Patent Description:
The present disclosure relates generally to the field of medical devices. More particularly, some embodiments relate to tumor ablation devices and related systems and methods. <CIT> describes devices and methods for monitoring the temperature of tissue at various locations in a treatment volume during fluid enhanced ablation therapy. <CIT> describes a tissue ablation probe, system, and method comprising an elongated member, an ablative element mounted on the distal end of the elongated member, and at least one thermoelectric device mounted to the member in thermal communication with the ablative element. <CIT> describes an electrode arrangement (<NUM>) for electrothermal treatment of human or animal bodies with at least one electrode for insertion into the body.

The written disclosure herein describes illustrative embodiments that are non-limiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which:.

Tumor ablation devices can be used to treat a tumor in a vertebra or other bones, such as the long bones of a patient. For example, in some embodiments, a distal end of a tumor ablation device may be inserted into a vertebra of a patient. Once the distal end of the tumor ablation device is inserted into the vertebra of the patient, an articulating distal portion of the tumor ablation device may be manipulated to position the tumor ablation device at a desired location within a tumor of the patient. The tumor ablation device may then be activated. Activation of the tumor ablation device may cause an electrical current (e.g., a radiofrequency current) to be applied to ablate tissue, such as the tumor. For instance, radiofrequency current may pass between a first electrode and a second electrode of the tumor ablation device. As the electrical current passes between the first electrode and the second electrode, the current may pass through tissue of the patient, thereby heating (and potentially killing) the adjacent tissue (e.g., tumor cells). The tumor ablation device may comprise one or more temperature sensors which may be used to measure the temperature of the heated tissue adjacent to the tumor ablation device. Based on the information obtained from impedance between the first electrode and the second electrode and/or from one or more temperature sensors, the duration, position, and/or magnitude of the delivered thermal energy may be tailored to ablate tumor tissue within a desired region of the tumor while avoiding the delivery of damaging amounts of thermal energy to healthy tissue. In some embodiments, once the tumor has been treated with thermal energy (e.g., converted radiofrequency energy), a cement may be delivered through with a different device to stabilize the vertebra of the patient.

The components of the embodiments as generally described and illustrated in the figures herein can be arranged and designed in a wide variety of different configurations. While various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

The phrase "coupled to" is broad enough to refer to any suitable coupling or other form of interaction between two or more entities. Two components may be coupled to each other even though they are not in direct contact with each other. For example, two components may be coupled to one another through an intermediate component. The phrases "attached to" or "attached directly to" refer to interaction between two or more entities that are in direct contact with each other and/or are separated from each other only by a fastener of any suitable variety (e.g., an adhesive).

The terms "proximal" and "distal" are opposite directional terms. For example, the distal end of a device or component is the end of the component that is furthest from the practitioner during ordinary use. The proximal end refers to the opposite end, or the end nearest the practitioner during ordinary use.

<FIG> illustrates a tumor ablation system <NUM> for use in one or more medical procedures, such as procedures to treat a spinal tumor in one or more vertebral bodies of a patient. The tumor ablation system <NUM> however is not limited to treating spinal tumors in vertebral bodies, but may be used to treat tumors in various other locations in the body, such as a hip, pelvis, or other long bones. The tumor ablation system <NUM> may comprise a base unit <NUM>, one or more medical devices <NUM> (or portions thereof) or medical device assemblies for use in a tumor ablation procedure, and a remote <NUM> that may enable a user to control energy delivery to the medical device <NUM>, or other aspects of the medical device <NUM>.

The base unit <NUM> may comprise a housing <NUM> that may house one or more power supplies (e.g., a radiofrequency ("RF") generator) that provides RF energy to a RF energy delivery probe <NUM> of the medical device <NUM>. The base unit <NUM> may further comprise ports <NUM>, <NUM>, <NUM> that couple the medical devices <NUM> and the remote <NUM> to the base unit <NUM>. The base unit <NUM> of <FIG> may include two power supplies (not shown) disposed in the housing <NUM>. In the illustrated embodiment, one of the power supplies may correspond to port <NUM> and the other power supply may correspond to port <NUM>. In other words, in some embodiments, each port <NUM>, <NUM> may be electrically coupled to, and powered by, an independent power supply.

In some embodiments, the remote <NUM> may include a cable <NUM> and plug <NUM> that are configured to couple the remote <NUM> to the base unit <NUM> via port <NUM>. This coupling may be configured to enable communication between the remote <NUM> and the base unit <NUM>. In some embodiments, the port <NUM> may be a wireless port that wirelessly connects with the remote <NUM>. The remote <NUM> may include a plurality of toggle buttons. The illustrated remote <NUM> of <FIG> illustrates two buttons <NUM> and <NUM>. In the illustrated embodiment, toggle button <NUM> is configured to correspond with port <NUM> and a first power supply (RF generator) disposed in the housing <NUM> and button <NUM> is configured to correspond with port <NUM> and a second power supply (RF generator) disposed in the housing <NUM>. Again, the two power supplies disposed in the housing <NUM> may be independent of each other. The toggle button <NUM> may thus be used toggle off and on the power supply (RF generator) corresponding to port <NUM> and thus toggle off and on energy delivery to a medical device coupled to port <NUM>. Similarly, toggle button <NUM> may be configured to toggle off and on the delivery of energy to a medical device coupled to port <NUM>.

The tumor ablation system <NUM> may further include one or more medical devices <NUM> for performing a tissue ablation. <FIG> illustrates a single medical device <NUM> that may be used for single pedicle (unipedicular) vertebral access to treat a tumor or lesion. However, the tumor ablation system <NUM> may include more than one medical device <NUM>. For example, <FIG> illustrates a tumor ablation system <NUM> with two medical devices <NUM> and <NUM>' for performing a two pedicle (bipedicular) vertebral access to treat tumors or lesions.

The medical device <NUM> may further include a housing <NUM> and a cable <NUM> and plug <NUM> that is configured to couple the medical device <NUM> to the base unit <NUM> to enable communication between the medical device <NUM> and the base unit <NUM> and to provide electrical energy to the RF energy delivery probe <NUM>. The base unit <NUM> may include an extension cable <NUM> and plug <NUM> that couples to port <NUM> or <NUM> and may extend the range of the RF energy delivery probe <NUM>. In some embodiments, the cable and plug <NUM> may couple directly to port <NUM> or <NUM> without the use of the extension cable <NUM>. As discussed above, each port <NUM> and <NUM> correspond with an independent power supply and medical device <NUM> may be coupled to either port <NUM> or <NUM> to access a power supply.

In the illustrated embodiment of <FIG>, the tumor ablation system <NUM> is shown comprising a single medical device <NUM>. The tumor ablation system <NUM> may include a plurality of identifying features that signify to a user which port (<NUM> or <NUM>) to which the medical device <NUM> is coupled. Systems within the scope of this disclosure may have any combination of the identifying features discussed below.

As detailed below, one or more portions of the medical device <NUM> or related components may have an indicator light or other feature that identifies the port (<NUM> or <NUM>) to which the medical device <NUM> is coupled. For example, the plug <NUM> may include a light <NUM> (e.g. LED) that lights up when the plug is coupled to either of the ports <NUM> and <NUM>. For example, if the medical device <NUM> is coupled to port <NUM> the light <NUM> may light up a first color (e.g. blue). If the medical device <NUM> is coupled to port <NUM> the light <NUM> may light up a second color (e.g. white). The light <NUM> may be a ring that extends around the circumference of the plug <NUM>.

