Porous extracellular matrix scaffold and method

• US 8,025,896 B2
• Filed: 07/15/2002
• Issued: 09/27/2011
• Est. Priority Date: 07/16/2001
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Products Incorporated (Johnson & Johnson)
• Inventors: Plouhar, Pamela L., Pelo, Mark J., Schwartz, Herbert E., Malaviya, Prasanna
• Primary Examiner(s): DRISCOLL, LORA E BARNHART
• Application Number:
  US10/195,354
• Publication Number:
  US 20030044444A1
• Time in Patent Office: 3,361 Days
• Field of Search: 424/423, 424/426, 623/11.11
• US Class Current: 424/423
• CPC Class Codes: A61B 2017/0646 for insertion into cartillege, e.g. meniscus
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2/30749 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2002/30294 Conical or frustoconical body made by spirally rolling up a sheet or a strip around itself
• CPC Class Codes: A61F 2002/30751 for attaching cartilage scaffolds to underlying bone
• CPC Class Codes: A61F 2002/30766 Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61L 2430/06 for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: A61L 27/3654 Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61L 27/3847 Bones
• CPC Class Codes: A61L 27/3852 Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof

Abstract

A method of making an implantable scaffold for repairing damaged or diseased tissue includes the step of suspending pieces of an extracellular matrix material in a liquid. The extracellular matrix material and the liquid are formed into a mass. The liquid is subsequently driven off so as to form interstices in the mass. Porous implantable scaffolds fabricated by such a method are also disclosed.

Claims

1. A method of making an implantable scaffold for repairing or regenerating body tissue, the method comprising the steps of:

cutting naturally occurring extracellular matrix material in the presence of a liquid to produce a cohesive mass of intertwined strips, ribbons, or fibers; and

freeze drying the cohesive mass to form a porous structure.

2. The method of claim 1, further comprising the step of freezing the cohesive mass to form a frozen composition, said frozen composition comprising ice crystals, the freezing step being performed prior to the freeze drying step.

3. The method of claim 1, wherein the extracellular matrix material comprises material selected from the group consisting of:

small intestine submucosa, bladder submucosa, stomach submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane.

4. The method of claim 1, further comprising the step of flashfreezing the cohesive mass prior to the freeze drying step.

5. The method of claim 1, further comprising the step of compacting the cohesive mass prior to the freeze drying step.

6. The method of claim 1, further comprising the step of centrifuging the cohesive mass prior to the freeze drying step.

7. The method of claim 1, further comprising the step of freezing the cohesive mass at a controlled rate of temperature drop.

8. A method of making an implantable scaffold for repairing or regenerating body tissue, the method comprising the steps of:

providing a naturally occurring extracellular matrix material selected from the group consisting of;

small intestine submucosa, stomach submucosa, bladder submucosa, respiratory submucosa, alimentary submucosa, genital submucosa, and liver basement membrane;

cutting the naturally occurring extracellular matrix material in the presence of a liquid to produce a cohesive mass of intertwined strips, ribbons, or fibers; and

freeze drying the cohesive mass to form a porous structure.

9. A method of making an implantable scaffold for repairing or regenerating body tissue, the method comprising the steps of:

cutting naturally occurring extracellular matrix material in the presence of a liquid to produce a cohesive mass of intertwined strips, ribbons, or fibers,

freezing the cohesive mass at a controlled rate of temperature drop, and

freeze drying the cohesive mass to form a porous structure,

wherein the cohesive mass is frozen by reducing the temperature of the naturally occurring extracellular matrix at a rate of −

1°

C./min or less.

10. A method of making an implantable scaffold for repairing or regenerating body tissue, the method comprising the steps of:

cutting naturally occurring extracellular matrix material in the presence of a liquid to produce a cohesive mass of intertwined strips, ribbons, or fibers,

freezing the cohesive mass at a controlled rate of temperature drop, and

freeze drying the cohesive mass to form a porous structure,

wherein the cohesive mass is frozen by reducing the temperature of the naturally occurring extracellular matrix at a rate of greater than −

1°

C./min.