WO2022155334A1

WO2022155334A1 - Ablation devices and methods of manufacturing the same

Info

Publication number: WO2022155334A1
Application number: PCT/US2022/012310
Authority: WO
Inventors: Calin Druma
Original assignee: Medtronic Holding Company Sárl
Priority date: 2021-01-14
Filing date: 2022-01-13
Publication date: 2022-07-21
Also published as: EP4277555A1

Abstract

An ablation device includes a probe body, a distal face covering a distal end of the probe body and defining a central aperture, a distal tip extending through the central aperture in sealing relation therewith, and a sensing probe. The distal tip extends from a proximal end within an interior volume of the probe body to a distal end distally-spaced therefrom and defines a lumen. The sensing probe is sealed within the lumen and extends from within the interior volume distally through a portion of the lumen to a position proximally-spaced from the distal end of the distal tip. A portion of the sensing probe is exposed within an unoccupied volume of the lumen defined between the sensing probe and the distal end of the distal tip to enable direct contact between the exposed portion of the sensing probe and tissue extending into the unoccupied volume.

Description

ABLATION DEVICES AND METHODS OF MANUFACTURING THE SAME

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of, and priority to, U.S. Provisional Patent Application No. 63/137,499, filed on January 14, 2021, the entire contents of which are hereby incorporated herein by reference.

FIELD

[0002] The present disclosure relates generally to ablation and, more particularly, to ablation devices such as, for example, fluid-cooled Radio Frequency (RF) ablation devices, and methods of manufacturing the same.

BACKGROUND

[0003] Treatment of certain diseases requires destruction of malignant tissue growths, e.g., tumors. Tumor tissue can be destroyed via ablation, which involves heating the tumor tissue to sufficiently high temperatures to destroy, e.g., ablate, the tumor tissue while maintaining tissue surrounding the energy applicator at lower temperatures to avoid charring of tissue abutting the applicator in order to promote a large ablation. Such ablation may be accomplished by applying electromagnetic energy such as RF energy or microwave energy to the tumor tissue to heat and, thereby, ablate the tumor tissue.

[0004] Nerve pain and spinal metastases are some of the most common causes of severe pain among patients with cancer. Spinal tumor ablation using electromagnetic radiation can be used for the palliative treatment of painful metastases and nerve pain secondary to advanced cancer disease.

SUMMARY

[0005] As used herein, the term “distal” refers to the portion that is being described which is farther from an operator (whether a human surgeon or a surgical robot), while the term “proximal” refers to the portion that is being described which is closer to the operator. Terms including “generally,” “about,” “substantially,” and the like, as utilized herein, are meant to encompass variations, e.g., manufacturing tolerances, material tolerances, use and environmental tolerances, measurement variations, and/or other variations, up to and including plus or minus 10 percent. Further, any or all of the aspects described herein, to the extent consistent, may be used in conjunction with any or all of the other aspects described herein. [0006] Provided in accordance with aspects of the present disclosure is an ablation device including a probe body, a distal face, a distal tip, and a sensing probe. The probe body defines an interior volume. The distal face covers a distal end of the probe body and defines a central aperture. The distal tip extends through the central aperture in sealing relation therewith. The distal tip includes a proximal end disposed within the interior volume, a distal end distally- spaced from the probe body, and a lumen extending longitudinally between the proximal and distal ends of the distal tip. The sensing probe is disposed in sealing relation within the lumen. The sensing probe extends from within the interior volume distally through a portion of the lumen to a position proximally-spaced from the distal end of the distal tip. A portion of the sensing probe is exposed within an unoccupied volume of the lumen defined between the sensing probe and the distal end of the distal tip to enable direct contact between the exposed portion of the sensing probe and tissue extending into the unoccupied volume.

[0007] In an aspect of the present disclosure, the distal end of the distal tip defines at least one cutting edge annularly surrounding the lumen. The at least one cutting edge may include a serrated annular cutting edge. The at least one cutting edge may alternatively include at least one beveled cutting edge and at least one peak cutting edge.

[0008] In another aspect of the present disclosure, the sensing probe includes a thermocouple configured to sense temperature of tissue in direct contact with the exposed portion of the sensing probe.