Another identifying feature may be a light <NUM> (e.g. LED) disposed along the length of the cable <NUM>. The light <NUM> of the cable <NUM> may light a first color (e.g. blue) when the medical device <NUM> is coupled to port <NUM> and may light up a second color (e.g. white) when the medical device <NUM> is coupled to port <NUM>.

Similar identifying features may be disposed on the extension cable <NUM> and plug <NUM>. For example, the plug <NUM> may include a light <NUM> (e.g. LED) that may light up a first color (e.g. blue) when the extension cable <NUM> and plug <NUM> are coupled to the port <NUM> and/or a medical device and may light up a second color (e.g. white) when the extension cable <NUM> and plug <NUM> are coupled to the port <NUM> and/or a medical device. The light <NUM> may be a ring that extends around the circumference of the plug <NUM>. The cable <NUM> may include a light <NUM> that is disposed along the length of the extension cable <NUM> and the light <NUM> may light up a first color (e.g. blue) when cable <NUM> and plug <NUM> are coupled to the port <NUM> and/or a medical device and a second color (e.g. white) when the cable <NUM> and plug <NUM> are coupled to the port <NUM> and/or a medical device.

Another identifying feature may be a light <NUM> (e.g. LED) disposed on the housing <NUM> of the medical device <NUM>. The light <NUM> of the housing <NUM> may light a first color (e.g. blue) when the medical device <NUM> is coupled to port <NUM> and may light up a second color (e.g. white) when the medical device <NUM> is coupled to port <NUM>.

Another identifying feature may be disposed on the remote <NUM>. The remote <NUM> may include lights that distinguish between which toggle button <NUM> and <NUM> correspond with each port <NUM> and <NUM>. For example, toggle button <NUM> may include a light <NUM> (e.g. LED) that lights up a first color (e.g. blue) when the remote is coupled to or wirelessly connected to port <NUM>. Toggle button <NUM> may include a light <NUM> (e.g. LED) that lights up a first color (e.g. white) when the remote <NUM> is coupled to or wirelessly connected to port <NUM>. Unlike the other identifying features, the toggle buttons <NUM> and <NUM> do not alternate between colors but are color specific to the corresponding port. Accordingly, the user may always know which toggle button <NUM> and <NUM> corresponds to which port <NUM> and <NUM>.

Again, the plurality of identifying features may be independent of the other identifying features or they may be in a number of different combinations. For example, in one embodiment, one of the lights <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> may be used as the only identifying feature. In another embodiment, light <NUM> of the plug <NUM> may work in conjunction with the light <NUM> of the housing <NUM>. A plurality of different combinations may be used in an attempt to help a physician identify which medical device is coupled to which port <NUM> and <NUM>.

The base unit <NUM> may further include a plurality of speakers <NUM>. The speakers <NUM> enable the base unit <NUM> to provide audible indicators to the user. For example, when a medical device is turned on and is coupled to port <NUM> and ablating, the base unit <NUM> may give a first audible indicator. If a second medical device is turned on and is coupled to port <NUM> and ablating, the base unit <NUM> may give a second audible indicator. The audible indicators are different from each other and the user would be able to know by sound if one or two medical devices are currently ablating.

<FIG> illustrate a probe of the medical device <NUM> in greater detail. <FIG> illustrates a side view of the RF energy delivery probe <NUM>, and <FIG> illustrates a detailed cross-sectional view of the distal portion of the RF energy delivery probe <NUM>. The RF energy delivery probe <NUM> may have a first pole or RF+ pole and a second pole, return pole, or RF-pole, the first tubular insulator <NUM>, the second tubular insulator <NUM>, and a primary insulator, or bushing insulator <NUM> that is disposed between the poles and may act as a bushing.

Though various elements of the embodiment of <FIG> are referenced as "tubular" (e.g. the first tubular conductor <NUM>, first tubular insulator <NUM>, second tubular insulator <NUM>, and second tubular conductor <NUM>), other geometries of these elements are within the scope of this disclosure. That is, one or more of these elements may be configured with a non-tubular geometry in some embodiments. Further, tubular elements with various cross-sectional shapes, including round, square, rectangular, triangular, polygonal, and so forth are likewise within the scope of this disclosure. Additionally, tubular elements wherein the cross-sectional geometry or size varies along the length of the tubular element are within the scope of this disclosure.

The first tubular conductor <NUM> may be a metallic tube that extends from a proximal anchor (e.g., a metallic anchor) to an open distal end. The first tubular conductor <NUM> may act as the second pole (RF-). In some embodiments, a complimentary tubular conductor <NUM> may be disposed within the first tubular conductor <NUM>. The complimentary tubular conductor may be metallic and may be physically and electrically connected to the first tubular conductor <NUM>.

The first tubular insulator <NUM> may be at least partially disposed within the first tubular conductor <NUM>. For example, the first tubular insulator <NUM> may extend through the first tubular conductor <NUM>. More particularly, in some embodiments, the first tubular insulator <NUM> extends through the first tubular conductor <NUM> such that a proximal end of the first tubular insulator <NUM> is proximal of the first tubular conductor <NUM> and a distal end of the first tubular insulator <NUM> is proximal of the first tubular conductor <NUM>. The first tubular insulator <NUM> and the second tubular insulator <NUM> may be made from any suitable insulating material, such as polymeric insulating materials. Examples of suitable polymeric insulating materials include polyimide, polycarbonate, polyetheretherketone (PEEK), and polyether block amides (e.g., PEBAX®). The first tubular insulator <NUM> may extend past the open of the first conductor <NUM> and may act as the primary insulator, or bushing insulator <NUM>, e.g., bushing, between the first pole or RF+ pole and the second pole, return pole, or RF- pole. That is, the first tubular insulator <NUM> may extend a sufficient distance to function as an insulator along the portion of the exemplary embodiment where the bushing insulator <NUM> is disposed. In this way the first tubular insulator <NUM> may take the place of the bushing insulator <NUM>, such that there is no separate element defining the bushing insulator <NUM>. Additionally, in some embodiments, the first tubular insulator <NUM> may extend along the device and comprise an enlarged section that defines the bushing insulator <NUM>. Thus, the first tubular insulator <NUM> and bushing insulator <NUM> may be a single part and may or may not have the same cross-sectional geometry and/or size. In other embodiments, the bushing insulator <NUM> may be a separate component from the first tubular insulator <NUM>. In such a case, materials such as ceramics (Zirconia) may be considered.

The second tubular insulator <NUM> may be disposed within the first tubular insulator <NUM>. For example, the second tubular insulator <NUM> may extend through the first tubular insulator <NUM>. More particularly, in some embodiments, the second tubular insulator <NUM> extends through the first tubular insulator <NUM> such that a proximal end of the second tubular insulator <NUM> is proximal of the first tubular insulator <NUM> and a distal end of the second tubular insulator <NUM> is in line with the distal end of the first tubular insulator <NUM>. The second tubular insulator <NUM> may be made from any suitable insulating material, such as polymeric insulating materials. Examples of suitable polymeric insulating materials include polyimide, polyetheretherketone.

(PEEK), and polyether block amides (e.g., PEBAX®). In some embodiments, the second tubular insulator <NUM> may act as the primary insulator or bushing insulator <NUM>, e.g., bushing, between the first pole or RF+ pole and the second pole, return pole, or RF- pole. That is, as with the first tubular insulator <NUM>, the second tubular insulator <NUM> may extend and form the bushing insulator <NUM> or may be a separate component from the bushing insulator <NUM>.

