Access device

• US 8,192,402 B2
• Filed: 04/18/2008
• Issued: 06/05/2012
• Est. Priority Date: 04/18/2007
• Status: Active Grant

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Access Scientific, LLC
• Inventors: Anderson, Janelle, Tal, Michael, Bierman, Steven F.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US12/106,119
• Publication Number:
  US 20080262430A1
• Time in Patent Office: 1,509 Days
• Field of Search: 60416501-16504, 604/164.01, 604/164.04, 604/164.07, 604/523, 604/533, 604/534, 604/535, 604/538, 604/539
• US Class Current: 604/164.1
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0693 Flashback chambers
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

An access device places a medical article within a body space of a patient. The device has a needle that includes a needle body and hub. The device further includes a dilator coaxially disposed and slideable over the needle body and a medical article. A viewing space is disposed between the dilator and the medical article with at least one passageway or conduit connecting the viewing space with the interior bore of the needle body. The passageway is defined at least in part by openings through the sides of the needle and dilator. At least a portion of the conduit or passageway can be defined by one or more grooves between the needle and dilator. The device can further include a guidewire and an interlock between the guidewire and the needle and/or dilator. The device can further include one or more stops disposed between the guidewire and the needle and/or dilator to limit the extent to which the guidewire can be moved (e.g., advanced) relative to the needle or inhibit such relative movement (e.g., backwards movement).

Claims

1. An access device for placing a medical article within a body space, comprising:

a needle having a needle body and an interior bore;

a dilator coaxially disposed about the needle body and having a dilator shaft;

a medical article coaxially disposed about the dilator;

a plurality of openings extending through a side of at least one of the needle body and the dilator shaft;

at least one opening in the other one of the needle body and dilator shaft, the plurality of openings being spaced about the one of the needle body or dilator shaft so that at least one of the plurality of openings at least partially overlaps the at least one opening in the other one of the needle body and dilator shaft when the needle body is rotationally clocked relative to the dilator shaft in a first position and in a second position, the second position being different than the first position;

a viewing space disposed between the dilator and the medical article;

at least one passageway connecting the viewing space with the interior bore of the needle body, the passageway being defined at least in part by the plurality of openings and the at least one opening;

a lock member configured to move between a lock state and an unlock state, the lock member connecting the needle to the dilator so as to inhibit at least relative axial movement between at least a portion of the needle and at least a portion of the dilator when the lock member is in at least the lock state; and

a guidewire configured to be coaxially disposed within at least a portion of the needle body, the guidewire comprising a release member separable from the lock member and configured to engage with the lock member so as to at least move the lock member from the lock state to the unlock state when the guidewire is coaxially advanced within the needle body.

2. The access device of claim 1, wherein the medical article is a catheter.

3. The access device of claim 1, wherein the medical article is a sheath.

4. The access device of claim 3, wherein the sheath comprises a body and a hub.

5. The access device of claim 3, wherein at least a portion of the sheath is clear.

6. The access device of claim 3, wherein at least a portion of the sheath is translucent.

7. The access device of claim 3, wherein at least a portion of the sheath is semi-opaque.

8. The access device of claim 3, wherein at least a portion of the sheath is transparent so as to provide a visual indication when blood or other body fluids flow into the needle body, through the plurality of openings and the at least one opening, and into the viewing space.

9. The access device of claim 1, wherein at least one of the plurality of openings at least partially overlaps the at least one opening in the other one of the needle body and dilator shaft regardless of a rotational orientation of the dilator shaft relative to the needle body.

10. The access device of claim 1, wherein the plurality of openings is irregularly spaced about the one of the needle body or dilator shaft.

11. The access device of claim 1, wherein the at least one opening and the plurality of openings define a plurality of passageways, each passageway connecting the viewing space with an interior bore of the needle body.

12. The access device of claim 1, wherein the at least one passageway has an incongruous shape between the needle outer surface and the dilator inner surface, the incongruous shape being a radial cross-sectional shape.