[0009] In another aspect of the present disclosure, at least one fluid conduit extends at least partially through the interior volume. The at least one fluid conduit is configured to deliver fluid to the interior volume or receive fluid from the interior volume to facilitate fluid circulation through the interior volume.

[0010] In still another aspect of the present disclosure, the probe body includes or defines at least one electrode configured to be energized with RF energy for ablating tissue. In such aspects, the at least one electrode may include an active electrode configured to conduct RF energy through tissue to a remote return pad in a monopolar configuration. Alternatively, the at least one electrode may include first and second electrodes configured to conduct RF energy therebetween and through tissue in a bipolar configuration.

[0011] In yet another aspect of the present disclosure, the ablation device further includes a connection hub supporting a proximal end portion of the probe body. In aspects, a cable coupled to the connection hub houses at least one electrical lead for connection to the probe body. In additional or alternative aspects, inflow and outflow tubing are coupled to the connection hub for providing fluid inflow and fluid outflow to and from the probe body. [0012] In still yet another aspect of the present disclosure, an outer insulative jacket is disposed about a portion of the probe body.

[0013] In another aspect of the present disclosure, the distal tip is welded to the distal face about the central aperture to seal the distal tip within the central aperture.

[0014] In another aspect of the present disclosure, the sensing probe is welded to the distal tip about the lumen to seal the sensing probe within the lumen.

[0015] In yet another aspect of the present disclosure, the distal face tapers distally and radially inwardly from an outer diameter of the probe body to the central aperture.

[0016] In still another aspect of the present disclosure, the distal tip includes a proximal portion and a distal portion. The distal portion tapers distally and radially inwardly from an outer diameter of the proximal portion to the lumen at the distal end of the distal tip.

[0017] A method of manufacturing an ablation device provided in accordance with aspects of the present disclosure includes inserting a distal tip partially through a central aperture defined within a distal face covering a distal end of a probe body such that a proximal end of the distal tip is disposed within an interior volume of the probe body while a distal end of the distal tip remains distally-spaced from the probe body. The method further includes welding the distal tip to the distal face about the central aperture to seal the distal tip within the central aperture of the distal face. The method additionally includes inserting a sensing probe partially through a lumen defined within the distal tip such that the sensing probe extends from within the interior volume distally through a portion of the lumen to a position proximally-spaced from a distal end of the distal tip. The method also includes welding the sensing probe to the distal tip about the lumen to seal the sensing probe within the lumen of the distal tip.

[0018] In an aspect of the present disclosure, the probe body includes or defines at least one electrode and the method further includes attaching an electrical lead to each of the at least one electrode.

[0019] In an aspect of the present disclosure, the method further includes attaching a connection hub to a proximal portion of the probe body. The connection hub includes inflow and outflow conduits extending therethrough for circulating fluid through the interior volume of the probe body.

BRIEF DESCRIPTION OF DRAWINGS

[0020] The above and other aspects and features of the present disclosure will become more apparent in view of the following detailed description when taken in conjunction with the accompanying drawings wherein like reference numerals identify similar or identical elements. [0021] FIG. 1 is a side view of an ablation device provided in accordance with the present disclosure;

[0022] FIG. 2 is a perspective view of the ablation device of FIG. 1 extending through an introducer and into a vertebral body for ablating tissue therein;

[0023] FIG. 3 A is a perspective view of a distal portion of the ablation device of FIG. 1;

[0024] FIG. 3B is a longitudinal, cross-sectional view of the distal portion of the ablation device of FIG. 1;

[0025] FIG. 4 is a perspective view of the distal portion of the ablation device of FIG. 1 including another distal tip configuration in accordance with the present disclosure;

[0026] FIGS. 5 and 6 are longitudinal, cross-sectional views of the distal portion of the ablation device of FIG. 1 including first and second electrode configurations, respectively;

[0027] FIGS. 7 and 8 are longitudinal, cross-sectional views of the distal portion of the ablation device of FIG. 1 including first and second cooling fluid circulation configurations, respectively; and

[0028] FIG. 9 is a schematic illustration of a robotic surgical system configured for use in accordance with the present disclosure.

