Cartridge for automated blood sampling system

• US 9,204,833 B2
• Filed: 03/27/2012
• Issued: 12/08/2015
• Est. Priority Date: 03/27/2012
• Status: Active Grant

• Current Assignee: Phlebotics, Inc.
• Original Assignee: Phlebotics, Inc.
• Inventors: Kissinger, Peter T., Kissinger, Candice B.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Foreman, Jonathan M
• Application Number:
  US13/431,377
• Publication Number:
  US 20130261499A1
• Time in Patent Office: 1,351 Days
• Field of Search: 600/573, 604/403, 604/409
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146

Abstract

A cartridge for an automated blood sampling system for collecting samples and a method of sampling fluids from a test subject using an automated blood sampling apparatus including a cartridge are disclosed.

Claims

1. A cartridge for a fluid sampling device for collecting a fluid sample from a test subject, including:

a pump being moveable in a first direction to draw fluid into the pump and a second direction to expel fluid from the pump;

a reservoir in fluid communication with the pump;

a first conduit fluidly connecting the reservoir to a first fluid fitting configured to fluidly connect the cartridge to a tubing having a distal end inserted into the subject;

a second conduit fluidly connecting the reservoir to a second fluid fitting configured to connect the cartridge to a sample collection component; and

a third conduit fluidly connecting the reservoir to a third fluid fitting configured to connect the cartridge to a sterile fluid supply;

wherein the pump is configured to move in the first direction and second direction in response to movement of a portion of the fluid sampling device when the cartridge is operably connected to the fluid sample device and the fluid conduits are configured such that when the cartridge is operably connected to the fluid sampling device, a first valve of the fluid sampling device controls fluid flow in the first fluid conduit, a second valve of the fluid sampling device controls fluid flow in the second fluid conduit, and a third valve of the fluid sampling device controls fluid flow in the third fluid conduit;

wherein the cartridge includes at least one window through a frame configured to allow the first valve of the fluid sampling device to extend through the frame to control fluid flow in the first fluid conduit by applying compressive force to the first fluid conduit, the second valve of the fluid sampling device to extend through the frame to control fluid flow in the second fluid conduit by applying compressive force to the second fluid conduit, and the third valve of the fluid sampling device to extend through the frame to control fluid flow in the third fluid conduit by applying compressive force to the third fluid conduit, and

wherein the pump, reservoir, and fluid conduits are secured to the frame configured to be removably attached to the first valve, the second valve, and the third valve of the fluid sampling device.

2. The cartridge of claim 1, wherein the valves are pinch valves.

3. The cartridge of claim 1, wherein the cartridge is a sterilized cartridge.

4. The cartridge of claim 1, further comprising a blisterpack surrounding the pump, reservoir, fluid conduits, and fluid fittings.

5. A cartridge for a fluid sampling device for collecting a fluid sample from a test subject, including:

a pump being moveable in a first direction to draw fluid into the pump and a second direction to expel fluid from the pump;

a reservoir in fluid communication with the pump;

a first conduit fluidly connecting the reservoir to a first fluid fitting configured to fluidly connect the cartridge to a tubing having a distal end inserted into the subject;

a second conduit fluidly connecting the reservoir to a second fluid fitting configured to connect the cartridge to a sample collection component; and

a third conduit fluidly connecting the reservoir to a third fluid fitting configured to connect the cartridge to a sterile fluid supply;

wherein the pump is configured to move in the first direction and second direction in response to movement of a portion of the fluid sampling device when the cartridge is operably connected to the fluid sample device and the fluid conduits are configured such that when the cartridge is operably connected to the fluid sampling device, a first valve of the fluid sampling device controls fluid flow in the first fluid conduit, a second valve of the fluid sampling device controls fluid flow in the second fluid conduit, and a third valve of the fluid sampling device controls fluid flow in the third fluid conduit;

wherein the cartridge includes stationary elements configured to cooperate with valve elements of the fluid sampling device to control fluid flow in the fluid conduits, the valve elements being driven from the fluid sampling device into engagement with the fluid conduits against the stationary elements to restrict or prevent fluid flow through the conduit; and

wherein the pump, reservoir, and fluid conduits are secured to a frame configured to be removably attached to the first valve, the second valve, and the third valve of the fluid sampling device.

