Cryoablation systems and methods

Abstract

A cryoablation system and method are provided. The system may include a probe having a hollow body defining an inlet and an outlet, the inlet configured to receive a thermal fluid for circulation through the hollow body, and the outlet configured to discharge the thermal fluid from the hollow body. A fluid supply console may be remote from the probe and in fluid communication with the probe inlet. The fluid supply console may be positioned to provide the thermal fluid to the probe during use to enable heating or cooling by the probe. The fluid supply console may include a heating element configured to selectively heat the thermal fluid before the thermal fluid is provided to the probe inlet to enable selective heating of the probe.

Description

[Technical Field]

[0001] This application claims priority from U.S. Provisional Patent Application No. 63 / 476,965, filed December 23, 2022, which is incorporated herein by reference.

[0002] SUMMARY The present disclosure relates to systems, methods, and devices for cryoablation therapy, ie, systems and methods that use low temperatures to destroy unwanted tissue. [Background technology]

[0003] Cryoablation is performed by inserting a cryoprobe needle into malignant tissue, usually under image guidance. After inserting one or more cryoprobe needles into the target tissue, the cryoprobe rapidly cools and removes heat from the tissue by conduction through physical contact with the cryoprobe. The rapid cooling of the cryoprobe occurs due to the Joule-Thomson effect, where rapid expansion of a gas changes its temperature. Argon gas exhibits Joule-Thomson cooling when rapidly expanded at room temperature.

[0004] When the high-pressure argon gas reaches the distal end of the cryoprobe, it is forced through a narrow orifice and rapidly expands to atmospheric pressure. The rapid expansion of the argon causes the gas to cool (Joule-Thomson effect), and the gas temperature is rapidly transferred to the metal walls of the cryoprobe by convection and conduction. The decompressed gas is expelled from the cryoprobe.

[0005] While rapid cooling of a cryoprobe or needle can be effective in destroying adjacent tissue, there may be situations, such as a patient's medical condition, that require the probe to be removed quickly. Rapid removal of a frozen probe without injuring the patient may be difficult or impossible. Also, known cryoprobes may be clumsy, cumbersome, inefficient, or prohibitively expensive.

[0006] The applicant believes there is room for improvement.

[0007] The foregoing description of the background to the present disclosure is intended only to facilitate understanding thereof, and it should be understood that the description is not an admission that any of the material referred to was part of the common general knowledge in the art at the priority date of this application. Summary of the Invention

[0008] According to an aspect of the present disclosure, a probe having a hollow body defining an inlet and an outlet, the inlet configured to receive a thermal fluid for circulation through the hollow body and the outlet configured to expel the thermal fluid from the hollow body; a fluid supply console remote from the probe and in fluid communication with an inlet of the probe, the fluid supply console being arranged to provide a thermal fluid to the probe in use to enable heating or cooling by the probe, the fluid supply console including a heating element configured to selectively heat the thermal fluid before the thermal fluid is provided to the inlet of the probe so as to enable selective heating of the probe in use; A cryoablation system is provided comprising:

[0009] The system may include a controller having a processor and a memory, the memory including instructions executable by the processor for performing functions of one or more components of the system. The controller may, for example, form part of or be housed in a fluid delivery console.

[0010] The fluid delivery console may include a valve system and / or one or more valves and / or at least one valve operable and / or selectable between a first state and a second state. In the first state, the valve may be configured to provide a thermal fluid to the probe, e.g., for cooling. In the second state, the valve may be configured to provide a thermal fluid to the probe that may be heated by a heating element.

[0011] The fluid delivery console may be operable, for example, upon receiving input from a user indicating that heating or cooling by the probe is required, to automatically select the first and / or second states of the valves and / or valve system to selectively provide heating or cooling to the probe in use.

[0012] The controller may be operable to control the heating element to selectively heat the thermal fluid.

[0013] The fluid supply console may be arranged to provide a single type of fluid as a thermal fluid to the probe to facilitate cooling by the probe during use, for example, by cryoablation cooling and / or freezing of the probe.

[0014] The heating element may be arranged to selectively heat or thaw the probe body to thaw or heat biological material or tissue surrounding the probe body, or to selectively heat a single type of thermal fluid before the single type of thermal fluid is provided to the probe to heat the probe body.

[0015] The fluid delivery console may be arranged to selectively provide one or more thermal fluids to the probe, for example, the fluid delivery console may be arranged to selectively provide a first thermal fluid for cooling the probe and a second thermal fluid for heating the probe.

[0016] The heating element of the fluid delivery console may be arranged to selectively heat the second thermal fluid before it is provided to the inlet of the probe, for example to thaw or heat the probe body, such as to thaw or heat biological material or tissue surrounding the probe body.

[0017] The fluid supply console may include a valve or valve system arranged to selectively provide a first thermal fluid for operatively cooling the probe. Additionally or alternatively, the valve or valve system may be arranged to selectively provide a second thermal fluid for operatively heating the probe.

[0018] The first thermal fluid may be a fluid selected to provide cooling by the Joule-Thomson effect, or may be a fluid selected to provide cooling in some other way.

[0019] The second thermal fluid may be a fluid selected to provide heating by thermal conduction or thermal convection.

[0020] The first fluid and / or the second fluid may be selected to be thermally conductive.

[0021] The first thermal fluid may be argon and the second thermal fluid may be argon. Alternatively, the first thermal fluid may be argon and the second thermal fluid may be air. Still alternatively, the first thermal fluid may be air and the second thermal fluid may be argon.

[0022] The thermal fluid may be selected from a list including argon or an argon-based fluid, air, helium or a helium-based fluid, nitrogen or a nitrogen-based fluid, liquid nitrogen, an inert gas or an ideal gas, or other gas or liquid capable of thermally heating or cooling the probe as the case may be.

[0023] The fluid supply console may be connected to a pressurized thermal fluid supply and / or may be connected to one or more pressurized thermal fluid supplies or supply reservoirs. For example, a first reservoir for pressurized argon may be provided and in fluid communication with the fluid supply console, and / or a second reservoir for pressurized air may be provided and in fluid communication with the fluid supply console.

[0024] The present disclosure extends to a fluid delivery console for use in a cryoablation system as defined above.

[0025] The present disclosure further extends to a probe for use in a cryoablation system as defined above.

[0026] The probe may have a hollow body extending from its proximal end to its distal end. The probe may include a fluid transport tube extending from the proximal end to the distal end within the hollow body and opening into the hollow body. The distal end of the hollow body may be closed to allow a thermal fluid to enter the hollow body through the fluid transport tube and potentially heat or cool the probe body. For example, the thermal fluid may cool the probe body via the Joule-Thomson (JT) effect. In other words, the probe may be positioned such that cooling occurs due to the expansion of the thermal fluid's volume as it exits the fluid transport tube within the hollow body of the probe. The probe body may be heated to thaw or heat biological material or tissue surrounding the probe body that has been frozen by the aforementioned JT effect cooling.

[0027] The distal end of the probe body may be positioned to be inserted into a patient, for example, for a cryoablation or cryotreatment. The probe body may also be referred to as a needle body.

[0028] According to another aspect of the present disclosure, there is provided a cryoablation system comprising a fluid supply console remotely connectable to a probe so as to be in operative fluid communication with an inlet of the probe, the fluid supply console including a conduit arranged to provide a thermal fluid to the probe during use to enable heating or cooling by the probe, the fluid supply console including a heating element configured to selectively heat the thermal fluid before the thermal fluid is provided to the inlet of the probe via the conduit to enable selective heating of the probe during use.

[0029] According to another aspect of the present disclosure, there is provided a method of applying a cryoablation procedure, the method comprising: providing a probe having a hollow body defining an inlet and an outlet, the inlet configured to receive a thermal fluid for circulation through the hollow body and the outlet configured to expel the thermal fluid from the hollow body; providing a fluid delivery console in fluid communication with the inlet of the probe; operatively supplying, by a fluid supply console, a thermal fluid to the probe to enable heating or cooling by the probe; Selectively heating the thermal fluid before it is provided to the probe inlet by a heating element in the fluid supply console to selectively heat the probe during use. Includes. [Brief explanation of the drawings]

