Claims for Patent: 10,485,902

Summary for Patent: 10,485,902

Title:	Antibiotic drug release sheath
Abstract:	An implantable medical device having a sheath formed of a polymer material, wherein the sheath forms a reservoir attached to or around the implantable medical device, and wherein the reservoir is sealed with a biocompatible pressure responsive coating; wherein the biocompatible coating is stable for at least 7-day post implantation into a body, and can be mechanically ruptured by application of an exterior pressure generating force.
Inventor(s):	Kepler; Christopher K. (Philadelphia, PA), Sevit; Alex Michael (Philadelphia, PA), Kurtz; Steven Michael (Philadelphia, PA), Hickok; Noreen J. (Philadelphia, PA), Forsberg; Flemming (Philadelphia, PA), Eisenbrey; John R. (Philadelphia, PA)
Assignee:	Thomas Jefferson University (Philadelphia, PA) Drexel University (Philadelphia, PA)
Application Number:	15/250,020
Patent Claims:	1. A biocompatible clip comprising a reservoir and a reservoir opening, wherein the reservoir is filled with gas and a therapeutic agent; and wherein the reservoir opening is sealed with a pressure: responsive material that can be ruptured upon application of a force from ultrasonic sound waves to said pressure-responsive material; said clip comprising a concave recess disposed along a longitudinal axis of said clip, wherein said concave recess is suitable for securing said clip to a medical device. 2. The biocompatible clip of claim 1 wherein said clip is made of polyether ether ketone (PEEK). 3. The biocompatible clip of claim 1 wherein said pressure-responsive material is made of polylactic acid (PLA). 4. The biocompatible clip of claim 1, wherein the therapeutic agent is selected from the group consisting of: an antibiotic, anti-viral, pain medication, growth factor, anti-fungal, antimycobacteria chemotherapeutic, osteogenic, non-toxic factor or metabolite, such as ascorbate to increase bone formation, parathyroid hormone, peptides, peptoids, NSAIDs, analgesics, or combinations thereof. 5. The biocompatible clip of claim 1 further comprising a second reservoir component attached thereto and wherein the second reservoir component is sealed with a second pressure-responsive material that has a different rupture profile from the first pressure-responsive material. 6. The biocompatible clip of claim 5 wherein the different rupture profile is formed by using a different pressure-responsive material than is used for the first pressure-responsive material. 7. The biocompatible clip of claim 5 wherein the different rupture profiles for the first and second pressure-responsive material are generated by using a thicker covering of pressure-responsive material for one of the materials. 8. The biocompatible clip of claim 1 wherein the medical device is a spinal fusion rod, and wherein the reservoir is filled with an antibiotic material. 9. A method for treatment of infection at a surgical site comprising: a. performing a surgical procedure comprising implanting a device to be inserted into the body, wherein said device comprises at least one biocompatible sheath that is attached to at least a portion of the device and comprises a reservoir filled with gas and a therapeutic material; wherein said sheath is further coated with a pressure-responsive material suitable for being ruptured; b. applying ultrasound waves to the site of the surgical procedure, wherein said ultrasound waves causes cavitation of gas bubbles leading to rupturing of the pressure-responsive material, wherein said therapeutic material is thereafter released from said sheath to the surgical site. 10. The method of claim 9 wherein the biocompatible sheath is PEEK. 11. The method of claim 9 wherein the pressure-responsive material is PLA. 12. The method of claim 9, wherein the pressure-responsive material is formed by dipping the sheath into a 50 mg/ml 250 mg/ml PLA/CHCl.sub.3 solvent and dipped between 5 and 10 times to form a pressure-responsive coating on the sheath. 13. The method of claim 9, wherein the reservoir contains a therapeutic selected from the group consisting of: an antibiotic, anti-viral, pain medication, growth factor, anti-fungal, antimycobacteria chemotherapeutic, osteogenic, non-toxic factor or metabolite, such as ascorbate to increase bone formation, parathyroid hormone, peptides, peptoids, NSAIDs, analgesics, or combinations thereof. 14. The method of claim 9 further comprising a second biocompatible sheath comprising a reservoir filled with a different therapeutic material and wherein the second biocompatible sheath is coated with a second pressure-responsive material having a different rupture profile than the first pressure-responsive material. 15. An implantable medical device comprising a sheath formed of a polymer material, secured to at least a portion of the implantable medical device, wherein the sheath forms a reservoir attached to or around the implantable medical device, and wherein the reservoir is sealed with a biocompatible pressure-responsive coating; wherein the biocompatible coating is stable for at least 7-day post implantation into a body, and can be mechanically ruptured by application of an exterior pressure generating force, said reservoir filled with gas and a therapeutic material, and wherein said mechanical rupture triggers release of the therapeutic material from the reservoir. 16. The implantable medical device of claim 15 further comprising a second sheath secured to a second portion of the implantable medical device, wherein the second sheath comprises a reservoir sealed with a biocompatible pressure-responsive coating having a different release profile from the first biocompatible pressure-responsive coating. 17. The implantable medical device of claim 15 wherein said polymer material is PEEK and said biocompatible pressure-responsive coating is PLA. 18. The implantable medical device of claim 15 wherein said reservoir is filled with gas and a therapeutic selected from the group consisting of: an antibiotic, anti-viral, pain medication, growth factor, anti-fungal, antimycobacteria chemotherapeutic, osteogenic, non-toxic factor or metabolite, such as ascorbate to increase bone formation, parathyroid hormone, peptides, peptoids, NSAIDs, analgesics, or combinations thereof.

Details for Patent 10,485,902

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2035-08-28