Granted Patent B2

US 12,740,769 · App. 18/101,937 · Granted Sep 22, 2026

Inventors: Gregory J. Bullington (Seattle, WA); Richard G. Patton (Seattle, WA); Shan E. Gaw (Seattle, WA)

Assignee: Magnolia Medical Technologies, Inc.

A61B10/0045A61B5/150351A61B10/0096A61J1/2096A61J1/1406A61J1/201B01L2200/026B01L2300/06

Abstract

Claims (31)

1 . A method, comprising:

establishing fluid communication between a patient and a transfer adapter, a distal end portion of the transfer adapter including a port fluidically coupleable to a diversion device configured to receive bodily fluid from a patient;

transferring a first volume of bodily fluid and potential contaminants contained therein to a pre-sample reservoir of the diversion device;

inserting a portion of a sample reservoir through a proximal end portion and into an inner volume of the transfer adapter;

moving the sample reservoir to a first position such that a contact surface of the sample reservoir is in contact with a disinfection member disposed in the inner volume; and

moving the sample reservoir to a second position such that a puncture member disposed in the inner volume of the transfer adapter punctures the contact surface of the sample reservoir to place the sample reservoir in fluid communication with the port.

2 . The method of claim 1 , further comprising:

removing a seal from a surface along the proximal end portion of the transfer adapter, the seal configured to fluidically isolate an inner volume of the transfer adapter prior to the removing, the inserting the portion of the sample reservoir through the proximal end portion of the transfer adapter includes inserting the portion of the sample reservoir after removing the seal from the surface.

3 . The method of claim 1 , wherein the transferring the first volume of bodily fluid includes transferring the first volume of bodily fluid and potential contaminants contained therein from the patient to the pre-sample reservoir while the diversion device is in a first configuration.

4 . The method of claim 3 , further comprising:

transitioning the diversion device to a second configuration after the first volume of bodily fluid is in the pre-sample reservoir; and

transferring a second volume of bodily fluid to the sample reservoir while the diversion device is in the second configuration and the sample reservoir is in the second position.

5 . The method of claim 4 , wherein the establishing fluid communication between the patient and the transfer adapter includes establishing the fluid communication between the patient and the transfer adapter when the port of the transfer adapter is fluidically coupled to the diversion device and the diversion device is in the second configuration.

6 . The method of claim 4 , further comprising:

preventing the diversion device from transitioning to the second configuration prior to the first volume of bodily fluid being in the pre-sample reservoir; and

preventing the sample reservoir from moving to the second position prior to the sample reservoir moving to the first position.

7 . The method of claim 6 , wherein the contaminants potentially contained in the first volume of bodily fluid are from a first source of potential contamination and the contact surface of the sample reservoir is a second source of potential contamination, and

the second volume of bodily fluid is substantially free of contaminants from (i) the first source of potential contamination as a result of preventing the diversion device from transitioning to the second configuration prior to the first volume of bodily fluid being in the pre-sample reservoir and (ii) the second source of potential contamination as a result of preventing the sample reservoir from moving to the second position prior to the sample reservoir moving to the first position.

8 . A method, comprising:

establishing fluid communication between a patient and an inlet of a diversion device, the diversion device forming a pre-sample reservoir and an outlet that is fluidically coupled to a transfer adapter;

transferring a first volume of bodily fluid from the inlet of the diversion device to the pre-sample reservoir while the diversion device is in a first configuration, the first volume of bodily fluid at risk of containing contaminants from a first source of potential contamination;

moving a sample reservoir to a first position in an inner volume of the transfer adapter such that a contact surface of the sample reservoir is in contact with a disinfection member disposed in the inner volume, the contact surface being a second source of potential contamination;

moving the sample reservoir to a second position in the inner volume of the transfer adapter such that a puncture member disposed in the inner volume of the transfer adapter punctures the contact surface of the sample reservoir; and

transferring a second volume of bodily fluid from the inlet of the diversion device to the sample reservoir while the diversion device is in a second configuration and the sample reservoir is in the second position, the second volume of bodily fluid being substantially free of contaminants from the first source of potential contamination and the second source of potential contamination.

9 . The method of claim 8 , further comprising:

transitioning the diversion device from the first configuration to the second configuration after the first volume of bodily fluid is in the pre-sample reservoir.

10 . The method of claim 9 , wherein the diversion device is configured to prevent the transitioning from the first configuration to the second configuration prior to the first volume of bodily fluid being in the pre-sample reservoir.

11 . The method of claim 8 , wherein the diversion device includes a housing that forms the inlet and the outlet, the pre-sample reservoir being at least partially disposed in the housing.

12 . The method of claim 8 , wherein the transfer adapter is configured to prevent moving the sample reservoir to the second position prior to moving the sample reservoir to the first position.

13 . The method of claim 8 , further comprising:

coupling a distal port of the transfer adapter to the outlet of the diversion device.

Assignments (2)

Continuity (4)

References Cited (386)