Medical guide element with diameter transition

• US 8,485,969 B2
• Filed: 09/18/2008
• Issued: 07/16/2013
• Est. Priority Date: 09/18/2008
• Status: Active Grant

• Current Assignee: Jeffrey Grayzel, Joseph Grayzel
• Original Assignee: Jeffrey Grayzel, Joseph Grayzel
• Inventors: Grayzel, Jeffrey, Grayzel, Joseph
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US12/233,272
• Publication Number:
  US 20100069880A1
• Time in Patent Office: 1,762 Days
• Field of Search: 600/184, 600/585, 604104-109, 606/190, 606/191, 606/197
• US Class Current: 600/184
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• 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 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2210/1021 Abdominal cavity
• CPC Class Codes: A61M 2210/1078 Urinary tract
• CPC Class Codes: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 2210/122 Pericardium
• CPC Class Codes: A61M 2210/125 Heart
• 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 25/0643 Devices having a blunt needle tip, e.g. due to an additional inner component
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Improved medical filaments for use with dilators to be inserted into a patient, for example into the vascular lumen, are provided, as well as combinations of filaments and dilators. Methods for use of such filaments and filament-dilator combinations are also described. The filament includes a proximal segment and a distal segment. The diameter of the distal segment is greater than the diameter of the proximal segment. The change in diameter is abrupt, providing a discrete step transition at a point along the filament which presents a proximally-facing surface on the distal segment. When the proximal segment of the filament is fully inserted into a dilator having a distal tip adapted for insertion into a patient, the dilator distal tip firmly abuts the proximally-facing end surface of the distal segment. The relative dimensions of the dilator tip and the discrete stepped transition of the filament provides full shielding or over shielding of the dilator tip, thereby facilitating passage of the dilator tip along the tissue track, through the puncture hole and into the orifice.

Claims

1. An apparatus for percutaneously dilating an opening in the wall of a blood vessel or other anatomic structure comprising, in combination:

an elongate, introducing guide element having a proximal segment and a distal segment which meet at a juncture, said proximal segment having a first outer diameter at said juncture and said distal segment having a second outer diameter at said juncture greater than said first outer diameter thereby forming an abrupt, circumferential step comprising a proximally-facing surface such that said circumferential step creates a discrete transition between said proximal segment and said distal segment,

said distal segment comprising a distal tip and an elongate portion extending from said step to said distal tip of said distal segment, said elongate portion having an outer diameter that is substantially constant over the entire length of said elongate portion and equal to said second outer diameter; and

a dilator matched to said introducing guide element having an interior bore of sufficient size to permit said dilator to slide over the entire proximal segment of said introducing guide element,

said dilator comprising a distal tip with an opening to said interior bore, said dilator distal tip having an inner diameter less than said second diameter and an outer diameter substantially equal to said second diameter, such that when assembled together with said dilator distal tip abutting said step, said dilator cannot pass distally beyond said step.

2. An apparatus as recited in claim 1 wherein at least a portion of said proximally facing surface of said step is angled proximally or distally at 60 to 90 degrees to the central longitudinal axis of the elongate introducing guide element.

3. An apparatus as recited in claim 1 wherein said proximally-facing surface of said step includes a proximally-extending conical portion having a base at said step, said base having a diameter less than the outer diameter of said elongate portion of said distal segment at said step.

4. An apparatus as recited in claim 1 wherein said proximally-facing surface of said step comprises a proximally-facing contoured surface, and said distal tip of said dilator comprises a distally-facing surface substantially complementary to said proximally-facing contoured surface.

5. An apparatus as recited in claim 1 wherein said proximally-facing surface of said step comprises an outer annular ring surrounding a recessed inner region, wherein at least a portion of said distal tip of said dilator fits in said recessed inner region.

6. An apparatus as recited in claim 1 wherein said dilator distal tip and said proximally-facing surface are adapted to interdigitate with each other.

