Systems and methods for phlebotomy through a peripheral IV catheter

• US 10,076,272 B2
• Filed: 08/26/2014
• Issued: 09/18/2018
• 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, Briganti, Richard Thomas, Cassidy, Kenneth Todd, Levine, Marc-Alan, Martel, Mark
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US14/468,826
• Publication Number:
  US 20140364766A1
• Time in Patent Office: 1,484 Days
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150526 Curved or bent needles
• 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 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• 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 2039/0202 for taking samples
• CPC Class Codes: A61M 2039/1077 Adapters, e.g. couplings adapting a connector to one or several other connectors
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence

Abstract

An apparatus includes a catheter, an introducer having a first member and a second member, a locking mechanism coupled to a distal end of the first member and configured to couple the introducer to a peripheral intravenous line, and an actuator coupled to the catheter. The actuator is configured to move from a first configuration, in which the catheter is disposed within the introducer, toward a second configuration to move the second member to a distal position relative to the first member. A portion of a guide of the second member being distal to the first member when the second member is in the distal position. The actuator is configured to move relative to the second member to be placed in the second configuration when the second member is in its distal position such that the catheter is disposed within and extending past an end of the peripheral intravenous line.

Claims

1. An apparatus, comprising:

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

an introducer having a first member and a second member, at least a portion of the second member movably disposed in the first member between a proximal position and a distal position relative to the first member, the second member including a guide, a distal end portion of the guide being disposed in a distal position relative to the first member when the second member is in the distal position;

a locking mechanism coupled to a distal end of the first member, the locking mechanism configured to couple the introducer to a peripheral intravenous line; and

an actuator coupled to the catheter, at least a portion of the actuator disposed in the second member and configured to move from a first configuration toward a second configuration to move the second member from its proximal position to its distal position, the actuator configured to move relative to the second member to be placed in the second configuration when the second member is placed in its distal position, the catheter being disposed within the introducer when the actuator is in the first configuration and disposed within and extending past an end of the peripheral intravenous line when the actuator is in the second configuration.

2. The apparatus of claim 1, further comprising:

an adapter coupled between the introducer and the peripheral intravenous line, the adapter including a first lumen and a second lumen, the catheter extending through the first lumen when the actuator is in the second configuration.

3. The apparatus of claim 1, wherein the first member defines a channel, the second member includes a protrusion at least partially disposed in the channel, the channel configured to define a range of motion associated with the second member relative to the first member.

4. The apparatus of claim 1, wherein the distal end of the first member includes a seal configured to be in contact with at least one of an outer surface of the guide or an outer surface of the catheter to inhibit a flow of bodily fluid into a volume outside of the catheter and proximal to the seal.

5. The apparatus of claim 1, wherein the distal end of the first member includes a seal configured to define a friction fit with an outer surface of the guide when the second member is its distal position, a friction force associated with the friction fit being sufficient to at least temporarily retain the second member in a fixed position when the actuator is moved relative to the second member.

6. The apparatus of claim 1, wherein at least a portion of the catheter is at least partially disposed within the guide, the distal end portion of the guide configured to extend through at least a portion of the peripheral intravenous line when the second member is in the distal position, the catheter configured to extend through the guide member to place the distal end portion of the catheter in a distal position relative to the peripheral intravenous line when the actuator is in the second configuration.

7. The apparatus of claim 1, wherein the actuator is maintained in a fixed position relative to the second member when the actuator moves the second member from its proximal position to its distal position.

8. The apparatus of claim 1, wherein the actuator is moved in response to an applied force, an amount of the applied force sufficient to move the second member relative to the first member being less than an amount of the applied force sufficient to move the actuator relative to the second member.

9. The apparatus of claim 1, wherein the second member is configured to be rotated within the first member when the second member is moved from the proximal position to the distal position.

10. An apparatus, comprising:

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

a first introducer having a proximal end portion and a distal end portion, the distal end portion of the first introducer configured to be coupled to a peripheral intravenous line, the first introducer having an inner surface that defines a channel;

a second introducer having a proximal end portion and a distal end portion, the distal end portion of the second introducer including a guide member, at least a portion of the second introducer movably disposed in the first introducer such that a protrusion extending from an outer surface of the second introducer is disposed in the channel, the second introducer having a range of motion relative to the first introducer defined at least in part by the channel; and

an actuator coupled to the catheter and at least partially disposed in the second introducer, the actuator configured to move the second introducer through at least a portion of the range of motion to advance a distal end portion of the guide member through at least a portion of the peripheral intravenous line, the actuator configured to move from a first position relative to the second introducer, in which the catheter is disposed in the guide member, to a second position relative to the second introducer, in which the distal end portion of the catheter extends beyond a distal end of the guide member.

11. The apparatus of claim 10, wherein the channel includes a proximal end portion having a first cross-sectional area and a distal end portion having a second cross-sectional area, the second cross-sectional area being greater than the first cross-sectional area.

12. The apparatus of claim 10, wherein the range of motion defined at least in part by the channel includes a rotational range of motion associated with the second introducer about a longitudinal centerline defined by the first introducer.

13. The apparatus of claim 10, wherein the range of motion defined at least in part by the channel includes a rotational range of motion associated with the second introducer about a longitudinal centerline defined by the first introducer, the rotational range of motion being up to about 180 degrees of rotation.

