# US 2024/0197622 A1 · Drug delivery for intervertebral disc pain management > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2024/0197622 A1 - Document ID: US20240197622A1 - Status: Published application - Kind: A1 - Application number: 18/067,344 - Filed: 2022-12-16 - Published: 2024-06-20 - Earliest claimed: 2022-12-16 - Assignees: Globus Medical, Inc. - Applicants: Globus Medical, Inc. - Inventors: David C. Paul; Amy Hill - Web page: https://patentgrep.com/patent/US20240197622A1 ## CPC - 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)} - A61K 9/0085: {Brain, e.g. brain implants; Spinal cord} - A61K 9/1647: {Polyesters, e.g. poly(lactide-co-glycolide)} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Biomaterials, implants, methods of making the biomaterial and implants, methods of providing pain relief by administering the biomaterial or implant to a patient, and kits that include such biomaterials, implants, or components thereof. The biomaterials may include microparticles including one or more active pharmaceutical agents, such as anesthetics, antibiotics, and corticosteroids, which help to provide pain relief over an extended period of time. The biomaterials may be applied directly to the intervertebral disc or in the disc space to provide direct therapy for the management of disc pain. ## Claims ### Claim 1 A composition for pain management comprising: an implant comprising a plurality of biodegradable microparticles loaded with active pharmaceutical agents including an anesthetic agent, an antibiotic agent, and an anti-inflammatory agent, wherein the plurality of biodegradable microparticles provides controlled release of the active pharmaceutical agents to maintain a therapeutic target dose of each agent for a given duration of time, and wherein the composition is configured to be applied directly to a pain site for pain relief, wherein the implant is positioned in a disc spaced between adjacent vertebrae, and wherein the implant engages endplates of the adjacent vertebrae and facilitates intervertebral fusion until the implant is fully resorbed. ### Claim 2 (depends on 1) The composition of claim 1, wherein the plurality of biodegradable microparticles includes a first set of biodegradable microparticles loaded with the anesthetic agent, a second set of biodegradable microparticles loaded with the antibiotic agent, and a third set of biodegradable microparticles loaded with the anti-inflammatory agent. ### Claim 3 (depends on 1) The composition of claim 1, wherein the plurality of biodegradable microparticles includes a population of microparticles each having at least three biodegradable layers, wherein a first layer is loaded with the anesthetic agent, a second layer is loaded with the antibiotic agent, and a third layer is loaded with the anti-inflammatory agent. ### Claim 4 (depends on 1) The composition of claim 1, wherein the microparticles are suspended in a biocompatible hydrogel to form an injectable composition. ### Claim 5 (depends on 4) The composition of claim 4, wherein the hydrogel is a temperature sensitive hydrogel that undergoes a sol-gel transition at physiological temperatures and conditions. ### Claim 6 (depends on 1) The composition of claim 1, wherein at least some of the microparticles are composed of at least one selected from the group consisting of polydioxane, polylactic-co-glycolic acid (PLGA), poly-L-lactic acid (PLLA), polycaprolactone fumarate (PCLF), and combinations thereof. ### Claim 7 (depends on 1) The composition of claim 1, wherein the microparticles are spherical. ### Claim 8 (depends on 1) The composition of claim 1, wherein the microparticles form a structural implant. ### Claim 9 (depends on 1) The composition of claim 1, wherein the microparticles are embedded in a solid or semi-solid carrier sheet. ### Claim 10 (depends on 9) The composition of claim 9, wherein the solid or semi-solid carrier sheet is rollable. ### Claim 11 A composition for pain management comprising: an implant comprising: a plurality of biodegradable microparticles loaded with active pharmaceutical agents including an anesthetic, an antibiotic, and a corticosteroid; and an excipient or carrier for supporting the biodegradable microparticles, wherein the composition is configured to be applied directly to a pain site for extended pain relief, wherein the time-release profile of the anesthetic is faster than the antibiotic and corticosteroid to provide acute relief, and wherein the time-release profile of the corticosteroid is longest to provide long term pain relief, wherein the implant is positioned in a disc spaced between adjacent vertebrae, and wherein the implant engages endplates of the adjacent vertebrae and facilitates intervertebral fusion until the implant is fully resorbed. ### Claim 12 (depends on 11) The composition of claim 11, wherein the biodegradable microparticles include a first set of biodegradable microparticles loaded with the anesthetic, a second set of biodegradable microparticles loaded with the antibiotic, and a third set of biodegradable microparticles loaded with the corticosteroid. ### Claim 13 (depends on 12) The composition of claim 12, wherein the first set of biodegradable microparticles loaded with the anesthetic have a smallest diameter, the third set of biodegradable microparticles loaded with the corticosteroid have a largest diameter, and the second set of biodegradable microparticles loaded with the antibiotic have an intermediate diameter between the smallest and largest diameters. ### Claim 14 (depends on 11) The composition of claim 11, wherein the plurality of biodegradable microparticles includes a population of microparticles each having at least three biodegradable layers, wherein a first layer is loaded with the anesthetic, a second layer is loaded with the antibiotic, and a third layer is loaded with the corticosteroid. ### Claim 15 (depends on 14) The composition of claim 14, wherein the first layer loaded with the anesthetic is an outermost layer, the third layer loaded with the corticosteroid is an inner layer, and the second layer loaded with the antibiotic is an intermediate layer between the outermost layer and the inner layer. ### Claim 16 (depends on 11) The composition of claim 11, wherein the plurality of biodegradable microparticles includes a population of microparticles having a single layer and multiple layers. ### Claim 17 (depends on 11) The composition of claim 11, wherein the microparticles are suspended in a biocompatible hydrogel to form an injectable composition, the microparticles form a structural implant, or the microparticles are embedded in a solid or semi-solid carrier to form a rollable sheet. ### Claim 18 A method of alleviating disc pain in a subject in need thereof, the method comprising: providing an implant comprising: a plurality of biodegradable microparticles loaded with active pharmaceutical agents including an anesthetic, an antibiotic, and a corticosteroid; and an excipient or carrier for supporting the biodegradable microparticles, wherein the composition is configured to be applied directly to a pain site for extended pain relief, wherein the time-release profile of the anesthetic is faster than the antibiotic and corticosteroid to provide acute relief, and wherein the time-release profile of the corticosteroid is longest to provide long term pain relief, positioning the implant in a disc spaced between adjacent vertebrae, and wherein the implant engages endplates of the adjacent vertebrae and facilitates intervertebral fusion until the implant is fully resorbed, wherein the implant includes a therapeutically effective amount of at least one composition containing at least one microparticle loaded with at least one active pharmaceutical agent including one or more anesthetics, antibiotics, and corticosteroids. ### Claim 19 (depends on 18) The method of claim 18, wherein the composition is an injectable gel. ### Claim 20 (depends on 19) The method of claim 19, wherein the composition is injected into the annulus fibrosis, the nucleus pulposus, or both of the intervertebral disc.