IP Library › Granted Patent US 12,594,403
Granted Patent B2
US 12,594,403 · App. 17/894,759 · Granted Apr 7, 2026

Introducer components, assemblies, and methods thereof

Inventor: Glade H. Howell (Draper, UT)
Assignee: Bard Access Systems, Inc.
A61M25/0606A61M25/0097A61M25/0693
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Quick Facts
Patent No.
US 12,594,403
App. No.
17/894,759
Granted
Apr 7, 2026
Kind
B2
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 (33)

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.

2 . The introducer assembly of claim 1 , wherein the elastomeric sleeve is adhered to the needle shaft over the needle slot.

3 . 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.

4 . The introducer assembly of claim 1 , wherein the valve port includes a slit in the elastomeric sleeve aligned with the needle slot.

5 . 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.

6 . The introducer assembly of claim 1 , wherein the valve further includes a rigid housing over the elastomeric sleeve.

7 . The introducer assembly of claim 6 , wherein the valve port further includes a through hole in the rigid housing aligned with the needle slot.

8 . 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.

9 . 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.

10 . 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.

11 . 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.

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.

13 . The needle assembly of claim 12 , wherein the elastomeric sleeve is adhered to the needle shaft over the needle slot.

14 . The needle assembly of claim 12 , wherein the valve port includes a slit in the elastomeric sleeve aligned with the needle slot.

15 . 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.

16 . The needle assembly of claim 12 , wherein the valve port further includes a through hole in the rigid housing aligned with the needle slot.

17 . 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.

Continuity (2)
Provisional Application 63236578 · Aug 24, 2021
Related Publication 20230064542A1 · Mar 2, 2023
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