# US 9,433,436 B2 · Therapeutic material delivery system for tissue voids and cannulated implants > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,433,436 B2 - Document ID: US9433436B2 - Status: Granted - Kind: B2 - Application number: 13/935,819 - Filed: 2013-07-05 - Published: 2013-11-07 - Granted: 2016-09-06 - Earliest claimed: 2008-11-20 - Assignees: Bioactive Surgical, Inc. - Applicants: Bioactive Surgical, Inc. - Inventors: Lew C. Schon; Richard H. Spedden; Laura J. Pingel - Web page: https://patentgrep.com/patent/US9433436B2 ## CPC - A61B 17/3472: {for bones, e.g. intraosseus injections} - A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)} - A61F 2/28: Bones - A61M 5/3295: {Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel} - A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)} - A61B 17/864: {hollow, e.g. with socket or cannulated} - A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008}) - 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) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract Described herein is a novel drug delivery assembly having particular applicability to the field of orthopedic and surgical medicine. The devices and assemblies described herein enable the efficient application and retention of potentially expensive therapeutic materials to very specific locations, particularly those associated with voids in bone and tissue. One particularly unique aspect of the present invention involves the introduction of constructs which promote the retention of therapeutic material in the target area of application for beneficial use, for example by forming a proximal barrier that prevents leakage of the therapeutic material out of the target area. Additionally, the present invention provides unique devices and methods for surgical introduction of such constructs. The present invention finds particular application in connection with introduction of stem and progenitor cells, bioactive molecules and bone scaffold materials in conjunction with bone voids and with the use of cannulated implants, such as bone screws (also surgical screws) and pins. The present invention also has beneficial use in the delivery of cancer drugs, antimicrobials, bone cements and other therapeutic materials. ## Claims ### Claim 1 An assembly for delivering therapeutic material into a void in a tissue or implanted prosthetic device, said void accessed by means of a proximal opening, said assembly comprising: a. a flowable plug in a plug reservoir having a volume, a distal end and a proximal end and a linear axis extending therebetween; b. one or more fluid cannulated flow tubes, each having a distal and a proximal ends; wherein each of the proximal ends comprise an attachment point to a therapeutic fluid reservoir and each of the distal ends comprises a therapeutic fluid discharge point; c. a flowable plug delivery structure comprising: i. a plug reservoir cannula having a proximal end and a distal end and an axial bore extending therebetween, said bore comprising, in part, said flowable plug in said reservoir, and wherein said distal end comprises one or more flowable plug discharge ports serving as a path for discharging said flowable plug into said void; ii. a plug pusher that transmits a force to said plug reservoir housing said flowable plug so as to discharge said flowable plug through said one or more flowable plug discharge ports into said void; and iii. a mechanism that coordinates discharge of said flowable plug through said one or more flowable plug discharge ports with a distalward axial displacement of said one or more fluid cannulated flow tubes into said void. ### Claim 2 (depends on 1) The assembly of claim 1, wherein at least one of said one or more fluid cannulated flow tubes comprises a hypodermic needle. ### Claim 3 (depends on 1) The assembly of claim 1, wherein said flowable plug takes the form of a liquid, emulsion, suspension, foam, gel, or hydrogel and is fabricated from a material selected from the group consisting of a wax, fat, thermoset resin, thermoplastic, acrylate resin, blood products, and bone products. ### Claim 4 (depends on 3) The assembly of claim 3, wherein said flowable plug is comprised, at least in part, of a bone product selected from the group consisting of bone, bone cement, bone was, bone matrix, bone putty, bone gel and combinations thereof. ### Claim 5 (depends on 1) The assembly of claim 1, wherein said flowable plug comprises one or more components and said plug reservoir comprises one or more sections. ### Claim 6 (depends on 1) The assembly of claim 1, wherein the one or more therapeutic materials is selected from the group consisting of stem cells, progenitor cells, biological cells, BMP, PDGF, TGF, growth factors, antimicrobials, clotting agents, fibronectin, anticoagulants, platelet rich plasma, platelet poor plasma and adipose tissue. ### Claim 7 (depends on 1) The assembly of claim 1, wherein said plug pusher comprises an elongated shaft having a plunger component at its distal end. ### Claim 8 (depends on 1) The assembly of claim 1, wherein relative linear dimensions of the one or more fluid cannulated flow tubes, the plug reservoir cannula, the plug pusher and the flowable plug are such that when used together, a. the distal ends of said one or more fluid cannulated