Patent Description:
The invention provides a medical device for spinal tumor ablation according to claim <NUM>.

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:.

Spinal tumor ablation devices can be used to treat a tumor in a vertebra of a patient. For example, a distal end of a spinal tumor ablation device may be inserted into a vertebra of a patient. In some instances, once the distal end of the spinal tumor ablation device is inserted into the vertebra of the patient, an articulating distal portion of the spinal tumor ablation device may be manipulated to position the tumor ablation device at a proper location within a tumor of the patient. The spinal tumor ablation device may then be activated. Activation of the spinal tumor ablation device may cause an electrical current (e.g., a radiofrequency current) to pass between a first electrode and a second electrode of the spinal 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). One or more temperature sensors may be used to measure the temperature of the heated tissue. Based on the information obtained from the one or more temperature sensors, the duration, position, and/or magnitude of the delivered thermal energy may be tailored to kill tissue within a desired region while avoiding the delivery of lethal amounts of thermal energy to healthy tissue. Once the tumor has been treated with thermal energy (e.g., radiofrequency energy), a cement may be delivered through a utility channel of the spinal tumor ablation 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 which 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 phrase "fluid communication" is used in its ordinary sense, and is broad enough to refer to arrangements in which a fluid (e.g., a gas or a liquid) can flow from one element to another element when the elements are in fluid communication with each other.

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> provide various views of a medical device <NUM> (or portions thereof) or a medical device assembly for use in a spinal tumor ablation procedure. More particularly, <FIG> provides an assembled perspective view of a medical device assembly comprising a medical device <NUM> and related medical implements <NUM>, <NUM>, <NUM>. <FIG> provides an exploded perspective view of the medical device <NUM>. <FIG> is a side view of the medical device <NUM>, with various components removed to expose other components. <FIG> is another side view of the medical device <NUM> with various component removed to expose other components. <FIG> is a perspective view of the medical device <NUM>, with a first portion of the housing <NUM> and the annular band <NUM> removed to expose certain components. <FIG> is another perspective view of the medical device <NUM>, with a second portion of the housing <NUM> and the annular band <NUM> removed to expose other components. <FIG> provide alterative cross-sectional views of the medical device <NUM>. <FIG> provide perspective views showing different portions of a handle <NUM> of the medical device <NUM>. <FIG> is a cross-sectional view of a distal portion of the medical device <NUM> in a linear configuration. <FIG> and <FIG> are cross-sectional views of the distal portion of the medical device <NUM> in different non-linear configurations.

As shown in <FIG>, the medical device <NUM> includes, among other elements, a first tubular conductor <NUM>, a tubular insulator <NUM>, a second tubular conductor <NUM>, a pointed distal end <NUM>, an elongate shaft <NUM>, a side port <NUM>, an outer sleeve <NUM>, a housing <NUM>, and a handle <NUM>.

The first tubular conductor <NUM> may be a metallic tube that extends from a proximal anchor <NUM> (e.g., a metallic anchor) to an open distal end. In some embodiments, the first tubular conductor <NUM> is rigid (or is rigid along most of its length). In some embodiments, the first tubular conductor <NUM> includes a plurality of slots <NUM> adjacent the open distal end of the first tubular conductor <NUM>. 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.

The tubular insulator <NUM> extends through the first tubular conductor <NUM> such that a proximal end of the tubular insulator <NUM> is proximal of the first tubular conductor <NUM> and a distal end of the tubular insulator <NUM> is distal of the first tubular conductor <NUM>. The 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®).

The second tubular conductor <NUM> may be a metallic tube that extends from a proximal anchor <NUM> (e.g., a metallic anchor) to an open distal end. The second tubular conductor <NUM> extends through the tubular insulator <NUM> such that a distal portion <NUM> of the second tubular conductor <NUM> is disposed distal of the tubular insulator <NUM>. The second tubular conductor <NUM> may form a utility channel <NUM> that extends from a proximal opening of the second tubular conductor <NUM> to a distal opening at the distal end of the second tubular conductor <NUM>. In some embodiments, the portion <NUM> of the second tubular conductor <NUM> that is disposed distal of the tubular insulator <NUM> is longitudinally offset from the first tubular conductor <NUM> by an exposed portion <NUM> of the tubular insulator <NUM>. The exposed portion <NUM> of the tubular insulator <NUM> may have a length of between <NUM> and <NUM>. Stated differently, the gap between the distal portion <NUM> of the second tubular conductor <NUM> and the distal end of the first tubular conductor <NUM> may be between <NUM> and <NUM>.

In some embodiments, the second tubular conductor <NUM> includes a plurality of slots <NUM> adjacent the distal end of the second tubular conductor <NUM>. The slots <NUM> may be perpendicular or angled relative to the primary axis of the second tubular conductor <NUM>. The plurality of slots <NUM> may be disposed opposite the slots <NUM> of the first tubular conductor <NUM>.

In some embodiments, the anchor <NUM> at the proximal end of the first tubular conductor <NUM> may be electrically coupled to an electrical contact <NUM> via a wire <NUM>. Similarly, in some embodiments, the anchor <NUM> at the proximal end of the second tubular conductor <NUM> may be electrically coupled to another electrical contact <NUM> via another wire <NUM>. In some embodiments, the wires <NUM>, <NUM> may travel through channels in the housing <NUM>. In some embodiments, one or both of the electrical contacts <NUM>, <NUM> are leaf spring contacts. When the electrical contacts <NUM>, <NUM> are coupled to a power source, the first tubular conductor <NUM> and the second tubular conductor <NUM> may function as electrodes with opposite polarity. In some embodiments, the electrical contacts <NUM>, <NUM> are secured to the housing <NUM> via one or more screws <NUM>.

