Prosthesis with improved biocompatibility

• US 5,116,371 A
• Filed: 07/06/1990
• Issued: 05/26/1992
• Est. Priority Date: 07/06/1990
• Status: Expired due to Term

• Current Assignee: Cystomedix, Inc.
• Original Assignee: James M. Christensen, Parviz R. Ainpour
• Inventors: Christensen, James M., Ainpour, Parviz R.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): GUALTIERI, GINA
• Application Number:
  US07/549,096
• Time in Patent Office: 690 Days
• Field of Search: 623/8, 623/11, 623/66
• US Class Current: 623/23.67
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/28 Materials for coating prostheses
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 33/00 Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and only one being terminated by only one carboxyl radical, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 33/20 Homopolymers or copolymers of acrylonitrile C08L55/02 takes precedence
• CPC Class Codes: C08L 39/00 Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

An implantable prosthesis comprises a hydrogel enclosed within a flexible envelope. The hydrogel contains both hydrophilic and hydrophobic domains. It is prepared by copolymerizing a hydrophilic monomer such as water soluble N-vinylpyrrolidone, acrylates or methacrylates with non-water soluble monomers such as acrylates, methacrylates, N-vinyl carbazole, its derivatives, or a non-water soluble derivative of N-vinylpyrrolidone. The flexible envelope may be either porous or non-porous. The hydrogel may be either solid or composed of particles of a size greater than the porosity of the envelope.

Claims

1. A surgically implantable prosthesis comprising at least an outer flexible envelope having enclosed therein a hydrogel having both hydrophobic and hydrophilic regions wherein the improvement consists of hydrophobic regions selected from the group consisting of polymerized N-vinylic hydrophobic monomers, hydrolyzed polyacrylonitriles, and combinations thereof.

2. The prosthesis of claim 1 wherein the hydrophobic regions of the hydrogel are held together with hydrophobic, ionic, dipolar, hydrogen bonding or a combination of these forces.

3. The prosthesis of claim 1 wherein at least the outer envelope is constructed of a non-porous material.

4. The prosthesis of claim 3 wherein the hydrogel filling is a blend of hydrogel particles dispersed in a liquid carrier.

5. The prosthesis of claim 1 wherein at least the outer envelope is constructed of a porous or semi-permeable material.

6. The prosthesis of claim 5 wherein the porosity of the outer envelope is designed to allow fluid interchange without large molecule or cellular infiltration.

7. The prosthesis of claim 5 wherein the outer envelope is designed to allow a controlled amount of tissue ingrowth and capsule formation.

8. The prosthesis of claim 5 wherein the outer envelope is constructed of a woven, knitted, felted, veloured, or foamed fabric.

9. The prosthesis of claim 5 wherein the outer envelope is constructed of a stretched or expanded material to create porosity or permeability.

10. The prosthesis of claim 1 further comprising an inner envelope enclosed within the outer envelope wherein at least the space between the inner and outer envelopes is filled with the hydrogel.

11. The prosthesis of claim 5 wherein the hydrogel filling is composed of particles having a size larger than the porosity of the outer envelope.

12. The prosthesis of claim 1 wherein the hydrogel is prepared by the copolymerization of a hydrophilic monomer with a N-vinylic hydrophobic monomer.

13. The prosthesis of claim 1 for use in augmenting or replacing breast tissue.

14. A surgically implantable prosthesis comprising at least an outer flexible envelope having enclosed therein a hydrogel having both hydrophobic and hydrophilic regions wherein the hydrogel is prepared by the copolymerization of a hydrophilic monomer with a N-vinylic hydrophobic monomer.

15. The prosthesis of claim 14 wherein the hydrophilic monomer is a water soluble vinylic compound of the formula ##STR5## wherein R is H or CH₃,

R'"'"' is CH₂ --CH₂ --OH, CH₂ --CH(CH₃)--OH, or CH₃ --CH(OH)--CH₂ --OH and

R" and R"'"'"' are H, CH₃, C₂ H₅, or CH₂ --CH(OH)--CH₃

and the hydrophobic monomer is a non-water soluble compound of the formula

16. A surgically implantable prosthesis comprising at least one flexible envelope having enclosed therein a hydrogel wherein the hydrogel comprises a hydrolyzed polyacrylonitrile having both carboxylic or amide groups and nitrile groups.