7. An apparatus as recited in claim 1 wherein said proximally-facing surface of said step comprises means to capture the distal tip of said dilator.

8. An apparatus as recited in claim 1 wherein said proximally-facing surface of said step comprises a centering portion extending proximally from said proximally-facing surface which serves to align said distal tip of said dilator with respect to the central longitudinal axis of said introducing guide element.

9. An apparatus as recited in claim 1 further including means for coupling said introducing guide element to said dilator.

10. An apparatus as recited in claim 9 wherein said dilator and said introducing guide element are assembled together with said dilator distal tip abutting said step, and said dilator and said introducing guide element are coupled to each other.

11. An apparatus as recited in claim 1 further including a coupling mechanism to couple said introducing guide element to said dilator.

12. An apparatus as recited in claim 11 wherein said dilator includes a hub and said coupling mechanism comprises a coupling element assembled onto said introducing guide element and adapted to engage with the hub of said dilator.

13. An apparatus as recited in claim 11 wherein the proximal end of said dilator comprises a compression mechanism adapted to engage said introducing guide element.

14. An apparatus of claim 11 wherein said proximal segment of said introducing guide element comprises a region with a roughened surface to interface with said coupling mechanism.

15. An apparatus of claim 1 further comprising a separate annular transition element that is adhered to the proximally facing surface of said circumferential step.

16. The apparatus of claim 15 wherein said transition element is cylindrical.

17. An apparatus of claim 15 wherein said transition element further comprises a proximally-facing outer annular surface surrounding a recessed inner surface.

18. An apparatus of claim 1 wherein said dilator has a maximum outer diameter of 9 French and said introducing guide element comprises an introducing guidewire with a distal segment having a maximum outer diameter of 0.038-inch.

19. An apparatus of claim 1 wherein said introducing guide element includes at least one marking to indicate the distance from said distal tip of said introducing guide element.

20. An apparatus as recited in claim 1 wherein said proximal segment of said introducing guide element is a core wire, and said elongate portion of said distal segment of said introducing guide element comprises said core wire and a wire coiled around said core wire, a portion of the last helical coil at the proximal end of said elongate portion being fabricated to comprise a planar surface as a portion of said proximally-facing surface.

21. An apparatus as recited in claim 1 wherein said elongate portion of said distal segment of said introducing guide element comprises a wire coiled around a longitudinal core element and said proximal portion of said introducing guide element is solely comprised of said core element.

22. An apparatus as recited in claim 1 further comprising a needle having a hollow bore matched to said second diameter of said introducing guide element, wherein said distal segment of said introducing guide element is longer than said needle.

23. An apparatus as recited in claim 22 wherein said elongate portion of said distal segment is at least 30 millimeters in length.

24. An apparatus as recited in claim 22 wherein said elongate portion of said distal segment is at least 70 millimeters in length.

25. An apparatus as recited in claim 22 wherein said elongate portion of said distal segment is at least 30 millimeters longer than the length of said needle.

26. An apparatus as recited in claim 1 wherein said elongate portion of said distal segment is at least 30 millimeters in length.

27. An apparatus as recited in claim 1 wherein said elongate portion of said distal segment is a least 70 millimeters in length.

28. An apparatus as recited in claim 1 wherein said blood vessel is the femoral artery.

29. An apparatus as recited in claim 1 further including a sheath sized to fit over the body of said dilator.

30. A kit containing components of an apparatus for percutaneously creating and dilating an opening in the wall of a blood vessel or other anatomic structure comprising:

a needle having a hollow bore;

an elongate, introducing guide element matched for use with said needle, having a proximal segment and a distal segment which meet at a juncture, said proximal segment having a first outer diameter at said juncture and said distal segment having a second outer diameter at said juncture greater than said first outer diameter thereby forming an abrupt, circumferential step comprising a proximally-facing surface such that said circumferential step creates a discrete transition between said proximal segment and said distal segment,

