MRI compatible handle and steerable sheath

• US 9,138,561 B2
• Filed: 12/13/2013
• Issued: 09/22/2015
• Est. Priority Date: 12/15/2011
• Status: Active Grant

• Current Assignee: Imricor Medical Systems, Inc.
• Original Assignee: Imricor Medical Systems, Inc.
• Inventors: Stenzel, Gregg S., Wedan, Steven R., Page, Douglas A., Lloyd, Thomas W., Kalthoff, James Alan, Brutlag, Bryan A.
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): Shapiro, Victor
• Application Number:
  US14/106,177
• Publication Number:
  US 20140100445A1
• Time in Patent Office: 648 Days
• Field of Search: 600/410, 600/411, 600/463, 604/8, 604/103.7, 604/95.04, 604/523, 604/528, 606/194, 607/122
• US Class Current: 1/1
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: G01R 33/285 Invasive instruments, e.g. catheters or biopsy needles, specially adapted for tracking, guiding or visualization by NMR
• CPC Class Codes: G01R 33/286 involving passive visualization of interventional instruments, i.e. making the instrument visible as part of the normal MR process
• CPC Class Codes: G01R 33/287 involving active visualization of interventional instruments, e.g. using active tracking RF coils or coils for intentionally creating magnetic field inhomogeneities
• CPC Class Codes: G01R 33/48 NMR imaging systems

Abstract

An MR compatible deflectable catheter and method of using the same is provided. The MR compatible deflectable catheter includes a steerable sheath having a tubular shaft. The tubular shaft receives first and second longitudinal movement wires at a distal end thereof. A control handle is coupled to a proximal end of the first and second longitudinal movement wires and causes longitudinal movement of the wires.

Claims

1. A MR compatible deflectable catheter comprising:

a steerable sheath having a tubular shaft defining a longitudinal axis, said tubular shaft receiving first and second longitudinal movement wires operably coupled to a distal end thereof;

a control handle having a main body configured to receive first and second rack screws, said first and second rack screws being mechanically coupled to each other such that movement of said second rack screw along the longitudinal axis of the tubular shaft causes movement of said first rack screw in an opposite direction along the longitudinal axis of the tubular shaft, said second rack screw including a threaded portion on an outer surface at an end thereof;

said first longitudinal movement wire operably coupled to said first rack screw and said second longitudinal movement wire operably coupled to said second rack screw; and

a rotatable adjustment knob operably engageable with said control handle, said rotatable adjustment knob having an internal threaded portion matingly engageable solely with the threaded portion of said second rack screw, said rotatable adjustment knob solely rotatably moveable between a first position and a second position in which the internal thread is configured to engage solely the thread on the outer surface of said second rack screw,

wherein said first position causes said second rack screw to move proximally along the longitudinal axis of the tubular shaft which in turn causes said first rack screw to move distally along the longitudinal axis of the tubular shaft and proximal movement of said second rack screw is configured to tension and cause proximal longitudinal movement of the second longitudinal movement wire,

and further wherein said second position is configured to move said second rack screw distally along the longitudinal axis of the tubular shaft which in turn causes said first rack screw to move proximally and distal movement of said second rack screw is configured to release tension on the second longitudinal movement wire.

2. The MR compatible deflectable catheter of claim 1 wherein said proximal longitudinal movement of said second longitudinal movement wire is configured to causes the distal end of said steerable sheath to deflect about 180 degrees from a longitudinal axis of the tubular shaft in a first direction.

3. The MR compatible deflectable catheter of claim 1 wherein said tubular shaft further includes a pull ring at a distal end thereof and said first and second longitudinal movement wires are operably coupled thereto.

4. The MR compatible deflectable catheter of claim 1 wherein said tubular shaft further includes two internal lumens positioned on opposite sides of said tubular shaft for housing said first and second longitudinal movement wires.

5. The MR compatible deflectable catheter of claim 2 wherein said tubular shaft includes a reinforcement construct at the distal end thereof configured to allow said steerable sheath to deflect at least 180 degrees from the longitudinal axis of the tubular shaft.

6. The MR compatible deflectable catheter of claim 5 wherein said reinforcement construct is selected from a braided configuration, a coiled configuration, a slit tube configuration and combinations of the foregoing.

7. The MR compatible deflectable catheter of claim 1 wherein said shaft includes one or more pressure relief holes.

8. The MR compatible deflectable catheter of claim 1 wherein said shaft includes a transition section having a durometer that is higher than the durometer of the distal end of the shaft and less than the durometers of the proximal end of said shaft.

9. The MR compatible deflectable catheter of claim 1 wherein a lumen of said tubular shaft is lined or coated with a hydrophilic material.

10. The MR compatible deflectable catheter of claim 1 wherein said tubular shaft further includes a ferrous marker, a magnetic marker or a fluoroscopy marker disposed on said tubular shaft.

11. The MR compatible deflectable catheter of claim 1 wherein said tubular shaft further includes an active tracking coil along a length, said active tracking coil comprising chokes, transformers, impedances and combinations of the foregoing.

12. The MR compatible deflectable catheter of claim 11 wherein said active tracking coil comprises traces on a circuit board, a coiled wire, a dipole and combinations of the foregoing.

13. The MR compatible deflectable catheter of claim 1 wherein said tubular shaft further includes one or more fluid ports configured to allow for hemostasis of the steerable sheath.

14. The MR compatible deflectable catheter of claim 5 wherein said reinforcement construct comprises a non-metallic material selected from Kevlar, PEEK, Nylon, fabric, polyimide, fiber optic, silica glass and combinations of the foregoing.

15. The MR compatible deflectable catheter of claim 5 wherein said reinforcement construct comprises a combination of metallic and non-metallic materials.

16. The MR compatible deflectable catheter of claim 1 further comprising first and second pinion gears operably engageable with an inner threaded channel of said first and second rack screws, wherein the proximal longitudinal movement of said second rack screw is configured to cause engagement of said first and second pinion gears to cause said first rack screw to move distally and release tension on said first longitudinal movement wire.

17. The MR compatible deflectable catheter of claim 16 wherein said second position of said adjustable rotation knob is configured to cause longitudinal distal movement of said second rack screw and release of tension on said second longitudinal movement wire.

18. The MR compatible deflectable catheter of claim 17 wherein proximal movement of said second rack screw is configured to release tension on said first longitudinal movement wire.

19. The MR compatible deflectable catheter of claim 1 wherein said distal movement of said second rack screw is configured to cause the distal end of said steerable sheath to deflect at least 180 degrees from a longitudinal axis of the tubular shaft in a second direction.