Device and method for treating conditions of a joint

• US 20050031665A1
• Filed: 06/23/2004
• Published: 02/10/2005
• Est. Priority Date: 11/03/2000
• Status: Abandoned Application

• Current Assignee: Control Delivery Systems Inc. (EyePoint Pharmaceuticals, Inc.)
• Original Assignee: Control Delivery Systems Inc. (EyePoint Pharmaceuticals, Inc.)
• Inventors: Laporte, Richard, Smith, Thomas J., Ashton, Paul, Chen, Jianbing, Watson, David A.
• Application Number:
  US10/875,055
• Publication Number:
  US 20050031665A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/82 for bone cerclage apparatus for manipulating wires or straps A61B17/8861; wires, bands or straps other than cerclage A61B17/842
• CPC Class Codes: A61B 17/8615 at the central region of the screw head
• CPC Class Codes: A61B 17/8877 characterised by the cross-section of the driver bit
• CPC Class Codes: A61B 17/8886 holding the screw head
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00429 with a roughened portion
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• CPC Class Codes: A61F 2002/30673 Lubricating means, e.g. synovial pocket
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• 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 2300/222 Steroids, e.g. corticosteroids
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2210/02 : Bones
• CPC Class Codes: A61M 31/002 : Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61P 19/02 : for joint disorders, e.g. arthritis, arthrosis

Abstract

A therapeutically effective compound is locally administered by associating the compound with a piece of orthopedic hardware that is implanted at an appropriate site within a body. The compound is adapted, such as through a sustained release device, to administer an effective dosage continuously over an extended period of time. The compound may be administered, for example, to a joint of a mammal by intraarticularly implanting a sustained release device to deliver the therapeutically effective compound within a synovial capsule of the joint, such that synovial fluid concentration of the compound is greater than plasma concentration of the compound. A wide range of orthopedic hardware, such as bone screws and staples, may be adapted to use in the systems described herein to provide treatment for a variety of medical conditions.

Claims

1. A system comprising:

an orthopedic hardware component attachable to a portion of a body; and

a sustained release device associated with the orthopedic hardware component, the sustained release device configured to release a compound having a therapeutic effect over an extended period of time.

2. The system of claim 1 wherein the orthopedic hardware component is a bone screw.

3. The system of claim 2 wherein the bone screw includes a head, the sustained release device being formed in a chamber in the head.

4. The system of claim 2 wherein the bone screw is at least one of a cannulated bone screw and an interference bone screw.

5. The system of claim 1 wherein the orthopedic hardware component is at least one of a staple, a tack, a dart, a screw, a bolt, a washer, a plate, a prosthetic joint, a component of a prosthetic joint, an anchor, a pin, a wire, or a button.

6. The system of claim 1 wherein the orthopedic hardware component is substantially rigid and is configured for at least partial insertion into a bone.

7. The system of claim 1 wherein the sustained release device is removably associated with the orthopedic hardware component.

8. The system of claim 7 wherein the sustained release device is threaded to the orthopedic hardware component such that the sustained release device is rotatably removable from and replaceable to the orthopedic hardware component.

9. The system of claim 8 wherein the sustained release device is a cap threaded to an outward projecting surface of the orthopedic hardware component.

10. The system of claim 8 wherein the sustained release device is a screw threaded to an inwardly projecting surface of the orthopedic hardware component.

11. The system of claim 7 wherein the sustained release device is attached to the orthopedic hardware component using an interference fit.

12. The system of claim 7 wherein the sustained release device includes a first suture eye and the orthopedic hardware component includes a second suture eye, the sustained release device being attached to the orthopedic hardware component using a suture through each of the first suture eye and the second suture eye.

13. The system of claim 7, the orthopedic hardware component including a chamber, the sustained release device configured for placement in the chamber of the orthopedic hardware component.

14. The system of claim 1 wherein the sustained release device is integrally formed with the orthopedic hardware component.

15. The system of claim 1 wherein the compound is a low-solubility compound.

16. The system of claim 15 wherein the compound comprises a matrix of an effective agent and a polymer that is permeable to the effective agent.