The second tubular conductor <NUM> may be a metallic tube that extends from a proximal end (e.g., a metallic anchor) to a distal end. In some embodiments, the second tubular conductor <NUM> is rigid (or is rigid along most of its length). The second tubular conductor <NUM> may be at least partially disposed within the second tubular insulator <NUM>. For example, the second tubular conductor <NUM> may extend through the second tubular insulator <NUM> such that a distal portion <NUM> of the second tubular conductor <NUM> is disposed distal of the first tubular conductor <NUM>, the first tubular insulator <NUM>, and the second tubular insulator <NUM>. In some embodiments, the distal portion <NUM> of the second tubular conductor <NUM> that is disposed distal of the first tubular insulator <NUM> is longitudinally offset from the first tubular conductor <NUM> by the longitudinal length of the bushing insulator <NUM>. The bushing insulator <NUM> may have a length A2 of between <NUM> and <NUM>. Stated differently, the gap between the distal portion <NUM> the second tubular conductor <NUM> and the distal end of the first tubular conductor <NUM> may be between <NUM> and <NUM> when the distal portion <NUM> is in a non-deployed or non-extended configuration, as further detailed below.

The distal portion <NUM> of the second tubular conductor <NUM> may act as the first probe electrode (RF+). The second tubular conductor <NUM> may extend and retract relative to the first tubular conductor <NUM>. In some embodiments, the second tubular conductor <NUM> may extend and retract axially up to <NUM>, as shown by arrow A1. In some embodiments, the RF energy delivery probe <NUM> may extend and retract up to <NUM>. In some embodiments, the RF energy delivery probe <NUM> may extend and retract up to <NUM>. The axial movement of the RF energy delivery probe <NUM> may be controlled by the physician or by another medical professional and may be displayed on the display <NUM>. The axial movement of the second tubular conductor <NUM> relative to the first tubular conductor <NUM> creates a continuous range of distances between the first tubular conductor <NUM> and the second tubular conductor <NUM>. As discussed later, the extension and retraction of the second tubular conductor <NUM> relative to the first tubular conductor <NUM> affects the size of the ablation zones created by the RF energy delivery probe <NUM>.

The RF energy delivery probe <NUM> may further comprise a plurality of thermocouples. In some embodiments, a distal thermocouple <NUM> may be disposed within the distal portion <NUM> of the second tubular conductor <NUM>. The distal thermocouple <NUM> may be disposed near, or directly at, the maximum distal tip of the RF energy delivery probe <NUM> (meaning the distal-most point on the distal end <NUM> of the RF energy delivery probe <NUM>). The distal thermocouple <NUM> may measure the temperature at the distal end <NUM> of the RF energy delivery probe <NUM>. The temperature measured by the distal thermocouple <NUM> may be used for physician's reference and/or by a generator algorithm.

The RF energy delivery probe <NUM> may further comprise a plurality of thermocouples that are disposed proximal to the distal thermocouple <NUM>. The illustrated embodiment of <FIG> illustrates four thermocouples that are proximal to the distal thermocouple <NUM>. The thermocouples may be evenly spaced apart. A first proximal thermocouple <NUM> may be <NUM> back from the center of an ablation zone. A second proximal thermocouple <NUM> may be <NUM> back from the center of the ablation zone. A third proximal thermocouple <NUM> may be <NUM> back from the center of the ablation zone. A fourth proximal thermocouple <NUM> may be <NUM> back from the center of the ablation zone. In some embodiments, the fourth proximal thermocouple <NUM> may be <NUM> back from the center of the ablation zone. The thermocouples <NUM>, <NUM>, <NUM>, <NUM> may be disposed between the first tubular insulator <NUM> and the second tubular insulator <NUM>. Further, more or fewer thermocouples, positioned at different relative positions are also within the scope of this disclosure. For example, the thermocouples may be positioned at <NUM> intervals as described above or at <NUM>, <NUM>, <NUM>, <NUM>, or other intervals. Spacing wherein the offset between adjacent thermocouples is not constant along the plurality of thermocouples is also within the scope of this disclosure.

The temperatures measured by the proximal thermocouples <NUM>, <NUM>, <NUM>, <NUM> and the temperature measured by the distal thermocouple <NUM> may be used for the physician's reference and/or may be employed by a generator algorithm. The algorithm may use the detected temperature to create symmetric ablation zones that reach a predetermined temperature or thermal dose to ablate or kill the targeted tumor or lesions. Thermal dose is a function of temperature and exposure time. For example, a thermal dose may vary the exposure time based on the temperature, and/or vary the temperature based on the exposure time. Thermal dose represents the accumulated thermal energy that the tissue in that location was subjected to during the total time of the procedure. In larger ablation sizes it takes much longer to reach a given temperature at the perimeter of the ablation zone than in smaller ablation zone sizes, and as a result a larger target ablation zone will be completed at a much lower temperature than a small ablation zone size (high temperature for a short time can deliver the same energy as low temperature for a long time). The thermal dose may allow better ablation size accuracy over a wide range of ablation sizes.

In some embodiments, the first tubular conductor <NUM> is rigid (or is rigid along most of its length). In some embodiments, a distal portion of the first tubular conductor <NUM> includes a plurality of slots <NUM> proximal to the open distal end and the proximal thermocouples <NUM>, <NUM>, <NUM>, and <NUM>. The proximal thermocouples <NUM>, <NUM>, <NUM>, and <NUM> and the distal thermocouple <NUM> are disposed on a rigid and straight section <NUM> of the RF energy delivery probe <NUM>. The rigid and straight section <NUM> may be configured to enable the RF energy delivery probe <NUM> to create symmetric ablation regions. The slots <NUM> may be perpendicular or angled relative to the primary axis of the first tubular conductor <NUM>. In other embodiments, the first tubular conductor <NUM> lacks a plurality of slots <NUM>. Other geometries of the slots <NUM> not specifically described herein fall within the scope of the disclosure.

The slots <NUM> may enable the distal portion <NUM> of the RF energy delivery probe <NUM> to articulate. In some instances, articulation of the distal portion <NUM> of the RF energy delivery probe <NUM> may facilitate placement of the distal portion <NUM> of the RF energy delivery probe <NUM> at a desired location for ablation. Stated differently, the RF energy delivery probe <NUM> may have an active steering capability that enables navigation to and within a tumor. In some instances, articulation of the distal portion <NUM> of the RF energy delivery probe <NUM> may, additionally or alternatively, mechanically displace tissue (e.g., tumor cells) within the vertebra of the patient. For example, the RF energy delivery probe <NUM> may function as an articulating osteotome that enables site-specific cavity creation. Stated differently, the articulating distal portion <NUM> of the RF energy delivery probe <NUM> may be robust enough to facilitate navigation through hard tissue of a patient. The practitioner may be able to articulate a distal portion <NUM> of the RF energy delivery probe <NUM> such that the distal portion <NUM> transitions from a linear configuration to a non-linear configuration. Articulation of the distal portion <NUM> may be similar to articulation of the medical device described in <CIT>, hereby incorporated by reference in its entirety.

In some embodiments, the articulation of the RF energy delivery probe <NUM> may be displayed on the display <NUM>. Accordingly, the user may be able to see the extent of articulation during the procedure.

<FIG> illustrate an alternative embodiment of the RF energy delivery probe <NUM>' that include an articulating portion with a plurality of slots <NUM>' that are adjacent to the open distal end and that corresponds with the proximal thermocouples <NUM>', <NUM>', <NUM>', and <NUM>'. The location of the articulating portion enables the RF energy delivery probe <NUM>' to create a variety of different of ablation regions for ablating tumors.

