Systems and methods for phlebotomy through a peripheral IV catheter

• US 10,064,576 B2
• Filed: 11/05/2015
• Issued: 09/04/2018
• Est. Priority Date: 04/26/2011
• Status: Active Grant

• Current Assignee: Velano Vascular, Inc. (Becton, Dickinson & Co)
• Original Assignee: Velano Vascular, Inc. (Becton, Dickinson & Co)
• Inventors: Devgon, Pitamber
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US14/933,403
• Publication Number:
  US 20160051174A1
• Time in Patent Office: 1,034 Days
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/1438 using pre-evacuated means
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• 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: A61M 2039/0202 for taking samples
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

An apparatus for performing phlebotomy through a peripheral intravenous line. The apparatus includes an introducer and a catheter configured to advance the catheter through a peripheral intravenous line. A y-adapter with a port of larger diameter is configured to receive the catheter and place in fluid communication with the peripheral intravenous line. When advanced the catheter is configured to transport a bodily fluid (i.e. blood) to a volume outside of the body.

Claims

1. An apparatus, comprising:

a catheter having a proximal end portion and a distal end portion and defining a lumen extending through the proximal end portion and the distal end portion;

an introducer having a proximal end portion and a distal end portion and defining a lumen extending through the proximal end portion of the introducer and the distal end portion of the introducer, the lumen of the introducer configured to receive the catheter, the distal end portion of the introducer configured to be coupled to an indwelling peripheral intravenous line; and

an actuator coupled to the introducer, a portion of the actuator being movably disposed within the introducer and coupled to the proximal end portion of the catheter, the actuator configured to move relative to the introducer to move the catheter between a first position and a second position, the catheter disposed within the introducer when in the first position, the distal end portion of the catheter disposed beyond the distal end portion of the introducer such that at least a portion of the catheter is disposed within the indwelling peripheral intravenous line when the catheter is in the second position and the introducer is coupled to the indwelling peripheral intravenous line, the introducer having a fixed length as the actuator moves the catheter between the first position and the second position.

2. The apparatus of claim 1, further comprising:

an adapter coupled between the introducer and the indwelling peripheral intravenous line, the adapter configured to selectively place the introducer in fluid communication with the indwelling peripheral intravenous line.

3. The apparatus of claim 1, further comprising:

an adapter coupled between the introducer and the indwelling peripheral intravenous line, the adapter configured to selectively place the introducer in fluid communication with the indwelling peripheral intravenous line,

the adapter coupled to a seal configured to selectively control fluid flow through a lumen defined by the adapter.

4. The apparatus of claim 1, wherein the portion of the actuator movably disposed in the introducer is a first portion of the actuator, the actuator including a second portion, the actuator configured to move relative to the introducer in response to a force exerted on the second portion of the actuator.

5. The apparatus of claim 1, wherein the catheter is in the first position when the actuator is in a first actuator position along a length of the introducer, the catheter being moved to the second position as the actuator is moved along the length of the introducer from the first actuator position to a second actuator position along the length of the introducer.

6. The apparatus of claim 1, further comprising:

a port coupled to the proximal end portion of the introducer, the port being in fluid communication with the catheter, the port configured to place the lumen of the catheter in fluid communication with a volume outside the introducer.

7. The apparatus of claim 1, further comprising one of a sheathed needle, a locking mechanism, a syringe, or an access port coupled to the proximal end portion of the catheter.

8. The apparatus of claim 1, wherein the catheter includes a first material portion having a first stiffness and a second material portion having a second stiffness greater than the first stiffness.

9. The apparatus of claim 1, wherein the catheter has a Shore durometer of approximately 20 Shore A to approximately 50 Shore D.

10. The apparatus of claim 1, wherein the catheter is maintained entirely within the introducer when the catheter is in the first position.

