Medical devices for renal nerve ablation having rotatable shafts

• US 10,022,182 B2
• Filed: 06/20/2014
• Issued: 07/17/2018
• Est. Priority Date: 06/21/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Willard, Martin R., Haverkost, Patrick A., Pederson, Jr., Gary J.
• Primary Examiner(s): FOWLER, DANIEL WAYNE
• Application Number:
  US14/310,996
• Publication Number:
  US 20140378967A1
• Time in Patent Office: 1,488 Days
• 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 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/1465 Deformable electrodes
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe

Abstract

A medical device for renal denervation may include a catheter shaft including an outer shaft having a lumen formed therein and an inner shaft extending within the lumen of the outer shaft. The catheter may further include an expandable member having a proximal region coupled to a distal region of the outer shaft, and a distal region of the expandable member may be coupled to a distal region of the inner shaft. In some embodiments, one or more active electrodes may be disposed on an exterior surface of the expandable member and capable of providing the renal denervation treatment. In some embodiments, the inner shaft may be rotatable in relation to the outer shaft and/or the outer shaft may be rotatable in relation to the inner shaft.

Claims

1. A method for providing treatment of a body passageway, the method comprising:

positioning an expandable balloon of a medical device near a treatment zone, the medical device comprising;

a catheter shaft including an outer shaft having a first lumen formed therein and an inner shaft extending within the first lumen;

the expandable balloon, the expandable balloon having a proximal region and a distal region, wherein the distal region of the outer catheter shaft is coupled near the proximal region of the expandable balloon and the distal region of the inner catheter shaft is coupled near the distal region of the expandable balloon; and

one or more flexible circuits each comprising one or more active electrodes disposed on an exterior surface of the expandable balloon and capable of providing treatment of a body passageway;

wherein the inner shaft is rotatable in relation to the outer shaft and/or the outer shaft is rotatable in relation to the inner shaft;

wherein a torque applied to one or more of the outer shaft and the inner shaft facilitates deflation of the expandable balloon from an inflated profile to a deflated profile in a way such that at least a portion of the expandable balloon is twisted in relation to a different portion of the expandable balloon; and

wherein, when the expandable balloon is deflated to a deflated shape, at least in part, by applying the torque to one or more of the outer shaft and the inner shaft, such that at least a portion of the expandable balloon is twisted in relation to a different portion of the expandable balloon, portions of the expandable balloon envelop the one or more flexible circuits due to the positioning of one or more flexible circuits on the surface of the expandable balloon;

activating the one or more active electrodes, thereby providing treatment at a desired location at the treatment zone; and

deflating the expandable balloon to the deflated shape after providing the treatment by, at least in part, applying said torque to one or more of the outer shaft and the inner shaft, such that at least a portion of the expandable balloon is twisted in relation to a different portion of the expandable balloon and portions of the expandable balloon envelop the one or more flexible circuits due to the positioning of one or more flexible circuits on the surface of the expandable balloon.

2. The method of claim 1, wherein the flexible circuits comprise electrode pads and tails, and wherein the arrangement and geometry of the electrode pads and the tails facilitate folding of the balloon when collapsed into an un-expanded state.

3. The method of claim 1, wherein a torque applied to the outer shaft facilitates the shifting of the expandable balloon from an inflated profile to a deflated profile or wherein a torque applied to the inner shaft facilitates the shifting of the expandable balloon from an inflated profile to a deflated profile.

4. The method of claim 1, further comprising a tubular member having a second lumen, wherein the catheter shaft is slidably disposed within the tubular member, the tubular member facilitating movement of the expandable balloon to a location near a treatment zone.

5. The method of claim 1, wherein one or more of the outer shaft and the inner shaft comprises a braided shaft.

6. The method of claim 1, wherein the expandable balloon is capable of being at least partially twisted at a proximal region of the expandable balloon while not being twisted at a distal region of the expandable balloon.

7. The method of claim 1, wherein the expandable balloon is capable of being at least partially twisted at a distal region of the expandable balloon while not being twisted at a proximal region of the expandable balloon.

8. The method of claim 1, wherein the expandable balloon is capable of being at least partially twisted from the proximal region to the distal region.

9. The method of claim 1, wherein a torque provided to at least one of the outer shaft and the inner shaft facilitates expansion of the expandable balloon.

