Steerable sheath including elastomeric member

• US 9,821,143 B2
• Filed: 09/28/2015
• Issued: 11/21/2017
• Est. Priority Date: 12/15/2011
• Status: Active Grant

• Current Assignee: Imricor Medical Systems, Inc.
• Original Assignee: Imricor Medical Systems, Inc.
• Inventors: Kimmel, Scott, Page, Douglas A.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Kabir, Zahed
• Application Number:
  US14/867,487
• Publication Number:
  US 20160058974A1
• Time in Patent Office: 785 Days
• Field of Search: 606 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 25/0108 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 33/286 involving passive visualization of interventional instruments, i.e. making the instrument visible as part of the normal MR process

Abstract

An MR compatible steerable sheath with elastomeric member is provided. The elastomeric member is configured to serve as a reservoir and receive contrast media therewithin. The elastomeric member is positioned on the distal end of the steerable sheath and may circumferentially surround the sheath shaft or be offset from a longitudinal axis thereof. In operation, the contrast media allows a user to view the distal tip of the steerable sheath by virtue of the contrast media contained within the elastomeric member.

Claims

1. An MR compatible steerable sheath comprising:

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 led 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;

an elastomeric member circumferentially positioned on said tubular shaft and including an elastomeric member lumen therewith;

a source of contrast media in fluid communication with said elastomeric member lumen,

wherein said elastomeric member is configured to denote the position of the steerable sheath.

2. The MR compatible steerable sheath of claim 1 wherein said elastomeric member lumen is in fluid communication with at least one tube defining a tube lumen configured to extend along a longitudinal axis of the tubular shaft on the outside of said tubular shaft.

3. The MR compatible steerable sheath of claim 1 wherein said elastomeric member comprises a plurality of elastomeric members each having an elastomeric member lumen.

4. The MR compatible steerable sheath of claim 3 wherein said plurality of elastomeric member lumens are each in fluid communication with a single tube lumen positioned on an outside of said tubular shaft.

5. The MR compatible steerable sheath of claim 3 wherein each of said elastomeric member lumens are in fluid communication with a plurality of tube lumens positioned on an outside of said tubular shaft.

6. The MR compatible steerable sheath of claim 3 wherein said elastomeric members are offset from each other along the longitudinal axis of said sheath.

7. The MR compatible steerable sheath of claim 6 wherein said elastomeric member and said sheath portion are constructed from the same material.

8. The MR compatible steerable sheath claim 1 wherein said elastomeric member includes a sheath portion operably coupled to said tubular shaft, said sheath portion defining a lumen therewithin in fluid communication with the lumen of said elastomeric member.

9. The MR compatible steerable sheath of claim 8 wherein said elastomeric member is integrally formed with said sheath portion.

10. The MR compatible steerable sheath of claim 9 wherein said elastomeric member and said sheath portion are constructed from different materials.

11. The MR compatible steerable sheath of claim 1 wherein said lumen is configured to allow the elastomeric member to be filled with viscous fluids.

12. The MR compatible steerable sheath of claim 1 wherein said elastomeric member has a shape selected from spherical, conical, dog-bone, tapered, circular, elliptical, cone-shaped and paddle-shaped.

13. The MR compatible steerable sheath of claim 1 wherein said elastomeric member comprises three elastomeric members positioned on said sheath in a spaced-apart relationship.

14. The MR compatible steerable sheath of claim 13 wherein each of said elastomeric members have a different shape configured to indicate to a user the direction of the steerable sheath when in use.

15. The MR compatible steerable sheath of claim 13 wherein one of said elastomeric members positioned proximal to the other elastomeric members has a shape different than said other elastomeric members.

16. The MR compatible steerable sheath of claim 1 wherein said elastomeric member is non-integrally formed with said sheath portion.