The elongate shaft <NUM> may be at least partially disposed within the utility channel <NUM> of the second tubular conductor <NUM>. In some embodiments, the elongate shaft <NUM> is coupled to the second tubular conductor <NUM> such that manipulation of the elongate shaft <NUM> causes articulation of an articulating distal portion <NUM> of the medical device <NUM>. For example, in some embodiments, only a distal portion <NUM> of the elongate shaft <NUM> is attached (e.g., welded) to the second tubular conductor <NUM> (see <FIG>) while the remaining portion of the elongate shaft <NUM> is unattached from the second tubular conductor <NUM>. In other words, the distal portion <NUM> of the elongate shaft <NUM> may be attached to the second tubular conductor <NUM> adjacent a distal end of the second tubular conductor <NUM>. By displacing the elongate shaft <NUM> relative to the proximal end of the second tubular conductor <NUM> as described in greater detail below in connection with reference to <FIG>, the articulating distal portion <NUM> of the medical device <NUM> may be displaced (e.g., transition from a linear configuration to a non-linear configuration and vice versa).

In the depicted embodiment, the elongate shaft <NUM> includes a bulbous proximal end <NUM>. Stated differently, the elongate shaft <NUM> may include a ball at its proximal end. A distal portion <NUM> of the elongate shaft <NUM> may have a semicircular (e.g., D-shaped) cross-section. Due, in part, to the semicircular cross section of the elongate shaft <NUM>, the elongate shaft <NUM> may flex when a force is applied to the elongate shaft <NUM> and then return to a linear position when the force is removed. The distal portion <NUM> of the elongate shaft <NUM> may extend from the distal end of the elongate shaft <NUM> to a position that is proximal of the proximal opening of the second tubular conductor <NUM>. In some embodiments, the bulbous proximal end <NUM> of the elongate shaft <NUM> and the distal portion <NUM> of the elongate shaft <NUM> are separated by an intermediate portion <NUM> of the elongate shaft <NUM> that has a circular cross-section.

Due to the semicircular shape of the distal portion <NUM> of the elongate shaft <NUM>, the elongate shaft <NUM> may occupy only a portion of the space within the utility channel <NUM> of the second tubular conductor <NUM>. The remaining portion (e.g., a D-shaped portion) of the utility channel <NUM> may be used for other purposes, such as for obtaining a biopsy sample, positioning temperature sensors, and/or delivering cement to a vertebra of a patient as described in greater detail below.

The port <NUM> may be configured to provide access to a proximal opening of the utility channel <NUM>. Stated differently, the port <NUM> may be in fluid communication with the utility channel <NUM> of the second tubular conductor <NUM>. In the depicted embodiment, the port <NUM> is a side port that is disposed proximal of the second tubular conductor <NUM>. The port <NUM> may be designed to accommodate various medical implements, such as one or more of a thermal energy delivery probe <NUM> having one or more temperature sensors <NUM>, <NUM>, an elongate cutting instrument <NUM>, and a cement delivery cartridge <NUM> (see <FIG>). Stated differently, in some embodiments, the medial device <NUM> is configured to permit sequential (<NUM>) insertion of an elongate cutting instrument <NUM> into the port <NUM>, (<NUM>) removal of the elongate cutting instrument <NUM> from the port <NUM>, (<NUM>) insertion of a thermal energy delivery probe <NUM> into the port <NUM>, (<NUM>) removal of the thermal energy delivery probe <NUM> from the port <NUM>, and (<NUM>) insertion of the cement delivery cartridge <NUM> across the port <NUM>. In some embodiments, the port <NUM> includes indicia that help the practitioner to determine the position of one or more temperature sensors as described in greater detail below.

The outer sleeve <NUM> is attached directly (e.g., laser welded) to the distal portion <NUM> of the second tubular conductor <NUM> (see <FIG>). In the depicted embodiment, the outer sleeve <NUM> is offset from the first tubular conductor <NUM>. In other words, the outer sleeve <NUM> is not attached to the first tubular conductor <NUM>. In some embodiments, the outer sleeve <NUM> generally has an outer diameter that is substantially identical to the outer diameter of the first tubular conductor <NUM>. In some embodiments, the outer sleeve <NUM> includes one or more protrusions <NUM>, <NUM>, <NUM> (e.g., radiopaque protrusions) or intrusions (not shown). The one or more protrusions <NUM>, <NUM>, <NUM> or intrusions may facilitate fluoroscopic visualization as described in greater detail below. The outer sleeve <NUM> is a metallic tube.

In some embodiments, the medical device <NUM> has a pointed distal end <NUM>. The pointed distal end <NUM> may be formed from one or both of the second tubular conductor <NUM> and the outer sleeve <NUM>. The pointed distal end <NUM> may be configured to facilitate penetration of bone within the vertebra of a patient.