<FIG> schematically illustrate a series of symmetric ablation zones 500a created by a RF energy delivery probe 410a. The symmetric ablation zones are symmetric about the poles of the first conductor <NUM> and the second conductor <NUM>. The symmetric ablation zones 500a are three-dimensional, even though the <FIG> illustrate them as two-dimensional. As compared with the RF energy delivery probe <NUM> of <FIG>, <FIG> illustrate variation on the design of the geometry of the distal tip of the RF energy delivery probe <NUM>, thus the reference numerals in these figures are designated with a final letter "a" to indicate the variation with the prior embodiment. Nonetheless, disclosure related in connection with the embodiment of <FIG> may be applied to the embodiment of <FIG> and vice versa. In the embodiment of <FIG>, a distal thermocouple 454a and proximal thermocouples 424a, 425a, 426a, 427a are shown in each of <FIG>.

<FIG> illustrates a first ablation zone 500a with a length L1. In some embodiments, the length of L1 is <NUM>. <FIG> illustrates a second configuration where the ablation zone 500a has a length L2. In some embodiments, the length of L2 is <NUM>. <FIG> illustrates a third configuration where the ablation zone 500a has a length L3. In some embodiments, the length of L3 is <NUM>. <FIG> illustrates a fourth configuration where the ablation zone 500a has a length L4. In some embodiments, the length of L4 is <NUM>. In other embodiments, the length of L4 is <NUM>. While the present disclosure contemplates multiple ablation zone sizes, the present disclosure is not limited to these proposed ablation zone sizes. In fact, multiple ablation zone sizes are within the scope of these disclosure based on a single probe design.

The size of the ablation zone 500a may be controlled by modulating the delivery of electrical energy, such as radiofrequency energy, to the RF energy delivery probe 410a. In the illustrated embodiment, correlation between a <NUM> offset proximal thermocouples, 424a, 425a, 426a, and 427a, and <NUM> increments of the ablation zone size (due to <NUM> growth of the ablation zone 500a on each side of the distal tip of the RF energy delivery probe 410a) is shown. Again, in other embodiments, different sizes of ablation zone, including different increments for controlling the ablation zone 500a size, and different placement of the proximal thermocouples 424a, 425a, 426a, and 427a may be used.

The medical device may be configured to create symmetric ablation zones even when the RF energy delivery probe 410a is articulated along a distal portion (such as distal portion <NUM> of <FIG>) because of the rigid and straight portion <NUM> where the thermocouples <NUM>, <NUM>, <NUM>, and <NUM> are disposed.

<FIG> illustrate a method for treating a spinal tumor or lesion <NUM> in one or more vertebral bodies <NUM> of a patient using the medical device <NUM> of <FIG> by unipedicular access. For example, some embodiments of a medical procedure may comprise obtaining the medical device (<NUM> of <FIG>) and inserting the distal end <NUM> of the RF energy delivery probe <NUM> into a vertebral body of a patient (e.g., a sedated patient in the prone position). In some embodiments, the distal end <NUM> of the RF energy delivery probe <NUM> may be pointed and the pointed distal end <NUM> may facilitate penetration of bone within the vertebra of the patient. Further, in some embodiments, the RF energy delivery probe <NUM> has sufficient strength to prevent buckling of the RF energy delivery probe <NUM> as the distal end of the RF energy delivery probe <NUM> is inserted within a vertebra (e.g., across the cortical bone) of the patient. In some embodiments, the distal end <NUM> of the RF energy delivery probe <NUM> is inserted into the patient via an introducer (not shown). In other embodiments, the distal end <NUM> of the RF energy delivery probe <NUM> may be inserted into the soft tissue of the patient without using an introducer.

<FIG> illustrates the RF energy delivery probe <NUM> inserted into the vertebra <NUM> of a patient with the tumor <NUM>. The distal portion (<NUM> of <FIG>) of the RF energy delivery probe <NUM> may be articulated to place the RF energy delivery probe <NUM> in a predetermined position. The RF energy delivery probe <NUM> may be activated and the RF generator may provide energy for the RF energy delivery probe <NUM> to ablate the tumor <NUM>. The RF energy delivery probe <NUM> may then create a symmetric ablation zone <NUM> (similar to the ablation zones 500a discussed in connection with <FIG>). With reference to <FIG> and <FIG>, the distal thermocouple <NUM> and the proximal thermocouples <NUM>, <NUM>, <NUM>, <NUM> may detect the temperature of the surrounding tissue and provide the temperature feedback to the base unit <NUM>, which may be displayed on the display <NUM>. This information may then be fed into the generator algorithm to maintain a symmetric ablation zone to ablate the tumor <NUM> and avoid damaging surrounding tissue.

<FIG> illustrates ablated tissue <NUM> of the tumor <NUM> as the tissue reaches a predetermined temperature such as <NUM> degrees Celsius, or thermal dose. Once the tumor <NUM> reaches the predetermined temperature or thermal dose, the RF generator may turn off the power, or otherwise modify current delivery to the RF energy delivery probe <NUM>. The diameter of the ablation zone <NUM> may be determined based on the size of the tumor <NUM>. If the tumor <NUM> is smaller, the ablation zone <NUM> may be smaller and a subset of the proximal thermocouples <NUM>, <NUM>, <NUM>, <NUM> may be used to detect the temperature in and immediately adjacent the ablation zone <NUM>. If the ablation zone <NUM> is larger, all of the proximal thermocouples <NUM>, <NUM>, <NUM>, <NUM> may be used to detect the temperature within and adjacent the ablation zone <NUM>. That is to say, while all the proximal thermocouples <NUM>, <NUM>, <NUM>, and <NUM> may monitor temperature and provide feedback to the base unit <NUM>, in some procedures, only a subset of the proximal thermocouples <NUM>, <NUM>, <NUM>, and <NUM> may be within and/or immediately adjacent the ablation zone <NUM>. <FIG> illustrates the dead tissue <NUM> of the ablated tumor <NUM> with the RF energy delivery probe <NUM> removed from the vertebra <NUM> of the patient.

As discussed previously, <FIG> illustrates a tumor ablation system <NUM>' with two medical devices <NUM> and <NUM>" for performing a bipedicular vertebral access to treat tumors. In the illustrated embodiment, the tumor ablation system <NUM>' comprises the base unit <NUM>, remote <NUM>, and medical device <NUM> of the tumor ablation system <NUM> of <FIG>. That is to say, a tumor ablation system may be configured with a single medical device <NUM> or two medical devices <NUM> and <NUM>", depending on the desired treatment. For clarity with connecting the disclosure of the tumor ablation system <NUM> and the tumor ablation system <NUM>' the tumor ablation system <NUM>', is shown as comprising the noted elements of the tumor ablation system <NUM>. Embodiments wherein elements such as the base unit <NUM> and remote <NUM> are configured for use with only one, with one or two, with only two, or with other numbers of medical devices <NUM>, <NUM>' are likewise within the scope of this disclosure.

The second medical device, medical device <NUM>", may be similar to the first medical device, medical device <NUM>, or may be different based on treatment needs of the patient. The remote <NUM> may allow the user to adjust the energy provided to each medical device <NUM> and <NUM>". In some embodiments, energy adjustment may be done automatically via an algorithm. For example, the remote <NUM> may have a button <NUM> for controlling the amount of energy to the medical device <NUM>, <NUM>" plugged into port <NUM> and a button <NUM> for controlling the amount of energy to the medical device <NUM>, <NUM>" plugged into port <NUM>.

As discussed above, each medical device <NUM> and <NUM>" may include a plurality of identifying features to help identify which medical device <NUM> and <NUM>" is coupled to which port <NUM> and <NUM>.

