Guidewire positioning catheter

• US 8,696,695 B2
• Filed: 01/19/2010
• Issued: 04/15/2014
• Est. Priority Date: 04/28/2009
• Status: Active Grant

• Current Assignee: Avinger Inc.
• Original Assignee: Avinger Inc.
• Inventors: Patel, Himanshu N., Simpson, John B.
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US12/689,748
• Publication Number:
  US 20100274270A1
• Time in Patent Office: 1,547 Days
• Field of Search: 606/80, 606/159, 606167-173, 606/180
• US Class Current: 606/159
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 5/066 Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• 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 25/0155 with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 25/0172 Exchanging a guidewire while keeping the catheter in place

Abstract

Described herein are guidewire positioning and support devices, method for using them, method of treating a subject using them, and systems including such guidewire positioning and support devices. These devices typically include a rotatable distal tip region that may include one or more wedges. The wedges may be extendable from the rotatable distal tip. The distal end of the device may be steerable, and may be steered while still rotating the distal end of the device. The wedges (which may include sharp forward-cutting blades and blunt lateral portions) can be extended from the distal housing and locked in any position (extended, partially extended or retracted) and rotated clockwise and/or counterclockwise while locked in a retracted, extended or partially extended position. The distal region of the device may also be controllable steered from the proximal end of the device. Systems including these guidewire support catheters are also described, as are method of using them, including methods of treating chronic total occlusions.

Claims

1. An elongate guidewire positioning catheter device for positioning a guidewire across an occluded portion of a vessel, the device comprising:

an elongate catheter body having an outer diameter and extending axially proximally to distally;

an integrated rotatable distal tip comprising one or more channeled flutes extending around the distal tip that are configured to be rotated in a first direction to cut tissue and a second direction for bluntly contacting tissue without cutting, wherein the maximum diameter of the distal tip is the same as the outer diameter of the elongate catheter body,

a driveshaft extending through the elongate catheter and attached to the integrated rotatable distal tip, wherein the driveshaft is configured to be moved axially to deflect the elongate catheter body at a predetermined location, wherein the predetermined location has an increased flexibility relative to the catheter body in order to allow the deflection, further wherein the axial position of the integrated distal tip is fixed relative to the distal end of the elongate catheter body and the driveshaft is configured to rotate the distal tip relative to the elongate catheter body;

a proximal handle region including a control for rotating the driveshaft so as to rotate the distal tip in either the first or second directions; and

a central lumen extending through the driveshaft configured to pass a guidewire.

2. The device of claim 1, wherein the one or more channeled flutes of the rotatable tip comprises a helical blade edge.

3. The device of claim 1, wherein the one or more channeled flutes of the rotatable distal tip comprises a substantially smooth, curved outer surface that presents an atraumatic surface for contacting tissue when rotated in the second direction and a that further presents a sharp surface for cutting tissue when rotated in the first direction.

4. The device of claim 1, further comprising forward cutting blades on the rotatable distal tip.

5. The device of claim 1, wherein the drive shaft is positioned between the central lumen and the outer diameter of the catheter body and extends from the rotatable tip to the proximal handle.

6. The device of claim 1 further comprising a slider at the proximal handle for deflecting the distal tip.

7. The device of claim 1, further comprising a tip indicator configured to indicate the angle of the distal tip when the elongate catheter body is deflected at the predetermined location.

8. The device of claim 1, wherein the control for rotating the distal tip is a manual control for manually rotating the distal tip.

9. An elongate guidewire positioning catheter device for positioning a guidewire across an occluded portion of a vessel, the device comprising:

an elongate catheter body having an outer diameter and extending axially proximally to distally, wherein there is a preset bend in the elongate body;

an integrated rotatable distal tip comprising one or more channeled flutes extending around the distal tip that comprise a substantially smooth, curved outer surface that presents an atraumatic surface for contacting tissue when rotated in a first direction, and a sharp surface for cutting tissue when rotated in a second direction, wherein the rotatable distal tip comprises a slip collar that engages a slip ring fixedly coupled to the distal end of the elongate catheter body to hold the axial position of the integrated distal tip fixed relative to the distal end of the elongate body while allowing rotation relative to the elongate catheter body;

a central lumen extending through the elongate catheter body configured to pass a guidewire; and

a drive shaft positioned between the central lumen and the outer diameter of the catheter body, the drive shaft extending between the rotatable tip and the proximal handle to drive rotation of the rotatable distal tip; and

a proximal handle region attached to the elongate catheter body and the drive shaft, the proximal handle region including a control for automatically rotating the distal tip in the first and second directions.

10. The device of claim 9, wherein the outer diameter of the distal tip is approximately the same as the outer diameter of the elongate catheter body.

11. The device of claim 9, wherein the one or more channeled flutes comprises a helical blade edge.

12. The device of claim 9, further comprising a second sharp tissue-cutting surface forming at least one forward cutting blade on the rotatable distal tip.

13. The device of claim 9, wherein the preset bend forms an angle of less than 45 degrees relative to the proximal region of the elongate body.

14. An elongate guidewire positioning catheter device for positioning a guidewire across an occluded portion of a vessel, the device comprising:

an elongate catheter body having an outer diameter and extending axially proximally to distally;

an integrated rotatable distal tip comprising one or more channeled flutes extending around the distal tip that comprise a substantially smooth, curved outer surface that presents an atraumatic surface for contacting tissue when rotated in a first direction, and a sharp surface for cutting tissue when rotated in a second direction, wherein the rotatable distal dip comprises a slip collar that engages a slip ring fixedly coupled to the distal end of the elongate catheter body to hold the axial position of the integrated distal tip fixed relative to the distal end of the elongate body while allowing rotation relative to the elongate catheter body;

a proximal handle region including a control for rotating the distal tip in either the first or second directions;

a control on the proximal handle for deflecting the elongate body at a hinged region of the elongate body, the hinged region configured such that the elongate body cannot deflect more than 60 degrees at the hinged region;

a central lumen extending through the elongate catheter body configured to pass a guidewire; and

a drive shaft positioned between the central lumen and the outer diameter of the catheter body to drive rotation of the rotatable distal tip.