The housing <NUM> may be configured to encompass and/or protect various components of the medical device <NUM>. For example, in the depicted embodiment, the housing <NUM> encompasses, at least in part, a rotatable sleeve <NUM>, a casing <NUM>, an O-ring <NUM>, and a guide insert <NUM>. In some embodiments, the rotatable sleeve <NUM> has the general shape of a top hat. Indeed, in the depicted embodiment, the rotatable sleeve <NUM> includes an annular brim <NUM> that extends radially outward from the base of the rotatable sleeve <NUM>. Stated differently, the rotatable sleeve <NUM> may comprise a brim <NUM> that extends radially outward. The O-ring <NUM> may be positioned around the brim <NUM> of the rotatable sleeve <NUM>. The rotatable sleeve <NUM> may include interior threads <NUM> that are configured to mate with exterior threads <NUM> on the casing <NUM>. The casing <NUM> may be designed to encompass a proximal end of an elongate shaft <NUM>. For example, in some embodiments, the casing <NUM> encompasses the bulbous proximal end <NUM> of the elongate shaft <NUM>. In some embodiments, the casing <NUM> is formed by attaching a first half of the casing <NUM> that includes a hemisphere-shaped indentation with a second half of the casing <NUM> that includes another hemisphere-shaped indentation. The indentations on each half of the casing <NUM> may cooperate to form a spherical pocket that accommodates a bulbous proximal end <NUM> of the elongate shaft <NUM>.

The guide insert <NUM> may be disposed within the housing <NUM> to facilitate insertion of one or more elongate instruments into the utility channel <NUM> of the second tubular conductor <NUM>. For example, in some embodiments, the guide insert <NUM> is formed from a first half and a second half that together combine to form a funnel-shaped surface that directs elongate instruments into the utility channel <NUM>.

The housing <NUM> may include various recesses (see, e.g., <FIG>). For example, the housing <NUM> may include a first recess <NUM> that is configured to accommodate both the rotatable sleeve <NUM> and the casing <NUM> that is partially disposed within the rotatable sleeve <NUM>. The first recess <NUM> may jut out to form a disk-shaped cavity <NUM> that is designed to snugly accommodate the annular brim <NUM> of the rotatable sleeve <NUM>. The housing <NUM> may also include a second recess <NUM> that is designed to accommodate (e.g., secure) an anchor <NUM> at the proximal end of the second tubular conductor <NUM>. The housing <NUM> may also include a third recess <NUM> that is configured to accommodate (e.g., secure) an anchor <NUM> at the proximal end of the first tubular conductor <NUM>. In the depicted embodiment, the first recess <NUM> is disposed proximal of the second recess <NUM>, and the second recess <NUM> is disposed proximal of the third recess <NUM>. Due to the relative position of the second recess <NUM> relative to the third recess <NUM>, the anchors <NUM>, <NUM> (and therefore the proximal ends of the tubular conductors <NUM>, <NUM>) are longitudinally offset from one another. Stated differently, the anchor <NUM> at the proximal end of the first tubular conductor <NUM> may be disposed distal of the anchor <NUM> at the proximal end of the second tubular conductor <NUM>. In this manner, at least a portion of the second tubular conductor <NUM> is fixedly disposed relative to the first tubular conductor <NUM>. A portion <NUM> of the tubular insulator <NUM> may be disposed around the second tubular conductor <NUM> within the gap between the anchor <NUM> for the first tubular conductor <NUM> and the anchor <NUM> for the second tubular conductor <NUM>. In some embodiments, the gap is greater than <NUM>. For example, in some embodiments, the gap is between <NUM> and <NUM> in length.

In some embodiments, the first portion of the housing <NUM> and the second portion of the housing <NUM> are held together by one or more of an adhesive, a fastener, and annular bands <NUM>, <NUM>.

The handle <NUM> may include a first portion <NUM> (e.g., a proximal portion) and a second portion <NUM> (e.g., a distal portion). The first portion <NUM> of the handle <NUM> may include one or more flexible arms and one or more teeth <NUM> that project radially inward from the one or more flexible arms. The one or more teeth <NUM> may be configured to engage with one or more outer protrusions <NUM> on the rotatable sleeve <NUM>. The first portion <NUM> of the handle <NUM> may be rotatable relative to the second portion <NUM> of the handle <NUM>. As described in further detail below, rotation of the first portion <NUM> of the handle <NUM> may cause displacement (e.g., articulation) of a distal portion <NUM> of the medical device <NUM>. Stated differently, manipulation of the handle <NUM> may cause displacement of the articulating distal portion <NUM>. In some embodiments, the second portion <NUM> of the handle <NUM> is integrally formed with the housing <NUM>.

The medical device <NUM> may be used in one or more medical procedures, which are not within the scope of the invention, such as procedures to treat a spinal tumor in one or more vertebral bodies of a patient. For example, some medical procedures may involve obtaining the medical device <NUM> and inserting a distal end <NUM> of the medical device <NUM> into a vertebral body of a patient (e.g., a sedated patient in the prone position). In embodiments in which the distal end <NUM> of the medical device <NUM> is pointed, the pointed distal end <NUM> may facilitate penetration of bone within the vertebra of the patient. In some embodiments, the medical device <NUM> has sufficient strength to prevent buckling of the medical device <NUM> as the distal end of the medical device <NUM> is inserted within a vertebra (e.g., across the cortical bone) of the patient. In some embodiments, the distal end <NUM> of the medical device <NUM> is inserted into the patient via an introducer (not shown). In other embodiments, the medical device is such that the distal end <NUM> of the medical device <NUM> may be inserted into the patient without using an introducer.

