Method and apparatus for diodegradable, osteogenic, bone graft substitute device

• US 5,133,755 A
• Filed: 06/21/1990
• Issued: 07/28/1992
• Est. Priority Date: 01/28/1986
• Status: Expired due to Term

• Current Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Original Assignee: THM Biomedical, Inc. (DSM-Firmenich AG)
• Inventors: Brekke, John H.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US07/541,627
• Time in Patent Office: 768 Days
• Field of Search: 623/16, 623/18, 623/11, 623/1, 623/66, 623/22, 623/23
• US Class Current: 623/23.51
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3601 for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices non-prosthetic internal fixation devices for the femoral head or neck A61B17/74
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30261 parallelepipedal
• CPC Class Codes: A61F 2002/30461 sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/4649 Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0082 parallelepipedal
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 27/36 containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: A61L 27/48 : with macromolecular fillers
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Device and method for treating mammalian bone deficiencies, defects, voids and conformational discontinuities produced by congenital deformities, osseous and/or soft tissue pathology, traumatic injuries and functional atrophy is described. The device is a one piece molded body member composed of four substances, each of which contributes to the device, a specific requirement (or requirements) for osteogenesis and/or osteoneogenesis. Taken as a whole, the functions of these device constituents are integrated into a single body member which, when implanted into a bone defect, has the capacity to restore functional architecture and mechanical integrity, initiate osteoinduction and osteogenesis, and maintain the biological processes of bone formation and remodeling while the host organism is simultaneously biodegrading the body member. The ultimate result of the functioning is formation of healthy, viable bone tissue where there was not bone before, while, simultaneously, the entire device is hydrolyzed and completely metabolized by the host organism. The device comprises four disparate elements: polylactic acid, hyaluronic acid bone morphogenetic protein and bone derived growth factor. Working together, these elements provide the following five biological functions prerequisite to the processes of osteoneogenesis: structural competence (polylactic acid), chemotaxis (hyaluronic acid), electronegative field (hyaluronic acid and physical-chemical electrokinetic events), osteoinduction (bone morphogenetic protein), and osteogenesis (bone derived growth factor).

Claims

1. A composition comprising a functional juxtaposition of a biodegradable polymer and a chemotactic ground substance fabricated together in such a manner as to produce a biodegradable and biologically inductive surgical implant which performs to restore a tissue void to its normal gross morphology, structural architecture, mechanical competence, biologic and physiologic activities, cell populations and biochemical functions, with the biodegradable polymer arranged as a gross structure with interconnecting voids, generally with each void communicating with all the others and with substantially the entire exterior of the gross structure, with the chemotactic ground substance located in the voids and carried by and seperate from the biodegradable polymer forming the gross structure.

2. The composition of claim 1 in which the chemotactic ground substance is selected from the group of:

a. a solid sheet adhered to the preformed partitions of the biodegradable polymer;

b. an open laced network of strands adhered to the preformed biodegradable polymer partitions;

c. a velour, felting or loosely woven sheet adhered to the preformed biodegradable polymer partitions;

or,

d. an open cell meshwork mass that is carried within the voids of the gross structure and is only incidentally adhered to the preformed biodegradable polymer partitions.

3. The composition of claim 1 further comprising at least one biological modifier incorporated into the implant selected from the group of:

a. joined to the surface of the biodegradable polymer partitions;

b. joined to the chemotactic ground substance;

c. located between the biodegradable polymer and the chemotactic ground substance at the interface of these components;

or,

d. carried within the chemotactic ground substance.

4. The composition of claim 1 in which the biodegradable polymer is synthesized either as a homogeneous polymer or as a co-polymer of at least two alphahydroxy acids.

5. The composition of claim 4 wherein said biodegradable polymer is selected from the group of D,L-polylactic acid, L-polylactic acid, glycolic acid or co-polymers thereof.

6. The composition of claim 1 in which the chemotactic ground substance microstructure is selected from the group of glycosamino glycans, glycoproteins, lamin or type IV collagen.

7. The composition of claim 3 in which the biological modifier is osteoinductive/osteogenic agents selected from the group of bone morphogenetic proteins or bone derived growth factor.

8. The composition of claim 1 wherein the biodegradable polymer is preformed into the gross structure prior to the introduction of the chemotactic ground substance.

9. The composition of claim 8 wherein the chemotactic ground substance is selected from the group of a velour, felting or loosely woven sheet prior to its introduction into the gross structure, with the velour, felting, or loosely woven sheet adhered to the preformed gross structure of the biodegradable polymer within the voids of the gross structure.

10. The composition of claim 8 wherein the voids are randomly shaped, sized and positioned in the gross structure, with the voids being formed by incomplete partitions of the biodegradable polymer.