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Summary for Patent: 7,727,954
|Title:||Drug depot implant designs|
|Abstract:||The present invention relates to novel drug depot implant designs for optimal delivery of therapeutic agents to subjects. The invention provides a method for alleviating pain associated with neuromuscular or skeletal injury or inflammation by targeted delivery of one or more therapeutic agents to inhibit the inflammatory response which ultimately causes acute or chronic pain. Controlled and directed delivery can be provided by drug depot implants, comprising therapeutic agents, specifically designed to deliver the therapeutic agent to the desired location by facilitating their implantation, minimizing their migration from the desired tissue location, and without disrupting normal joint and soft tissue movement.|
|Inventor(s):||McKay; William F. (Memphis, TN)|
|Assignee:||Warsaw Orthopedic, Inc. (N/A)|
|Patent Claims:||1. A drug depot implant comprising: a body having a surface and opposites sides; an anchoring system extending from the body, the anchoring system comprising at least two
angled flexible barbs, each of the at least two angled flexible barbs comprising a point adapted to allow forward translational movement of the body and limit backward translational movement of the body from a targeted tissue, wherein the at least two
angled flexible barbs are on the surface of the body and the at least two angled flexible barbs are located on opposite sides of the body; and a therapeutic agent comprising a NFkB inhibitor disposed throughout the body and the anchoring system, wherein
the body and the anchoring system are capable of eluting the therapeutic agent and the drug depot implant is solid and provides an optimal concentration of the therapeutic agent from 1 cm to 5 cm from the drug depot implant.
2. The drug depot implant of claim 1 wherein the anchoring system provides a surface adapted to abut against a tissue plane.
3. The drug depot implant of claim 2 wherein the anchoring system further comprises an end cap disposed on an end of the body of the drug depot implant.
4. The drug depot implant of claim 1 wherein the anchoring system further comprises a suture.
5. The drug depot implant of claim 1 further comprising a radiographic marker adapted to assist in radiographic imaging of the drug depot implant.
6. The drug depot implant of claim 5 wherein the radiographic marker is selected from the group consisting of barium, calcium phosphate, and metal beads.
7. The drug depot implant of claim 1 wherein the body is formed from a biodegradable material.
8. The drug depot implant of claim 7 further comprising a plurality of microspheres disposed in the biodegradable material, the microspheres encapsulating at least a portion of the therapeutic agent.
9. The drug depot implant of claim 1 wherein the body and anchoring system are biodegradable.
10. The drug depot implant of claim 1 wherein the targeted tissue site is a synovial joint.
11. The drug depot implant of claim 1 wherein the targeted tissue site is a soft tissue.
12. The drug depot implant of claim 11 wherein the soft tissue is selected from the group consisting of muscle, ligament, tendon, and cartilage.
13. The drug depot implant of claim 1 wherein the targeted tissue site is a disc.
14. The drug depot implant of claim 1, wherein the NFkB inhibitor is an anti-inflammatory agent and the drug depot implant further comprises at least one additional anti-inflammatory agent, which is selected from the group consisting of soluble tumor necrosis factor .alpha. receptors, pegylated soluble tumor necrosis factor .alpha. receptors, monoclonal antibodies, polyclonal antibodies, antibody fragments, COX-2 inhibitors, metalloprotease inhibitors, such as TAPI, glutamate antagonists, glial cell derived neurotrophic factors (GDNF), B2 receptor antagonists, Substance P receptor (NK1) antagonists, Downstream regulatory element antagonistic modulator (DREAM), iNOS, inhibitors of tetrodotoxin (TTX)-resistant Na+-channel receptor subtypes PN3 and SNS2, inhibitors of interleukins, such as IL-1, IL-6, IL-8 and IL-10, TNF binding protein, dominant-negative TNF variants, Nanobodies.TM., kinase inhibitors, Adalimumab, Infliximab, Etanercept, Pegsunercept (PEG sTNF-R1), Onercept, Kineret.RTM., sTNF-R1, CDP-870, CDP-571, CNI-1493, RDP58, ISIS 104838, 1.fwdarw.3-.beta.-D-glucans, Lenercept, PEG-sTNFRII Fc Mutein, D2E7, Afelimomab, AMG 108, 6-methoxy-2-napthylacetic acid) or betamethasone, capsaiein, civanide, TNFRc, ISIS2302 and GI 129471, integrin antagonists, alpha-4 beta-7 integrin antagonists, cell adhesion inhibitors, interferon gamma antagonists, CTLA4-Ig agonists/antagonists (BMS-188667), CD40 ligand antagonists, Humanized anti-IL-6 mAb (MRA, Tocilizumab, Chugai), HMGB-1 mAb (Critical Therapeutics Inc.), anti-IL2R antibody (daclizumab, basilicimab), ABX (anti IL-8 antibody), recombinant human IL-10, HuMax IL-15 (anti-IL 15 antibody), NF Kappa B inhibitors, glucocorticoids, clonidine, nonsteroidal anti-inflammatory drugs (NSAIDs), sulindac and tepoxalin, antioxidants, dithiocarbamate, sulfasalazine [2-hydroxy-5-[-4-[C2-pyridinylamino)sulfonyl]azo]benzoic acid], and flucinolone, and combinations thereof.