In some circumstances, and with particular reference to <FIG>, once the distal end <NUM> of the medical device <NUM> is disposed within a vertebra of the patient, an elongate cutting instrument <NUM> may be inserted through the port <NUM> of the medical device <NUM> and into the utility channel <NUM> of the second tubular conductor <NUM>. The guide insert <NUM> may provide a funnel shaped opening that guides the elongate cutting instrument <NUM> into the utility channel <NUM>. The elongate cutting instrument <NUM> may include an elongate shaft <NUM> that terminates in a serrated end <NUM> (see <FIG>). The elongate shaft <NUM> may be flexible, thereby allowing the elongate shaft <NUM> to adopt a non-linear configuration. As the elongate cutting instrument <NUM> is inserted through the port <NUM>, the serrated end <NUM> of the elongate shaft <NUM> may emerge from an opening at the distal end <NUM> of the utility channel <NUM> and enter into tissue of the patient. By rotating the elongate cutting instrument <NUM> as shown in <FIG>, the serrated end <NUM> of the elongate cutting instrument <NUM> may cut into tissue of the patient to obtain a biopsy sample. Once the biopsy sample has been cut from the patient, the elongate cutting instrument <NUM> may be removed from the patient, and the sample may subjected to one or more tests.

In some embodiments, the elongate cutting instrument <NUM> includes interior threads <NUM> that mate with exterior threads <NUM> on the port <NUM> (see <FIG>). Mating of the interior threads <NUM> of the elongate cutting instrument <NUM> with exterior threads <NUM> on the port <NUM> may help a practitioner determine or estimate the position of the serrated end <NUM> of the elongate cutting instrument <NUM>.

In some embodiments, once the distal end <NUM> of the medical device <NUM> is disposed within a vertebra of the patient, the articulating distal portion <NUM> of the medical device <NUM> may be displaced. For example, the articulating distal portion <NUM> of the medical device <NUM> may be transitioned from a linear configuration (<FIG>) to one or more of a non-linear configuration (<FIG> and <FIG>). To effectuate this transition, the proximal portion <NUM> of the handle <NUM> may be rotated relative to the housing <NUM>. As the proximal portion <NUM> of the handle <NUM> is rotated, the inward-extending teeth <NUM> may engage with protrusions <NUM> on the rotatable sleeve <NUM>, thereby causing the rotatable sleeve <NUM> to rotate.

As the rotatable sleeve <NUM> is rotated, the casing <NUM> is proximally or distally displaced relative to the housing <NUM>. More specifically, due to the interaction of the interior threads <NUM> of the rotatable sleeve <NUM> with the exterior threads <NUM> of the casing <NUM>, the casing <NUM> is displaced in a proximal direction when the rotatable sleeve <NUM> is rotated in a first direction and in a distal direction when the rotatable sleeve <NUM> is rotated in a second direction that is opposite to the first direction. In the depicted embodiment, when the rotatable sleeve <NUM> is rotated, the rotatable sleeve <NUM> is not appreciably displaced in a proximal direction or a distal direction due to the interactions of the O-ring <NUM> and/or the brim <NUM> of the rotatable sleeve <NUM> with the cavity <NUM> of the first recess <NUM>. In other words, in some embodiments, the rotatable sleeve <NUM> does not move in a proximal direction or a distal direction with respect to the housing <NUM> because the rotatable sleeve <NUM> is snugly positioned within the disk-shaped cavity <NUM> of the first recess <NUM>. In the depicted embodiment, the casing <NUM> does not rotate due to the interaction of one or more flat surfaces of the casing <NUM> with the first recess <NUM>.

As the casing <NUM> is displaced in a proximal direction or a distal direction, the casing <NUM> may exert a force on the elongate shaft <NUM>, thereby causing the elongate shaft <NUM> to be displaced in a proximal direction or in a distal direction relative to the housing <NUM>, the anchors <NUM>, <NUM>, and/or at least a portion of the second tubular body <NUM>. Stated differently, due to the engagement of the casing <NUM> with the bulbous proximal end <NUM> of the elongate shaft <NUM>, the casing <NUM> may exert a proximal or distal force on the elongate shaft <NUM>, causing the elongate shaft <NUM> to be displaced in a proximal direction or a distal direction.

As the elongate shaft <NUM> is displaced in a distal direction, the distal portion <NUM> of the medical device <NUM> may transition from the linear configuration (<FIG>) to a non-linear configuration (<FIG>) in which the slots <NUM> of the second tubular conductor <NUM> are disposed on the convex side of the bend, and the slots <NUM> of the first tubular conductor <NUM> are disposed on the concave side of the bend. In contrast, when the elongate shaft <NUM> is displaced in a proximal direction, the distal portion <NUM> of the medical device <NUM> may transition to a non-linear configuration in which the slots <NUM> of the second tubular conductor <NUM> are disposed on the concave side of the bend while the slots <NUM> of the first tubular conductor <NUM> are disposed on the convex side of the bend (see <FIG>). As the elongate shaft <NUM> is displaced in proximal and distal directions, the distal portion <NUM> of the medical device <NUM> may transition from a linear configuration to a non-linear configuration in only a single plane. Stated differently, in some embodiments, movement of the distal portion <NUM> of the medical device <NUM> is limited to a single plane. By rotating the rotatable sleeve <NUM> a selected amount, the articulating distal portion <NUM> may be bent to a selected degree.

