Infusion and blood collection device and method

• US 9,855,386 B2
• Filed: 12/31/2013
• Issued: 01/02/2018
• Est. Priority Date: 12/31/2012
• Status: Active Grant

• Current Assignee: MedTG LLC
• Original Assignee: MedTG LLC
• Inventors: Close, Benjamin W., Hall, Thomas A.
• Primary Examiner(s): Kremer, Matthew
• Application Number:
  US14/145,717
• Publication Number:
  US 20140188002A1
• Time in Patent Office: 1,463 Days
• Field of Search: None
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• 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: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61M 2005/1416 placed on the body of the patient
• CPC Class Codes: A61M 2039/0202 for taking samples
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 5/1418 Clips, separators or the like for supporting tubes or leads
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

An infusion and blood collection device allows clean blood collections into a collection tube via a previously installed angiocatheter without interrupting the administration of intravenous therapies after initial installation. The device optionally includes passive control of the blood collection flow rate to prevent contamination of the collected blood draw with the IV therapy fluid being simultaneously infused through the angiocatheter. A blood collection method uses an infusion and blood collection device to draw a clean blood sample from a patient and into a collection tube via a previously installed angiocatheter without interrupting the administration of intravenous therapies.

Claims

1. An infusion and blood collection device for use with a patient catheter and an IV infusion line providing IV therapy fluid to the patient, comprising:

a blood collection component having a draw inlet;

a housing enclosing a valve and having an actuator and an IV infusion inlet coupled to the IV infusion line;

a blood collection channel configured to be in fluid communication with the patient catheter, the blood collection channel accessible by the draw inlet of the blood collection component;

wherein the valve includes a valve pathway configured to fluidly couple to the blood collection channel and the IV infusion inlet;

wherein the valve is configured to permit fluid flow between the blood collection channel and the IV infusion inlet via the valve pathway when the valve rotates to an infusion/non-collection mode, and wherein the valve pathway within the housing between the blood collection channel and the IV infusion inlet is configured to be blocked when the valve rotates to an infusion/collection mode;

wherein the blood collection component is releasably attached to the housing;

wherein engagement of the blood collection component with the housing is configured to rotate the valve to the infusion/collection mode, and wherein disengagement of the blood collection component from the housing is configured to rotate the valve to the infusion/non-collection mode; and

wherein the blood collection component is configured to engage with the housing with an axial movement and a rotational movement relative to the housing, the axial movement placing the draw inlet in fluid communication with the blood collection channel and the rotational movement of the blood collection component operating the valve.

2. The infusion and blood collection device of claim 1, wherein:

the valve is configured to flush blood left in the valve pathway and the blood collection channel while in the infusion/collection mode into the patient catheter with the IV therapy fluid when the valve rotates to the infusion/non-collection mode.

3. The infusion and blood collection device of claim 1,

wherein the draw inlet is configured to limit a volume flow rate of blood drawn through the patient catheter to inhibit the IV therapy fluid exiting a microlumen from entering the patient catheter in the infusion/collection mode.

4. The infusion and blood collection device of claim 3, wherein a distal end of the microlumen is configured to extend beyond the patient catheter.

5. The infusion and blood collection device of claim 4, wherein the microlumen is configured to thread coaxially through the patient catheter.

6. The infusion and blood collection device of claim 5, wherein:

the housing includes a fluid head connector for coupling to the patient catheter;

the microlumen exits the housing from within the fluid head connector; and

the blood collection channel is in fluid communication with the fluid head connector.

7. The infusion and blood collection device of claim 1, wherein the valve includes a rotary valve.

8. The infusion and blood collection device of claim 7, wherein the rotary valve is a two-way valve configured to fluidly couple to the blood collection channel and to the IV infusion inlet.

9. The infusion and blood collection device of claim 8, wherein the draw inlet of the blood collection component is extendable into the valve pathway.

10. The infusion and blood collection device of claim 1, wherein the draw inlet includes a needle positionable to extend into the valve pathway in the infusion/collection mode.

11. The infusion and blood collection device of claim 1, wherein the blood collection component is configured to fluidly couple a vacuum blood collection tube to the blood collection channel.

12. An infusion and blood collection device for use with a patient catheter and an IV infusion line providing IV therapy fluid to a patient, comprising:

a housing having an actuator and an IV infusion inlet configured to couple to the IV infusion line, wherein the actuator in a first position permits administration of the IV therapy fluid to the patient while inhibiting blood collection from the patient, and the actuator in a second position permits simultaneous administration of the IV therapy fluid to the patient and blood collection from the patient;

a blood collection component;

a microlumen configured to collocate with the patient catheter, the microlumen in fluid communication with the IV infusion inlet;

a blood collection channel configured to fluidly communicate with the patient catheter;

a passive restriction device configured to limit a volume flow rate of blood drawn by the patient catheter to inhibit the IV therapy fluid exiting the microlumen from entering the patient catheter while the IV therapy fluid is being administered;

wherein the actuator within the housing includes a pathway configured to permit fluid flow between the blood collection channel and the IV infusion inlet via the pathway when the actuator rotates to the first position, and wherein the pathway between the blood collection channel and the IV infusion inlet is configured to be blocked when the actuator rotates to the second position; and

wherein the passive restriction device is an elongate tube with an internal diameter selected to limit the volume flow rate of blood through the elongate tube, the elongate tube fluidly coupling the blood collection component and the blood collection channel; and

wherein the blood collection component is configured to engage with the housing with an axial movement and a rotational movement relative to the housing, the axial movement placing the elongated tube in fluid communication with the blood collection channel and the rotational movement of the blood collection component operating the actuator.