[0030] Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0031] [Figure 1] FIG. 1 is a front view of an exemplary embodiment of a fluid delivery console for a cryoablation system according to aspects of the present disclosure. [Figure 2] 2 is a rendering showing a three-dimensional view of the console of FIG. 1. [Figure 3] 2 is a diagrammatic representation of an exemplary embodiment of the distal tip of a probe or cryoprobe that may be used with the console of FIG. 1; [Figure 4] 2 is a diagrammatic representation of the distal tip and distal portion of an exemplary probe showing details of the inner or fluid transport tube, and also showing an exemplary cross-sectional view taken along line AA of the view. [Figure 5] 1 is an exemplary embodiment of a probe or cryoprobe that may be used in an exemplary cryoablation system of the present disclosure. [Figure 6] FIG. 1 is a high-level block diagram of an exemplary embodiment of a cryoablation system. [Figure 7] FIG. 2 is a high-level block diagram of another exemplary embodiment of a cryoablation system. [Figure 8] 1 is a front view of an exemplary heating element or heater that may form part of or be incorporated into a fluid supply console. [Figure 9] FIG. [Figure 10] FIG. 10 is a cross-sectional view taken along line AA of FIG. 9, showing the internal components of the heater in more detail. [Figure 11] 3D is a three-dimensional view of a heater, a three-dimensional rendering of a heater, and a three-dimensional rendering showing a cross section through the heater. [Figure 12] 12A-12C illustrate the stresses in the heater of FIGS. 8-11 during an exemplary test or test simulation. [Figure 13] 3A and 3B show photographs of an exemplary embodiment of a heater partially disassembled and assembled. [Figure 14] 10 shows a photograph of a further exemplary prototype of a heater for use in a cryoablation system according to aspects of the present disclosure. [Figure 15] 1 is a rendering of an exemplary embodiment of the internal components of a fluid delivery console for a cryoablation system, showing an exemplary manifold and valve system that may be implemented. [Figure 16] 1 is a rendering of an exemplary embodiment of the internal components of a fluid delivery console for a cryoablation system, showing an exemplary manifold and valve system that may be implemented. [Figure 17] 1 is a rendering of a top view of an exemplary embodiment of a fluid delivery console for a cryoablation system, also showing the internal components of the console. [Figure 18] 1 is a rendering of a three-dimensional view of an exemplary embodiment of a fluid delivery console for a cryoablation system, also showing the internal components of the console. [Figure 19]1 is a three-dimensional rendering of an exemplary embodiment of a heater for use in a cryoablation system, showing an exemplary test or test simulation of the heater. [Figure 20] 1 is a three-dimensional rendering of an exemplary embodiment of a heater for use in a cryoablation system, illustrating an exemplary test or test simulation of the heater. [Figure 21] FIG. 1 is a front view of an exemplary probe according to an embodiment of the present disclosure. [Figure 22] FIG. 22 is a cross-sectional view taken along line BB in FIG. 21. [Figure 23] FIG. 23 is an enlarged view of a portion of the probe designated "D" in FIG. 22. [Figure 24] FIG. 10 is a front view of another exemplary probe according to an embodiment of the present disclosure. [Figure 25] FIG. 25 is a cross-sectional view taken along line CC in FIG. 24. [Figure 26] FIG. 26 is an enlarged view of a portion of the probe designated "E" in FIG. 25. [Figure 27] FIG. 1 is a high-level block diagram of the pneumatic and / or fluid flow architecture of an exemplary embodiment of a cryoablation system. [Figure 28] FIG. 1 is a high-level block diagram of an exemplary embodiment of a cryoablation system. [Figure 29] FIG. 1 is a high-level block diagram of an exemplary embodiment of a cryoablation system. [Figure 30] FIG. 2 is another high-level block diagram of an exemplary embodiment of a cryoablation system. [Figure 31] FIG. 1 is a high-level block diagram of the pneumatic and / or fluid flow architecture of an exemplary embodiment of a cryoablation system. [Figure 32] FIG. 1 is a flow diagram illustrating an exemplary method of applying cryoablation therapy. [Figure 33]FIG. 1 is a high-level block diagram of an exemplary control software architecture that may be implemented by an exemplary embodiment of the cryoablation system of the present disclosure. [Figure 34] 10A-10C are three-dimensional cutaway views of further exemplary embodiments of heaters or heating elements, according to aspects of the present disclosure. [Figure 35] 10A-10C are three-dimensional cutaway views of further exemplary embodiments of heaters or heating elements, according to aspects of the present disclosure. [Figure 36] 10A-10C are three-dimensional cutaway views of further exemplary embodiments of heaters or heating elements, according to aspects of the present disclosure. [Figure 37] 10A-10C are three-dimensional cutaway views of further exemplary embodiments of heaters or heating elements, according to aspects of the present disclosure. [Figure 38] 10A-10C are three-dimensional cutaway views of further exemplary embodiments of heaters or heating elements, according to aspects of the present disclosure. [Figure 39] 10A-10C are three-dimensional cutaway views of further exemplary embodiments of heaters or heating elements, according to aspects of the present disclosure. [Figure 40] 1 is a cross-sectional view of an exemplary heating element illustrating an exemplary flow of thermal fluid therethrough. [Figure 41] 1 is a three-dimensional view of an exemplary fluid connector for connecting a probe to a fluid delivery console, also showing a close-up of an exemplary button and locking device. [Figure 42] 42 is an exemplary cross-sectional view of the fluid connector of FIG. 41 in an unplugged state. [Figure 43] FIG. 42 is an exemplary diagram of a console with the fluid connector of FIG. 41. [Figure 44] 42 is an exemplary cross-sectional view of the fluid connector of FIG. 41 in a plugged state. [Figure 45] 10 is a three-dimensional view of another exemplary fluid connector for connecting a probe to a fluid delivery console, also showing a close-up view of an exemplary lever and locking device. [Figure 46] 46 is an exemplary cross-sectional view of the fluid connector of FIG. 45 in an unplugged state. [Figure 47]46 is an exemplary cross-sectional view of the fluid connector of FIG. 45 in a plugged state. [Figure 48] 1 is a cross-sectional view of an exemplary probe tip showing the flow of thermal fluid therethrough. [Figure 49] 1A-1C are three-dimensional views of exemplary probe tip configurations according to aspects of the present disclosure. [Figure 50] 1A-1C are three-dimensional views of exemplary probe tip configurations according to aspects of the present disclosure. [Figure 51] 1A-1C are three-dimensional views of exemplary probe tip configurations according to aspects of the present disclosure. [Figure 52] 1 is an exemplary cross-section through an exemplary probe tip illustrating the flow of thermal fluid therethrough. [Figure 53] 1A-1C are cross-sectional views through an exemplary probe tip, illustrating further exemplary probe tip configurations according to aspects of the present disclosure. [Figure 54] 1A-1C are cross-sectional views through an exemplary probe tip illustrating further exemplary probe tip configurations according to aspects of the present disclosure. [Figure 55] 1A-1C are cross-sectional views through an exemplary probe tip illustrating further exemplary probe tip configurations according to aspects of the present disclosure. [Figure 56] 1A-1C are cross-sectional views through an exemplary probe tip illustrating further exemplary probe tip configurations according to aspects of the present disclosure. [Figure 57] 1A-1C are cross-sectional views through an exemplary probe tip illustrating further exemplary probe tip configurations according to aspects of the present disclosure. [Figure 58] 1A-1C are cross-sectional views through an exemplary probe tip illustrating further exemplary probe tip configurations according to aspects of the present disclosure. [Figure 59] FIG. 10 is a side view of another exemplary embodiment of a probe according to aspects of the present disclosure. [Figure 60] FIG. 60 is an exemplary cross-sectional view through the probe tip of FIG. 59 taken along line DD. [Figure 61]FIG. 60 is an exemplary cross-sectional view through the probe of FIG. 59 taken along line EE. [Figure 62] FIG. 60 is an exemplary three-dimensional cutaway view of the probe of FIG. 59. [Figure 63] FIG. 1 is a high-level block diagram illustrating exemplary components of a cryoablation system according to aspects of the present disclosure. [Figure 64] 64 is an exemplary state machine showing details of a state machine that may form part of the system of FIG. 63. [Figure 65] FIG. 64 is a high-level block diagram illustrating further exemplary components of the cryoablation system of FIG. 63. [Figure 66] FIG. 64 is another high-level block diagram illustrating still further exemplary components of the cryoablation system of FIG. 63. [Figure 67] FIG. 1 is a high-level block diagram of an exemplary pneumatic and / or fluid flow architecture of an exemplary embodiment of a cryoablation system in which a heating element is implemented in each of multiple heating channels for a cryoprobe. DETAILED DESCRIPTION OF THE INVENTION

[0032] Embodiments of the present disclosure relate to systems, methods, and devices for cryoablation therapy, i.e., cryosurgery. A probe or needle may be used that includes an elongated, hollow body, also referred to as a needle body. The hollow body may, in certain embodiments, include an inner tube or passageway for a thermal fluid. The probe or needle body may extend from its proximal end to its distal end, which is closed but preferably sharpened for insertion into a patient or mammal. It is understood that animals or other mammals (in addition to humans) may also be treated with the systems and methods of the present disclosure. The probe may be referred to as a cryoprobes. It is understood that the probe may be configured to provide cooling, for example, by cryoablation freezing, during which biological material, water, or tissue surrounding the probe is significantly cooled and / or frozen. It is further understood that the probe may also be configured to provide heating, for example, by "thawing" the cryoprobe after it has cooled or frozen, i.e., by heating the probe body to thaw or heat biological material or tissue surrounding the probe body. The probe or cryoneedle may also be referred to as a lancing device or piercing rod having one or more internal cavities for circulating a thermal fluid, such as air, argon, or other gas or fluid, within the needle body, for example, in either a direction from the inner region to the outer region of the needle, or vice versa.

[0033] A console or central control unit / module may be provided to supply thermal fluid to the probe or needle, and connecting tubes, valves, and ports may be provided to provide a fluid interface between the console and the probe or pointed needle device. The console may be in fluid communication with the fluid intake or inlet of the probe and may be configured to provide a thermally conductive fluid to the probe to heat or cool the probe during use. The probe, or a portion of the probe needle, may be frozen (and / or the biological material, tissue, or water surrounding it may be frozen) in a first cooling step or cooling mode of the console / system, and thawed in a second heating step of the console / system, e.g., heating the probe body to thaw or heat the biological material or tissue surrounding the probe body. The freezing or cooling may be achieved by the Joule-Thomson effect or by heat transfer via convection and conduction. Heating may also be provided by heat transfer via convection or conduction. Multiple pressure regulators may form part of the fluid supply device or console of the system. Optionally, the pressure regulator may form part of the probe.

[0034] Embodiments of the present disclosure relate to a cryoablation system, a fluid delivery console (also referred to as a fluid delivery module or unit), and a probe (also referred to as a cryoprobe) for use in the cryoablation system. Exemplary embodiments of the fluid delivery console are illustrated in Figures 1 and 2, and exemplary embodiments of the probe or cryoprobe are illustrated in Figures 3-5. Exemplary embodiments of the cryoablation system are also illustrated in the block diagrams of Figures 6 and 7. Further features of the cryoablation system are described in detail below. Like reference numerals may be used throughout the figures to indicate like features or components.

[0035] Referring to FIG. 6, in one embodiment, a cryoablation system (100) may include a probe (110) or cryoprobe. An exemplary embodiment of a probe (10) that may be used in the cryoablation system of the present disclosure is shown in FIG. 5. Optionally, a sliding shaft (17) or sleeve may be provided, although it is understood that the present disclosure is not limited to the use of a sliding shaft or insulating sleeve. The probe (10) may be used alone with various systems of the present disclosure, or other types of probes may be used. The probe (10) may have a closed, sharp distal end (12) or tip to facilitate insertion of the probe into a patient (not shown) for cryotherapy or cryoablation treatment (e.g., to destroy malignant tissue by low or freezing temperatures). The probe may be elongated and hollow and have a proximal end (14) or section. Optionally, a handle (16) may be provided to facilitate insertion into a patient and manipulation of the probe (which may also be referred to as a cryoneedle) during use.

