Method and apparatus for crossing intravascular occlusions

• US 6,428,552 B1
• Filed: 01/22/2001
• Issued: 08/06/2002
• Est. Priority Date: 01/22/2001
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: LuMend, Inc. (Cardinal Health, Inc.)
• Inventors: Sparks, Kurt D.
• Primary Examiner(s): Lindsey, Rodney M.
• Application Number:
  US09/768,376
• Publication Number:
  US 20020099397A1
• Time in Patent Office: 561 Days
• Field of Search: 606/1, 606/159, 606/170, 606/171, 606/180, 606/192, 606/194, 606/195, 606/198, 604/22, 604/96.01
• US Class Current: 606/159
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• 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: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

An apparatus for treating occlusions. In one embodiment, the apparatus comprises an outer catheter shaft with at least one axial lumen therethrough, wherein the outer catheter shaft comprises a distal end having an outer diameter, and an inner catheter shaft having an average diameter slidably disposed in the at least one axial lumen of the outer catheter shaft. The inner catheter shaft comprises at least one axial lumen therethrough, and an a traumatic, tapered protuberance comprising a distal end and a proximal end, wherein a diameter of the a traumatic, tapered protuberance tapers upward from the average diameter at the distal end to a greatest diameter at the proximal end. The embodiment further comprises a guidewire slidably disposed in the at least one axial lumen of the inner catheter shaft, wherein the guidewire is advanced through the body lumen into the occlusion. When the outer catheter shaft is advanced distally to closely approach the proximal end of the atraumatic, tapered protuberance, the outer catheter shaft and the inner catheter shaft present a relatively smooth tapering surface to the occlusion such that the outer catheter shaft may enter the occlusion.

Claims

1. An apparatus for crossing occlusions in a body lumen, comprising:

an outer catheter shaft with at least one axial lumen therethrough, wherein the outer catheter shaft comprises a distal end having an outer diameter;

an inner catheter shaft having an average diameter slidably disposed in the at least one axial lumen of the outer catheter shaft, wherein the inner catheter shaft comprises,

at least one axial lumen therethrough; and

an atraumatic, tapered protuberance comprising a distal end and a proximal end, wherein a diameter of the atraumatic, tapered protuberance tapers upward from the average diameter at the distal end to a greatest diameter at the proximal end;

a guidewire slidably disposed in the at least one axial lumen of the inner catheter shaft, wherein the guidewire is advanced through the body lumen into the occlusion; and

wherein the outer catheter shaft can be advanced distally to closely approach the proximal end of the atraumatic, tapered protuberance such that the outer catheter shaft and the inner catheter shaft present a relatively smooth tapering surface to the occlusion such that the outer catheter shaft may enter the occlusion.

2. The apparatus of claim 1, wherein the guidewire comprises at least one bend in a distal section of the guidewire to assist in directing the guidewire.

3. The apparatus of claim 1, wherein the outer catheter shaft comprises a working element selected from a group comprising an inflatable balloon, a cutting element, and an abrading element.

4. The apparatus of claim 1, wherein the outer catheter shaft is fabricated using at least one element selected from a group comprising a wire, a coil, a wire braid, and a mesh, and wherein the outer catheter shaft is fabricated using at least one method selected from a group comprising embedding the at least one element in the outer catheter shaft, bonding the at least one element to the outer catheter shaft, and winding the at least one element around the outer catheter shaft.

5. The apparatus of claim 1, wherein the outer catheter shaft is fabricated using at least one element selected from a group comprising Tecoflex, polyethylene, PEBAX, polyurethane, nylon and polyamide.

6. The apparatus of claim 1, wherein the inner catheter shaft is fabricated using at least one element selected from a group comprising a wire, a coil, a wire braid, and a mesh, and wherein the inner catheter shaft is fabricated using at least one method selected from a group comprising embedding the at least one element in the inner catheter shaft, bonding the at least one element to the inner catheter shaft, and winding the at least one element around the inner catheter shaft.

7. The apparatus of claim 1, wherein the inner catheter shaft is fabricated using at least one element selected from a group comprising Tecoflex, polyethylene, PEBAX, polyurethane, nylon and polyamide.

8. The apparatus of claim 1, wherein the guidewire comprises:

a spirally wound coil about a distal section of the guidewire;

at least one taper; and

an atraumatic distal cap at a distal end of the guidewire.

9. A method of treating an occlusion in a body lumen comprising:

advancing a guidewire of an apparatus into the body lumen and into the occlusion;

advancing an inner catheter shaft distally over the guidewire until an atraumatic, tapered protrusion of the inner catheter shaft contacts the occlusion;

advancing an outer catheter shaft distally over the inner catheter shaft until a distal end of the outer catheter shaft closely approaches a proximal end of the atraumatic, tapered protrusion such that the outer catheter shaft and the guidewire present a relatively smooth tapering surface to the occlusion;

applying a proximal biasing force to the inner catheter shaft so as to maintain the distal end of the outer catheter shaft in close proximity to the proximal end of the atraumatic, tapered protrusion; and

simultaneously advancing the inner catheter shaft and the outer catheter shaft through the occlusion.

10. The method of claim 9, wherein the guidewire comprises a bend in a distal section of the guidewire, the method further comprising applying torque to the guidewire to direct the guidewire through the body lumen and through the occlusion.

11. The method of claim 9, wherein the outer catheter shaft comprises a working element, and wherein the method further comprises deploying the work element.

12. The method of claim 11, wherein the working element is an inflatable balloon, and wherein deploying comprises inflating the inflatable balloon in the occlusion.