MEDICAL GUIDE ELEMENT WITH DIAMETER TRANSITION

• US 20100069880A1
• Filed: 09/18/2008
• Published: 03/18/2010
• Est. Priority Date: 09/18/2008
• Status: Active Grant

• Current Assignee: Jeffrey Grayzel, Joseph Grayzel
• Original Assignee: Jeffrey Grayzel, Joseph Grayzel
• Inventors: Grayzel, Joseph, Grayzel, Jeffrey
• Granted Patent: US 8,485,969 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• 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:

an elongate guide element having a proximal segment and a distal segment which at their juncture form an abrupt, circumferential step comprising a proximally-facing surface,

said distal segment having an outer diameter adjacent said step greater than the outer diameter of said proximal segment adjacent said step; and

a dilating catheter having an interior bore of sufficient size to permit said catheter to slide over the proximal segment of said elongate guide element,

said dilating catheter having distal tip with an outer diameter substantially equal to or smaller than the diameter of said distal segment adjacent said step.

2. An apparatus as recited in claim 1 wherein at least a portion of said proximally-facing surface of said circumferential step is substantially perpendicular to a central longitudinal axis of said proximal segment.

3. 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 and longitudinal axis of the elongate guide element.

4. An apparatus as recited in claim 1 wherein said distal segment has a length of 300 millimeters or less and said proximal segment has a length of 300 millimeters or less.

5. An apparatus as recited in claim 1 wherein said distal segment has a portion of maximum diameter that is at least 3 millimeters in length to block the flow of fluid through said opening when said guide element resides within said opening.

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

7. 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 dilating catheter comprises a distally-facing surface substantially complementary to said proximally-facing contoured surface.

8. 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 dilating catheter fits in said recessed inner region.

9. The apparatus as recited in claim 1 wherein said dilating catheter distal tip and said proximally-facing surface are adapted to interdigitate with each other.

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

11. An apparatus as recited in claim 1 wherein said proximally-facing surface of said step comprises means for aligning said distal tip of said dilating catheter with respect to the central longitudinal axis of said elongate guide element.

12. An apparatus as recited in claim 1 further including means for coupling said guide element to said dilating catheter.

13. An apparatus as recited in claim 12 wherein said dilating catheter and said elongate guide element are assembled, said distal tip abutting said step, and coupled to each other.

14. An apparatus as recited in claim 1 further including a coupling mechanism to couple said guide element to said dilating catheter.

15. An apparatus as recited in claim 14 wherein said coupling mechanism comprises an element assembled onto said guide element and adapted to engage with the hub of said dilating catheter.

16. An apparatus as recited in claim 14 wherein said dilating catheter comprises a compression mechanism adapted to engage said elongate guide element.

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

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

19. The apparatus of claim 18 wherein said transition element is cylindrical.

20. An apparatus of claim 18 wherein said transition element further comprises a proximally-facing outer annular surface surrounding a recessed inner surface.

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

22. An apparatus of claim 1 wherein said elongate guide element comprises a distal tip and includes at least one marking to indicate the distance from said distal tip.

23. An apparatus of claim 1 further including a coupling mechanism to couple said guide element to said dilating catheter when said guide element and said dilating catheter are in an abutting relationship, said distal segment having a portion of maximum diameter that is at least 3 millimeters in length to block the flow of fluid through said opening when said guide element resides within said opening.

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

an elongate guide element, having a proximal segment and a distal segment which at their juncture form an abrupt, circumferential step comprising an annular proximally-facing surface,

said distal segment having an outer diameter adjacent said step greater than the outer diameter of said proximal segment adjacent said step; and

a dilating catheter having an interior bore of sufficient size to permit said catheter to slide over the proximal segment of said elongate guide element,

said dilating catheter having a distal tip with an opening into said bore and having an inner diameter smaller than the outer diameter of said elongate guide element distal segment adjacent to said step.

25. An apparatus of claim 24 wherein said dilating catheter distal tip has an outer diameter substantially equal to the outer diameter of said distal segment adjacent said step.

