Catheters with enhanced flexibility and associated devices, systems, and methods

• US 10,188,829 B2
• Filed: 11/13/2017
• Issued: 01/29/2019
• Est. Priority Date: 10/22/2012
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Beasley, Rudy, Goshgarian, Justin, Ku, Vincent
• Primary Examiner(s): Stigell, Theodore
• Application Number:
  US15/811,351
• Publication Number:
  US 20180064907A1
• Time in Patent Office: 442 Days
• Field of Search: 604525, 604531
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/06 caused by chemical reaction , e.g. moxaburners
• 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 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2018/00386 Coronary vessels
• 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 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/0085 Devices for generating hot or cold treatment fluids
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/056 : Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 2007/0021 : Neural system treatment
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

A neuromodulation catheter includes an elongate shaft and a neuromodulation element. The shaft includes two or more first cut shapes and two or more second cut shapes along a helical path extending around a longitudinal axis of the shaft. The first cut shapes are configured to at least partially resist deformation in response to longitudinal compression and tension on the shaft and torsion on the shaft in a first circumferential direction. The second cut shapes are configured to at least partially resist deformation in response to longitudinal compression on the shaft and torsion on the shaft in both first and second opposite circumferential directions.

Claims

1. A method for treating a human patient, the method comprising:

advancing a neuromodulation element of a neuromodulation catheter along a transradial approach to a target site within a renal artery of the patient, wherein the neuromodulation element is at a distal end portion of a shaft of the neuromodulation catheter, and wherein the shaft includes two or more first cut shapes and two or more second cut shapes interspersed along a helical path extending about a longitudinal axis of the shaft;

applying torsion to the shaft about the longitudinal axis while advancing the neuromodulation element, wherein the first cut shapes, to a greater extent than the second cut shapes, resist deformation of the shaft in response to the torsion;

operating the neuromodulation element to modulate one or more nerves proximate a wall of the renal artery;

withdrawing the neuromodulation element along the transradial approach after operating the neuromodulation element; and

applying tension to the shaft along the longitudinal axis while withdrawing the neuromodulation element, wherein the second cut shapes, to a greater extent than the first cut shapes, resist deformation of the shaft in response to the tension.

2. The method of claim 1 wherein applying torsion to the shaft includes distally transferring rotational motion from an extracorporeal handle of the neuromodulation catheter to the neuromodulation element via the shaft.

3. The method of claim 1, further comprising interlocking the first cut shapes in response to the torsion.

4. The method of claim 3, further comprising interlocking the second cut shapes in response to the tension.

5. The method of claim 1 wherein:

the first and second cut shapes are portions of a continuous cut;

the first cut shapes, to a greater extent than the second cut shapes, resist deformation of the shaft at the continuous cut in response to the torsion; and

the second cut shapes, to a greater extent than the first cut shapes, resist deformation of the shaft at the continuous cut in response to the tension.

6. The method of claim 1 wherein the first cut shapes, to a greater extent than the second cut shapes, resist diametrical deformation of the shaft in response to the torsion.

7. The method of claim 6 wherein the second cut shapes, to a greater extent than the first cut shapes, resist elongation of the shaft in response to the tension.

8. The method of claim 1, further comprising locating the first and second cut shapes at a sharply angled portion of the transradial approach when the neuromodulation element is operably positioned within the renal artery.

9. The method of claim 1, further comprising locating the first and second cut shapes within a subclavian artery of the patient when the neuromodulation element is operably positioned at the target site within the renal artery.

10. The method of claim 1 wherein:

the torsion is torsion in a second circumferential direction;

the method further comprises applying torsion to the shaft about the longitudinal axis in a first circumferential direction opposite to the second circumferential direction while advancing the neuromodulation element; and

the first and second cut shapes resist deformation of the shaft in response to the torsion in the first circumferential direction.

11. The method of claim 1 wherein:

the shaft includes two or more third cut shapes interspersed with the first and second cut shapes along the helical path;

the third cut shapes, to a greater extent than the first cut shapes, resist deformation of the shaft in response to the tension; and

the third cut shapes, to a greater extent than the second cut shapes, resist deformation of the shaft in response to the torsion.

12. The method of claim 1 wherein operating the neuromodulation element to modulate the one or more nerves includes operating an electrode of the neuromodulation element to modulate the one or more nerves.

13. The method of claim 1, further comprising advancing the shaft over a guidewire that exits the shaft via an exit opening at one of the second cut shapes.

14. The method of claim 1, further comprising advancing the shaft over a guidewire that exits the shaft via an exit opening spaced apart from the helical path.

15. A method for treating a human patient, the method comprising:

intravascularly advancing a neuromodulation element of a neuromodulation catheter along a transradial approach to a renal artery of the patient, wherein the neuromodulation element is at a distal end portion of a shaft of the neuromodulation catheter, and wherein the shaft includes

a tubular wall,

a first hypotube segment concentrically disposed within the tubular wall, the first hypotube segment being made at least partially of a first shape-memory alloy having a first shape-memory transformation temperature range, and

a second hypotube segment concentrically disposed within the tubular wall proximal to the first hypotube segment along a longitudinal axis of the shaft, the second hypotube segment being made at least partially of a second shape-memory alloy having a second shape-memory transformation temperature range lower than the first shape-memory transformation temperature range; and

operating the neuromodulation element to modulate one or more nerves proximate a wall of the renal artery.

16. The method of claim 15, further comprising distally transferring rotational motion from a handle of the neuromodulation catheter to the neuromodulation element via the shaft.

17. The method of claim 15 wherein:

the first shape-memory alloy is nitinol; and

the method further comprises causing the nitinol of the first hypotube segment to assume an austenite phase while advancing the neuromodulation element.

18. The method of claim 17 wherein:

the second shape-memory alloy is nitinol; and

the method further comprises causing the nitinol of the second hypotube segment to assume a martensite phase while advancing the neuromodulation element.

19. The method of claim 17 wherein operating the neuromodulation element to modulate the one or more nerves includes operating an electrode of the neuromodulation element to modulate the one or more nerves.

20. The method of claim 15, further comprising withdrawing the neuromodulation element along the transradial approach after operating the neuromodulation element.