17. The system of claim 15 wherein the sustained release device includes an inner core containing the compound, the sustained release device further comprising a non- bioerodible polymer coating layer, the non-bioerodible polymer coating layer being permeable to the compound, wherein the non-bioerodible polymer coating layer covers the inner core and is essentially non-release rate limiting.

18. The system of claim 1 wherein the compound comprises a soluble compound.

19. The system of claim 18 wherein the compound is surrounded by an outer layer that covers the compound and includes a first surface and a second surface, the first surface being substantially impermeable to the compound and the second surface being permeable to the compound and limiting a release rate of the compound.

20. The system of claim 1, the compound including at least one of a steroid, an antibiotic, an anti-inflammatory drug, an antiproliferative compound, an antimyotic compound, an antimitotic compound, an antimetabolite compound, a pain-relieving drug, a corticosteroid, an angiostatic steroid, a non-steroidal anti-inflammatory agent, or a co-drug.

21. The system of claim 1, the therapeutic effect including at least one of an anti- inflammatory effect, a pain-relief effect, an anesthetic effect, an immune suppressant effect, an antibiotic effect, an anti-viral effect, a cancer-fighting effect, an anti-cancer effect, an anti-proliferative effect, a cartilage-protecting effect, or an anti-scarring effect.

22. A system comprising:

a hardware means for forming an attachment to a bone of a body;

a drug delivery means for providing sustained release of a drug; and

an attachment means for attaching the drug delivery means to the hardware means.

23. A method comprising:

attaching an orthopedic hardware component to a portion of a body;

providing a compound having a therapeutic effect;

associating the compound with the orthopedic hardware component; and

releasing the compound over an extended period of time.

24. The method of claim 23 wherein attaching the orthopedic hardware component further comprises screwing the component into a bone of the body;

25. The method of claim 23 wherein attaching the orthopedic hardware component further comprises driving a pin into a bone of the body;

26. The method of claim 23 wherein attaching the orthopedic hardware component further comprises suturing the component to a soft tissue of the body.

27. The method of claim 23 wherein the orthopedic hardware component includes at least one of a staple, a tack, a dart, a bolt, a washer, a plate, a prosthetic joint, a component of a prosthetic joint, an anchor, a pin, a wire, or a button.

28. The method of claim 23 wherein associating the compound with the orthopedic hardware component further comprises removably attaching a sustained release device that includes the compound to the orthopedic hardware component using at least one of threads that rotatably engage the sustained release device to the orthopedic hardware component, an interference fit between the sustained release device and the orthopedic hardware component, a pin passing through the orthopedic hardware component and the sustained release device, or a suture passing between a suture eye of each one of the orthopedic hardware component and the sustained release device.

29. The method of claim 23 wherein the compound is a low-solubility compound, releasing the compound further comprising exposing the compound to a bodily fluid such that the compound dissolves into the bodily fluid.

30. The method of claim 23 wherein the compound is a high-solubility compound, releasing the compound further comprising exposing the compound to a bodily fluid through a membrane that limits a rate of release of the compound.

31. The method of claim 23 wherein the compound includes at least one of a steroid, an antibiotic, an anti-inflammatory drug, an antiproliferative compound, an antimyotic compound, an antimitotic compound, an antimetabolite compound, a pain-relieving drug, a corticosteroid, an angiostatic steroid, a non-steroidal anti-inflammatory agent, or a co-drug.

32. The method of claim 23 wherein the therapeutic effect includes at least one of an anti-inflammatory effect, a pain-relief effect, an anesthetic effect, an immune suppressant effect, an antibiotic effect, an anti-viral effect, a cancer-fighting effect, an anti-cancer effect, an anti-proliferative effect, a cartilage-protecting effect, or an anti-scarring effect.

33. The method of claim 23 wherein attaching the orthopedic hardware component comprises attaching the component within a synovial capsule of a joint, the compound including one or more treatments for at least one of osteoarthritis or rheumatoid arthritis.