System and method for tumor ablation using a multi-probe integrated electrothermal module (ETM) device

Abstract

A system and method for ablation of a tumor using a tumor ablation probe device with a controlled precision temperature distribution may include deploying a distal end of the tumor ablation probe device in tissue, the distal end including a plurality of electrothermal modules (ETMs) on one or more probe arms, each ETM including a first surface component electrically connected to a second surface component; supplying a first voltage having a first polarity or a second voltage having an opposite second polarity to at least one of the plurality of ETMs, and repeatedly alternating between the first polarity and the second polarity based on a timing cycle. When the first polarity is supplied, at least one ETM heats the first surface component and cools the second surface component, and when the second polarity is supplied, at least one ETM cools the first surface component and heats the second surface component. Each ETM and / or probe arm is configured to be independently controlled by a circuit controller.

Description

Technical Field

[0001] The present specification relates generally to medical devices for treating cancer and, more particularly, to medical devices configured and operable to ablate a tumor in a treatment region within a patient to achieve tumor necrosis. Background Art

[0002] Common treatments used to address tumor growths include invasive surgical resection techniques and minimally invasive ablation techniques. Radiofrequency (RF) therapy is a recognized ablative technique. In general, RF therapy may encounter difficulties when attempting to completely destroy the tumor. In addition, RF therapy may result in imprecisely defined tumor margins that may affect tissue areas outside the ablation target site, such as heat transfer to surrounding healthy tissue areas, and other potential complications related to probe placement within the disease area. Other treatment methods that result in direct (thermal) or indirect thermal (microwave) ablation may present similar complications.

[0003] Therefore, there is a need for tumor ablation systems and methods that can precisely control the temperature distribution of the affected area to enhance tumor necrosis while maintaining good tumor margins to eliminate unhealthy tissue relative to the affected area, thereby avoiding external areas. Summary of the invention

[0004] In one embodiment, a system for ablation of a tumor using a tumor ablation probe device with a controlled precision temperature distribution may include a tumor ablation probe device, and a circuit controller communicatively coupled to the tumor ablation probe device and a non-transient computer storage medium. The distal end may include a plurality of electrothermal modules (ETMs) disposed proximally on the surface of the device. Each ETM may include a first surface component and a second surface component opposite to the first surface component and electrically connected to the first surface component. The non-transient computer storage medium stores instructions that, when executed by the circuit controller, cause the system to supply one of a first voltage having a first polarity and a second voltage having a second polarity opposite to the first polarity to at least one ETM in the plurality of ETMs via the circuit controller, and to repeatedly alternate between the first polarity and the second polarity based on a timing cycle via the circuit controller. When the first polarity is supplied, at least one ETM heats the first surface component and cools the second surface component. When the second polarity is supplied, at least one ETM cools the first surface component and heats the second surface component. Each ETM may be configured to be independently controlled by the circuit controller.

[0005] In another embodiment, a method for ablation of a tumor using a tumor ablation probe device with a controlled precision temperature distribution may include deploying a distal end of the tumor ablation probe device in tissue, the distal end including a plurality of electrothermal modules (ETMs) proximally deployed on the surface of the device. Each ETM may include a first surface component and a second surface component opposite to the first surface component and electrically connected to the first surface component. The method may also include supplying one of a first voltage having a first polarity and a second voltage having a second polarity opposite to the first polarity to at least one ETM in the plurality of ETMs via a circuit controller communicatively coupled to the tumor ablation probe device. When the first polarity is supplied, at least one ETM heats the first surface component and cools the second surface component, and when the second polarity is supplied, at least one ETM cools the first surface component and heats the second surface component. The method may also include repeatedly alternating between the first polarity and the second polarity using a timing cycle via the circuit controller. Each ETM may be configured to be independently controlled by the circuit controller.

[0006] In another embodiment, a method for ablation of a tumor with a controlled precision temperature distribution using a tumor ablation probe device may include deploying a distal end of the tumor ablation probe device in a tissue, the distal end including at least one electrothermal module (ETM) on a first probe arm and at least one ETM on a second probe arm, and supplying one of a first voltage having a first polarity and a second voltage having a second polarity opposite to the first polarity to at least one ETM on the first probe arm, at least one ETM on the second probe arm, or both, as one or more voltage-supplied ETMs via a circuit controller communicatively coupled to the tumor ablation probe device. Each ETM may include a first surface component and a second surface component opposite to the first surface component and electrically connected to the first surface component. When the first polarity is supplied, one or more voltage-supplied ETMs heat the first surface component and cool the second surface component, respectively. When the second polarity is supplied, one or more voltage-supplied ETMs cool the first surface component and heat the second surface component, respectively. The method may also include repeatedly alternating between the first polarity and the second polarity using a timing cycle via the circuit controller. Each of the first probe arm and the second probe arm may be configured to be independently controlled by the circuit controller.

[0007] These and additional features provided by the embodiments described herein will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The embodiments illustrated in the drawings are illustrative and exemplary in nature and are not intended to limit the subject matter defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, in which similar structures are indicated by similar reference numerals and in which:

[0009] Figure 1 is a side perspective view of a tumor ablation probe device having multiple probes including an integrated electrothermal module (ETM) according to one or more embodiments shown and described herein;

[0010] Figure 2 According to one or more embodiments shown and described herein Figure 1 A side view of a tumor ablation probe device for treating a tumor;

[0011] Figure 3 According to one or more embodiments shown and described herein Figure 1 A side elevation view of an embodiment of a tumor ablation probe device;

[0012] Figure 4 is a side view of another embodiment of a catheter of another tumor ablation probe device including a balloon opening according to one or more embodiments shown and described herein;

[0013] Figure 5 is a side view of a needle with a balloon according to one or more embodiments shown and described herein, the balloon including Figure 4 ETM used with catheters;

[0014] Figure 6 is a side view of another tumor ablation probe head device including a needle having an integrated ETM mounted thereon according to one or more embodiments shown and described herein;

[0015] Figure 7 is a side view of another tumor ablation probe head device including a ribbed cone with an integrated ETM according to one or more embodiments shown and described herein;

[0016] Figure 8 is a side view of a catheter according to one or more embodiments shown and described herein, the catheter including an opening, Figure 7 The ribbed cone is configured to expand or retract from the opening;

[0017] Fig. 9 is a perspective view of an integrated electric thermal module (ETM) according to one or more embodiments shown and described herein;

[0018] Fig.10 is the use of one or more embodiments shown and described herein Figure 1-9 A flowchart of a process of a tumor ablation probe device system;

[0019] Fig.11 is the use of one or more embodiments shown and described herein Figure 1-9 A flowchart of another process of a tumor ablation probe device system; and

[0020] Fig.12 Schematically illustrates a method for implementing a computer and software based method to utilize a Figure 1-9 A system of tumor ablation probe device systems. DETAILED DESCRIPTION

[0021] Referring generally to the drawings, embodiments of the present disclosure relate to systems and methods for tumor ablation using a tumor ablation probe device as described herein. Various embodiments of such systems and methods are described in detail herein.

