# US 2016/0256501 A1 · A therapeutic agent delivery system and method for arteries > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2016/0256501 A1 - Document ID: US20160256501A1 - Status: Published application - Kind: A1 - Application number: 15/028,822 - Filed: 2014-10-20 - Published: 2016-09-08 - Earliest claimed: 2013-10-22 - Assignees: Tulip Endovascular Innovation Limited - Applicants: Tulip Endovascular Innovation Limited - Inventors: Sherif SULTAN; Niamh HYNES - Web page: https://patentgrep.com/patent/US20160256501A1 ## CPC - A61K 35/545: Embryonic stem cells; Pluripotent stem cells; Induced pluripotent stem cells; Uncharacterised stem cells - A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)} - A61K 35/19: Platelets; Megacaryocytes - A61K 38/18: Growth factors; Growth regulators - A61K 38/36: Blood coagulation or fibrinolysis factors - A61K 38/39: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG] - A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence) - A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)} - A61M 25/1011: {Multiple balloon catheters} - A61M 2025/09183: {having tools at the distal tip} - A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector} - A61M 2202/0437: Blood stem cells - 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) - 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 A delivery system for delivery of a therapeutic agent such as stem cells into a vein and across a micro circulation system into an artery comprises a multi lumen catheter for delivery of a therapeutic agent. A discharge device is located in a vein. The operation of the delivery device is controlled by a pressure stem cell solution delivery gun system. There are multiple delivery stages. These may include delivery of an elixir to open up the pressure bed, a platelet-rich plasma, stem cells, scaffolds, and finally an elixir to provide emichment and nourishment of the stem cells. ## Claims ### Claim at position 1 1-54. (canceled) ### Claim 55 A delivery system for delivery of a therapeutic agent into a vein and across a micro circulation system into an artery. ### Claim 56 (depends on 55) The delivery system as claimed in claim 55, wherein the delivery system comprises a multi-lumen catheter for delivery of a therapeutic agent and a discharge device for location in a vein. ### Claim 57 (depends on 55) The delivery system as claimed in claim 55, comprising a multi-lumen catheter for delivery of a therapeutic agent and a discharge device for location in a vein, and wherein the discharge device is mounted to the catheter. ### Claim 58 (depends on 55) The delivery system as claimed in claim 55, comprising a multi-lumen catheter for delivery of a therapeutic agent and a discharge device for location in a vein, and wherein the discharge device is mounted to the catheter, and wherein at least one lumen of the catheter is used to control the operation of the stem cell discharge device; and wherein the system comprises a first balloon which is located proximally of the delivery device; and wherein the system comprises a second balloon which is located distally of the delivery device. ### Claim 59 (depends on 55) The delivery system as claimed in claim 55, wherein the delivery system comprises a pressure stem cell solution delivery device configured to control said therapeutic agent delivery. ### Claim 60 (depends on 55) The delivery system as claimed in claim 55, wherein the delivery system comprises a pressure stem cell solution delivery device configured to control said therapeutic agent delivery; and wherein the pressure stem cell delivery device is supplied by at least one canister. ### Claim 61 (depends on 55) The delivery system as claimed in claim 55, wherein the system is adapted to deliver the therapeutic agent by infusion. ### Claim 62 (depends on 55) The delivery system as claimed in claim 55, wherein the system is adapted to deliver a therapeutic agent under a pressure of up to 90 mmHg and at a flow rate in the range of 0.3 to 1.4 ml/min and for a duration of up to 120 mins. ### Claim 63 (depends on 55) The delivery system as claimed in claim 55, wherein the system is adapted to deliver different therapeutic agents in successive stages, each with a corresponding set of delivery parameters. ### Claim 64 (depends on 55) The delivery system as claimed in claim 55, wherein the system is adapted to deliver different therapeutic agents in successive stages, each with a corresponding set of delivery parameters; and wherein the agents include an elixir stem cell solution to open collapsed venules for infusion across a micro-circulation system at a pressure up to 90 mmHg and for a duration in the range of 10 min to 20 min. ### Claim 65 (depends on 55) The delivery system as claimed in any of claim 55, wherein the system is adapted to deliver different therapeutic agents in successive stages, each with a corresponding set of delivery parameters; and wherein the agents include an elixir stem cell solution to open collapsed venules for infusion across a micro-circulation system, and wherein the agents include platelet-rich plasma delivered after the elixir to prepare the vascular bed for delivery of stem cells at a pressure of up to 90 mmHg and for a duration in the range of 10 min to 20 min. ### Claim 66 (depends on 55) The delivery system as claimed in claim 55, wherein the system is adapted to deliver different therapeutic agents in successive stages, each with a corresponding set of delivery parameters; and wherein the agents include an elixir stem cell solution to open collapsed venules for infusion across a micro-circulation system, and wherein the agents include platelet-rich plasma delivered after the elixir to prepare the vascular bed for delivery of stem cells and wherein the system is adapted to deliver stem cells and growth factors in a third stage after said plasma delivery with a delivery pressure under 25 mmHg and a flow rate in the range of 0.33 to 0.44 ml/min ### Claim 67 (depends on 55) The delivery system as claimed in claim 55, wherein the system is adapted to deliver different therapeutic agents in successive stages, each with a corresponding set of delivery parameters; and wherein the agents include an elixir stem cell solution to open collapsed venules for infusion across a micro-circulation