NEEDLE ASSEMBLIES WITH FLASHBACK INDICATOR AND RELATED METHODS

• US 20160175563A1
• Filed: 12/21/2015
• Published: 06/23/2016
• Est. Priority Date: 12/23/2014
• Status: Active Grant

• Current Assignee: B Braun Melsungen AG (B. Braun Holding GmbH & Co. KG)
• Original Assignee: B Braun Melsungen AG (B. Braun Holding GmbH & Co. KG)
• Inventors: Chin, Y Ying, Woehr, Kevin, Teoh, Hui Kuun
• Granted Patent: US 10,543,343 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1422 provided with indicating means, e.g. for vein entry
• CPC Class Codes: A61M 2039/0244 having means for detecting an inserted needle
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0612 Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
• CPC Class Codes: A61M 25/0693 Flashback chambers

Abstract

Aspects of the present disclosure include needle devices in which a needle has a notch or slot. A flashback indicator is provided at least in part in the needle lumen at the notch, adjacent the notch, or partially inside and partially outside of the notch. In use, blood flow through the needle lumen is indicated at the flashback indicator. When used with a catheter tube, the flashback indicator can be viewed through the catheter tube. The needle with the notch and flashback indicator may be used with a variety of needle applications, including as catheter assemblies, indwelling assemblies, and most, if not all, over-the-needle type devices.

Claims

1. A needle assembly comprising:

a needle hub with a needle comprising a wall surface defining a needle shaft having a needle lumen and a needle tip;

a notch formed through the wall surface of the needle proximal of the needle tip, and

the notch is equipped, loaded, or packed with a flashback indicator;

wherein the flashback indicator comprises a material configured to absorb fluid, change color, or both.

2. The needle assembly of claim 1, further comprising a catheter hub having an interior cavity and a catheter tube having a bore and wherein the needle projects through the bore of the catheter tube and the notch is located inside the catheter tube.

3. The needle assembly of claim 2, further comprising a needle shield for covering the needle tip located substantially in the interior cavity of the catheter hub.

4. The needle assembly of claim 1, wherein the flashback indicator is made from at least one of a cellulose acetate material, a colloid material, a cotton material, a chromogenic polymer, an acrylic copolymer material, a fibrous material coated with an amphipathic material comprising carboxylates (RCO₂), sulfates (RSO₄), sulfonates (RSO₃), or phosphates, or combinations thereof.

5. The needle assembly of claim 1, further comprising a support element having a catheter tube extending from a distal end thereof, a catheter hub attached to the support element via a flexible buffer element, and a needle hub positioned proximally of the catheter hub;

wherein the needle projects through the catheter tube and the notch is located inside the flexible buffer element or inside the catheter tube.

6. The needle assembly of claim 5, wherein the needle is coupled to the needle hub via a needle wire.

7. The needle assembly of claim 1, wherein the flashback indicator is located in the notch and at least partly in the needle lumen, partially inside the notch and partially outside the notch, or wholly outside of the notch.

8. The needle assembly of claim 7, further comprising at least one ridge formed in the bore of the catheter tube.

9. The needle assembly of claim 8, wherein the at least one ridge has a width and a length and wherein the width is wider than a width of the notch, the length is longer than a length of the notch, and the at least one ridge contacts the needle shaft.

10. The needle assembly of claim 8, wherein the flashback indicator comprises a distal edge that lies above the notch, aligned with a proximal edge of the notch, or is located just proximal of the proximal edge of the notch.

11. The needle assembly of claim 8, wherein the flashback indicator is a sheet wrapped around an exterior of the needle shaft.

12. The needle assembly of claim 8, wherein the at least one ridge blocks an opening of the notch.

13. The needle assembly of claim 2, wherein the flashback indicator, when filled with blood, prevents blood from dripping out of the needle.

14. The needle assembly of claim 2, wherein the notch comprises two side edges, and a flow channel defined at least partly by one of the two side edges.

15. The needle assembly of claim 2, wherein the bore of the catheter tube comprises a first and a second ridge extending inwardly from an interior surface of the bore, extending lengthwise along a length of the catheter tube, and defining a flow channel with the shaft.

16. The needle assembly of claim 2, further comprising a secondary tipping section proximal of a distal opening of the catheter tube.

17. The needle assembly of claim 16, further comprising two tapered sections located on either side of the secondary tipping section.

18. The needle assembly of claim 16, further comprising a first flow space located distally of the secondary tipping section and a second flow space located proximally of the secondary tipping section.

19. The needle assembly of claim 1, further comprising a sleeve wrapped around the flashback indicator.

20. The needle assembly of claim 1, further comprising a recessed section on the needle shaft for receiving the flashback indicator.

21. A needle assembly comprising:

a needle hub with a needle comprising a wall surface defining a needle shaft having a needle lumen and a needle tip;

an elongated slot formed through the wall surface of the needle and extends a length of the needle shaft and through part of a needle bevel;

a tube comprising a bore with at least one ridge formed inside the bore; and

wherein the at least one ridge contacts the needle shaft and covers the elongated slot.

22. The needle assembly of claim 21, further comprising a catheter hub having an interior cavity attached to the tube.

23. A method for manufacturing a needle assembly comprising:

forming a needle hub with a needle comprising a wall surface defining a needle shaft having a needle lumen, a needle tip, and a notch formed through the wall surface of the needle shaft;

equipping the notch with a flashback indicator, the flashback indicator having an absorbent material to indicate presence of a fluid;

forming a catheter tube and projecting the needle through the catheter tube and out a distal end of the catheter tube.

24. The method of claim 23, wherein the flashback indicator is made from at least one of a cellulose acetate material, a colloid material, a cotton material, a chromogenic polymer, an acrylic copolymer material, a fibrous material coated with an amphipathic material comprising carboxylates (RCO₂), sulfates (RSO₄), sulfonates (RSO₃), or phosphates, acrylic copolymer material, or combinations thereof.

25. The method of claim 23, wherein the flashback indicator comprises an absorbable paper.

26. The method of claim 23, further comprising:

forming a catheter hub having an interior cavity, said catheter hub being joined to the catheter tube; and

locating the notch inside the catheter tube.

27. The method of claim 23, further comprising:

forming a support element and extending the catheter tube out a distal end thereof and attaching a catheter hub to the support element via a flexible buffer element; and

locating the notch inside the flexible buffer element.

28. The method of claim 23, further comprising locating the flashback indicator in the notch and at least partly in the needle lumen, or partially inside the notch and partially outside the notch, or wholly outside the notch.

29. The method of claim 23, further comprising forming at least one ridge extending inwardly from an interior surface of the bore and extending lengthwise along a length of the catheter tube.

30. The method if claim 23, further comprising forming a secondary tipping section proximally of a distal opening of the catheter tube.