said distal segment comprising a distal tip and an elongate portion extending from said step to said distal tip of said distal segment, said elongate portion having an outer diameter that is substantially constant over the entire length of said elongate portion and equal to said second outer diameter; and

a dilator matched to said introducing guide element having an interior bore of sufficient size to permit said dilator to slide over the entire proximal portion of said introducing guide element,

said dilator comprising a distal tip with an opening to said interior bore, said dilator distal tip having an inner diameter less than said second diameter and an outer diameter substantially equal to said second diameter, such that when assembled together with said dilator distal tip abutting said step, said dilator cannot pass distally beyond said step.

31. A kit as recited in claim 30 further including a sheath sized to fit over the body of said dilator.

32. An apparatus as recited in claim 30 wherein said elongate portion of said distal segment is at least 30 millimeters in length.

33. An apparatus as recited in claim 30 wherein said elongate portion of said distal segment is at least 70 millimeters in length.

34. An apparatus as recited in claim 30 wherein said blood vessel is the femoral artery.

35. An apparatus for percutaneously dilating an opening in the wall of a blood vessel or other anatomic structure created by a hollow cylindrical needle comprising, in combination:

an elongate, introducing guide element having a proximal segment and a distal segment which meet at a juncture, said proximal segment having a first outer diameter at said juncture and said distal segment having a second outer diameter at said juncture greater than said first outer diameter thereby forming an abrupt, circumferential step comprising a proximally-facing surface such that said circumferential step creates a discrete transition between said proximal segment and said distal segment,

said distal segment comprising a distal tip and an elongate portion extending from said step to said distal tip of said distal segment, said elongate portion having an outer diameter that is substantially constant over the entire length of said elongate portion and equal to said second outer diameter; and

a dilator matched to said introducing guide element having an interior bore of sufficient size to permit said dilator to slide over the entire proximal segment of said introducing guide element,

said dilator comprising a distal tip with an opening to said interior bore, said dilator distal tip having an inner diameter less than said second diameter, such that when assembled together with said dilator distal tip abutting said step, said dilator cannot pass distally beyond said step, and

said dilator distal tip having an outer diameter substantially equal to or smaller than the outer diameter of said hollow cylindrical needle.

36. An apparatus as recited in claim 35 wherein said elongate portion of said distal segment is at least 30 millimeters in length.

37. An apparatus as recited in claim 35 wherein said elongate portion of said distal segment is at least 70 millimeters in length.

38. An apparatus of claim 35 wherein said dilator has a maximum outer diameter of 9 French and said introducing guide element comprises an introducing guidewire with a distal segment having a maximum outer diameter of 0.038-inch.

39. An apparatus as recited in claim 35 further including means for coupling said introducing guide element to said dilator.

40. An apparatus as recited in claim 35 wherein said outer diameter of said dilator distal tip is equal to said second outer diameter.

41. An apparatus as recited in claim 35 wherein said blood vessel is the femoral artery.

42. An apparatus for percutaneously dilating an opening in the wall of a blood vessel or other anatomic structure comprising, in combination:

an elongate, introducing guide element having a proximal segment and a distal segment which meet at a juncture, said proximal segment having a first outer diameter at said juncture and said distal segment having a second outer diameter at said juncture greater than said first outer diameter thereby forming an abrupt, circumferential step comprising a proximally-facing surface such that said circumferential step creates a discrete transition between said proximal segment and said distal segment,

said distal segment comprising a distal tip and an elongate portion extending from said step to said distal tip of said distal segment, said elongate portion having an outer diameter that is substantially constant over the entire length of said elongate portion and equal to said second outer diameter; and

a dilator matched to said introducing guide element having an interior bore of sufficient size to permit said dilator to slide over the entire proximal segment of said introducing guide element,

said dilator comprising a distal tip with an opening to said interior bore, said dilator distal tip having an outer diameter smaller than said second diameter, such that when assembled together with said dilator distal tip abutting said step, said dilator cannot pass distally beyond said step.

