CA2494295A1 - Biocompatible phase invertable proteinaceous compositions and methods for making and using the same - Google Patents

Biocompatible phase invertable proteinaceous compositions and methods for making and using the same Download PDF

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Publication number
CA2494295A1
CA2494295A1 CA002494295A CA2494295A CA2494295A1 CA 2494295 A1 CA2494295 A1 CA 2494295A1 CA 002494295 A CA002494295 A CA 002494295A CA 2494295 A CA2494295 A CA 2494295A CA 2494295 A1 CA2494295 A1 CA 2494295A1
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CA
Canada
Prior art keywords
phase invertable
composition according
phase
substrate further
invertable composition
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
CA002494295A
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French (fr)
Other versions
CA2494295C (en
Inventor
Kemal Schankereli
Ronald Dieck
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.)
Baxter International Inc
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Individual
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Filing date
Publication date
Priority claimed from US10/243,482 external-priority patent/US20040052850A1/en
Application filed by Individual filed Critical Individual
Publication of CA2494295A1 publication Critical patent/CA2494295A1/en
Application granted granted Critical
Publication of CA2494295C publication Critical patent/CA2494295C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09J—ADHESIVES; NON-MECHANICAL ASPECTS OF ADHESIVE PROCESSES IN GENERAL; ADHESIVE PROCESSES NOT PROVIDED FOR ELSEWHERE; USE OF MATERIALS AS ADHESIVES
    • C09J189/00—Adhesives based on proteins; Adhesives based on derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61L24/0021—Plasticisers
    • 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
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/10—Polypeptides; Proteins
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/044—Proteins; Polypeptides; Degradation products thereof
    • 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

Abstract

Biocompatible phase invertable proteinaceous compositions and methods for making and using the same are provided. The subject phase invertable compositions are prepared by combining a proteinaceous substrate and a cross-linker. The proteinaceous substrate includes one or more proteins and an adhesion modifier, and may also include one or more of: a pasticizer, a carbohydrate, or other modification agent. In certain embodiments, the cross-linker is a heat-treated dialdehyde, e.g., heat-treated glutaraldehyde. Also provided are kits for use in preparing the subject compositions. The subject compositions, kits and systems find use in a variety of different applications.

Claims (76)

