EP0282091A2
Expired / Lapsed
EP
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Medical device with heparin slow-release
Assignee: Baxter International Inc
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Filing: 1988-03-11
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Granted: —
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Expires: 2008-03-11
Abstract
Abstract Materials and devices useful in blood-contacting medical applications are prepared by embedding collagen on the surface and throughout the porous interior of a synthetic polymer, covalently binding protamine to the embedded collagen, then ionically binding heparin to the protamine. The materials, and devices fabricated therefrom, are biocompatible and have prolonged anticoagulative activity due to slow release of heparin therefrom.
Inventors
- 👤 Roger H. Tu
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-22 20:52
CPC Classifications
A; A61; A61L; A61L33/00; A61L33/0005; A61L33/0011; A61L33/0029
Claims Analysis
Total Claims: 33
Claim 1
Independent Claim
45 words
A material for use in blood-contacting medical applications, comprising a porous synthetic polymer having collagen embedded both on the surface and in the porous interior of said synthetic polymer, wherein protamine is covalently bound to said collagen, and heparin is ionically bound to said protamine.
Claim 2
Dependent Claim
45 words
A material for use in blood-contacting medical applications, comprising a porous synthetic polymer having collagen embedded both on the surface and in the porous interior of said synthetic polymer, wherein protamine is covalently bound to said collagen, and heparin is ionically bound to said protamine.
Claim 3
Dependent Claim
34 words
The material of claim 1, wherein said porous synthetic polymer has a degree of porosity sufficient to allow collagen to be embedded both on the surface and within the porous interior of said polymer.
Claim 4
Dependent Claim
19 words
The material of claim 2, wherein said synthetic polymer has a degree of porosity of about 50% or higher.
Claim 5
Dependent Claim
34 words
The material of claim 1, 2, or 3, wherein said porous synthetic polymer is selected from the group consisting of polyethylene terephthalates, polyurethanes, polyethylene, polypropylene, polystyrene, polyvinyl alcohol, polycarbonate, inert polyolefins, silicones and polytetrafluoroethylene.
Claim 6
Dependent Claim
19 words
The material of claim 1, wherein said collagen is tanned by treatment with a tanning agent under tanning conditions.
Claim 7
Dependent Claim
11 words
The material of claim 5, wherein said tanning agent is glutaraldehyde.
Claim 8
Dependent Claim
18 words
The material of claim 1, wherein said protamine is covalently bound to said collagen through a crosslinking agent.
Claim 9
Dependent Claim
11 words
The material of claim 7, wherein said crosslinking agent is glutaraldehyde.
Claim 10
Dependent Claim
18 words
A medical device having a blood-contacting application, wherein said device is fabricated from the material of claim 1.
Claim 11
Dependent Claim
37 words
The medical device of claim 9, wherein said device is selected from the group consisting of adhesion suppressants, prosthetic ligaments, tendons, and heart valves, blood oxygenator components, dialysis membranes, arterial filters, blood reservoirs, and blood storage containers.
Claim 12
Dependent Claim
15 words
The medical device of claim 9, wherein said device is in the form of tubing.
Claim 13
Dependent Claim
29 words
The medical device of claim 11, wherein said device is selected from the group consisting of vascular prostheses, catheters, and tubing which is part of a blood-contacting medical apparatus.
Claim 14
Independent Claim
45 words
A method for preparing materials useful in blood-contacting medical applications, comprising: a) embedding collagen both on the surface and within the porous interior of a porous synthetic polymer, b) covalently binding protamine to the embedded collagen, and then c) ionically binding heparin to the protamine.
Claim 15
Independent Claim
45 words
A method for preparing materials useful in blood-contacting medical applications, comprising: a) embedding collagen both on the surface and within the porous interior of a porous synthetic polymer, b) covalently binding protamine to the embedded collagen, and then c) ionically binding heparin to the protamine.
