Catheter placement device including guidewire and catheter control elements

• US 10,688,281 B2
• Filed: 04/12/2018
• Issued: 06/23/2020
• Est. Priority Date: 05/14/2010
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Blanchard, Daniel B., Ribelin, Rex A., Russell, Thomas S., Stats, Jason R., Sherwood, Joshua D., Rich, Matthew C.
• Primary Examiner(s): Schmidt, Emily L
• Application Number:
  US15/951,954
• Publication Number:
  US 20180229004A1
• Time in Patent Office: 803 Days
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0618 having means for protecting only the distal tip of the needle, e.g. a needle guard
• CPC Class Codes: A61M 25/065 Guide needles
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires

Abstract

An insertion tool for inserting a catheter into a patient'"'"'s body is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component. Guidewire and catheter locking systems are also disclosed.

Claims

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

obtaining a catheter insertion tool, comprising;

a housing;

a needle distally extending from the housing, the catheter pre-disposed over the needle; and

a guidewire having a distal end pre-disposed in a lumen of the needle,

the catheter including;

a catheter hub pre-disposed in the housing;

a catheter tube extending from the catheter hub, the catheter tube including a first material from a proximal end to a distal tip; and

a reinforcement component included in the distal tip of the catheter tube, the reinforcement component including a second material more rigid than the first material;

grasping the catheter insertion tool with a first hand;

inserting a distal end of the needle into the patient; and

using the first hand to;

advance the guidewire out of a distal opening of the needle utilizing a guidewire advancement assembly; and

move the catheter over the needle utilizing a catheter advancement assembly including a proximal portion in locking engagement with the housing when the guidewire advancement assembly is in a guidewire retracted position, wherein using the first hand to advance the guidewire comprises advancing the guidewire advancement assembly to a guidewire advanced position to disengage the proximal portion of the catheter advancement assembly from the housing.

2. The method according to claim 1, wherein the guidewire advancement assembly includes a locking member designed to prevent proximal retraction of the guidewire after the catheter advancement assembly has been distally advanced from a catheter retracted position.

3. The method according to claim 1, wherein the catheter advancement assembly includes a handle assembly having a head portion and a tail portion removably attached to the catheter, the tail portion including the proximal portion of the catheter advancement assembly, wherein using the first hand to move the catheter comprises moving the handle assembly in a distal direction with respect to the housing.

4. The method according to claim 3, wherein the handle assembly includes a living hinge to enable the handle assembly to be removed from the catheter hub, further comprising detaching the handle assembly from the catheter hub.

5. The method according to claim 1, wherein the catheter advancement assembly includes a safety housing having a safety clip therein, the safety clip disposed over the needle, wherein utilizing the catheter advancement assembly comprises moving the housing in a direction away from the catheter advancement assembly until the safety clip captures the distal end of the needle.

6. The method according to claim 5, further comprising the step of detaching the catheter insertion tool from the catheter advancement assembly by continued moving of the housing in a direction away from the catheter advancement assembly until the safety housing separates from the catheter advancement assembly.

7. The method according to claim 1, wherein the step of using the first hand to move the catheter is prevented by the catheter insertion tool until using the first hand to advance the guidewire is complete.

8. The method according to claim 1, wherein the reinforcement component of the catheter comprises an annular sleeve defining at least a portion of a lumen in the distal tip of the catheter tube.

9. The method according to claim 1, wherein the second material is non-softening at an internal body temperature.

10. The method according to claim 9, wherein the second material has a melt temperature similar to a melt temperature of the first material.

11. The method according to claim 1, wherein the second material is selected from the group consisting of aromatic polyurethane, carbothane, isoplast, pebax, nylon, stainless steel, titanium, nitinol, and combinations thereof.

12. The method according to claim 1, wherein the reinforcement component of the catheter includes a radiopacifier selected from the group consisting of bismuth trioxide, barium sulfate, and combinations thereof.

13. The method according to claim 1, wherein the reinforcement component of the catheter defines a distal opening in the distal tip of the catheter tube.

14. The method according to claim 1, wherein the housing includes a top housing portion and a bottom housing portion, wherein using the first hand to move the catheter comprises utilizing a catheter advancement assembly including at least one wing extending laterally from the housing between the top portion and the bottom portion in a catheter insertion tool first position.

15. The method according to claim 14, wherein the step of using the first hand to move the catheter comprises moving the at least one wing in a distal direction with respect to the housing.

16. The method according to claim 14, wherein the housing includes a stability structure having a top portion included with the top housing portion and a bottom portion included with the bottom housing portion, wherein the bottom portion of the stability structure includes a first arm designed to spread apart from a second arm to enable the catheter to pass out of the housing, wherein moving the at least one wing in the distal direction with respect to the housing causes the first arm to spread apart from the second arm.

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

obtaining a catheter insertion tool, comprising;

a housing including;

a top housing portion;

a bottom housing portion; and

a stability structure having a top portion included with the top housing portion and a bottom portion included with the bottom housing portion, wherein the bottom portion of the stability structure includes a first arm designed to spread apart from a second arm to enable the catheter to pass out of the housing;

a needle distally extending from the housing, the catheter pre-disposed over the needle; and

a guidewire having a distal end pre-disposed in a lumen of the needle,

the catheter including;

a catheter hub pre-disposed in the housing;

a catheter tube extending from the catheter hub, the catheter tube including a first material from a proximal end to a distal tip; and

a reinforcement component included in the distal tip of the catheter tube, the reinforcement component including a second material more rigid than the first material;

grasping the catheter insertion tool with a first hand;

inserting a distal end of the needle into the patient; and

using the first hand to;

advance the guidewire out of a distal opening of the needle; and

move the catheter over the needle utilizing a catheter advancement assembly including at least one wing extending laterally from the housing between the top portion and the bottom portion in a catheter insertion tool first position by moving the at least one wing in a distal direction with respect to the housing, thereby causing the first arm of the bottom portion of the stability structure to spread apart from the second arm.

18. The method according to claim 17, wherein the catheter advancement assembly includes a safety housing having a safety clip therein, the safety clip disposed over the needle, wherein utilizing the catheter advancement assembly comprises moving the housing in a direction away from the catheter advancement assembly until the safety clip captures the distal end of the needle.

19. The method according to claim 18, further comprising the step of detaching the catheter insertion tool from the catheter advancement assembly by continued moving of the housing in a direction away from the catheter advancement assembly until the safety housing separates from the catheter advancement assembly.

20. The method according to claim 17, wherein using the first hand to move the catheter is prevented by the catheter insertion tool until using the first hand to advance the guidewire is complete.