1. ~A phase invertable composition produced by combining:
(a) ~a substrate comprising a proteinaceous material, and (b) ~a crosslinking agent.
2. ~The phase invertable composition according to Claim 1, wherein said proteinaceous material comprises one or more of: albumin, elastin, fibrin and soluble and insoluble forms of collagen and combinations thereof.
3. ~The phase invertable compostiion according to Claim 1, wherein said substrate further comprises an adhesion modifier.
4. ~The phase invertable composition according to Claim 3, wherein said adhesion modifier is chosen from polyethyleneimine, gelatin and carboxymethylcellulose.
5. ~The phase invertable composition according to Claim 1, wherein said substrate further comprises a plasticizer.
6. ~The phase invertable composition according to Claim 4, wherein the plasticizer is chosen from polyethylene glycol, glycerin, a fatty acid, butylhydroxytoluene, and combinations thereof.
7. ~The phase invertable composition according to Claim 1, wherein said substrate further comprises a carbohydrate.
8. ~The phase invertable composition according to Claim 1, wherein said substrate further comprises a filler.
9. ~The phase invertable composition according to Claim 1, wherein said substrate further comprises a polyblend.
10. The phase invertable composition according to Claim 1, wherein said substrate further comprises a biologically active agent.
11. The phase invertable composition according to Claim 1, wherein said substrate further comprises a foaming agent.
12. The phase invertable composition according to Claim 1, wherein said crosslinking agent comprises an aldehyde.
13. The phase invertable composition according to Claim 12, wherein said crosslinking agent comprises glutaraldehyde.
14. The phase invertable composition according to Claim 13, wherein said glutaraldehyde is heat stabilized.
15. A phase invertable composition produced by combining:
(a) a substrate comprising:
(i) a proteinaceous material, and (ii) an adhesion modifier; and (b) a crosslinking agent.
16. The phase invertable composition according to Claim 15, wherein said proteinaceous material comprises one or more of: albumin, elastin, fibrin and soluble and insoluble forms of collagen and combinations thereof.
17. The phase invertable composition according to Claim 15, wherein said substrate further comprises a plasticizer.
18. The phase invertable composition according to Claim 17, wherein the plasticizer is chosen from polyethylene glycol, glycerin, a fatty acid, butylhydroxytoluene, and combinations thereof.
19. The phase invertable composition according to Claim 15, wherein said adhesion modifier is chosen from polyethyleneimine, gelatin and carboxymethylcellulose.
20. The phase invertable composition according to Claim 15, wherein said substrate further comprises a carbohydrate.
21. The phase invertable composition according to Claim 15, wherein said substrate further comprises a filler.
22. The phase invertable composition according to Claim 15, wherein said substrate further comprises a polyblend.
23. The phase invertable composition according to Claim 15, wherein said substrate further comprises a biologically active agent.
24. The phase invertable composition according to Claim 15, wherein said substrate further comprises a foaming agent.
25. The phase invertable composition according to Claim 15, wherein said crosslinking agent comprises an aldehyde.
26. The phase invertable composition according to Claim 25, wherein said crosslinking agent comprises glutaraldehyde.
27. The phase invertable composition according to Claim 26, wherein said glutaraldehyde is heat stabilized.
28. A phase invertable composition produced by combining:
(a) a substrate comprising:
(i) a proteinaceous material;
(ii) an adhesion modifier; and (iii) a plasticizer; and (b) a crosslinking agent.
29. The phase invertable composition according to Claim 28, wherein said proteinaceous material comprises one or more of: albumin, elastin, fibrin and soluble and insoluble forms of collagen and combinations thereof.
30. The phase invertable composition according to Claim 28, wherein the plasticizer is chosen from polyethylene glycol, glycerin, a fatty acid, butylhydroxytoluene, and combinations thereof.
31. The phase invertable composition according to Claim 28, wherein said adhesion modifier is chosen from polyethyleneimine, gelatin and carboxymethylcellulose.
32. The phase invertable composition according to Claim 28, wherein said substrate further comprises a carbohydrate.
33. The phase invertable composition according to Claim 28, wherein said substrate further comprises a filler.
34. The phase invertable composition according to Claim 28, wherein said substrate further comprises a polyblend.
35. The phase invertable composition according to Claim 28, wherein said substrate further comprises a biologically active agent.
36. The phase invertable composition according to Claim 28, wherein said substrate further comprises a foaming agent.
37. The phase invertable composition according to Claim 28, wherein said crosslinking agent comprises an aldehyde.
38. The phase invertable composition according to Claim 37, wherein said crosslinking agent comprises glutaraldehyde.
39. The phase invertable composition according to Claim 38, wherein said glutaraldehyde is heat stabilized.
40. A method of producing a phase invertable composition, said method comprising: combining:
(a) a substrate comprising a proteinaceous material; and (b) a crosslinking agent;
to produce said phase invertable composition.
41. The method according to Claim 40, wherein said proteinaceous material comprises one or more of: albumin, elastin, fibrin and soluble and insoluble forms of collagen and combinations thereof.
42. The method according to Claim 40, wherein said substrate further comprises an adhesion modifier.
43. The method according to Claim 42, wherein said adhesion modifier is chosen from polyethyleneimine, gelatin and carboxymethylcellulose.
44. The method according to Claim 40, wherein said substrate further comprises a plasticizer.
45. The method according to Claim 44, wherein the plasticizer is chosen from polyethylene glycol, glycerin, a fatty acid, butylhydroxytoluene, and combinations thereof.
46. The method according to Claim 40, wherein said substrate further comprises a carbohydrate.
47. The method according to Claim 40, wherein said substrate further comprises a filler.
48. The method according to Claim 40, wherein said substrate further comprises a polyblend.
49. ~The method according to Claim 40, wherein said substrate further comprises a biologically active agent.
50. ~The method according to Claim 40, wherein said substrate further comprises a foaming agent.
51. ~The method according to Claim 40, wherein said crosslinking agent comprises an aldehyde.
52. ~The method according to Claim 51, wherein said crosslinking agent comprises glutaraldehyde.
53. ~The method according to Claim 52, wherein said glutaraldehyde is heat stabilized.
54. ~A solid phase composition produced by the method of Claim 40.
55. ~A method of placing a biocompatible composition to a site of a subject, said .
method comprising:
(a) preparing a phase invertable composition according to Claim 1; and (b) introducing said phase invertable composition to said site of said subject.
56. ~The method according to Claim 55, wherein said phase invertable composition is prepared at a site external to said subject.
57. ~The method according to Claim 55, wherein said phase invertable composition is prepared in situ at said site.
58. ~A method for producing a biocomposite structural member at a tubular site, said method comprising:

