Intravenous catheter insertion device and method of use

• US 9,162,037 B2
• Filed: 07/06/2006
• Issued: 10/20/2015
• Est. Priority Date: 07/06/2005
• Status: Active Grant

• Current Assignee: Vascular Pathways, Inc. (Becton, Dickinson & Co)
• Original Assignee: Vascular Pathways, Inc. (Becton, Dickinson & Co)
• Inventors: Belson, Amir, Hall, Gregory W., Daniel, Scott A., Brommer, Robert
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): PENG, LAUREN MICHELE
• Application Number:
  US11/577,491
• Publication Number:
  US 20080300574A1
• Time in Patent Office: 3,393 Days
• Field of Search: 604/95.01, 604/156, 604/157, 604/159, 604/164.01, 604/164.09, 604/164.1, 604/164.11, 604/164.12, 604/164.13, 604/507, 604/508, 604/510, 600/585
• US Class Current: 1/1
• CPC Class Codes: A61M 2025/09133 having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 25/065 Guide needles
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: A61M 5/3232 Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
• CPC Class Codes: A61M 5/3234 Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612
• CPC Class Codes: A61M 5/3257 Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means

Abstract

An intravenous catheter insertion device and method of use are described. The insertion device coordinates movement of an access needle, a coaxial intravenous catheter and a flexible safety guidewire. A vein is punctured with the access needle, then an actuation member on the insertion device is used to advance the safety guidewire into the vein. The safety guidewire allows the access needle and the intravenous catheter to be safely advanced into the vein. Then, the actuation member is actuated to simultaneously withdraw the access needle and the safety guidewire, leaving only the intravenous catheter in the vein. The intravenous catheter is then disconnected from the insertion device and connected to a source of intravenous fluid, medication, etc.

Claims

1. A catheter insertion device, comprising:

an outer housing;

having a first end and a second end;

a tubular access needle attached to a needle carrier, wherein said needle carrier is initially fully advanced in a distal direction but slidable in a proximal direction with respect to said outer housing;

a tubular catheter releasably attached at a distal end of said outer housing and positioned coaxially around said tubular access needle;

a safety guidewire sized and configured to be advanced through said tubular access needle, wherein the safety guidewire is initially fully retracted in a proximal direction relative to said outer housing;

an actuator mechanism configured to selectively advance said safety guidewire out through said tubular access needle in a distal direction and subsequently to simultaneously withdraw said safety guidewire and said tubular access needle in a proximal direction with respect to said tubular catheter, said actuator mechanism comprising a compression spring located at a distal end of the outer housing coaxially over the tubular access needle and safety guidewire and an interlock attached at the first end to the needle and at the second end to the outer housing, which interlock can be selectively released to allow the compression spring to elongate to simultaneously withdraw said safety guidewire and said tubular access needle.

2. The catheter insertion device of claim 1, further

comprising:

an actuator handle configured to move distally with respect to said outer housing to selectively advance said safety guidewire out through said tubular access needle in a distal direction, wherein said actuator handle is configured to rotate laterally to disengage said interlock to release the needle from the outer housing and allow withdrawal of said safety guidewire and said tubular access needle in a proximal direction with respect to said tubular catheter.

3. The catheter insertion device of claim 1, further comprising:

an elongated slot in said outer housing, said elongated slot having a narrow proximal portion and a widened distal portion; and

an actuator handle is movable with respect to said elongated slot, such that said narrow proximal portion of said elongated slot constrains said actuator handle to move in a longitudinal direction to selectively advance said safety guidewire out through said tubular access needle in a distal direction and said widened distal portion allows said actuator handle to move in a lateral direction to actuate withdrawal of said safety guidewire and said tubular access needle in a proximal direction with respect to said tubular catheter.

4. The catheter insertion device of claim 3, wherein said interlock comprises a front plug affixed to said distal end of said outer housing, said front plug having a proximal end with a tab that rotatably interlocks with a spiral pawl on a distal end of said needle carrier;

wherein said spring is compressed between said front plug and said needle carrier; and

wherein the lateral movement of said actuator handle rotates said needle carrier thereby releasing said needle carrier from said front plug and allowing said spring to urge said needle carrier in a proximal direction with respect to said outer housing.