In some instances, articulation of the distal portion <NUM> of the medical device <NUM> may facilitate placement of the distal portion <NUM> of the medical device <NUM> at a desired location for ablation. Stated differently, the medical device <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 medical device <NUM> may additionally or alternatively mechanically displace tissue (e.g., tumor cells) within the vertebra of the patient. For example, the medical device <NUM> may function as an articulating osteotome that enables site-specific cavity creation. Stated differently, the articulating distal portion <NUM> of the medical device <NUM> may be robust enough to facilitate navigation through hard tissue of a patient. Thus, in the manner described above, manipulation of the handle <NUM> may cause displacement of both the elongate shaft <NUM> and the articulating distal portion <NUM> of the medical device <NUM>. Stated differently, the practitioner may articulate a distal portion <NUM> of the medical device <NUM> such that the distal portion <NUM> transitions from a linear configuration to a non-linear configuration (and vice versa).

In some embodiments, the medical device <NUM> is configured to prevent a practitioner from exerting an excessive amount of torque on the rotatable sleeve <NUM>, which could potentially damage one or more components (e.g., the elongate shaft <NUM> or the articulating distal portion <NUM>) of the medical device <NUM>. For example, in some embodiments, the one or more teeth <NUM> that project radially inward from arms of the proximal portion <NUM> of the handle <NUM> (see <FIG>) may be configured to deflect outward when too much torque is provided, thereby causing the proximal portion <NUM> of the handle <NUM> to disengage from the protrusions <NUM> on the rotatable sleeve <NUM> (see <FIG>). More particularly, at a selected torque-for example a torque ranging from greater than about <NUM> inch-pounds but less than about <NUM> inch-pounds-the proximal portion <NUM> of the handle <NUM> may disengage from the protrusions <NUM> on the rotatable sleeve <NUM>. Such disengagement prevents the practitioner from exerting an excessive amount of force on the rotatable sleeve <NUM>. Stated differently, the proximal portion <NUM> of the handle <NUM> may function as a torque limiter.

Once the distal tip <NUM> of the medical device <NUM> has been inserted into the patient and the articulating distal portion <NUM> of the medical device has been positioned at the desired location (e.g., within a tumor) in a preferred orientation (e.g., such that the distal portion <NUM> is bent), the medical device <NUM> may be activated for ablation within a vertebra of a patient such that an electrical current flows between the distal portion <NUM> of the second tubular conductor <NUM> to the first tubular conductor <NUM> via tissue within the vertebra of the patient. Stated differently, the first tubular conductor <NUM> may function as first electrode and the second tubular conductor <NUM> may function as a second electrode such that an electrical current flows between the first electrode and the second electrode via tissue within a vertebral body of the patient. In some procedures, the temperature of tissue within the vertebral body of the patient may be measured as the electrical current flows between the first electrode and the second electrode. In some procedures, the process of treating a spinal tumor does not involve advancement or retraction of the electrodes relative to one another. In some procedures, the process of treating a spinal tumor does not involve displacement of the first electrode and/or the second electrode via a spring. Stated differently, in some procedures, neither the first electrode nor the second electrode is coupled to a spring.

To activate the medical device <NUM> for ablation, the practitioner may, as shown in <FIG>, insert a thermal energy delivery probe <NUM> through the port <NUM> such that the thermal energy delivery probe <NUM> is at least partially disposed within the utility channel <NUM> of the second tubular conductor <NUM>. The guide insert <NUM> may facilitate such insertion by guiding the thermal energy delivery probe <NUM> into the utility channel <NUM>. In the depicted embodiment, the thermal energy delivery probe <NUM> includes a shell <NUM>, a main body <NUM>, a stylet <NUM>, a first electrical contact <NUM>, a second electrical contact <NUM>, and an adaptor <NUM> for connecting to a power supply. In some embodiments, the shell <NUM> of the thermal energy delivery probe <NUM> is rotatable relative to a main body <NUM> of the thermal energy delivery probe <NUM>. In some embodiments, the shell <NUM> of the thermal energy delivery probe <NUM> may be rotated (see <FIG>) relative to the port <NUM> to selectively couple the thermal energy delivery probe <NUM> to the port <NUM>. In some embodiments, the thermal energy delivery probe <NUM> may further include interior threads <NUM> that are configured to engage with exterior threads <NUM> on the port <NUM>. In other words, rotation of the thermal energy delivery probe <NUM> relative to the port <NUM> may cause thread-based displacement of the thermal energy delivery probe <NUM> relative to the second tubular conductor <NUM>. Stated differently, rotating the thermal energy delivery probe <NUM> relative to a side port <NUM> of the medical device <NUM> may result in adjustment of the position(s) of one or more temperature sensors <NUM>, <NUM> that are attached to the stylet <NUM> of the thermal energy delivery probe <NUM>.

