Catheter Placement Device Including Guidewire and Catheter Control Elements

• US 20150231364A1
• Filed: 05/01/2015
• Published: 08/20/2015
• 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., Stats, Jason R., Muse, Jay A., Ribelin, Rex A., Russell, Thomas S., Sherwood, Joshua D., Sheffield, Andrew C., Rich, Matthew C.
• Granted Patent: US 9,950,139 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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. An insertion tool for inserting a catheter into a body of a patient, comprising:

a housing in which at least a portion of the catheter is initially disposed;

an at least partially hollow needle distally extending from the housing, at least a portion of the catheter pre-disposed over the needle;

a guidewire;

a guidewire advancement assembly for selectively advancing the distal end of the guidewire out a distal opening of the needle in preparation for distal advancement of the catheter; and

a catheter advancement assembly for selectively advancing the catheter in a distal direction,

wherein the insertion tool is grasped by a hand of a user during use, and wherein actuation of the guidewire advancement assembly and the catheter advancement assembly is achieved by a user without a need for relocation of the hand of the user grasping the insertion tool.

2. The insertion tool as defined in claim 1, wherein the guidewire advancement assembly includes a finger pad slidably disposed on the housing and wherein the catheter advancement assembly includes at least one wing extending from the housing.

3. The insertion tool as defined in claim 2, wherein the user grasps the housing of the insertion tool in a location that is at least partially proximal to the finger pad and the at least one wing.

4. The insertion tool as defined in claim 2, wherein the finger pad of the guidewire advancement assembly is distally slidable by a user to distally advance the guidewire out the distal opening of the needle, and wherein distal advancement of the catheter is prevented until the guidewire is fully advanced in the distal direction.

5. The insertion tool as defined in claim 4, wherein movement of the guidewire advancement assembly is prevented when the catheter has been distally advanced by the catheter advancement assembly.

6. The insertion tool as defined in claim 1, wherein the housing includes a stability structure for supporting the needle proximate an exit point of the needle from the housing.

7. The insertion tool as defined in claim 6, wherein the housing includes a top housing portion and a bottom housing portion, and wherein a stability structure is defined by portions of the top and bottom housing portions.

8. The insertion tool as defined in claim 1, wherein the guidewire includes a proximal end secured to a portion of the insertion tool, a distal end pre-disposed within the needle, and an intermediate portion substantially defining a U-shaped bend.

9. A method for inserting a catheter into a body of a patient using a catheter insertion tool, the insertion tool including a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing, a guidewire initially pre-disposed within the needle, the method comprising:

inserting the needle extending from the insertion tool into the patient;

without the need for relocation of a first hand of a user grasping the insertion tool, advancing the guidewire out a distal opening of the needle and into the patient via a guidewire advancement assembly of the insertion tool;

without the need for relocation of the first hand of the user grasping the insertion tool, advancing the catheter for insertion into the patient; and

detaching the insertion tool from the catheter.

10. The method for inserting the catheter as defined in claim 9, wherein at least one of advancing the guidewire and advancing the catheter is performed by a second hand of the user without the need for relocation of the first hand of the user grasping the insertion tool.

11. The method for inserting the catheter as defined in claim 9, wherein at least one of advancing the guidewire and advancing the catheter is performed by the first hand of the user grasping the insertion tool without the need for relocation of the first hand.

12. The method for inserting the catheter as defined in claim 9, wherein advancement of the catheter is not enabled before distal advancement of the guidewire is performed.

13. The method for inserting the catheter as defined in claim 9, wherein the housing of the insertion tool includes a stability structure configured to support the needle proximate an exit point of the needle from the housing.

14. The method for inserting the catheter as defined in claim 13, wherein advancing the catheter includes separating first and second arms of the stability structure to enable passage of the catheter past the stability structure.

15. An insertion tool for inserting a catheter into a body of a patient, comprising:

a housing in which at least a portion of the catheter is initially disposed;

a needle distally extending from the housing, at least a portion of the catheter pre-disposed over the needle;

a guidewire;

a guidewire advancement assembly for selectively distally advancing the distal end of the guidewire out a distal opening of the needle in preparation for distal advancement of the catheter; and

a catheter advancement assembly for selectively advancing the catheter in a distal direction, at least one of the guidewire advancement assembly and the catheter advancement assembly configured to prevent advancement of the catheter until distal advancement of the guidewire is performed.

