Devices, systems, and methods for monitoring and/or controlling deployment of a neuromodulation element within a body lumen and related technology

• US 10,610,292 B2
• Filed: 04/24/2015
• Issued: 04/07/2020
• Est. Priority Date: 04/25/2014
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Ku, Vincent, Ballakur, Sowmya, Shah, Jignesh
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Demie, Tigist S
• Application Number:
  US14/696,058
• Publication Number:
  US 20150305808A1
• Time in Patent Office: 1,810 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 2018/00267 having a basket shaped structure
• 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 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/144 Wire
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

The present disclosure relates to devices, systems and methods providing evaluation and feedback to an operator of a device providing neuromodulation treatment, such as modulation of renal nerves of a human patient. In one embodiment, for example, a system monitors parameters or values generated before treatment. Feedback provided to an operator is based on the monitored values and relates to an assessment of various electrical properties associated with an electrode carried by a catheter. The electrode measures an electrical property of biological material making contact with the electrode while deploying the electrode, the electrical property being dependent on a ratio of a wall-interface area to a fluid-interface area.

Claims

1. A method, comprising:

advancing a catheter including an elongate shaft and a neuromodulation element operably connected to the shaft toward a treatment location within a body lumen of a human patient, the neuromodulation element including an elongate electrode slidably disposed within a dielectric sleeve carried by and positioned within the elongate shaft, wherein the elongate electrode comprises a wire electrode having a proximal end, a distal end coupled to a distal end of the neuromodulation element, and an engagement portion therebetween and positioned to engage an inner wall surface of the body lumen;

deploying the neuromodulation element after advancing the catheter, wherein deploying the neuromodulation element includes—

a first deployment phase during which the elongate electrode moves radially outward while the size of a fluid-interface area of the elongate electrode increases due to an increasing size of an exposed segment of the elongate electrode,

a second deployment phase following the first deployment phase during which the elongate electrode moves radially outward into contact with the inner wall surface of the body lumen while the size of a wall-interface area of the elongate electrode increases,

a third deployment phase following the second deployment phase, during which the fluid-interface area or the wall-interface area remain constant; and

using the elongate electrode to measure an electrical property of a sum of material adjacent to the elongate electrode, wherein the electrical property is a function of the size of the fluid-interface area and/or the size of the wall-interface area; and

generating a status indication and/or enabling a neuromodulation treatment in response to the electrical property remaining constant within a predetermined range for a period of time during the third deployment phase.

2. The method of claim 1 wherein the electrical property is impedance.

3. The method of claim 1 wherein

the first deployment phase is defined by a decrease in the electrical property;

the second deployment phase is defined by an increase in the electrical property; and

the third deployment phase is defined by the electrical property remaining constant.

4. The method of claim 1, further comprising generating a signal to alert a user if a rate of change of the electrical property during the first deployment phase and/or the second deployment phase is less than a threshold rate of change.

5. The method of claim 1 wherein the wire electrode is helical during the third deployment phase.

6. The method of claim 1 wherein deploying the neuromodulation element includes pushing the proximal end of the elongate electrode in a distal direction.

7. A method, comprising:

intravascularly advancing a distal portion of a neuromodulation catheter to a target site within a renal blood vessel of a patient, wherein the distal portion of the catheter comprises a neuromodulation element operably coupled to a catheter shaft, and wherein the neuromodulation element includes an elongate electrode having a proximal end, a distal end coupled to a distal end of the neuromodulation element, and an engagement portion between the proximal end and the distal end and positioned to engage an inner wall surface of the renal blood vessel;

deploying the neuromodulation element at the target site within the renal blood vessel, wherein deploying the neuromodulation element includes—

a first deployment phase during which the elongate electrode moves radially outward while the size of a fluid-interface area of the elongate electrode increases due to an increasing size of an exposed segment of the elongate electrode,

a second deployment phase following the first deployment phase during which the elongate electrode moves radially outward into contact with the inner wall surface of the renal blood vessel while the size of a wall-interface area of the elongate electrode increases,

a third deployment phase following the second deployment phase, during which the fluid-interface area or the wall-interface area remain constant; and

using the elongate electrode to measure an electrical property of a sum of material adjacent to the wire electrode, wherein the electrical property is a function of the size of the fluid-interface area and/or the size of the wall-interface area; and

enabling a neuromodulation treatment in response to the electrical property remaining constant within a predetermined range for a period of time during the third deployment phase.