Five degree of freedom ultrasound catheter and catheter control handle

• US 10,183,149 B2
• Filed: 10/14/2014
• Issued: 01/22/2019
• Est. Priority Date: 12/28/2004
• Status: Active Grant

• Current Assignee: St. Jude Medical, Atrial Fibrillation Division, Inc. (Abbott Laboratories)
• Original Assignee: St. Jude Medical, Atrial Fibrillation Division, Inc. (Abbott Laboratories)
• Inventors: Tegg, Troy Terrance, Senn, Andrew, Kauphusman, James V., Bednarek, Michael C.
• Primary Examiner(s): Medway, Scott
• Application Number:
  US14/514,106
• Publication Number:
  US 20150105655A1
• Time in Patent Office: 1,561 Days
• Field of Search: 604523, 604528, 604585, 604 9501, 604264
• CPC Class Codes: A61B 1/0052 Constructional details of control elements, e.g. handles
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6855 with a distal curved tip
• 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 8/4466 involving deflection of the probe
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Catheter ultrasound systems including a sheath, a handle, a sheath lumen, and an ultrasound catheter disposed within the lumen of the sheath with ultrasound elements capable of visualizing anatomical regions. The handle allowing the ultrasound catheter to rotate with respect to the sheath using a rotation adjustment knob within the handle or alternatively an separate manipulation handle attached to the proximal end of the ultrasound catheter. The sheath, ultrasound catheter, or both may also include one or more electrodes or other location sensor for both orienting the ultrasound element as well as for diagnostic purposes.

Claims

1. An apparatus for maneuvering an instrument catheter, the apparatus comprising:

a flexible body having a lumen therethrough and a deflection wire, the flexible body having a distal end portion and a proximal end portion, with the distal end portion operably coupled to the deflection wire;

a handle that extends along a longitudinal axis, the handle coupled to the proximal end portion of the flexible body, the handle comprising;

a first actuator;

a second actuator;

a handle grip;

a handle lumen extending through the first actuator, the second actuator, and the handle grip, wherein the first actuator and the second actuator are independently rotatable about the longitudinal axis and are disposed longitudinally adjacent with respect to one another;

a slide operably coupled to the first actuator and to the deflection wire; and

a rotation assembly operably coupled to the second actuator, the rotation assembly having a tube extending therethrough, the tube being coupled to the rotation assembly and the tube having an inner surface capable of being fixedly attached to an instrument catheter; and

a continuous lumen extending from the distal end portion of the flexible body to the proximal end of the tube, the continuous lumen comprising the lumen of the flexible body, the handle lumen, and the tube;

an instrument catheter disposed within the continuous lumen, wherein the instrument catheter is coaxial with the first actuator and the second actuator;

wherein rotating the first actuator engages the slide causing the slide to displace axially imparting a tensile force to the deflection wire thereby causing the distal end portion of the flexible body to deflect and thereby a distal end portion of the instrument catheter to deflect, and rotation of the second actuator imparts a torque to the tube of the rotation assembly causing the tube to rotate about the longitudinal axis of the handle and thereby rotate the received instrument catheter.

2. The apparatus of claim 1, wherein:

the flexible body comprises a plurality of deflection wires; and

the instrument catheter extends from a proximal side of the handle, through the handle and out of a distal end of the handle.

3. The apparatus of claim 2, wherein the flexible body comprises a plurality of slides, each slide being operably coupled to one of the plurality of deflection wires.

4. The apparatus of claim 1, wherein the rotation assembly comprises a drive gear, one or more ratio gears, and a positioning gear, the drive gear operably coupled to the second actuator to receive a torque, the one or more ratio gears disposed to engage the drive gear and positioning gear thereby transferring torque from the drive gear to the positioning gear, the positioning gear being coupled to the tube thereby causing the tube to rotate with the positioning gear.

5. The apparatus of claim 4, wherein:

the drive gear, the one or more ratio gears, and the positioning gear are disposed distal of the slide;

the distal portion of the flexible body includes an ultrasound element; and

rotation of the second actuator imparts a torque to the ultrasound element.

6. The apparatus of claim 1, wherein the rotation assembly causes a substantially one to one ratio between angular displacement of the second actuator and angular displacement of the tube of the rotation assembly.

7. The apparatus of claim 1, the distal end portion of the flexible body further including one of an electrode or a magnetic tracking coil configured to be operably connected to an electroanatomical mapping system.

