Biocompatible composite material

• US 5,522,896 A
• Filed: 04/01/1994
• Issued: 06/04/1996
• Est. Priority Date: 02/15/1989
• Status: Expired due to Term

• Current Assignee: Xomed Surgical Products, Inc. (Medtronic Plc)
• Original Assignee: Xomed Inc. (Medtronic Plc)
• Inventors: Prescott, Anthony D.
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/222,313
• Time in Patent Office: 795 Days
• Field of Search: 623/7, 623/8, 623/11, 623/16, 623/17, 623/18, 433/212.1
• US Class Current: 623/23.56
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2090/0816 for preventing adhesion
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2/18 Internal ear or nose parts, e.g. ear-drums implants for middle ear ventilation or drainage A61F11/202
• CPC Class Codes: A61F 2/186 Nose parts
• CPC Class Codes: A61F 2/30728 Collars; Bone edge protectors A61F2/30734 takes precedence; sealing collars for use during cementing A61B17/8808
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/4241 for hands, e.g. fingers
• CPC Class Codes: A61F 2002/183 Ear parts
• CPC Class Codes: A61F 2002/2807 Chin implants
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30331 made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30574 with an integral complete or partial collar or flange
• CPC Class Codes: A61F 2002/30731 Bone edge protectors
• CPC Class Codes: A61F 2002/30878 with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/4251 : for metacarpo-phalangeal joints, i.e. MCP or MP joints, e.g. knuckle joints
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61L 27/44 : having a macromolecular matrix
• CPC Class Codes: A61L 27/46 : with phosphorus-containing inorganic fillers

Abstract

A non-percutaneous prosthesis, reconstructive sheeting and composite material which exhibit excellent tissue adhesion, outstanding biocompatibility, moldability, trimability and flexibility are disclosed. The non-percutaneous prosthesis, reconstructive sheeting and composite material can be easily molded into various shapes, trimmed with a scalpel and deformed during prosthetic positioning. The non-percutaneous prothesis comprises a biocompatible composite material which is made of an elastomeric material and bio-active ceramic or glass particles and has a predetermined shape. The bio-active ceramic or glass particles are dispersed throughout a matrix of the elastomeric material having a predetermined shape, or the elastomeric material is formed to the predetermined shape and the bio-active ceramic or glass particles are coated on a surface of the elastomeric material. In another embodiment, the non-percutaneous prosthesis comprises a base material of predetermined shape and a layer of elastomeric material provided on the base material, wherein a layer of elastomeric material has distributed therein or provided thereon bio-active ceramic or glass particles. The elastomeric material is preferably one of silicone, polyurethane and its derivatives, hydrogel and C-Flex® and, more preferably, is silicone or hydrogel. The bio-active ceramic or glass particles are preferably made of hydroxylapatite. The reconstructive sheeting comprises a biocompatible composite material made of an elastomeric material and bio-active ceramic or glass particles. Also, the present invention provides a biocompatible composite material comprising hydrogel and particles of a bio-active ceramic or glass material. The particles are preferably dispersed throughout a matrix of hydrogel.

Claims

1. A non-porous, non-resorbable synthetic flexible prosthesis for replacement of a soft tissue structure, said prosthesis adapted for connection to soft tissue in the human body, said prosthesis consisting of:

an elastomeric synthetic hydrogel matrix;

a plurality of hydroxylapatite particles distributed throughout said matrix with said hydroxylapatite particles less than 87% by weight and more than 40% by weight of said matrix; and

said matrix cured to form said flexible prosthesis such that an applied force can distort said flexible prosthesis and said flexible prosthesis will substantially return to its original shape after said force is removed.

2. A non-porous, non-resorbable prosthesis according to claim 1, wherein said particles have a particle size in the range of 2 to 500 microns and comprise less than 72% by weight of said matrix.

3. A non-resorbable flexible prosthesis having a shape, comprising:

a matrix of a non-resorbable synthetic hydrogel;

a plurality of bioceramic particles dispersed throughout said matrix with said bioceramic particles less than 87% by weight and more than 25% by weight of said matrix; and

wherein said matrix is cured such that an applied force can distort said prosthesis from said shape, and said prosthesis will substantially return to said shape after said force is removed.

4. A non-resorbable prosthesis according to claim 3, wherein said bioceramic particles have a particle size in the range of 2 to 500 microns and comprise more than 40% weight of said matrix.

5. A non-resorbable prosthesis according to claim 3, wherein said bioceramic particles comprise hydroxylapatite.

6. A non-resorbable prosthesis according to claim 3, wherein said prosthesis has a shape adaptable to augment or replace a human breast.

7. A non-resorbable prosthesis according to claim 3, wherein said prosthesis has a shape adaptable to augment or replace a human chin.

8. The prosthesis of claim 3, wherein said non-resorbable synthetic hydrogel comprises a polyvinyl pyrrolidone hydrogel.

9. The prosthesis of claim 3 wherein said bioceramic particles comprise hydroxylapatite.

10. A non-resorbable flexible prosthesis comprising:

a matrix of an elastomeric material selected from the group consisting of polyhema, styrene-ethylene-butylene-syrene (SEBS) modified polymer, and silicone; and

a plurality of bioceramic particles dispersed throughout said matrix with said bioceramic particles less than 87% by weight and more than 25% by weight of said matrix, wherein said matrix is cured to form said flexible prosthesis such that an applied force can distort said flexible prosthesis from its original shape and said flexible prosthesis will substantially return to said original shape when said force is removed.

11. The prosthesis of claim 10 wherein said bioceramic particles comprise hydroxylapatite.