Biostable polyurethane products

a porous polyurethane and foam technology, applied in the field of biostable porous polyurethane foam implant material, can solve the problems of material ultimately affecting material and device integrity, polyether polyurethanes are not suitable candidates, and polyether polyurethanes are susceptible to phagocyte mediated environmental stress cracking, etc., and achieve the effect of strongly contributing to the hard phase stability

Inactive Publication Date: 2002-06-13
SALVIAC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

0119] The incorporation of isocyanurate linkages in the hard phase contributes strongly to stability of the hard phase. These cyclic structures are highly stable. The incorporation of isocyanurates into a soft tissue contacting material is a unique feature of the invention.
0120] The materials of this invention can be manufactured to indentation hardness which match the complia

Problems solved by technology

Known medical grade polyether polyurethane elastomers are susceptible to phagocyte mediated Environmental Stress Cracking (ESC).
Because of this known surface phenomenon such polyether polyu

Method used

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  • Biostable polyurethane products
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  • Biostable polyurethane products

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0122] For preparation of porous biostable polytetramethylene oxide polyurethane urea isocyanurate biomaterial, a polyol resin and an isocyanate pre-polymer were prepared. In the preparation of the polyol resin the following raw materials were added to a heated round bottom flask and mixed at 50-60.degree. C. for a minimum of 25-30 minutes.

3 Raw material Quantity (php) Terathane (MW 1000).sup.1 100 Triethanolamine.sup.2 4.6 Water.sup.2 2.56 1,4 Butanediol.sup.2 8.05 BF 2270.sup.3 1.0 RC Catalyst 105.sup.4 2.96 Desmorapid PP.sup.5 0.34 Kac / Deg.sup.6 0.73 .sup.1PTMEG (Du Pont), .sup.2Sigma Aldrich, .sup.3Th GoldSchmidt, .sup.4Triethylenediamine (Rhein Chemie), .sup.5Whitchem, .sup.6Potassium acetate (Sigma Aldrich)

[0123] An isocyanate pre-polymer with an NCO content of 15.6% was prepared by charging flake MDI (Desmodur 44M flakes from Bayer, MDI-2,4' isomer content of 1.37%) into a heated round bottom flask and allowing the flakes to melt. Upon complete melting of the MDI, the PTMEG (...

example 2

[0142] For preparation of porous biostable polytetramethylene oxide polyurethane urea isocyanurate biomaterial, a polyol resin and an isocyanate pre-polymer were prepared. The polyol is prepared per example 1 using the following chemicals

4 Raw material Quantity (php) Terathane (MW 1000).sup.1 100 Triethanolamine.sup.2 4.6 Water.sup.2 3.0 1,4 Butanediol.sup.2 8.0 BF 2270.sup.3 1.2 RC Catalyst 105.sup.4 0.52 DABCO BL11.sup.5 0.13 Kac / Deg.sup.6 0.73 .sup.1PTMEG (Du Pont), .sup.2Sigma Aldrich, .sup.3Th GoldSchmidt, .sup.4Triethylenediamine solution (Rhein Chemie), .sup.5Air Products, .sup.6Potassium acetate solution (Sigma Aldrich)

[0143] An isocyanate pre-polymer with a NCO content of 25.0% was prepared as per example 1 using PTMEG polyol (Terathane MW 650).

[0144] The polytetramethylene oxide polyurethane urea isocyanurate biomaterial was prepared per the method of example 1 at an isocyanate index of 1.13 with the exception that the combined shot size of the components was 1.3 g

[0145] R...

example 3

[0147] For preparation of a porous biostable polycarbonate polyurethane urea isocyanurate biomaterial, a polyol resin and an isocyanate pre-polymer were prepared.

[0148] The polyol is prepared per example 1 using the following chemicals.

5 Raw material Quantity (php) Polycarbonate CX 5510 (MW 1000).sup.1 100 Triethanolamine.sup.2 3.6 Water.sup.2 3.0 BF 2270.sup.3 1.2 RC Catalyst 105.sup.4 1.66 DABCO BL 11.sup.5 0.8 Kac / Deg.sup.6 0.73 .sup.1Nissei Chemical Company, Japan. .sup.2Sigma Aldrich .sup.3Th GoldSchmidt .sup.4Triethylene diamine solution (Rhein Chemie) .sup.5Air Products .sup.6Potassium acetate solution (Sigma Aldrich)

[0149] The isocyanate pre-polymer was prepared as per example 1 using polycarbonate CX 5510 (MW 1000) to produce a prepolymer with an isocyanate content of 15.6%

[0150] Polycarbonate CX5510 is a random co-polymer comprising hexamethylene carbonate and pentamethylene carbonate sequences of 1000MW.

[0151] The materials were mixed at an isocyanate index of 1.13 in an ...

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Abstract

A biostable porous polyether or polycarbonate polyurethane implant is manufactured from diphenyl methane diisocyanate, difunctional polytetramethylene ether glycol or a polycarbonate polyol, a trimerisation catalyst, a chain extender, water, a cross-linking agent, a blowing and/or gelling catalyst and a surfactant. The porous biomaterial has isocyanurate linkages and avoid content in excess of 85%. The implant may be used as an occluder or a tissue bridge.

Description

[0001] This invention relates to biostable biocompatible polyurethane implants suitable for short and long term implantation in vivo.[0002] Known medical grade polyether polyurethane elastomers are susceptible to phagocyte mediated Environmental Stress Cracking (ESC). Because of this known surface phenomenon such polyether polyurethanes are not suitable candidates to provide a foam implant. Conventional polyurethane foam structures have ether linkages which are subject to oxidation induced by an inflammatory response in vivo. This is the first stage in ESC which for foam materials ultimately represents a complete loss of material and device integrity.[0003] There is therefore a need for a polyurethane based foam implant material which will overcome these problems.[0004] In particular it is an object of the current invention to provide a new class of low density biostable polymers suitable for implantation.STATEMENTS OF INVENTION[0005] According to the invention there is provided a b...

Claims

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Application Information

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IPC IPC(8): A61L29/06A61L29/14A61L31/06A61L31/14C08G18/10C08G18/48C12M3/00C12N5/00
CPCA61L29/06A61L29/146C12N2533/30C12N2531/00C12N5/0068C08G2101/0083C08G2101/0008A61L31/06A61L31/146C08G18/10C08G18/48C08G2101/00C08L75/08C08G18/32C08G2110/0083C08G2110/0008
Inventor BRADY, EAMONCANNON, ANN MARIEFARRELL, FERGAL
Owner SALVIAC
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