26. An apparatus of claim 24 wherein said dilating catheter distal tip has an outer diameter smaller than the outer diameter of said distal segment adjacent said step.

27. An apparatus of claim 24 wherein said dilating catheter distal tip has an outer diameter larger than the outer diameter of said distal segment adjacent said step.

28. An apparatus as recited in claim 24 wherein said elongate guide element comprises an introducing guidewire having a maximum outer diameter of 0.038-inch and wherein said dilating catheter has a maximum outer diameter of 9 French.

29. An apparatus as recited in claim 24 wherein at least a portion of said proximally-facing surface of said step is substantially perpendicular to a central longitudinal axis of said proximal segment.

30. An apparatus as recited in claim 24 wherein said distal segment has a portion of maximum diameter that is at least 3 millimeters in length to block the flow of fluid through said opening when which said guide element resides within said opening.

31. An apparatus as recited in claim 24 wherein said proximally-facing surface of said step comprises an outer annular ring surrounding a recessed inner region.

32. An apparatus as recited in claim 24 wherein said proximally-facing surface of said step comprises means to capture the distal tip of said dilating catheter.

33. An apparatus as recited in claim 24 wherein said proximally-facing surface of said step comprises means for aligning said distal tip of said dilating catheter with respect to the central longitudinal axis of said elongate guide element.

34. An apparatus as recited in claim 24 further including a coupling mechanism to couple said guide element to said dilating catheter

35. An apparatus as recited in claim 24 wherein said proximal segment of said elongate guide element is a core wire, and said distal segment of said elongate guide element comprises said core wire and a wire coiled around said core wire, the last helical coil at the proximal end of said distal segment being fabricated flat to comprise a portion of said proximally-facing surface.

36. The apparatus of claim 24 further including a coupling mechanism to couple said guide element to said dilating catheter when said guide element and said dilating catheter are in an abutting relationship, wherein said distal segment has a portion of maximum diameter that is at least 3 millimeters in length to block the flow of fluid through said opening when said guide element resides within said opening.

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

an elongate guide element having a proximal segment and a distal segment which at their juncture form an abrupt, circumferential step comprising an annular proximally-facing surface said distal segment having a portion of maximum diameter that is at least 3 millimeters in length to block the flow of fluid through said opening when said guide element resides within said opening; and

a dilating catheter having an interior bore of sufficient size to permit said catheter to slide over the proximal segment of said elongate guide element,

said dilating catheter having a distal tip with an opening into said bore and said tip having an outer diameter substantially equal to or smaller than the diameter of said distal segment adjacent said step.

38. An apparatus for use in percutaneously delivering a dilating catheter to and through an opening in the wall of a blood vessel or other anatomic structure comprising:

an elongate guide element having a proximal segment and a distal segment which at their juncture form an abrupt, circumferential step comprising a proximally-facing surface,

said distal segment having an outer diameter adjacent said step greater than the outer diameter of said proximal segment adjacent said step and having a portion of maximum outer diameter that extends a length of at least 3 millimeters to block the flow of fluid through said opening.

39. An apparatus as recited in claim 38 wherein said elongate guide element includes at least one marking to indicate the distance from the distal tip of said guide element.

40. An apparatus as recited in claim 38 wherein said proximal segment of said guide element comprises a region with a roughened surface.

41. An apparatus as recited in claim 38 wherein said distal segment comprises a wire coiled around a longitudinal core element and said proximal portion is solely comprised of said core element.

42. An apparatus as recited in claim 38 wherein at least a portion of said proximally-facing surface of said step is substantially perpendicular to a central longitudinal axis of said proximal segment.

43. An apparatus as recited in claim 38 wherein said distal segment has a minimum length of 1.0-inches to assure that said distal segment has sufficient length to extend through said opening and assure that said step resides outside said opening.

44. An apparatus as recited in claim 38 wherein said proximal segment is of substantially uniform outer diameter over its entire length, said diameter being equal to its outer diameter adjacent said step.

