IP Library Granted Patent US 11,998,332
Granted Patent B2
US 11,998,332 · App. 18/381,369 · Granted Jun 4, 2024

Fluid diversion mechanism for bodily-fluid sampling

Inventors: Gregory J. Bullington (Seattle, WA); Richard G. Patton (Seattle, WA); Jay M. Miazga (Langley, WA); Shan E. Gaw (Seattle, WA)
Assignee: Magnolia Medical Technologies, Inc.
A61B5/150221A61B5/1405A61B5/150099A61B5/150229A61B5/150236A61B5/150251A61B5/150946A61B5/150992A61B5/153A61B5/15003
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Quick Facts
Patent No.
US 11,998,332
App. No.
18/381,369
Granted
Jun 4, 2024
Kind
B2
Abstract

An apparatus includes a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir.

Claims (39)

1. A bodily-fluid transfer device, comprising:

a housing having an inlet port configured to be fluidically coupled to a bodily-fluid source and an outlet port configured to be fluidically coupled to a sample reservoir;

a fluid reservoir disposed in the housing and at least partially defined by the housing, the fluid reservoir configured to receive and sequester a first amount of bodily-fluid withdrawn from the bodily-fluid source; and

a flow controller disposed in an inner volume of the housing and forming a friction fit with an inner surface defining at least a portion of the inner volume, the flow controller configured to transition from (i) a first configuration in which the inlet port is in fluid communication with the fluid reservoir to facilitate a flow of the first amount of the bodily-fluid from the inlet port, through a first fluid flow path, to the fluid reservoir, to (ii) a second configuration in which the inlet port is in fluid communication with the outlet port to facilitate a flow of a second amount of the bodily-fluid from the inlet port, through a second fluid flow path, to the outlet port;

the flow controller configured to automatically transition from the first configuration to the second configuration after the first amount of the bodily-fluid flows into to the fluid reservoir.

2. The bodily-fluid transfer device of claim 1 , further comprising:

a seal member at least partially disposed in the housing and in fluid communication with the fluid reservoir.

3. The bodily-fluid transfer device of claim 2 , wherein the seal member is configured to form a substantially fluid tight seal with at least a portion of an inner surface of the housing.

4. The bodily-fluid transfer device of claim 2 , wherein the seal member allows a negative pressure differential to form in the fluid reservoir such that the first amount of the bodily-fluid flows from the inlet port and into the fluid reservoir.

5. The bodily-fluid transfer device of claim 2 , wherein the seal member defines a fluidic seal with inner walls of the housing to at least partially define the fluid reservoir such that the first amount of the bodily-fluid is contained therein.

6. The bodily-fluid transfer device of claim 1 , wherein the first amount of the bodily-fluid is less than approximately 5 ml.

7. The bodily-fluid transfer device of claim 1 , wherein the first amount of the bodily-fluid is at least a volume of a lumen of a needle fluidically coupled to the inlet port.

8. The bodily-fluid transfer device of claim 1 , wherein the first amount of the bodily-fluid is at least a volume of a lumen of a lumen-containing device fluidically coupled to the inlet port.

9. The bodily-fluid transfer device of claim 1 , wherein the first amount of the bodily-fluid is approximately 0.1 ml to approximately 5 ml.

10. The bodily-fluid transfer device of claim 1 , wherein the outlet port is fluidically isolated from the fluid reservoir when the flow controller is in the second configuration.

11. A bodily-fluid transfer device, comprising:

a housing having an inlet port configured to be fluidically coupled to a bodily-fluid source and an outlet port configured to be fluidically coupled to a sample reservoir;

a fluid reservoir disposed in the housing and at least partially defined by the housing, the fluid reservoir configured to receive a first amount of bodily-fluid withdrawn from the bodily-fluid source;

a seal member at least partially disposed in the housing to at least partially define the fluid reservoir; and

a flow controller disposed in an inner volume of the housing and forming a friction fit with an inner surface defining at least a portion of the inner volume, the flow controller configured to transition from (i) a first configuration in which the inlet port is placed in fluid communication with the fluid reservoir to facilitate a flow of the first amount of the bodily-fluid from the inlet port, through an inlet portion of the fluid reservoir, and then toward the seal member, to (ii) a second configuration in which the inlet port is placed in fluid communication with the outlet port to facilitate a flow of a second amount of the bodily-fluid from the inlet port toward the outlet port via a sampling path;

the flow controller configured to transition from the first configuration to the second configuration only after the first amount of the bodily-fluid is at least partially disposed in the fluid reservoir and without manual intervention.