DETAILED DESCRIPTION

[0029] FIG. 1 illustrates an ablation device in accordance with the present disclosure shown generally identified by reference numeral 10. Ablation device 10 may be configured to facilitate spinal tumor ablation, as detailed below, although it is also contemplated that ablation device 10 be utilized to facilitate ablation of other tissue structures, ablation of tissue at other anatomical locations, and/or to otherwise treat, e.g., coagulate, transect, etc., tissue. Ablation device 10 generally includes an energizable ablation probe 100, a connection hub 200, a cable 300, and inflow and outflow tubing 400, 500. Although ablation device 10 is detailed herein as configured to deliver RF energy to tissue to ablate or otherwise treat tissue, it is contemplated that ablation device 10 may additionally or alternatively be configured to deliver other suitable forms of energy such as, for example, microwave, ultrasonic, thermal, etc.

[0030] Ablation probe 100 defines an elongated configuration and may be substantially linear, curved, or otherwise configured to facilitate accessing tissue to be ablated. In aspects, ablation probe 100 is at least partially formed form a resiliently flexible material, e.g., a shape memory material, to enable resilient flexion of ablation probe 100 to assume as desired trajectory for accessing tissue to be ablated. In additional or alternative aspects, ablation probe 100 is at least partially formed from a rigid, semi-rigid, malleable, and/or other suitable material (s). Ablation probe 100 includes a body 110 and a distal tip 120. In aspects, an outer insulative jacket 102 is disposed about a portion of body 110 such that ablation probe 100 defines a more-proximal insulated portion and a more-distal treating portion. Distal tip 120, as detailed below, may be configured to facilitate penetration into and/or anchoring within tissue including hard tissue, e.g., bone. Ablation probe 100 is described in greater detail below as are additional features and/or components thereof.

[0031] Connection hub 200 supports a proximal end portion of body 110 of ablation probe 100 with ablation probe 100 extending distally from connection hub 200 to distal tip 120. In aspects, connection hub 200 functions as a handle of ablation device 10, enabling a user to grasp and manipulate connection hub 200 to thereby manipulate ablation probe 100. Alternatively, connection hub 200 may be configured to mount on a robotic arm 1002, 1003 of a robotic surgical system 1000 (see FIG. 9) to enable robotic manipulation of ablation probe 100. Electrical connections such as, for example, electrode lead wires, e.g., an active electrode lead (in monopolar RF configurations) or positive and negative electrode leads (in bipolar RF configurations), sensing leads, e.g., thermocouple leads, and/or other energy-delivery, sensing, or communication leads extend from cable 300 into connection hub 200 for connection to and/or routing through ablation probe 100. Inflow and outflow tubing 400, 500 likewise extend into connection hub 200 for routing to and/or through ablation probe 100, e.g., to enable the circulation of cooling fluid through ablation probe 100, as detailed below.

[0032] Continuing with reference to FIG. 1, cable 300 includes a plug 310 disposed at a first end thereof configured to connect to an energy source (not shown), e.g., an electrosurgical generator. Cable 300 extends from plug 310 to connection hub 200 and houses the electrical connections, e.g., energy-delivery, sensing, and/or communication leads, to establish electrical connection of ablation probe 100 with the electrosurgical generator upon connection of plug 310 to the electrosurgical generator. The electrosurgical generator is configured to provide suitable energy to ablation probe 100 for treating, e.g., ablating, tissue. For example, generator 300 may provide monopolar or bipolar RF energy to ablation probe 100 for ablating tissue, as detailed below, although other suitable forms of energy, e.g., microwave, ultrasonic, thermal, etc., and/or tissue treatments are also contemplated. The electrosurgical generator is further configured to receive temperature feedback information from ablation probe 100, e.g., for display on a display screen associated with the electrosurgical generator, feedback-based control of the supply of energy, safety control, etc.

[0033] Inflow and outflow tubing 400, 500 may be routed through cable 300, separately from cable 300, or may include one or more portions routed through cable 300 and one or more portions routed separately from cable 300. Inflow and outflow tubing 400, 500, as noted above, extend into connection hub 200 for routing to and/or through ablation probe 100, e.g., to enable the circulation of cooling fluid through ablation probe 100, as detailed below. Inflow and outflow tubing 400, 500 include connectors 410, 510, respectively, configured to connect to a fluid system (not shown) or to separate supply and collection systems (not shown). The fluid system(s) may be closed or open loop. The fluid system(s) may include a pump to facilitate the circulation of fluid to/from ablation device 10. The fluid system(s) may be integrated with the electrosurgical generator or may be separate from the electrosurgical generator. The fluid may be water or any other suitable cooling fluid.