10. A method for providing a treatment of a body passageway, the method comprising:

positioning an expandable balloon of a medical device near a treatment zone, the medical device comprising;

a catheter shaft including an outer shaft having a first lumen formed therein and an inner shaft extending within the first lumen;

the expandable balloon coupled to a distal region of the outer shaft and to a distal region of the inner shaft balloon having a proximal region and a distal region, wherein the distal region of the outer catheter shaft is coupled near the proximal region of the expandable balloon and the distal region of the inner catheter shaft is coupled near the distal region of the expandable balloon; and

one or more active electrodes disposed on one or more flexible circuits disposed on an exterior surface of the expandable balloon and capable of providing body passageway treatment;

wherein the inner shaft is rotatable in relation to the outer shaft and/or the outer shaft is rotatable in relation to the inner shaft;

wherein a torque applied to one or more of the outer shaft and the inner shaft facilitates deflation of the expandable balloon from an inflated profile to a deflated profile in a way such that at least a portion of the expandable balloon is twisted in relation to a different portion of the expandable balloon; and

wherein, when the expandable balloon is deflated to the deflated profile, at least in part, by applying said torque to one or more of the outer shaft and the inner shaft such that at least a portion of the expandable balloon is twisted in relation to a different portion of the expandable balloon, portions of the expandable balloon envelop the one or more flexible circuits due to the positioning of one or more flexible circuits on the surface of the expandable balloon;

activating the one or more active electrodes, thereby providing treatment at a desired location at the treatment zone; and

deflating the expandable balloon to a deflated shape after providing the treatment by, at least in part, applying said torque to one or more of the outer shaft and the inner shaft, such that at least a portion of the expandable balloon is twisted in relation to a different portion of the expandable balloon and portions of the expandable balloon envelop the one or more flexible circuits due to the positioning of one or more flexible circuits on the surface of the expandable balloon.

11. The method of claim 10, wherein the flexible circuits comprise electrode pads and tails, and wherein the arrangement and geometry of the electrode pads and the tails facilitate folding the expandable balloon into a relatively compact state upon deflation and application of torque to one or more of the outer shaft and the inner shaft.

12. A method for providing treatment of a body passageway, the method comprising:

positioning an expandable balloon of a system near a treatment zone, the system comprising;

a power source capable of providing energy for performing body passageway treatment; and

a treatment catheter coupled to the power source, the treatment catheter including;

a first catheter shaft having a lumen, the first catheter shaft having a proximal region and a distal region;

a second catheter shaft positioned within the lumen of the first catheter shaft, the second catheter shaft having a proximal region and a distal region, wherein the first catheter shaft is rotatable in relation to the second catheter shaft and/or the second catheter shaft is rotatable in relation to the first catheter shaft;

the expandable balloon, the expandable balloon having a proximal region and a distal region, wherein the distal region of the first catheter shaft is coupled near the proximal region of the expandable balloon and the distal region of the second catheter shaft is coupled near the distal region of the expandable balloon; and

one or more flexible circuits comprising one or more active electrodes positioned on a surface of the expandable balloon, the one or more active electrodes capable of providing treatment using energy received from the power source;

wherein a torque applied to one or more of the first catheter shaft and the second catheter shaft facilitates deflation of the expandable balloon from an inflated profile to a deflated profile in a way such that at least a portion of the expandable balloon is twisted in relation to a different portion of the expandable balloon; and

wherein, when the expandable balloon is deflated to a deflated shape, at least in part, by applying said torque to one or more of the first catheter shaft and the second catheter shaft, such that at least a portion of the expandable balloon is twisted in relation to a different portion of the expandable balloon, portions of the expandable balloon envelop the one or more flexible circuits due to the positioning of one or more flexible circuits on the surface of the expandable balloon;

activating the one or more active electrodes, thereby providing treatment at a desired location at the treatment zone; and

deflating the expandable balloon to a deflated shape after providing the treatment by, at least in part, applying said torque to one or more of the first catheter shaft and the second catheter shaft, such that at least a portion of the expandable balloon is twisted in relation to a different portion of the expandable balloon and portions of the expandable balloon envelop the one or more flexible circuits due to the positioning of one or more flexible circuits on the surface of the expandable balloon.

13. The method of claim 12, wherein the flexible circuits comprise electrode pads and tails, and wherein the arrangement and geometry of the electrode pads and the tails facilitate folding the expandable balloon into a relatively compact state upon deflation and application of torque to one or more of the outer shaft and the inner shaft.

14. The method of claim 12, further comprising a guide catheter capable of receiving the treatment catheter with the expandable balloon in a deflated state, the guide catheter capable of positioning the distal region of the treatment catheter near a treatment region.

15. The method of claim 12, wherein a torque applied to the first catheter shaft and/or the second catheter shaft facilitates expansion of the expandable balloon.