[0022] Tumor ablation is a minimally invasive procedure that can be used to treat tumors such as liver, lung, kidney and bone. During tumor ablation, thermal energy is used to heat or cool surrounding tissue to cytotoxic levels, such as below -40 degrees Celsius or above 60 degrees Celsius. Tumor ablation can use modes such as radiofrequency (RF), heat, microwaves, chemotherapy, interventional radiology, lasers, high-intensity focused ultrasound, local radiation, cryoablation using extreme cold to destroy tissue associated with the tumor (e.g., causing tissue necrosis) and irreversible electroporation. This treatment may not achieve complete tumor destruction, especially when the tumor margins are not clearly defined. In addition, ablation of surrounding healthy tissue may cause complications.

[0023] For the tumor ablation probe device described herein, an electrothermal module (ETM) is integrated at the distal end of the probe or catheter, and via thermal modulation (e.g., switching between heating / cooling of the same device), tumor necrosis is achieved within the modulated tumor ablation margin. The ETM can be integrated on multiple probes housed within an overall needle / probe design. This individual, individually movable, individually controlled probe is advanced into the tumor, and when activated, a cycle of heat and cryotherapy is initiated, thereby causing tumor necrosis within precise tumor margins.

[0024] The ETM can be a thermoelectric generator, such as a Seebeck generator. A Seebeck generator converts a temperature difference directly into electrical energy (e.g., through the Seebeck effect phenomenon, in which a temperature difference between two electrically connected junctions generates an electromagnetic force between the junctions). A Seebeck generator can operate in reverse, so that applying a voltage to the device can cause it to act as a heater or a cooler, depending on the magnitude and polarity of the voltage (e.g., through the Peltier effect phenomenon, in which a voltage applied across two electrically connected junctions generates a temperature difference between the junctions).

[0025] The ETM integrated devices included in the devices, systems and methods described herein can precisely control the amount of heat generated and provide rapid heat / cooling cycles directly to the tumor to enhance tumor necrosis while maintaining tumor margins through precise temperature control of the focus area while minimizing the risk to surrounding healthy tissue. The tumor ablation probe device described herein may include a plurality of independently movable and controllable probe arms, each probe arm including one or more ETMs made of pn pairs and associated circuit systems configured to repeatedly alternate between hot and cold to induce tumor necrosis within a precise temperature control range (e.g., by as described below with respect to Fig.12 Processor 704 described in more detail). For example, the ETM can be placed around the probe arms of the probe device, which can be extended into the tumor area separately. In embodiments, the ETMS can be spaced around the probe arms of the probe device, integrated into the probe arms of the probe device, or a combination thereof. The handle can track the depth of insertion of the probe into the tumor.

[0026] refer to Figure 1 , the tumor ablation probe device 100 includes a probe 102 having a middle surface 104, a distal end 106, and a proximal end 108. The distal end 106 includes a tip 110 configured to penetrate into a tumor. The middle surface 104 includes a plurality of openings 114 defined thereon. Although the plurality of openings 114 are shown as being concentrically and evenly spaced around the middle surface 104, the plurality of openings 114 may be deployed at uneven and / or staggered positions around the middle surface 104. Alternatively, the tumor ablation probe device 100 may include one opening 114. The proximal end 108 includes a plurality of holes 112 configured to receive and accommodate a corresponding plurality of probe arms 116. Each probe arm 116 is respectively configured to extend or retract from each opening 114 of the middle surface 104 individually and / or independently.

[0027] Each probe arm 116 includes one or more integrated electrothermal modules (ETMs) 118. Each probe arm 116 may include a distal piercing portion configured to penetrate a portion of a tumor. In embodiments, the tumor ablation probe device 100 may be semi-rigid, rigid, catheter-based, or a similar type controlled via a handheld device including a controller circuit configured to switch the polarity of input power provided to the integrated ETM 118 (e.g., as described below with respect to Fig.12 The processor 704 described in more detail). This repetitively changing polarity switching over a predetermined timing cycle corresponds to and affects a predetermined cycle of heating and cooling cycles of the ETM 118 introduced into the tumor site in a minimally invasive manner to cause tissue necrosis. The tumor ablation probe device 100 can be battery powered and / or can utilize a voltage supply to provide input power.

[0028] refer to Figure 2 , the tumor ablation probe device 100 is shown being advanced into a tumor 124 at a tumor site 125. The tumor ablation probe device 100 also includes a handle 120 that includes a metric display component 122 to track the advancement of a probe arm 116 including an ETM 118 into or retracting from the tumor 124 when the tip 110 is deployed within the tumor 124. The metric display component 122 can measure such advancement in centimeters, millimeters, inches, or other common length units. Thus, the metric display component 122 provides a measurement system that can be associated with each individual probe arm 116 to determine the length that the probe arm 116 has been extended or retracted. In an embodiment, one or more metric display components 122 can be included on the tumor ablation probe device 100. By way of example and not limitation, each probe arm 116 can include a corresponding metric display component 122.