[0034] Referring also to FIG. 2, in use ablation probe 100 of ablation device 10 (FIG. 1) is inserted through an introducer 600 and into a vertebral body “V” to a position adjacent tissue, e.g., a tumor, to be treated, e.g., ablated. Distal tip 120 of ablation probe 100 may penetrate the vertebral body “V” and anchor therein to facilitate positioning and to maintain the positioning of ablation probe 100 within the vertebral body “V.” Once the desired position of ablation probe 100 has been achieved, ablation probe 100 is energized to ablate the tumor. Ablation probe 100 may be energized in accordance with any suitable mode of operation such as, for example: at a suitable energy intensity, e.g., LOW power or HIGH power; for a suitable energy duration, e.g., 1 minute, 2 minutes, or 5 minutes; or in accordance with a suitable energy profile, e.g., continuous, pulsed, etc. Ablation probe 100 may be cooled via the circulation of fluid through ablation probe 100: simultaneously with energy delivery, intermittently during energy delivery, using temperature feedback control, or in any other suitable manner. Ablation probe 100, as mentioned above, may alternatively be utilized for treating other tissue, at other anatomical locations, and/or for other treatment effects, e.g., coagulation.

[0035] Turning to FIGS. 3A and 3B, as noted above, ablation probe 100 of ablation device 10 (FIG. 1) includes a body 110 and a distal tip 120. Ablation probe 100 further includes a distal face 140 defining a central aperture 150, and a sensing probe 160. As noted above, ablation probe 100 may also include, in aspects, an outer insulative jacket 102 (FIG. 1).

[0036] Body 110 of ablation probe 100 defines an elongated configuration, is substantially cylindrical (although other configurations are also contemplated) and defines a substantially hollow interior volume 130. At least a portion of body 110 may be formed from an electrically- conductive material adapted to connect to the electrosurgical generator to enable the at least a portion of body 110 to function as one or more electrodes in an RF energy circuit for heating and treating, e.g., ablating, tissue. Alternatively or additionally, electrodes may be disposed on or within body 110 for similar purposes. Exemplary electrode configurations of body 110 are detailed below with reference to FIGS. 5 and 6. Interior volume 130 of body 110 enables the circulation of fluid through body 110 to facilitate cooling ablation probe 100 during and/or after use. Exemplary cooling configurations for circulating fluid through interior volume 130 of body 110 are detailed below with reference to FIGS. 7 and 8.

[0037] Continuing with reference to FIGS. 3 A and 3B, distal face 140 is disposed at a distal end of body 110 and central aperture 150 is defined through distal face 140. Distal face 140 extends from and is monolithically formed with body 110. Distal face 140 tapers radially inwardly and distally from an outer diameter of body 110 to central aperture 150, e.g., in a conical fashion or other suitable manner. Central aperture 150 is aligned on a longitudinal axis defined through body 110 and communicates with interior volume 130 of body 110.

[0038] Distal tip 120 of ablation probe 100 extends through central aperture 150 of distal face 140 such that a distal portion of distal tip 120 extends distally from distal face 140 and body 110 (externally of body 110) while a proximal portion of distal tip 120 extends into interior volume 130 of body 110 (internally within body 110). Distal tip 120 may be welded to distal face 140, e.g., seam welded about central aperture 150, may be secured to distal face 140 in any other suitable manner, e.g., via an adhesive, overmolding, crimping, soldering, mechanical fastening, etc., or may be monolithically formed with distal face 140. Regardless of the specific manner of attachment, distal tip 120 is received within and sealingly coupled with distal face 140 to inhibit the passage of fluid, e.g., cooling fluid, therebetween. Distal tip 120 may be formed from an electrically-conductive material and may be in electrical communication, e.g., via direct contact, with body 110 to enable energization thereof together with body 110, or may insulated or isolated from body 110.