6. A cartridge for a fluid sampling device for collecting a fluid sample from a test subject, including:

a reservoir;

a first conduit fluidly connecting the reservoir to a first fluid fitting configured to fluidly connect the cartridge to a tubing having a distal end inserted into the subject;

a second conduit fluidly connecting the reservoir to a second fluid fitting configured to connect the cartridge to a sample collection component;

a third conduit fluidly connecting the reservoir to a third fluid fitting configured to connect the cartridge to a sterile fluid supply; and

a fourth conduit fluidly connecting the reservoir to a fourth fluid fitting configured to connect the cartridge to a pump being moveable in a first direction to draw fluid into the pump and a second direction to expel fluid from the pump;

wherein the fluid conduits are configured such that when the cartridge is operably connected to the fluid sampling device, a first valve of the fluid sampling device controls fluid flow in the first fluid conduit, a second valve of the fluid sampling device controls fluid flow in the second fluid conduit, and a third valve of the fluid sampling device controls fluid flow in the third fluid conduit;

wherein the cartridge includes at least one window through a frame configured to allow the first valve of the fluid sampling device to extend through the frame to control fluid flow in the first fluid conduit by applying compressive force to the first fluid conduit, the second valve of the fluid sampling device to extend through the frame to control fluid flow in the second fluid conduit by applying compressive force to the second fluid conduit, and the third valve of the fluid sampling device to extend through the frame to control fluid flow in the third fluid conduit by applying compressive force to the third fluid conduit; and

wherein the pump, reservoir, and fluid conduits are secured to the frame configured to be removably attached to the first valve, the second valve, and the third valve of the fluid sampling device.

7. The cartridge of claim 6, wherein the valves are pinch valves.

8. The cartridge of claim 6, wherein the cartridge is a sterilized cartridge.

9. The cartridge of claim 6, further comprising a blisterpack surrounding the reservoir, fluid conduits, and fluid fittings.

10. A cartridge for a fluid sampling device for collecting a fluid sample from a test subject, including:

a reservoir;

a first conduit fluidly connecting the reservoir to a first fluid fitting configured to fluidly connect the cartridge to a tubing having a distal end inserted into the subject;

a second conduit fluidly connecting the reservoir to a second fluid fitting configured to connect the cartridge to a sample collection component;

a third conduit fluidly connecting the reservoir to a third fluid fitting configured to connect the cartridge to a sterile fluid supply; and

a fourth conduit fluidly connecting the reservoir to a fourth fluid fitting configured to connect the cartridge to a pump being moveable in a first direction to draw fluid into the pump and a second direction to expel fluid from the pump;

wherein the fluid conduits are configured such that when the cartridge is operably connected to the fluid sampling device, a first valve of the fluid sampling device controls fluid flow in the first fluid conduit, a second valve of the fluid sampling device controls fluid flow in the second fluid conduit, and a third valve of the fluid sampling device controls fluid flow in the third fluid conduit;

wherein the cartridge includes stationary elements configured to cooperate with valve elements of the fluid sampling device to control fluid flow in the fluid conduits, the valve elements being driven from the fluid sampling device into contact with the fluid conduits against the stationary elements to restrict or prevent fluid flow through the conduit; and

wherein the pump, reservoir, and fluid conduits are secured to a frame configured to be removably attached to the first valve, the second valve, and the third valve of the fluid sampling device.