[0029] refer to Figure 3 , shows an embodiment of a tumor ablation probe device 100', which is similar to the tumor ablation probe device 100 except for the differences described herein. The tumor ablation probe device may include a plurality of openings 114, including staggered openings 114A and 114B. In an embodiment, the tumor ablation probe device 100' includes an opening at the proximal end 108, the opening having a diameter 130 of 6.0 mm and a wall thickness 132 of 1.0 mm. The opening having the diameter 130 of the probe device 100' extends into the probe device 100' as an inner cavity, which also includes a diameter of 6.0 mm. The tumor ablation probe device 100' also includes a first half 134 and a second half 144 of the middle surface 104 separated along the longitudinal axis. The staggered openings 114A and 114B include opening lengths 136, 140, respectively, which can each be 4.5 mm and staggered at a distance 138 of 2.0 mm between the proximal ends. The corresponding probe arms 116 ( Figure 2 ) can be configured to extend through corresponding staggered openings 114A, 114B. The staggered openings 114A, 114B can be longitudinally staggered, angularly staggered, axially staggered, radially staggered, or a combination thereof. The staggered openings 114A, 114B can be angularly offset from each other, such as by 180 degrees. The staggered openings 114A, 114B can be configured to have a size that is less than half of the circumference of the probe device 100'. In an embodiment, the staggered openings 114B closest to the distal end 106 are spaced a distance 142 of 10 mm from the starting point of the tip 110 of the distal end 106. The tumor ablation probe device 100' may include a length 146 of 200 mm between the proximal end 108 and the tip 110 of the distal end 106.

[0030] refer to Figure 4 and Figure 5, the ETM 118 is attached to a balloon 230 that is configured to expand outward through a corresponding balloon opening 214 of the tumor ablation probe device 200. Figure 4 The tumor ablation probe device 200 shown in FIG. 1 includes a probe 202 for enclosing a Figure 5 The needle 216 is a needle (e.g., as an embodiment of a probe arm). It should be understood that references to the needle within the present disclosure are references to the probe arm described herein, as the needle is an embodiment of a probe arm. The needle 216 includes a plurality of balloons 230 on which one or more ETMs 118 are deployed. Figure 5 In the embodiment of the present invention, six balloons 230 are shown evenly deployed on opposite sides, but it should be understood that different numbers of balloons and / or balloons with different spacings may be used within the scope of the present disclosure. In an embodiment, approximately two to five ETMs 118 may be placed at different locations on each balloon 230. The needle 216 may be made of stainless steel. The probe 202 may alternatively be a catheter. The probe 202 may be made of stainless steel.

[0031] The probe 202 includes an intermediate surface 204 disposed between a distal end 206 of the probe 202 and a proximal end 208 of the probe 202. The intermediate surface 204 includes a plurality of balloon openings 214, the size and shape of which allow each corresponding balloon 230 of the needle 216 to be advanced and / or retracted. The distal end 206 includes a tip 210 extending from the intermediate surface 204. The needle housing opening 211 is defined by an edge of the intermediate surface 204 and at least a portion of the tip 210 and extends as a lumen between the distal end 206 and the proximal end 208. The needle housing opening is configured to accommodate the needle 216 in a position such that the plurality of balloons 230 are aligned with the corresponding plurality of balloon openings 214. In embodiments, the tip of the needle 216 may extend beyond the end of the tip 210, may move within the needle housing opening 211, may remain within the needle housing opening 211, or a combination thereof.

[0032] During use, the tumor ablation probe device 200 is advanced into a tumor at a tumor site. When the balloon 230 is inflated under pressure, the balloon 230 is advanced through the corresponding balloon opening 214, and the ETM 118 on each balloon 230 thus protrudes through the plurality of balloon openings 214 together with the balloon 230 to be located flush with the tumor at the tumor site. As described in more detail below, electrical energy is supplied to the ETM 118 so that the ETM 118 is treated by a heating / cooling cycle that is manually, automatically, or partially automatically controlled. This localized heating / cooling results in necrosis of the tumor or tissue that the ETM 118 directly contacts in a precisely controlled manner within the desired tumor margin. Thus, precise control of the temperature distribution of the affected tumor site can be achieved by the tumor ablation probe device described herein, such as the tumor ablation probe device 200. The tumor ablation probe device described herein is suitable for minimally invasive use to further effectively provide precisely controlled tumor necrosis. When the pressure is released, the plurality of balloons 230 deflate to retract into the plurality of balloon openings 214 along with the ETM 118 .

[0033] refer to Figure 6 In another embodiment, the ETM 118 is mounted adjacent to the needle 316 and proximate to the distal end 306 of the tumor ablation probe device 300. When the tumor ablation probe device 300 is advanced into the tumor so that the ETM is positioned flush with the tumor, energy supplied to the ETM 118 provides a heating / cooling cycle as further described below to induce tumor necrosis.

[0034] refer to Figure 7 and Figure 8 , the ETM 118 is mounted on a ribbed cone 440 that is configured to expand or retract from an opening 460 of a catheter 402 (e.g., as an embodiment of a probe) of a tumor ablation probe device 400 at a distal end 406. In embodiments, the ETM 118 may be mounted on an outer surface of the ribbed cone 440, on an inner surface of the ribbed cone 440, extend through an opposing surface of the ribbed cone 440, or a combination thereof. Figure 7 As shown in FIG. 4 , a ribbed cone 440 is disposed at the distal end of a needle 416, which is configured to be Figure 8 Slide inside the catheter 402.

[0035] refer to Fig. 9, an exemplary ETM 118 is illustrated. The ETM 118 includes a first surface component 150 and a second surface component 152 opposite to the first surface component 150. The first surface component 150 and the second surface component 152 may be made of ceramic or other suitable conductive materials. An electrical junction such as a pn pair is disposed between the first surface component 150 and the second surface component 152 to power the surface components 150, 152 by sending current to the circuit system of the surface components 150, 152. In an embodiment, the ETM 118 is a semiconductor module including a pn pair 154 as an electrical junction. The pn pair is configured so that a supplied first polarity causes heating of one side / surface area such as the first surface component 150 and cooling of the other side such as the second surface component 152, and a supplied second polarity opposite to the first polarity causes, for example, cooling of the first surface component 150, and, for example, heating of the second surface component 152. Such a pn pair 154 is electrically connected to the surface components 150, 152 by an interface connection including a p-type semiconductor material and an n-type semiconductor material, and in the present disclosure, the interface allows current to pass in a direction controlled by the associated polarity. In an embodiment, a circuit system can be used to control the cycle and temperature range of heating and cooling. As an example and not limitation, the first surface component 150 can be heated to a temperature from about 45 degrees Celsius to about 50 degrees Celsius, while the second surface component 152 is cooled. In an embodiment, the second surface component can be cooled to about -10 degrees Celsius. Then, the polarity can be reversed to cool the first surface component to about -10 degrees Celsius and heat the second surface component 152. In an embodiment, the second surface component 152 can be heated to a temperature from about 45 degrees Celsius to about 50 degrees Celsius. Then the polarity can be reversed again to heat the first surface component 150 to a temperature from about 45 degrees Celsius to about 50 degrees Celsius while cooling the second surface component 152. The polarity can be reversed any number of times sufficient to provide the desired clinical results. Polarity reversals may occur at a frequency of a timing cycle determined by an operator to provide a desired clinical outcome. In an example embodiment, polarity reversals may occur at a frequency of a timing cycle defined by a switching period of approximately 2 seconds between each polarity reversal.