<FIG> illustrate a method for treating a spinal tumor <NUM>' in one or more vertebral bodies <NUM>' of a patient using the medical devices <NUM> and <NUM>" using bipedicular access. For example, some embodiments of a medical procedure may involve obtaining the medical devices <NUM> and <NUM>" and inserting the distal ends <NUM> and <NUM>" of the RF energy delivery probes <NUM>, <NUM>" into a vertebral body of a patient (e.g., a sedated patient in the prone position). In other embodiments, the distal end <NUM> and <NUM>" of the first tubular conductor <NUM> may be inserted into a vertebral body of the patient. In some embodiments, the distal ends <NUM> and <NUM>" of the RF energy delivery probes <NUM>, <NUM>" or the distal end <NUM> and <NUM>" of the first tubular conductor <NUM> may be pointed and the pointed distal ends may facilitate penetration of bone within the vertebra <NUM>' of the patient. In some embodiments, the RF energy delivery probes <NUM>, <NUM>" have sufficient strength to prevent buckling of the RF energy delivery probes <NUM>, <NUM>" as the distal ends <NUM> and <NUM>" of the RF energy delivery probes <NUM>, <NUM>" are inserted within the vertebra <NUM>' (e.g., across the cortical bone) of the patient. In some embodiments, the distal ends <NUM> and <NUM>" of the RF energy delivery probes <NUM>, <NUM>" are inserted into the patient via an introducer (not shown). In other embodiments, the distal ends <NUM> and <NUM>" of the RF energy delivery probes <NUM>, <NUM>" are inserted into the patient without using an introducer.

<FIG> illustrates the medical devices <NUM> and <NUM>" inserted into a vertebra <NUM>' of a patient with a tumor <NUM>'. The distal portions <NUM> and <NUM>" of the RF energy delivery probes <NUM> and <NUM>" may be articulated to place the RF energy delivery probes <NUM> and <NUM>" in predetermined positions. The RF energy delivery probes <NUM> and <NUM>" may be activated and the RF generator may provide energy to the RF energy delivery probes <NUM> and <NUM>" to ablate the tumor <NUM>'. The RF energy delivery probes <NUM> and <NUM>" may each create symmetric ablation zones <NUM>, <NUM>', similar to the ablation zones <NUM> discussed in <FIG>. The distal thermocouples <NUM> and <NUM>" and the proximal thermocouples <NUM>, <NUM>, <NUM>, <NUM>, <NUM>', <NUM>", <NUM>", and <NUM>" may detect the temperature of the surrounding tissue and provide the temperature feedback to the base unit <NUM>, which may be displayed on the display <NUM>. This information may be fed into the generator algorithm to maintain a symmetric ablation zone <NUM>, <NUM>' to ablate the tumor <NUM>' and avoid damaging surrounding tissue.

<FIG> illustrates the ablated tissue <NUM>' of the tumor <NUM>' as the tissue reaches a predetermined thermal dose or temperature, such as <NUM> degrees Celsius. Once the tumor <NUM>' reaches the predetermined temperature or thermal dose, the RF generator may turn off the power, or otherwise modify current delivery to the RF energy delivery probes <NUM> and <NUM>'. The diameter of the ablation zones <NUM>, <NUM>' may be determined based on the size of the tumor <NUM>'. If the tumor <NUM>' is smaller, the ablation zones <NUM>, <NUM>' may be smaller and only a subset of the proximal thermocouples <NUM>, <NUM>, <NUM>, <NUM>, <NUM>", <NUM>", <NUM>", and <NUM>" may be used to detect the temperature in and immediately adjacent the ablation zones <NUM>, <NUM>', as also described above in connection with <FIG>. <FIG> illustrates the dead tissue <NUM>' of the ablated tumor <NUM>' with the RF energy delivery probes <NUM> and <NUM>' removed from the vertebra <NUM>' of the patient.

<FIG> is a block diagram of a tumor ablation system <NUM> in communication with a probe <NUM> according to one embodiment. The tumor ablation system <NUM> may be the same tumor ablation system <NUM> illustrated in the previous figures. The tumor ablation system <NUM> includes a generator <NUM> that can produce an electrical current to output to the probe <NUM>. In some embodiments, the tumor ablation system <NUM> may drive two probes with two independent generators. The electrical current can be conducted between a first conductor and a second conductor (probe conductors <NUM>) as radio frequency (RF) energy is converted into thermal energy via tissue heating within a desired ablation region. The tumor ablation system <NUM> modulates power output based on temperature and impedance of tissue surrounding the probe <NUM>.

In some embodiments, the probe <NUM> comprises a first conductor at a proximal portion of the probe <NUM> and a second conductor nearer a distal portion than the first conductor. An insulator separates the first conductor and the second conductor. The tissue within the desired ablation region provides a conduit through which the electrical current is conducted from the first conductor to the second conductor.

The probe <NUM> further comprises a set of thermocouples <NUM>. In some embodiments, a first thermocouple is positioned to measure a temperature at a location on the first conductor. In some embodiments, the thermocouples <NUM> include a second thermocouple, a third thermocouple, and a fourth thermocouple on the first conductor. Each thermocouple on the second conductor may define a point along potential ablation zone perimeters. In some embodiments, the thermocouples <NUM> include a distal thermocouple on the second conductor.

The tumor ablation system <NUM> can include a memory <NUM>, one or more processors <NUM>, a network interface <NUM>, an input/output interface <NUM>, and a system bus <NUM>.

The one or more processors <NUM> may include one or more general purpose devices, such as an Intel®, AMD®, or other standard microprocessor. The one or more processors <NUM> may include a special purpose processing device, such as ASIC, SoC, SiP, FPGA, PAL, PLA, FPLA, PLD, or other customized or programmable device. The one or more processors <NUM> can perform distributed (e.g., parallel) processing to execute or otherwise implement functionalities of the presently disclosed embodiments. The one or more processors <NUM> may run a standard operating system and perform standard operating system functions. It is recognized that any standard operating systems may be used, such as, for example, Microsoft® Windows®, Apple® MacOS®, Disk Operating System (DOS), UNIX, IRJX, Solaris, SunOS, FreeBSD, Linux®, ffiM® OS/<NUM>® operating systems, and so forth.

The memory <NUM> may include static RAM, dynamic RAM, flash memory, one or more flip-flops, ROM, CD-ROM, DVD, disk, tape, or magnetic, optical, or other computer storage medium. The memory <NUM> may include a plurality of program modules <NUM> and program data <NUM>. The memory <NUM> may be local to the tumor ablation system <NUM>, as shown, or may be distributed and/or remote relative to the tumor ablation system <NUM>.

The program modules <NUM> may include all or portions of other elements of the tumor ablation system <NUM>. The program modules <NUM> may run multiple operations concurrently or in parallel by or on the one or more processors <NUM>. In some embodiments, portions of the disclosed modules, components, and/or facilities are embodied as executable instructions embodied in hardware or in firmware, or stored on a non-transitory, machine-readable storage medium. The instructions may comprise computer program code that, when executed by a processor and/or computing device, cause a computing system to implement certain processing steps, procedures, and/or operations, as disclosed herein. The modules, components, and/or facilities disclosed herein may be implemented and/or embodied as a driver, a library, an interface, an API, FPGA configuration data, firmware (e.g., stored on an EEPROM), and/or the like. In some embodiments, portions of the modules, components, and/or facilities disclosed herein are embodied as machine components, such as general and/or application-specific devices, including, but not limited to: circuits, integrated circuits, processing components, interface components, hardware controller(s), storage controller(s), programmable hardware, FPGAs, ASICs, and/or the like. Accordingly, the modules disclosed herein may be referred to as controllers, layers, services, engines, facilities, drivers, circuits, subsystems and/or the like.