13. The access device of claim 12, wherein an inner side surface of the dilator shaft has an oval shape and an outer side surface of the needle body has a circular shape.

14. The access device of claim 1, wherein the viewing space is disposed at a distal portion of the medical article.

15. The access device of claim 1, wherein at least a portion of the viewing space has a linear shape along at least a portion of an axial length of the medical article.

16. The access device of claim 1, wherein at least a portion of the viewing space has a curved shape along at least a portion of an axial length of the medical article.

17. The access device of claim 1, wherein at least a portion of the viewing space has a spiral shape along at least a portion of an axial length of the medical article.

18. The access device of claim 1, wherein the viewing space has an annular shape.

19. The access device of claim 18, wherein an axial length of the viewing space is substantially coextensive with a length of the medical article.

20. The access device of claim 18, wherein an axial length of the viewing space is substantially less than a length of the medical article.

21. An access device for placing a medical article within a body space, comprising:

a needle having a needle body;

a dilator coaxially disposed about the needle body and having a dilator shaft;

a lock member configured to move between a lock state and an unlock state, the lock member connecting the needle to the dilator so as to inhibit at least relative axial movement between at least a portion of the needle and at least a portion of the dilator when the lock member is in at least the lock state;

a guidewire configured to be coaxially disposed within at least a portion of the needle body, the guidewire comprising a release member separable from the lock member and configured to engage with the lock member so as to at least move the lock member from the lock state to the unlock state when the guidewire is coaxially advanced within the needle body; and

an interlock between the guidewire and at least one of the needle and the dilator.

22. The access device of claim 21, wherein the interlock is configured to retain the guidewire to the access device.

23. The access device of claim 21 further comprising a medical article coaxially disposed about the dilator.

24. The access device of claim 21, wherein the interlock comprises an attachment connecting the guidewire to at least one area of at least one of the needle and the dilator.

25. The access device of claim 24, wherein the one area is a surface on the needle body.

26. The access device of claim 24, wherein the needle includes a needle hub, the one area being a surface on the needle hub.

27. The access device of claim 24, wherein the dilator includes a dilator hub, the one area being a surface on the dilator hub.

28. The access device of claim 24, wherein the attachment connects the guidewire to at least two areas, the two areas being on one of the needle, the dilator, and the needle and the dilator.

29. The access device of claim 24, wherein the attachment is disposed relative to the guidewire so that the guidewire does not have a full range of motion in at least one direction when moving axially relative to the needle body.

30. The access device of claim 24, wherein the attachment is disposed relative to the guidewire so that the guidewire is limited in moving in a proximal direction so as to prevent the guidewire from completely retracting into the needle body.

31. The access device of claim 24, wherein the attachment is disposed relative to the guidewire so that the guidewire is limited in moving in a distal direction so as to prevent the guidewire from completely exiting the needle body.

32. The access device of claim 24, wherein the attachment is disposed relative to the guidewire so that the guidewire is limited in moving in a distal direction so as to maintain a minimum length of the guidewire beyond a tip of the needle.

33. An access device for placing a medical article within a body space, comprising:

a needle having a needle body;

a dilator coaxially disposed about the needle body;

a lock member configured to move between a lock state and an unlock state, the lock member connecting the needle to the dilator so as to inhibit at least relative axial movement between at least a portion of the needle and at least a portion of the dilator when the lock member is in at least the lock state; and

a guidewire configured to be coaxially disposed within at least a portion of the needle body, the guidewire comprising a release member separable from the lock member and configured to engage with the lock member so as to at least move the lock member from the lock state to the unlock state when the guidewire is coaxially advanced within the needle body.

34. The access device of claim 33, wherein the release member is configured so that as the release member is moved from a separated position to engage with the lock member to move the lock member to the unlock state, the guidewire simultaneously moves with the release member.

35. The access device of claim 33, wherein the release member is configured so that when the release member engages with the lock member and moves the lock member to the unlock state, at least relative axial movement between at least a portion of the guidewire and at least a portion of at least one of the needle and the dilator is inhibited.