[0036] The tumor ablation probe device described herein includes a controller circuit configured to switch the polarity of input power directed to the ETM 118, such as via a relay or switch board, to control the temperature distribution by controlled repeated alternation between heating and cooling cycles. The controller circuit is configured to control the predetermined cycle of heating and cooling on the ETM 118 introduced to the tumor site to cause a desired clinical result, such as tissue / tumor necrosis of the area contacted by the ETM 118 through, for example, heating / cooling cycle switching. The controller circuit can be pre-programmed or manually controlled to switch the polarity of the input voltage delivered to the ETM 118, thereby producing corresponding predetermined heating and cooling cycles on the opposing surface components 150, 152 of the ETM 118. The ETM 118 can be individually controlled and set to output different temperatures at each ETM 118 based on the received input voltage polarity supplied by the controller circuit. Therefore, tumor ablation within a predetermined threshold range of a desired tumor area can be achieved on the temperature distribution of the ETM 118 to obtain tumor ablation at the tumor edge within a predetermined threshold range with respect to a specific tumor location, thereby resulting in controlled local tumor ablation at the controlled tumor edge.

[0037] In an embodiment, the switch is configured to cause a change in the polarity of the provided voltage. In an embodiment, for example, a positive +5V input can be switched to a negative -5V input, for example, after a controlled timing cycle. It is contemplated and within the scope of the present disclosure that other voltage amplitudes are possible. It is further contemplated and within the scope of the present disclosure that the polarity switching can be switched between different voltage amplitudes rather than between opposite polarities of the same voltage amplitude. The resulting temperature of the first surface component 150 or the second surface component 152 of the ETM 118 is based at least in part on the voltage amplitude. The controlled timing cycle can be in the range of about every 2 seconds to about every 5 seconds. In this case, the positive +5V causes the ETM 118 to heat the first surface component 150 to provide heating to the tumor, and causes the ETM 118 to heat the second surface component 152 to provide cooling to the tumor, while the negative -5V causes the ETM 118 to cool the first surface component 150 to provide cooling to the tumor and causes the ETM 118 to heat the second surface component 152 to provide heating to the tumor.

[0038] The tumor ablation probe devices 100, 200, 300, 400 as described herein may include a probe arm, such as a needle, catheter, or hypotube. The various components of the tumor ablation probe device, such as the probes 102, 202, 402 and probe arms 116, 216, 316, 416 described herein, may be made of metal, metal alloys, polymers, 3D printed materials, or combinations thereof. The base probe of the tumor ablation probe device may include multi-layer ETM 118 branches along the length and / or around the circumference, such as for Figure 1The probe arm 116 is shown. The tumor ablation probe device can be disposable or non-disposable. The tumor ablation probe device can be battery-powered, so that power is provided via an internal battery and / or via an external electrical component to supply a voltage electrically coupled to the tumor ablation probe device.

[0039] The tumor ablation probe device as described herein is configured to precisely control the heat generated and provide a rapid heating / cooling cycle. This configuration enhances tumor necrosis while maintaining good tumor margins. For example, the area of ​​tumor tissue to which such rapid heating / cooling is applied via the corresponding ETM 118 as described herein is based on providing the heating / cooling while the surface area of ​​the first surface component 150 or the second surface component 152 of the ETM 118 disposed in and flush with the affected tissue is affected. The amount or amplitude and polarity of the voltage supplied to the first surface component 150 or the second surface component 150 of the corresponding ETM 118 and the configuration of one or more pn pairs disposed between the first surface component 150 and the second surface component 150 of the corresponding ETM 118 as described herein are parameters that contribute to the rapid heating / cooling cycle to cause tumor necrosis within the desired tumor margin. Therefore, the device described herein provides precise temperature control by controlling at least the amplitude and direction of the voltage applied to the ETM 118 of the device and increasing the accuracy of the lethal tumor necrosis zone area due to such precise temperature control. The resulting region of the lethal tumor necrosis interval is determined at least in part by a temperature profile established by precise temperature control, which is controlled by the amplitude and polarity of the voltage applied to the ETM 118 during the timing cycle and includes repeated alternations between voltage polarities. As described herein, the controlled temperature profile is applied to the tumor via one or more ETMs 118 to accurately induce lethal tumor necrosis in the interval region within the precise tumor margin. This increased accuracy more effectively ablates the tumor within the desired interval region without ablating undesired areas that may be located near the desired interval region. The increased precision allows for repeatability of these results within tight margins of error.

[0040] Fig.10 The diagram is related to this article Figure 1-9The process 500 for use with the tumor ablation probe device 100, 100', 200, 300, 400 described herein. The process 500 includes a method for ablation of a tumor using the tumor ablation probe device 100, 100', 200, 300, 400 with a temperature distribution of controlled precision. In block 502, the distal end 106, 206, 306, 406 of the tumor ablation probe device 100, 100', 200, 300, 400 is deployed in tissue 124. By way of example and not limitation, the distal end 106, 206, 306, 406 includes or includes at least two electrothermal modules (ETMs) 118 of a plurality of ETMs on a surface of the device at the proximal end, each ETM 118A and 118B ( Figure 1 ) includes a first surface component 150 and a second surface component 152 (opposite to the first surface component 150 and electrically connected to the first surface component 150) Fig. 9 ).

