Cryotherapy, thermal therapy, temperature modulation therapy, and probe apparatus therefor

• US 10,327,830 B2
• Filed: 08/31/2015
• Issued: 06/25/2019
• Est. Priority Date: 04/01/2015
• Status: Active Grant

• Current Assignee: Monteris Medical Incorporated (Monteris Medical US, Inc.)
• Original Assignee: Monteris Medical Incorporated (Monteris Medical US, Inc.)
• Inventors: Grant, Mark, Ren, Brooke, Tyc, Richard
• Primary Examiner(s): Stoklosa, Joseph A
• Assistant Examiner(s): Avigan, Adam J
• Application Number:
  US14/841,109
• Publication Number:
  US 20160287308A1
• Time in Patent Office: 1,394 Days
• 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 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/0231 Characteristics of handpieces or probes
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2018/20361 with redirecting based on sensed condition, e.g. tissue analysis or tissue movement
• CPC Class Codes: A61B 2018/2266 with a lens, e.g. ball tipped
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

A variable length interstitial probe apparatus includes: a probe for effecting thermal therapy and/or cryotherapy to a tissue; a flexible umbilical sheath permanently affixed to the probe, including at least one interface for supplying energy, cooling fluid, cooling gas, heating fluid, and/or heating gas to the probe; and an adjustable depth stop configured to slide along a length of a shaft region of the probe, and lock to the shaft region at a selected position. The adjustable depth stop is configured to engage a probe driver and/or a skull mount apparatus to stabilize positioning of the probe and to control a depth of entry of the probe into a patient. The probe may be configured to effect temperature modulation therapy, where processing circuitry activates a modulation pattern of thermal therapy emission and cryogenic therapy emission for applying a thermal dose to the tissue.

Claims

1. A variable length interstitial probe apparatus for effecting treatment to a tissue, comprising:

a probe portion for effecting at least one of thermal therapy and cryotherapy to the tissue;

a flexible umbilical sheath portion permanently affixed to the probe portion, wherein the flexible umbilical sheath portion includes a plurality of interfaces for supplying at least two of energy, cooling fluid, cooling gas, heating fluid, and heating gas to the probe portion,

wherein at least two of the plurality of interfaces are separated by internal respective lumens, and

the flexible umbilical sheath portion is reinforced to provide torque strength and kink resistance during probe rotation;

a transitional junction disposed between the probe portion and the flexible umbilical sheath portion, the transitional junction being configured to permanently affix the probe portion to the flexible umbilical sheath portion, wherein the transitional junction has an outer housing configured for grasping, thereby enabling manual manipulation of the variable length interstitial probe apparatus; and

an adjustable depth stop comprising

a first portion and a second portion,

a plurality of clamping elements,

wherein at least one of the first portion and the second portion is configured to slideably move along a length of a shaft region of the probe portion to a selected position, and

the first portion is configured for manual manipulation relative to the second portion to cause the plurality of clamping elements to releasably clamp down against the shaft region of the probe portion at the selected position, and

a releasably engageable fastener configured to releasably engage a probe driver to automatically rotate the probe portion about its longitudinal axis.

2. The variable length interstitial probe apparatus of claim 1, wherein the shaft region comprises a plurality of gradation markings for selecting a measurement correlating to depth of entry of the probe portion into the patient.

3. The variable length interstitial probe apparatus of claim 1, wherein the outer housing of the transitional junction includes at least one indent configured for grasping the variable length interstitial probe apparatus while sliding the adjustable depth stop in relation to the shaft region.

4. The variable length interstitial probe apparatus of claim 3, wherein the plurality of interfaces comprises a fluid supply tube, and the transitional junction includes at least one vent for venting return gasses supplied via the fluid supply tube.

5. The variable length interstitial probe apparatus of claim 1, further comprising a side-firing energy delivery element, wherein the adjustable depth stop comprises at least one of an alignment marker and a projection for providing a visible indication of a side-firing direction of the probe portion upon aligning the at least one of the alignment marker and the projection with an alignment marking on the shaft portion.

6. The variable length interstitial probe apparatus of claim 5, wherein a line presented lengthwise upon the shaft portion functions as the alignment marking, wherein the plurality of gradation markings are marked upon the line.

7. The variable length interstitial probe apparatus of claim 1, wherein the flexible umbilical sheath portion is reinforced an internal layer comprising at least one of a plurality of windings and a braided material.

8. The variable length interstitial probe apparatus of claim 1, wherein a distal end of the flexible umbilical sheath comprises a plurality of connectors, wherein at least one connector provides a control connection for remotely controlling emission of the probe portion.

9. The variable length interstitial probe apparatus of claim 1, further comprising:

processing circuitry; and

a memory having instructions stored thereon, wherein the instructions, when executed by the processing circuitry, cause the processing circuitry to, while the probe portion is positioned proximate the tissue,

activate temperature modulation therapy by the interstitial probe apparatus utilizing a modulation pattern of thermal therapy emission and cryogenic therapy emission for applying an energy output based on the thermal dose to the tissue, wherein the modulation pattern comprises

at least one higher thermal output corresponding to activation of a first thermal therapy element disposed within the probe portion for a first time interval, and

at least one lower thermal output corresponding to activation of a first cryogenic therapy element disposed within the probe portion for a second time interval different than the first time interval.