11. A method of collecting a fluid sample from a test subject, the method comprising:

(a) removably attaching a cartridge to a fluid sampling device including a first valve, a second valve and a third valve, the cartridge comprising;

a pump being moveable in a first direction to draw fluid into the pump and a second direction to expel fluid from the pump;

a reservoir in fluid communication with the pump, the reservoir having a first opening and a second opening;

a first conduit fluidly connecting the reservoir to a first fluid fitting configured to fluidly connect the cartridge to tubing having a distal end inserted into the subject;

a second conduit fluidly connecting the reservoir to a second fluid fitting configured to connect the cartridge to a sample collection component; and

a third conduit fluidly connecting the reservoir to a third fluid fitting configured to connect the cartridge to a sterile fluid supply;

wherein the pump is configured to move in the first direction and second direction in response to movement of a portion of the fluid sampling device when the cartridge is operably connected to the fluid sample device and the fluid conduits are configured such that when the cartridge is operably connected to the fluid sampling device, the first valve of the fluid sampling device controls fluid flow in the first fluid conduit, the second valve of the fluid sampling device controls fluid flow in the second fluid conduit, and the third valve of the fluid sampling device controls fluid flow in the third fluid conduit, each valve having an open state and a closed state; and

wherein the fluid sampling device includes a controller for controlling the pump and valve;

(b) connecting the distal end of the tubing to the subject;

(c) opening the first valve, and moving the pump in the first direction to draw sample fluid through the first conduit and into the reservoir;

thereby forming a sample fluid/sterile fluid interface;

(d) opening the second valve, and moving the pump in the second direction to force sample fluid from the reservoir through the second conduit to the sample collection component;

(e) re-opening the first valve, and moving the pump in the second direction to force the sterile fluid out of the first fluid fitting, thereby flushing the first conduit;

(f) re-opening the second valve, and moving the pump in the second direction to force the sterile fluid out of the second fluid fitting, thereby flushing the second conduit and the sample collection component, (g) opening the third valve, and moving the pump in the first direction to draw the sterile fluid through the third fluid fitting and into the pump through the first opening of the third conduit; and

(h) removing the cartridge from the fluid sampling device;

wherein steps (c)-(g) are executed by the controller.

12. The method of claim 11, wherein the controller repeats steps (c)-(g) a plurality of times in succession.

13. The method of claim 11, wherein the method further comprises prior to step (c):

actuating the pump to fill the pump with the sterile fluid;

opening second valve, and actuating the pump to fill the reservoir and the second conduit with the sterile fluid;

opening the first valve and actuating the pump to fill the first conduit with the sterile fluid;

coupling the tubing to the first fluid fitting;

opening the first valve, and actuating the pump to draw a first amount of fluid from the tubing; and

opening the first valve, and actuating the pump to return the first amount of blood through the tubing to the subject.

14. The method of claim 11, wherein the test subject is an adult human.

15. The method of claim 11, wherein the test subject is a human child.

16. The method of claim 11, wherein the cartridge includes at least one window through a frame, and removably attaching the cartridge the fluid sampling device includes extending the first valve of the fluid sampling device through a window of the at least one window and fitting the first valve around the first conduit, extending the second valve of the fluid sampling device through a window of the at least one window and fitting the second valve around the second conduit, and extending the third valve of the fluid sampling device through a window of the at least one window and fitting the third valve around the third conduit.

17. The method of claim 11, further comprising the steps of:

(i) removably attaching a second cartridge to the fluid sampling device, the second cartridge comprising;

a pump being moveable in a first direction to draw fluid into the pump and a second direction to expel fluid from the pump;

a reservoir in fluid communication with the pump, the reservoir having a first opening and a second opening;

a first conduit fluidly connecting the reservoir to a first fluid fitting configured to fluidly connect the cartridge to tubing having a distal end inserted into the subject;

a second conduit fluidly connecting the reservoir to a second fluid fitting configured to connect the cartridge to the sample collection component; and

a third conduit fluidly connecting the reservoir to a third fluid fitting configured to connect the cartridge to the sterile fluid supply

wherein the pump of the second cartridge is configured to move in the first direction and second direction in response to movement of the portion of the fluid sampling device when the cartridge is operably connected to the fluid sample device and the fluid conduits of the second cartridge are configured such that when the second cartridge is operably connected to the fluid sampling device, the first valve of the fluid sampling device controls fluid flow in the first fluid conduit, the second valve of the fluid sampling device controls fluid flow in the second fluid conduit, and the third valve of the fluid sampling device controls fluid flow in the third fluid conduit.