Reentry catheter and method thereof

• US 10,709,872 B2
• Filed: 10/04/2017
• Issued: 07/14/2020
• 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., Godleski, Christine, Bowe, Wade A., Carver, Rob, Dwelle, Paola A., Lindstrom, Jeff, Nevrla, David S., Matin, Shahriar, Magee, Matthew M.
• Primary Examiner(s): Farrar, Lauren P
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US15/725,089
• Publication Number:
  US 20180043134A1
• Time in Patent Office: 1,014 Days
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• 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 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0172 Exchanging a guidewire while keeping the catheter in place
• CPC Class Codes: A61M 25/0194 Tunnelling catheters

Abstract

Embodiments of the invention are directed towards a rapid exchange catheter configured for insertion into a subintimal space and crossing an occlusion in a subintimal space. The catheter includes a proximal end, a distal end, a first lumen configured to receive a first wire, the first lumen extending longitudinally through a least a lateral port of the catheter, and a second lumen having at least a portion distal of the lateral port and extending through at least the distal end of the catheter. The catheter also includes an exchange port, arranged on an exterior portion of the catheter configured to receive a second wire and second rapid exchange port in communication with the second lumen. Moreover, other embodiments of the invention are directed towards methods for using the rapid exchange catheter to cross an obstruction in a vessel, e.g., a total or partial occlusion, in a subintimal space.

Claims

1. A rapid exchange catheter system, comprising:

a shaft having an inner lumen, an exchange port lumen and an exchange port fluidly coupled with the exchange port lumen, the exchange port arranged on a distal portion of the shaft, the inner lumen configured to receive a first wire, and the exchange port lumen and the exchange port configured to receive a wire; and

a rigid shroud coupled to the distal portion of the shaft, the rigid shroud comprising a first lumen, a second lumen, and a lateral port fluidly coupled with the second lumen of the shroud and the inner lumen of the shaft, the second lumen and the lateral port configured to receive the first wire, the first lumen comprising a proximal port and a distal port in the rigid shroud, wherein the exchange port is disposed proximally of the lateral port and the proximal port is disposed distally of the lateral port;

wherein, as viewed from a distal end view of the rapid exchange catheter system, the exchange port is disposed radially exterior of the rigid shroud.

2. The rapid exchange catheter system of claim 1, further comprising a cannula disposed within the second lumen, the cannula configured to extend from the lateral port and receive the first wire.

3. The rapid exchange catheter system of claim 1, wherein the exchange port is disposed proximally relative to the rigid shroud.

4. The rapid exchange catheter system of claim 1, wherein the rigid shroud further comprises a wire guide configured to receive the second wire, wherein the wire guide is adjacent the proximal port of the first lumen.

5. The rapid exchange catheter system of claim 4, wherein the lateral port is disposed proximally relative to the wire guide.

6. The rapid exchange catheter system of claim 5, wherein, as viewed from the end view of the rapid exchange catheter system, the lateral port, the exchange port, and a center of the rigid shroud define an angle, the angle having a vertex at the center of the rigid shroud, a first side intersecting the center of the rigid shroud and the lateral port, and a second side intersecting the center of the rigid shroud and a center of the exchange port, and the angle is less than 180 degrees.

7. The rapid exchange catheter system of claim 1, further comprising a marker band carried by the rigid shroud.

8. The rapid exchange catheter system of claim 1, wherein the shaft comprises three coils.

9. The rapid exchange catheter system of claim 8, wherein the three coils are oppositely wound.

10. The rapid exchange catheter system of claim 1, wherein, as viewed from the end view of the rapid exchange catheter system, the lateral port, the exchange port, and a center of the rigid shroud define an angle, the angle having a vertex at the center of the rigid shroud, a first side intersecting the center of the rigid shroud and the lateral port, and a second side intersecting the center of the rigid shroud and a center of the exchange port, and the angle is less than 180 degrees.

11. A method of using a rapid exchange catheter system, the method comprising:

advancing a first wire into a subintimal space within a blood vessel;

advancing the rapid exchange catheter system over the first wire into the subintimal space, wherein the rapid exchange catheter system comprises;

a shaft having an inner lumen, and exchange port lumen and an exchange port fluidly coupled with the exchange port lumen, the exchange port arranged on a distal portion of the shaft, the inner lumen configured to receive a wire, and the exchange port lumen and the exchange port receiving the first wire; and

a rigid shroud coupled to the distal portion of the shaft, the rigid shroud comprising a first lumen, a second lumen, and a lateral port fluidly coupled with the second lumen and the inner lumen of the shaft, the second lumen and the lateral port configured to receive the wire, the first lumen comprising a proximal port and a distal port in the rigid shroud, wherein the first lumen is configured to receive the first wire, wherein the exchange port is disposed proximally of the lateral port and the proximal port is disposed distally of the lateral port;

wherein, as viewed from a distal end view of the rapid exchange catheter system, the exchange port is disposed radially exterior of the rigid shroud;

advancing the wire through inner lumen of the shaft and the second lumen of the rigid shroud; and

advancing the wire through the lateral port of the rigid shroud into a lumen of the blood vessel.

12. The method of claim 11, further comprising advancing a cannula a predetermined distance out of the lateral port.

13. The method of claim 11, further comprising actuating an actuator to mechanically advance a cannula a predetermined distance out of the lateral port.

14. The method of claim 11, wherein the exchange port and the lateral port are disposed distally relative to an occlusion in the lumen of the blood vessel as a result of advancing the rapid exchange catheter system over the first wire.

15. The method of claim 11, wherein, as viewed from the end view of the rapid exchange catheter system, the lateral port, the exchange port, and a center of the rigid shroud define an angle, the angle having a vertex at the center of the rigid shroud, a first side intersecting the center of the rigid shroud and the lateral port, and a second side intersecting the center of the rigid shroud and a center of the exchange port, and the angle is less than 180 degrees.

16. The method of claim 11, wherein the exchange port is disposed proximally relative to the rigid shroud.

17. The method of claim 11, wherein the rigid shroud further comprises a wire guide, wherein the wire guide is adjacent the proximal port of the first lumen, and further comprising the step of receiving the first wire in the wire guide.

18. The method of claim 17, wherein the lateral port is disposed proximally relative to the wire guide and distally relative to the exchange port.