Rotator cuff repair using engineered tissues

• US 6,755,863 B2
• Filed: 06/13/2002
• Issued: 06/29/2004
• Est. Priority Date: 10/08/1999
• Status: Expired due to Fees

• Current Assignee: Anova Corp.
• Original Assignee: Bret A. Ferree
• Inventors: Ferree, Bret A.
• Primary Examiner(s): Jackson, Suzette J.
• Application Number:
  US10/171,283
• Publication Number:
  US 20040093092A1
• Time in Patent Office: 747 Days
• Field of Search: 623/13.17, 623/19.11, 623/908, 623/915, 623/919, 623/17.11
• US Class Current: 623/19.11
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• 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 2002/30383 made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30584 filled with gas
• CPC Class Codes: A61F 2002/30828 parallel
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30879 Ribs
• CPC Class Codes: A61F 2002/4435 Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/4445 Means for culturing intervertebral disc tissue
• CPC Class Codes: A61F 2002/448 comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0015 Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/3633 : Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3662 : Ligaments, tendons
• CPC Class Codes: A61L 27/367 : Muscle tissue, e.g. sphincter
• CPC Class Codes: A61L 27/3804 : characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/386 : Ligaments, tendons
• CPC Class Codes: A61L 27/3873 : Muscle tissue, e.g. sphincter
• CPC Class Codes: Y10S 623/901 : Method of manufacturing prosthetic device
• CPC Class Codes: Y10S 623/915 : Method or apparatus for preparing biological material

Abstract

Living fibrocytes are combined with rotator cuff extracellular matrix obtained from recently deceased human or animal donors to eliminate pain in patients with tendonitis and other rotator cuff deficiencies. According to the method, fibrocytes from a living donor, preferably the patient, and rotator cuff tissue is harvested from a recently deceased human or animal donor in a manner which retains the extracellular matrix. The harvested cells are combined with the extracellular matrix to produce an engineered rotator cuff tissue, which is then transplanted into or onto a patient'"'"'s rotator cuff to be repaired. Additional therapeutic substances such as culture medium, growth factors, differentiation factors, hydrogels, polymers, antibiotics, anti-inflammatory medications, or immunosuppressive medications could be added to the transplanted annulus fibrosis tissue. In like fashion, the processes described herein may be used to repair or replace other tissues or organs of the body such as the pancreas, liver, kidney, heart, etc. Healthy live cells would be obtained thorough biopsy and tissue culture. The live cells would be added to the extracellular matrix of tissues or organs harvested to recently deceased human or animals.

Claims

1. A method of rotator cuff repair, comprising the steps of:

harvesting fibrocytes from a living donor;

harvesting rotator cuff tissue from a recently deceased human or animal donor, keeping the extracellular matrix intact;

combining the harvested fibrocytes with the extracellular matrix to produce engineered rotator cuff tissue; and

transplanting the engineered rotator cuff tissue into or onto a patient'"'"'s rotator cuff to be repaired.

2. The method of claim 1, further including the step of delivering the engineered rotator cuff tissue through a percutaneous or laparoscopic procedure.

3. The method of claim 1, further including the step of adding one or more therapeutic substances to the engineered rotator cuff tissue.

4. The method of claim 3, wherein the therapeutic substances include one or more of the following:

culture media, growth factors, differentiation factors, hydrogels, polymers, antibiotics, anti-inflammatory medications, or immunosuppressive medications.

5. The method of claim 1, further including the step of keeping the harvested fibrocytes viable until delivered.

6. An engineered rotator cuff according to the method of claim 1.

7. The engineered rotator cuff of claim 1, further including one or more therapeutic substances.

8. The engineered annulus fibrosis of claim 7, wherein the therapeutic substances include one or more of the following:

culture media, growth factors, differentiation factors, hydrogels, polymers, antibiotics, anti-inflammatory medications, or immunosuppressive medications.