Method and apparatus for catheterization access

• US 5,454,790 A
• Filed: 05/09/1994
• Issued: 10/03/1995
• Est. Priority Date: 05/09/1994
• Status: Expired due to Term

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: InnerDyne, Inc. (Medtronic Plc)
• Inventors: Dubrul, William R.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/240,059
• Time in Patent Office: 512 Days
• Field of Search: 604/104, 604/105, 604/284, 604/103, 604/106, 604/107, 604/264, 604/178, 604/175, 604/163, 604/164
• US Class Current: 604/104
• CPC Class Codes: A61B 17/3474 Insufflating needles, e.g. Veress needles
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0668 splittable, tear apart

Abstract

An apparatus and method for percutaneous placement of access tubes, such as feeding and drainage tubes, vascular catheters, and the like, comprises an elastic access tube in an internal stylet. The stylet is received within a central lumen of the access tube and is used to axially elongate the tube, resulting in a reduced diameter. In a first embodiment, the diameter of the access tube is reduced sufficiently so that it can be placed through a relatively narrow penetration and so that it will radially expand by an amount sufficient to cause a tight anchor and seal against the penetration when the stylet is removed. In a second embodiment, the stylet has a sharpened distal tip which extends beyond the distal end of the access tube when in its axially extended configuration. The sharpened tip allows self-introduction of the assembly of access tube and stylet. In a third embodiment, a distal portion of the access tube is covered with a lubricous sheath. The lubricous sheath facilitates use of the assembly in combination with a dilation member which is radially expanded when the assembly of access tube and stylet is introduced therethrough.

Claims

1. An access tube assembly comprising:

an elastic access tube having a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end, wherein the tube has an intrinsic length and intrinsic outer diameter when not restrained under axial tension or radial compression;

a stylet receivable within the central lumen and coupled to the distal end of the elastic access tube; and

a removable sheath covering at least a distal portion of the elastic tube and having an inner diameter which is less than the intrinsic outer diameter of the elastic tube;

wherein the elastic access tube is releasably restrained so as to have a reduced outer diameter.

2. An access tube assembly as in claim 1, wherein the elastic access tube has an expandable anchor near its distal end.

3. An access tube assembly as in claim 2, wherein the expandable anchor is a malecot structure which is elongated and collapsed when the stylet engages the distal end of the elastic access tube.

4. An access tube assembly as in claim 2, wherein the expandable anchor is an inflatable balloon.

5. An access tube assembly as in claim 1, wherein the elastic access tube has a closed distal tip which is engaged by the stylet and at least one side port located proximally of the closed distal tip.

6. An access tube assembly as in claim 5, wherein the side port is formed by one or more axial slits which open when the access tube is not under axial tension.

7. An access tube assembly as in claim 1, further comprising a latch mechanism on the stylet for releasably securing the proximal end of the access tube, wherein the latch mechanism is located at a distance from a distal end of the stylet which is at least 20% longer than the intrinsic length of the elastic access tube.

8. An access tube assembly as in claim 7, wherein the elastic access tube has an intrinsic length in the range from 2 cm to 20 cm and an intrinsic outer diameter in the range from 2 mm to 8 mm.

9. An access tube assembly as in claim 8, further comprising a fixture on the proximal end of the elastic access tube, which fixture is secured by the latch mechanism and the latch mechanism is located at a distance from the distal end of the stylet in the range from 3 cm to 40 cm.

10. An access tube assembly as in claim 1, wherein the removable sheath is a polymeric tube having an inside diameter in the range from 2 mm to 8 mm.

11. An access tube assembly as in claim 10, wherein the polymeric tube is axially scored or split on at least one side to facilitate splitting and removing of the sheath.

12. An access tube assembly comprising:

an elastic access tube having a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end, wherein the tube has an intrinsic length and intrinsic outer diameter when not under axial tension or radial compression, and a reduced outer diameter when under an axial tension; and

a stylet having a proximal end and a distal end and being receivable within the central lumen of the elastic access tube, wherein the distal end of the stylet is detachably securable to the distal end of the access tube and is capable of applying the axial tension to the elastic tube, and the stylet includes a penetration element at its distal end for facilitating percutaneous introduction.

13. An access tube assembly as in claim 12, wherein the elastic access tube has an expandable anchor near its distal end.

14. An access tube assembly as in claim 13, wherein the expandable anchor is a malecot structure which is elongated and collapsed when the stylet engages the distal end of the elastic access tube.

15. An access tube assembly as in claim 13, wherein the expandable anchor is an inflatable balloon.

16. An access tube assembly as in claim 12, further comprising a latch mechanism on the stylet for releasably securing the proximal end of the access tube, wherein the latch mechanism is located at a distance from a distal end of the stylet which is at least 20% longer than the intrinsic length of the elastic access tube.