[0036] Referring to Figures 3-5, the probe 10 may have a hollow body 18 defining an inlet 20 and an outlet 22. The probe's inlet 20 may be connected, during use, to a fluid delivery console 112 (e.g., as shown in Figure 6). The console 112 is described in more detail below. The inlet 20 may be defined, for example, by the probe's hollow body 18, for example, by an inner tube 24 extending within the probe's hollow body 18. The inner tube 24 can be seen in Figure 4 and in the diagrammatic representation of the distal tip of the probe shown in Figure 3. Of course, many other configurations are possible.

[0037] The inlet (20) of the probe (10) may be configured to accept a thermal fluid for circulation through the hollow body (18) of the probe (10), as shown, for example, by the arrow pointing left inside the inner tube (24) in FIG. 3 . The outlet (22) of the probe (10) may be configured to exhaust the thermal fluid from the hollow body (18). The outlet (22), sometimes referred to as a vent, may be positioned to exhaust the thermal fluid away from the distal tip (12) of the probe (10) (e.g., back to atmospheric pressure). Embodiments of the present disclosure may allow the thermal fluid to expand, preferably rapidly, after entering the hollow probe body (18). In an exemplary embodiment, the thermal fluid may enter the inlet (20), travel through the inner tube (24), and expand within the hollow body (18) at the distal end region (26) of the inner tube (24). This reduces the temperature of the thermal fluid, thereby causing cryocooling, or cryoablation, which freezes the probe body (18) or substantially reduces the temperature of the probe body (e.g., when inserted into a patient) to cause cryoablation treatment of surrounding tissue.

[0038] The probe 10 may also be referred to as a cryoprobe, and multiple cryoprobes or probes may be implemented in the systems and methods of the present disclosure. The cryoprobe may include a needle portion with an outer tube including a distal section or portion with a gas supply line (also referred to as an inner tube 24) coaxially disposed within the outer tube or probe body 18. The gas supply line 24 may be arranged to supply pressurized argon gas that expands within an expansion chamber located near the distal portion 12 of the probe body 18, where a central gas supply line 24 terminates. This expansion of the pressurized argon gas may cause the gas to rapidly cool in accordance with the Joule-Thomson effect. The cooled gas absorbs heat from the metal walls of the cryoprobe by convection and conduction, causing water to form an ice ball on the exterior surface of the cryoprobe needle (e.g., within a patient's body during use). The depressurized gas may be exhausted from the cryoprobe. In addition to the needle, the cryoprobe may include a handle (16) for the physician to hold and manipulate the needle and a tube (for the thermal fluid) connected to the console. To control the length of the ice ball that forms on the cryoprobe needle, a sleeve (17) that slides over the needle can be implemented (see Figure 4), providing an insulating layer between the cooled outer metal surface of the needle and the patient. The length of the sleeve can be user-adjustable (15) to create ice balls of different lengths. The cryoprobe can have a temperature-sensing element inside the needle, i.e., the probe body (18), for measuring the expansion gas temperature, which can be displayed on the console's graphical user interface. The cryoprobe can also have a digitally controlled color element, such as an RGB LED, embedded in the handle and correlated to the probe's color displayed on the console's display (117).

[0039] An exemplary embodiment of the fluid delivery console (112) and its housing or enclosure is shown in Figures 1 and 2. It is understood that the housing may be used with other embodiments of the present disclosure, such as the embodiment of the console (212) shown in Figure 7 (described in more detail elsewhere in this disclosure). In an embodiment of the present disclosure, thermal fluid may be delivered to the inlet (20) of the probe (10) by, for example, the fluid delivery console (112, 212).

[0040] The fluid delivery console 112, 212 may be remote from the probe 10 and in fluid communication with the inlet 20 of the probe 10. Tubing or tubing (not shown) may be provided to fluidly connect the probe to a fluid delivery console or unit. The probe 10 may be handheld (e.g., as shown in FIG. 5 ), although embodiments may be possible in which the probe is mechanically or electrically operated (optionally in an automatic or controlled manner), e.g., robotically operated or operated by a device or machine. Fabrication of the probe may be fairly simple, and the probe may include a hollow body (e.g., made from surgical steel or other metal, a rigid material, or a composite material). The inlet may simply be connectable to a fluid delivery conduit or tubing that connects the inlet to a separate fluid delivery console that may be powered and located remotely from the probe. This may be advantageous because it allows more complex components to be provided separate from the console while maintaining a simple and cost-effective probe construction.

[0041] Referring to FIG. 6 , the fluid delivery console 112 may be configured to deliver thermal fluid to the probe 10 during use, enabling heating or cooling by the probe. It is understood that other embodiments of the fluid delivery console of the present disclosure may be similarly configured. In this embodiment, the fluid delivery console 112 includes a heating element 114 configured to selectively heat the thermal fluid before the thermal fluid is delivered to the inlet 20 of the probe 10, enabling selective heating of the probe 10 during use. This may be advantageous because once the probe has substantially cooled or frozen, a user (e.g., a surgeon, physician, or their assistant) may need to remove the probe. Indeed, this often needs to be accomplished quickly. The present disclosure may enable thawing or heating of the probe, for example, by selectively delivering heated thermal fluid to the probe after the thermal fluid has been heated by the heating element 114. This may be advantageous because rapid thawing or rapid heating of the probe body 18 may be achieved, thereby hastening the probe removal process. The heating element (114) may also have an energy source provided at the console, which allows more energy to be provided to the thermal fluid by the heating element. Other thermal energy, such as electrical energy or combustion energy in the case of a gas-powered heating element, may be provided at the console remotely or separately from the probe.

[0042] Still referring to FIG. 6 , the fluid supply console (112) of this embodiment may include a valve system and / or valve (116). The valve may be, for example, a selector valve. The valve may be operable and / or selectable between a first state and a second state. In the first state, the valve (116) may be configured to provide a thermal fluid to the probe (10, 110), for example, for cooling. In the second state, the valve may be configured to provide a thermal fluid heated by the heating element (114) to the probe (10, 110). In this embodiment of the fluid supply console (112), a single type of thermal fluid may be used, which in this embodiment is argon. A supply (118) of pressurized argon (in this embodiment, in the form of a pressurized argon tank, reservoir, etc.) may be included in the console or fluidly coupled to the console. One or more pressure regulators may be provided. It is understood that the embodiment described with reference to FIG. 6 may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0043] In this embodiment, a first pressure regulator (129) is provided, for example, for the first (preferably higher pressure) argon stream (124), and a second pressure regulator (122) is provided, for example, for the second (preferably lower pressure) argon stream (126). In other words, the first pressure regulator may provide a high-pressure fluid output, and the second pressure regulator may provide a low-pressure fluid output (i.e., an output lower than the output of the first pressure regulator). Both argon streams or fluid flow paths may be supplied by a single argon supply (118), i.e., a single pressurized hot fluid supply, although multiple fluid supplies or argon supplies may be used if desired. However, it may be advantageous to use a single fluid supply, such as a single argon tank, and split the flows, as shown in FIG. 6.

[0044] The second fluid path or flow may optionally be heated by a heater or heating element 114, for example, when the console 112 receives a user input. The heater may be activated mechanically or electrically, preferably automatically, when the user input is received (e.g., digitally). Thus, a heated thermal fluid (e.g., heated argon 128) may be provided by the heater or heating element 114. Optionally, an internal temperature sensor may be provided at or near the heating element and may provide temperature feedback to a processor, for example, which may be associated with the console.

[0045] The fluid delivery consoles (112, 212) of the present disclosure may include one or more processors (101, 201) and memory (102, 202), which may optionally form part of a controller (105, 205). The controller may be housed in the console, which may include, for example, a user interface or display. The present disclosure extends to embodiments of the systems (100, 200) in which the consoles (112, 212) include processors (101, 201) for performing the functions of the components described in this disclosure, preferably automatically or upon user input. The components of the consoles (112, 212) may be provided by hardware or by software units executing on the processors (101, 201) associated with the respective consoles (112, 212) and / or controllers (105, 205). The software units may be stored in memory components (102, 202), and instructions may be provided to the processors (101, 201) to perform the functions of the described components. In some cases, for example in cloud computing implementations, a software unit arranged to manage and / or process data for the console (112, 212) may be provided remotely. Some or all of the components may be provided by a software application downloadable and executable on the console (112, 212), i.e., the fluid delivery console. It will be understood that the embodiments described with reference to Figures 6 and 7 may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0046] The selector valve (or any of the other valves, pressure regulators, compressors, or heaters) may be operated or actuated automatically, for example, by receiving data or commands from the processor (101, 201). For example, if a cryoprobe or probe cooling or cryoablation is desired, the user may select the cooling option, and the selector valve may be actuated to a first state to provide thermal fluid (e.g., argon) to the probe, for example, for cooling via the Joule-Thomson effect, or by the thermal fluid itself being cooled (e.g., liquid nitrogen or other liquid or cooling fluid). Cooling (i.e., heat transfer from the tissue / material surrounding the tip and hollow body of the probe) may continue, freezing tissue, for example, during cryotherapy. If a surgeon, physician, assistant, or other user requests heating, the user may press a button (not shown) or provide other input data to the processor (101, 201), after which the selector valve may be actuated to a second state to provide thermal fluid heated by the heating element (114) to the probe. These actuations of the selector valves may be performed, for example, by receiving actuation data or commands digitally or analogically from a processor. Embodiments are also possible in which pneumatics or hydraulics are used to effectuate the control of the various components of the console (112, 212).