Upon insertion, the first electrical contact <NUM> of the thermal energy delivery probe <NUM> may be in electrical communication with the electrical contact <NUM> of the medical device <NUM>, and the second electrical contact <NUM> may be in electrical communication with the electrical contact <NUM> of the medical device <NUM>. In some embodiments, one or both of the electrical contacts <NUM>, <NUM> are leaf spring contacts. The leaf spring contacts <NUM>, <NUM> may be configured to maintain electrical contact with the contacts <NUM>, <NUM> of the thermal energy delivery probe <NUM> as the stylet <NUM> of the thermal energy delivery probe <NUM> is displaced relative to the second tubular conductor <NUM>. In other words, electrical communication between the contacts <NUM>, <NUM> of the thermal energy delivery probe <NUM> and the contacts <NUM>, <NUM> may be maintained despite movement of the thermal energy delivery probe <NUM> relative to the housing <NUM>. Electrical communication between the contacts <NUM>, <NUM> and the contacts <NUM>, <NUM> may create an electrical circuit for the delivery of thermal energy to tissue of the patient. The electrical contacts <NUM>, <NUM> may be raised electrical contacts that are hard wired to the adaptor <NUM> (e.g., a LEMO style adaptor).

The thermal energy delivery probe <NUM> may be inserted through the port <NUM> to vary the position of one or more temperature sensors <NUM>, <NUM> (e.g., thermocouples) that are attached to or otherwise coupled to the stylet <NUM> of the thermal energy delivery probe <NUM>. In other words, in some embodiments, the thermal energy delivery probe <NUM> is displaceable with respect to the second tubular conductor <NUM>, thereby enabling displacement of the one or more temperature sensors <NUM>, <NUM> relative to the second tubular conductor <NUM>. For example, in some embodiments, the thermal energy delivery probe <NUM> is inserted such that a temperature sensor <NUM> is aligned with a protrusion <NUM> of the on the outer sleeve <NUM>. In some instances, indicia on the port <NUM> may help a practitioner to determine the position of a temperature sensor.

For example, in some embodiments, when the thermal energy delivery probe <NUM> is inserted into the port <NUM> and rotated such that the bottom edge of a hub <NUM> of the thermal energy delivery probe <NUM> is aligned with a first indicium <NUM>, a temperature sensor <NUM> may be disposed a particular distance (D<NUM> of <FIG>) (e.g., <NUM>) from a center of the exposed portion <NUM> of the tubular insulator <NUM>. When the bottom edge of the hub <NUM> is aligned with the second indicium <NUM>, the temperature sensor <NUM> may be disposed a different distance (D<NUM> of <FIG>) (e.g., <NUM>) from a center of the exposed portion <NUM> of the tubular insulator <NUM>. When the bottom edge of the hub <NUM> is aligned with the third indicium <NUM>, the temperature sensor <NUM> may be disposed still another distance (D<NUM> of <FIG>) (e.g., <NUM>) from a center of the exposed tubular insulator <NUM>.

In some embodiments, when the bottom edge of the hub <NUM> (or some other portion of the thermal energy delivery probe <NUM>) is aligned with an indicium <NUM>, <NUM>, <NUM> on the port <NUM>, the temperature sensor <NUM> may be aligned with a protrusion <NUM>, <NUM>, <NUM> or intrusion (not shown) on the outer sleeve <NUM>, thereby allowing the practitioner to determine the position of the temperature sensor by fluoroscopy. In some embodiments, a second temperature sensor <NUM> may be disposed proximal of a first temperature sensor <NUM>. For example, a first temperature sensor <NUM> of the thermal energy delivery probe <NUM> may be disposed at or adjacent to the distal end of the stylet <NUM> while a second temperature sensor <NUM> is disposed proximal of the first temperature sensor <NUM>.

In some embodiments, such as the embodiment depicted in <FIG>, instead of one or more protrusions on the outer sleeve <NUM>', the medical device <NUM>' may instead include one or more intrusions <NUM>', <NUM>', <NUM>' or protrusions (not shown) adjacent the distal end of the first tubular conductor <NUM>'. In other words, in some embodiments, one or more protrusions or intrusions <NUM>', <NUM>', <NUM>' are disposed proximal of the insulator <NUM>'. The intrusions <NUM>', <NUM>', <NUM>' or protrusions may be visible by radiography. The medical device <NUM>' may be configured such that a temperature sensor of the thermal energy delivery probe is aligned with an intrusion <NUM>', <NUM>', <NUM>' or protrusion when the bottom edge of the hub (or some other portion of the thermal energy delivery probe) is aligned with an indicium (e.g., an indicium on the port). Aligning a temperature sensor with one of the intrusions <NUM>', <NUM>', <NUM>' may be accomplished in a manner similar to that described above in connection with protrusions <NUM>, <NUM>, <NUM> on the outer sleeve <NUM>. In some embodiments, protrusions and/or intrusions are disposed on both the outer sleeve and the first tubular conductor. Some embodiments may lack protrusions and/or intrusions on both the outer sleeve and the first tubular conduit.