[0041] In block 504, one of a first voltage having a first polarity and a second voltage having a second polarity opposite to the first polarity is supplied to at least one ETM 118A or 118B of the plurality of ETMs 118 via a circuit controller communicatively coupled to the tumor ablation probe device 100, 100', 200, 300, 400. In an embodiment, when the first polarity is supplied, the at least one ETM heats the first surface component 150 and cools the second surface component 152, and when the second polarity is supplied, the at least one ETM cools the first surface component 150 and heats the second surface component 152. Each ETM 118 may be configured to be independently controlled by the circuit controller.

[0042] In blocks 506, 506', the other of the first voltage of the first polarity and the second voltage of the second polarity is supplied to at least one ETM 118A or 118B of the plurality of ETMs 118 via a circuit controller to repeatedly alternate between polarities by switching polarity based on a timing cycle. In blocks 508, 508', the voltage is switched to the other of the first voltage of the first polarity and the second voltage of the second polarity relative to the corresponding first or second ETM 118A, 118B based on the timing cycle. In an embodiment, the timing cycle may include a first timing cycle associated with a heating phase of the ETM 118 and a second timing cycle associated with a cooling phase of the ETM 118 and different from the first timing cycle. In either embodiment, whether the first timing cycle is the same as or different from the second timing cycle, the process 500 includes switching between the first polarity and the second polarity via the circuit controller based on the timing cycle. As a non-limiting example, the timing cycle is in the range of about 2 seconds to about 5 seconds, and when the first polarity is supplied, the at least one ETM 118A heats the first surface component 150 to a range of about 45 degrees Celsius and about 50 degrees Celsius and cools the second surface component 152. The second surface component 152 may be cooled to about -10 degrees Celsius. When the second polarity is supplied, the at least one ETM 118A cools the first surface component 150 to about -10 degrees Celsius and heats the second surface component 152. The second surface component 152 may be heated to a range between about 45 degrees Celsius and about 50 degrees Celsius.

[0043] The distal end 106, 206, 306, 406 may include or proximally include at least one ETM 118A on the first probe arm 116A and at least one ETM 118A on the second probe arm 116B ( Figure 1 ), and each of the first probe arm 116A and the second probe arm 116B can be configured to be independently controlled by the circuit controller. In an embodiment, the ETM 118 on the same probe arm 116 can be independently controlled and / or the ETM 118 on different probe arms 116 (such as the first and second probe arms 116A, 116B) can be independently controlled. The first polarity can be positive so that the second polarity is negative. Alternatively, the first polarity can be negative so that the second polarity is positive. The first voltage can be equal to the second voltage, or the first voltage can be different from the second voltage.

[0044] In an embodiment, one of a first voltage having a first polarity and a second voltage having a second polarity is supplied to one ETM 118A, 118B as an ETM to which voltage is supplied among the plurality of ETMs 118, but not supplied to another ETM 118A, 118B as an ETM to which voltage is removed. Therefore, the supplied ETM heats or cools the corresponding first or second surface part 150, 152 based on the polarity of the supplied voltage as described herein, while the ETM to which voltage is removed provides neither heating nor cooling to the corresponding first or second surface part 150, 152.

[0045] The first surface component 150 can be electrically connected to the second surface component 152 through a pn pair 154. The pn pair 154 includes a p-type semiconductor in which the charge carriers in the material are positive "holes" and an n-type semiconductor material in which the charge carriers in the material are negative electrons. The current flow can be controlled in direction based on the polarity of the applied voltage. As an example and not limitation, the pn pair 154 includes an n-type semiconductor material connected to a p-type semiconductor material so that a positive voltage causes the ETM 118 to which the positive voltage is supplied to heat one of the first surface component 150 and the second surface component 152, while a negative voltage supplied to the ETM 118 alternately causes the ETM 118 to heat the other of the first surface component 150 and the second surface component 152.

[0046] Fig.11 A process 600 is illustrated for use with the tumor ablation probe device 100, 100', 200, 300, 400 described herein. The process 500 includes another method for ablation of a tumor using the tumor ablation probe device 100, 100', 200, 300, 400 with a controlled precision temperature distribution. In block 602, the distal end 106, 206, 306, 406 of the tumor ablation probe device 100, 100', 200, 300, 400 is deployed in the tissue 124. By way of example and not limitation, the distal end 106, 206, 306, 406 includes at least one ETM 118A on a first probe arm 116A and at least one ETM 118B on a second probe arm 116B, each ETM 118A and 118B ( Figure 1 ) includes a first surface component 150 and a second surface component 152 (opposite to the first surface component 150 and electrically connected to the first surface component 150) Fig. 9 ).

[0047] In block 604, one of a first voltage having a first polarity and a second voltage having a second polarity opposite to the first polarity is supplied to at least one ETM 118A on the first probe arm 116A, at least one ETM 118B on the second probe arm 116B, or both via a circuit controller communicatively coupled to the tumor ablation probe device 100, 100', 200, 300, 400. In an embodiment, the first polarity is configured to heat the first surface component 150 and cool the second surface component 152, and the second polarity is configured to cool the first surface component 150 and heat the second surface component 152. Each probe arm 116, such as the first probe arm 116A and the second probe arm 116B, may be configured to be independently controlled by the circuit controller.

[0048] In blocks 606, 606', the other of the first voltage of the first polarity and the second voltage of the second polarity is supplied to at least one ETM 118A on the first probe arm 116A, at least one ETM 118B on the second probe arm 116B, or both via a circuit controller as one or more ETMs supplied with voltage to repeatedly change and switch polarity based on a timing cycle. In blocks 608, 608', the voltage is again switched to the other of the first voltage of the first polarity and the second voltage of the second polarity relative to the corresponding first or second ETM 118A, 118B using the timing cycle. Process 600 involves repeated changes between the first polarity and the second polarity using the timing cycle via the circuit controller.

[0049] In an embodiment, each ETM 118 may be configured to be independently controlled by a circuit controller, the first polarity is one of positive and negative, the second polarity is the other of positive and negative, and / or the first voltage may be equal to or different from the second voltage.