[0047] In the embodiment of FIG. 6, argon is used as the thermal fluid for both fluid paths (124, 126) (i.e., the first and second fluid paths), and heating or cooling of the probe is achieved by actuating a selector valve (e.g., a solenoid valve, etc.) between a first and second state of the valve (i.e., by selecting the first or second fluid path). The argon or other thermal fluid is then supplied to the probe (e.g., via a conduit, pipe, or fluid passageway connected to the console (112, 212) at the inlet (20)) and may flow through the hollow body (18) of the probe (e.g., as shown in FIG. 3). After cooling (or heating) occurs in the probe body, the thermal fluid may be exhausted, i.e., returned to atmospheric pressure, through the outlet (22). Depending on the particular arrangement, the thermal fluid may be exhausted to the ambient (e.g., into the chamber or surroundings of the handle of the probe), or the thermal fluid may return to the console (112, 212) via a conduit.

[0048] The fluid supply console 112 may be operable to automatically select the first and / or second states of the valves 116 and / or valve system to provide selective heating or cooling of the probe 10, 110 during use, for example, upon receiving input from a user indicating that heating or cooling is required by the probe. The fluid supply console 112 may be configured to supply a single type of fluid (e.g., argon) as a thermal fluid to the probe 10, 110 to facilitate cooling of the probe during use, for example, by cryoablation cooling and / or by freezing the probe, and the single type of fluid (e.g., argon) may be heated by a heating element to heat the probe body to facilitate thawing or heating of the probe body or to thaw or heat biological material or tissue surrounding the probe body. The heating element 114 may be configured to selectively heat the single type of thermal fluid before the single type of thermal fluid is provided to the probe 10, 110 to selectively heat or thaw the probe body. Similar features may also be implemented by console (212) of Figure 7. It is understood that this embodiment may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0049] An alternative embodiment of the console (212) is shown in FIG. 7. This embodiment is similar to the embodiment described with reference to FIG. 6, but includes two different types of thermal fluids, in this case argon (219) (e.g., supplied by a pressurized argon supply / vessel) and air (221) (e.g., supplied from the atmosphere or a pressurized air vessel). It is understood that any type of fluid may be used depending on practical considerations. The fluid supply console (212) may be arranged to selectively provide one or more thermal fluids (219, 221) to the probe. The fluid supply console (212) may be arranged to selectively provide a first thermal fluid (219) (e.g., argon) for cooling the probe (10, 210) and a second thermal fluid (221) (e.g., air) for heating the probe (10, 210). Optionally, a compressor (or multiple compressors) may be provided to pressurize one or more of the thermal fluids. In this embodiment, an air compressor (230) is connected to an ambient air supply (221). Similar to the embodiment of FIG. 6, a first fluid flow path (224) may be provided for a first thermal fluid (e.g., argon for cooling the probe), and a second fluid flow path (226) may be provided for a second thermal fluid (e.g., air that can be used to heat the probe). A heating element or heater (214) may be provided in either the first or second fluid flow path, in this embodiment, the air flow path. The heating element (214) may also have an internal temperature sensor, for example, to provide temperature feedback to the processor (201), which may be analyzed and appropriate action taken (e.g., increasing or decreasing the heater's heating of the associated thermal fluid). A pressure regulator (229) may be provided similar to that shown in FIG. 6. It is understood that this embodiment may include or implement one or more features of other embodiments of the present disclosure, and vice versa. A pressure regulator (220) may also be provided (preferably under the control of a processor), for example, to regulate the argon pressure before it is directed to the probe by the switching valve, similar to the other embodiments of FIG.

[0050] The heating element 214 (an air heater in this embodiment) of the fluid supply console 212 may be arranged to selectively heat the second thermal fluid 221 (air in this embodiment) before it is provided to the inlet 20 of the probe 10, 210, for example, to thaw, heat, or "defrost" the probe, or to heat the probe body to thaw or heat biological material or tissue surrounding the probe body. The heating element may be controlled by a processor or controller 205. Heating of the probe may be achieved by convective or conductive heat transfer of the heated fluid to the probe body 18, for example, via a conduit connecting the console 212 and the inlet of the probe body 18.

[0051] In embodiments of the disclosed systems (100, 200), the fluid supply console (112, 212) may include a valve or valve system (116, 216) that may be configured to selectively provide a first thermal fluid (124, 224) for operatively cooling the probe (110, 210, 10) during use. Alternatively or additionally, the valve or valve system (116, 216) may be configured to selectively provide a second thermal fluid (126, 226) for operatively heating the probe. The first and second fluids may be the same (e.g., both may be argon) or may be different (e.g., argon for cooling and air for heating). The fluid supply console (110, 210) may include a valve or valve system that may be configured to selectively provide a first thermal fluid for operatively cooling the probe, and / or the valve or valve system may be configured to selectively provide a second thermal fluid for operatively heating the probe during use.

[0052] The first thermal fluid may be any fluid selected to provide cooling via the Joule-Thomson effect or by other methods. For example, in the exemplary embodiment, the first thermal fluid may be argon, which rapidly expands upon exiting the inner tube 24 of the probe 10, significantly reducing the temperature of the argon and freezing or significantly cooling tissue or material adjacent to the probe (particularly near the distal tip or end 12 of the probe). However, it is understood that many other probe body configurations are possible, and that embodiments may also be possible in which the fluid circulates for cooling (or heating) in other ways (e.g., by internal conduits within the body of the probe itself, rather than using an inner tube). The entire length of the probe body may be cooled by the thermal fluid, whether by the Joule-Thomson effect (e.g., to facilitate heat transfer by conduction and convection) or by the fluid itself being cooled. For example, although not preferred in this embodiment, it is contemplated that liquid nitrogen or other gases, liquids, or fluids may be used in place of argon. Similarly, instead of argon or air, other gases, liquids, or fluids (e.g., helium, heated water, etc.) may be used for heating. The thermal fluid used for heating promotes heat transfer to the probe body, for example, by convection or conduction. In other words, the second thermal fluid (126, 226) may be any fluid selected to provide heating by thermal conduction or thermal convection. The first and / or second fluids may be selected to be thermally conductive. The thermal fluid may be selected from a list including argon or argon-based fluids, air, helium or helium-based fluids, nitrogen or nitrogen-based fluids, liquid nitrogen, inert gases, or ideal gases, or other gases or liquids capable of thermally heating or cooling the probe, as the case may be.

[0053] The fluid supply consoles (112, 212) may be connected to a pressurized thermal fluid supply (e.g., 118, 219, 221, 230) and / or may be connected to one or more pressurized thermal fluid supplies or supply reservoirs. For example, a first reservoir (118) for pressurized argon may be provided and in fluid communication with the fluid supply console (112). Additionally or alternatively, a second reservoir (not shown) for pressurized air may be provided and in fluid communication with the fluid supply console (212). The fluid supply consoles (112, 212) may be used with cryoablation systems according to the present disclosure. However, it is understood that the fluid supply consoles may be manufactured and / or sold separately from the cryoprobes or probes. This may be advantageous because a single fluid supply console may be modularly arranged and / or configured for use with multiple probes or cryoprobes. For example, the fluid supply console may be provided with multiple fluid supply channels, each similar to FIG. 6 or FIG. 7, as the case may be. This allows multiple probes to be connected to a central fluid delivery console or hub so that each of the multiple probes can be individually controlled for heating and cooling of each probe during use.

[0054] Referring again to Figures 3-5, each probe 10 may have a hollow body 18 extending from its proximal end 14 to its distal end 12. The probe may include a fluid transport tube 24 extending from the proximal end to the distal end within the hollow body. The fluid transport tube, or inner tube, may be positioned to open into the hollow body 18. The distal end 12 of the hollow body may be closed to allow thermal fluid to pass through the fluid transport tube and enter the hollow body, potentially heating or cooling the probe body. The distal end of the probe body may be sharpened or positioned or configured for insertion into a patient, for example, for cryoablation or cryotherapy.

[0055] The present disclosure extends to a cryoablation system (100, 200) comprising a fluid supply console (112, 212) that may be remotely connectable from the probe (10, 110, 210) so as to be in operative fluid communication with the inlet (120, 220) of the probe (10, 110, 210). The fluid supply console (112, 212) may include a conduit (135, 235) or one or more conduits that may be arranged to provide thermal fluid to the probe during use to enable heating or cooling by the probe. The fluid supply console (112, 212) may include a heating element or heater (114, 214) that may be configured to selectively heat thermal fluid before the thermal fluid is supplied to the inlet of the probe via the conduit to enable selective heating of the probe during use. It is understood that this embodiment may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0056] Referring to FIG. 32 , the present disclosure extends to a method (1000) of applying cryoablation therapy. The method may include providing (1010) a probe (10, 110, 210) that may have a hollow body (18) defining an inlet and an outlet. The inlet may be configured to receive a thermal fluid for circulation through the hollow body. The outlet may be configured to expel the thermal fluid from the hollow body. The method may further include providing (1012) a fluid supply console (112, 212) in remote fluid communication with the inlet (20) of the probe (10, 110, 210). The method may further include operably supplying (1014) a thermal fluid (118, 219, 221) to the probe (10, 110, 210) by the fluid supply console (112, 212) to enable heating or cooling by the probe during use. The method may further include selectively heating (1016) the thermal fluid before it is provided to the inlet of the probe (10, 110, 210) by a heating element (114, 214) of the fluid delivery console (112, 212) to selectively heat the probe during use. It is understood that this embodiment may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0057] The cryoablation system of the present disclosure can be used, for example, for the cryodestruction of tissue during minimally invasive procedures. The cryoablation system can be used as a cryosurgical instrument in the fields of general surgery, dermatology, neurology (including cryoanesthesia), thoracic surgery (excluding cardiac tissue), otolaryngology (ENT), gynecology, oncology, proctology, and urology. The system can be used to destroy tissue (including the prostate, kidney tissue, liver metastases, tumors, and skin lesions) through the application of substantial or extremely low temperatures.