[0039] Distal tip 120 includes a proximal body portion 122 that extends through central aperture 150 of distal face 140 and into body 110 of ablation probe 100, and a distal end portion 124 that extends distally from proximal body portion 122 distally of body 110 of ablation probe 100. Distal tip 120 also defines a lumen 126, e.g., a cylindrical lumen, extending longitudinally therethrough that communicates with interior volume 130 of body 110 via an open proximal end. Proximal body portion 122 defines a generally cylindrical configuration having an outer diameter that generally approximates the diameter of central aperture 150 to enable the abovedetailed sealed attachment therebetween. Distal end portion 124 of distal tip 120 tapers radially inwardly and distally from an outer diameter of body 110 to an open distal end of lumen 126 and defines a serrated annular distal edge 128 surrounding the open distal end of lumen 126. Serrated annular distal edge 128 facilitates the penetration of distal tip 120 through tissue including hard tissue such as bone, as well as the anchoring of distal tip 120 within tissue. The taper of distal end portion 124 of distal tip 120 facilitates advancement of distal tip 120 through tissue.

[0040] Referring still to FIGS. 3A and 3B, sensing probe 160 is received partially within body 110 of ablation probe 100 and extends distally into the open proximal end of lumen 126 of distal tip 120 through a portion of lumen 126 of distal tip 120 such that a distal -most extent of sensing probe 160 is positioned distally of body 110 but proximally of the open distal end of lumen 126. That is, the distal-most extent of sensing probe 160 is recessed from the open distal end of lumen 126. In this manner, with sensing probe 160 received within lumen 126 of distal tip 120, an unoccupied volume 170 of lumen 126 is defined annularly within distal end portion 124 of distal tip 120 and longitudinally between the distal end of sensing probe 160 and the open distal end of lumen 126.

[0041] Sensing probe 160 defines a generally cylindrical configuration having an outer diameter that generally approximates the diameter of lumen 126 to enable sealed attachment of sensing probe 160 within lumen 126 of distal tip 120, thereby inhibiting the passage of fluid, e.g., cooling fluid, from interior volume 130 of body 110 of ablation probe 100 through lumen 126. Sensing probe 160 may be attached to distal tip 120 via welding, e.g., seam welded about lumen 126, or may be secured thereto in any other suitable manner, e.g., via an adhesive, overmolding, crimping, soldering, mechanical fastening, etc.

[0042] Sensing probe 160 may be a thermocouple probe. More specifically, sensing probe 160 may be a sheathed (or unsheathed) thermocouple probe including a pair of thermoelements 162, a connector 164 coupling the thermoelements 162 at their distal ends, and insulation 165 encasing the thermoelements 162 and connector 164. Other suitable thermocouple probe configurations are also contemplated. In sheathed configurations, a sheath 166 surrounds insulation 165. A distal end cap 168 may be disposed at the distal end of sheath 166 (although, in aspects, distal end cap 168 may be integrally formed with sheath 166 or omitted). Connector 164 may be grounded to distal end cap 168 or positioned adjacent (but not electrically coupled to) distal end cap 168. Alternatively, connector 164 may be exposed to define an exposed thermocouple probe. In any of the above or other configurations, connector 164 enables temperature measurement at the distal end of sensing probe 160, e.g., of tissue in contact with an outer surface of distal end cap 168 (and/or other distal portion of sensing probe 160).

[0043] As a result of the above-detailed arrangement of sensing probe 160 within distal tip 120, the outer surface of distal end cap 168 (and/or other distal portion of sensing probe 160) is exposed within unoccupied volume 170 of lumen 126. Thus, as distal tip 120 penetrates tissue and is anchored therein, tissue enters unoccupied volume 170 of lumen 126 and is directly contacted by the outer surface of distal end cap 168 of sensing probe 160 (and/or another distal portion of sensing probe 160). Such a configuration enables direct temperature measurement of the tissue via sensing probe 160 without intermediate structures, e.g., body 110, distal tip 120, etc., therebetween. Thus, a more accurate and more real-time tissue temperature reading can be obtained.

[0044] A cable 169 extends from sensing probe 160 proximally through body 110, into connection hub 200, and through cable 300 to enable connection to the electrosurgical generator to enable display of tissue temperature, temperature-based energy control, implementation of temperature-based safety features, etc.