[0050] refer to Fig.12 , illustrating a method for implementing a computer and software based method to utilize Figure 1-9 Tumor ablation probe equipment and Figure 10-11 The system 700 of the process of performing a tumor ablation probe device 712 is provided, and the system 700 can be implemented together with a graphical user interface (GUI) accessible at a user workstation (e.g., computer 724). The system 700 includes a communication path 702, one or more processors 704, a memory component 706, a tumor ablation probe device 712 which can be any of the tumor ablation probe devices 100, 100', 200, 300, 400 described herein, a storage device or database 714, a switching component 716, a network interface hardware 718, a server 720, a network 722, and at least one computer 724. The various components of the system 700 and their interactions will be described in detail below.

[0051] In some embodiments, system 700 is implemented using a wide area network (WAN) or network 722, such as an intranet or the Internet, or other wired or wireless communication network that may include cloud computing-based network configurations. Workstation computer 724 may include digital systems and other devices that allow connection to and navigation of a network. Figure 7 The lines depicted in the drawings indicate communications between the various components rather than physical connections.

[0052] As described above, system 700 includes communication path 702. Communication path 702 can be formed by any medium capable of transmitting signals, such as, for example, a wire, a conductive trace, an optical waveguide, or other medium capable of transmitting signals, or a combination of media capable of transmitting signals. Communication path 702 communicatively couples various components of system 700. As used herein, the term "communicatively coupled" means that the coupled components are capable of exchanging data signals with each other, such as, for example, electrical signals via a conductive medium, electromagnetic signals via air, optical signals via an optical waveguide, or other data signals via a corresponding data signal exchange medium.

[0053] As previously described, system 700 includes processor 704. Processor 704 can be any device capable of executing machine-readable instructions. Therefore, processor 704 can be a controller, such as a circuit controller, an integrated circuit, a microchip, a computer, or any other computing device described herein. Processor 704 is communicatively coupled to other components of system 700 via communication path 702. Therefore, communication path 702 can communicatively couple any number of processors to each other and allow modules coupled to communication path 302 to operate in a distributed computing environment. Specifically, each module can operate as a node that can send and / or receive data. Processor 704 can process input signals received from system modules and / or extract information from these signals.

[0054] As previously described, the system 700 includes a memory component 706 coupled to the communication path 702 and communicatively coupled to the processor 704. The memory component 706 may be a non-transitory computer-readable medium or a non-transitory computer-readable memory, and may be configured as a non-volatile computer-readable medium. The memory component 706 may include a RAM, a ROM, a flash memory, a hard drive, or any device capable of storing machine-readable instructions so that the machine-readable instructions can be accessed and executed by the processor 704. The machine-readable instructions may include logic or (one or more) algorithms written in any programming language, such as, for example, a machine language that can be directly executed by a processor, or an assembly language, object-oriented programming (OOP), a scripting language, a microcode, etc. that can be compiled or assembled into machine-readable instructions and stored on the memory component 706. Alternatively, the machine-readable instructions may be written in a hardware description language (HDL), such as logic implemented via a field programmable gate array (FPGA) configuration or an application-specific integrated circuit (ASIC) or its equivalent. Therefore, the methods described herein may be implemented in any conventional computer programming language, as a pre-programmed hardware element, or as a combination of hardware and software components. In an embodiment, system 700 may include a processor 704 communicatively coupled to a memory component 706 storing instructions that, when executed by processor 704, cause the processor to perform one or more functions as described herein.

[0055] Still reference Fig.12 As previously described, the system 700 includes a display such as a GUI on a screen of a computer 724 for providing visual output such as, for example, information, graphical reports, messages, or a combination thereof. The computer 724 may include one or more cross-platform computing devices, or may be communicatively coupled to cross-platform devices, such as mobile smart devices including smart phones, tablets, laptops, and / or other smart devices. The display may include any medium capable of transmitting light output, such as, for example, a cathode ray tube, a light emitting diode, a liquid crystal display, a plasma display, or other light output transmission medium. In addition, note that the display or computer 724 may include at least one of a processor 704 and a memory component 706. Although the system 700 is Fig.12 is shown as a single integrated system, but in other embodiments, the systems may be independent systems.

[0056] The system 700 includes a tumor ablation probe device 712 for causing tumor necrosis via one or more ETMs 118 as described herein, and a switch component 716 for causing heating and cooling cycles to power the ETMs 118 to act to apply thermal energy to tissue through a timed cycle, thereby causing repeated changes between voltage polarities to affect heat distribution and thereby enhance tumor necrosis. The tumor ablation probe device 712 and the switch component 716 are coupled to the communication path 702 and are communicatively coupled to the processor 704. As will be described in further detail below, the processor 704 can process input signals received from system modules and / or extract information from such signals.

[0057] The system 700 includes network interface hardware 718 for communicatively coupling the system 700 to a computer network such as network 722. The network interface hardware 718 is coupled to the communication path 702 so that the communication path 702 communicatively couples the network interface hardware 718 to other modules of the system 700. The network interface hardware 718 can be any device capable of transmitting and / or receiving data via a wireless network. Thus, the network interface hardware 718 can include a communication transceiver for sending and / or receiving data according to any wireless communication standard. For example, the network interface hardware 718 can include a chipset (e.g., an antenna, a processor, machine-readable instructions, etc.) to communicate via a wired and / or wireless computer network (such as, for example, Wireless Fidelity (Wi-Fi), WIMAX, Bluetooth, IRDA, Wireless USB, Z-WAVE, ZIGBEE, or other chipsets).

[0058] Still reference Fig.12 , data from various applications running on the computer 724 can be provided from the computer 724 to the system 700 via the network interface hardware 318. The computer 724 can be any device having hardware (e.g., a chipset, a processor, a memory, etc.) for communicatively coupling with the network interface hardware 718 and the network 722. In particular, the computer 724 can include an input device having an antenna for communicating over one or more of the wireless computer networks described above.

[0059] The network 722 may include any wired and / or wireless network, such as, for example, a wide area network, a metropolitan area network, the Internet, an intranet, a cloud, a satellite network, or other network. Thus, the network 722 may be used by the computer 724 as a wireless access point to access one or more servers (e.g., server 720). The server 720 and any additional servers typically include a processor, memory, and chipset for delivering resources via the network 722. Resources may include, for example, processing, storage, software, and information provided from the server 720 to the system 700 via the network 722. In addition, it is noted that the server 720 and any additional servers may share resources with each other via the network 722, such as, for example, via a wired portion of the network, a wireless portion of the network, or a combination thereof.

