Vacuum Pressure Regulators for Use During Blood Collection

• US 20160089070A1
• Filed: 05/15/2013
• Published: 03/31/2016
• Est. Priority Date: 05/15/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Russ, Craig Owen, Chia, Neville Yu Leng, Crawford, Jamieson W., Smith, Kenneth James, Wilkinson, Bradley M.
• Granted Patent: US 10,888,262 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150587 by friction fit
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/15074 Needle sets comprising wings, e.g. butterfly type, for ease of handling
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61M 2039/2433 Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc
• CPC Class Codes: A61M 2039/246 being fixed along all or a part of its periphery
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: G05D 7/0113 the sensing element acting as a valve

Abstract

A regulator for in-line modulation of the flow rate of fluid during blood collection includes a fluid transfer device for transferring fluid from a patient to a collection device. The fluid transfer device comprises a fluid passageway defined by a tubular sidewall and a flexible member associated with a portion of the tubular sidewall. The flexible member is configured for movement with respect to the fluid passageway upon exposure of the fluid transfer device to a differential pressure during a blood collection procedure to prevent collapse of a patients blood vessel. The flexible member of the regulator can be a frame surrounding a flexible diaphragm. Alternatively, the flexible member can include a flexible material integrally formed within the tubular sidewall of the pressure regulator.

Claims

1. A regulator for flow modulation during fluid collection, comprising:

a fluid transfer device for transferring fluid from a patient to a collection device, the fluid transfer device comprising a fluid passageway defined by a tubular sidewall, and a flexible member associated with a portion of the tubular sidewall, wherein the flexible member is configured for movement with respect to the fluid passageway upon exposure of the fluid transfer device to a differential pressure.

2. The regulator of claim 1, wherein the flexible member forms a barrier between the fluid flowing through the fluid passageway and the atmosphere.

3. The regulator of claim 1, wherein the flexible member comprises a spring element.

4. The regulator of claim 1, wherein the collection device further comprises an evacuated tube in fluid communication with the fluid passageway and wherein connection of the collection device to the evacuated tube creates a vacuum within the fluid passageway.

5. The regulator of claim 4, wherein exposure of the fluid passageway to the vacuum creates a pressure gradient across the flexible member causing at least a portion of the flexible member to extend into the fluid passageway resulting in a restricted flow path within the fluid passageway.

6. The regulator of claim 1, wherein the flexible member comprises a frame surrounding a flexible diaphragm.

7. The regulator of claim 6, wherein the tubular sidewall of the fluid transfer device includes an open portion, and wherein the frame surrounding the flexible diaphragm is associated with the open portion such that the diaphragm is configured to extend through the open portion and into the fluid passageway upon exposure of the fluid transfer device to the differential pressure.

8. The regulator of claim 1, wherein the flexible member comprises a flexible material integrally formed within the tubular sidewall.

9. The regulator of claim 1, wherein the flexible member is configured to at least partially collapse toward the fluid passageway to restrict a flow area of the fluid passageway upon exposure of the fluid transfer device to the differential pressure.

10. The regulator of claim 1, further including a venturi channel associated with the flexible member adapted to accelerate flow of fluid through an area adjacent the flexible member upon exposure to the differential pressure.

11. The regulator of claim 10, wherein the venturi channel is adapted to cause an increased pressure drop in a flow path adjacent thereto due to an increased pressure differential across the flexible member.

12. The regulator of claim 1, further including a thumb pad associated with the flexible member adapted to enable a user to over-ride any automatic regulation of fluid flow, and to manually regulate flow of fluid through the fluid passageway.

13. A fluid transfer device for flow modulation during blood collection, comprising:

a first cannula having a patient end;

a second cannula having a non-patient end;

a hub supporting at least a portion of the first and second cannulae, wherein the first and second cannulae establish a fluid pathway;

a tube holder associated with the second cannula, the tube holder configured for receiving a blood collection tube, the blood collection tube including a seal for containing a vacuum therein; and

a regulator associated with a fluid pathway, the regulator comprising;

a blood flow passageway defined by a tubular sidewall; and

a flexible member associated with a portion of the tubular sidewall, wherein the flexible member is configured for movement with respect to the blood flow passageway upon exposure of the flexible member to a differential pressure,

wherein application of the differential pressure within the blood flow passageway causes the automatic movement of the flexible member with respect to the blood flow passageway to modulate a flow of blood moving through the blood flow passageway.

14. The fluid transfer device of claim 13, wherein the application of the differential pressure is achieved by insertion of the blood collection tube within the tube holder and piercing of the seal of the blood collection tube.

15. The fluid transfer device of claim 13, further including a thumb pad associated with the flexible member to enable a user to over-ride the automatic movement of the flexible member and to manually regulate the flow of blood through the blood flow passageway.

16. The fluid transfer device of claim 13, wherein the flexible member comprises a frame surrounding a flexible diaphragm.

17. The fluid transfer device of claim 16, wherein the tubular sidewall of the regulator includes an open portion and wherein the frame surrounding the flexible diaphragm is associated with the open portion such that the diaphragm is configured to extend through the open portion and into the blood flow passageway upon exposure of the flexible member to the differential pressure.

18. The fluid transfer device of claim 13, wherein the flexible member comprises a flexible material integrally formed within the tubular sidewall.

19. The fluid transfer device of claim 13, wherein the flexible member is configured to at least partially collapse toward the blood flow passageway to restrict a flow area of the blood flow passageway upon exposure of the fluid transfer device to the differential pressure.

20. The fluid transfer device of claim 13, further including a venturi channel associated with the flexible member adapted to accelerate the flow of fluid through an area adjacent the flexible member upon exposure to the differential pressure.

21. A fluid transfer device for flow modulation during blood collection, comprising:

a tube holder configured for receiving a blood collection tube, the blood collection tube including a seal for containing a vacuum therein, the tube holder defining a fluid pathway therein; and

a regulator associated with the fluid pathway, the regulator comprising;

a blood flow passageway defined by a tubular sidewall; and

a flexible member associated with a portion of the tubular sidewall, wherein the flexible member is configured for movement with respect to the blood flow passageway upon exposure of the flexible member to a differential pressure,

wherein application of the differential pressure within the blood flow passageway causes the automatic movement of the flexible member with respect to the blood flow passageway to modulate a flow of blood moving through the blood flow passageway.

22. The fluid transfer device of claim 21, wherein the application of the differential pressure is achieved by insertion of the blood collection tube within the tube holder and piercing of the seal of the blood collection tube.

23. The fluid transfer device of claim 21, wherein the flexible member comprises a frame surrounding a flexible diaphragm.

24. The fluid transfer device of claim 21, wherein the flexible member comprises a flexible material integrally formed within the tubular sidewall.

25. The fluid transfer device of claim 21, wherein the flexible member is configured to at least partially collapse toward the blood flow passageway to restrict a flow area of the blood flow passageway upon exposure of the fluid transfer device to the differential pressure.