Systems and methods to treat pain locally

• US 8,969,397 B2
• Filed: 02/05/2010
• Issued: 03/03/2015
• Est. Priority Date: 10/22/2004
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Burright, Eric N., Shafer, Lisa L., McKay, Bill, Zanella, John
• Primary Examiner(s): Stucker, Jeffrey
• Assistant Examiner(s): Gucker, Stephen
• Application Number:
  US12/701,261
• Publication Number:
  US 20100159015A1
• Time in Patent Office: 1,852 Days
• Field of Search: 424/424, 424/489, 514/275, 514/277, 514/311, 514/419, 514/423, 514/460, 514/529, 514/385
• US Class Current: 514/385
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/185 Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids hydroxamic acids A61K31/16; peroxy acids A61K31/327
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/352 condensed with carbocyclic rings, e.g. methantheline cannabinoids A61K31/658
• CPC Class Codes: A61K 31/366 having six-membered rings, e.g. delta-lactones
• CPC Class Codes: A61K 31/381 having five-membered rings
• CPC Class Codes: A61K 31/401 Proline; Derivatives thereof, e.g. captopril
• CPC Class Codes: A61K 31/4168 having a nitrogen attached in position 2, e.g. clonidine
• CPC Class Codes: A61K 31/4402 only substituted in position 2, e.g. pheniramine, bisacodyl
• CPC Class Codes: A61K 31/498 Pyrazines or piperazines ortho- and peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• 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: A61K 9/0085 Brain, e.g. brain implants; Spinal cord
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• 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
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: G01N 2800/2842 : Pain, e.g. neuropathic pain, psychogenic pain

Abstract

Disclosed herein are systems and methods for contributing to the local treatment of pain. More specifically, the disclosed systems and methods contribute to the local treatment pain by inhibiting the NFκB family of transcription factors.

Claims

1. A method of treating pain comprising:

administering one or more depots containing clonidine and a statin locally to a target tissue site causing pain in a patient in need thereof to inhibit pro-inflammatory cytokines associated with pain, wherein the pain comprises at least one of acute pain, neuropathic pain, pain from sciatica, or radicular pain.

2. A method according to claim 1 wherein said one or more depots comprise a biodegradable polymer containing PLGA (polylactide-co-glycolide) that provides sustained release of the clonidine.

3. A method according to claim 1 wherein one or more depots comprise microspheres containing the clonidine.

4. A method according to claim 1 wherein said one or more depots containing the clonidine are administered locally to the perispinal region of the lumbar region of a spinal cord or are administered locally to the epidural space or the intrathecal space of the lumbar region of a spinal cord.

5. A method according to claim 1 wherein said one or more depots containing the clonidine are administered locally from an administration route selected from the group consisting of a catheter and drug pump, one or more local injections, polymer release, and combinations thereof.

6. A method according to claim 1 wherein said pain is acute pain.

7. A method according to claim 1 wherein said pain is from sciatica.

8. A dosing regimen comprising one or more depots containing clonidine and a statin and instructional information that directs the administration of said one or more depots for the local treatment of pain, wherein the pain comprises at least one of acute pain, neuropathic pain, pain from sciatica, or radicular pain.

9. A dosing regimen according to claim 8 wherein said one or more depots comprise a polymer and clonidine disposed in the polymer, wherein the polymer allows sustained release of the clonidine.

10. A dosing regimen according to claim 8 wherein said one or more depots contain a polymer comprising PLGA (polylactide-co-glycolide) and the instructional information directs said one or more depots to be administered locally to the perispinal region of the lumbar region of a spinal cord or to be administered locally to the epidural space or the intrathecal space of the lumbar region of a spinal cord.

11. A dosing regimen according to claim 8 wherein said instructional information directs said one or more depots containing the clonidine to be administered locally from an administration route selected from the group consisting of a catheter and drug pump, one or more local injections, polymer release, and combinations thereof.

12. A dosing regimen according to claim 8 wherein said instructional information directs said one or more depots containing the clonidine to be administered for the treatment of acute or neuropathic pain.

13. A dosing regimen according to claim 8 wherein said instructional information directs said one or more depots containing the clonidine to be administered for the treatment of sciatica or radicular pain.

14. A dosing regimen according to claim 8 wherein said dosing regimen is part of a kit used for the treatment of pain.