14. The apparatus of claim 10, wherein the first introducer includes an inner distal surface defining a first portion of the channel and an inner proximal surface defining a second portion of the channel, the inner distal surface configured to limit movement of the second member in the distal direction, the inner proximal surface configured to limit movement of the second member in the proximal direction.

15. The apparatus of claim 10, wherein the protrusion is a first protrusion,

the proximal end portion of the second introducer including a second protrusion extending from an inner surface;

and

the actuator defining a slot configured to movably receive the second protrusion, the second protrusion configured to engage a surface of the actuator defining the slot to limit a movement of the actuator relative to the second introducer.

16. The apparatus of claim 10, wherein the guide member has a first stiffness and the catheter has a second stiffness less than the first stiffness.

17. The apparatus of claim 10, wherein the guide member has a first stiffness and the catheter has a second stiffness substantially equal to the first stiffness, the catheter being disposed within the guide member such that the guide member and the catheter collectively define a third stiffness greater than the first stiffness, the third stiffness being sufficient to allow the guide member to pass through at least the portion of the peripheral intravenous line.

18. The apparatus of claim 10, wherein the actuator includes a cannula coupled to the proximal end portion of the catheter to couple the actuator to the catheter, the cannula having a first stiffness and the catheter having a second stiffness less than the first stiffness.

19. The apparatus of claim 10, wherein the guide member has a length and a stiffness, the length and the stiffness being sufficient to pass through at least the portion of the peripheral intravenous line, the portion of the peripheral intravenous line including at least one of a hub, a basket, or a valve.

20. The apparatus of claim 10, wherein the actuator is configured to be coupled to a port, the port configured to place the lumen of the catheter in fluid communication with a fluid reservoir.

21. The apparatus of claim 10, wherein the distal end portion of the catheter has a semi-annular cross-sectional shape configured to increase a fluid flow rate through the catheter when the catheter is in the second position.

22. The apparatus of claim 10, wherein the distal end portion of the catheter is formed by a coiled wire configured to increase a flexibility of the distal end portion of the catheter to limit plastic deformation of the distal end portion when the catheter is moved from the first position toward the second position.

23. The apparatus of claim 10, wherein the catheter includes a stiffening member at least temporarily disposed within the lumen defined by the catheter, the stiffening member configured to prevent at least one of a collapse of the catheter, a deformation of the catheter, or an air embolism within the lumen defined by the catheter.

24. The apparatus of claim 10, wherein the catheter includes a stiffening member at least temporarily disposed within the lumen defined by the catheter, the stiffening member configured to at least temporarily occlude the lumen defined by the catheter.

25. A method, comprising:

coupling a fluid transfer device to a peripheral intravenous line, the fluid transfer device including an introducer having a first member, a second member movably disposed in the first member and including a guide member, an actuator movably disposed in the second member, and a catheter coupled to the actuator;

exerting a first force on the actuator, the first force being sufficient to move the second member relative to the first member from a first position, in which the guide member is disposed in the first member, to a second position, in which a distal end portion of the guide member is inserted through a port of the peripheral intravenous line;

exerting a second force on the actuator, the second force sufficient to move the actuator relative to the second member when the second member is in the second position to advance the catheter from a first position, in which the catheter is disposed in the introducer, to a second position, in which a distal end portion of the catheter extends past an end of the peripheral intravenous line;

coupling a fluid reservoir to the fluid transfer device, the fluid reservoir being fluidically coupled to the catheter; and

withdrawing a volume of bodily fluid through the lumen of the catheter into the fluid reservoir.

26. The method of claim 25, further comprising:

rotating the second member relative to the first member when the distal end portion of the catheter extends past the end of the peripheral intravenous line, the rotation of the second member configured to limit a suctioning of the distal end portion of the catheter to a vascular structure.

27. The method of claim 25, wherein at least a portion of the second force exerted on the actuator results in a rotation of the catheter relative to the first member as the catheter is advanced from the first position to the second position, the rotation of the catheter configured to facilitate the advancement of the catheter past an obstruction within at least one of the guide member, the peripheral intravenous line, or a vascular structure.

28. The method of claim 25, wherein a minimum force to move the second member relative to the first member is less than a minimum force to move the actuator relative to the second member.

29. The method of claim 25, wherein the first member of the introducer includes a seal member disposed about a portion of the guide member to define a substantially fluid tight seal, the method further comprising:

exerting a third force on the actuator after the actuator is placed in its second position, the third force configured to move the actuator from its second position toward its first position; and

exerting a fourth force on the actuator after the actuator is moved from its second position, the fourth force configured to move the actuator toward its second position,

the exerting of the third force and the fourth force configured to move the catheter relative to the peripheral intravenous line to limit occlusion of the lumen defined by the catheter, a friction force defined between the seal member and the guide member being sufficient to maintain the guide member in a substantially fixed position as the catheter is moved relative to the peripheral intravenous line.

30. The method of claim 25, wherein the guide member has a first stiffness and the catheter has a second stiffness, the first stiffness being sufficient to allow the guide member to be passed through the portion of the peripheral intravenous line, the second stiffness being less than the first stiffness.