# US 12,005,231 B2 · Injection devices and systems and methods for using them > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,005,231 B2 - Document ID: US12005231B2 - Status: Granted - Kind: B2 - Application number: 17/673,675 - Filed: 2022-02-16 - Published: 2022-10-06 - Granted: 2024-06-11 - Earliest claimed: 2017-09-27 - Applicants: Clph, LLC - Inventors: Stephen A. Leeflang; Christian S. Eversull - Web page: https://patentgrep.com/patent/US12005231B2 ## CPC - A61M 5/16813: {by controlling the degree of opening of the flow line} - A61M 5/1452: {pressurised by means of pistons} - A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body} - A61M 5/168: Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters - 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 Systems and methods are provided for injecting one or more agents into tissue within a patient's body. In one embodiment, an injection device is provided that includes an outer tubular member comprising a proximal end, a distal end sized for introduction into the patient's body, and a lumen extending between the proximal end and the distal end; a relatively small cross-section needle tip extending distally beyond the distal end; and an internal pressure release member slidably disposed within the lumen between a distal position and a proximal position to prevent viscous injectate from expressing from the needle tip. ## Claims ### Claim 1 A method for delivering an injectate into tissue within a patient's body using an injection device comprising an outer member including a proximal end, a distal end, and a lumen extending therebetween, a needle tip extending from the distal end, and a pressure release member slidably disposed within the lumen, the method comprising: introducing the distal end of the outer member into a body lumen adjacent a target injection site; inserting the needle tip into the tissue at the target injection site; with a distal end of the pressure release member disposed adjacent the needle tip within the lumen, delivering the injectate from a source through the lumen around the pressure release member and through a passage in the needle tip into the tissue at the target injection site; and after the delivery of the injectate, withdrawing the pressure release member proximally such that the distal end of the pressure release member moves proximally away from the passage to prevent the injectate from expressing out the needle tip, wherein the distal end of the pressure release member is disposed immediately proximal to the passage during the delivery of the injectate, and in a proximal position, the distal end of the pressure release member is directed proximally away from the passage to prevent the injectate from expressing from the needle tip. ### Claim 2 (depends on 1) The method of claim 1, wherein the insertion of the needle tip comprises advancing the injection device until a substantially flat distal surface adjacent the needle tip contacts a wall of the body lumen to limit penetration of the needle tip into the tissue at the target injection site. ### Claim 3 (depends on 1) The method of claim 1, further comprising coupling the source to the proximal end of the outer member, and wherein the delivery of the injectate comprises actuating an actuator of the source to direct the injectate from the source through the lumen and out an outlet in the needle tip. ### Claim 4 (depends on 1) The method of claim 1, wherein the injection device includes a handle on the proximal end of the outer member, wherein a proximal end of the pressure release member extends from the handle, and wherein the withdrawal of the pressure release member comprises pulling the proximal end of the pressure release member. ### Claim 5 (depends on 1) The method of claim 1, wherein the injection device includes a biasing mechanism coupled to the pressure release member such that the pressure release member is automatically withdrawn from a distal position to the proximal position after the delivery of the injectate. ### Claim 6 (depends on 5) The method of claim 5, wherein the biasing mechanism biases the pressure release member to the distal position during the delivery of the injectate. ### Claim 7 (depends on 1) The method of claim 1, wherein the pressure release member comprises an inner member having an outer profile smaller than an inner profile of the lumen such that the injectate passes through the lumen around the inner member. ### Claim 8 (depends on 1) The method of claim 1, further comprising a distal stop on the outer member distal end, the needle tip extending distally beyond the distal stop. ### Claim 9 (depends on 8) The method of claim 8, wherein the distal stop comprises one or more passages communicating between the lumen and the passage in the needle tip. ### Claim 10 (depends on 8) The method of claim 8, wherein the distal stop comprises a body having an outer dimension larger than an outer dimension of the outer member distal end. ### Claim 11 (depends on 8) The method of claim 8, wherein the distal stop comprises a rounded or flat distal surface adjacent the needle tip to limit penetration of the needle tip into the tissue at the target injection site.