Systems and methods for delivering a fluid to a patient with reduced contamination

• US 9,931,466 B2
• Filed: 08/28/2015
• Issued: 04/03/2018
• Est. Priority Date: 10/11/2012
• Status: Active Grant

• Current Assignee: Magnolia Medical Technologies Limited
• Original Assignee: Magnolia Medical Technologies Limited
• Inventors: Bullington, Gregory J., Patton, Richard G., Gaw, Shan E.
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US14/838,794
• Publication Number:
  US 20150367069A1
• Time in Patent Office: 949 Days
• Field of Search: 604 28
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/150992 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 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61M 2039/229 Stopcocks
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407

Abstract

An apparatus includes a cannula assembly, a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing includes an inlet port removably coupled to the cannula assembly and defines an inner volume. The fluid reservoir is fluidically coupled to the housing and configured to receive and isolate a volume of bodily fluid from a patient. The flow control mechanism is at least partially disposed in the inner volume. The actuator is operably coupled to the flow control mechanism and is configured to move the flow control mechanism between a first configuration, in which bodily fluid can flow, via a fluid flow path defined by the flow control mechanism, from the cannula assembly, through the inlet port and into the fluid reservoir, to a second configuration, in which the fluid reservoir is fluidically isolated from the cannula assembly.

Claims

1. An apparatus, comprising:

a cannula assembly;

a housing including a proximal end portion and a distal end portion and defining an inner volume therebetween, the housing having an inlet port configured to be removably coupled to the cannula assembly;

a fluid reservoir coupled to the housing and configured to move from a first configuration to a second configuration to create a negative pressure in the fluid reservoir, the fluid reservoir configured to receive and isolate a first volume of bodily fluid withdrawn from the patient;

a flow control mechanism at least partially disposed in the inner volume of the housing and configured to move relative to the housing between a first configuration and a second configuration, the flow control mechanism defining a fluid flow path between the cannula assembly and the fluid reservoir in the first configuration; and

an actuator operably coupled to the flow control mechanism and configured to move the flow control mechanism from the first configuration in which the inlet port is placed in fluid communication with the fluid reservoir such that bodily fluid can flow from the cannula assembly, through the inlet port via the fluid flow path and to the fluid reservoir in response to the negative pressure, to the second configuration, in which the fluid reservoir is fluidically isolated from the cannula assembly.

2. The apparatus of claim 1, wherein the flow control mechanism includes a fluid communicator configured to be moved from a first position to a second position to place the flow control mechanism in the second configuration.

3. The apparatus of claim 2, wherein the fluid communicator is configured to extend through the inlet port and beyond the distal end portion of the housing in the first position.

4. The apparatus of claim 2, wherein the fluid communicator is configured to be retracted into the inner volume of the housing in the second position.

5. The apparatus of claim 1, wherein the flow control mechanism includes a first member movably disposed in the inner volume of the housing, and a second member coupled to the first member and configured to extend through the inlet port and beyond the distal end portion of the housing in the first configuration.

6. The apparatus of claim 5, wherein the first member includes a proximal end portion and a distal end portion, and defines a lumen therethrough.

7. The apparatus of claim 6, wherein the second member includes a proximal end portion and a distal end portion, and defines a lumen therethrough.

8. The apparatus of claim 7, wherein the proximal end portion of the second member is configured to be disposed in the lumen defined by the first member.

9. The apparatus of claim 7, wherein the distal end portion of the second member is configured to extend beyond a distal end of the cannula assembly when the flow control mechanism is in the first configuration.

10. The apparatus of claim 1, wherein the flow control mechanism includes a spring configured to expand and move the flow control mechanism from the first configuration to the second configuration.

11. The apparatus of claim 10, wherein the actuator is configured to release the spring from a compressed state when actuated by a user.

12. The apparatus of claim 1, wherein the movement of the fluid reservoir from the first configuration to the second configuration results in an increase in a volume of the fluid reservoir, the increase in the volume of the fluid reservoir configured to create the negative pressure in the fluid reservoir.

13. The apparatus of claim 1, wherein the fluid reservoir includes a proximal end portion and a distal end portion and defines an inner volume therebetween, the inner volume configured to selectively receive at least a portion of the flow control mechanism.

14. The apparatus of claim 1, wherein the fluid reservoir is moved relative to the housing from a first position to a second position to move the fluid reservoir from the first configuration to the second configuration.

15. An apparatus, comprising:

a cannula assembly;

a housing including a proximal end portion and a distal end portion and defining an inner volume therebetween, the housing having an inlet port configured to be removably coupled to the cannula assembly;

a fluid reservoir coupled to the housing and configured to move from a first position to a second position to create a negative pressure within the fluid reservoir, the fluid reservoir configured to receive and isolate a first volume of bodily fluid withdrawn from the patient;

a flow control mechanism at least partially disposed in the inner volume of the housing and configured to move relative to the housing between a first configuration and a second configuration, the flow control mechanism defining a fluid flow path between the cannula assembly and the fluid reservoir in the first configuration; and

an actuator operably coupled to the flow control mechanism and configured to move the flow control mechanism from the first configuration in which the inlet port is placed in fluid communication with the fluid reservoir such that bodily fluid can flow from the cannula assembly, through the inlet port via the fluid flow path and to the fluid reservoir in response to the negative pressure, to the second configuration, in which the fluid reservoir is fluidically isolated from the cannula assembly.

16. The apparatus of claim 15, wherein the flow control mechanism includes a fluid communicator configured to be moved from a first position to a second position to place the flow control mechanism in the second configuration.

17. The apparatus of claim 16, wherein the fluid communicator is configured to extend through the inlet port and beyond the distal end portion of the housing in the first position.

18. The apparatus of claim 16, wherein the fluid communicator is configured to be retracted into the inner volume of the housing in the second position.

19. The apparatus of claim 15, wherein the flow control mechanism includes a first member movably disposed in the inner volume of the housing, and a second member coupled to the first member and configured to extend through the inlet port and beyond the distal end portion of the housing in the first configuration.

20. The apparatus of claim 19, wherein the first member includes a proximal end portion and a distal end portion, and defines a lumen therethrough.

21. The apparatus of claim 20, wherein the second member includes a proximal end portion and a distal end portion, and defines a lumen therethrough.

22. The apparatus of claim 21, wherein the proximal end portion of the second member is configured to be disposed in the lumen defined by the first member.

23. The apparatus of claim 21, wherein the distal end portion of the second member is configured to extend beyond a distal end of the cannula assembly when the flow control mechanism is in the first configuration.

24. The apparatus of claim 15, wherein the flow control mechanism includes a spring configured to expand and move the flow control mechanism from the first configuration to the second configuration.

25. The apparatus of claim 24, wherein the actuator is configured to release the spring from a compressed state when actuated by a user.

26. The apparatus of claim 15, wherein the fluid reservoir includes a proximal end portion and a distal end portion and defines an inner volume therebetween, the inner volume configured to selectively receive at least a portion of the flow control mechanism.

27. The apparatus of claim 15, wherein the fluid reservoir is moved relative to the housing from the first position to the second position to move the fluid reservoir from a first configuration to a second configuration.