16. The insertion tool as defined in claim 15, wherein at least one of the guidewire advancement assembly and the catheter advancement assembly is configured to prevent distal advancement or proximal retraction of the guidewire after the catheter has been distally advanced from an initial position.

17. The insertion tool as defined in claim 15, wherein at least one of the guidewire advancement assembly and the catheter advancement assembly is configured to prevent advancement of the catheter until full distal advancement of the guidewire is performed.

18. The insertion tool as defined in claim 15, wherein the guidewire advancement assembly includes a spring arm that is configured to engage with a pocket within the housing to prevent proximal retraction of the guidewire after full distal advancement of the guidewire is performed.

19. The insertion tool as defined in claim 18, wherein the spring arm is disposed on a guidewire lever, the guidewire lever attached to a finger pad slidably disposed on the housing, and wherein the pocket is included in a needle hub within the housing, a proximal end of the needle mounted to the needle hub.

20. The insertion tool as defined in claim 19, wherein the catheter advancement assembly includes a safety housing, a needle safety component disposed within the safety housing, the safety housing initially disposed at an initial position adjacent the needle hub, and wherein distal movement of the safety housing via the catheter advancement assembly enables a free end of the spring arm to seat in the pocket of the needle hub after full distal advancement of the guidewire is performed.

21. The insertion tool as defined in claim 20, wherein the catheter advancement assembly is configured such that proximal movement of the safety housing to the initial position adjacent the needle hub pushes the free end of the spring arm out of the pocket of the needle hub to once again enable guidewire advancement and retraction.

22. The insertion tool as defined in claim 19, wherein the guidewire lever includes an actuation block, the actuation block configured to engage a portion of the catheter advancement assembly when the guidewire is fully distally advanced, the engagement of the actuation block with the portion of the catheter advancement assembly enabling the catheter to be distally advanced.

23. The insertion tool as defined in claim 22, wherein the actuation block engages with at least one arm of a handle assembly of the catheter advancement assembly when the guidewire is fully distally advanced, the engagement of the actuation block with the arm configured to resiliently disengage a notch of the at least one arm from at least one guide post of the needle hub to enable catheter distal advancement.

24. An insertion tool for inserting a catheter into a body of a patient, comprising:

a housing in which at least a portion of the catheter is initially disposed;

a needle distally extending from the housing, at least a portion of the catheter pre-disposed over the needle;

a guidewire; and

a guidewire advancement assembly for selectively advancing the distal end of the guidewire out a distal opening of the needle in preparation for distal advancement of the catheter,

wherein the housing includes a stability structure configured to support the needle extending from the housing, the needle stability assembly configured to separate upon distal advancement of the catheter to enable the catheter to exit the housing.

25. The insertion tool as defined in claim 24, wherein the housing includes a top housing portion and a bottom housing portion, and wherein a bottom portion of the stability structure is included with the bottom housing portion and a top portion of the stability structure is included with the top housing portion, the stability structure disposed at an exit point of the needle from the housing.

26. The insertion tool as defined in claim 25, wherein the bottom portion of the stability structure is configured to be substantially flexible in a first direction and substantially rigid in a second direction and wherein the top portion of the stability structure is configured to be substantially flexible in the second direction and substantially rigid in the first direction.

27. The insertion tool as defined in claim 25, wherein the bottom and top portions of the stability structure are configured to overlap one another so as to provide the support to the needle.

28. The insertion tool as defined in claim 27, wherein the bottom stability structure includes first and second arms that are laterally spreadable so as to enable the catheter to pass the first and second arms when the catheter advancement assembly is distally advanced.

29. The insertion tool as defined in claim 28, wherein the top portion of the stability structure is included on a distal portion of the top housing portion, the top portion of the stability structure being vertically flexible and including a slot defined in the distal portion of the top housing portion, the first and second arms of the bottom portion of the stability structure extending partially through the slot before distal advancement of the catheter occurs so as to provide the support for the needle.

30. The insertion tool as defined in claim 29, wherein the top portion of the stability structure includes a horseshoe feature that is disposed adjacent the slot and partially about the needle.

31. The insertion tool as defined in claim 30, wherein upon distal advancement of the catheter the catheter advancement assembly is configured to impinge on the top housing portion so as to cause the first and second arms of the bottom portion of the stability structure to recede from the slot of the top portion of the stability structure, the catheter spreading the first and second arms to enable passage of the catheter.