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

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

an elongate guide element having a proximal segment and a distal segment which at their juncture form an abrupt, circumferential step comprising an annular proximally-facing surface,

said distal segment having an outer diameter adjacent said step greater than the outer diameter of said proximal segment adjacent said step, the diameter of the distal segment being sized to match the diameter of the hollow bore of said tubular device.

46. A kit as recited in claim 45 wherein said tubular device is a vascular needle.

47. A kit of claim 45 wherein said hollow bore has a maximum diameter of 0.020-inch and said proximal segment has a maximum diameter of 0.010 inch.

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

a needle having a hollow bore; and

an elongate guide element for use with said needle having a maximum outer diameter of 0.038-inch and having a proximal segment and a distal segment which at their juncture form an abrupt, circumferential step comprising an annular proximally-facing surface,

said distal segment having an outer diameter adjacent said step greater than the outer diameter of said proximal segment adjacent said step and having one or more portions of such length and diameter to permit it to block the flow of fluid through the hollow bore of said needle when positioned therein and to block the flow of fluid from said opening when said needle is removed.

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

a needle having a hollow bore;

an elongate guide element for use with said needle, having a proximal segment and a distal segment which at their juncture form an abrupt, circumferential step comprising an annular proximally-facing surface,

said distal segment having an outer diameter adjacent said step greater than the outer diameter of said proximal segment adjacent said step and having one or more portions of such length and diameter to permit it to block the flow of fluid through the hollow bore of said needle when positioned therein and to block the flow of fluid from said opening when said needle is removed; and

a dilating catheter having an interior bore of sufficient size to permit said catheter to slide over the proximal portion of said elongate guide element,

said dilating catheter having a distal tip with an opening to said bore, said distal tip having an outer diameter equal to or smaller than the outer diameter of said guide element distal segment adjacent said step, said distal tip being shielded behind said step during insertion of the catheter into said opening.

50. A kit as recited in claim 49 further including a sheath.

51. A kit of claim 49 wherein said hollow bore has a maximum diameter of 0.020-inch and said proximal segment has a maximum diameter of 0.010-inch.

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

a needle having a hollow bore;

an elongate guide element having a maximum diameter of 0.038-inch for use with said needle, and having a proximal segment and a distal segment which at their juncture form an abrupt, circumferential step comprising an annular proximally-facing surface,

said distal segment having an outer diameter adjacent said step greater than the outer diameter of said proximal segment adjacent said step,

said distal segment having one or more portions of such length and diameter to permit it to block the flow of fluid through the hollow bore of said needle when positioned therein and to block the flow of fluid from said opening when said needle is removed;

a dilating catheter having a maximum outer diameter of 9-French and having an interior bore of sufficient size to permit said catheter to slide over the proximal portion of said elongate guide element,

said dilating catheter having a distal tip with an opening to said bore and said tip having an outer diameter equal to or smaller than the outer diameter of said guide element distal segment adjacent said step, said distal tip shielded behind said step during insertion of the catheter into said opening;

a sheath sized to fit over the body of said dilating catheter; and

a coupling mechanism to couple said guide element to said dilating catheter.

53. In a method for percutaneously creating and dilating an opening in the wall of a blood vessel or other anatomic structure wherein a pointed hollow tubular device is used to create an opening into said wall, a guide element is inserted through said tubular device into said opening, said tubular device is removed over said guide element and a dilating catheter is advanced over said guide element, the improvement comprising:

deploying a guide element having a proximal segment and a distal segment which at their juncture form an abrupt, circumferential step comprising a proximally facing surface, such that said step is positioned outside said wall as said tubular device is removed; and

advancing said dilating catheter distally along said proximal segment of said guide element until the distal tip of said dilating catheter abuts said circumferential step.

54. A method as recited in claim 53 wherein after the tip of said dilating catheter abuts said step and prior to advancing said dilating catheter and guidewire together into said opening, said dilating catheter and said guidewire are coupled together to prevent movement of one relative to the other.

55. A method as recited in claim 53 wherein said dilating catheter has a distal tip with an outer diameter substantially equal to or smaller than the diameter of said distal segment adjacent said step, and

wherein said step is positioned above the skin level as said tubular device is removed.