8. The apparatus of claim 1, wherein the slide comprises external threads, wherein the handle further comprises a shaft operably coupled to the first actuator and to the slide, the shaft comprising internal threads that engage the external threads of the slide.

9. A guiding catheter, comprising:

a flexible body having a lumen therethrough, the flexible body having a distal end portion and a proximal end portion;

a deflection wire operably connected to the distal end portion of the flexible body;

a handle coupled to the proximal end portion of the flexible body, the handle comprising a first actuator, a second actuator, and a handle grip, the handle having a lumen extending through the first actuator, the second actuator, and the handle grip; and

a separate medical device that includes an elongate flexible body;

a tube defining a lumen, the tube having an inner wall configured to be affixed to the separate medical device flexible body, the tube lumen and the handle lumen comprising a continuous lumen, the tube configured to rotate relative to the guiding catheter flexible body lumen, the continuous lumen being capable of receiving the separate medical device;

wherein actuation of the first actuator imparts a tensile force to the deflection wire, thereby causing the distal end portion of the guiding catheter flexible body to deflect, further wherein actuation of the second actuator imparts a torque to the tube, thereby causing the tube and the elongate flexible body of the separate medical device to rotate relative to the guiding catheter tubular body without substantially changing the deflection of the guiding catheter tubular body, wherein the elongate flexible body extends from a proximal side of the handle, through the handle and out of a distal end of the guiding catheter.

10. The guiding catheter of claim 9, further comprising a plurality of deflection wires.

11. The guiding catheter of claim 10, further comprising a plurality of slides, each slide being operably coupled to one of the plurality of deflection wires.

12. The guiding catheter of claim 9, further comprising one of an electrode or a magnetic tracking coil attached to the distal end portion of the flexible body and configured to be operably connected to an electroanatomical mapping system.

13. The apparatus of claim 9, further comprising a drive gear, one or more ratio gears, and a positioning gear, the drive gear operably coupled to the second actuator to receive a torque, the one or more ratio gears disposed to engage the drive gear and positioning gear thereby transferring torque from the drive gear to the positioning gear, the positioning gear being coupled to the tube thereby causing the tube to rotate with the positioning gear.

14. The apparatus of claim 13, further comprising a slide being operably coupled to the deflection wire, wherein the drive gear, the one or more ratio gears, and the positioning gear are disposed distal of the slide.

15. The apparatus of claim 14, wherein the drive gear, one or more ratio gears, and positioning gear cause a substantially one to one ratio between angular displacement of the second actuator and angular displacement of the tube of the rotation assembly.

16. The apparatus of claim 14, wherein the slide comprises external threads, wherein the handle further comprises a shaft operably coupled to the first actuator and to the slide, the shaft comprising internal threads that engage the external threads of the slide.

17. A guiding elongate medical device comprising:

a flexible body having a lumen therethrough, the flexible body having a distal end portion and a proximal end portion;

a deflection wire operably connected to the distal end portion of the flexible body;

a handle coupled to the proximal end portion of the flexible body, the handle comprising a first actuator operably coupled to the deflection wire and a second actuator, the handle defining a lumen that extends through the handle for the passage of an instrument elongate medical device shaft;

the instrument elongate medical device shaft extending from a proximal end of the handle, through the lumen of the handle and out a distal end of the flexible body; and

a hemostasis tube extending through the lumen of the flexible body, the hemostasis tube operably coupled to the second actuator and configured to be affixed to the instrument elongate medical device shaft and to rotate relative to the flexible body, wherein the hemostasis tube is coaxial with and surrounds a portion of the instrument elongate medical device shaft;

wherein actuation of the first actuator imparts a tensile force to the deflection wire and actuation of the second actuator imparts a torque to the hemostasis tube, thereby causing the tube and the instrument elongate medical device to rotate relative to the flexible body.

18. The guiding elongate medical device of claim 17, wherein the hemostasis tube extends distally from the distal end of the flexible body lumen.

19. The guiding elongate medical device of claim 17, further comprising a drive gear, one or more ratio gears, and a positioning gear, the drive gear operably coupled to the second actuator to receive a torque, the one or more ratio gears disposed to engage the drive gear and positioning gear thereby transferring torque from the drive gear to the positioning gear, the positioning gear being coupled to the tube thereby causing the tube to rotate with the positioning gear.

20. The guiding elongate medical device of claim 17, further comprising one of an electrode or a magnetic tracking coil attached to the distal end portion of the flexible body and configured to be operably connected to an electroanatomical mapping system.