[0058] The cryoablation systems of the present disclosure may include a pressurized gas source, which may be referred to as a console gas source (or a gas source associated with or forming part of the console), and one or more cryoprobes connected to the console. The console may be used with a gas or fluid reservoir, cylinder, or tank, or the reservoir may be incorporated into the console. Alternatively or in addition, the console may include or be connected to a compressor, for example, for compressing fluids or gases used in the systems and methods of the present disclosure. For example, an air compressor may be used, or other types of fluid compressors may be used.

[0059] The console may also house one or more temperature probes, which are temperature sensors that assist in monitoring the spread of cooling by the cryoprobes within the patient. Temperature data may be received by the console from a temperature sensor at or near the probe. Alternatively, or in addition, a separate temperature-sensing element, or temperature-sensing probe, may be connected to the console and inserted into the patient (e.g., near the cryoprobes) to, for example, send temperature data or signals indicative of the temperature to the console's controller. The temperature probe may be shaped similarly to the cryoprobes, or hollow probes, used for cooling or heating (i.e., for forming ice balls and / or thawing).

[0060] Each cryoprobe may have a temperature sensor that provides feedback to the console and the user (e.g., via a display). A separate port may be available for an additional dedicated temperature probe to be inserted into the patient to provide feedback of the temperature of the surrounding tissue. This may provide feedback that may indicate, for example, the size of the ice ball. These temperatures may also be displayed by the console to assist the user during the procedure.

[0061] It is further contemplated that embodiments may be possible in which one or more temperature sensors are provided within or along the probe (i.e., cryoprobes) to detect temperature data from various points along the probe body in near real time. This allows a physician or user to view real-time temperature data on a display associated with the console, and this data may be automatically analyzed by the console to enable the implementation of action, e.g., preventative or emergency measures. The consoles are contemplated as being reusable. In preferred embodiments, the cryoprobes are single-use disposable items. This may be advantageous because it can limit or prevent the spread of infection, protecting both the physician and the patient. To be more cost-effective, particularly in countries with limited resources for medical equipment, complex and expensive components of the system may be provided in a reusable console. It is understood that these embodiments may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0062] As shown in the exemplary embodiment of Figures 1 and 2, a console that may form part of the systems and methods of the present disclosure may be a portable console with a touchscreen interface that may allow a user to control the application of pressurized argon gas (or other thermal fluid) to one or more cryoprobes. The console may alternatively be stationary or non-portable in certain embodiments. The console may also be separate from the probes.

[0063] The console may use an argon gas source (e.g., 118 in FIG. 6 ), which may be provided by an argon gas tank. The console may be configured to adjust the incoming gas pressure to a pressure appropriate for the cryoablation procedure being performed. The console may have multiple channels or fluid paths for connecting multiple cryoprobes. The console (112, 212) may be capable of independently controlling gas flow to each channel. The system may either freeze or actively thaw / heat the cryoprobe needle or probe body. The freezing function may be implemented by applying high-pressure argon gas to the cryoprobe. Active thaw / heating may be performed by applying low-pressure, electrically heated argon gas to the cryoprobe. It is envisioned that the heating element (114) may be an electric heating element configured to heat argon gas or other types of thermal fluid.

[0064] In the exemplary embodiment of FIG. 6, the console's pneumatic pathway (or fluid flow path) may include the following features: Two pressure regulators (122, 129) may be provided, one for high-pressure argon used for freezing the cryoprobe needle and one for low-pressure heated argon gas used for active thawing / heating. A manifold may be provided and one or more solenoid valves may be implemented to control the argon flow path. Similarly, in the embodiment shown in FIG. 7, one or more solenoid valves may be provided to control the argon or air fluid flow path. The solenoid valves may be controlled by a controller (105, 205) to automatically control the flow of the first thermal fluid and / or the second thermal fluid.

[0065] It will be understood that the fluid flow path shown in Figure 6 is just one exemplary embodiment (100) of a pneumatic or fluid flow path in which argon gas is used to both heat and cool the cryoprobe needle, i.e., the probe body. A second exemplary embodiment (200) of a pneumatic path is shown in Figure 7 in which compressed and heated ambient air may be used to heat the cryoprobe needle instead of argon gas. Both embodiments may implement active gas heating.

[0066] One advantage of implementing active heating within the console is that it may reduce the complexity of the cryoprobe compared to other arrangements, for example, if the heating is implemented in the needle or the handle of the needle itself. This may substantially reduce the cost of the needle. Another significant advantage may be electrical safety. The absence of a heating element in the cryoprobe eliminates the need for a high-power power source within the probe needle, making the needle inherently safer and lighter and therefore easier to operate (an advantage that adds to the option of disposable needles, as discussed elsewhere in this disclosure). This may also provide advantages such as ease of manufacturing, reduced or resilient failures, and reduced part count.

[0067] Referring now to FIGS. 8-13, an exemplary embodiment of a heater or heating element (300) is shown. The heater or heating element may be configured to heat a thermal fluid (e.g., as indicated by reference numerals (114, 214) in the exemplary block diagrams of FIGS. 6-7). Referring to the cross-sectional view of FIG. 10, the exemplary heater may include a heating element (310), one or more pressure seals (312), an outlet (314) for the heated fluid, and an inlet (316) for receiving an unheated or cool fluid. In this embodiment, the heater is an electric heater for heating the thermal fluid (whether air, argon, or other thermal fluid). In other words, the heating element (310) may be electrically powered by a power source (not shown), which may be associated with the console (112, 212). The heater may also be referred to as a gas heater or a thermal fluid heater. While other heating elements or methods, such as combustion, are contemplated, electric heating may be preferred. The thermal fluid flow path may be controlled electronically, electrically, or digitally via a console graphical user interface, such as the touch screen (117) of the device shown in Figure 2. Multiple ports, conduits, or channels may be provided for fluid flow path, for example, to multiple probes. Exemplary embodiments of these ports or conduit terminals can be seen in Figures 1 and 2.

[0068] The exemplary embodiment of the heater shown in FIGS. 8-13 may also be referred to as an active gas heater (which may be incorporated within the console). The heater may include an electric heating element (310) inserted into a shaft (318) or tube, preferably made of a rigid material such as metal or steel. The heating element (310) may be located near a central region of the heater, which may be referred to as a gas chamber (320). When pressurized gas or thermal fluid is applied or provided to the heater (300), the gas may enter one port of the heater (e.g., inlet (316)), flow over a heated central rod, shaft (318) or tube that transfers heat to the gas or thermal fluid as it flows through the chamber (320), and exit a different port of the heater (300) (e.g., outlet (314)). It is understood that the heater shown in FIGS. 8-13 is merely an exemplary heater, and that many other types of heaters or other types of fluid heating devices may be used to heat the thermal fluid before it is provided to the probe. In other words, an active heating element may be used in the console to heat a gas or fluid to heat a needle, cryoneedle, or probe. It is understood that this embodiment may include or embody one or more features of other embodiments of the present disclosure, and vice versa.

[0069] The console of various embodiments of the present disclosure may provide a cryomode. In the cryomode, the console may be configured to provide a thermal fluid, such as argon, at a pressure in the range of about 200 bar (2*10^7 Pascals), or about 2900 psi. The console may be configured to sequentially turn on and off the flow of the thermal fluid at a pressure of about 200 bar (2*10^7 Pascals), or about 2900 psi, to an operator-selected cryoablation probe channel via command input from a user interface (e.g., 117).

[0070] The console of various embodiments of the present disclosure may also provide a defrosting mode or a heating mode (also referred to as a heating mode). The console may be capable of providing low-pressure thermal fluid (e.g., argon gas) (e.g., between 2 bar and 100 bar, or about 2 bar, about 100 bar, about 25 bar, about 50 bar, or 75 bar, or any pressure between these pressures (these may be absolute pressures as opposed to gauge pressures, which may be about 1 bar less, i.e., between 1 bar and 99 bar), as may actually be needed). The thermal fluid may be provided at a temperature up to 150°C to an operator-selected cryoablation probe channel for heating via command input from a user interface (e.g., 117), although other temperatures are possible. The console may also be configured to perform one or more temperature measurements. For example, the console may allow the operator to continuously measure and display the temperature from an operator-selected temperature probe (i.e., a probe / cryoprobe equipped with a temperature-sensing element).

[0071] Referring to FIG. 5 , it is understood that the probe 10 may include or be connected to piping, tubing, or conduits for supplying thermal fluid from the console port 119 to the probe needle or probe body. It is further contemplated that data or signal cables, wires, or other transmission media may be provided between the probe and the console, for example, to provide temperature feedback from the probe's temperature sensor to the console's controller and / or to provide data communication. The piping and / or tubing and / or cable may be referred to as an "umbilical." One or more plugs may be provided on the probe or probe handle for connecting the tubing or cable. The console port 119 may also be referred to as a probe port. The console may have an associated display 117 and may be provided with an emergency button, for example, to initiate emergency defrosting or heating if probe removal is necessary. One or more warning indicators, lights, or sound devices may also be provided, for example, to alert a user or operator that a temperature reading from the probe exceeds or falls below a predetermined threshold. For example, an emergency button may be provided to automatically initiate emergency heating or cooling of the probe, as the case may be. The console may also have an on / off button or power switch, or a USB port or other data communication means, for example, to provide data communication with a remote server or computer. Optionally, the console may include a fuse box and a vent valve for venting the thermal fluid (e.g., from the probe or from the thermal fluid supply). The console may include one or more inlets for the thermal fluid and one or more outlets for the thermal fluid. The outlets are, for example, at port (119), which may be connected to a probe. A manual vent valve may be provided. For example, a pressure hose or pipe may be provided to connect an argon tank (or other thermal fluid reservoir) to the console (112, 212).