The modules <NUM> may comprise a power output module <NUM>, an impedance monitor <NUM>, and a temperature monitor <NUM>. The power output module <NUM> determines a primary thermocouple by determining which of the multiple thermocouples is nearest an outer perimeter of the desired ablation region. The power output module <NUM> adjusts an output current of the generator <NUM>. For example, the power output module <NUM> may receive impedance measurements of the tissue around the probe <NUM> from the impedance monitor <NUM>. The power output module <NUM> may cause the generator <NUM> to decrease the output power when the impedance increases or when a maximum distal temperature is reached. The maximum distal temperature is the hottest reading that a distal thermocouple measures before the tumor ablation system <NUM> decreases output power. In some embodiments, the power output module <NUM> may increase power output if the impedance does not increase.

In some embodiments, the power output module <NUM> may control the output current of the generator <NUM> based on a thermal energy set point or temperature set point. The power output module <NUM> also causes the generator <NUM> to stop the output current when a temperature measurement or thermal energy (temperature and time), received by the temperature monitor <NUM>, at the primary thermocouple reaches a target threshold. In some embodiments, the temperature of a distal thermocouple is also used to control the generator power output.

In some embodiments power output module <NUM> may control the output current of the generator <NUM> based on the procedure. For example, the user may input the therapy type to be administered, and the power output module <NUM> may control the output current of the generator <NUM> based on a profile associated with that therapy type.

The power output module <NUM> can also control the generator power output based on user input data <NUM>. In some embodiments, the user input data <NUM> can include a target temperature threshold, a thermal dose, a target time at the target temperature threshold, a target output power, or other user-defined parameters. For example, the tumor ablation system <NUM> can receive manual ablation input from a user to selectively override impedance-based control of the generator <NUM>.

The memory <NUM> may also include the data <NUM>. Data generated by the tumor ablation system <NUM>, such as by the program modules <NUM> or other modules, may be stored on the memory <NUM>, for example, as stored program data <NUM>. The data <NUM> may be organized as one or more databases.

The data <NUM> may include user input data <NUM> and image data <NUM>. The user input data <NUM> may include a target temperature threshold, a thermal dose, a target time at the target temperature threshold, a target output power, or other user-defined parameters. The image data <NUM> may include an image of the tissue. For example, the image may be a magnetic resonance imaging scan.

The input/output interface <NUM> may facilitate user interaction with one or more input devices and/or one or more output devices. The input device(s) may include a keyboard, mouse, touchscreen, light pen, tablet, microphone, sensor, or other hardware with accompanying firmware and/or software. The output device(s) may include a monitor or other display, printer, speech or text synthesizer, switch, signal line, or other hardware with accompanying firmware and/or software. For example, in one embodiment, the input/output interface <NUM> comprises a display to provide a graphical user interface illustrating the potential ablation perimeters. The input/output interface <NUM> can receive size input from a user to specify which of the potential ablation perimeters is to be used to define the desired ablation region. In some embodiments, the input/output interface <NUM> is a touchscreen, and the size input is received via the touchscreen. In some embodiments, the input/output interface <NUM> can superimpose one or more of the potential ablation perimeters on an image of the tissue.

In some embodiments, the tumor ablation system <NUM> includes an indicator light on each generator port, and the probe <NUM> also includes an indicator light. The tumor ablation system <NUM> may cause the indicator light on a port attached to the probe <NUM> to change colors to match the indicator light on the probe <NUM> to provide the user a visual indicator of the port providing power to the probe <NUM>.

The network interface <NUM> may facilitate communication with other computing devices and/or networks and/or other computing and/or communications networks. The network interface <NUM> may be equipped with conventional network connectivity, such as, for example, Ethernet (IEEE <NUM>), Token Ring (IEEE <NUM>), Fiber Distributed Datalink Interface (FDDI), or Asynchronous Transfer Mode (ATM). Further, the network interface <NUM> may be configured to support a variety of network protocols such as, for example, Internet Protocol (IP), Transfer Control Protocol (TCP), Network File System over UDP/TCP, Server Message Block (SMB), Microsoft® Common Internet File System (CIFS), Hypertext Transfer Protocols (HTTP), Direct Access File System (DAFS), File Transfer Protocol (FTP), Real-Time Publish Subscribe (RTPS), Open Systems Interconnection (OSI) protocols, Simple Mail Transfer Protocol (SMTP), Secure Shell (SSH), Secure Socket Layer (SSL), and so forth.

The system bus <NUM> may facilitate communication and/or interaction between the other components of the system <NUM>, including the one or more processors <NUM>, the memory <NUM>, the input/output interface <NUM>, and the network interface <NUM>.

<FIG> illustrate a graphical user interface that may be displayed by the tumor ablation system <NUM> of <FIG>.

Specifically, <FIG> is an interface <NUM> to control a tumor ablation system (e.g., the tumor ablation system <NUM> of <FIG>) with a generator coupled to a single probe, according to one embodiment. The interface <NUM> enables configuration of parameters, setting of preferences, and the like for a tumor ablation procedure. Additionally, the interface <NUM> displays a current state of the tumor ablation procedure.

In the illustrated embodiment, the interface <NUM> includes a center configuration bar <NUM> dividing the interface <NUM> into two subinterfaces (i.e., probe A interface <NUM>, probe B interface <NUM>). The center configuration bar <NUM> includes a menu button <NUM>, a first temperature measurement point informational element 804a, a second measurement point informational element 804b, and a remote informational element <NUM>. The menu button <NUM> allows a user to open a settings menu. The first measurement point informational element 804a and the second measurement point information element display temperature measurements from two optional stand-alone remote thermocouple that the physician can place for additional thermal data. The remote informational element <NUM> indicates a status of a remote controller (e.g., coupled, uncoupled, error).

Each subinterface facilitates control of a probe and allows a user to monitor conditions associated with the probe. For example, the probe A interface <NUM> allows a user to control and monitor a probe coupled to the first port. The probe B interface <NUM> allows a user to control and monitor a probe coupled to the second port.

The probe A interface <NUM> includes a first zone input 812a, a second zone input 812b, a third zone input 812c, and a fourth zone input 812d, collectively referred to herein as zone inputs <NUM>. The zone inputs <NUM> allow the user to control area size of an ablation zone. For example, if the user selects the first zone input 812a, the ablation zone will have a length of <NUM> centimeter. In some embodiments, the user may control the zone inputs <NUM> through a touchscreen interface. In some embodiments, the user may select a desired zone input via a curser. In some embodiments, the zone inputs <NUM> may correspond to physical buttons that a user may select to control the zone inputs <NUM>.

The probe A interface <NUM> also includes a visual representation of a probe <NUM> coupled to port A. As illustrated, the probe <NUM> includes an illustration of a distal thermocouple 816a, a first proximal thermocouple 816b, a second proximal thermocouple 816c, a third proximal thermocouple 816d, and a fourth proximal thermocouple 816e, collectively referred to herein as thermocouples <NUM>. Each of the thermocouples <NUM> is associated with a temperature measurement (i.e., first temperature measurement 814a, second temperature measurement 814b, third temperature measurement 814c, fourth temperature measurement 814d, and fifth temperature measurement 814e, collectively referred to herein as temperature measurements <NUM>). The temperature measurements <NUM> display the temperature measurements from the thermocouples <NUM>. In some embodiments, the temperature measurements <NUM> display a live temperature measurement from each of the thermocouples.