Once the articulating distal portion <NUM> of the medical device <NUM> is properly positioned within the tissue of the vertebra and the one or more temperature sensors <NUM>, <NUM> are properly positioned within the utility channel <NUM> of the medical device <NUM>, the medical device <NUM> may be activated for ablation, thereby causing an electrical current to flow between the distal portion <NUM> of the second tubular conductor <NUM> and the first tubular conductor <NUM> via tissue within the vertebra of the patient. For example, an adaptor <NUM> of the thermal energy delivery probe <NUM> may be connected to a power supply (e.g., a radiofrequency generator). An actuator that is in electrical communication with the power supply and/or the thermal energy delivery probe may then be actuated, thereby creating a radiofrequency current that flows through a circuit that includes the thermal energy delivery device <NUM>, the electrical contacts <NUM>, <NUM>, the electrical contacts <NUM>, <NUM>, the wires <NUM>, <NUM>, the first tubular conductor <NUM>, the second tubular conductor <NUM>, and the tissue of the patient. The radiofrequency current may flow from the radiofrequency generator, through the electrical contacts <NUM>, <NUM>, through the wire <NUM> down the second tubular conductor <NUM>, arching across the exposed portion <NUM> of the insulator <NUM> through tissue of the patient to the first tubular conductor <NUM>, through the wire <NUM>, across the contacts <NUM>, <NUM>, and back to the generator. In this manner, radiofrequency energy may be provided between the first tubular conductor <NUM> and the second tubular conductor <NUM> via tissue of the patient. Due to the oscillation of the current at radio frequencies, the tissue through which the electrical current travels and/or tissue within the near-field region may be heated. Stated differently, due to the electrical current flowing between the electrodes, ionic agitation occurs, thereby creating friction which heats up nearby tissue. Once the tissue has reached a sufficient temperature (e.g., approximately <NUM>, such as between <NUM> and <NUM>) as measured by one or more temperature sensors, such as the temperature sensors <NUM>, <NUM> on the stylet <NUM> of the thermal energy delivery probe <NUM>, the medical device <NUM> may be deactivated, thereby preventing the unintended heating of healthy tissue. Stated differently, one or more thermocouples may be used to actively monitor temperature within the desired ablation region. When radiofrequency energy from the thermal energy delivery device <NUM> causes the tissue to reach a predetermined (e.g., ablation) temperature, the medical device <NUM> may be deactivated, thereby restricting ablation to the desired region. In this manner, predictable, measurable, and/or uniform ablation zones may be created in cancerous tissue. In other words, once temperature measurements from the one or more temperature sensors have been obtained, the practitioner may, based on the input from the one or more temperature sensors, (<NUM>) alter the location of the distal end <NUM> of the medical device <NUM>, (<NUM>) change the flow rate of electrical current, and/or (<NUM>) change the voltage across the electrodes.

If desired, multiple rounds of ablation may be carried out in a single procedure. For example, after a portion of the tissue within a tumor has been ablated using the technique described above, the articulating distal portion <NUM> of the medical device <NUM> may be repositioned to a new location within the tumor. Once positioned in this new location, the medical device <NUM> may be activated to kill tissue in a second region of the tumor. This process may be completed as many times as is necessary to ensure that the entire tumor is adequately treated. Once there is no need or desire for further ablation, the thermal energy delivery probe <NUM> may be retracted and removed from the port <NUM> of the medical device <NUM>.

Once the tissue from the tumor has been treated by radiofrequency energy, a bone cement may be delivered to a cavity within the vertebra of the patient, thereby providing stabilization to the vertebra. For example, in some embodiments, the medical device <NUM> includes a cement delivery cartridge <NUM> (see <FIG>) that is configured to facilitate delivery of a bone cement through the utility channel <NUM> of the medical device <NUM> and out of a distal opening at the distal end <NUM> of the second tubular conductor <NUM>. The cement delivery cartridge <NUM> may include a stylet <NUM>, an elongate tubular distal portion <NUM>, an inflexible hollow portion <NUM>, a proximal adaptor <NUM> (e.g., a luer connection), and a latch <NUM>.

To deliver bone cement to the vertebra of the patient, the distal end of the cement delivery cartridge <NUM> may be inserted into the port <NUM> of the medical device <NUM> as shown in <FIG>. As the cement delivery cartridge <NUM> is inserted into the port <NUM>, the stylet <NUM> of the cement delivery cartridge <NUM> may be disposed within a channel of the cement delivery cartridge. The stylet <NUM> may confer increased rigidity to the tubular distal portion <NUM> of the cement delivery cartridge <NUM> during insertion into the utility channel <NUM> of the medical device <NUM>.

In some embodiments, the tubular distal portion <NUM> of the cement delivery device <NUM> can be inserted into the utility channel <NUM> of the medical device <NUM> only one way due to the geometry of the cement delivery cartridge <NUM> and the port <NUM>. In some embodiments, the tubular distal portion <NUM> is flexible, thereby allowing the tubular distal portion <NUM> to adopt a non-linear path.

As the cement delivery cartridge <NUM> is inserted into the port <NUM>, a latch <NUM> on the side of the cement delivery cartridge <NUM> may slide across a discontinuity <NUM> in the threads <NUM> and become seated within a recess <NUM> in the port <NUM>. In this manner, the latch <NUM> may lock the cement delivery cartridge <NUM> to the port <NUM> without rotation of the cement delivery cartridge <NUM> relative to the port <NUM>. Once the cement delivery cartridge <NUM> is locked to the port <NUM>, the stylet <NUM> may be removed (see <FIG>).

Once the stylet <NUM> has been removed (see <FIG>), the cement delivery cartridge <NUM> may be coupled to a pump (not shown) that is configured to pump bone cement into a cavity in the vertebra of a patient. For example, the pump may deliver bone cement to the proximal adaptor <NUM> of the cement delivery cartridge <NUM> and then advance the bone cement through the cement delivery cartridge <NUM> into the vertebra of the patient.