17. An access tube assembly as in claim 16, wherein the elastic access tube has an intrinsic length in the range from 2 cm to 20 cm and an intrinsic outer diameter in the range from 2 mm to 8 mm.

18. An access tube assembly as in claim 17, further comprising a fixture on the proximal end of the elastic access tube, which fixture is secured by the latch mechanism and the latch mechanism is located at a distance from the distal end of the stylet in the range from 3 cm to 40 cm.

19. An access tube assembly as in claim 12, wherein the penetration element comprises a sharpened distal tip which extends distally beyond the access tube when the stylet is fully received within the access tube.

20. An access tube assembly as in claim 19, wherein the stylet includes a tapered cylinder at its distal end which tapered cylinder defines an annular recess for receiving the distal end of the access tube.

21. An access tube assembly comprising:

an elongate dilation member including a radially expandable tubular body having a proximal end, a distal end, an axial lumen, and a penetration member at the distal end;

an elastic access tube having a proximal end, distal end, and a central lumen extending from the proximal end to the distal end, wherein the tube has an intrinsic length and intrinsic outer diameter when not under axial tension or radial compression; and

a stylet receivable within the central lumen and engagable against the distal end of the elastic access tube, wherein a tapered distal end is formed on the elastic access tube when under axial tension from the stylet, whereby the tapered distal end facilitates introduction of the access tube and stylet through the axial lumen of the elongate dilation member.

22. An access tube assembly as in claim 21, wherein the elongate dilation member further includes a removable sheath formed over the radially expandable tubular body, wherein the sheath covers the tubular body while the elongate dilation member is percutaneously advanced and can thereafter be removed to permit radial expansion of the tubular body as the tapered end of the elastic access tube is advanced through said tubular body.

23. An access tube assembly as in claim 21, wherein the radially expandable tubular body is an elastomeric tube or a tubular braid.

24. An access tube assembly as in claim 21, wherein the penetration member comprises an elongate penetrating element having a sharpened distal tip, which element is removedly received within the axial lumen of the radially expandable tubular body with the sharpened distal tip extending distally therefrom.

25. An access tube assembly as in claim 21, wherein the elongate dilator member further includes an expandable anchor near its distal end.

26. An access tube assembly as in claim 21, wherein the elastic access tube has an expandable anchor near its distal end.

27. An access tube assembly as in claim 26, wherein the expandable anchor is a malecot structure which is elongated and collapsed when the stylet engages the distal end of the elastic access tube.

28. An access tube assembly as in claim 26, wherein the expandable anchor is an inflatable balloon.

29. An access tube assembly as in claim 21, wherein the elastic access tube has a closed distal tip which is engaged by the stylet and at least one side port located proximally of the closed distal tip.

30. An access tube assembly as in claim 29, wherein the side port is formed by one or more axial slits which open when the access tube is not under axial tension.

31. An access tube assembly as in claim 21, further comprising a latch mechanism on the stylet for releasably securing the proximal end of the access tube, wherein the latch mechanism is located at a distance from the distal end of the stylet which is at least 20% longer than the intrinsic length of the elastic access tube.

32. An access tube assembly as in claim 31, wherein the elastic access tube has an intrinsic length in the range from 2 cm to 20 cm and an intrinsic outer diameter in the range from 2 mm to 8 mm.

33. An access tube assembly as in claim 32, further comprising a fixture on the proximal end of the elastic access tube, which fixture is secured by the latch mechanism and the latch mechanism is located at a distance from the distal end of the stylet in the range from 3 cm to 40 cm.

34. An access tube assembly as in claim 21, wherein the removable sheath is a polymeric tube having an inside diameter in the range from 2 mm to 8 mm.

35. An access tube assembly as in claim 34, wherein the polymeric tube is axially scored or slit on at least one side to facilitate splitting and removing of the sheath.

36. A method for introducing and anchoring an access tube in a tissue penetration, said method comprising:

introducing the access tube through the penetration to a target location while the access tube is under sufficient axial tension so that the outer diameter of the tube is at least 10% less than the intrinsic diameter when the tube is not under axial tension; and

releasing the axial tension so that the diameter of the tube expands and seals radially against peripheral tissue along the penetration.

37. A method as in claim 36, wherein the target location is a hollow body organ selected from the group consisting of the stomach, the intestines, the kidney, the gall bladder, chest, lungs, peritoneum, blood vessel, and bladder, or is a cyst.

38. A method as in claim 36, wherein the access tube is introduced in a previously formed tissue penetration.

39. A method as in claim 36, wherein the access tube is introduced simultaneously with forming the tissue penetration.

40. A method as in claim 39, wherein the tissue penetration is formed by advancing a penetrating element secured to a distal end of the axially tensioned access tube through the tissue to the target location.

