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Title:
INTRODUCER NEEDLE AND ASSEMBLY
Document Type and Number:
WIPO Patent Application WO/2023/018669
Kind Code:
A4
Abstract:
Disclosed is an introducer needle (104) and an introducer assembly (100). The introducer assembly (100) includes a fluidly connected syringe (102) and the needle (104). The needle (104) includes a needle shaft and a needle hub, which includes a port and a valve disposed in the port. The port is in a side of the needle hub proximal of a proximal end of the needle shaft. The valve is configured to form a fluid-tight seal around an elongate medical device such as an access guidewire (106) when passed through the port and into a needle-hub lumen of the needle hub. Such an access guidewire (106) can be pre-disposed in the introducer assembly just proximal of a needle tip of the needle. In this way, the access guidewire (106) can be immediately advanced into a blood-vessel lumen upon establishing a needle tract thereto with the needle (104).

Inventors:
HOWELL GLADE (US)
Application Number:
PCT/US2022/039742
Publication Date:
May 04, 2023
Filing Date:
August 08, 2022
Export Citation:
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Assignee:
BARD ACCESS SYSTEMS INC (US)
International Classes:
A61M25/06; A61M25/09
Attorney, Agent or Firm:
WIGHT, Todd, W. (US)
Download PDF:
Claims:
AMENDED CLAIMS received by the International Bureau on 17 February 2023 (17.02.2023)

1. An introducer assembly, comprising: a syringe; a needle fluidly connected to the syringe, the needle including: a needle shaft; and a needle hub over a proximal portion of the needle shaft, the needle hub including: a port directly in a side of the needle hub proximal of a proximal end of the needle shaft; and a valve disposed in the port configured to form a fluid-tight seal around an elongate medical device when passed through the port and into a needle-hub lumen of the needle hub; and an access guidewire slidably disposed in the introducer assembly in a ready-to- deploy state of the introducer assembly, a bare-wire portion of the access guidewire distally extending through the valve such that the valve forms a fluid-tight seal around the bare-wire portion of the access guidewire.

2. The introducer assembly of claim 1, the access guidewire passing through the needle-hub lumen, through the proximal end of the needle shaft, and into a needle-shaft lumen of the needle shaft such that a guidewire tip in a distal portion of the access guidewire is disposed just proximal of a needle tip in a distal portion of the needle shaft.

3. The introducer assembly of claim 2, wherein the guidewire tip is a T-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 the needle tip in a deployed state of the introducer assembly.

4. The introducer assembly of either claim 2 or 3, wherein the access guidewire includes a wound-wire portion proximal of the bare-wire portion.

5. The introducer assembly of any claim of claims 2-4, wherein the access guidewire includes a proximal portion proximally extending from the 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.

6. The introducer assembly of any claim of claims 1-5, wherein the valve includes a split septum compressed in the port.

7. The introducer assembly of any claim of claims 1-6, wherein the needle hub further includes a needle-hub connector including a needle-hub bore proximal of the port, a syringe tip of the syringe disposed in the needle-hub bore, thereby fluidly connecting the needle to the syringe.

8. An introducer needle, comprising: a needle shaft; and a needle hub over a proximal portion of the needle shaft, the needle hub including: an opening directly in a side of the needle hub proximal of a proximal end of the needle shaft; and a valve disposed in the opening configured to form a fluid-tight seal around an elongate medical device when passed through the opening and into a needle-hub lumen of the needle hub.

9. The introducer needle of claim 8, wherein the valve includes a split septum compressed in the port.

10. The introducer needle of either claim 8 or 9, wherein the needle hub further includes a needle-hub connector including a needle-hub bore proximal of the opening configured to accept a syringe tip inserted therein for fluidly connecting the needle to the syringe.

11. A method for securing vascular access, comprising: obtaining an introducer assembly, the introducer assembly including: a syringe; a needle fluidly coupled to the syringe, the needle including a needle hub having a port directly in a side of the needle hub proximal of a proximal end of a needle shaft disposed in the needle hub; and an access guidewire slidably disposed in the introducer assembly, a bare- wire portion of the access guidewire distally extending through a valve disposed in the port such that the valve forms a fluid-tight seal around the bare-wire portion of the access guidewire, and the access guidewire

19

AMENDED SHEET (ARTICLE 19) further passing through a needle-hub lumen of the needle hub, through the proximal end of the needle shaft, and into a needle-shaft lumen of the needle shaft; establishing a needle tract from an area of skin to a blood-vessel lumen of a patient with the needle; and advancing the access guidewire into the blood-vessel lumen for the securing of the vascular access.

12. The method of claim 11, further comprising adjusting the introducer assembly such that the introducer assembly is in a ready-to-deploy state thereof with a guidewire tip in a distal portion of the access guidewire disposed just proximal of a needle tip in a distal portion of the needle shaft for the advancing of the access guidewire into the blood-vessel lumen immediately upon the establishing of the needle tract.

13. The method of claim 12, wherein the advancing of the access guidewire into the blood-vessel lumen allows the guidewire tip of the access guidewire to transition from a straightened state in the access-guidewire passageway to a curved state in the blood-vessel lumen.

14. The method of any claim of claims 11-13, further comprising withdrawing a plunger from a barrel of the syringe to create a slight vacuum before reaching the blood-vessel lumen, the slight vacuum ensuring blood flashes back into at least a syringe tip to confirm the establishing of the needle tract.

15. The method of any claim of claims 11-14, further comprising aspirating blood with the syringe to confirm the establishing of the needle tract, the fluid-tight seal of the valve around the bare-wire portion of the access guidewire maintaining a vacuum during the aspirating of the blood with the syringe.

16. The method of any claim of claims 11-15, further comprising withdrawing the needle from the patient leaving the access guidewire in the blood-vessel lumen.

17. The method of claim 16, wherein the withdrawing of the needle includes holding the guidewire in place at or near the area of skin including the needle tract while withdrawing the needle over a proximal portion of the access guidewire.

20

AMENDED SHEET (ARTICLE 19)

18. The method of either claim 16 or 17, further comprising disconnecting the needle from the syringe before withdrawing the needle from the patient.

19. The method of either claim 16 or 17, further comprising bleeding air into the port while withdrawing the needle from the patient by pushing the access guidewire to a side of the port against the valve, the bleeding of air into the port obviating disconnecting the needle from the syringe.

20. The method of claim 19, wherein the valve includes a split septum compressed in the port.

AMENDED SHEET (ARTICLE 19)