[0072] Embodiments of the present disclosure extend to embodiments of a system in which suction (e.g., to the central chamber 714 of the probe's handle in FIG. 26 ) is applied to the inner tube (e.g., 24) (i.e., by applying negative pressure or using a pump at the console to draw the liquid from the probe) to pull the thermal fluid from the probe's outlet 22 through the probe body 18 toward the distal end or tip 12 of the probe 10. If the outlet 22 is open to atmosphere, this negative pressure or pumping can draw ambient air into the needle or probe body 18, which can heat the probe (e.g., if the probe is frozen or below ambient temperature). Thus, "hot" air can be drawn into the tip. If the probe's outlet 22 is connected to a console via tubing, hot thermal fluid, such as air, is drawn from the console toward the probe's outlet, or in other words, expelling the hot thermal fluid in the direction opposite the directional arrow shown in FIG. 3 . This may also be referred to as a reverse vent-out. In other words, heated thermal fluid, i.e., thermal fluid at a temperature higher than that of the probe, may be provided in either direction (i.e., from the outer portion of the hollow body 18 toward the inner tube, or from the inner tube 24 toward the outer portion of the hollow body). In some embodiments, cooling fluid may also be provided in either direction, as explained above, for example, if the fluid does not utilize the Joule-Thomson effect but is rather cold itself (e.g., liquid nitrogen).

[0073] It is further understood that, if suction is not available, embodiments of the present disclosure may rely on applying a hot thermal fluid to the inner tube and having the hot fluid / air travel outside the inner tube and through the inner tube to the tip of the probe. It is also envisioned that the probe body (18) (also referred to as the needle body) may be heated or cooled during use using thermal conduction. For example, if stainless steel is used to construct the needle body, the system may be configured to rely on thermal conduction in the stainless steel needle tube from the heated fluid entering the probe inlet (reference numeral 20 in FIGS. 3-5, or 22 in some embodiments when implementing a reverse flow, e.g., where the outlet acts as the inlet) toward the tip.

[0074] Referring again to FIGS. 8-13, the heater (300) or heating system having the heating element (300) can be arranged to provide a reduced thermal mass, which can be advantageous and efficient. The chamber (320) can have a relatively small volume due to the tight tolerances between the heating element, rod (318), and outer body (319) of the heater (300). The chamber (320) can be a peripheral chamber (preferably a narrow peripheral chamber) formed between the inner heating element (310) and the heater's outer body (319) such that the volume therein is small and stagnation can be reduced. The heater can be high-pressure rated, and a pressure seal (312) can be arranged to withstand high pressure and heat. For safety, a full system pressure of 300 bar / 6000 psi (absolute) can be implemented. The contemplated pressure and temperature ranges of 2-100 bar (absolute) (i.e., 29-1450 psi) and thermal fluid from 30°C to 150°C are feasible, although embodiments are possible in which thermal fluid above 150°C, above 400°C, or above 550°C may be heated and used, for example, to control heat loss in the probe body or inner tube. The temperature of the thermal fluid may be between 0°C and 550°C, or above 550°C. Also, embodiments are possible in which thermal fluid below 0°C may be implemented.

[0075] An embodiment of the console (112, 212) may implement one heater (300) per channel of four channels in the console (e.g., two of the ports (119) may be channels, one channel used for cooling and one used for heating). In one embodiment, four heaters may be implemented in the console, which includes four channels and eight ports (each channel capable of cooling or heating). However, it will be understood that many other configurations are possible. Embodiments are also possible in which the two ports (119) of a set of channels are symmetrical in operation. In other words, when connected, both ports may be used for cooling and heating simultaneously.

[0076] Figure 12 shows an exemplary trial conducted on heater 300 using a simulated 40 bar pressure vessel. High material stresses were observed only at non-critical locations (e.g., designated by reference numeral 305). A physical example of heater 300 and its heating element rod or shaft 318 is shown in the photograph in Figure 13.

[0077] FIG. 14 shows a photograph of another exemplary embodiment of a heater (400) having internal heating elements or fins (410) for heat transfer to a thermal fluid, which may be used in embodiments of the present disclosure. The thermal fluid may pass through these fins within a heating chamber (412), which may be heated, for example, electrically. An embodiment of the internal components of an exemplary cryoablation system console is shown in the renderings of FIGS. 15 and 16. This exemplary embodiment includes four channels, each of which may provide heating or cooling. Two ports per channel may be used for heating. Two ports per channel may be used for cooling. Each channel may be switched between heating and cooling, for example, by a selector valve. It is understood that this embodiment may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0078] It is contemplated that a single heater (400) may optionally be used for all four channels, including all eight ports (419). All four channels (8 ports) may be used for cooling. However, as noted above, it may be preferable to implement four compact heaters (300), e.g., one heater (300) per channel. Solenoid valves (425) may be used to control fluid flow to each port, controlled, for example, by a controller in the console. As described with reference to FIGS. 6 and 7, one or more switching valves (optionally automatically actuated by the controller) may be implemented. Manifolds may also be used to, in some cases, direct the flow of first and / or second fluids (e.g., a heated fluid and an unheated / cooled fluid for cooling) to various ports. Renderings of an exemplary embodiment of a console (500) incorporating the internal components of FIGS. 16-17 are shown in FIGS. 17-18. As before, it is understood that these embodiments of the present disclosure may include or implement one or more features of other described embodiments, and vice versa. For example, each channel may implement a single heating element (300) or heater instead of using finned heaters (400) for all four channels.

[0079] Further trials and simulations of heater (300) are shown in Figures 19 and 20, demonstrating the simplified fluid flow path and reduced volume of the heating chamber (i.e., in terms of the tolerance or gap between the outer body (319) and the shaft / rod (318) for the heating element (310)).

[0080] The systems and methods of the present disclosure may thaw an ice ball (e.g., in the tissue surrounding the probe needle) more quickly than using currently available systems or methods. The heated fluid may facilitate thawing / heating of the probe and / or surrounding ice ball to facilitate the probe's detachment from the ice ball within the patient's body.

[0081] 21-23, an exemplary embodiment of a probe or cryoprobe 600 is shown. The probe 600 may be used with the systems and methods of the present disclosure. The probe 600 may include a needle portion 601 (also referred to as a probe body) and an outer tube 602 (e.g., over an inner needle body). A grip or handle 603 may be provided, and the handle or grip inner body 604 may be positioned to securely position the needle 601 within the handle or grip 603. Optionally, the grip 603 may be separate from the main probe handle portion 612 or may be incorporated into a single housing or structure that houses the components of the probe 600. A cap, also referred to as a cap body 605, may be provided to close the proximal portion of the probe 600. The probe handle portion (612) may optionally be provided with a plurality of adjustment notches (606) for an adjustable insulating sleeve (e.g., FIG. 5) that may be positioned to slide over the needle, for example, to adjust the distal portion of the needle to form an ice ball and the intermediate portion of the needle to be insulated against freezing. A second cap or closure (607) may be provided to secure the inner body (604) to the handle or grip of the probe (600) and provide a substantially fluid-tight seal, for example, via an O-ring seal (611) or other type of seal. An umbilical (608) may be provided for connecting the probe to a console of the present disclosure. The umbilical may also have or be insulated around the umbilical to reduce heat transfer to the environment, thereby increasing the efficiency of heat transfer to and from the probe during use. A heat or cold barrier or insulation may be provided around the umbilical. An "umbilical" or "umbilical cord / tether" may also be referred to as a thermal fluid tube, and optionally also includes a signal cable or wire, or a data communication cable.

[0082] An "umbilical" may have insulation on its internal components (electrical and fluid tubing) for several reasons, including but not limited to electrical safety, protecting the user from burns or freezing, maintaining flexibility, reducing heat loss during thawing, and absorbing heat during freezing.

[0083] Insulation materials may be selected or integral moldings may be used, and specific materials or combinations of materials may be used, to handle both high and low temperatures (i.e., temperatures substantially close to or below 0° C.), which may result in further reductions in gas usage during treatment, resulting in energy savings for the user and / or patient.

[0084] Still referring to FIGS. 21-23, a first thermal fluid tube 609 may be provided, for example, for supplying argon or other thermal fluid from a console to the probe 600. The first thermal fluid tube 609 may connect the inlet of the probe / needle body 601 to a fluid supply console (e.g., 112, 212, 500), for example. An inner tube 610 may be provided extending inside the needle body (also referred to as probe body 18 in FIG. 3). The inner tube 610 may be similar to the inner tube 24 described above. It may also be referred to as an inner argon tube, for example, if argon is used as the thermal cooling fluid. It is understood that the embodiments described with reference to FIGS. 21-23 may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0085] Another embodiment of a probe or cryoprobe 700 is shown in Figures 24-26. The probe 700 may be used with the systems and methods of the present disclosure. The needle 701, outer tube 702, grip 703, inner body 704, cap 705, adjustment notch 706, second cap 707, umbilical, tubing and / or cable 708, first thermal tube 709 for a first thermal fluid, e.g., argon, inner tube 710, and seal 711 may be similar to the components described above with reference to Figures 21-23. However, this embodiment of the probe 700 may be provided with a heated fluid tube 712 for receiving a heated thermal fluid, e.g., heated argon or heated air or other heated fluid, from the console 112, 212, 500. The heating fluid tube or conduit may be connected to an associated one of the console ports (e.g., 119) for providing a thermal fluid heated by a heating element of a heater (e.g., 114, 214, 300, 400, as the case may be). In other words, a first fluid supply conduit (710) may be provided for a first thermal fluid (e.g., pressurized argon) and a second fluid supply conduit (712) may be provided for a second thermal fluid (e.g., heated argon or heated air, as the case may be). It is understood that this embodiment may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0086] Heated thermal fluid (e.g., heater air) may flow from the console through a second fluid supply conduit (712), which in this embodiment is a larger diameter tube, and the heated thermal fluid may be discharged or introduced into a central heat transfer chamber (714) of the probe (700) (see dashed arrow (718) in FIG. 26). This heated thermal fluid may generally cause heat transfer to the inner body (704) of the probe and the probe body by conduction and / or convection. The inner body (704) of the probe (700) may be fabricated from a thermally conductive material (e.g., metal) to facilitate heat transfer. Heating may be provided by the inner body (704) toward the needle body (701) (also referred to as the probe body (e.g., 18) in FIG. 3) (e.g., in the region (733) that holds the cryoneedle, i.e., proximal end, of the probe body). The proximal end of the needle body / probe body may be held in this region 733 of the inner body 704 of the probe 700. Heat transfer from this heated thermal fluid may heat the cryoneedle by conduction.

