Reentry catheter and method thereof

• US 9,775,969 B2
• Filed: 02/25/2015
• Issued: 10/03/2017
• Est. Priority Date: 06/30/2011
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Inventors: Alvarez, Jeffery B., Nevrla, David S.
• Primary Examiner(s): ALEMAN, SARAH WEBB
• Application Number:
  US14/631,592
• Publication Number:
  US 20150165163A1
• Time in Patent Office: 951 Days
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61M 2025/0058 having an electroactive polymer material, e.g. for steering purposes, for control of flexibility, for locking, for opening or closing
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• 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 25/0194 Tunnelling catheters

Abstract

The invention generally relates to method and apparatus for crossing an obstruction in a tubular member, and more particularly to a medical device method for crossing of a chronic occlusion in a subintimal or interstitial space of an artery.

Claims

1. A catheter system, comprising:

a catheter body having a proximal end, a distal end, at least one lumen running along a longitudinal axis from the proximal end through the distal end, and a lateral opening disposed on a periphery of the catheter body and in communication with the at least one lumen; and

a tubular reentry member comprising a distal end, the distal end comprising;

a first sharp edge parallel to the longitudinal axis to permit cutting, wherein the first sharp edge is formed on at least a portion of a bottom distal edge and extending outwardly from a surface of the tubular reentry member, wherein the bottom distal edge is parallel to the longitudinal axis, the bottom distal edge being opposite a top edge of the tubular reentry member;

a second sharp edge to permit cutting, wherein the second sharp edge and the first sharp edge meet at an angle and form a distal tip of the distal end of the tubular reentry member, wherein the angle is less than 90 degrees;

wherein the tubular reentry member is configured to flex from a first position inside the at least one lumen to a second position outside of the at least one lumen and through the lateral opening of the catheter body when an axial eccentric load is placed on the top edge of the tubular reentry member.

2. The catheter system of claim 1, wherein the axial eccentric load is applied with at least one of a control wire, a cabling device, a ramp, and an elastomeric member.

3. The catheter system of claim 1, wherein the reentry member comprises a material selected from the group consisting of an electroactive polymer, a thermo-active polymer, an electroactive metal and combinations thereof.

4. The catheter system of claim 3, wherein the axial eccentric load is applied with an electrical signal applied to the reentry member.

5. The catheter system of claim 1, wherein the reentry member comprises a pre-resilient shape.

6. The catheter system of claim 1, wherein the reentry member comprises a material selected from the group consisting of stainless steel, nitinol, alloy, titanium, thermoplastics, polyether ether ketone (PEEK), polyimide, and combinations thereof.

7. The catheter system of claim 1, wherein the catheter body further comprises a second lumen, wherein the second lumen is configured to receive a guide wire having a diameter in a range from about 0.01 inches to about 0.04 inches.

8. The catheter system of claim 1, wherein the catheter body comprises a material selected from the group consisting of a polyester, a polyurethane, a polyamide, a polyolefin, a polyethylene, a polypropylene, a nylon, a polyester elastomer, a polyether/block polyamide, a Hytrel, a fluoro-polymer, a polyether ether ketone, a polyolefin copolymer, a tetrafluoroethylenes, a polytetrafluoroethylene, a steel, a laser cut stainless steel and combinations thereof.

9. The catheter system of claim 1, wherein the at least one lumen of the catheter body is configured to receive a supplemental treatment device.

10. The catheter system of claim 9, wherein the supplemental treatment device is selected from the group consisting of a guide wire, a medical instrument, a balloon, a stent, a laser catheter, a medication, an optical catheter and combinations thereof.

11. The catheter system of claim 1, further comprising at least one radiopaque marker arranged on a distal portion of at least one of the reentry member and the catheter body.

12. The catheter system of claim 1, wherein the reentry member further comprises at least one void space in a circumferential portion of the reentry member that is configured to enable flexing of the reentry member from the first position to the second position, and wherein the at least one void space is disposed along the longitudinal axis of the catheter body.

13. The catheter system of claim 12, wherein the at least one void space comprises a plurality of cut out sections.

14. The catheter system of claim 13, wherein the plurality of cut out sections comprise at least one of the following geometrical configurations:

a tear drop configuration, a diamond configuration, a square configuration, a pentagon configuration, a hexagon configuration and combinations of the same.

15. The catheter system of claim 1, further comprising an exchange port arranged on at least a distal portion of the catheter body, wherein the exchange port comprises at least one lumen configured to receive a guidewire and the catheter body is configured to track over the guidewire to a treatment site.

16. A method of crossing an obstruction in a blood vessel, comprising the steps of:

advancing a first guide wire into a lumen of the vessel towards the obstruction in the vessel;

advancing the first guide wire into a subintimal space of the vessel to a location distal of the obstruction;

advancing a catheter having at least one lumen running along a longitudinal axis and comprising a tubular reentry member over the guide wire to a location where a port disposed on a periphery of the catheter is at a location distal of the obstruction, wherein the tubular reentry member comprises a distal end, the distal end comprising a first sharp edge parallel to the longitudinal axis formed on at least a portion of a bottom distal edge and extending outwardly from a surface of the tubular reentry member, wherein the bottom distal edge is parallel to the longitudinal axis, the bottom distal edge being opposite a top edge of the tubular reentry member, and a second sharp edge, wherein the second sharp edge and the first sharp edge meet at an angle and form a distal tip of the distal end of the tubular reentry member, wherein the angle is less than 90 degrees, the tubular reentry member being configured to flex from a first position inside the at least one lumen to a second position outside of the at least one lumen and through the port of the catheter when an axial eccentric load is placed on the top edge of the reentry member; and

cutting with at least one of the first sharp edge and the second sharp edge of the tubular reentry member from a first location within the subintimal space of the vessel through the port to a second location within a true lumen of the vessel.

17. The method of claim 16, further comprising the steps of:

returning the reentry member from the second location to the first location; and

removing the reentry member from the vessel.

18. The method of claim 16, wherein the cutting step comprises inflating an elastomeric member.

19. The method of claim 16, wherein the cutting step comprises applying a force to a control wire, cable, or tether element.

20. A catheter system, comprising:

a catheter body having a proximal end, a distal end, at least one lumen running from the proximal end through the distal end, and a lateral opening disposed on a periphery of the catheter body and in communication with the at least one lumen; and

a reentry member comprising a distal end, the distal end comprising;

a first sharp edge to permit cutting, wherein the first sharp edge is formed on at least a portion of a bottom distal edge of the reentry member, wherein the distal end of the reentry member comprises a tear drop shaped cross section tapering to form the first sharp edge;

a second sharp edge to permit cutting, wherein the second sharp edge is formed on a leading edge of the distal end of the reentry member;

wherein the reentry member is configured to flex from a first position inside the at least one lumen to a second position outside of the at least one lumen and through the lateral opening of the catheter body when an axial eccentric load is placed at a portion of the reentry member.