[0045] As an alternative to a thermocouple probe, sensing probe 160 may incorporate any other suitable temperature-sensing device such as, for example, a thermistor, infrared sensor, thermometer, change-of-state sensor, or silicon diode. Further still, other sensing devices for sensing other properties of tissue, e.g., electrical properties, acoustic properties, optical properties, etc., may additionally or alternatively be incorporated into sensing probe 160 for direct contact measurement of tissue properties. Such sensed properties may likewise be transmitted to the electrosurgical generator to enable display, feedback-based energy control, implementation of safety features, etc.

[0046] With reference to FIG. 4, as an alternative to having an annular distal edge 128 define a serrated configuration (FIGS. 3A and 3B), distal tip 120 of ablation probe 100 may define an annular distal edge 1128 having a plurality of beveled cutting edge portions 1129a and/or cutting peak edge portions 1129b. The beveled cutting edge portion(s) 1129a and/or cutting peak edge portion(s) 1129b may be arranged to define any suitable configuration such as, for example, a trocar cutting tip, a diamond cutting tip, etc.

[0047] Referring to FIG. 5, in aspects, ablation probe 100 defines a monopolar configuration wherein an active lead 180 is coupled to body 110 of ablation probe 100 and the electrosurgical generator such that body 110 (and, in aspects, distal tip 120 via electrical communication with body 110) functions as the active electrode, while a remote return electrode pad (not shown) disposed on the patient and connected to the electrosurgical generator functions as the return electrode to complete the monopolar circuit. Thus, when body 110 is energized, RF energy is conducted from body 110 to tissue to heat and treat, e.g., ablate, tissue, before returning to the electrosurgical generator via the return electrode pad.

[0048] FIG. 6 illustrates a bipolar configuration of ablation probe 100 wherein body 110 includes one or more positive electrodes 192 and one or more negative electrodes 194, e.g., disposed in alternating fashion or otherwise arranged. In aspects, electrodes 192, 194 are configured as rings disposed about or within body 110. Each electrode 192, 194 may be disposed on, within, or formed as part of body 110. In such aspects, body 110 may be at least partially formed from an electrically-insulative material, at least partially coated with an electrically-insulative material, or otherwise configured to maintain isolation between the positive electrodes 192 and negative electrodes 194. Positive and negative leads 193, 195, are coupled to positive and negative electrodes 192, 194, respectively, and the electrosurgical generator such that energy may be conducted between the positive and negative electrodes 192, 194 and through tissue adjacent thereto to heat and treat, e.g., ablate, tissue.

[0049] As shown in FIG. 7, body 110 of ablation probe 100 includes an inflow conduit 700 extending therethrough. Inflow conduit 700 may extend at least a majority of a length of body 110, may extend at least 75% of the length of body 110, or may extend at least 90% of the length of body 110. Inflow conduit 700 may be longitudinally aligned on a longitudinal axis of body 110 or may be offset relative thereto. Inflow conduit 700 may extend about a portion of sensing probe 160 and/or distal tip 120 or may terminate proximally thereof. Inflow conduit 700 is coupled to inflow tubing 400 (FIG. 1), e.g., within connection hub 200 (FIG. 1), to enable the flow of fluid from inflow tubing 400 (FIG. 1) distally through inflow conduit 700 and into interior volume 130 of body 110. Inflow conduit 700 may have an open distal end and/or one or more openings, e.g., apertures, slots, etc., defined therethrough to enable the flow of fluid from inflow conduit 700 into the interior volume 130 of body 110. The fluid is thus permitted to flow distally within interior volume 130 of body 110, externally of inflow conduit 700, back to connection hub 200, wherein outflow tubing 500 (FIG. 1) is coupled to interior volume 130 to receive the returned cooling fluid. During use, this circulation of cooling fluid through ablation probe 100 serves to cool ablation probe 100 to inhibit excessive thermal damage such as charring to adjacent tissue.