[0060] Project List

[0061] Item 1. A system for ablation of a tumor using a tumor ablation probe device with a controlled precision temperature distribution may include a tumor ablation probe device having a distal end, the distal end including a plurality of electrothermal modules (ETMs) disposed on a surface of the device at a proximal end, each ETM including a first surface component and a second surface component opposite to and electrically connected to the first surface component. The system may also include a circuit controller communicatively coupled to the tumor ablation probe device and a non-transitory computer storage medium. The non-transitory computer storage medium stores instructions that, when executed by the circuit controller, may cause the system to supply one of a first voltage having a first polarity and a second voltage having a second polarity opposite to the first polarity to at least one ETM of the plurality of ETMs via the circuit controller, and to repeatedly alternate between the first polarity and the second polarity using a timing cycle via the circuit controller. When the first polarity is supplied, the at least one ETM heats the first surface component and cools the second surface component. When the second polarity is supplied, the at least one ETM cools the first surface component and heats the second surface component, and each ETM may be configured to be independently controlled by the circuit controller.

[0062] Item 2. The system described in Item 1, wherein the non-transitory computer storage medium stores further instructions which, when executed by the circuit controller, cause the system to supply one of a first voltage having a first polarity and a second voltage having a second polarity to at least one ETM among the multiple ETMs without supplying it to at least one other ETM among the multiple ETMs.

[0063] Item 3. A system as described in any of Items 2-3, wherein the distal end includes at least one ETM of the multiple ETMs on the first probe arm and at least one ETM of the multiple ETMs on the second probe arm, and each of the first probe arm and the second probe arm is configured to be independently controlled by a circuit controller.

[0064] Item 4. The system of any one of Items 1-3, wherein the first polarity is positive and the second polarity is negative.

[0065] Item 5. The system of any one of Items 1-3, wherein the first polarity is negative and the second polarity is positive.

[0066] Item 6. The system of any one of Items 1-5, wherein the first voltage is equal to the second voltage.

[0067] Item 7. The system of any one of Items 1-5, wherein the first voltage is different from the second voltage.

[0068] Item 8. The system of any one of Items 1-7, wherein the timing cycle is about 2 seconds to about 5 seconds.

[0069] Item 9. A system as described in any of Items 1-8, wherein when the first polarity is supplied, the at least one ETM heats the first surface component to a range from about 45 degrees Celsius to about 50 degrees Celsius, and when the second polarity is supplied, the at least one ETM cools the first surface component to about -10 degrees Celsius.

[0070] Item 10. The system of any one of Items 1-9, wherein the first surface component of each ETM is electrically connected to the second surface component of each corresponding ETM through a pn pair.

[0071] Item 11. A method for ablation of a tumor with a controlled precision temperature distribution using a tumor ablation probe device may include deploying a distal end of the tumor ablation probe device in tissue, the distal end including a plurality of electrothermal modules (ETMs) deployed proximally on a surface of the device, each ETM including a first surface component and a second surface component opposite to and electrically connected to the first surface component. The method may also include supplying one of a first voltage having a first polarity and a second voltage having a second polarity opposite to the first polarity to at least one of the plurality of ETMs via a circuit controller communicatively coupled to the tumor ablation probe device, and repeatedly alternating between the first polarity and the second polarity based on a timing cycle via the circuit controller. When the first polarity is supplied, the at least one ETM heats the first surface component and cools the second surface component. When the second polarity is supplied, the at least one ETM cools the first surface component and heats the second surface component, and each ETM may be configured to be independently controlled by the circuit controller.

[0072] Item 12. The method of Item 11, wherein one of a first voltage having a first polarity and a second voltage having a second polarity is supplied to at least one ETM among the plurality of ETMs but not supplied to at least one other ETM among the plurality of ETMs.

[0073] Item 13. The method described in any one of Items 11-12, wherein the distal end includes at least one ETM of the multiple ETMs on the first probe arm and at least one other ETM of the multiple ETMs on the second probe arm, and each of the first probe arm and the second probe arm is configured to be independently controlled by a circuit controller.

[0074] Item 14. A method for ablation of a tumor with controlled precision temperature distribution using a tumor ablation probe device may include deploying a distal end of the tumor ablation probe device in tissue, the distal end including at least one electrothermal module (ETM) on a first probe arm and at least one ETM on a second probe arm; supplying one of a first voltage having a first polarity and a second voltage having a second polarity opposite to the first polarity to at least one ETM on the first probe arm, at least one ETM on the second probe arm, or both as one or more voltage-supplied ETMs via a circuit controller communicatively coupled to the tumor ablation probe device; and repeatedly alternating between the first polarity and the second polarity using a timing cycle via the circuit controller. Each ETM may include a first surface component and a second surface component opposite to the first surface component and electrically connected to the first surface component. When the first polarity is supplied, the one or more voltage-supplied ETMs heat the first surface component and cool the second surface component, respectively. When the second polarity is supplied, the one or more voltage-supplied ETMs cool the first surface component and heat the second surface component, respectively, and each of the first probe arm and the second probe arm may be configured to be independently controlled by the circuit controller.

[0075] Item 15. The method described in Item 14, wherein when one of a first voltage of a first polarity and a second voltage of a second polarity is supplied to one of at least one ETM on a first probe arm and at least one ETM on a second probe arm, it is not supplied to the other of at least one ETM on the first probe arm and at least one ETM on the second probe arm.

[0076] Item 16. The method of any one of Items 14-15, wherein each ETM is configured to be independently controlled by a circuit controller.

[0077] Item 17. The method of any one of Items 14-16, wherein the first polarity is positive and the second polarity is negative.

[0078] Item 18. The method of any one of Items 14-16, wherein the first polarity is negative and the second polarity is positive.

[0079] Item 19. The method of any one of Items 14-18, wherein the first voltage is equal to the second voltage.

[0080] Item 20. The method of any one of Items 11-15, wherein the first voltage is different from the second voltage.