[0087] Additionally, as discussed above with reference to FIG. 3, the probe body (701, 18) may have an outlet (22, FIG. 3). In a counterflow implementation, heated thermic fluid is forced into this outlet (22, FIG. 3), which effectively acts as an inlet (722) for the thermic fluid, in this case, the heated thermic fluid. As discussed above, fluid flow in both directions may be implemented, with heated fluid being pushed through the outlet (722) (acting as an inlet), or heated air being pulled through the outlet (722), for example, by applying negative pressure to the chamber (714) and supplying heated fluid, for example, through the first fluid supply conduit (710). In other words, embodiments may be possible in which heated air or a heated fluid, such as heated argon, is pushed / pushed or pulled / sucked through the needle body, as the case may be. This may allow for heat transfer to the needle, i.e., the probe body (18, 701), both by convection and conduction, both for heating and cooling / freezing.

[0088] The addition of a second supply line / conduit (712) to the probe assembly (also referred to as a needle assembly) with a much larger orifice or larger diameter compared to the first fluid supply conduit (710) may facilitate more fluid flow and heat transfer with reduced JT effects. This may be advantageous because heat transfer (in the case of heating) may be improved with a lower JT effect, increasing the rate at which the needle or probe body thaws or heats, improving patient safety and ease of use for the user / physician / surgeon. It is understood that the embodiments described with reference to Figures 24-26 may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0089] 27-31 and 33 are self-explanatory high-level block diagrams of exemplary embodiments of the system of the present disclosure. 27-29 are high-level block diagrams of exemplary embodiments of the system of the present disclosure. 30 is another high-level block diagram of an exemplary embodiment of a cryoablation system. 31 is a high-level block diagram of the pneumatic and / or fluid flow architecture of an exemplary embodiment of a cryoablation system according to embodiments of the present disclosure. 33 is a high-level block diagram of an exemplary control software architecture that may be implemented by an embodiment of a cryoablation system of the present disclosure, for example, by a processor and / or controller associated with a console. It is understood that these embodiments may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0090] The following list illustrates some exemplary, non-limiting features that may form part of the devices, systems, and methods of the present disclosure. 1. The console may have a physical emergency stop button that will stop the flow of argon gas through the console by closing all valves. Pressing the emergency button may also activate an alarm. 2. The console may have an emergency defrost button that will stop active freezing of all channels and begin active defrosting of all active channels. 3. The console may have an information display that provides the user with information such as current temperature, freezing power, and treatment time. 4. The UI may visually indicate whether a connected cryoprobe is available for use. 5. The console can display information graphically. 6. The console may not allow new cryoprobes to be connected to pressurized channels or may stop the flow of argon in channels where the console detects that a new cryoprobes are connected. 7. Each connected probe may have a color element that corresponds to the color of the particular probe displayed in the console's UI. 8. The console may have a cryoprobe placement recommendation feature that indicates the preferred channel to use for the next procedure. The preferred channel may be determined based on the total number of operating cycles that all channels have undergone. 9. A user interface (UI) can guide the user through the initial testing process. 10. The console may have a defrosting function with an active means for heating the needle tip of the cryoprobe. 11. Each cryoprobe channel may be capable of the following operations: 11.1.Start 11.2.Stop 11.3.Pause 11.4. Yes / No Buttons There may also be an option to apply one of these actions to all available ports. 12. The console may prevent a particular probe from being used for multiple procedures. The console may prevent the use of probes for which it cannot determine the probe's previous use. This may facilitate the "single-use" feature of each probe, reducing the risk of infection and / or reducing or eliminating the need to clean the probe after use because the probe may be discarded. The console may discourage or prevent users from reusing a probe or needle by tracking a unique identifier associated with the probe, keeping a record indicating that the probe has been used, and warning or preventing the user from reusing the same probe / needle. 13. The console may display the current argon working pressure in psi or Pa. 14. The console may have a freeze power function that may provide an adjustable measurement of gas delivery to a selected cryoprobe channel as a percentage of full working pressure. This may be implemented as a 10-second duty cycle. For example, 80% pressure may be implemented as 8 seconds of full working pressure followed by 2 seconds of no pressure. 15. The console can automatically detect a cryoprobes after a probe is connected to the console during treatment mode and can add the new probe to the list of cryoprobes available for treatment. 16. The console can generate and display a procedure report, which includes: 16.1 Freezing temperature of the cryoprobe for each freezing cycle. 16.2 Freeze time of the cryoprobe for each freeze cycle. 16.3 Cryoprobe thaw time for each thaw cycle. 16.4 Cryoprobe freezing power applied for each freezing cycle. 16.5 Working gas pressure at the beginning and end of the procedure. 16.6 ID numbers of all probes used during the procedure. 16.7 Date and time of action 16.8 Cryoprobe test results. 16.9 Console ID. 17. The console may generate and display a unique number for each procedure. 18. The console may have means to emit an audible alarm. 19. The console may have means for indicating alarm conditions other than a touch display and may be capable of producing red and orange / yellow lights respectively in response to alarm conditions. 20. The UI may provide feedback to the user regarding the status of the alarm and how to resolve the reason for the alarm (e.g., the detected temperature or detected pressure is above or below a threshold). Additionally, one or more pressure sensors may be implemented at various locations in the system (eg, probes, piping, or a console), and pressure detection signals may be received and analyzed by the console.

[0091] 34-39 illustrate a number of exemplary heating elements (3400, 3500, 3600, 3700, 3800, 3900) in which embodiments of the present disclosure may be implemented. Each of these heating elements may have, for example, an internal cavity (e.g., 3410) through which a thermal fluid may flow. The heater body (3412) may be made of a solid material, such as a metal, that has good thermal conductivity. A plurality of internal baffles may be formed in the solid body, which may cause turbulence as the thermal fluid flows through the cavity (3410). The heater may be heated by an electric coil (3414), for example, by induction, under the control of, for example, a controller. As a thermal fluid (e.g., argon, air, etc.) passes through on its way to the cryoprobe, electrical induction may heat the body (3412), which may transfer heat to the thermal fluid. The heating elements (e.g., 3400) may be provided by a fluid supply console. Optionally, multiple of these heating elements may be implemented, for example, one for each of multiple channels or fluid supply paths connecting multiple probes. Various configurations of baffles are possible, as seen in the exemplary embodiments of Figures 34-39. Optionally, the internal baffle may be omitted, allowing the thermal fluid to pass straight through the center of the void.

[0092] FIG. 40 shows an exemplary cross-sectional view through the heating element 3800 of FIG. 38. A cool, or relatively cold, thermal fluid (e.g., argon) may enter the heating element at 3810. An internal baffle may cause turbulence in the thermal fluid, leading to heat transfer from a heated core or body 3812, which may be heated by induction in a coil 3814. The heating element may be insulated by an insulating layer 3817 to limit heat loss. The heated thermal fluid (e.g., argon) may then exit the heating element 3800, for example, at 3820, toward further components of the system, such as a cryoprobe. It is understood that other heating elements may function similarly.

[0093] These heaters, or heating elements, may be mounted on a console (e.g., 112 in FIG. 1). The heaters may also be referred to as miniature heaters. A channel may be provided with one heater per two cryoprobes. The heater body may function as a pressure vessel. The surface area for heat transfer may be maximized, for example, by baffles. Maximum turbulence may be implemented for the thermal fluid to disrupt the boundary layer for improved heat transfer. Variable temperature control may be implemented by a controller. The system may provide a fast ramp-up to maximum output. Features of the present disclosure may include a duty cycle by which the thermal fluid output temperature is controlled (e.g., by a controller). Ice ball size control may also be implemented, using additional heated argon injection instead of switching high-pressure refrigerant gas on and off to improve solenoid life (e.g., reducing the need for constant switching of the solenoid valve controlling the thermal fluid flow). The heating system may operate at reduced pressure (e.g., approximately 25 bar). Optionally, an additional argon (or other type of thermal fluid) cylinder may be used for heating purposes. This can minimize gas wastage (e.g., freezing can use a cylinder from 6000 psi to 3000 psi, with the remaining gas generally being discarded). A 3000 psi tank can be connected to a heating system, allowing it to be used down to less than 500 psi. Induction heating mechanisms can be implemented according to aspects of the present disclosure.

[0094] In the present embodiments of FIGS. 34-40, the heater body and heating element may be the same. These embodiments may alleviate the need for pressure seals. The heater may be readily integrated into existing high-pressure systems. The heater may include a heater core and insulation, such as an aerogel blanket or similar. This insulation (e.g., 3817) may separate the heater core / body from the induction coil. Isolating the heater from the console interior may also reduce heating effects and improve efficiency by keeping heat internal. The insulation may electrically isolate the induction / heating core from the induction coil. It is understood that the embodiments described with reference to FIGS. 34-40 may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0095] Referring to FIG. 48, an exemplary probe 4800 and its tip according to an embodiment of the present disclosure are shown in detail. The probe's body 4810, which may also be referred to as a needle body, is made of, for example, stainless steel. An adjustable insulating sleeve 4812 may be provided to control the size of an ice ball formed by the needle, for example, inside the human body. The sleeve may include an air gap or vacuum 4814, for example, to facilitate insulation. The sleeve may also be made of, for example, stainless steel or other strong material. Heated thermal fluid may enter the probe through a first fluid path 4816, while cooling thermal fluid may enter the probe through a second fluid path 4818 (see, for example, FIG. 49). An exemplary cross-sectional view through the probe is shown in FIG. 52 (taken along line FF in FIG. 48). The vacuum or insulating material 4814 is shown diagrammatically in FIG. 52, as are the heated thermal fluid 4816 and the cooling thermal fluid 4816. A return, outlet or exhaust fluid path (4820) may also be provided.

[0096] Different arrangements of the outlet or exhaust fluid paths (5320, 5420) are shown in Figures 53-54. Different arrangements of the inlets of the heating fluid paths (5316, 5416) are shown in Figures 53-54. Different arrangements of the inlets of the cooling fluid paths (5318, 5418) are shown in Figures 53-54. It will be appreciated that many other configurations are possible, as shown in Figures 55-62.

