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

• US 9,149,576 B2
• Filed: 10/09/2013
• Issued: 10/06/2015
• Est. Priority Date: 10/11/2012
• Status: Active Grant

• Current Assignee: Magnolia Medical Technologies Limited
• Original Assignee: Magnolia Medical Technologies Limited
• Inventors: Patton, Richard G., Gaw, Shan E., Bullington, Gregory J
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US14/049,326
• Publication Number:
  US 20140107564A1
• Time in Patent Office: 727 Days
• Field of Search: 604/28
• US Class Current: 1/1
• 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. A method of delivering a fluid to a patient using a fluid transfer device, the method comprising:

establishing fluid communication between the patient and the fluid transfer device;

disposing a flow control mechanism in a first configuration to establish fluid communication between the patient and a fluid reservoir;

withdrawing a predetermined volume of a bodily fluid from the patient;

transferring the predetermined volume of the bodily fluid to the fluid reservoir;

fluidically isolating the fluid transfer device from the fluid reservoir to sequester the predetermined volume of the bodily fluid in the fluid reservoir; and

automatically moving the flow control mechanism to a second configuration after the redetermined volume of the bodily fluid has been transferred to the fluid reservoir to establish fluid communication between the patient and a fluid source.

2. The method of claim 1, whereby sequestering the predetermined volume of the bodily fluid in the fluid reservoir establishes a sterile fluid flow path between the fluid source and the patient.

3. The method of claim 1, further comprising:

delivering fluid from the fluid source to the patient.

4. The method of claim 1, wherein the fluid reservoir includes an indicator associated with the predetermined volume of the bodily fluid, the indicator configured to indicate an amount of the predetermined volume of bodily fluid between about 0.5 milliliters (mL) to 5 mL.

5. The method of claim 1, wherein the fluid transfer device includes a cannula assembly defining a lumen configured to be placed in fluid communication with the patient, the predetermined volume of the bodily fluid being greater than a volume of the lumen and less than 5 mL.

6. A method of delivering a fluid to a patient using a fluid transfer device, the method comprising:

establishing fluid communication between the patient and a fluid reservoir defined by the fluid transfer device;

disposing a flow control mechanism in a first configuration to establish fluid communication between the patient and the fluid reservoir;

transferring a predetermined volume of a bodily fluid from the patient to the fluid reservoir;

sequestering the predetermined volume of the bodily fluid in the fluid reservoir, whereby the sequestering the predetermined volume of the bodily fluid sequesters microbes present in the predetermined volume of the bodily fluid;

automatically moving the flow control mechanism to a second configuration after the predetermined volume of the bodily fluid has been transferred to the fluid reservoir to establish fluid communication between the patient and a fluid source; and

transferring fluid from the fluid source to the patient via the fluid transfer device.

7. The method of claim 6, further comprising:

coupling the fluid transfer device to a cannula assembly prior to the establishing fluid communication between the patient and the fluid reservoir, the cannula assembly defining a lumen configured to be placed in fluid communication with the patient,

the predetermined volume of the bodily fluid being greater than a volume of the lumen defined by the cannula assembly and less than 5 mL.

8. The method of claim 6, wherein the transferring the predetermined volume of the bodily fluid is in response to a negative pressure within the fluid reservoir.

9. The method of claim 8, wherein the magnitude of the negative pressure within the fluid reservoir decreases during the transferring of the predetermined volume of the bodily fluid, the predetermined volume of the bodily fluid being transferred to the fluid reservoir while the magnitude of the pressure within the fluid reservoir is less than the magnitude of a pressure outside of the fluid reservoir.

10. The method of claim 6, wherein the fluid transfer device includes the flow control mechanism, the sequestering the predetermined volume of the bodily fluid includes moving the flow control mechanism from the first configuration, in which the flow control mechanism places the fluid reservoir in fluid communication with the patient, to the second configuration, in which the flow control mechanism (1) fluidically isolates the fluid reservoir from the patient and (2) places the fluid source in fluid communication with the patient.

11. The method of claim 6, wherein the fluid source is an external fluid source, the establishing fluid communication between the patient and the fluid source includes fluidically coupling the fluid source to the fluid transfer device.

12. A method of delivering a fluid to a patient using a fluid transfer device, the fluid transfer device including a flow control mechanism, the method comprising:

establishing fluid communication between the patient and the fluid transfer device;

disposing the flow control mechanism in a first configuration to define a first fluid flow path, the first fluid flow path placing a fluid reservoir defined by the fluid transfer device in fluid communication with the patient;

transferring a predetermined volume of a bodily fluid from the patient to the fluid reservoir;

automatically moving the flow control mechanism to a second configuration after the transferring the predetermined volume of the bodily fluid to (1) fluidically isolate the predetermined volume of the bodily fluid in the fluid reservoir and (2) define a second fluid flow path, the second fluid flow path placing a fluid source fluidically coupled to the fluid transfer device in fluid communication with the patient; and

transferring fluid from the fluid source to the patient via the second fluid flow path.

13. The method of claim 12, wherein the predetermined volume of the bodily fluid is greater than a volume associated with the first fluid flow path and less than 5 mL.

14. The method of claim 12, wherein disposing the flow control mechanism in the second configuration sequesters, in the fluid reservoir, the predetermined volume of the bodily fluid and microbes present in the predetermined volume of the bodily fluid to reduce microbial contamination within a volume of the fluid transfer device outside of the fluid reservoir.

15. The method of claim 14, wherein the second fluid flow path is a substantially sterile fluid flow path.

16. The method of claim 12, wherein the fluid transfer device includes an actuator, the method further comprising:

actuating the actuator prior to transferring the predetermined volume of the bodily fluid to move the flow control mechanism within the fluid transfer device, the transferring of the predetermined volume of the bodily fluid being in response to a negative pressure produced by the movement of the flow control mechanism.

17. The method of claim 12, wherein the fluid transfer device is coupled to a cannula assembly defining a lumen and is configured to be placed in fluid communication with the patient,

the disposing the flow control mechanism in the first configuration includes placing the first fluid flow path in fluid communication with the lumen of the cannula assembly;

and

the disposing the flow control mechanism in the second configuration includes placing the second fluid flow path in fluid communication with the lumen of the cannula assembly.