[0081] It is noted that the terms "substantially" and "about" and "approximately" may be used herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[0082] Although specific embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. In addition, although various aspects of the claimed subject matter have been described herein, these aspects need not be used in combination. Therefore, the appended claims are intended to cover all such changes and modifications within the scope of the claimed subject matter.

Claims

1. A system for performing tumor ablation using a tumor ablation probe device with a controlled precision temperature distribution, the system comprising: A tumor ablation probe device comprising a distal end, wherein the distal end comprises a plurality of electrothermal modules ETM disposed on a surface of the device at a proximal end, each electrothermal module ETM comprising a first surface component and a second surface component opposite to the first surface component and electrically connected to the first surface component; as well as a circuit controller communicatively coupled to the tumor ablation probe device and a non-transitory computer storage medium, wherein the non-transitory computer storage medium stores instructions that, when executed by the circuit controller, cause the system to: supplying one of a first voltage having a first polarity and a second voltage having a second polarity opposite to the first polarity to at least one electric heating module ETM among the plurality of electric heating modules ETM via the circuit controller, wherein when the first polarity is supplied, the at least one electric heating module ETM heats the first surface component and cools the second surface component, and when the second polarity is supplied, the at least one electric heating module ETM cools the first surface component and heats the second surface component; as well as Via the circuit controller, the first polarity and the second polarity are repeatedly alternated based on a timing cycle, wherein each electrothermal module ETM is configured to be independently controlled by the circuit controller.

2. The system of claim 1, wherein the non-transitory computer storage medium stores further instructions which, when executed by the circuit controller, cause the system to supply one of a first voltage having a first polarity and a second voltage having a second polarity to at least one of the plurality of electric heating modules ETM but not to at least one other of the plurality of electric heating modules ETM.

3. The system of claim 1 , wherein the distal end comprises at least one of the plurality of electrothermal modules ETM on the first probe arm and at least one other of the plurality of electrothermal modules ETM on the second probe arm, and each of the first probe arm and the second probe arm is configured to be independently controlled by a circuit controller.

4. The system of claim 1, wherein the first polarity is positive and the second polarity is negative.

5. The system of claim 1, wherein the first polarity is negative and the second polarity is positive. The system of claim 1 , wherein the first voltage is equal to the second voltage.

7. The system of claim 1, wherein the first voltage is different from the second voltage.

8. The system of claim 1, wherein the timing cycle is 2 seconds to 5 seconds.

9. The system of claim 1, wherein the at least one electrothermal module ETM heats the first surface component to a range from 45 degrees Celsius to 50 degrees Celsius when the first polarity is supplied, and the at least one electrothermal module ETM cools the first surface component to about -10 degrees Celsius when the second polarity is supplied.

10. The system of claim 1, wherein the first surface component of each electrothermal module ETM is electrically connected to the second surface component of each corresponding electrothermal module ETM through a pn pair.

11. A device for ablation of a tumor using a tumor ablation probe device with controlled precision temperature distribution, The distal end of the tumor ablation probe device is deployed in the tissue, and the distal end includes a plurality of electric heating modules ETM deployed on the device surface at the proximal end, and each electric heating module ETM includes a first surface component and a second surface component opposite to the first surface component and electrically connected to the first surface component; The device comprises: means for supplying one of a first voltage having a first polarity and a second voltage having a second polarity opposite to the first polarity to at least one of the plurality of electric heating modules ETM via a circuit controller communicatively coupled to the tumor ablation probe device, wherein when the first polarity is supplied, the at least one electric heating module ETM heats the first surface component and cools the second surface component, and wherein when the second polarity is supplied, the at least one electric heating module ETM cools the first surface component and heats the second surface component; as well as Means for repeatedly alternating between a first polarity and a second polarity using a timing cycle via a circuit controller, wherein each electrothermal module ETM is configured to be independently controlled by the circuit controller.

12. The apparatus of claim 11, wherein the one of the first voltage having the first polarity and the second voltage having the second polarity is supplied to the at least one electric heating module ETM among the plurality of electric heating modules ETM, but is not supplied to at least one other electric heating module ETM among the plurality of electric heating modules ETM.

13. The device of claim 11, wherein the distal end comprises at least one of the plurality of electrothermal modules ETM on the first probe arm and at least one other of the plurality of electrothermal modules ETM on the second probe arm, and each of the first probe arm and the second probe arm is configured to be independently controlled by a circuit controller.

14. A device for ablation of a tumor using a tumor ablation probe device with controlled precision temperature distribution, The distal end of the tumor ablation probe device is deployed in the tissue, and the distal end includes at least one electric heating module ETM on the first probe arm and at least one electric heating module ETM on the second probe arm, each electric heating module ETM includes a first surface component and a second surface component opposite to the first surface component and electrically connected to the first surface component; The device comprises: A device for supplying one of a first voltage having a first polarity and a second voltage having a second polarity opposite to the first polarity to at least one electric heating module ETM on the first probe arm, at least one electric heating module ETM on the second probe arm, or both of the one or more electric heating modules ETM supplied with voltage, via a circuit controller communicatively coupled to the tumor ablation probe device, wherein when the first polarity is supplied, the one or more electric heating modules ETM supplied with voltage heat the first surface component and cool the second surface component, respectively, and when the second polarity is supplied, the one or more electric heating modules ETM supplied with voltage cool the first surface component and heat the second surface component; as well as Means for repeatedly alternating between the first polarity and the second polarity using a timing cycle via a circuit controller, wherein each of the first probe arm and the second probe arm is configured to be independently controlled by the circuit controller.

15. An apparatus as claimed in claim 14, wherein said one of the first voltage of the first polarity and the second voltage of the second polarity is supplied to one of the at least one electric heating module ETM on the first probe arm and the at least one electric heating module ETM on the second probe arm, and is not supplied to the other of the at least one electric heating module ETM on the first probe arm and the at least one electric heating module ETM on the second probe arm.

16. The apparatus of claim 14, wherein each electrothermal module ETM is configured to be independently controlled by a circuit controller.

17. The apparatus of claim 14, wherein the first polarity is positive and the second polarity is negative.

18. The apparatus of claim 14, wherein the first polarity is negative and the second polarity is positive.

19. The apparatus of claim 14, wherein the first voltage is equal to the second voltage.

20. The apparatus of claim 14, wherein the first voltage is different from the second voltage.

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