11. An apparatus, comprising:

a catheter having a proximal end portion and a distal end portion and defining a lumen extending through the proximal end portion and the distal end portion;

an introducer having a proximal end portion and a distal end portion, the introducer defining a lumen extending through the proximal end portion of the introducer and the distal end portion of the introducer and configured to receive the catheter, the distal end portion of the introducer configured to be coupled to an indwelling peripheral intravenous line, the introducer defining a slot along a predetermined length of the introducer; and

an actuator coupled to the catheter, a portion of the actuator disposed within the slot defined by the introducer and movable within the slot along the predetermined length of the introducer from a first position to a second position, the catheter being disposed within the introducer when the actuator is in the first position, at least a portion of the catheter being disposed distal to the introducer when the actuator is in the second position such that, when the introducer is coupled to the indwelling peripheral intravenous line, the distal end portion of the catheter extends beyond a distal end portion of the indwelling peripheral intravenous line.

12. The apparatus of claim 11, wherein the introducer is one of integrally coupled or removably coupled to an adapter, the adapter configured to couple the introducer to the indwelling peripheral intravenous line.

13. The apparatus of claim 11, wherein the proximal end portion of the catheter is configured to be coupled to a fluid collection device.

14. The apparatus of claim 11, wherein the distal end portion of the introducer includes a locking mechanism, the locking mechanism configured to couple the introducer to the indwelling peripheral intravenous line.

15. The apparatus of claim 11, wherein the introducer has a fixed length defined between the proximal end portion of the introducer and the distal end portion of the introducer, the predetermined length being along the fixed length of the introducer.

16. An apparatus, comprising:

a catheter having a proximal end portion and a distal end portion and defining a lumen extending through the proximal end portion and the distal end portion;

an introducer having a proximal end portion and a distal end portion, the introducer defining a lumen extending through the proximal end portion of the introducer and the distal end portion of the introducer and configured to receive the catheter;

a locking mechanism coupled to the distal end portion of the introducer and configured to physically and fluidically couple the introducer to an indwelling peripheral intravenous line; and

an actuator coupled to the introducer, a portion of the actuator being movably disposed within the introducer and coupled to the proximal end portion of the catheter, the actuator configured to move relative to the introducer to move the catheter between a first position and a second position, the locking mechanism configured to fluidically isolate the catheter within the introducer when the catheter is in the first position, the locking mechanism configured to receive a portion of the catheter as the catheter is moved toward the second position, the distal end portion of the catheter disposed beyond a distal end of the indwelling peripheral intravenous line when the catheter is in the second position and the locking mechanism is coupled to the indwelling peripheral intravenous line, the introducer having a fixed length as the actuator moves the catheter between the first position and the second position.

17. The apparatus of claim 16, wherein the locking mechanism is transitioned from a first configuration, in which at least a portion of a lumen defined by the locking mechanism is substantially sealed to a second configuration, in which the lumen defined by the locking mechanism is substantially unsealed, when the locking mechanism is coupled to the indwelling peripheral intravenous line, a portion of the catheter extending through the lumen of the locking mechanism when the locking mechanism is in the second configuration and the catheter is moved to the second position.

18. The apparatus of claim 16, wherein the locking mechanism is configured to be coupled to an adapter, the adapter configured to be coupled between the locking mechanism and the indwelling peripheral intravenous line, the adapter defining at least one lumen, the catheter configured to extend through the at least one lumen of the adapter when the catheter is in the second position.

19. The apparatus of claim 16, wherein the catheter is in the first position when the actuator is disposed in a first actuator position along a predetermined length of the introducer, the catheter being moved to the second position as the actuator is moved along the predetermined length of the introducer from the first actuator position to a second actuator position, the predetermined length being along the fixed length of the introducer defined between the proximal end portion of the introducer and the distal end portion of the introducer.

20. The apparatus of claim 16, further comprising:

a port coupled to the proximal end portion of the catheter, the port being at least one of a sheathed needle, a locking mechanism, a syringe, or an access port.