In some embodiments, the bone cement comprises methyl methacrylate. In some embodiments, the bone cement is an ultra-high viscosity bone cement with an extended working time. The bone cement, once hardened, may stabilize the vertebra of the patient.

Once the cement has been delivered to the patient, the cement delivery cartridge <NUM> may be uncoupled from the port <NUM> of the medical device <NUM> by pressing the latch <NUM> toward the adaptor <NUM> and pulling the cement delivery cartridge <NUM> out of both the utility channel <NUM> and the port <NUM>.

Articulation or bending of the distal portion <NUM> of the medical device <NUM> may be utilized to position the distal portion <NUM> of the medical device <NUM> for delivery of cement via the cement delivery cartridge <NUM>, positioning of the elongate cutting instrument <NUM> when taking a biopsy, and/or for targeting the area to which thermal energy is delivered and the thermal energy delivery probe <NUM> is coupled to the medical device <NUM>.

Devices, assemblies and methods may deviate somewhat from the particular devices and methods discussed above in connection with the medical device <NUM>. For example, in some procedures, no biopsy sample is obtained during the medical procedure. Stated differently, in some procedures, no elongate cutting instrument is employed during the medical procedure. In some procedures, no cement is delivered through a utility channel of a medical device that is also used for ablation. In other words, in some procedures, cement delivery involves the use of a separate medical device. For example, in some embodiments, one or both of the second tubular conductor and the outer sleeve have sealed distal ends that do not allow for the delivery of cement through the medical device.

<FIG> and <FIG> depict an embodiment of a medical device <NUM> that resembles the medical device <NUM> described above in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to "<NUM>. " For example, the embodiment depicted in <FIG> includes a handle <NUM> that may, in some respects, resemble the handle <NUM> of <FIG>. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the medical device <NUM> and related components shown in <FIG> may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the medical device <NUM> and related components depicted in <FIG> and <FIG>. Any suitable combination of the features, and variations of the same, described with respect to the medical device <NUM> and related components illustrated in <FIG> can be employed with the medical device <NUM> and related components of <FIG> and <FIG>, and vice versa.

<FIG> provides a perspective view of the medical device <NUM>, while <FIG> provides a cross-sectional side view of the medical device <NUM>. Like the medical device <NUM> described above, the medical device <NUM> is configured to facilitate tumor ablation, but is not designed for the delivery of bone cement to the patient. In other words, in embodiments that use the medical device <NUM>, bone cement is generally delivered using a separate medical device.

More particularly, the medical device <NUM> includes a side adaptor <NUM> that is integrated with the housing <NUM>. The adaptor <NUM> is configured to couple to a power supply that delivers radiofrequency energy to heat and/or kill tissue within the patient.

The medical device <NUM> further includes a slidable tab <NUM> that is configured to facilitate placement of one or more temperature sensors <NUM>, <NUM> within a utility channel <NUM> of the medical device <NUM>. More particularly, the slidable tab <NUM> may be coupled to a rod <NUM> that is coupled to a stylet <NUM>. By sliding the slidable tab <NUM> in a proximal direction, the stylet <NUM> may be retracted. Conversely, by sliding the slidable tab <NUM> in a distal direction, the stylet <NUM> may be advanced. In this manner, the position of temperature sensors <NUM>, <NUM> that are attached to the stylet <NUM> may be controlled. For example, in some embodiments, the housing <NUM> includes one of more indicia that help a practitioner determine the location of one or more temperature sensors. For example, when the slidable tab <NUM> is aligned with a first indicium on the housing <NUM>, a temperature sensor <NUM> on the stylet <NUM> may be aligned with a first protrusion <NUM> on the outer sleeve. When the slidable tab <NUM> is aligned with a second indicium on the housing <NUM>, the temperature sensor <NUM> may be aligned with a second protrusion <NUM> on the outer sleeve. Other indicia may indicate alignment of a temperature sensor <NUM> with one or more other features or elements of the medical device <NUM>.

Any methods disclosed herein, which fall outside the scope of the invention, 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 method, the order and/or use of specific steps and/or actions may be modified. Moreover, subroutines 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.

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 medical device (<NUM>, <NUM>) for spinal tumor ablation, the medical device comprising:
a first tubular conductor (<NUM>);
a tubular insulator (<NUM>) extending through the first tubular conductor such that a proximal end of the tubular insulator is proximal of the first tubular conductor and a distal end of the tubular insulator is distal of the first tubular conductor;
a second tubular conductor (<NUM>) extending through the tubular insulator (<NUM>) such that a distal portion of the second tubular conductor (<NUM>) is disposed distal of the tubular insulator (<NUM>), wherein at least a portion of the second tubular conductor is fixedly disposed relative to the first tubular conductor; and
an articulating distal portion (<NUM>) of the medical device that is configured to transition from a linear configuration to a non-linear configuration;
characterized in that it further comprises,
an outer sleeve (<NUM>) which is a metallic tube that is attached directly to the distal portion of the second tubular conductor (<NUM>) and the outer sleeve is not attached to the first tubular conductor (<NUM>), wherein a majority of the outer sleeve (<NUM>) has an outer diameter that is substantially identical to the outer diameter of the first tubular conductor (<NUM>);
wherein the medical device is configured such that, when the medical device is activated for ablation within a vertebra of a patient, an electrical current flows between the distal portion of the second tubular conductor (<NUM>) and the first tubular conductor (<NUM>) via tissue within the vertebra of the patient.