Intravenous Catheter Insertion Device and Method of Use

• US 20080300574A1
• Filed: 07/06/2006
• Published: 12/04/2008
• 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: Hall, Gregory W., Belson, Amir, Brommer, Robert, Daniel, Scott A.
• Granted Patent: US 9,162,037 B2
• Time in Patent Office: Days
• US Class Current: 604/510
• 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• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle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;

a tubular access needle attached to a needle carrier, wherein said needle carrier is slidable 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;

and an actuator mechanism configured to selectively advance said safety guidewire out through said tubular access needle in a distal direction and subsequently to withdraw said safety guidewire and said tubular access needle in a proximal direction with respect to said tubular catheter.

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

a biasing member configured to automatically withdraw said safety guidewire and said tubular access needle in a proximal direction with respect to said tubular catheter upon actuation by said actuator mechanism.

3. The catheter insertion device of claim 2, 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;

and said actuator handle is configured to rotate laterally 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, further comprising:

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

wherein said 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.

5. The catheter insertion device of claim 4, further comprising:

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;

said biasing member having a compressed state wherein said biasing member is compressed between said front plug and said needle carrier;

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

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

7. The catheter insertion device of claim 5, further comprising:

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.

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

said safety guidewire is connected to said slider.

9. 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.

10. The catheter insertion device according to any of the preceding claims, wherein said safety guidewire has a distal portion formed into a spiral curve.

11. The catheter insertion device of claim 10, 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.

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

13. The catheter insertion device according to any of the preceding claims, 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.

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

15. The catheter insertion device according to any of the preceding claims, wherein said safety guidewire is formed from a superelastic Nickel-Titanium alloy.

16. 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 that is slidable 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, and an actuator mechanism;

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

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

advancing a distal end of said tubular catheter into the patient;

actuating said actuator mechanism to withdraw said safety guidewire and said tubular access needle in a proximal direction with respect to said tubular catheter.

17. The method of claim 16, further comprising:

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

18. The method of claim 16, wherein said actuator mechanism comprises a biasing member configured to automatically withdraw said safety guidewire and said tubular access needle in a proximal direction with respect to said tubular catheter upon actuation by said actuator mechanism.

19. The method of claim 18, wherein said catheter insertion device further comprises an interlocking member within said outer housing, which is engaged with a mating interlocking member on said needle carrier;

wherein said biasing member is initially in a compressed state and constrained by the engagement of said interlocking member with said mating interlocking member; and

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

20. The method of claim 16, 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 actuate withdrawal of said safety guidewire and said tubular access needle in a proximal direction with respect to said tubular catheter.

21. The method of claim 16, 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 out through said tubular access needle in a distal direction.

22. The method of claim 16, further comprising:

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