43. An apparatus as recited in claim 42 wherein said elongate portion of said distal segment is at least 30 millimeters in length.

44. An apparatus as recited in claim 42 wherein said elongate portion of said distal segment is at least 70 millimeters in length.

45. An apparatus as recited in claim 42 wherein said dilator has a maximum outer diameter of 9 French and said introducing guide element comprises an introducing guidewire with a distal segment having a maximum outer diameter of 0.038-inch.

46. An apparatus as recited in claim 42 further including means for coupling said introducing guide element to said dilator.

47. An apparatus as recited in claim 42 wherein said blood vessel is the femoral artery.

48. A kit containing components of an apparatus for percutaneously creating and dilating an opening in the wall of a blood vessel or other anatomic structure comprising:

a needle having a hollow bore;

an elongate, introducing guide element matched for use with said needle, having a proximal segment and a distal segment which meet at a juncture, said proximal segment having a first outer diameter at said juncture and said distal segment having a second outer diameter at said juncture greater than said first outer diameter thereby forming an abrupt, circumferential step comprising a proximally-facing surface such that said circumferential step creates a discrete transition between said proximal segment and said distal segment,

said distal segment comprising a distal tip and an elongate portion extending from said step to said distal tip of said distal segment, said elongate portion having an outer diameter that is substantially constant over the entire length of said elongate portion and equal to said second outer diameter; and

a dilator matched to said introducing guide element having an interior bore of sufficient size to permit said dilator to slide over the entire proximal portion of said introducing guide element,

said dilator comprising a distal tip with an opening to said interior bore, said dilator distal tip having an outer diameter smaller than said second diameter, such that when assembled together with said dilator distal tip abutting said step, said dilator cannot pass distally beyond said step.

49. An apparatus as recited in claim 48 wherein said elongate portion of said distal segment is at least 30 millimeters in length.

50. An apparatus as recited in claim 48 wherein said elongate portion of said distal segment is at least 70 millimeters in length.

51. An apparatus as recited in claim 48 wherein said dilator has a maximum outer diameter of 9 French and said introducing guide element comprises an introducing guidewire with a distal segment having a maximum outer diameter of 0.038-inch.

52. An apparatus as recited in claim 48 further including means for coupling said introducing guide element to said dilator.

53. An apparatus as recited in claim 48 wherein said blood vessel is the femoral artery.

54. A kit containing components of an apparatus for percutaneously creating, accessing and dilating an opening in the wall of a blood vessel or other anatomic structure comprising:

a tubular device having a sharp distal tip and a hollow bore;

an elongate, introducing guide element having a proximal segment and a distal segment which meet at a juncture, said proximal segment having a first outer diameter at said juncture and said distal segment having a second outer diameter at said juncture greater than said first outer diameter thereby forming an abrupt, circumferential step comprising a proximally-facing surface such that said circumferential step creates a discrete transition between said proximal segment and said distal segment,

said distal segment comprising a distal tip and an elongate portion extending from said step to said distal tip of said distal segment, said outer diameter of said elongate portion being substantially constant from said step extending distally for a distance of at least 30 millimeters towards said distal tip of said distal segment; and

a dilator comprising an elongate cylindrical body and a distal end portion tapering towards a distal tip, said dilator matched to said introducing guide element having an interior bore of sufficient size to permit said dilator to slide over the entire proximal segment of said introducing guide element,

said dilator comprising a distal tip with an opening to said interior bore, said dilator distal tip having an inner diameter less than said second diameter, such that when assembled together with said dilator distal tip abutting said step, said dilator cannot pass distally beyond said step, and

said dilator distal tip having an outer diameter substantially equal to or less than the outer diameter of said tubular device.

55. An apparatus as recited in claim 54 wherein the outer diameter of said dilator distal tip is equal to the diameter of said bore of said tubular device.