[0097] The needle body may provide a return path (exhaust) for fluids / gases. An insulating sleeve (or vacuum) may be provided for thermal insulation. The sleeve may be adjustable along its length, for example, to control the size of the ice ball. The freeze tube may supply argon to implement the Joule-Thomson freezing effect. A minimal orifice diameter may be selected to increase the pressure differential for the JT effect. One or more thaw tubes may supply heated argon for thawing or heating. Multiple configurations are possible, and using larger diameter tubes may increase thermal energy transfer at lower pressures. It is understood that the embodiments described with reference to Figures 48-62 may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0098] Referring now to FIGS. 41-44, an exemplary embodiment of a connector 4100 or coupler system that may be used to connect a thermal fluid conduit (e.g., to a probe) to a fluid delivery console is shown. The console may be provided with a socket 4110. A plug 4112 or connection device may be provided for connecting the thermal fluid to the socket. The plug may have, for example, two prongs. FIG. 41 also shows a close-up view of an exemplary button locking device that may be implemented. The locking device may have a button 4114 that may move a locking plate 4116 to lock or unlock the plug or connector from the socket. The button may be spring-loaded, for example, by a spring 4118. A plug body 4120 may be provided on a handle with an internal exhaust chamber and exhaust line. This embodiment may also be referred to as a cryoprobe-to-console connection with a linearly actuated button 4114. Heating (preferably low-pressure) lines or tubing 4122 may be provided by the plug 4120. Cooling (preferably high-pressure) lines or tubing 4124 may also be provided by the plug 4120. A circular connector 4126 for a thermocouple or other temperature sensor may also be provided. The locking plate 4116 may be pressed by a user to release the plug or connector therefrom. An O-ring seal 4128 may facilitate a fluid-tight coupling. When the locking plate moves to release the plug, a sensor may detect this electrically, and the controller may receive a signal indicating that the plug has been removed. When this occurs, the controller may activate an automatic shut-off valve (e.g., a solenoid valve) to stop the flow of thermal fluid.

[0099] A second spring (not shown) may be provided for the button 4114. The probe side of the coupler 4100 may include a male gas coupler (nipple) 4130. The console side (i.e., the socket 4110 side) may include a corresponding female gas receiver 4132. The button may be activated by pushing the button forward (i.e., toward the right in FIG. 41 ), pushing the pin 4115 (or pins) forward, which cams or slides the plate 4116 downward and opens it. The plate then disengages from the male gas coupler, allowing the connector handle 4120 to be withdrawn. The pin 4115 on the button may drive the vertical linear movement of the locking plate 4116. A keyhole in the plate may lock onto the male gas coupler. An O-ring seal may be provided between the male gas coupler and the female gas receiver. The connector handle (4120) may form a cavity or chamber therein for exhaust gas or exhaust thermal fluid. The male gas coupler may slide into the female gas receiver. An exemplary embodiment of a console having a plug or fluid connector connected to a socket is shown in FIG. 43. The line connecting the plug or connector to the probe may be called an "umbilical." The console may be provided with one or more automatic fluid shut-off valves. The fluid shut-off valves may implement one or more solenoids or other actuators controlled by a controller. The probe is omitted from this illustration. It is understood that the embodiments described with reference to FIGS. 41-44 may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0100] An alternative embodiment of a connector or coupler system 4500 is shown in FIGS. 45-47. This embodiment 4500 is similar to the embodiment described with reference to FIGS. 41-44. However, in this embodiment, a linearly actuated lever or tab 4510 may be used to actuate a locking plate 4516. As noted above, the locking plate may lock or unlock the fluid connector or fluid coupler between the probe and console in various embodiments of the present disclosure. This embodiment may be referred to as a cryoprobe connection to a console with a linearly actuated lever. A heating (e.g., low-pressure) line 4522 may be provided. A cooling (e.g., high-pressure) line 4524 may also be provided. A handle 4520 with an exhaust chamber and exhaust line may be similar to that of FIG. 41. A circular connector 4526 for a thermocouple or other sensor may also be provided. The locking plate slides downward to release the connector, allowing it to be removed. As described above, an O-ring seal 4528 may be implemented. A lever 4510, tab, or handle may extend from the locking plate. As described above, the probe side of the connector system 4500 may include a male gas coupler (nipple) 4530. The console side may include a female gas receiver 4532 or socket. The handle or lever 4510 may be actuated by pulling down, sliding the plate downward. The plate then disengages from the male gas coupler, allowing the handle of the connector 4520 or plug to be withdrawn. A keyhole in the plate may lock onto the male gas coupler 4528. An O-ring seal may be present between the male gas coupler and the female gas receiver. The handle of the connector or plug may form a cavity or chamber therein for the exhaust fluid, and the male gas coupler may operatively slide into the corresponding female gas receiver. It will be understood that the embodiments described with reference to Figures 45-47 may include or implement one or more features of other embodiments of the present disclosure, and vice versa.

[0101] 63-67 are self-explanatory, high-level block diagrams illustrating exemplary components of a cryoablation system according to embodiments of the present disclosure. One or more functions of the system may be implemented by intelligent digital control of a controller in a console. For example, as shown in FIG. 67, multiple heaters may be implemented, each serving a different fluid supply channel leading to a different probe. Each channel and its respective heating element may be controlled, for example, by a controller controlling, for example, the voltage or duty cycle of a heating coil. One or more temperature sensors in the probe may provide temperature feedback to the controller, which may be digitally processed, for example, to more precisely control the temperature at the tip of the probe. Heating response time may also be reduced, which may be advantageous, especially in emergencies where rapid thawing or heating of the probe is required.

[0102] Multiple channels or fluid paths may be provided and each channel may be individually controlled. In an exemplary embodiment, four pressure channels may be used, with only one or two channels being used at a time to extend the life of the solenoids used.

[0103] High pressure fluid channels may be used for cooling and heating may occur via low pressure channels, which may be efficient as high pressure may be cumbersome and costly. Each needle or probe may be provided with a freezing or cooling tube and each needle or probe may be provided with a heating tube.

[0104] It may be advantageous to provide multiple induction heaters rather than a single heater with multiple solenoid valves to control the flow of heating fluid to the probe. Heaters may generally be less expensive than solenoids. Manifolds may optionally facilitate the flow of heating or cooling thermal fluid.

[0105] The foregoing description has been presented for purposes of illustration, and is not intended to be exhaustive or to limit the invention to the precise form disclosed. Those skilled in the relevant art will recognize that many modifications and variations are possible in light of the above disclosure.

[0106] The language used herein has been selected primarily for ease of reading and explanation, and not to define or limit the inventive subject matter. Accordingly, it is intended that the scope of the invention be limited not by this detailed description, but rather by the claims that appear in an application based upon this specification. Accordingly, the disclosure of embodiments of the invention is intended to be illustrative, but not limiting, of the scope of the invention, which is defined in the following claims.

[0107] Finally, throughout this specification and the appended claims, unless the context otherwise requires, the word "comprise" or variations such as "comprises" or "comprising" will be understood to mean the inclusion of a stated integer or group of integers, but not the exclusion of any other integer or group of integers.

Claims

1. a probe having a hollow body defining an inlet and an outlet, the inlet configured to receive a thermal fluid for circulation through the hollow body, and the outlet configured to expel the thermal fluid from the hollow body; a fluid delivery console remote from the probe and in fluid communication with the inlet of the probe, the fluid delivery console being arranged to provide the thermal fluid to the probe in use to enable heating or cooling by the probe, the fluid delivery console including a heating element configured to selectively heat the thermal fluid before it is provided to the inlet of the probe to enable selective heating of the probe in use; A cryoablation system comprising:

2. the system includes a controller having a processor and a memory, the memory including instructions executable by the processor for performing functions of one or more components of the system; The cryoablation system of claim 1 .

3. the fluid delivery console includes at least one valve operable between a first state and a second state, wherein in the first state the valve is configured to provide the thermal fluid to the probe for cooling, and in the second state the valve is configured to provide the thermal fluid heated by the heating element to the probe; 3. The cryoablation system of claim 1 or 2.

4. the controller is operable to automatically select the first state and / or the second state of the valve to selectively provide heating or cooling of the probe during use. The cryoablation system of claim 3 .

5. the controller is operable to control the heating element to selectively heat the thermal fluid. The cryoablation system of claim 2 .

6. the fluid supply console is arranged to provide a single type of fluid to the probe as the thermal fluid to facilitate cooling by the probe during use; The cryoablation system according to any one of claims 1 to 5.

7. the heating element is arranged to selectively heat the probe body and to selectively heat the single type of thermal fluid before the single type of fluid is provided to the probe; The cryoablation system of claim 6 .

8. the fluid supply console is configured to selectively provide a first thermal fluid for cooling the probe and a second thermal fluid for heating the probe. The cryoablation system according to any one of claims 1 to 5.

9. the heating element of the fluid delivery console is positioned to selectively heat the second thermal fluid before it is provided to the inlet of the probe. The cryoablation system of claim 8 .

10. the fluid supply console is connected to a pressurized thermal fluid supply; A cryoablation system according to any one of claims 1 to 9.

11. A fluid delivery console for use in a cryoablation system according to any preceding claim.

12. A probe for use in a cryoablation system according to any one of claims 1 to 9.

13. 1. A method of applying cryoablation therapy, comprising: providing a probe having a hollow body defining an inlet and an outlet, the inlet configured to receive a thermal fluid for circulation through the hollow body, and the outlet configured to expel the thermal fluid from the hollow body; providing a fluid delivery console remote from and in fluid communication with the inlet of the probe; operatively supplying, by the fluid supply console, the thermal fluid to the probe to enable heating or cooling by the probe; Selectively heating the thermal fluid by a heating element of the fluid supply console before the thermal fluid is provided to the inlet of the probe so as to selectively heat the probe during use. A method comprising:

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