# US 12,594,403 B2 · Introducer components, assemblies, and methods thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,594,403 B2 - Document ID: US12594403B2 - Status: Granted - Kind: B2 - Application number: 17/894,759 - Filed: 2022-08-24 - Published: 2023-03-02 - Granted: 2026-04-07 - Earliest claimed: 2021-08-24 - Assignees: Bard Access Systems, Inc. - Applicants: Bard Access Systems, Inc. - Inventors: Glade H. Howell - Web page: https://patentgrep.com/patent/US12594403B2 ## CPC - A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters} - A61M 25/09041: {Mechanisms for insertion of guide wires} - A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)} - A61M 25/06: Body-piercing guide needles or the like - A61M 25/065: {Guide needles} - A61M 25/0693: {Flashback chambers} - A61M 5/3291: {Shafts with additional lateral openings} - A61M 5/3293: {characterised by features of the needle hub} - 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 Disclosed are introducer components, assemblies, and methods. For example, an introducer assembly can include an access guidewire loaded in a needle assembly fluidly connected to a syringe. The needle assembly can include a needle and a valve thereover. The needle can include a needle shaft including a needle lumen, a needle slot in a proximal portion of the needle shaft, and a needle hub over the proximal portion of the needle shaft but proximal of the needle slot. The valve can be over the needle slot with a valve port aligned with the needle slot. The access guidewire can be loaded in the needle lumen and sealed therein by way of the valve port in a ready-to-deploy state of the introducer assembly. In this way, the access guidewire can be immediately advanced into a blood-vessel lumen of a patient upon establishing a needle tract thereto with the needle assembly. ## Claims ### Claim 1 An introducer assembly, comprising: a vacuum-generating device; a needle assembly fluidly connected to the vacuum-generating device, the needle assembly including: a needle including: a needle shaft including a needle lumen; a needle slot in a proximal portion of the needle shaft; and a needle hub over the proximal portion of the needle shaft but proximal of the needle slot; and a valve over the needle slot, the valve including an elastomeric sleeve having a valve port aligned with the needle slot; and an access guidewire loaded in the needle lumen and sealed therein around an outer diameter of the access guidewire by way of the valve port in a ready-to-deploy state of the introducer assembly, wherein the access guidewire includes a ‘J’-shaped guidewire tip that assumes a straightened state in the ready-to-deploy state of the introducer assembly and a curved state when the guidewire tip is advanced beyond a distal end of the needle shaft in a deployed state of the introducer assembly. ### Claim 2 (depends on 1) The introducer assembly of claim 1, wherein the elastomeric sleeve is adhered to the needle shaft over the needle slot. ### Claim 3 (depends on 1) The introducer assembly of claim 1, wherein the valve port includes a hole in the elastomeric sleeve aligned with the needle slot, the hole having an inner diameter smaller than the outer diameter of the access guidewire. ### Claim 4 (depends on 1) The introducer assembly of claim 1, wherein the valve port includes a slit in the elastomeric sleeve aligned with the needle slot. ### Claim 5 (depends on 1) The introducer assembly of claim 1, wherein the valve port includes a plurality of intersecting slits in the elastomeric sleeve aligned with the needle slot. ### Claim 6 (depends on 1) The introducer assembly of claim 1, wherein the valve further includes a rigid housing over the elastomeric sleeve. ### Claim 7 (depends on 6) The introducer assembly of claim 6, wherein the valve port further includes a through hole in the rigid housing aligned with the needle slot. ### Claim 8 (depends on 7) The introducer assembly of claim 7, wherein the valve port further includes an ‘O’-ring disposed in the through hole having an inner diameter smaller than the outer diameter of the access guidewire. ### Claim 9 (depends on 1) The introducer assembly of claim 1, wherein the access guidewire includes a bare-wire portion and a wound-wire portion proximal of the bare-wire portion, the bare-wire portion distally extending through the valve port in at least the ready-to-deploy state of the introducer assembly. ### Claim 10 (depends on 1) The introducer assembly of claim 1, wherein the access guidewire includes a proximal portion proximally extending from the valve port in the ready-to-deploy state of the introducer assembly, the proximal portion of the access guidewire disposed in a sterile barrier configured to maintain sterility of the access guidewire. ### Claim 11 (depends on 1) The introducer assembly of claim 1, wherein the needle hub further includes a needle-hub connector including a needle-hub bore in a proximal portion of the needle hub, a syringe tip of a syringe as the vacuum-generating device disposed in the needle-hub bore, thereby fluidly connecting the needle assembly to the vacuum-generating device in the ready-to- deploy state of the introducer assembly. ### Claim 12 A needle assembly, comprising: a needle including: a needle shaft including a needle lumen; a needle slot in a proximal portion of the needle shaft; and a needle hub over the proximal portion of the needle shaft but proximal of the needle slot; and a valve including: an elastomeric sleeve over the needle slot, the valve including a valve port aligned with the needle slot; and a rigid housing over the elastomeric sleeve. ### Claim 13 (depends on 12) The needle assembly of claim 12, wherein the elastomeric sleeve is adhered to the needle shaft over the needle slot. ### Claim 14 (depends on 12) The needle assembly of claim 12, wherein the valve port includes a slit in the elastomeric sleeve aligned with the needle slot. ### Claim 15 (depends on 12) The needle assembly of claim 12, wherein the valve port includes a plurality of intersecting slits in the elastomeric sleeve aligned with the needle slot. ### Claim 16 (depends on 12) The needle assembly of claim 12, wherein the valve port further includes a through hole in the rigid housing aligned with the needle slot. ### Claim 17 (depends on 12) The needle assembly of claim 12, wherein the needle hub further includes a needle-hub connector including a needle-hub bore in a proximal portion of the needle hub, the needle-hub bore configured to accept a syringe tip of a syringe inserted therein for fluidly connecting the needle assembly to the syringe.