Systems and methods for energy delivery

Patent metadata

Field	Value
Publication number	US-11832879-B2
Application number	US-201916297173-A
Country	US
Kind code	B2
Filing date	Mar 8, 2019
Priority date	Mar 8, 2019
Publication date	Dec 5, 2023
Grant date	Dec 5, 2023

Abstract

The present invention relates to flexible sheath assemblies capable of maintaining a desired positioning at a desired tissue region during medical procedures involving use insertion and withdrawal of medical tools through the flexible sheath, and related systems and methods.

First claim

We claim:

1. A flexible sheath for use in endoscopic procedures, comprising an elongate tubular body; the elongate tubular body comprising
a) an elongate tubular body proximal end having a proximal end opening and an elongate tubular body distal end having a distal end opening, and an elongate tubular main body region positioned between the elongate tubular body proximal end and the elongate tubular body distal end;
b) an elongate tubular body interior portion and an elongate tubular body exterior portion, wherein the elongate tubular body interior portion extends from the elongate tubular body proximal end to the elongate tubular body distal end, wherein the elongate tubular body exterior portion extends from the elongate tubular body proximal end to the elongate tubular body distal end; and
c) a flexible-rigid region positioned only in the elongate tubular body distal end, wherein the flexible-rigid region is positioned on a most exterior region of the elongate tubular body exterior portion of the elongate tubular body distal end;
wherein the elongate tubular body interior portion comprises a hollow port extending into the proximal end opening, through the elongate tubular body proximal end, through the elongate tubular body distal end, and out the distal end opening, wherein the size of the hollow port is such that it can accommodate the passing of a properly sized tool into the hollow port, through the hollow port, and out the hollow port;
wherein the diameter of the flexible sheath is less than 5 mm;
wherein the flexible-rigid region is configured to selectively alternate between a flexible state and a rigid state;
wherein if the flexible-rigid region is in a rigid state then the elongate tubular body distal end is stabilized in a desired position with respect to a tissue region in contact with the flexible-rigid region; and
wherein if the flexible-rigid region is in a flexible state then the elongate tubular body distal end is not stabilized with respect to a tissue region in contact with the flexible-rigid region.

2. The flexible sheath of claim 1 ,
wherein the elongate tubular body interior portion further comprises an elongate tubular body coolant intake channel, an elongate tubular body distal end contained region, and an elongate tubular body coolant outtake channel,
wherein the elongate tubular body distal end contained region is positioned at the elongate tubular body distal end,
wherein the elongate tubular body interior portion is configured to a) receive coolant into the elongate tubular body proximal end via the elongate tubular body coolant intake channel, b) circulate the received coolant through the elongate tubular body coolant intake channel to the elongate tubular body distal end contained region, and c) circulate the coolant from the elongate tubular body distal end contained region through the elongate tubular body outtake channel and out of the elongate tubular body proximal end,
wherein
the diameter of the elongate tubular body outtake channel is larger than the diameter of the elongate tubular body intake channel, or
the diameter of the elongate tubular body outtake channel is smaller than the diameter of the elongate tubular body intake channel, or
the diameter of the elongate tubular body outtake channel and the diameter of the elongate tubular body intake channel are identical,

wherein
the hollow port, elongate tubular body intake channel, and elongate tubular body outtake channel are positioned in a multiaxial manner, or
the hollow port, elongate tubular body intake channel, and elongate tubular body outtake channel are concentrically positioned in a coaxial manner,

wherein the coolant is selected from water, glycol, air, inert gasses, carbon dioxide, nitrogen, helium, sulfur hexafluoride, ionic solutions, dextrose in water, Ringer's lactate, organic chemical solutions, oils, liquid metals, freons, halomethanes, liquified propane, other haloalkanes, anhydrous ammonia, sulfur dioxide, and a coolant gas compressed at or near its critical point.

3. The flexible sheath of claim 2 , wherein the one or more flexible-rigid regions comprise thermoplastic polymers that have an appropriate glass-transition temperature of 15-25 degrees Celsius.

4. The flexible sheath of claim 3 ,
wherein the thermoplastic polymer comprises copolymers of lactic acid and caprolactone,
wherein the thermoplastic polymer comprises a copolymer of L-lactide and caprolactone with an L-lactide to caprolactone monomer ratio of 70:30 or less.

5. The flexible sheath of claim 2 ,
wherein the temperature of the flexible-rigid region is regulated through circulation of coolant into and out of the elongate tubular body containment region,
wherein maintenance of a flexible-rigid region temperature at approximately −40 degrees Celsius results in a flexible state for the flexible-rigid region,
wherein maintenance of a flexible-rigid region temperature at approximately −5 degrees Celsius results in a rigid state for the flexible-rigid region,
wherein the temperature of the flexible-rigid region is regulated through circulation of coolant into and out of the elongate tubular body containment region via a Joule-Thompson effect, an endothermic chemical reaction, or an exothermic chemical reaction,
wherein the elongate tubular body interior region further comprises a steerable pull ring configured to permit a user to steer the flexible sheath in any desired manner,
wherein the flexible sheath is designed to be operational within a microwave field or microwave zone without sustaining microwave field or microwave zone related damage,
wherein the flexible sheath is designed to be operational within a tissue region experiencing high temperatures without sustaining high temperature related damage.

6. The flexible sheath of claim 1 ,
wherein the properly sized tool is selected from an obturator, ablation probe, energy delivery device, or biopsy tool,
wherein the flexible sheath has sufficient flexibility to access a circuitous route through a subject,
wherein the composition of the elongate tubular body is a polymer material,
wherein the composition of the elongate tubular body is selected from a higher temperature rated polymer material, fluorinated ethylene propylene (FEP), a thermoplastic copolyester, and a fluoropolymer or perfluoroalkoxy alkane (PFA).

7. A system comprising a primary catheter, the flexible sheath described in claim 1 , and an energy delivery device.

8. The system of claim 7 , wherein the primary catheter is an endoscope.

9. The system of claim 7 , wherein the energy delivery device is a microwave energy delivery device.

10. A method of treating a tissue region, comprising providing a system of claim 7 , inserting the primary catheter into a tissue region, inserting the flexible sheath through the primary catheter to a desired tissue region to be treated, securing the flexible sheath at the desired tissue region to be treated via the flexible-rigid region, inserting the energy delivery device through the flexible sheath to the desired tissue region to be treated, and treating the tissue region to be treated with the energy delivery device.

11. The method of claim 10 , wherein the tissue region to be treated is within a subject.

12. The method of claim 11 , wherein the subject is a human subject.

13. The flexible sheath of claim 1 , wherein the temperature of the flexible-rigid region is regulated through circulation of a gas coolant into and out of the elongate tubular body containment region via a Joule-Thompson effect.

Assignees

• Neuwave Medical Inc

Inventors

• Schaning Matthew
• Katrana Nicholas
• Thiel Matthew
• Mingione Louis
• Thom Mark
• Schefelker Richard

Classifications

• A61B18/1815 Primary

  using microwaves · CPC title

• A61L29/06

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds · CPC title

• A61L29/14

  Materials characterised by their function or physical properties {, e.g. lubricating compositions} · CPC title

• A61B2018/00023

  closed, i.e. without wound contact by the fluid · CPC title

• A61B2018/00095

  high, i.e. heat conducting · CPC title