13. The infusion and blood collection device of claim 12, wherein:

the blood collection component is configured to fluidly couple a vacuum blood collection tube to the blood collection channel.

14. The infusion and blood collection device of claim 12, wherein a distal end of the microlumen is configured to position coaxially within the patient catheter and extend beyond the patient catheter.

15. An infusion and blood collection device for use with a patient catheter and an IV infusion line providing IV therapy fluid to a patient, comprising:

a housing having an actuator and an IV infusion inlet configured to couple to the IV infusion line, the actuator enabling at least an infusion/non-collection mode of operation and an infusion/collection mode of operation, wherein the actuator in the infusion/non-collection mode permits administration of the IV therapy fluid to the patient while inhibiting blood collection from the patient, and wherein the actuator in the infusion/collection mode permits simultaneous administration of the IV therapy fluid to the patient and blood collection from the patient;

a microlumen configured to thread coaxially through the patient catheter, a distal end of the microlumen extending beyond the patient catheter, and the microlumen being in fluid communication with the IV infusion inlet;

a blood collection channel configured to fluidly communicate with the patient catheter;

a blood collection tube holder releasably attachable to the housing and having a draw needle, wherein the draw needle is selectively in fluid communication with the blood collection channel in the infusion/collection mode, and wherein the draw needle provides a restriction limiting a volume flow rate of blood drawn by the patient catheter in the infusion/collection mode to inhibit the IV therapy fluid exiting the microlumen from reversing in a patient blood vessel and being drawn into the patient catheter;

wherein the actuator includes a pathway configured to permit fluid flow between the blood collection channel and the IV infusion inlet via the pathway when the actuator actuates to the infusion/non-collection mode, and wherein the pathway between the blood collection channel and the IV infusion inlet is configured to be blocked when the actuator actuates to the infusion/collection mode; and

wherein the blood collection tube holder is configured to engage with the housing with an axial movement and a rotational movement relative to the housing, the axial movement placing the draw needle in fluid communication with the blood collection channel and the rotational movement of the blood collection tube holder operating the actuator.

16. An infusion and blood collection device for use with a patient catheter and an IV infusion line providing IV therapy fluid to a patient, comprising:

a blood collection component having a draw inlet;

a housing having an IV infusion inlet configured to couple to the IV infusion line;

a blood collection channel configured to be in fluid communication with the patient catheter, the blood collection channel selectively accessible by the draw inlet of the blood collection component;

wherein the housing includes a valve with a valve pathway configured to fluidly couple to the blood collection channel and the IV infusion inlet;

wherein the valve is configured to permit fluid flow between the blood collection channel and the IV infusion inlet via the valve pathway when the valve actuates to an infusion/non-collection mode, and wherein the valve pathway within the housing between the blood collection channel and the IV infusion inlet is configured to be blocked when the valve actuates to an infusion/collection mode;

wherein the blood collection component is releasably attached to the housing;

wherein engagement of the blood collection component with the housing is configured to actuate the valve to the infusion/collection mode, and wherein disengagement of the blood collection component from the housing is configured to actuate the valve to the infusion/non-collection mode;

wherein the draw inlet is configured to limit a volume flow rate of blood drawn through the patient catheter to inhibit the IV therapy fluid exiting a microlumen from entering the patient catheter in the infusion/collection mode;

wherein a distal end of the microlumen is configured to extend beyond the patient catheter; and

wherein the microlumen is configured to thread coaxially through the patient catheter.

17. The infusion and blood collection device of claim 16, wherein:

the valve is configured to flush blood left in the valve pathway and the blood collection channel while in the infusion/collection mode into the patient catheter with the IV therapy fluid when the valve actuates to the infusion/non-collection mode.

18. The infusion and blood collection device of claim 16, wherein the draw inlet includes a needle positionable to extend into the valve pathway in the infusion/collection mode.

19. The infusion and blood collection device of claim 16, wherein the blood collection component is configured to fluidly couple a vacuum blood collection tube to the blood collection channel.

20. The infusion and blood collection device of claim 16, wherein:

the housing includes a fluid head connector for coupling to the patient catheter;

the microlumen exits the housing from within the fluid head connector; and

the blood collection channel is in fluid communication with the fluid head connector.

21. The infusion and blood collection device of claim 16, wherein the blood collection component is configured to engage with the housing with an axial movement and a rotational movement relative to the housing, the axial movement placing the draw inlet in fluid communication with the blood collection channel and the rotational movement of the blood collection component operating the valve.

22. The infusion and blood collection device of claim 16, wherein the valve includes a rotary valve.

23. The infusion and blood collection device of claim 22, wherein the rotary valve is a two-way valve configured to fluidly couple to the blood collection channel and selectively couple to the IV infusion inlet.

24. The infusion and blood collection device of claim 23, wherein the draw inlet of the blood collection component is extendable into the valve pathway of the rotary valve.