5. The catheter insertion device of claim 4, wherein said front plug further comprises a distal end having a luer slip fitting for releasable attaching said tubular catheter to said front plug.

6. The catheter insertion device of claim 4, wherein said actuator mechanism comprises:

a slider located within said outer housing, said slider connected to said actuator handle, said slider having a distal end with a projection configured to engage said needle carrier and to transfer rotation of said slider to said needle carrier to release said needle carrier from said front plug.

7. The catheter insertion device of claim 6, wherein:

said safety guidewire is connected to said slider.

8. The catheter insertion device of claim 1, further comprising:

a thumbwheel configured to rotate with respect to said outer housing to selectively advance said safety guidewire out through said tubular access needle in a distal direction.

9. The catheter insertion device of claim 1, wherein said safety guidewire has a distal portion formed into a spiral curve.

10. The catheter insertion device of claim 9, wherein said spiral curve of said safety guidewire comprises a first spiral rotation and a second spiral rotation, said first spiral rotation being of a smaller diameter than said second spiral rotation.

11. The catheter insertion device of claim 10, wherein said first spiral rotation of said spiral curve of said safety guidewire is approximately coplanar with said second spiral rotation.

12. The catheter insertion device of claim 1, wherein said safety guidewire comprises a proximal portion and a distal portion, said proximal portion having a diameter that is greater than a diameter of said distal portion.

13. The catheter insertion device of claim 12, wherein said distal portion of said safety guidewire is formed into a spiral curve.

14. The catheter insertion device of claim, wherein said safety guidewire is formed from a superelastic Nickel-Titanium alloy.

15. A method for inserting a catheter into a patient, comprising:

providing a catheter insertion device comprising an outer housing, a tubular access needle attached to a needle carrier, an interlock attached at a first end to the needle carrier and at the second end to said outer housing, a tubular catheter releasably attached at a distal end of said outer housing and positioned coaxially around said tubular access needle, a safety guidewire sized and configured to be advanced through said tubular access needle, and an actuator mechanism having a handle coupled to the safety guidewire and a compressed spring disposed coaxially over a proximal portion of the tubular access needle and the safety guidewire;

inserting a distal end of said tubular access needle into the patient;

actuating the said actuator mechanism to advance said safety guidewire out through said tubular access needle in a distal direction;

disengaging the tubular catheter from the outer housing;

advancing a distal end of said tubular catheter over the tubular access needle and the safety guidewire into the patient; and

actuating the handle of said actuator mechanism to disengage the interlock to release the needle carrier from the outer housing which allows the compressed spring to expand and engage the needle carrier and the safety guidewire to simultaneously withdraw said safety guidewire and said tubular access needle in a proximal direction with respect to said tubular catheter.

16. The method of claim 15, further comprising:

releasing said tubular catheter from said distal end of said outer housing.

17. The method of claim 15, wherein the interlock comprises a pair of interlocking members wherein a first interlocking member is disposed within said outer housing and is engaged with a mating interlocking member of said needle carrier;

wherein said compressed spring is constrained by the engagement of said first interlocking member with said mating interlocking member; and

wherein said actuator mechanism is actuated to disengage said mating interlocking member from said first interlocking member, thus releasing said compressed spring to urge said needle carrier in a proximal direction with respect to said outer housing.

18. The method of claim 15, further comprising:

moving an actuator handle distally with respect to said outer housing to selectively advance said safety guidewire out through said tubular access needle in a distal direction; and

moving said actuator handle laterally to release said compressed spring to initiate withdrawal of said safety guidewire and said tubular access needle in a proximal direction with respect to said tubular catheter.

19. The method of claim 15, wherein a distal portion of said safety guidewire is initially constrained in a straightened configuration within said tubular access needle;

and wherein said distal portion of said safety guidewire assumes a spiral curve configuration upon advancement of said safety guidewire though said tubular access needle in a distal direction.

20. The method of claim 15, further comprising:

rotating a thumbwheel with respect to said outer housing to selectively advance said safety guidewire through said tubular access needle in a distal direction.