36. The access device of claim 33, wherein the lock member is attached to the needle and releasably attaches to the dilator.

37. The access device of claim 33, wherein the lock member is attached to the dilator and releasably attaches to the needle.

38. The access device of claim 33, wherein each of the needle and the dilator comprises a hub, the lock member connecting the hubs.

39. The access device of claim 33, wherein the guidewire comprises an end cap, the end cap comprising the release member.

40. An access device for placing a medical article within a body space, comprising:

a needle having a needle body;

a dilator coaxially disposed about the needle body and having a dilator shaft;

a lock member configured to move between a lock state and an unlock state, the lock member connecting the needle to the dilator so as to inhibit at least relative axial movement between at least a portion of the needle and at least a portion of the dilator when the lock member is in at least the lock state;

a guidewire configured to be coaxially disposed within at least a portion of the needle body, the guidewire comprising a release member separable from the lock member and configured to engage with the lock member so as to at least move the lock member from the lock state to the unlock state when the guidewire is coaxially advanced within the needle body; and

one or more stops disposed between the guidewire and at least one of the needle and the dilator.

41. The access device of claim 40, wherein the one or more stops have a maximum circumference that is greater than a minimum circumference of the guidewire.

42. The access device of claim 40, wherein the one or more stops comprise silicon.

43. The access device of claim 40, wherein the one or more stops have a generally round shape.

44. The access device of claim 40, wherein the one or more stops contacts an inner surface on the needle body at least when the guidewire is slid in a distal direction.

45. The access device of claim 40, wherein the one or more stops is disposed so as to connect the guidewire to at least an area of one of the needle and the dilator.

46. The access device of claim 40, wherein the one or more stops is disposed on the guidewire so that the guidewire does not have a full range of motion in at least one direction when moving axially relative to the needle body.

47. The access device of claim 40, wherein the one or more stops is disposed on the guidewire so that the guidewire is limited in moving in a proximal direction to prevent the guidewire from completely retracting into the needle body.

48. The access device of claim 40, wherein the one or more stops is disposed on the guidewire so that the guidewire is limited in moving in a distal direction to prevent the guidewire from completely exiting the needle body.

49. The access device of claim 40, wherein the one or more stops is disposed on the guidewire so that the guidewire is limited in moving in a distal direction to maintain a minimum length of the guidewire beyond a tip of the needle.

50. The access device of claim 40 further comprising a medical article coaxially disposed about the dilator.

51. The access device of claim 40, wherein the one or more stops are attached to the guidewire.

52. The access device of claim 51, wherein the one or more stops are movable along a length of the guidewire.

53. The access device of claim 51, wherein the one or more stops are inhibited from moving along the length of the guidewire.

54. The access device of claim 51, wherein an interference fit exists between the one or more stops and the guidewire.

55. The access device of claim 51, wherein a friction fit exists between the one or more stops and the guidewire.

56. The access device of claim 51, wherein the one or more stops are mechanically coupled to the guidewire.

57. The access device of claim 51, wherein the one or more stops are adhered to the guidewire.

58. An access device for placing a medical article within a body space, comprising:

a needle having a needle body;

a dilator coaxially disposed about the needle body;

a lock member configured to move between a lock state and an unlock state, the lock member connecting the needle to the dilator so as to inhibit at least relative axial movement between at least a portion of the needle and at least a portion of the dilator when the lock member is in at least the lock state; and

a guidewire configured to be coaxially disposed within at least a portion of the needle body, the guidewire comprising a release member separable from the lock member and configured to engage with the lock member so as to at least move the lock member from the lock state to the unlock state when the guidewire is coaxially advanced within the needle body

wherein the lock member comprises hinged clips that releasably attach to at least one of the needle and dilator, and the release member is configured to engage the hinged clips to rotate the clips and cause them to release the at least one of the needle and the dilator.