Syringe-based fluid diversion mechanism for bodily fluid sampling

Patent metadata

Field	Value
Publication number	US-12502109-B2
Application number	US-202318380259-A
Country	US
Kind code	B2
Filing date	Oct 16, 2023
Priority date	Nov 30, 2012
Publication date	Dec 23, 2025
Grant date	Dec 23, 2025

Abstract

A bodily-fluid transfer device includes a housing, a pre-sample reservoir, and an actuator. The housing defines an inner volume between a substantially open proximal end portion and a distal end portion that includes a port couplable to a lumen-defining device. The pre-sample reservoir is fluidically couplable to the port to receive a first volume of bodily fluid. The actuator is at least partially disposed in the inner volume and has a proximal end portion that includes an engagement portion and a distal end portion that includes a sealing member. The engagement portion is configured to allow a user to selectively move the actuator between a first configuration such that bodily fluid can flow from the port to the pre-sample reservoir, and a second configuration such that bodily fluid can flow from the port to a sample reservoir defined at least in part by the sealing member and the housing.

First claim

The invention claimed is:

1 . A blood transfer system, comprising:
a lumen-containing device fluidically coupleable to a patient; and a blood transfer device having an inlet port in fluid communication with the lumen-containing device, the blood transfer device having a channel defining at least a portion of a first fluid flow path that receives a first volume of blood, the blood transfer device having a valve disposed in the first fluid flow path and configured to transition between a closed configuration in which the valve contacts a valve seat to form a substantially fluid tight seal and an open configuration in which at least a portion of the first volume of blood flows in the first fluid flow path toward the valve, the channel extending from a proximal end of the inlet port when the portion of the first volume of blood flows in the first fluid flow path toward the valve, the valve transitions from the closed configuration to the open configuration in response to a difference in pressure between a valve inlet and a valve outlet, the valve automatically returns to the closed configuration in response to an equalization of pressure between the valve inlet and the valve outlet, the blood transfer device including a second fluid flow path that is separate from the channel and configured to receive a second volume of blood from the patient when the valve is in the closed configuration, the valve in the closed configuration allowing negative pressure within the second fluid flow path to draw a second volume of blood through a portion of the second fluid flow path.

2 . The blood transfer system of claim 1 , wherein the valve in the open configuration allows at least the portion of the first volume of blood to flow via the first fluid flow path past the valve.

3 . The blood transfer system of claim 1 , wherein the valve in the closed configuration substantially prevents the portion of the first volume of blood from contaminating the second volume of blood as the second volume of blood is drawn into the second fluid flow path.

4 . The blood transfer system of claim 1 , wherein the second fluid flow path includes at least a portion of the first fluid flow path.

5 . The blood transfer system of claim 1 , wherein the valve automatically returns to the closed configuration after the portion of the first volume of blood is received into the blood transfer device.

6 . A blood transfer system, comprising:
a lumen-containing device fluidically coupleable to a patient; and a blood transfer device having an inlet port in fluid communication with the lumen-containing device, the blood transfer device having a channel defining at least a portion of a first fluid flow path that receives a first volume of blood, the blood transfer device having a valve disposed in the first fluid flow path and configured to transition between a closed configuration in which the valve contacts a valve seat to form a substantially fluid tight seal and an open configuration in which at least a portion of the first volume of blood flows in the first fluid flow path toward the valve, the channel extending from a proximal end of the inlet port when the portion of the first volume of blood flows in the first fluid flow path toward the valve, the valve transitions from the closed configuration to the open configuration in response to a difference in pressure between a valve inlet and a valve outlet, the valve automatically returns to the closed configuration in response to an equalization of pressure between the valve inlet and the valve outlet, the blood transfer device including a second fluid flow path that is separate from the channel, the second fluid flow path configured to receive a second volume of blood from the patient when the valve is in the closed configuration and to provide the second volume of blood substantially free of contaminants from the portion of the first volume of blood into a sample container containing a culture medium.

7 . The blood transfer system of claim 6 , wherein the valve in the open configuration allows at least the portion of the first volume of blood to flow via the first fluid flow path past the valve.

8 . The blood transfer system of claim 6 , wherein the second fluid flow path includes at least a portion of the first fluid flow path.

9 . The blood transfer system of claim 6 , wherein the valve automatically returns to the closed configuration after the portion of the first volume of blood is received into the blood transfer device.

10 . A blood transfer system, comprising:
a lumen-containing device fluidically coupleable to a patient; and a blood transfer device having an inlet port in fluid communication with the lumen-containing device, the blood transfer device having a housing and a channel at least partially disposed in the housing, the channel defining at least a portion of a first fluid flow path that receives a first volume of blood, the blood transfer device having a valve disposed in the first fluid flow path and configured to transition between a closed configuration in which the valve contacts a valve seat to form a substantially fluid tight seal and an open configuration in which at least a portion of the first volume of blood is received into the blood transfer device via the first fluid flow path, the channel extending from a proximal end of the inlet port when the portion of the first volume of blood flows in the first fluid flow path toward the valve, the valve transitions from the closed configuration to the open configuration in response to a difference in pressure between a valve inlet and a valve outlet, the valve automatically returns to the closed configuration in response to an equalization of pressure between the valve inlet and the valve outlet, the housing including a second fluid flow path that receives a second volume of blood from the patient when the valve is in the closed configuration, the valve in the closed configuration enabling negative pressure within the second fluid flow path to draw a second volume of blood through a portion of the second fluid flow path that is separate from the channel.

11 . The blood transfer system of claim 10 , wherein the valve in the open configuration allows at least the portion of the first volume of blood to flow via the first fluid flow path past the valve.

12 . The blood transfer system of claim 10 , wherein the valve in the closed configuration substantially prevents the portion of the first volume of blood from contaminating the second volume of blood as the second volume of blood is drawn into the portion of the second fluid flow path.

13 . The blood transfer system of claim 10 , wherein the second fluid flow path includes at least a portion of the first fluid flow path.

14 . The blood transfer system of claim 10 , wherein the valve automatically returns to the closed configuration after the portion of the first volume of blood is received into the blood transfer device.

Assignees

• Magnolia Medical Technologies Inc

Inventors

• Bullington Gregory J
• Patton Richard G
• Gaw Shan E

Classifications

• A61B5/150633

  Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves · CPC title

• A61B5/150389

  Hollow piercing elements, e.g. canulas, needles, for piercing the skin · CPC title

• A61B5/150343

  Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes (sampling from within body cavities A61B5/150015, A61B5/150045) · CPC title

• A61B5/1405

  Devices for taking blood samples (devices for taking samples of other body liquids A61B10/0045) · CPC title

• A61B5/1438

  using pre-evacuated means · CPC title