# US 11,980,701 B2 · Joint implant with constant and continuous release of therapeutic agent > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,980,701 B2 - Document ID: US11980701B2 - Status: Granted - Kind: B2 - Application number: 17/576,635 - Filed: 2022-01-14 - Published: 2022-07-21 - Granted: 2024-05-14 - Earliest claimed: 2021-01-15 - Assignees: Diffusion RX, Inc. - Applicants: Diffusion RX, Inc. - Inventors: Robert N. Hotchkiss; Paul Ashton; Martin Nazzaro - Web page: https://patentgrep.com/patent/US11980701B2 ## CPC - A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} - A61B 17/844: {with expandable anchors or anchors having movable parts} - A61B 17/8605: {Heads, i.e. proximal ends projecting from bone} - A61B 17/864: {hollow, e.g. with socket or cannulated} - A61B 17/8685: {comprising multiple separate parts} - A61F 2/28: Bones - A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone - A61L 27/06: Titanium or titanium alloys - A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds - A61B 17/1675: {for the knee} - A61B 17/84: Fasteners therefor {or fasteners being internal fixation devices} - A61B 17/8625: {Shanks, i.e. parts contacting bone tissue} - A61B 17/866: {Material or manufacture} - A61B 17/8875: {Screwdrivers, spanners or wrenches} - A61B 2017/8655: {with special features for locking in the bone} - A61F 2002/2825: {Femur} - A61F 2002/3021: {frustoconical} - A61F 2002/30593: {hollow} - A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body} - A61F 2002/3068: {the pharmaceutical product being in a reservoir} - A61F 2002/3085: {with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface} - A61F 2002/30884: {Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity} - A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys - A61L 2300/222: Steroids, e.g. corticosteroids - A61L 2430/02: for reconstruction of bones; weight-bearing implants - A61L 2430/24: for joint reconstruction - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - 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) ## Abstract Provided herein are devices and methods for treating inflammation and pain of articular joints (e.g., the knee). An implantable device includes an elongate body extending from a proximal end to a distal end, a flange disposed at the proximal end, a bore extending from an opening at the proximal end into the elongate body, one or more fixation members disposed on an outer surface of the elongate body, and a payload (e.g., a drug-polymer core) having a therapeutic agent disposed within the bore. The payload has a substantially constant surface area on an exposed portion throughout elution of the therapeutic agent after the implantable device is implanted in a body. The therapeutic agent is configured to elute using zero-order kinetics, constantly and continuously at an amount that is above a predetermined lower threshold and does not exceed a predetermined upper threshold unlike a pulse-dose injection. ## Claims ### Claim 1 An intra-articular implant sized and configured to be implanted in a periarticular region of a joint, the intra-articular implant comprising: an elongate body extending from a proximal end to a distal end, the elongate body comprising a bone anchor; a flange disposed at the proximal end and extending radially outwards from the elongate body, the flange configured to be exposed to synovial fluid of the joint; a bore extending from an opening at the proximal end into the elongate body, wherein the bore comprises an inner surface where it extends into the elongate body; one or more fixation members disposed on an outer surface of the elongate body; and a payload disposed within the bore, wherein the payload comprises a therapeutic agent configured to elute constantly and continuously over a predetermined time period, wherein the payload erodes during elution, wherein a substantially constant surface area of an exposed portion of the payload is present throughout elution, and wherein the inner surface of the bore of the intra-articular implant is sealed and only the opening at the proximal end of the bore exposes the constant surface area of the exposed portion of the payload, wherein the bore comprises a depth of about 0.5 mm to about 12 mm, wherein the depth of the bore is larger than a maximum height of the flange, wherein a length from the proximal end to the distal end is about 7 mm to about 12 mm, wherein the substantially constant surface area of the exposed portion of the payload is substantially planar with a plane of the flange throughout elution, wherein, except for the opening at the proximal end, the intra-articular implant is devoid of any means exposing payload to bodily environment, wherein the intra-articular implant is configured to achieve substantially zero-order kinetic drug delivery in said periarticular region of the joint. ### Claim 2 (depends on 1) The intra-articular implant of claim 1, wherein the one or more fixation members comprises one or more interference rings disposed along the elongate body. ### Claim 3 (depends on 1) The intra-articular implant of claim 1, wherein the one or more