Catheter having a steerable tip

• US 9,833,596 B2
• Filed: 08/30/2013
• Issued: 12/05/2017
• Est. Priority Date: 08/30/2013
• Status: Active Grant

• Current Assignee: Kemet Electronics Corporation (Yageo Corporation)
• Original Assignee: Novasentis, Inc. (Yageo Corporation)
• Inventors: Ducharme, Richard, Levatich, Mark, Ramstein, Christophe
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): SHAH, NILAY J
• Application Number:
  US14/015,841
• Publication Number:
  US 20150065953A1
• Time in Patent Office: 1,558 Days
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0158 with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

A catheter includes an electromechanical polymer (EMP) actuator disposed in a steerable tip at the distal end of the catheter. When activated, the EMP actuator deflects the steerable tip through an angle between 0 and 270 degrees, thus permitting the operator to steer the steerable tip through the vasculature. The steerable tip also has at least a first relatively stiff region and a second relatively flexible region, and the EMP actuator is provided next to the first relatively stiff region so that the steerable tip may toward the flexible region when activated. In one implementation, an external interface allows a user to select by name one of many sets of control signals, with each set of control signals being signals calibrated for configuring the catheter to mimic a known catheter.

Claims

1. A catheter assembly, comprising an elongated catheter shaft enclosing a lumen for accommodating a guide wire, the catheter shaft having a proximal end, a distal end, and an intermediate region between the distal end and the proximal end, wherein the distal end comprises a steerable tip having (i) a first region, (ii) a second region that is flexible relative to the first region, and (iii) an electromechanical polymer (EMP) actuator having an upper surface and corresponding sides embedded in the second region and a bottom surface exposed to the lumen, the EMP actuator being configured to cause the steerable tip to deform in response to an electrical control signal;

and wherein the proximal end comprises a power source that provides the electrical control signal.

2. The catheter assembly of claim 1, wherein the control signals activate the EMP actuator in the steerable tip so as to perform at least one of the following applications:

tissue ablation, electrical mapping, stent delivery, embolics delivery, device delivery, access, contrast injection, imaging, stimulation, dilation and guide wire steering.

3. The catheter assembly of claim 1, further comprising a control circuit provided at the proximal end of the catheter shaft, wherein the control circuit controls the electrical control signal from the power source, thereby controlling a deflection of the steerable tip.

4. The catheter assembly of claim 3, wherein the electrical control signal comprises an AC component modulated on a DC bias voltage.

5. The catheter assembly of claim 3, further comprising:

a storage medium for storing selectable predefined electrical control signals corresponding to predefined deflections; and

an external interface for receiving selection information which enables the control circuit to select one of the predefined electrical control signals from the storage medium.

6. The catheter assembly of claim 5, wherein the external interface is programmable to allow a user to select by name one of a plurality of sets of control signals, each set of control signals being signals calibrated for configuring the catheter assembly to mimic a known catheter, wherein the selected set of control signals include the selected predefined electrical control signal.

7. The catheter assembly of claim 6, wherein the external interface is programmable to allow further adjustment to the catheter assembly configured by the selected set of control signals.

8. The catheter assembly of claim 6, further comprising, in the distal end, one or more sensors for providing sensor signals representative of environment conditions surrounding the steerable tip.

9. The catheter assembly of claim 8, wherein the sensors comprise one or more EMP actuators acting as sensors.

10. The catheter assembly of claim 9, wherein one or more of the EMP actuators act as both actuator and sensor.

11. The catheter assembly of claim 8, wherein the sensor signals are processed in the control circuit to accordingly dynamically adjust the electrical control signal.

12. The catheter assembly of claim 11, wherein the sensors perform pressure sensing function and wherein the deflection of the steerable tip is adjusted to maintain a predetermined level of deflection in accordance with the sensed pressure.

13. The catheter assembly of claim 1, wherein the steerable tip deforms in the direction of the second region in response to the electrical control signal.

14. The catheter assembly of claim 13, wherein the first region is adjacent a first portion of the lumen, and the second region is adjacent a second portion of the lumen, and wherein the EMP actuator is located in a portion of the steerable tip that is adjacent the intermediate region.

15. The catheter assembly of claim 13, wherein the second region comprises a strain-relief region embedding the EMP actuator and surrounding the lumen.

16. The catheter assembly of claim 15, wherein the first region surrounds a portion of the strain-relief region that embeds the EMP actuator.

17. The catheter assembly of claim 13, wherein the first region comprises a material having a durometer of about 75 A Shore, and wherein the second region comprises a material having a durometer of about 5 A Shore.

18. The catheter assembly of claim 13, wherein the first and second regions are both formed out of urethane materials.

19. The catheter assembly of claim 13, wherein the first region comprises a plurality of longitudinal strips disposed on one side of the lumen.

20. The catheter assembly of claim 13, wherein the first region comprises a helical strip disposed at a peripheral region of the steerable tip.

21. The catheter assembly of claim 1, wherein the steerable tip and the intermediate region of the catheter shaft are integrally formed.