system, and wherein the agents include platelet-rich plasma delivered after the elixir to prepare the vascular bed for delivery of stem cells and wherein the system is adapted to deliver stem cells and growth factors in a third stage after said plasma delivery; and wherein the system is adapted to deliver scaffolds in a fourth stage after said third stage with a delivery pressure under 25 mmHg and a flow rate in the range of 0.33 to 0.44 ml/min ### Claim 68 (depends on 55) The delivery system as claimed in claim 55, wherein the system is adapted to deliver different therapeutic agents in successive stages, each with a corresponding set of delivery parameters; and wherein the agents include an elixir stem cell solution to open collapsed venules for infusion across a micro-circulation system, and wherein the agents include platelet-rich plasma delivered after the elixir to prepare the vascular bed for delivery of stem cells and wherein the system is adapted to deliver stem cells and growth factors in a third stage after said plasma delivery; and wherein the system is adapted to deliver scaffolds in a fourth stage after said third stage; and wherein the system is adapted to deliver an elixir in a fifth stage after said scaffold delivery with a delivery pressure under 25 mmHg and a flow rate in the range of 0.33 to 0.44 ml/min ### Claim 69 A method for treatment of an occlusion in an artery comprising the step of delivering a therapeutic agent into a venous system, across a microcirculation system and into the artery, or into a microcirculation system and onwards to the artery. ### Claim 70 (depends on 69) The method as claimed in claim 69, wherein the therapeutic agent comprises stem cells and/or proteins, and/or multiple growth factors, and/or fibrinogen and fibrin nano-scaffolds, and/or platelet rich plasma and/or pharmaceutical agents. ### Claim 71 (depends on 69) The method as claimed in claim 69, comprising a step of maintaining a thermo-balanced environment at a temperature of from 34° C. to 37° C. ### Claim 72 (depends on 69) The method as claimed in claim 69, wherein the therapeutic agent is delivered under a pressure from neutral pressure to 90 mm Hg, said pressure being dependent on a pressure wire sensor gradient at a desired location of delivery. ### Claim 73 (depends on 69) The method as claimed in claim 69, wherein a plurality of agents are delivered from a plurality of reservoirs. ### Claim 74 (depends on 69) The method as claimed in claim 69, wherein a plurality of agents are delivered from a plurality of reservoirs; wherein a first reservoir contains elixir stem cells solution which is delivered to a desired location in order to open collapsed venules at a pressure up to 90 mmHg and for a duration in the range of 10 min to 20 min. ### Claim 75 (depends on 69) The method as claimed in claim 69, wherein a plurality of agents are delivered from a plurality of reservoirs; wherein a first reservoir contains elixir stem cells solution which is delivered to a desired location in order to open collapsed venules; wherein a second reservoir contains autologous platelet rich plasma which is delivered to a desired location in a micro circulation system to prepare the vascular bed for the delivery of stem cells, wherein a third reservoir contains allogenic stem cells and growth factors delivered at a flow rate of 0.33-0.44 ml/min over a period of 45-60 min, so as not to damage the stem cells and their functional capacity. ### Claim 76 (depends on 69) The method as claimed in claim 69, wherein a plurality of agents are delivered from a plurality of reservoirs; wherein a first reservoir contains elixir stem cells solution which is delivered to a desired location in order to open collapsed venules; wherein a second reservoir contains autologous platelet rich plasma which is delivered to a desired location in a micro circulation system to prepare the vascular bed for the delivery of stem cells, wherein a third reservoir contains allogenic stem cells and growth factors delivered at a flow rate of 0.33-0.44 ml/min over a period of 45-60 min, so as not to damage the stem cells and their functional capacity; and wherein a fourth reservoir contains scaffolds which are delivered to a desired location to promote sustained release of growth factors. ### Claim 77 (depends on 69) The method as claimed in claim 69, wherein a plurality of agents are delivered from a plurality of reservoirs; wherein a first reservoir contains elixir stem cells solution which is delivered to a desired location in order to open collapsed venules; wherein a second reservoir contains autologous platelet rich plasma which is delivered to a desired location in a micro circulation system to prepare the vascular bed for the delivery of stem cells, wherein a third reservoir contains allogenic stem cells and growth factors delivered at a flow rate of 0.33-0.44 ml/min over a period of 45-60 min, so as not to damage the stem cells and their functional capacity; and wherein a fourth reservoir contains scaffolds which are delivered to a desired location to promote sustained release of growth factors; and wherein said scaffolds are Fibrin and Fibrinogen nano-scaffolds, the delivery pressure of the scaffolds is under 25 mmHg, and the flow rate is in the range of 0.33 to 0.44 ml/min. ### Claim 78 (depends on 69) The method as claimed in claim 69, wherein a plurality of agents are delivered from a plurality of reservoirs; wherein a first reservoir contains elixir stem cells solution which is delivered to a desired location in order to open collapsed venules; wherein a second reservoir contains autologous platelet rich plasma which is delivered to a desired location in a micro circulation system to prepare the vascular bed for the delivery of stem cells, wherein a third reservoir contains allogenic stem cells and growth factors delivered at a flow rate of 0.33-0.44 ml/min over a period of 45-60 min, so as not to damage the stem cells and their functional capacity; and wherein a fourth reservoir contains scaffolds which are delivered to a desired location to promote sustained release of growth factors; and wherein a fifth reservoir contains elixir stem cells solution which is delivered to a desired location in order to sustain the viability of the previously delivered agents.