fixation members comprises two or more wing tabs disposed along the elongate body. ### Claim 4 (depends on 3) The intra-articular implant of claim 3, wherein the two or more wing tabs are disposed opposite one another. ### Claim 5 (depends on 1) The intra-articular implant of claim 1, wherein the one or more fixation members comprises threads disposed along the elongate body. ### Claim 6 (depends on 1) The intra-articular implant of claim 1, wherein the distal end comprises a conical shape. ### Claim 7 (depends on 1) The intra-articular implant of claim 1, wherein the distal end comprises a frustoconical shape. ### Claim 8 (depends on 1) The intra-articular implant of claim 1, wherein a diameter of the bore is about 0.5 mm to about 9.5 mm. ### Claim 9 (depends on 1) The intra-articular implant of claim 1, wherein the bore extends only partially into the elongate body. ### Claim 10 (depends on 1) The intra-articular implant of claim 1, wherein the elongate body comprises a first diameter and the flange comprises a second diameter. ### Claim 11 (depends on 10) The intra-articular implant of claim 10, wherein the second diameter is larger than the first diameter. ### Claim 12 (depends on 10) The intra-articular implant of claim 10, wherein the first diameter is about 1.0 mm to about 10.0 mm. ### Claim 13 (depends on 10) The intra-articular implant of claim 10, wherein the second diameter is about 1.25 mm to about 12.0 mm. ### Claim 14 (depends on 1) The intra-articular implant of claim 1, wherein the payload is in direct contact with the inner surface of the bore. ### Claim 15 (depends on 1) The intra-articular implant of claim 1, wherein the payload is configured to elute the therapeutic agent constantly and continuously for about six months. ### Claim 16 (depends on 1) The intra-articular implant of claim 1, wherein the payload is configured to elute the therapeutic agent constantly and continuously for about seven months. ### Claim 17 (depends on 1) The intra-articular implant of claim 1, wherein the payload is configured to elute the therapeutic agent constantly and continuously for about eight months. ### Claim 18 (depends on 1) The intra-articular implant of claim 1, wherein the payload is configured to elute the therapeutic agent constantly and continuously for about nine months. ### Claim 19 (depends on 1) The intra-articular implant of claim 1, wherein the payload is configured to elute the therapeutic agent constantly and continuously for about ten months. ### Claim 20 (depends on 1) The intra-articular implant of claim 1, wherein the payload is configured to elute the therapeutic agent constantly and continuously for about eleven months. ### Claim 21 (depends on 1) The intra-articular implant of claim 1, wherein the payload is configured to elute the therapeutic agent constantly and continuously for about a year. ### Claim 22 (depends on 1) The intra-articular implant of claim 1, wherein the payload is configured to elute the therapeutic agent constantly and continuously for at least a year. ### Claim 23 (depends on 1) The intra-articular implant of claim 1, wherein the therapeutic agent comprises a corticosteroid. ### Claim 24 (depends on 23) The intra-articular implant of claim 23, wherein the corticosteroid comprises dexamethasone. ### Claim 25 (depends on 1) The intra-articular implant of claim 1, wherein the elongate body comprises titanium. ### Claim 26 (depends on 1) The intra-articular implant of claim 1, wherein the elongate body comprises polyetherketoneketone (PEKK). ### Claim 27 (depends on 1) The intra-articular implant of claim 1, wherein the elongate body comprises polyether ether ketone (PEEK). ### Claim 28 (depends on 1) The intra-articular implant of claim 1, wherein the therapeutic agent is configured to elute constantly and continuously at an amount that is above a predetermined lower threshold and does not exceed a predetermined upper threshold. ### Claim 29 (depends on 1) A method of treating an inflammatory condition, the method comprising: implanting the intra-articular implant of claim 1 into a bone, thereby allowing the payload to elute the therapeutic agent into an intra-articular space at a constant and continuous rate for at least a year. ### Claim 30 (depends on 1) A method of treating an inflammatory condition, the method comprising: providing the intra-articular implant of claim 1; forming a hole in a bone; inserting the intra-articular implant into the formed hole thereby securing the intra-articular implant in the bone. ### Claim 31 (depends on 30) The method of claim 30, wherein the hole is formed using a drill. ### Claim 32 (depends on 30) The method of claim 30, wherein the hole has a depth of about 8 mm to about 16 mm. ### Claim 33 (depends on 30) The method of claim 30, wherein the hole has a depth of about 12 mm. ### Claim 34 (depends on 30) The method of claim 30, wherein the hole is formed in a non-load-bearing portion of the bone. ### Claim 35 (depends on 30) The method of claim 30, wherein the bone is a femur. ### Claim 36 (depends on 35) The method of claim 35, wherein the hole is formed in a periarticular region.