Drug depot with anchor

• US 9,623,222 B2
• Filed: 10/30/2008
• Issued: 04/18/2017
• Est. Priority Date: 10/30/2008
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: McKay, William F.
• Primary Examiner(s): Tran, Susan
• Assistant Examiner(s): CRAIGO, WILLIAM A
• Application Number:
  US12/261,956
• Publication Number:
  US 20100112034A1
• Time in Patent Office: 3,092 Days
• Field of Search: 424426, 424423
• 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: 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: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027

Abstract

A drug depot implantable at or near a target tissue site beneath the skin of a patient is provided, the drug depot comprising a therapeutically effective amount of a drug; at least one line having a distal end and a proximal end, the proximal end of the line attached to the drug depot; an anchor attached to the distal end of the line and configured to limit movement of the drug depot at or near the target tissue site, wherein the drug depot is capable of releasing the therapeutically effective amount of the drug over a period of at least one day. In some embodiments, the drug depot provided can include an effective amount of at least analgesic and/or at least one anti-inflammatory agent at or near a target site, and can reduce, prevent or treat inflammation and/or pain.

Claims

1. A drug depot for implantation at or near a target tissue site beneath the skin of a patient, the drug depot comprising a solid body comprising one or more immediate release layers that release a bolus dose of a drug and one or more sustained release layers that release a therapeutically effective amount of the drug and a polymer having an average molecular weight of about 10,000 to about 100,000, wherein the drug depot is attached to at least one line comprising a shape memory polymer and a coating comprising a drug, the at least one line having a distal end and a proximal end, the proximal end of the line attached to the drug depot;

and the distal end of the line is attached to an anchor that is configured to limit movement of the drug depot at or near the target tissue site, wherein the anchor comprises a pellet that is rotatably attached to the line, the pellet comprising a cylindrical shape having a distal end defining a planar surface and a tapered proximal end, the pellet may be turned clockwise or counterclockwise when implanted so as to lodge the pellet at or near the target tissue site and the pellet comprising a polymer having an average molecular weight of about 10,000 to about 100,000, wherein the drug depot is capable of releasing the therapeutically effective amount of the drug over a period of at least one day, and wherein the line spaces the drug depot from the anchor by a distance of from about 0.1 mm to about 5 cm, and the line comprises a diameter smaller than the pellet and the drug depot.

2. A drug depot according to claim 1, wherein the anchor comprises a biodegradable pellet.

3. A drug depot according to claim 1, wherein the drug depot is biodegradable and the line is attached to a distal end of the drug depot.

4. A drug depot according to claim 1, wherein the target tissue site is an annular tear.

5. A drug depot according to claim 1, wherein the at least one line comprises a suture, yarn, thread, and/or wire.

6. A drug depot according to claim 5, wherein the line is a biodegradable suture.

7. A drug depot according to claim 6, wherein the suture is attached to the anchor at a point off center.

8. A drug depot according to claim 6, wherein the suture is attached to the drug depot and/or the anchor by a knot, rim, bead or clip.

9. A drug depot according to claim 1, wherein the drug depot, the at least one line and the anchor are biodegradable and the anchor degrades slower than the line and drug depot.

10. A drug depot according to claim 1, wherein the line spaces the drug depot from the anchor a distance of from about 0.5 mm to about 2 mm.

11. A drug depot according to claim 1, wherein the drug depot comprises an analgesic and an anti-inflammatory agent.

12. A drug depot according to claim 1, wherein the one or more immediate release layers comprises poly(lactide-co-glycolide) (PLGA), and the one or more sustain release layers comprises polylactide (PLA).

13. A drug depot according to claim 1, wherein the drug depot further comprises a pore forming agent.

14. A drug depot for implantation at or near a target tissue site beneath the skin of a patient, the drug depot comprising a solid body comprising one or more immediate release layers that release a bolus dose of a drug and one or more sustained release layers that release a therapeutically effective amount of the drug, and a biodegradable polymer having an average molecular weight of about 10,000 to about 100,000;

wherein the drug depot is attached to at least one suture comprising a shape memory polymer and a coating comprising a drug, the at least one suture having a distal end and a proximal end, the proximal end of the suture attached to the drug depot; and

wherein an anchor is attached to the distal end of the suture and configured to limit movement of the drug depot at or near the target tissue site, wherein the anchor comprises a pellet that is rotatably attached to the suture, the pellet comprising a cylindrical shape having a distal end defining a planar surface and a tapered proximal end, the pellet may be turned clockwise or counterclockwise when implanted so as to lodge the pellet at or near the target tissue site and the pellet comprising a polymer having an average molecular weight of about 10,000 to about 100,000, wherein the drug depot is capable of releasing the therapeutically effective amount of the drug over a period of at least one day, and wherein the suture spaces the drug depot from the anchor by a distance of from about 0.1 mm to about 5 cm and wherein the suture is biodegradable, degrades slower than said biodegradable polymer, and comprises a diameter smaller than the pellet and the drug depot, and the target tissue site is an annular tear.

15. A drug depot according to claim 14, wherein the anchor comprises a biodegradable pellet.

16. A drug depot according to claim 14, wherein the at least one suture is attached to a distal end of the drug depot.

17. A drug depot according to claim 14, wherein the suture is attached to the anchor at a point off center.

18. A drug depot according to claim 14 wherein the suture spaces the drug depot from the anchor a distance of from about 0.5 mm to about 2 mm.

19. A drug depot according to claim 14, wherein the drug depot comprises an analgesic and an anti-inflammatory agent.

20. A drug depot according to claim 14, wherein the anchor is biodegradable and the anchor degrades slower than the suture and drug depot.