Medical guide element with diameter transition

• US 9,238,124 B2
• Filed: 06/15/2013
• Issued: 01/19/2016
• 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): SHI, KATHERINE MENGLIN
• Application Number:
  US13/918,906
• Publication Number:
  US 20140163471A1
• Time in Patent Office: 948 Days
• US Class Current: 1/1
• 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 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;

wherein said guide element comprises an introducing guidewire having a maximum outer diameter of 0.038-inch or less; 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 having a distally-facing annular surface with an opening into said interior bore,

said dilator distal tip having an inner diameter less than said second diameter, such that when assembled together said dilator cannot pass distally beyond said step,

said dilator distal tip having an outer diameter substantially equal to said second outer diameter, such that that when assembled together with said dilator distal tip abutting said step their respective outer diameters match one another to provide precise shielding of said dilator distal tip and a smooth transition from said introducing guide element distal segment outer diameter to said dilator distal tip outer diameter, thereby permitting said dilator distal tip to smoothly enter said opening without resistance from said wall of said blood vessel or anatomic structure.

2. An apparatus as recited in claim 1 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.

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 introducing 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 portion of maximum diameter 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 dilator 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 means to capture the distal tip of said dilator.

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 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 an 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 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 step.

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

17. 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.

18. 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.

19. An apparatus of claim 1 further including a coupling mechanism to couple said introducing guide element to said dilator when said guide element and said dilator are assembled together 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.

20. An apparatus as recited in claim 1 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 second 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.

21. An apparatus as recited in claim 1 further including an introducing sheath, said sheath sized to fit over and around the body of said dilator so as to be carried in tandem with said dilator during insertion into said opening, wherein said dilator may be removed from within said sheath by pulling it proximally from said sheath.

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

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

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 an proximally-facing surface such that said step creates a discrete transition between said proximal segment and said distal segment,

said distal segment having a portion of maximum outer diameter that is at least 3 millimeters in length to block the flow of fluid through said opening when said portion of maximum outer diameter resides within said opening; and

a dilator 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 having a distally-facing annular surface with an opening into said interior bore,

said dilator distal tip having an inner diameter less than said second diameter, such that when assembled together said dilator cannot pass distally beyond said step.

24. An apparatus as recited in claim 23 wherein said introducing guide element includes at least one marking to indicate the distance from the distal tip of said introducing guide element.

25. An apparatus as recited in claim 23 wherein said distal segment comprises a wire coiled around a longitudinal core element and said proximal portion is solely comprised of said core element.

26. An apparatus as recited in claim 23 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.

27. An apparatus as recited in claim 23 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 in said wall of a blood vessel or other anatomic structure and assure that said step resides outside said opening in said wall of a blood vessel or other anatomic structure.

28. An apparatus as recited in claim 23 wherein said blood vessel is the femoral artery.

29. An apparatus as recited in claim 23 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 second 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.

30. An apparatus as recited in claim 23 wherein said portion of maximum diameter is of a diameter greater than the outer diameter at another portion of said distal segment of said introducing guide element.

31. An apparatus as recited in claim 23 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.

32. An apparatus as recited in claim 23 further including an introducing sheath, said sheath sized to fit over and around the body of said dilator so as to be carried in tandem with said dilator during insertion into said opening, wherein said dilator may be removed from within said sheath by pulling it proximally from said sheath.

33. An apparatus as recited in claim 23 further including means for coupling said introducing guide element to said dilator.

34. An apparatus as recited in claim 33 wherein said dilator and said introducing guide element are assembled together, with said dilator distal tip abutting said step, and coupled to each other.

35. 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, in combination:

a tubular device having a sharp distal tip and a hollow bore for percutaneous puncture of said wall to create said opening; and

an elongate introducing guide element for passage through said tubular device to access said opening, said 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 step creates a discrete transition between said proximal segment and said distal segment,

said distal segment having a portion of maximum outer diameter,

said maximum outer diameter matched to the diameter of the hollow bore of said tubular device, thereby blocking the flow of fluid through said hollow bore when said portion of maximum outer diameter resides within said hollow bore,

said portion of maximum outer diameter being at least 3 millimeters in length to block the flow of fluid through said opening when said needle is removed and said portion of maximum outer diameter resides within said opening.

36. A kit of claim 35 wherein said tubular device is a vascular needle.

37. A kit of claim 35 wherein said distal segment has a maximum outer diameter of 0.053-inch or less.

38. An apparatus as recited in claim 35 wherein said portion of maximum diameter is of a diameter greater than the outer diameter at another portion of said distal segment of said introducing guide element.

39. An apparatus as recited in claim 35 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 portion of maximum diameter resides within said opening.

40. 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 for percutaneous puncture of said wall to create said opening; and

an elongate introducing guide element for passage through said needle to access said opening, said 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 step creates a discrete transition between said proximal segment and said distal segment,

said distal segment comprising one or more portions having an outer diameter matched to the diameter of said hollow bore of said needle to permit it to block the flow of fluid through the hollow bore of said needle when said distal segment is positioned therein; and

a dilator 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 having a distally-facing annular surface 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 said dilator cannot pass distally beyond said step,

said dilator distal tip having an outer diameter substantially equal to said second outer diameter, such that that when assembled together with said dilator distal tip abutting said step their respective outer diameters match one another to provide precise shielding of said dilator distal tip and a smooth transition from said introducing guide element distal segment outer diameter to said dilator distal tip outer diameter, thereby permitting said dilator distal tip to smoothly enter said opening without resistance from said wall of said blood vessel or anatomic structure.

41. An apparatus as recited in claim 40 wherein said blood vessel is the femoral artery.

42. An apparatus as recited in claim 40 further including an introducing sheath, said sheath sized to fit over and around the body of said dilator so as to be carried in tandem with said dilator during insertion into said opening, wherein said dilator may be removed from within said sheath by pulling it proximally from said sheath.

43. An apparatus as recited in claim 40 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.

44. An apparatus as recited in claim 40 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 introducing guide element.

45. An apparatus as recited in claim 40 further including a coupling mechanism to couple said introducing guide element to said catheter dilator.

46. An apparatus as recited in claim 40 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.

47. 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 for percutaneous puncture of said wall to create said opening;

an elongate introducing guide element 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 step creates a discrete transition between said proximal segment and said distal segment,

said distal segment having a portion of maximum outer diameter that is at least 3 millimeters in length and of a diameter to permit it to block the flow of fluid through said hollow bore of said needle when positioned therein and to block the flow of fluid from said opening when said needle is removed and said portion of maximum outer diameter resides within said opening; and

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

said dilator having a distal tip having a distally-facing annular surface with an opening to said interior bore,

said dilator distal tip having an inner diameter smaller than said second diameter,

such that when assembled together said dilator cannot pass distally beyond said step.

48. A kit as recited in claim 47 further including an introducing sheath, said sheath sized to fit over and around the body of said dilator so as to be carried in tandem with said dilator during insertion into said opening, wherein said dilator may be removed from within said sheath by pulling it proximally from said sheath.

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

50. An apparatus of claim 47 wherein said dilating catheter distal tip has an outer diameter substantially equal to the outer diameter of said distal segment adjacent said step.

51. An apparatus of claim 47 wherein said dilating catheter distal tip has an outer diameter smaller than the outer diameter of said distal segment adjacent said step.

52. An apparatus of claim 47 wherein said dilating catheter distal tip has an outer diameter larger than the outer diameter of said distal segment adjacent said step.