Catheter insertion device including top-mounted advancement components

• US 10,384,039 B2
• Filed: 05/13/2016
• Issued: 08/20/2019
• 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: Ribelin, Rex A., Blanchard, Daniel B., Rich, Matthew C.
• Primary Examiner(s): Schmidt, Emily L
• Application Number:
  US15/154,808
• Publication Number:
  US 20160256667A1
• Time in Patent Office: 1,194 Days
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• 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 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• 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 25/0693 Flashback chambers
• 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. 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 the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly with a first finger pad is included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. A catheter advancement assembly with a second finger pad is also included for selectively advancing the catheter into the patient. The finger pads are positioned such that a user can begin to advance the second finger pad after advancing the first finger pad without substantially re-positioning the thumb or finger of the user so as to successively advance the guidewire and catheter.

Claims

1. An insertion device 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 having a proximal end secured in the housing and a distal end initially positioned in the needle;

a guidewire advancement assembly including a first user engagement component configured for thumb or finger application by a user 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 including a second user engagement component configured for thumb or finger application by the user for selectively advancing the catheter in a distal direction, wherein a proximal end of the first user engagement component intersects a plane orthogonal to a longitudinal axis of the insertion device in which at least a portion of the second user engagement component lies so that the user can begin to advance the second user engagement component after advancing the first user engagement component without substantially re-positioning the thumb or finger used for the guidewire and catheter advancement.

2. The insertion device as defined in claim 1, wherein the first user engagement component is distally slidable to a distal termination point that is proximate a proximal commencement point of the second user engagement component.

3. The insertion device as defined in claim 2, wherein the first user engagement component includes a first finger pad and wherein the second user engagement component includes a second finger pad.

4. The insertion device as defined in claim 3, wherein the second finger pad defines a cove in which the first finger pad is configured to seat when the first finger pad is distally slid to the distal termination point and the second finger pad is disposed at the proximal commencement point.

5. The insertion device as defined in claim 3, wherein the second finger pad includes a curved, raised surface configured to assist the user with distal sliding of the second finger pad.

6. The insertion device as defined in claim 1, wherein the guidewire advancement assembly is configured to prevent advancement of the catheter until distal advancement of the guidewire is performed.

7. The insertion device as defined in claim 1, 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.

8. The insertion device as defined in claim 7, 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.

9. The insertion device as defined in claim 8, 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.

10. The insertion device as defined in claim 9, 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.

11. The insertion device as defined in claim 8, 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.

12. The insertion device as defined in claim 1, wherein the housing includes a stability structure configured to support the needle extending from the housing, the stability structure configured to separate upon distal advancement of the catheter to enable the catheter to exit the housing.

13. The insertion device as defined in claim 12, 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.

14. The insertion device as defined in claim 13, 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.

15. The insertion device as defined in claim 14, 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.

16. The insertion device as defined in claim 15, wherein the bottom portion of the 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.

17. The insertion device as defined in claim 16, 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.

18. The insertion device as defined in claim 17, wherein the top portion of the stability structure includes a horseshoe feature that is disposed adjacent the slot and partially about the needle.

19. The insertion device as defined in claim 18, 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.

20. The insertion device as defined in claim 19, wherein the second user engagement component include a head portion that wraps around a portion of the top housing portion, wherein distal sliding of the head portion causes upward movement of the top housing portion so as to enable passage of the catheter distally from the housing.

21. An insertion device 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 having a proximal end secured in the housing and a distal end initially positioned in the needle;

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, the guidewire advancement assembly including a sliding member with a retracted position and an extended position; and

a catheter advancement assembly for selectively advancing the catheter in a distal direction, the catheter advancement assembly including a handle laterally extending from the housing, wherein prior to actuation, a plane orthogonal to a longitudinal axis of the insertion device passes through the handle and a proximal portion of the sliding member in the sliding member extended position.

22. The insertion device as defined in claim 21, wherein the sliding member includes a finger pad slidably disposed on the housing.

23. The insertion device as defined in claim 22, wherein the insertion device is designed to be grasped by a user in a location that is at least partially proximal to the finger pad and the handle.

24. The insertion device as defined in claim 22, 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.

25. The insertion device as defined in claim 24, wherein movement of the guidewire advancement assembly is prevented when the catheter has been distally advanced by the catheter advancement assembly.

26. The insertion device as defined in claim 21, wherein the housing includes a stability structure for supporting the needle proximate an exit point of the needle from the housing.

27. The insertion device as defined in claim 26, wherein the stability structure is defined by a stability top portion included in a top portion of the housing and a stability bottom portion included in a bottom portion of the housing.

28. The insertion device as defined in claim 27, wherein the stability top portion and the stability bottom portion overlap one another.

29. The insertion device as defined in claim 28, wherein the stability bottom portion 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.

30. The insertion device as defined in claim 29, wherein the stability top portion includes a slot in the top portion of the housing, at least a portion of the first and second arms of the stability bottom portion extending through the slot prior to distal advancement of the catheter.

31. The insertion device as defined in claim 21, wherein the proximal end of the guidewire is secured to the housing, and wherein an intermediate portion of the guidewire defines a U-shaped bend.

32. The insertion device as defined in claim 21, wherein the guidewire advancement assembly is configured to prevent advancement of the catheter until distal advancement of the guidewire is performed.

33. The insertion device as defined in claim 21, 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.

34. The insertion device as defined in claim 33, 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.

35. The insertion device as defined in claim 34, 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.

36. The insertion device as defined in claim 35, 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.

37. The insertion device as defined in claim 34, 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.