Tissue treatment device and related methods

• US 9,629,675 B2
• Filed: 10/19/2012
• Issued: 04/25/2017
• Est. Priority Date: 10/19/2011
• Status: Active Grant

• Current Assignee: Confluent Medical Technologies, Inc.
• Original Assignee: Confluent Medical Technologies, Inc.
• Inventors: Kleshinski, Stephen J., Cheng, Christopher P.
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): Shapiro, Victor
• Application Number:
  US13/656,601
• Publication Number:
  US 20130103026A1
• Time in Patent Office: 1,649 Days
• Field of Search: 606 41, 604 28, 60410311, 604508, 60410101, 604523, 361747, 600585, 607 96
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• 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 2018/00017 with gas
• 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 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/0087 Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

A hypotube based deliver system is used to position one or more elements in position for treatment within the body. The elements may include electrodes, sensors or injection ports or even anchors. The hypotubes may have pre-set shapes or are plastically deformed prior to positioning as they exit a positioning device. There are methods of providing therapy using the hypotubes including mixed mode therapies are also described.

Claims

1. A method for performing a procedure in the body using a multiple hollow leg positioning device, comprising:

advancing a distal most end of a catheter within a lumen of the body to a position based on a predetermined deployed position of the multiple hollow leg positioning device suited to performing the procedure;

advancing the multiple hollow leg positioning device beyond the distal most end of the catheter to place a portion of each one of the legs of the multiple hollow leg positioning device against an inner wall of the lumen such that at least one opening in a leg in the multiple hollow leg positioning device is positioned relative to a treatment location based on a pre-determined trajectory of a hypotube disposed within a lumen of the leg;

advancing the hypo tube through the opening in the leg until a distal most portion of the hypotube is passed completely through a wall of the lumen and an element on the distal portion of the hypotube is positioned to perform the procedure in proximity to the treatment location; and

performing the procedure in the treatment location using the element.

2. The method of claim 1 wherein the performing the procedure step occurs outside of the lumen of the body.

3. The method of claim 1 wherein the performing the procedure step treats a neural treatment target unrelated to the lumen.

4. The method of claim 1 the performing the procedure step further comprising:

delivering energy using the element.

5. The method of claim 1 further comprising:

monitoring the progress or effectiveness of the performing the procedure step using an element on a hypotube provided through a lumen of another hollow leg of the multiple hollow leg positioning device.

6. The method of claim 1 further comprising continuing to advance the hypotube through the wall of the lumen to anchor the element in a position for performing the procedure.

7. The method of claim 1 wherein the lumen is a renal artery and the procedure is a denervation procedure.

8. The method of claim 1 the performing the procedure in the treatment location further comprising:

delivering a fluid via the hypotube to the treatment location.

9. The method of claim 1 wherein positioned to perform a procedure in proximity to the treatment location is a position related to the therapeutic range of the energy delivered by the element.

10. The method of claim 1 wherein positioned to perform a procedure in proximity to the treatment location is a position related to the dispersion of a fluid delivered by the element.

11. A method of performing a therapy within a patient, comprising:

positioning a delivery catheter within a blood vessel of the patient at a treatment location;

advancing a positioning device via the delivery catheter into the blood vessel at the treatment location;

expanding a plurality of outwardly biased hollow legs of the positioning device into engagement with an interior wall of the blood vessel in proximity to the treatment location;

advancing hypotubes out of the hollow legs so as to pass a distal most portion of each hypotube completely through a blood vessel wall to position an element carried by the hypotube within a therapeutic range of a target in the treatment location; and

performing an action in furtherance of the therapy using the element.

12. The method of claim 11 wherein the action in furtherance of the therapy is ablating at least a portion of the target.

13. The method of claim 12 wherein the action in furtherance of the therapy is monitoring, measuring or recording the effectiveness or progress of the ablating at least a portion of the target step.

14. The method of claim 11 wherein the target is one or more of a nerve, a ligament, a tumor, a vessel, a sphincter, an organ or a muscle.

15. The method of claim 11 wherein after the advancing hypotubes step the distal most portion of the hypotubes have exited the hollow legs via the distal most end of the hollow leg.

16. The method of claim 11 wherein after the advancing step the distal most portion of the hypotubes have exited the hollow legs via an opening in a sidewall of the hollow leg.