(a) positioning a distal end of a fluid composition delivery device comprising first and second occlusion members flanking an expandable mandrel at said tubular site;
(b) deploying said first and second occlusion members and expandable mandrel to produce a mold space at said tubular site and introducing into said mold space a phase invertable fluid composition according to Claim 1;
(c) allowing said fluid composition to undergo a phase inversion to a solid state; and (d) removing said fluid composition delivery device to produce said biocomposite structural member at said tubular site.
59. ~The method according to Claim 58, wherein said biocomposite structural member is a stent.
60. ~The method according to Claim 58, wherein said first and second occlusion members are balloons.
61. ~The method according to Claim 58, wherein said first and second occlusion members each deploy to produce a collar structure.
62. ~The method according to Claim 58, wherein said expandable mandrel expands as a function of said first and second occlusion members.
63. ~The method according to Claim 58, wherein said expandable mandrel expands as a function of said introduction of said fluid composition.
64. ~The method according to Claim 58, wherein said substrate and crosslinking agent of said phase invertable composition are combined to produce said phase invertable fluid composition at said distal end of said fluid composition delivery device.
65. ~The method according to Claim 58, wherein said substrate and crosslinking agent of said phase invertable composition are combined to produce said phase invertable fluid composition at a location upstream of said distal end of said fluid composition delivery device.
66. ~The method according to Claim 58, wherein said tubular site is a vascular site.
67. ~A device for producing a biocomposite structural member at a vascular site, said device comprising:
a fluid composition delivery element having a distal end comprising first and second occlusion members flanking;
(a) an expandable mandrel; and (b) a fluid composition delivery port;
wherein said expandable mandrel expands as a function of either:
(i) deployment of said first and second occlusion members; or (ii) introduction of a fluid composition.
68. ~The device according to Claim 67, wherein said first and second occlusion members are balloons.
69. ~The device according to Claim 67, wherein said first and second occlusion members each deploy to produce a collar structure.
70. ~The device according to Claim 67, wherein said expandable mandrel expands as a function of said first and second occlusion members.
71. ~The device according to Claim 67, wherein said expandable mandrel expands as a function. of introduction of a fluid composition.
72. ~The device according to Claim 67, wherein said device is a catheter device.
73. ~The device according to Claim 67, wherein said device further comprises a fluid removal port.
74. ~A kit for producing a phase invertable composition, said kit comprising:
(a) a substrate comprising a proteinaceous material;
(b) a crosslinking agent.
75. ~The kit according to Claim 74, wherein said kit further comprises a phase invertable fluid delivery device.
76. ~The kit according to Claim 75, wherein said phase invertable fluid delivery device is a device according to Claim 67.
CA2494295A 2002-08-06 2003-08-05 Biocompatible phase invertable proteinaceous compositions and methods for making and using the same Expired - Lifetime CA2494295C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US40128202P 2002-08-06 2002-08-06
US60/401,282 2002-08-06
US10/243,482 2002-09-13
US10/243,482 US20040052850A1 (en) 2002-09-13 2002-09-13 Proteinaceous hemostatic tissue sealant
PCT/US2003/024457 WO2004012678A2 (en) 2002-08-06 2003-08-05 Biocompatible phase invertable proteinaceous compostions and methods for making and using the same

Publications (2)

Publication Number Publication Date
CA2494295A1 true CA2494295A1 (en) 2004-02-12
CA2494295C CA2494295C (en) 2012-05-01

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Family Applications (1)

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CA2494295A Expired - Lifetime CA2494295C (en) 2002-08-06 2003-08-05 Biocompatible phase invertable proteinaceous compositions and methods for making and using the same

Country Status (7)

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US (2) US7303757B2 (en)
EP (4) EP1545411B1 (en)
JP (3) JP4966494B2 (en)
AU (1) AU2003257180A1 (en)
CA (1) CA2494295C (en)
ES (1) ES2703438T3 (en)
WO (1) WO2004012678A2 (en)

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CA2494295C (en) 2012-05-01
JP2014036878A (en) 2014-02-27
EP1545411B1 (en) 2018-09-26
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