56. An apparatus as recited in claim 54 wherein the outer diameter of said dilator distal tip is equal to the outer diameter of said distal segment at said step.

57. An apparatus as recited in claim 54 wherein the outer diameter of said dilator distal tip is less than the outer diameter of said distal segment at said step.

58. An apparatus as recited in claim 54 wherein said blood vessel is the femoral artery.

59. An apparatus for percutaneously dilating an opening in the wall of a blood vessel or other anatomic structure, in combination:

an elongate, introducing guide filament having a proximal segment and a distal segment which meet at a juncture, said proximal segment having a first outer diameter at said juncture and said distal segment having a second outer diameter at said juncture greater than said first outer diameter thereby forming an abrupt, circumferential step comprising a proximally-facing annular surface such that said circumferential step creates a discrete transition between said proximal segment and said distal segment,

said annular surface having an outer diameter equal said second outer diameter and an inner diameter equal to said first outer diameter,

said distal segment comprising a distal tip and an elongate portion extending from said step to said distal tip of said distal segment, said outer diameter of said elongate portion being substantially constant from said step extending distally for a distance of at least 30 millimeters towards said distal tip of said distal segment; and

a dilator comprising an elongate cylindrical body and a distal end portion tapering towards a distal tip, said dilator having an interior bore of sufficient size to permit said dilator to slide over the entire proximal segment of said introducing guide filament,

said dilator distal tip comprising a distally-facing annular surface matched to said proximally-facing annular surface of said introducing guide filament such that the outer diameter of said distally facing surface of said dilator is substantially equal to said outer diameter of said proximally-facing annular surface of said introducing guide filament, such that when assembled together with said dilator distal tip abutting said step, said dilator cannot pass distally beyond said step.

60. An apparatus as recited in claim 59 wherein said dilator has a maximum outer diameter of 9 French and said introducing guide filament comprises an introducing guidewire with a distal segment having a maximum outer diameter of 0.038-inch.

61. An apparatus as recited in claim 59 further including means for coupling said introducing guide filament to said dilator.

62. An apparatus as recited in claim 59 wherein said blood vessel is the femoral artery.

63. An apparatus for percutaneously dilating an opening in the wall of a blood vessel or other anatomic structure, in combination:

an elongate, introducing guide filament having a proximal segment and a distal segment which meet at a juncture, said proximal segment having a first outer diameter at said juncture and said distal segment having a second outer diameter at said juncture greater than said first outer diameter thereby forming an abrupt, circumferential step comprising a proximally-facing annular surface such that said circumferential step creates a discrete transition between said proximal segment and said distal segment,

said annular surface having an outer diameter equal said second outer diameter and an inner diameter equal to said first outer diameter,

said distal segment comprising a distal tip and an elongate portion extending from said step to said distal tip of said distal segment, said outer diameter of said elongate portion being substantially constant from said step extending distally for a distance of at least 30 millimeters towards said distal tip of said distal segment; and

a dilator comprising an elongate cylindrical body and a distal end portion tapering towards a distal tip, said dilator having an interior bore of sufficient size to permit said dilator to slide over the entire proximal segment of said introducing guide filament,

said dilator distal tip comprising a distally-facing annular surface matched to said proximally-facing annular surface of said introducing guide filament such that the outer diameter of said distally-facing surface of said dilator is less than said outer diameter of said proximally-facing annular surface of said introducing guide filament, such that when assembled together with said dilator distal tip abutting said step, said dilator cannot pass distally beyond said step.

64. An apparatus as recited in claim 63 wherein said dilator has a maximum outer diameter of 9 French and said introducing guide filament comprises an introducing guidewire with a distal segment having a maximum outer diameter of 0.038-inch.

65. An apparatus as recited in claim 63 further including means for coupling said introducing guide filament to said dilator.

66. An apparatus as recited in claim 63 wherein said blood vessel is the femoral artery.