The probe A interface <NUM> also includes a visual representation of potential ablation zones (i.e., a first ablation zone 818a, a second ablation zone 818b, a third ablation zone 818c, and a fourth ablation zone 818d, collectively referred to herein as ablation zones <NUM>). In the illustrated embodiment, the potential ablation zones <NUM> only display a quarter of an actual ablation area. However, the remainder of the actual ablation area may be assumed to be symmetric. Each of the ablation zones <NUM> has a boundary point defined by one of the thermocouples <NUM>. The ablation zones <NUM> may display for a user the current state of the tissue (e.g., ablated tissue, non-ablated tissue). In some embodiments, the ablation zones <NUM> are superimposed on an image of the tissue (e.g., MRI image). In some embodiments, the ablation zones that are selectable to the user may be limited based on the distance between the second tubular conductor <NUM> and to the first tubular conductor <NUM> because the distance affects the size of the ablation zones.

In some embodiments, the interface <NUM> includes a visual representation of fifth ablation zone 818d' bordered by a fifth proximal thermocouple 816e' at <NUM>. In some embodiments, the probe may include the fifth proximal thermocouple 816e' at <NUM> and not include the fourth proximal thermocouple 816e at <NUM>. In some embodiments, the probe may include the fourth proximal thermocouple 816e at <NUM> and not include the fifth proximal thermocouple 816e' at <NUM>. In some embodiments, the probe may include the fifth proximal thermocouple 816e' at <NUM> and the fourth proximal thermocouple 816e at <NUM>.

The probe A interface <NUM> also includes a generator wattage section <NUM>, a timer <NUM>, and an impedance section <NUM>. The generator wattage section <NUM> shows the current power output of the generator. The timer <NUM> shows the time elapsed during an ablation procedure. A timer reset button <NUM> may be used to reset the timer <NUM>. The impedance section <NUM> displays the current impedance measurement of the tissue surrounding the probe.

In the illustrated embodiment, the tumor ablation generator is only coupled to one probe via the first port. Because of this, the probe A interface <NUM> is enabled while the probe B interface <NUM> is disabled. In the illustrated embodiment, the interface <NUM> indicates that the probe B interface <NUM> is disabled by graying out probe B interface <NUM> and making elements of the probe B interface <NUM> non-interactive. In some embodiments, the interface <NUM> hides a subinterface that is disabled. These disabled cues may visually indicate to a user that no probe is coupled to the second port, or if a probe is connected to the second port, that the probe is malfunctioning. The probe B interface <NUM> includes the same elements as the probe A interface <NUM>. The probe B interface <NUM> may be used to control and monitor a second probe as described with reference to the probe controlled and monitored by the probe A interface <NUM>.

<FIG> illustrates the interface <NUM> of <FIG> at a first instance of a tumor ablation procedure. The timer <NUM> indicates that the tumor ablation procedure has been in progress for <NUM> seconds. As shown, the probe A interface <NUM> provides feedback to the user concerning the current conditions of the ablation zone, the probe, and the generator power output.

For this example, the user has selected the fourth zone input 812d. The interface <NUM> indicates the selection by filling in the fourth zone input 812d. In some embodiments, the interface <NUM> may fill the selected zone input in with a different color, highlight the selected zone input, and/or indicate the selected zone input using a heavier line representing the ablation zone.

The interface <NUM> may indicate that power is being sent from the generator to the probe. For example, the interface <NUM> may include an RF symbol <NUM> to indicate that the probe is radiating. The interface <NUM> in the illustrated embodiment includes the generator wattage section <NUM> to display the current power output of the generator. As shown, during the first instance of a tumor ablation procedure, the power may be <NUM> watts.

The impedance section <NUM> indicates the impedance of the tissue between the conductors of the probe. In the illustrated embodiment, the impedance remains the same as it was before the tumor ablation procedure, as shown in <FIG>. If the impedance is increased, the tumor ablation procedure may become less effective. The impedance increasing is an indication that tissue charring has occurred, which reduces the efficacy of the RF transmission between the conductors of the probe. To limit the increase of impedance, in some embodiments, the generator reduces the power output if the impedance increases and/or if the maximum distal temperature is reached.

In the illustrated first instance of a tumor ablation procedure, the thermocouples <NUM> indicate temperature measurements <NUM> of the tissue after <NUM> seconds. Specifically, at <NUM> seconds the first proximal thermocouple 816b has exceeded <NUM>° C. In some embodiments when <NUM>° C is reached, the tissue has been determined killed. In some embodiments, the system may consider the thermal dose (time and temperature function) received by the tissue to determine when the tissue is killed. The interface <NUM> indicates the area of the ablated or dead tissue by shading the first ablation zone 818a.

<FIG> illustrates the interface <NUM> of <FIG> at a second instance of a tumor ablation procedure. The timer <NUM> indicates that the tumor ablation procedure has been in progress for one minute and one second. As shown, the probe A interface <NUM> provides feedback to the user concerning the current conditions of the ablation zone, the probe, and the generator power output.

As shown, in this example the impedance section <NUM> has not increased between <NUM> seconds (<FIG>) and a minute one second (<FIG>). In some embodiments, because the impedance has not increased, the generator may increase power output. In some embodiments, the power can be increased while the distal thermocouple measures a temperature below a maximum temperature setpoint. In some embodiments, the maximum temperature setpoint may be <NUM> ° C. Thus, in some embodiments, power may be increased as long as the distal thermocouple measures a temperature below a reference temperature, such as <NUM> ° C. In some embodiments, the generator may increase the power output based on a combination of impedance measurements and distal thermocouple temperature measurements. For example, power may be increased if the impedance and the temperature are below a maximum threshold. As shown in the generator wattage section <NUM>, in this example the power output has been increased to <NUM> watts. The additional power output by the generator can result in faster tumor ablation.

In the illustrated second instance of a tumor ablation procedure (<FIG>), the thermocouples <NUM> indicate temperature measurements <NUM> of the tissue after one minute and one second. Specifically, the second proximal thermocouple 816c has exceeded <NUM>° C. The interface <NUM> indicates the tissue within the second ablation zone 818b is ablated or dead by shading the second ablation zone 818b.

<FIG> illustrates the interface <NUM> of <FIG> at a third instance of a tumor ablation procedure. The timer <NUM> indicates that the tumor ablation procedure has been in progress for one minute and eighteen seconds. The probe A interface <NUM> provides feedback to the user concerning the current conditions of the ablation zone, the probe, and the generator power output.

In this example the impedance section <NUM> has not increased between a minute one second (<FIG>) and one minute and eighteen seconds (<FIG>). Because the impedance has not increased, the generator may increase power output. However, the power output by the generator may be limited by the generator or based on user settings. As shown in the generator wattage section <NUM>, in this example the power output has remained at <NUM> watts.

In the illustrated third instance of a tumor ablation procedure (<FIG>), the thermocouples <NUM> indicate temperature measurements <NUM> of the tissue after one minute and eighteen seconds. Specifically, the third proximal thermocouple 816d area gets filled when the temperature at the third proximal thermocouple 816d reaches a target value during which cell death is set to occur (e.g., exceeding <NUM>° C for a predetermined amount of time). The interface <NUM> indicates the tissue within the third ablation zone 818c is ablated or dead by shading the third ablation zone 818c.

<FIG> illustrates the interface <NUM> of <FIG> at a fourth instance of a tumor ablation procedure. The timer <NUM> indicates that the tumor ablation procedure has been in progress for one minute and thirty-three seconds. The probe A interface <NUM> provides feedback to the user concerning the current conditions of the ablation zone, the probe, and the generator power output.

In the illustrated fourth instance of a tumor ablation procedure, the thermocouples <NUM> indicate temperature measurements <NUM> of the tissue after one minute and thirty-three seconds. Specifically, the fourth proximal thermocouple 816e has exceeded <NUM>° C. The interface <NUM> indicates the tissue within the fourth ablation zone 818d is ablated or dead by shading the second ablation zone 818d.

