Vascular access device

• US 10,682,157 B2
• Filed: 06/01/2018
• Issued: 06/16/2020
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Asspv, LLC
• Inventors: Bierman, Steven F., Pluth, Richard A., Nguyen, Tu
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US15/995,512
• Publication Number:
  US 20180271558A1
• Time in Patent Office: 746 Days
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0006 which can be secured against axial movement, e.g. by using a locking cuff
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 25/0693 Flashback chambers

Abstract

An access device for placing a medical article within a body space includes a needle, a dilator, and a sheath. The dilator can be coaxially and slideably disposed about the needle, and the sheath can be coaxially and slideably disposed about the dilator. The access device can further include a inner member coaxially disposed between the needle and dilator. The needle can include a fenestration in fluid communication with a space between the needle and inner member. When the needle punctures a blood vessel, the fenestration allows blood to flow into the space between the needle and inner member to provide a visual indicator to a physician or healthcare professional that the needle is in a vessel.

Claims

1. An access device for placing a medical article within a body space, the access device comprising:

a needle comprising a fenestration near a distal end of the needle;

a dilator disposed about the needle, the dilator comprising a dilator hub and a dilator body, a distal end of the dilator body positioned against the needle and distal to the fenestration; and

an inner member coaxially disposed between the needle and the dilator, a distal end of the inner member positioned against the needle and distal to the dilator hub;

wherein a space at least partially defined by an outer surface of the needle and the inner member defines a flash channel in fluid communication with the fenestration to allow bodily fluid to flow from an interior of the needle through the fenestration to the flash channel.

2. The access device of claim 1, wherein the distal end of the inner member is distal to the fenestration and proximal to the distal end of the dilator, wherein the space is at least partially between the outer surface of the needle and an inner surface of the inner member.

3. The access device of claim 1, wherein the distal end of the inner member is proximal to the fenestration, wherein the space is at least partially between the outer surface of the needle and an outer surface of the inner member.

4. The access device of claim 1 further comprising a sheath coaxially disposed about the dilator.

5. The access device of claim 1, wherein the needle is 21 gauge and the dilator is 7 French.

6. The access device of claim 1, wherein a thickness of the flash channel is in the range of about 0.002 inches to about 0.005 inches.

7. The access device of claim 1, wherein at least a portion of the inner member and dilator are configured to allow visualization of bodily fluid in the flash channel.

8. The access device of claim 1, wherein the fenestration allows blood to flow from an interior of the needle through the fenestration to the flash channel when the needle punctures a vessel.

9. An access device for placing a medical article within a body space, the access device comprising:

a needle comprising a needle body and a fenestration, an outer surface of at least a portion of the needle body disposed at a radius r₁ from a central longitudinal axis of the needle;

a dilator comprising a dilator hub and a dilator body, an inside surface of at least a portion of the dilator body disposed at a radius r₂ from a central longitudinal axis of the dilator, a distal end of the dilator body positioned against the needle body and distal to the fenestration; and

an inner member comprising an inner member body having a body width, the body width being less than r₂−

r₁ such that the inner member can be positioned in a flash channel between the needle body and the dilator body, a distal end of the inner member body being positioned against the needle body and distal to the dilator hub.

10. The access device of claim 9, wherein the distal end of the inner member is distal to the fenestration and proximal to the distal end of the dilator, wherein the flash channel is at least partially between the outer surface of the needle and an inner surface of the inner member.

11. The access device of claim 9, wherein the distal end of the inner member is proximal to the fenestration, wherein the flash channel is at least partially between the outer surface of the needle and an outer surface of the inner member.

12. The access device of claim 9 further comprising a sheath coaxially disposed about the dilator.

13. The access device of claim 9, wherein an inner surface of at least a portion of the inner member body is disposed at an inner radius from a central longitudinal axis of the inner member, wherein the inner radius is greater than r₁.

14. The access device of claim 9, wherein an outer surface of at least a portion of the inner member body is disposed at an outer radius from a central longitudinal axis of the inner member, wherein the outer radius is less than r₂.

15. The access device of claim 9, wherein the inner member is configured to occupy more of the flash channel between the needle and the dilator at a first position distal the fenestration than a second position proximal the fenestration.

16. The access device of claim 9, wherein the inner member channels a majority of bodily fluid exiting the fenestration proximally along the flash channel.

17. The access device of claim 9, wherein an inner surface of the inner member is disposed a distance d₂ from the outer surface of the needle, the distance d₂ being less than one-half of the distance r₂−

r₁.