flow tubes are deployed at a predetermined depth into said tissue or implanted prosthetic device, b. the flowable plug is injected at a predetermined depth, and c. a relationship of the distal ends of said one or more fluid cannulated flow tubes and the distal end of the flowable plug is predetermined and allows for free passage of therapeutic material through said one or more fluid cannulated flow tubes to a distal side of the flowable plug in the target void. ### Claim 9 (depends on 1) The assembly of claim 1, wherein said therapeutic fluid reservoir contains stem cells, other biological cells or therapeutic molecules. ### Claim 10 (depends on 1) The assembly of claim 1, wherein said one or more fluid reservoirs contains material selected from the group consisting of bone marrow products, blood products, adipose tissue products, and fluids from the reproduction system or products thereof. ### Claim 11 (depends on 1) The assembly of claim 1, wherein said mechanism for coordinating simultaneous distalward axial displacement of said flowable plug and said one or more fluid cannulated flow tubes comprises a force transmitting contact or linkage between one of said fluid cannulated flow tubes and said plug pusher. ### Claim 12 (depends on 1) The assembly of claim 1, wherein said mechanism for coordinating simultaneous axial displacement of said flowable plug and said one or more fluid cannulated flow tubes comprises a linkage between one of said fluid cannulated flow tubes and said plug pusher. ### Claim 13 (depends on 12) The assembly of claim 12, wherein said linkage comprises a locked configuration, wherein said flow tube and plug pusher move as a single unit, and an unlocked configuration, wherein the plug pusher maintains the plug in position while said flow tube is retracted. ### Claim 14 An assembly for delivering therapeutic material into a void in a tissue or implanted prosthetic device, said void accessed by means of a proximal opening, said assembly comprising: a. one or more flowable plug delivery cannulas; b. an assembly body having a proximal end and a distal end with a flowable plug discharge port at the distal end of said assembly body, wherein said discharge port is hydraulically connected to a flowable plug in a plug reservoir; c. one or more fluid cannulated flow tubes, each having a proximal end and a distal end, wherein each of the proximal ends comprises an attachment point to a therapeutic fluid reservoir and each of the distal ends comprises a therapeutic fluid discharge point and wherein said distal ends of said one or more of said fluid cannulated flow tubes are at a point more distal to the assembly body than said flowable plug discharge port; d. an adapter section at the distal end of said assembly body wherein said flowable plug discharge port and the distal ends of said one or more fluid cannulated flow tubes are located within a perimeter defining a surface wherein said surface is compatible with a medical implant or tissue void and provides at least a partial hydraulic seal with said void. ### Claim 15 (depends on 14) The assembly of claim 14, wherein relative linear dimensions of the one or more fluid cannulated flow tubes, the one or more flowable plug delivery cannulas, and the adapter section, the volume of said flowable plug and a dimension of the target void are such that when used together, a. the distal ends of the one or more fluid cannulated flow tubes are deployed at a predetermined depth into said tissue or implanted prosthetic device, b. the flowable plug is injected at a predetermined depth, and c. a relationship between the distal ends of the one or more fluid cannulated flow tubes and the distal end of the flowable plug is predetermined and allows for free passage of therapeutic material through said one or more fluid cannulated flow tubes to a distal side of the flowable plug in the target void. ### Claim 16 (depends on 1) A method for delivering therapeutic material into a void in a tissue or implanted prosthetic device, said void accessed by means of a proximal opening, using the assembly of claim 1, said method comprising the steps of: a. placing the one or more fluid cannulated flow tubes into contact with said plug pusher to form a unitary component; b. placing the distal end of the assembly in contact with said void, wherein said void comprises in part an opening in patient tissue; c. simultaneously displacing the distal ends of said fluid cannulated flow tubes into said void and said flowable plug; wherein the flowable plug is introduced at a point proximal to the distal end of said fluid tube in a manner to impede fluid outflow therethrough; and d. injecting one or more therapeutic materials through said one or more fluid cannulated flow tubes, into the void on a distal side of the plug material. ### Claim 17 (depends on 16) The method of claim 16, wherein said step (d) involves attaching a syringe or other reservoir containing one or more therapeutic materials to the proximal ends of said one or more fluid cannulated flow tubes. ### Claim 18 (depends on 16) The method of claim 16, wherein step (d) is followed by step (e): removing said one or more fluid cannulated flow tubes in a manner whereby the flowable plug and therapeutic material remain in the tissue or the implanted prosthetic device.