[0050] Referring to FIG. 8, body 110 of ablation probe 100 includes a pair of spaced-apart inflow conduits 800 extending therethrough. Inflow conduits 800 may extend similar or different amounts and may extend at least majority of a length of body 110, may extend at least 75% of the length of body 110, or may extend at least 90% of the length of body 110. Inflow conduits 800 are coupled to inflow tubing 400 (FIG. 1), e.g., within connection hub 200 (FIG. 1), to enable the flow of fluid from inflow tubing 400 (FIG. 1) distally through inflow conduits 800 and into interior volume 130 of body 110. Inflow conduits 800 may have open distal ends and/or one or more openings, e.g., apertures, slots, etc., defined therethrough to enable the flow of fluid from inflow conduits 800 into the interior volume 130 of body 110. The fluid is thus permitted to flow distally within interior volume 130 of body 110, externally of inflow conduits 800, back to connection hub 200, wherein outflow tubing 500 (FIG. 1) is coupled to interior volume 130 to receive the returned fluid. As above, this circulation of cooling fluid through ablation probe 100 serves to cool ablation probe 100 to inhibit excessive thermal damage such as charring to adjacent tissue.

[0051] As an alternative to providing two inflow conduits 800, one of the conduits 800 may function as an inflow and the other as an outflow, such that cooling fluid flows from the inflow conduit 800 into interior volume 130 and from interior volume 130 into the outflow conduit 800 for cooling ablation probe 100.

[0052] Referring to FIGS. 1, 7, and 8, suitable seals (not shown) may be provided at the proximal end of ablation probe 100 and/or within connection hub 200 to direct fluid from inflow tube 400 into inflow conduits 700, 800 and/or into interior volume 130 and to direct fluid from outflow conduit 800 and/or interior volume 130 to outflow tube 500.

[0053] With general reference to FIGS. 1-8, ablation device 10 and, more specifically, ablation probe 100 thereof, enables direct contact temperature measurement of tissue. That is, when distal tip 120 penetrates and is anchored within tissue, tissue enters unoccupied volume 170 of distal tip 120 and contacts sensing probe 160, thus enabling direct contact temperature measurement of the tissue via sensing probe 160. In addition to being positioned for direct contact temperature measurement of tissue, the sealed coupling of sensing probe 160 within lumen 126 of distal tip 120 also serves to close lumen 126 of distal tip 120, thus sealing the distal end of interior volume 130 of body 110 to enable circulation of cooling fluid through body 110 without loss of fluid.

[0054] Turning to FIG. 9, a robotic surgical system 1000 configured for use in accordance with the present disclosure is shown. Aspects and features of robotic surgical system 1000 not germane to the understanding of the present disclosure are omitted to avoid obscuring the aspects and features of the present disclosure in unnecessary detail.

[0055] Robotic surgical system 1000 generally includes a plurality of robot arms 1002, 1003; a control device 1004; and an operating console 1005 coupled with control device 1004. Operating console 1005 may include a display device 1006, which may be set up in particular to display three-dimensional images; and manual input devices 1007, 1008, by means of which a person, e.g., a surgeon, may be able to telemanipulate robot arms 1002, 1003 in a first operating mode. Robotic surgical system 1000 may be configured for use on a patient 1013 lying on a patient table 1012 to be treated in a minimally invasive manner. Robotic surgical system 1000 may further include a database 1014, in particular coupled to control device 1004, in which are stored, for example, pre-operative data from patient 1013 and/or anatomical atlases.

[0056] Each of the robot arms 1002, 1003 may include a plurality of members, which are connected through joints, and a mounted device which may be, for example, a surgical tool “ST.” The surgical tools “ST” may include, for example, one or more of the ablation devices of the present disclosure, one or more introducers, an endoscope or other visualization device, etc.

[0057] Robot arms 1002, 1003 may be driven by electric drives, e.g., motors, connected to control device 1004. The motors, for example, may be rotational drive motors configured to provide rotational inputs to accomplish a desired task or tasks. Control device 1004, e.g., a computer, may be configured to activate the motors, in particular by means of a computer program, in such a way that robot arms 1002, 1003, and, thus, their mounted surgical tools “ST” execute a desired movement and/or function according to a corresponding input from manual input devices 1007, 1008, respectively. Control device 1004 may also be configured in such a way that it regulates the movement of robot arms 1002, 1003 and/or of the motors.

[0058] Control device 1004, more specifically, may control one or more of the motors based on rotation, e.g., controlling to rotational position using a rotational position encoder (or Hall effect sensors or other suitable rotational position detectors) associated with the motor to determine a degree of rotation output from the motor and, thus, the degree of rotational input provided. Alternatively or additionally, control device 1004 may control one or more of the motors based on torque, current, or in any other suitable manner.

