Robotically augmented catheter manipulation handle

• US 10,675,442 B2
• Filed: 02/06/2017
• Issued: 06/09/2020
• Est. Priority Date: 02/08/2016
• Status: Active Grant

• Current Assignee: Nextern Innovation LLC A Delaware Limited Liability Company
• Original Assignee: Nextern, Inc.
• Inventors: Douglas, Ryan, Farrell, Richard, Berke, Dennis, Flanagan, Davis, Bontrager, David, Loushine, Brian
• Primary Examiner(s): Hayman, Imani N
• Application Number:
  US15/425,982
• Publication Number:
  US 20170224955A1
• Time in Patent Office: 1,219 Days
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 25/0113 Mechanical advancing means, e.g. catheter dispensers
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

Apparatus and associated methods relate to a catheter manipulation handle with user interface controls for steering a catheter in situ while providing an augmented (e.g., motorized, powered and tunable precision steering, and perforation safeguards) control and feedback user experience. In an illustrative example, the catheter manipulation handle may provide motor assisted operation to automatically rotate and/or deflect a distal tip of the catheter to steer and guide the distal tip to a target location in the patient'"'"'s vasculature system. The augmented feedback may include, for example, haptic feedback via the handle. Haptic, audible, and/or visual feedback via the handle may indicate, for example, proximity or engagement of the distal tip with sensitive tissue. In some examples, the handle'"'"'s augmented operation may advantageously amplify feedback signals to enhance the user'"'"'s perception of the patient'"'"'s safety with respect to the safe passage of the distal tip through the patient'"'"'s vasculature.

Claims

1. A hand-held catheter apparatus, comprising:

a handle body extending from a proximal end to a distal end along a longitudinal axis;

a user input interface on an outer surface of the handle body, wherein the user input interface generates a rotation command signal in response to user input at the user input interface;

a rotational actuator module positioned in the handle body and having a rotatable output, wherein the rotational actuator module controls an angular rotation of the rotatable output in response to the rotational command signal;

a handle coupling disposed at the distal end of the handle body and configured to releasably couple to a replaceable catheter head at a proximal end of a disposable catheter structure adapted to extend distally therefrom, wherein when the handle coupling is engaged with the catheter head, the rotational actuator module is operative to rotate the catheter structure about the longitudinal axis in response to rotation of the rotatable output, wherein the handle coupling comprises a handle deflection interface adapted to releasably couple to a catheter deflection interface in the catheter head;

a first deflection actuator disposed in the handle body and configured to impart, via the handle deflection interface and the catheter deflection interface, a first deflection angle command in a first plane to a steerable tip at a distal end of the catheter structure.

2. The apparatus of claim 1, wherein the handle body further comprises a hollow region that contains the rotational actuator module.

3. The apparatus of claim 1, further comprising a gear module to couple the rotatable output to the catheter coupling.

4. The apparatus of claim 1, wherein a processor further generates the first deflection angle command in response to a first user input deflection command signal received at the user input interface.

5. The apparatus of claim 1, further comprising a feedback interface on the handle body configured to couple to the catheter interface to receive feedback signals from feedback elements in the catheter;

and, a processor disposed in the handle body and operably coupled to receive the feedback signals and to generate in response thereto a predetermined haptic feedback to the user while the user is holding the handle body, wherein the processor is configured to generate the predetermined haptic feedback at a predetermined amplification.

6. The apparatus of claim 5, wherein the predetermined amplification is based on a predetermined sensitivity of the patient tissue proximate to the steerable tip at a distal end of the catheter structure.

7. A hand-held catheter apparatus comprising:

a handle body extending from a proximal end to a distal end along a longitudinal axis;

a user input interface on the handle body, wherein the user input interface generates a rotation command signal in response to user input at the user input interface;

a rotational actuator module positioned in the handle body and having a rotatable output, wherein the rotational actuator module controls an angular rotation of the rotatable output in response to the rotational command signal;

a handle coupling disposed at the distal end of the handle body and configured to releasably couple to a replaceable catheter head disposed at a proximal end of a disposable catheter structure extending distally from a catheter interface rotatably coupled to a distal end of the handle body, wherein when the handle coupling is engaged with the catheter head, the rotational actuator module is operative to rotate the catheter structure about the longitudinal axis in response to rotation of the rotatable output, wherein the handle coupling comprises a handle deflection interface adapted to releasably couple to a catheter deflection interface disposed in the catheter head; and

,

at least one deflection actuator disposed in the handle body and configured to impart, via the handle deflection interface when coupled to the catheter deflection interface, a first deflection angle command in a first plane to a steerable tip at a distal end of the catheter structure.

8. The apparatus of claim 7, wherein the handle body further comprises a hollow region that contains the rotational actuator module.

9. The apparatus of claim 7, further comprising a gear module to couple the rotatable output to the catheter head.

10. The apparatus of claim 7, wherein the handle deflection interface comprises a jack.

11. The apparatus of claim 10, wherein the catheter deflection interface comprises a plug compatible with the jack.

12. The apparatus of claim 7, wherein the catheter deflection interface comprises a jack.

13. The apparatus of claim 12, wherein the handle deflection interface comprises a plug compatible with the jack.

14. The apparatus of claim 7, further comprising a processor disposed in the handle body, the processor operably coupled to receive the feedback signals and generate feedback to a user while the user is holding the handle body.

15. The apparatus of claim 14, wherein the feedback generated to a user by the processor is a predetermined haptic feedback at a predetermined amplification.

16. The apparatus of claim 7, wherein the catheter deflection interface is attached to one or more control wires routed in the catheter structure.