At this point in the procedure, the ablation zone has reached the limit set by the user (<NUM>). As shown, the generator stops providing power once the thermocouple at the edge of the desired ablation zone has reached <NUM>° C for a certain amount of time. In some embodiments, the generator stops providing power once the thermocouple at the edge of the desired ablation zone has received a target thermal dose which the system may determine using time at a temperature. In some such embodiments, the generator may stop before <NUM>° C.

<FIG> illustrates the interface <NUM> of <FIG> with the generator coupled to two probes. As shown, both the probe A interface <NUM> and the probe B interface <NUM> are functional and neither is grayed out. In some embodiments, the generator may detect capabilities or configuration of the probe and adapt the interface <NUM> accordingly. For example, if a probe had only a single thermocouple, the representation on the interface <NUM> would only comprise one thermocouple. As another example, in some embodiments, the generator may detect how far the conductors are extended from one another when the probe is extendable and alter distances associated with the zone control inputs.

The two probes may operate independent of each other. For example, there may be two generators, and each probe may be powered by a separate generator. The generators may modulate power output to the individual ports independently. The user may select a different size ablation zones for each of the probes.

In some embodiments, the generator modulates power output to individual ports in a dual probe configuration. For example, a first current output associated with a first port can be decreased when the impedance measured between conductors of a first probe increases, and a second current output from a second port can be decreased when the impedance measured between conductors of a second probe increases. In some embodiments, a tumor ablation system may monitor a third impedance, where the third impedance is between the first probe and the second probe. In some embodiments, the first current output and the second current output are decreased when the third impedance increases.

Some embodiments may include indicator lights associated with the ports and/or the probes. The indicator lights may be different colors. In some embodiments, elements of the interface <NUM> may be shown in different colors. The indicator lights and/or elements of the display may match a color of a light on a probe coupled to the port to indicate which port the probe is connected to.

In some embodiments, the tumor ablation system may emit a tone indicating that the generators are outputting power. In embodiments where two probes are being used, two different tones may be emitted to indicate that power is being output to two probes. In some embodiments, if a first probe indicates that the desired ablation zone is reached prior to a second probe, power output to the first probe may cease and a tone associated with the first probe may stop while power output to the second probe may continue and a tone associated with the second probe may continue.

<FIG> illustrates a settings menu <NUM> for a tumor ablation generator, according to one embodiment. As shown, the settings menu <NUM> may comprise a general settings section <NUM>, where the user may change the date and time and view information about the generator. The settings menu <NUM> may also comprise a brightness control <NUM> and a volume control <NUM>.

In the illustrated embodiment, the settings menu <NUM> includes an export logs section <NUM>. A user may use the export logs section <NUM> to export the data from a tumor ablation procedure. The data may include but is not limited to power output by generator, duration of operation, size of ablation area, and temperature measurements. For example, the exported data may send the temperature and an amount of time at the temperature for all thermocouples. In some embodiments, the position of the probe (e.g., position within the bone and/or shape of the distal end of the probe) may also be exported. The exported data may also correlate the data to time readings so that the process of the surgery may be reviewed. In some embodiments, the exported data may be used to overlay the procedure on an image (e.g., MRI). For example, a display may illustrate the growth of the ablation zone on the image at any stage of the procedure. The overlay may be done in real-time as the surgery progresses or reviewed after the surgery. In some embodiments, the data may be used to generate a three-dimensional visualization of the ablation zone.

In some embodiments, the shape of the overlay may be affected based on the articulation of the distal end of the probe. For example, the overlay may provide a visual image of a shape of a potential ablation zone prior to a procedure based on the articulation of the distal end of the probe. In some embodiments, the potential ablation zones <NUM> on the interface <NUM> may change based on the articulation of the distal end of the probe. In some embodiments, the probes may include a piezoelectric sensor to determine the amount of articulation.

The illustrated embodiment also includes a probe A mode section <NUM> and a probe B mode section <NUM> (collectively mode sections). The mode sections <NUM>, <NUM> include a toggle (i.e., first toggle <NUM>, second toggle <NUM>) that allows a user to select automatic mode or manual mode. In automatic mode, the generator adjusts power output based on temperature measurements and impedance measurements. In manual mode, the user may determine the power output. A first slider <NUM> and second slider <NUM> may control a target temperature for a desired thermocouple to reach before turning off RF power output.

<FIG> illustrates the interface <NUM> of <FIG> coupled to two probes, where the probe A interface <NUM> is in automatic mode, and the probe B interface <NUM> is also in operation. When in the illustrated mode, the probe B interface <NUM> includes an adjustable power output <NUM> and an adjustable target temperature <NUM> for the selected thermocouple. The user may adjust these inputs manually based on the desired procedure. For example, the user may desire that the target temperature be <NUM>° C for <NUM> seconds.

<FIG> illustrates a flow chart of a method <NUM> for controlling a power output of a generator of a tumor ablation system based on tissue impedance. A tumor ablation system monitors <NUM> temperature of tissue surrounding a probe via multiple thermocouples. The multiple thermocouples measure temperature at different points along a length of the probe. The tumor ablation system receives <NUM> input from a user indicating a desired ablation region. The tumor ablation system determines <NUM> a primary thermocouple by determining which of the multiple thermocouples is nearest an outer perimeter of the desired ablation region. The tumor ablation system monitors <NUM> an impedance of the tissue between a first conductor and a second conductor of the probe. The tumor ablation system adjusts <NUM> an output current of a generator based on the measured impedance and temperature. The generator produces an electrical alternating current to be conducted between the first conductor and the second conductor via tissue within the desired ablation region. In one embodiment, the tumor ablation system decreases the output power when the impedance increases and/or when a maximum distal temperature is reached, and stops the output current when a temperature or thermal energy measurement at the primary thermocouple reaches a target threshold.

Any methods disclosed herein are not claimed as such. They include one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method.

Reference throughout this specification to an "embodiment" means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, references to embodiments throughout this specification are not necessarily all referring to the same embodiment.

Similarly, it should be appreciated by one of skill in the art with the benefit of this disclosure that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim requires more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims.

Claim 1:
A system for tumor ablation <NUM>, the system comprising:
a probe <NUM> comprising:
a first conductor <NUM>;
a second conductor <NUM> disposed distal to the first conductor <NUM> and extendable and/or retractable relative to the first conductor;
an insulator bushing <NUM> disposed between the first conductor <NUM> and the second conductor <NUM>;
a first thermocouple <NUM> to measure a temperature at a location on the second conductor <NUM>;
a second thermocouple <NUM> on the second conductor <NUM>;
a third thermocouple <NUM> on the second conductor <NUM>; and
a fourth thermocouple <NUM> on the second conductor <NUM>,
a generator to produce a current to be conducted between the first conductor <NUM> and the second conductor <NUM> to create an ablation region with a first potential ablation perimeter, and wherein the second thermocouple <NUM>, the third thermocouple <NUM>, and the fourth thermocouple <NUM> respectively define a second point along a second potential ablation perimeter, a third point along a third potential ablation perimeter, and a fourth point along a fourth potential ablation perimeter, wherein each of the potential ablation perimeters is different;
a processor (<NUM>) to:
monitor the temperature at the first, second, third, and fourth thermocouple;
monitor an impedance of the tissue between the first conductor <NUM> and the second conductor <NUM>; and
control an output of the generator to decrease the current when the impedance increases and to stop the current when a thermal dose reaches a target threshold; and
a display to provide a graphical user interface illustrating the first potential ablation perimeter, the second potential ablation perimeter, the third potential ablation perimeter, and the fourth potential ablation perimeter and the ablation region.