Steerable sheath catheter and methods of use

• US 10,286,183 B2
• Filed: 11/22/2016
• Issued: 05/14/2019
• Est. Priority Date: 11/25/2015
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Flygare, Mark, Jenkins, Richard D., Jensen, Jon, McArthur, Gregory R., Jenkins, Richard Paul
• Primary Examiner(s): Bouchelle, Laura A
• Application Number:
  US15/358,549
• Publication Number:
  US 20170143940A1
• Time in Patent Office: 903 Days
• CPC Class Codes: A61B 1/00066 Proximal part of endoscope body, e.g. handles A61B1/0052 takes precedence
• CPC Class Codes: A61B 1/0052 Constructional details of control elements, e.g. handles
• CPC Class Codes: A61B 2018/00309 passive, e.g. palpable click when activating a button
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 25/0133 Tip steering devices
• 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: A61M 25/09041 Mechanisms for insertion of guide wires

Abstract

A steerable sheath catheter for providing access into body vasculature, the catheter including a sheath handle with an actuator and a control mechanism operative to selectively deflect a tip section of the catheter, and a feedback mechanism that provides, for example, tactile feedback that is felt by the user as the control mechanism passes a neutral position while deflecting the tip section.

Claims

1. A catheter system, comprising:

a handle section;

an actuator operably coupled to the handle section;

a catheter coupled to the handle section, the catheter comprising a body section extending from the handle section and a tip section coupled to a distal end of the body section;

the tip section of the catheter operably coupled to the actuator such that displacement of the actuator with respect to the handle section manipulates the position of the tip section of the catheter with respect to the body section of the catheter,

wherein the tip section of the catheter is operably coupled to the actuator by a drive mechanism comprising a right guide and a left guide; and

a feedback mechanism configured to provide feedback to a user regarding the position of the tip section of the catheter with respect to the body section of the catheter, wherein the feedback mechanism comprises;

a first tab disposed on the right guide and a second tab disposed on the left guide, wherein the first and second tabs contact each other as the right and left guides are longitudinally displaced, thus providing the feedback.

2. The catheter system of claim 1, wherein the feedback mechanism provides tactile feedback.

3. The catheter system of claim 1, wherein the feedback mechanism provides audible feedback.

4. The catheter system of claim 1, wherein the drive mechanism further comprises:

a right guide wire and a left guide wire coupled to the tip section of the catheter;

wherein the right guide is connected to the right guide wire and the left guide is connected to the left guide wire; and

a threaded drive tube having right and left threads operably connected to respective threads in the right and left guides, the threaded drive tube coupled to the actuator such that upon rotation of the threaded drive tube by the actuator, the left and right guides are longitudinally translated in opposite directions.

5. The catheter system of claim 4, wherein the first and second tabs contact each other when the tip section of the catheter is in a neutral position with respect to the body section of the catheter.

6. The catheter system of claim 5, wherein the neutral position corresponds to longitudinal alignment of the tip section of the catheter and the body section of the catheter.

7. The catheter system of claim 5, wherein the feedback mechanism further comprising a third tab configured to provide feedback to a user at a position other than the neutral position.

8. The catheter system of claim 4, wherein at least one of the first and second tabs is disposed on a cantilever arm.

9. A steerable sheath catheter system, comprising:

a handle section;

an actuator disposed in or on the handle section;

a sheath that is insertable into a body vascular and having a proximal end and a distal end, the sheath being connected at its proximal end to the handle section;

a tip section disposed at a distal end of the sheath;

first and second guide wires threaded through the sheath and connected to the tip section;

a drive mechanism disposed in the handle section operable for displacing the first and second guide wires to manipulate the tip section between a neutral position and a selected left position and between the neutral position and a selected right position;

a feedback mechanism operable to provide tactile feedback to the user, wherein the feedback mechanism comprises multiple tactile indicators indicating different tip positions.

10. The steerable sheath catheter system of claim 9, wherein the drive mechanism comprises:

a right guide connected to the first guide wire and a left guide connected to the second guide wire; and

a threaded drive tube having right and left threads operably connected to respective threads in the right and left guides, wherein upon rotation of the threaded drive tube by the actuator, the left and right guides are longitudinally translated in opposite directions.

11. The steerable sheath catheter system of claim 10, further comprising a first tab disposed on the right guide and a second tab disposed on the left guide, wherein the first and second tabs contact each other as the right and left guides pass the neutral position thereby providing the tactile feedback.

12. The steerable sheath catheter system of claim 9, wherein rotation of the actuator with respect to the handle section manipulates the tip section between the neutral position and a selected left position and between the neutral position and a selected right position.

13. The steerable sheath catheter system of claim 12, wherein the actuator is configured to rotate more than 360°

with respect to the handle when manipulating the tip section between the neutral position and at least one of the selected left position and the selected right position.

14. The steerable sheath catheter system of claim 13, wherein at least one of the selected left position and the selected right position comprises a maximum left displacement of the tip or a maximum right displacement of the tip, respectively.

15. The steerable sheath catheter system of claim 9, wherein the feedback mechanism further provides audible feedback to the user.

16. A method of displacing a steerable catheter tip comprising:

displacing a first guide member with respect to a second guide member, the first and second guide members operably coupled to a tip section of the catheter such that displacement of the first and second guide members manipulates the position of the tip section of the catheter; and

displacing a first tab with respect to a second tab such that contact between the first and second tabs provides feedback to a user, wherein the first tab is coupled to the first guide and the second tab is coupled to the second guide.

17. The method of claim 16, wherein the feedback comprises tactile feedback.

18. The method of claim 16, wherein the feedback comprises audible feedback.

19. The method of claim 16, further comprising displacing a third tab such that the relative position of the third tab with respect to at least one of the first tab and the second tab provides secondary feedback to a user.

20. The method of claim 19, wherein contact between the third tab and a fourth tab provides the secondary feedback.

21. A method of using a steerable sheath catheter having a control handle during a medical procedure on a patient, comprising the steps of:

positioning a sheath into a body vascular of the patient;

actuating a control mechanism on the control handle of the catheter to selectively deflect a tip section of the catheter;

providing tactile feedback that is felt by the user as the control mechanism passes a neutral position while deflecting the tip section;

provide tactile feedback to the user as the control mechanism passes a position other than the neutral position.