Devices and methods for crossing a chronic total occlusion

• US 20050049574A1
• Filed: 09/02/2003
• Published: 03/03/2005
• Est. Priority Date: 09/02/2003
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Velocimed DMC, Inc. (Abbott Laboratories)
• Inventors: Keith, Peter T., Wahr, Dennis W., Petrick, Timothy B., Willard, Steven N.
• Granted Patent: US 7,763,012 B2
• Time in Patent Office: Days
• US Class Current: 604/525
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/09191 made of twisted wires
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter comprising an elongate tubular member having a proximal end and a distal end, and a deflectable tip at the distal end of the elongate tubular member. The deflectable tip comprises a first helical coil having a first diameter and a second helical coil having a second diameter, the first diameter being larger than the second diameter. The first and second helical coils are arranged in the manner of a double helix. When viewed in cross-section, the first helical coil and the second helical coil are aligned at a first point on a circumference of each coil and misaligned at a second point on the circumference of each coil, where the second point is approximately 180 degrees from the first point. In certain embodiments the catheter further includes a dilatation balloon. Methods of use for crossing a chronic total occlusion are also described.

Claims

1. A catheter, comprising:

an elongate tubular member having a proximal end and a distal end; and

a deflectable tip at the distal end of the elongate tubular member, the deflectable tip comprising a first helical coil having a first diameter and a second helical coil having a second diameter, the first diameter being larger than the second diameter, the first and second helical coils being arranged in the manner of a double helix,

wherein, when viewed in cross-section, the first helical coil and the second helical coil are aligned at a first point on a circumference of each coil and misaligned at a second point on the circumference of each coil, where the second point is approximately 180 degrees from the first point.

2. The catheter of claim 1, wherein the alignment and misalignment repeats for successive turns of the double helix.

3. The catheter of claim 1, wherein the first helical coil and the second helical coil are bonded at least at one point of alignment on a turn of the double helix.

4. The catheter of claim 1, wherein the first helical coil and the second helical coil are bonded at the point of alignment on every second successive turn of the double helix.

5. The catheter of claim 1, wherein the first helical coil and the second helical coil are bonded at the point of alignment on every third successive turn of the double helix.

6. The catheter of claim 1, further comprising a dilatation balloon that communicates with an inflation lumen that extends to the proximal end of the catheter.

7. The catheter of claim 1, further comprising a control wire operable from the proximal end of the catheter and extending to the distal end of the catheter where the control wire is bonded at a distal region of the deflectable tip.

8. The catheter of claim 7, wherein the control wire extends through the deflectable tip and is disposed within an eccentric annulus between the first helical coil and the second helical coil within the circumferential region where the first helical coil and the second helical coil are misaligned.

9. The catheter of claim 7, wherein the control wire is a metallic wire.

10. The catheter of claim 7, wherein the control wire is a polymeric thread.

11. The catheter of claim 1, further comprising a radiopaque marker attached to a distal region of the catheter.

12. The catheter of claim 1, wherein the elongate tubular member further comprises a lumen extending between the proximal and the distal end.

13. The catheter of claim 12, further comprising a guidewire slideably disposed within the lumen of the elongate tubular member.

14. A method for catheterization of an artery, comprising the steps of:

providing a catheter comprising an elongate tubular member having a proximal end and a distal end, and a deflectable tip at the distal end of the elongate tubular member, the deflectable tip comprising a first helical coil having a first diameter and a second helical coil having a second diameter, the first diameter being larger than the second diameter, the first and second helical coils being arranged in the manner of a double helix, wherein, when viewed in cross-section, the first helical coil and the second helical coil are aligned at a first point on a circumference of each coil and misaligned at a second point on the circumference of each coil, where the second point is approximately 180 degrees from the first point;

advancing the catheter to a region of interest in the artery;

operating the control wire to direct the deflectable tip toward the region of interest; and

advancing a guidewire through the lumen of the catheter and into the region of interest.