15. The drug depot implant of claim 4 wherein beads are linearly disposed along the suture.
16. A solid drug depot implant comprising: a rod-shaped body having a surface and opposite sides; an anchoring system extending from the rod-shaped body, the anchoring system adapted to limit movement of the rod-shaped body from a targeted tissue, the anchoring system comprising at least four barbs on the surface of the rod-shaped body, a first pair of the at least four barbs located on opposite sides of the rod-shaped body, each barb of the first pair comprising a point adapted to limit backward movement of the body from a targeted tissue and a second pair of the at least four barbs located on opposites sides of the rod-shaped body, each barb of the second pair comprising a point adapted to limit forward movement of the body from a targeted tissue; and a therapeutic agent comprising a NFkB inhibitor disposed throughout the rod-shaped body and the anchoring system, wherein the rod-shaped body and anchoring system are capable of eluting the therapeutic agent.
17. A solid drug depot implant according to claim 16, wherein the anchoring system comprises flexible barbs and the flexible barbs snap on the rod-shaped body.
|Applicant||Tradename||Biologic Ingredient||Dosage Form||BLA||Number||Approval Date||Patent No.||Assignee||Estimated Patent Expiration||Status||Orphan||Source|
|Centocor Inc||REMICADE||infliximab||VIAL||103772||001||1998-08-24||Start Trial||Warsaw Orthopedic, Inc. (N/A)||2026-04-13||RX||Orphan||search|
|Immunex||ENBREL||etanercept||VIAL; SUBCUTANEOUS||103795||001||1998-11-02||Start Trial||Warsaw Orthopedic, Inc. (N/A)||2026-04-13||RX||Orphan||search|
|Immunex||ENBREL||etanercept||SYRINGE||103795||002||1998-11-02||Start Trial||Warsaw Orthopedic, Inc. (N/A)||2026-04-13||RX||Orphan||search|
|Abbvie Inc||HUMIRA||adalimumab||SYRINGE||125057||001||2002-12-31||Start Trial||Warsaw Orthopedic, Inc. (N/A)||2026-04-13||RX||search|
|Abbvie Inc||HUMIRA||adalimumab||VIAL||125057||002||2002-12-31||Start Trial||Warsaw Orthopedic, Inc. (N/A)||2026-04-13||RX||search|
|Genentech||ACTEMRA||tocilizumab||INJECTABLE; INJECTION||125276||001||2010-01-08||Start Trial||Warsaw Orthopedic, Inc. (N/A)||2026-04-13||RX||search|
|>Applicant||>Tradename||>Biologic Ingredient||>Dosage Form||>BLA||>Number||>Approval Date||>Patent No.||>Assignee||>Estimated Patent Expiration||>Status||>Orphan||>Source|
|Country||Patent Number||Estimated Expiration|
|European Patent Office||2007353||Start Trial|
|United States of America||2007243225||Start Trial|
|United States of America||2007243228||Start Trial|
|>Country||>Patent Number||>Estimated Expiration|
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