IP Library Granted Patent US 9,283,320
Granted Patent B2
US 9,283,320 · App. 13/879,988 · Granted Mar 15, 2016

Fluid conveyance safety devices, methods, and systems

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Quick Facts
Patent No.
US 9,283,320
App. No.
13/879,988
Granted
Mar 15, 2016
Kind
B2
Abstract

The disclosed subject matter includes a structure and method for making a dual-lumen needle from single lumen needles to take advantage of the much higher economies of scale. Variations include two needles joined by a flow junction and one needle and a single cannula joined by a flow junction. In addition disclosed are methods of using a dual-lumen needle in a two needle access for blood treatment is disclosed in which at least venous flow is provided through a dual-lumen needle with arterial flow just sufficient to provide air infiltration detection in the event of withdrawal of the dual-lumen needle.

Claims (46)

1. A method of manufacturing a dual-lumen needle, comprising:

providing a first single lumen needle with a first metal cannula and a first plastic hub that supports the first metal cannula;

providing a monolithic junction part of plastic having three cylindrical openings, first and second of the openings being coaxial and a third opening having an axis that crosses the common axis of the first two openings;

providing a second metal cannula whose internal diameter is larger than an inner diameter of the first metal cannula;

the second opening being sized and shaped to receive the first plastic hub;

coupling the second cannula to the first opening;

inserting the first plastic hub in the second opening, including aligning the first metal cannula with the common axis of the first and second openings;

the coupling and inserting including aligning the first and second metal cannulas coaxially;

the monolithic junction part being configured such that the coupling and inserting form a fluid flow channel joining the third opening for fluid communication with an annular space coaxial with and lying between the first and second metal cannulas that is isolated from a port of the first single lumen needle; and

solvent bonding the first plastic hub to the second opening;

wherein the providing a second metal cannula includes providing the second metal cannula supported by a second plastic hub, the combination of the second metal cannula and the second plastic hub defining a second single lumen needle with a port configured for attachment to a fluid line, wherein the coupling the second cannula includes inserting the second plastic hub supporting the second cannula in the first opening.

2. The method of claim 1 , wherein the coupling the second cannula is performed before the inserting the first plastic hub.

3. The method of claim 1 , wherein the coupling the second cannula is performed after the inserting the first plastic hub.

4. The method of claim 1 , wherein at least one of the hubs has a pair of opposing wings configured for handling and taping, each wing extending from the at least one of the hubs in a radial direction perpendicular to aligned axes of the first and second cannulas.

5. A method of manufacturing a dual-lumen needle, comprising:

providing a first single lumen needle with a first cannula and a first plastic hub that supports the first cannula, the first plastic hub having a top end and a heel end, the first cannula extending from the top end, the heel end having a port for fluid communication with the first cannula;

providing a junction part of plastic having three cylindrical openings, first and second of the openings being coaxial and a third opening having an axis that crosses the common axis of the first two openings;

providing a second cannula whose internal diameter is larger than an inner diameter of the first cannula;

the second opening being sized and shaped to receive the first plastic hub;

coupling the second cannula to the first opening;

inserting the top end of the first plastic hub in the second opening, including aligning the first cannula with the common axis of the first and second openings, the heel end of the first plastic hub remaining external to the junction part after the inserting;

the coupling and inserting including aligning the first and second cannulas coaxially;

the junction part being configured such that the coupling and inserting form a fluid flow channel joining the third opening for fluid communication with an annular space coaxial with and lying between the first and second cannulas that is isolated from said port of the first single lumen needle;

wherein the providing a second cannula includes providing the second cannula supported by a second plastic hub, the combination of the second cannula and the second plastic hub defining a needle with a port configured for attachment to a fluid line, wherein the coupling the second cannula includes inserting the second plastic hub supporting the second cannula in the first opening.

6. The method of claim 5 , wherein the coupling the second cannula is performed before the inserting the first plastic hub.

7. The method of claim 5 , wherein the coupling the second cannula is performed after the inserting the first plastic hub.

8. The method of claim 5 , further comprising solvent bonding the first plastic hub to the second opening.

9. The method of claim 5 , wherein at least one of the hubs has a pair of opposing wings configured for handling and taping, each wing extending from the at least one of the hubs in a radial direction perpendicular to aligned axes of the first and second cannulas.

10. A method of manufacturing a dual-lumen needle, comprising:

providing a first single lumen butterfly needle with a first cannula and a first hub that supports the first cannula, the first single lumen butterfly needle having a first pair of wings extending from the first hub in a radial direction perpendicular to a longitudinal axis of the first cannula;

providing a junction part having three cylindrical openings, first and second of the openings being coaxial and a third opening having an axis that crosses the common axis of the first two openings;

providing a second cannula whose internal diameter is larger than an inner diameter of the first cannula;

the second opening being sized and shaped to receive the first hub;

coupling the second cannula to the first opening;

inserting the first hub in the second opening, including aligning the first cannula with the common axis of the first and second openings;

the coupling and inserting including aligning the first and second cannulas coaxially and forming a seal that defines a fluid flow channel between the third opening and an annular space between the first and second cannulas;

the junction part being configured such that the coupling and inserting form the fluid flow channel joining the third opening for fluid communication with the annular space coaxial with and lying between the first and second cannulas that is isolated from a port of the first single lumen butterfly needle.

11. The method of claim 10 , wherein the coupling the second cannula is performed before or after the inserting the first hub.

12. The method of claim 10 , wherein the forming a seal includes applying epoxy in a position that forms a part of an interior surface of the fluid flow channel.

13. The method of claim 10 , wherein:

the providing a second cannula includes providing the second cannula supported by a second hub having a second pair of wings extending from the second hub in a radial direction perpendicular to a longitudinal axis of the second cannula, the combination of the second cannula and the second hub defining a second single lumen butterfly needle with a port configured for attachment to a fluid line,

the coupling the second cannula includes inserting the second hub supporting the second cannula in the first opening, and

after the coupling the second cannula and the inserting the first hub, at least portions of the first and second pair of wings remain external to the junction part so as to be accessible to a user for handling or taping.

14. The method of claim 10 , wherein the forming the seal comprises solvent bonding the hub to the second opening.

15. The method of claim 10 , wherein the first opening of the junction part has an internal diameter that is the same as an outer diameter of the second cannula.

16. The method of claim 10 , wherein the coupling and the inserting are such that a longitudinal position of a tip of the first cannula along aligned axes of the first and second cannulas is fixed with respect to a longitudinal position of a tip of the second cannula.

Assignments (4)
RELEASE OF SECURITY INTEREST Recorded Feb 21, 2019
From: CAPITAL ONE, NATIONAL ASSOCIATION (AS SUCCESSOR BY MERGER TO HEALTHCARE FINANCIAL SOLUTIONS, LLC)
To: NXSTAGE MEDICAL, INC.
Reel/Frame 048407/0865 →
ASSIGNMENT OF INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Nov 16, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS RETIRING AGENT
To: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS SUCCESSOR AGENT
Reel/Frame 037112/0376 →
SECURITY INTEREST Recorded Jun 10, 2014
From: NXSTAGE MEDICAL, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS ADMINISTRATIVE AGENT
Reel/Frame 033123/0836 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 18, 2013
From: BURBANK, JEFFREY H.; BRUGGER, JAMES M.; TURK, JOSEPH E.
To: NXSTAGE MEDICAL, INC.
Reel/Frame 030240/0086 →