Claim 16
Dependent Claim
34 words
The method of claim 13, wherein said porous synthetic polymer has a degree of porosity sufficient to allow collagen to be embedded both on the surface and within said porous interior of said polymer.
Claim 17
Dependent Claim
19 words
The method of claim 14, wherein said synthetic polymer has a degree of porosity of about 50% or higher.
Claim 18
Dependent Claim
33 words
The method of claim 13, 14, or 15, wherein said porous synthetic polymer is selected from the group consisting of polyesters, polyurethanes, polyethylene, polypropylene, polystyrene, polyvinyl alcohol, polycarbonate, inert polyolefins, silicones and polytetrafluoroethylene.
Claim 19
Dependent Claim
15 words
The method of claim 16, wherein said polymer is a composite of silicone and polytetrafluoroethylene.
Claim 20
Dependent Claim
20 words
The method of claim 13, wherein said embedded collagen is tanned by treatment with a tanning agent under tanning conditions.
Claim 21
Dependent Claim
11 words
The method of claim 18, wherein said tanning agent is glutaraldehyde.
Claim 22
Dependent Claim
38 words
The method of claim 13, wherein said collagen is embedded by a method selected from the group consisting of soaking, spraying, coating and centrifugally forcing said collagen onto the surface and into the pores of said synthetic polymer.
Claim 23
Dependent Claim
53 words
The method of claim 13, wherein said synthetic polymer is in the form of a tube, and the collagen is embedded by filling the lumen of said tube with a solution comprising said collagen, then pressurizing said solution, thereby depositing collagen on the luminal surface and in the interior matrix of said polymer.
Claim 24
Dependent Claim
73 words
The method of claim 13, wherein said protamine is covalently bound to the embedded collagen by: (a) immersing the collagen-impregnated synthetic polymer in a solution containing protamine under conditions which allow deposition of protamine on the surface and in the porous interior of the synthetic polymer, then (b) contacting the synthetic polymer (having collagen and protamine embedded therein) with a crosslinking agent under conditions effective in crosslinking the protamine to the embedded collagen.
Claim 25
Dependent Claim
18 words
The method of claim 22, wherein said solution containing protamine comprises about 0.1 to about 5% (w/v) protamine.
Claim 26
Dependent Claim
38 words
The method of claim 23, wherein said synthetic polymer (having collagen embedded therein) is immersed in from about 10 mls to about 30 mls of said solution containing protamine per gram of embedded collagen, for about one hour.
Claim 27
Dependent Claim
21 words
The method of claim 22, wherein said crosslinking agent is selected from the group consisting of formaldehyde, dialdehyde starch or glutaraldehyde.
Claim 28
Dependent Claim
43 words
The method of claim 25, wherein said crosslinking agent is glutaraldehyde, and said synthetic polymer having collagen and protamine embedded therein is immersed in a solution comprising from about 0.2 to about 2% (w/v) glutaraldehyde for from about 1/2 to about 5 hours.
Claim 29
Dependent Claim
39 words
The method of claim 13, wherein heparin is ionically bound to the protamine by immersing said polymer (having said protamine covalently bound to the collagen embedded therein in a solution comprising from about 0.2 to about 5% (w/v) heparin.
Claim 30
Dependent Claim
21 words
The method of claim 27, wherein said polymer is immersed in the heparin solution for about 1 to about 30 hours.
Claim 31
Dependent Claim
27 words
The method of claim 27, wherein said polymer is immersed in from about 5 to about 20 mls of the heparin solution per 5 grams of polymer.
Claim 32
Dependent Claim
19 words
The method of claim 27, wherein the pH of the heparin solution is from about 2 to about 8.
Claim 33
Dependent Claim
38 words
The method of claim 27, wherein said polymer is immersed in about 10 mls per 5 grams of polymer of a solution comprising about 1% (w/v) heparin, and having a pH of about 6.5 for about 24 hours.
References Cited (Backward Citations)
No citation records indexed.
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