32. The insertion tool as defined in claim 24, wherein the guidewire includes a rigid portion that is disposed adjacent a distal end of the needle upon full distal advancement of the guidewire, the rigid portion configured to prevent piercing of the catheter by the distal end of the needle.

33. The insertion tool as defined in claim 32, wherein the rigid portion includes a sleeve that is included on the guidewire.

34. The insertion tool as defined in claim 24, wherein the guidewire includes a notch, the notch configured to provide a preferential break point for the guidewire, a portion of the guidewire that is distal to the notch including a length that is sufficient to safely remove the guidewire from the patient.

35. The insertion tool as defined in claim 24, wherein a distal portion of the catheter includes a reinforcement structure configured to prevent collapse of the distal portion of the catheter during aspiration of fluids through the catheter.

36. The insertion tool as defined in claim 35, wherein the reinforcement structure includes an annular sleeve that is included in a wall of the catheter.

37. An insertion tool for inserting a catheter into a body of a patient, comprising:

a housing in which at least a portion of the catheter is initially disposed;

a needle distally extending from the housing, at least a portion of the catheter pre-disposed over the needle;

a guidewire; and

a guidewire advancement assembly for selectively advancing the distal end of the guidewire out a distal opening of the needle in preparation for distal advancement of the catheter,

wherein the guidewire includes a rigid portion that is disposed adjacent a distal end of the needle upon at least partial distal advancement of the guidewire.

38. The insertion tool as defined in claim 37, wherein the rigid portion is configured to prevent piercing of the catheter by the distal end of the needle.

39. The insertion tool as defined in claim 37, wherein the rigid portion includes a sleeve that is included on the guidewire.

40. The insertion tool as defined in claim 37, wherein the guidewire includes a notch, the notch configured to provide a preferential break point for the guidewire, a portion of the guidewire that is distal to the notch including a length that is sufficient to safely remove the guidewire from the patient.

41. A catheter assembly, comprising:

an elongate catheter tube defining at least one lumen extending between a proximal end and a distal end, the distal end defining at least one distal opening; and

an annular reinforcement component included proximate the distal end of the catheter tube, the reinforcement component configured to prevent collapse of the at least one distal opening during aspiration of a fluid through the at least one lumen.

42. The catheter assembly as defined in claim 41, wherein the reinforcement component includes a thermoplastic.

43. The catheter assembly as defined in claim 41, wherein the reinforcement component defines a portion of the at least one distal opening.

44. The catheter assembly as defined in claim 41, wherein the reinforcement component is integrated with the catheter tube via an radiofrequency tipping process.

45. An insertion tool for inserting a catheter into a body of a patient, comprising:

a housing in which at least a portion of the catheter is initially disposed;

a needle distally extending from the housing, at least a portion of the catheter pre-disposed over the needle;

a guidewire;

a guidewire advancement assembly for selectively distally advancing the distal end of the guidewire out a distal opening of the needle in preparation for distal advancement of the catheter; and

a catheter advancement assembly for selectively advancing the catheter in a distal direction, the catheter advancement assembly including a handle assembly, at least one of the guidewire advancement assembly and the handle assembly configured to prevent advancement of the catheter until distal advancement of the guidewire is performed.

46. The insertion tool as defined in claim 45, wherein the handle assembly includes a head portion and a tail portion, the head portion and the tail portion removably attached to the catheter, the tail portion being engageable with the guidewire advancement assembly to selectively enable distal advancement of the catheter.

47. The insertion tool as defined in claim 45, wherein the catheter includes a catheter hub, the handle assembly removably attached to the catheter hub, wherein a valve is removably included in the catheter hub, wherein a safety housing is removably disposed in the valve, the safety housing configured to be removed in a lateral direction, and wherein the handle assembly and catheter hub are configured to separate from one another in a vertical direction.

48. The insertion tool as defined in claim 47, wherein the valve includes at least one laterally extending rib to assist in removal of the valve from the catheter hub.

49. The insertion tool as defined in claim 45, wherein the catheter includes a catheter hub, the handle assembly removably attached to the catheter hub, the handle assembly including a living hinge configured to enable the handle assembly to be selectively removed from the catheter hub.

50. The insertion tool as defined in claim 49, wherein the handle assembly includes a valve that is removably disposed in the catheter hub.

51. The insertion tool as defined in claim 45, wherein the handle assembly includes first and second wings, the wings including ridges to assist with user grasping of the wings.