Arthroscopic chondrocyte implantation method and device

• US 20060241568A1
• Filed: 02/05/2004
• Published: 10/26/2006
• Est. Priority Date: 02/12/2003
• Status: Abandoned Application

• Current Assignee: Advanced Surgical Design and Manufacture Limited
• Original Assignee: Advanced Surgical Design and Manufacture Limited
• Inventors: Roger, Gregory James
• Application Number:
  US10/545,225
• Publication Number:
  US 20060241568A1
• Time in Patent Office: Days
• US Class Current: 604/891.100
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/4618 of cartilage
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30233 Stepped cylinders, i.e. having discrete diameter changes
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30762 Means for culturing cartilage
• CPC Class Codes: A61F 2002/30764 Cartilage harvest sites
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/4627 with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 27/225 : Fibrin; Fibrinogen
• CPC Class Codes: A61L 27/3817 : Cartilage-forming cells, e.g. pre-chondrocytes
• CPC Class Codes: A61L 27/3843 : Connective tissue
• CPC Class Codes: A61L 27/3847 : Bones
• CPC Class Codes: A61L 31/005 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/046 : Fibrin; Fibrinogen

Abstract

A chondrocyte delivery device that has a main body (14) containing chondrocytes. The delivery device is at least partially insertable into a bone (18) of a patient and allowed or caused to elute the chondrocyte from the main body of the delivery device to damaged cartilage (17) in the region.

Claims

1. A chondrocyte delivery device comprising a main body containing a plurality of chondrocytes, said delivery device at least partially insertable into a bone of a patient.

2. The chondrocyte delivery device of claim 1 wherein the main body comprises an internal chamber to house the chondrocytes.

3. The chondrocyte delivery device of claim 2 wherein the main body has at least one open or openable end in fluid communication with the chamber.

4. The chondrocyte delivery device of claim 2 wherein the main body includes at least one aperture in a side wall, said at least one aperture in fluid communication with the chamber.

5. The chondrocyte delivery device of claim 4 wherein the at least one aperture is substantially sealed by a removable or biodegradable sealing member.

6. The chondrocyte delivery device of claim 2 wherein the main body has one or more additional chambers for storing bioactive substances.

7. The chondrocyte delivery device of any one of the preceding claims wherein the main body has a leading end and a trailing end wherein said leading end is tapered.

8. The chondrocyte delivery device of any one of the preceding claims, said delivery device insertable in a region of bone substantially adjacent a region of damaged or destroyed cartilaginous tissue.

9. The chondrocyte delivery device of any one of the preceding claims wherein the entire main body is implantable within a region of bone of a patient.

10. The chondrocyte delivery device of any one of the preceding claims wherein said device is insertable through a region of fibrous tissue adjacent said bone of the patient.

11. The chondrocyte delivery device of any one of claim 1 to 9 wherein the device is insertable through a structure comprising a fibrin mesh scaffold and said bone of the patient.

12. The chondrocyte delivery device of any one of the preceding claims wherein the main body further comprises an osmotic pump to pump the chondrocyte cells from the chamber following insertion into said bone.

13. The chondrocyte delivery device of any one of the preceding claims wherein the main body is formed from a biocompatible material including a biocompatible metal or metal alloy, including titanium.

14. The chondrocyte delivery device of any one of claims 1 to 12 wherein the main body is formed from a bioresorbable material including a material selected from the group comprising calcium phosphate, hydroxyapatite, and PLLA.

15. The chondrocyte delivery device of claim 7 wherein the trailing end of the delivery means or device has a fibrin cap.

16. The chondrocyte delivery device of any one of the preceding claims said device insertable in a region of bone of a knee joint of the patient.

17. A means for delivering a quantity of chondrocytes to a location within a patient, the delivery means being insertable into a bone of the patient, or a structure positioned therein, at or adjacent said location.

18. An apparatus for inserting a chondrocyte delivery device containing a quantity of chondrocytes into a bone of a patient, the apparatus comprising a syringe means having a needle adapted to contain the delivery device and insertable into the bone, and a plunger means adapted to expel the delivery device from the needle at a desired location in the bone.

19. The apparatus of claim 18 wherein the needle is formed of stainless steel and is suitable for insertion into the fibrous tissue and bone of the patient.

20. The apparatus of claim 18 or claim 19 wherein the needle has a leading tapered end to facilitate its insertion into a bone of the patient and wherein the diameter of the needle expands moving back along its length away from the leading tapered end.

21. The apparatus of any one of claims 18 to 20 wherein when in use, said needle forms a cavity in the bone, said cavity housing the chondrocyte delivery device.

22. A method of delivering chondrocyte cells to a location within a patient, the method comprising:

(i) inserting a chondrocyte delivery device comprising a main body containing a plurality of chondrocytes to said location; and

(ii) allowing or causing the chondrocyte cells to elute from the main body of the delivery device.

23. The method of claim 22 wherein the location comprises a region of damaged cartilage in a joint of the patient.

24. The method of claim 23 wherein the device is implanted into the bone substantially beneath or surrounding the region of damaged or destroyed cartilage.

25. The method of any one of claims 22 to 24 wherein the delivery device is inserted in an orientation that is substantially perpendicular to the surface of the bone and wherein the chondrocyte cells elute from an end of the device following insertion.

26. The method of any one of claims 22 to 24 wherein the device is inserted in an oblique orientation relative to the surface of the bone and wherein the chondrocyte cells elute from a fissure in at least a portion of the length of a sidewall of the main body.

27. The method of any one of claims 22 to 26 wherein the device is inserted as part of a mininally invasive procedure.

28. The method of claim 23 including a first step of harvesting chondral tissue from the region of damaged cartilage.

29. The method of claim 28 wherein chondrocyte cells are cultured from said chondral tissue for implantation into the patient.

30. The method of claim 28 wherein during the harvesting of the chondral tissue, the subchondral bone plate at the site of harvest is disrupted by a technique including drilling, abrasion, or microfracture.

31. The method of claim 30 wherein said disruption of the subchondral bone plate leads to the formation of fibrous tissue.

32. The method of claim 23 including the further step of inserting a fibrin mesh scaffold into the joint at the site of the damage to the cartilage.

33. The method of claim 32 wherein the scaffold is held in position with resorbable darts driven into the bone of the patient around the damaged cartilage.

34. A method of delivering chondrocyte cells to a location within a patient, the method comprising:

(i) inserting a delivery means containing a quantity of chondrocyte cells to said location; and

(ii) allowing or causing the chondrocyte cells to elute from the delivery means.

35. A method of forming fibrous tissue at a site of damaged cartilaginous tissue of a bone joint, the method comprising the steps of:

(i) violating the subchondral bone plate at said site using a technique selected from the group comprising drilling, abrasion, or microfracture;

said technique leading to local bleeding and transport of bone marrow cells into the bone and to subsequent formation of fibrous scar tissue; and

(ii) positioning a biocompatible mesh scaffold at said site;

wherein said scaffold raises the level of the resultant fibrous tissue to level or substantially level with the surrounding cartilage.

36. The method of claim 35 wherein step (i) comprises a technique of drilling.

37. The method of claim 35 wherein step (ii) is performed after said technique to violate the subchondral bone plate but prior to formation of the fibrous tissue.

38. A mesh scaffold for use in a process of fibrous scar formation at a site of damaged cartilaginous tissue of a bone joint.

39. The mesh scaffold of claim 38 said scaffold comprising a fibrin mesh scaffold.