Telescopic side port catheter device with imaging system and method for accessing side branch occlusions

• US 9,867,530 B2
• Filed: 03/15/2013
• Issued: 01/16/2018
• Est. Priority Date: 08/14/2006
• Status: Active Grant

• Current Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Original Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Inventors: Pursley, Matt D.
• Primary Examiner(s): Akar, Serkan
• Application Number:
  US13/841,476
• Publication Number:
  US 20130303897A1
• Time in Patent Office: 1,768 Days
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 1/01 Guiding arrangements therefore
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4488 the transducer being a phased array
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A medical device and method are provided for accessing a side branch in an artery utilizing an on-board imaging device. The device includes a catheter having a sidewall, an internal lumen, and a side port formed through the sidewall. A perforating guide wire has a proximal portion within the internal lumen and a distal portion arranged to be movable out of the side port. The guide wire can be delivered through the side port to a side branch artery when the catheter is deployed to a location with the side port aligned with the side branch artery. In one embodiment, the catheter includes an on-board imaging system disposed adjacent the side opening. The imaging system images tissue adjacent the side opening to assist with alignment of the guide wire to enter a side branch and/or cross an occlusion within the side branch.

Claims

1. A method of crossing an occlusion within a vessel, the method comprising:

positioning a catheter within a vessel of a patient, the catheter including;

an imaging element,

a steering assembly comprising a first tube and a second tube, wherein the first tube is located within the second tube and slides with respect to the second tube, wherein the first and second tubes are telescopically movable with respect to each other,

an occlusion crossing wire extending out of an opening in the first tube through a side port in the second tube that provides an exit opening in a side of the catheter,

a stabilizing element that provides stability to the catheter located either proximal to or distal to the exit opening, and

a visual marker element positioned on the catheter and aligned with the exit opening in the catheter, the visual marker element configured to be within a field of view captured by the imaging element;

advancing the imaging element through a main vessel to a position adjacent an occlusion of a side vessel;

imaging the occlusion along with a portion of the side vessel;

aligning the exit opening in the side of the catheter with the occlusion based on a visual indication of an orientation of the exit opening with respect to the imaged occlusion and the side vessel provided by the visual marker element;

changing an orientation of the crossing wire with the steering assembly by moving the second tube telescopically with respect to the first tube, thereby to cause the crossing wire to change its angle with respect to the catheter; and

advancing the crossing wire through the opening of the first tube and the exit opening in the side of the catheter and into the occlusion.

2. The method of claim 1, wherein the imaging includes evaluating tissue characteristics of at least one of the occlusion and the side vessel.

3. The method of claim 1, wherein the catheter includes the marker detectible by the imaging element, and the aligning further includes rotationally aligning the marker with the side vessel.

4. The method of claim 1, wherein the imaging includes activating at least one ultrasound transducer.

5. The method of claim 1, wherein the imaging includes activating an optical coherence tomography sensing system.

6. The method of claim 1, wherein the steering assembly includes an inner catheter positioned within the catheter, the crossing wire extending within at least a portion of the inner catheter and exiting a distal opening;

and further including moving the inner catheter with respect to the exit opening to thereby change the alignment of the crossing wire before advancing the crossing wire through the exit opening.

7. The method of claim 1, further including imaging the side branch vessel and the crossing wire during the advancing the crossing wire through the exit opening and into the occlusion.

8. The method of claim 7, further including adjusting the path of the crossing wire utilizing the steering assembly based on the imaging during the advancing of the crossing wire.

9. A vessel occlusion crossing system comprising:

a catheter body having a lumen and a side port that provides an exit opening in a side of the catheter body;

an imaging element disposed on a distal portion of the catheter;

a crossing wire;

a steering assembly comprising a first tube slidably located within the lumen of the catheter body, wherein the first tube is telescopically movable within the lumen of the catheter body, wherein the crossing wire is slidably disposed within the first tube, and wherein the crossing wires are configured to extend to the side port in the side of the catheter body, the steering assembly configured to change a direction of the crossing wire after exit through the side port by moving the first tube telescopically with respect to the lumen of the catheter body thereby to cause the crossing wire to change its angle with respect to the catheter body;

a stabilizing element that provides stability to the catheter located either proximal to or distal to the exit opening; and

a visual marker element positioned on the catheter and aligned with the exit opening in the catheter, the visual marker element configured to be within a field of view captured by the imaging element and further configured to provide a visual indication of the orientation of the exit opening of the catheter with respect to an imaged vessel occlusion.

10. The system of claim 9, wherein the imaging element includes an ultrasound transducer.

11. The system of claim 9, wherein the imaging element comprising an array of ultrasound transducers.

12. The system of claim 10, wherein the ultrasound transducer is rearward looking away from a distal end of the catheter body.

13. The system of claim 9, further including a communication connector coupled to the imaging element, the communication connector extending within at least a portion of the catheter.

14. The system of claim 13, the communication connector is embedded into a sidewall of the catheter.

15. The system of claim 9, further including a balloon carried by the catheter.