixture comprising calcium sulfate hemihydrate, calcium sulfate dehydrate, and a binder; and an aqueous mixing solution.
2. The kit of claim 1, wherein the binder comprises stearic acid.
3. The kit of claim 1, wherein the binder comprises a material selected from the group consisting of hydroxypropylmethylcellulose, hydroxymethylcellulose, and hyaluronic acid.
4. The kit of claim 1, wherein the mixture comprises >95 wt % of calcium sulfate hemihydrate;
about 0.1 to about 0.5 wt % of calcium sulfate dehydrate; and about 1.5 to about 2 wt % of the binder.
5. The kit of claim 1, wherein the saline solution comprises sodium chloride.
6. The kit of claim 1, wherein the calcium sulfate dehydrate comprises sucrose.
7. A kit, comprising:
a mixture comprising calcium sulfate hemihydrate, a first material selected from the group consisting of potassium sulfate and sodium sulfate, and a binder; and an aqueous mixing solution.
8. The kit of claim 7, wherein the binder comprises stearic acid.
9. The kit of claim 7, wherein the binder comprises a material selected from the group consisting of hydroxypropylmethylcellulose, hydroxymethylcellulose, and hyaluronic acid.
10. The kit of claim 7, wherein the mixture comprises >95 wt % of calcium sulfate hemihydrate;
about 0.1 to about 0.5 wt % of the first material; and about 1.5 to about 2 wt % of the binder.
11. The kit of claim 7, wherein the saline solution comprises sodium chloride.
12. A composition, comprising:
calcium sulfate hemihydrate;
calcium sulfate dihydrate;
stearic acid; and a mixing solution, wherein the composition is capable of hardening to about 4 MPa within about 10 minutes.
13. The composition of claim 12, wherein the composition is injectable.
14. The composition of claim 13, wherein the composition is injectable through a 6 cm long, 11-gauge needle.
15. The composition of claim 12, comprising:
>95 wt % of calcium sulfate hemihydrate;
about 0.1 to about 0.5 wt % of calcium sulfate dihydrate; and about 1.5 to about 2 wt % of stearic acid.
16. A composition, consisting essentially of:
calcium sulfate hemihydrate;

calcium sulfate dehydrate;
a binder; and a mixing solution.
17. The composition of claim 16, wherein the binder includes stearic acid.
18. The composition of claim 17, consisting essentially of:
>95 wt % of calcium sulfate hemihydrate;
about 0.1 to about 0.5 wt % of calcium sulfate dehydrate; and about 1.5 to about 2 wt % of stearic acid.
19. A method, comprising:
providing a mixture comprising:
>95 wt % of calcium sulfate hemihydrate;
about 0.1 to about 0.5 wt % of calcium sulfate dehydrate; and about 1.5 to about 2 wt % of stearic acid; and contacting the mixture with a saline solution to form a composition.
20. The method of claim 19, further comprising injecting the composition through a needle.
CA2480839A 2002-03-29 2003-03-28 Bone graft substitute composition Expired - Lifetime CA2480839C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US36892402P 2002-03-29 2002-03-29
US60/368,924 2002-03-29
PCT/US2003/009715 WO2003082158A1 (en) 2002-03-29 2003-03-28 Bone graft substitute composition

Publications (2)

Publication Number Publication Date
CA2480839A1 true CA2480839A1 (en) 2003-10-09
CA2480839C CA2480839C (en) 2011-01-04

Family

ID=28675555

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2480839A Expired - Lifetime CA2480839C (en) 2002-03-29 2003-03-28 Bone graft substitute composition

Country Status (7)

Country Link
US (3) US7211266B2 (en)
EP (1) EP1489998B1 (en)
AT (1) ATE490745T1 (en)
AU (1) AU2003258172B2 (en)
CA (1) CA2480839C (en)
DE (1) DE60335248D1 (en)
WO (1) WO2003082158A1 (en)

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Also Published As

Publication number Publication date
AU2003258172B2 (en) 2008-02-28
US20030185903A1 (en) 2003-10-02
US8968465B2 (en) 2015-03-03
US7211266B2 (en) 2007-05-01
AU2003258172A1 (en) 2003-10-13
DE60335248D1 (en) 2011-01-20
CA2480839C (en) 2011-01-04
EP1489998A1 (en) 2004-12-29
EP1489998B1 (en) 2010-12-08
ATE490745T1 (en) 2010-12-15
US8657952B2 (en) 2014-02-25
WO2003082158A8 (en) 2004-04-22
WO2003082158A1 (en) 2003-10-09
EP1489998A4 (en) 2008-08-06
US20140134227A1 (en) 2014-05-15
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