[0059] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques).

[0060] While several configurations of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular configurations. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims

WHAT IS CLAIMED IS:

1. An ablation device, comprising: a probe body defining an interior volume; a distal face covering a distal end of the probe body and defining a central aperture; a distal tip extending through the central aperture in sealing relation therewith, the distal tip including a proximal end disposed within the interior volume, a distal end distally-spaced from the probe body, and a lumen extending longitudinally between the proximal and distal ends of the distal tip; and a sensing probe disposed in sealing relation within the lumen, the sensing probe extending from within the interior volume distally through a portion of the lumen to a position proximally-spaced from the distal end of the distal tip, wherein a portion of the sensing probe is exposed within an unoccupied volume of the lumen defined between the sensing probe and the distal end of the distal tip to enable direct contact between the exposed portion of the sensing probe and tissue extending into the unoccupied volume.

2. The ablation device according to claim 1, wherein the distal end of the distal tip defines at least one cutting edge annularly surrounding the lumen.

3. The ablation device according to claim 2, wherein the at least one cutting edge includes a serrated annular cutting edge.

4. The ablation device according to claim 2, wherein the at least one cutting edge includes at least one beveled cutting edge and at least one peak cutting edge.

5. The ablation device according to claim 1, wherein the sensing probe includes a thermocouple configured to sense temperature of tissue in direct contact with the exposed portion of the sensing probe.

6. The ablation device according to claim 1, further comprising at least one fluid conduit extending at least partially through the interior volume and configured to deliver fluid to the interior volume or receive fluid from the interior volume to facilitate fluid circulation through the interior volume.

7. The ablation device according to claim 1, wherein the probe body includes or defines at least one electrode configured to be energized with RF energy for ablating tissue.

8. The ablation device according to claim 7, wherein the at least one electrode includes an active electrode configured to conduct RF energy through tissue to a remote return pad in a monopolar configuration.

9. The ablation device according to claim 7, wherein the at least one electrode includes first and second electrodes configured to conduct RF energy therebetween and through tissue in a bipolar configuration.

10. The ablation device according to claim 1, further comprising a connection hub supporting a proximal end portion of the probe body.

11. The ablation device according to claim 10, further comprising a cable coupled to the connection hub and housing at least one electrical lead for connection to the probe body.

12. The ablation device according to claim 10, further comprising inflow and outflow tubing coupled to the connection hub for providing fluid inflow and fluid outflow to and from the probe body.

13. The ablation device according to claim 1, further comprising an outer insulative jacket disposed about a portion of the probe body.

14. The ablation device according to claim 1, wherein the distal tip is welded to the distal face about the central aperture to seal the distal tip within the central aperture.

15. The ablation device according to claim 1, wherein the sensing probe is welded to the distal tip about the lumen to seal the sensing probe within the lumen.

16. The ablation device according to claim 1, wherein the distal face tapers distally and radially inwardly from an outer diameter of the probe body to the central aperture.

17. The ablation device according to claim 1, wherein the distal tip includes a proximal portion and a distal portion, the distal portion tapering distally and radially inwardly from an outer diameter of the proximal portion to the lumen at the distal end of the distal tip.

18. A method of manufacturing an ablation device, comprising: inserting a distal tip partially through a central aperture defined within a distal face covering a distal end of a probe body such that a proximal end of the distal tip is disposed within an interior volume of the probe body while a distal end of the distal tip remains distally- spaced from the probe body; welding the distal tip to the distal face about the central aperture to seal the distal tip within the central aperture of the distal face; inserting a sensing probe partially through a lumen defined within the distal tip such that the sensing probe extends from within the interior volume distally through a portion of the lumen to a position proximally-spaced from a distal end of the distal tip; and welding the sensing probe to the distal tip about the lumen to seal the sensing probe within the lumen of the distal tip.

19. The method according to claim 18, wherein the probe body includes or defines at least one electrode, and wherein the method further comprises attaching an electrical lead to each of the at least one electrodes.

20. The method according to claim 18, further comprising attaching a connection hub to a proximal portion of the probe body, the connection hub including inflow and outflow conduits extending therethrough for circulating fluid through the interior volume of the probe body.

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