12. The bodily-fluid transfer device of claim 11 , wherein the seal member is configured to form a substantially fluid tight seal with at least a portion of an inner surface of the housing.

13. The bodily-fluid transfer device of claim 11 , wherein the seal member defines a fluidic seal with inner walls of the housing to at least partially define the fluid reservoir such that the first amount of the bodily-fluid is contained therein.

14. The bodily-fluid transfer device of claim 11 , wherein the first amount of the bodily-fluid is less than approximately 5 ml.

15. The bodily-fluid transfer device of claim 11 , wherein the first amount of the bodily-fluid is at least a volume of a lumen of a lumen-containing device fluidically coupled to the inlet port.

16. The bodily-fluid transfer device of claim 11 , wherein the outlet port is fluidically isolated from the fluid reservoir when the flow controller is in the second configuration.

17. The bodily-fluid transfer device of claim 11 , wherein the seal member allows a negative pressure differential to form in the fluid reservoir such that the first amount of the bodily-fluid flows from the inlet port and into the fluid reservoir.

18. A bodily-fluid transfer device, comprising:

a housing having an inlet port configured to be fluidically coupled to a bodily-fluid source and an outlet port configured to be fluidically coupled to a sample reservoir;

a fluid reservoir disposed in the housing and at least partially defined by the housing, the fluid reservoir configured to receive and sequester a first amount of bodily-fluid withdrawn from the bodily-fluid source;

a seal member at least partially disposed in the housing to at least partially define the fluid reservoir; and

a flow controller disposed in an inner volume of the housing and forming a friction fit with an inner surface defining at least a portion of the inner volume, the flow controller configured to transition from (i) a first configuration in which the inlet port is placed in fluid communication with the fluid reservoir to facilitate a flow of the first amount of the bodily-fluid from the inlet port, through an inlet portion of the fluid reservoir, and then toward the seal member, to (ii) a second configuration in which the inlet port is placed in fluid communication with the outlet port to facilitate a flow of a second amount of the bodily-fluid from the inlet port toward the outlet port via a sampling path.

19. The bodily-fluid transfer device of claim 18 , wherein the seal member is configured to form a substantially fluid tight seal with at least a portion of an inner surface of the housing.

20. The bodily-fluid transfer device of claim 18 , wherein the seal member defines a fluidic seal with inner walls of the housing to at least partially define the fluid reservoir such that the first amount of the bodily-fluid is contained therein.

21. The bodily-fluid transfer device of claim 18 , wherein the first amount of the bodily-fluid is less than approximately 5 ml.

22. The bodily-fluid transfer device of claim 18 , wherein the first amount of the bodily-fluid is at least a volume of a lumen of a lumen-containing device fluidically coupled to the inlet port.

23. The bodily-fluid transfer device of claim 18 , wherein the outlet port is fluidically isolated from the fluid reservoir when the flow controller is in the second configuration.

24. The bodily-fluid transfer device of claim 18 , wherein the seal member allows a negative pressure differential to form in the fluid reservoir such that the first amount of the bodily-fluid flows from the inlet port and into the fluid reservoir.

25. The bodily-fluid transfer device of claim 18 , wherein the flow controller is configured to transition from the first configuration to the second configuration only after the first amount of the bodily-fluid is at least partially disposed in the fluid reservoir.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 28, 2024
From: BULLINGTON, GREGORY J.; PATTON, RICHARD G.; MIAZGA, JAY M.; GAW, SHAN E.
To: MAGNOLIA MEDICAL TECHNOLOGIES, INC.
Reel/Frame 066589/0369 →
PATENT SECURITY AGREEMENT Recorded Jan 2, 2024
From: MAGNOLIA MEDICAL TECHNOLOGIES, INC.
To: SYMBIOTIC CAPITAL AGENCY LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 066178/0969 →
Continuity (7)
Continuation 17138056 · Dec 30, 2020
Continuation 16986940 · Aug 6, 2020
Continuation 15854273 · Dec 26, 2017
Continuation 14712437 · May 14, 2015
Continuation 13904691 · May 29, 2013
Provisional Application 61652887 · May 30, 2012
Related Publication 20240041369A1 · Feb 8, 2024
Cited By (12)
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