41. A method as in claim 36, wherein the tissue penetration has an effective diameter which is less than the intrinsic diameter of the access tube and wherein sufficient axial tension is placed on the access tube to reduce the outside diameter to less than said effective diameter.

42. A method as in claim 41, wherein the effective diameter of the tissue penetration is in the range from 1 mm to 6 mm, the intrinsic diameter of the access tube is in the range from 2 mm to 8 mm, and the outer diameter of the access tube when introduced under axial tension is in the range from 2 mm to 8 mm.

43. A method as in claim 36, wherein the access tube is covered with a sheath while being introduced through the penetration, further comprising removing the sheath to permit radial expansion of the access tube.

44. A method as in claim 43, wherein the sheath is axially scored or slit along at least one side to facilitate removal.

45. A method as in claim 36, further comprising dilating the tissue being penetrated.

46. A method as in claim 45, wherein the tissue penetration is dilated prior to introducing the access tube.

47. A method as in claim 46, wherein the tissue penetration is dilated as the access tube is introduced.

48. A method as in claim 36, further comprising expanding an anchor near a distal end of the access tube on a posterior side of the tissue penetration.

49. A method as in claim 48, wherein the anchor is a malecot structure which expands as the axial tension on the access tube is released.

50. A method as in claim 48, wherein the anchor is a balloon which is inflated after the access tube has been introduced.

51. A method as in claim 36, further comprising axially extending the access tube over an internal stylet to provide the sufficient axial tension.

52. A method as in claim 51, further comprising removedly securing a proximal end of the access tube to the stylet to maintain the axial tension while the access tube is being introduced.

53. A method as in claim 52, wherein releasing the axial tension comprises releasing the proximal and of the access tube from the stylet whereby the diameter of the access tube increases.

54. A method for introducing and anchoring an access tube in a tissue penetration, said method comprising:

penetrating an elongate dilation member through tissue to a target location;

introducing the access tube through a lumen of the elongate dilation member while the access tube is under sufficient axial tension so that the outer diameter of the tube is at least 10% less than the intrinsic diameter when the tube is not under stress;

removing the elongate dilation member to leave the access tube in the tissue penetration; and

releasing the axial tension so that the diameter of the tube expands so as to dilate and seal radially against peripheral tissue along the penetration.

55. A method as in claim 54, wherein the target location is a hollow body organ selected from the group consisting of the stomach, the intestines, the kidney, the gall bladder, chest, lungs, peritoneum, blood vessel, and bladder, or is a cyst.

56. A method as in claim 54, wherein the access tube is introduced through the dilation member substantially immediately after the tissue penetration has been formed.

57. A method as in claim 54, wherein the outer diameter of the access tube when introduced under tension is larger than the lumen diameter of the elongate dilation member, whereby the diameter of the dilation member is radially expanded as the access tube is advanced from a proximal end of the member through a distal end of the member.

58. A method as in claim 57, wherein the lumen diameter of the dilation member is in the range from 1 mm to 6 mm and the outer diameter of the access tube when introduced under axial tension is in the range from 2 mm to 8 mm, and the intrinsic diameter of the access tube is in the range from 5 mm to 8 mm.

59. A method as in claim 54, wherein the access tube is covered with a sheath while being introduced through the lumen of the dilation member, further comprising removing the sheath to permit redial expansion of the access tube.

60. A method as in claim 59, wherein the sheath is axially scored along at least one side to facilitate removal.

61. A method as in claim 54, further comprising expanding on anchor near a distal end of the access tube on a posterior side of the tissue penetration.

62. A method as in claim 61, wherein the anchor is a malecot structure which expands as the axial tension on the access tube is released.

63. A method as in claim 61 wherein the anchor is a balloon which is inflated after the access tube has been introduced.

64. A method as in claim 54, further comprising axially extending the access tube over an internal stylet to provide the sufficient axial tension.

65. A method as in claim 64, further comprising removably securing a proximal end of the access tube to the stylet to maintain the axial tension while the access tube is being introduced.

66. A method as in claim 65, wherein releasing the axial tension comprises releasing the proximal end of the access tube from the stylet.

67. An access tube assembly comprising:

an elastic access tube having a proximal end, a distal end, and a radially sealed central lumen extending from the proximal end to the distal end, wherein the tube has an intrinsic length and intrinsic outer diameter when not restrained under an axial tension or a radial compression;

a stylet receivable within the central lumen and coupled to the distal end of the elastic access tube; and

a removable sheath covering at least a distal portion of the elastic tube and having an inner diameter which is less than the intrinsic outer diameter of the elastic tube;

wherein the elastic access tube is releasably restrained so as to have a reduced outer diameter.

68. An access tube assembly as claimed in claim 67, wherein the elastic access tube is releasably restrained under the radial compression by the removable sheath.

69. An access tube assembly as claimed in claim 67, wherein the elastic access tube is releasably restrained under the axial tension by the stylet.