15-22. -22. (Cancelled)

23. A catheter, comprising:

an elongate tubular member having a proximal region, a distal region, and a lumen extending therebetween;

a multilayer torque cable in the proximal region of the elongate tubular member, the multilayer torque cable having a first helical coil and a second helical coil, the first helical coil nested within the second helical coil and wound in a reverse direction from the second helical coil so that rotation of the first helical coil in a first direction causes the first helical coil to expand while rotation of the second helical coil in the first direction causes the second helical coil to compress and thereby interfere with the expansion of the first helical coil;

a monolayer helical coil in the distal region of the elongate tubular member; and

an outer jacket surrounding the monolayer helical coil to restrict expansion on rotation of the monolayer helical coil.

24-30. -30. (Cancelled)

31. A method for catheterization of an artery, comprising the steps of:

providing a catheter comprising an elongate tubular member having a proximal region, a distal region, and a lumen extending therebetween, the catheter having a multilayer torque cable in the proximal region of the elongate tubular member, the multilayer torque cable having a first helical coil and a second helical coil, the first helical coil nested within the second helical coil and wound in a reverse direction from the second helical coil so that rotation of the first helical coil in a first direction causes the first helical coil to expand while rotation of the second helical coil in the first direction causes the second helical coil to compress and thereby interfere with the expansion of the first helical coil, the catheter having a monolayer helical coil in the distal region of the elongate tubular member and an outer jacket surrounding the monolayer helical coil to restrict expansion on rotation of the monolayer helical coil;

advancing the catheter to a region of interest in the artery; and

applying torque to the proximal region of the catheter, wherein torque is transmitted through the multilayer torque cable in the proximal region of the elongate tubular member, and torque is transmitted through the monolayer helical coil in the distal region of the elongate tubular member.

32-39. -39. (Cancelled)

40. A catheter, comprising:

a proximal handle;

a torque cable extending distally from the proximal handle; and

an outer jacket extending distally from the proximal handle and surrounding the torque cable with an annular gap disposed between the torque cable and the outer jacket, the annular gap allowing the torque cable to rotate independently of the outer jacket for at least a portion of the length of the outer jacket.

41-47. -47. (Cancelled)

48. A method for catheterization of an artery, comprising the steps of:

providing a catheter comprising a proximal handle, a torque cable extending distally from the proximal handle, and an outer jacket extending distally from the proximal handle and surrounding the torque cable with an annular gap disposed between the torque cable and the outer jacket;

advancing the catheter to a region of interest in the artery; and

applying torque to the proximal handle, wherein torque is transmitted through the torque cable with the outer jacket remaining stationary for a substantial portion of its length, the annular gap allowing the torque cable to rotate independently of the outer jacket.

49-56. -56. (Cancelled)

57. A catheter, comprising:

an elongate tubular member having a proximal region, a distal region, and a lumen extending therebetween;

a multilayer torque cable in the proximal region of the elongate tubular member, the multilayer torque cable having a first helical coil and a second helical coil, the first helical coil nested within the second helical coil and wound in a reverse direction from the second helical coil, the torque cable having a first axial segment and a second axial segment distal the first axial segment, the second helical coil being wound around the first helical coil under higher tension in the first axial segment, the second helical coil being wound around the first helical coil under lower tension in the second axial segment, the second axial segment having a higher flexibility as compared with the first axial segment.

58-62. -62. (Cancelled)

63. A method for catheterization of an artery, comprising the steps of:

providing a catheter comprising an elongate tubular member having a proximal region, a distal region, a lumen extending therebetween, and a multilayer torque cable in the proximal region of the elongate tubular member, the multilayer torque cable having a first helical coil and a second helical coil, the first helical coil nested within the second helical coil and wound in a reverse direction from the second helical coil, the torque cable having a first axial segment and a second axial segment distal the first axial segment, the second helical coil being wound around the first helical coil under higher tension in the first axial segment, the second helical coil being wound around the first helical coil under lower tension in the second axial segment, the second axial segment having a higher flexibility as compared with the first axial segment;

advancing the catheter to a region of interest in the artery; and

applying torque to the proximal region of the catheter, wherein torque is transmitted through the multilayer torque cable in the proximal region of the elongate tubular member, and torque is transmitted through the monolayer helical coil in the distal region of the elongate tubular member.

64-71. -71. (Cancelled)