ENDOMETRIAL ABLATION

CROSS-REFERENCE

[0001] N/A

STATEMENT AS TO FEDERALLY SPONSORED RESEARCH

[0002] N/A

BACKGROUND

[0003] The present disclosure relates to medical devices, systems, and methods. In particular, the present disclosure relates to medical devices for therapeutically ablating tissue, such as endometrial tissue.

[0004] Menorrhagia, otherwise known as heavy menstrual bleeding, is a condition which affects many adult women and can be indicative of more serious conditions such as uterine cancer, uterine fibroids, endometrial polyps, or uterine infection. There are many ways to treat menorrhagia, including hormonal medication or other drugs, endometrial ablation or the ablation of the uterine lining, myomectomy or the surgical removal of uterine fibroids, or in the most serious cases, hysterectomy, or the complete removal of the uterus.

[0005] Endometrial ablation has been an increasingly prevalent treatment because it can be an outpatient procedure and can have relatively high success rates. In at least some cases, however, current systems, devices, and method for endometrial ablation can be less than ideal.

[0006] In many cases, the tissue is ablated with radiofrequency (RF) energy, and the power and ablation time of the RF energy may need to be in a precise range to effect the desired tissue ablation while minimizing the risk of undesired tissue injury. Typically, the power setting of the RF generator and hence the power of the ablation is a function of the measured dimensions of the uterus, i.e., its length and width and surface area. In many current endometrial ablation devices, the dimensions of the uterus must be manually measured before being manually input into the RF generator. Accordingly, there may be errors associated with the manual data input and the manual measurement of uterine dimensions.

[0007] In many cases, current endometrial ablation devices are manufactured to meet product specifications within the tolerances the endometrial ablation devices are designed for. Each of the components of the endometrial ablation devices, however, may have their own tolerances which may stack up for the complete endometrial ablation device. Additionally, the ablation energy generator (e.g., RF energy generator) and/or the interface of the generator with the ablation device may have their own tolerances as well that may stack up with the coupled ablation device. These stacked-up tolerances may result in device performance that deviates from the product specification such that the endometrial ablation devices may need to be calibrated before use. Calibration may add undesired extra steps to ablation procedures and users may not calibrate the devices correctly or even know to calibrate the devices. Therefore, improvements to the calibration process may be desired.

[0008] In many cases, current systems, devices, and methods for performing endometrial ablation may be less than ideal. For example, the ablation systems may provide treatment progress information to the user or operator in a less than ideal fashion. Also, the ablation systems may provide safety checks that are less than ideal.

[0009] For at least these reasons, improved systems, devices, and methods for ablating tissue, particularly endometrial tissue, are desired.

[0010] References that may be of interest include: U.S. Patents Nos. 4,815,299, 5,445,635, 5,769,880, 6,032,673, 6,261,247, 6,369,812, 6,508,815, 6,554,780, 7,344,533, 7,470,271, 7,792,589, 8,079,957, 8,237,784, 8,276,091, 8,323,208, 8,443,634, 8,476, 172, 8,795,205, 8,805,480, 8,814,796, 8,821,490, 8,834,487, 8,840,626, 8,874,230, 9,072,882, 9,272, 161, 9,462,960, 9,474,566, and 9,554,853, and U.S. Publications Nos. 2015/150497, 2016/095648, and 2017/071781.

SUMMARY

[0011] The present disclosure relates to systems, devices, and methods of tissue ablation, particularly endometrial ablation, which overcomes at least some of the aforementioned drawbacks. Exemplary tissue ablation devices described herein may include one or more sensors to automatically measure the dimensions of the target bodily organ, typically the uterus, and automatically transmit the dimensional information to a coupled ablation energy generator or other controller. The one or more sensors are typically electronic sensors and comprise at least some electronics such as to transit the data to other device(s). The dimensional information may be shown on the controller or a display coupled to the controller as a virtual representation of the target bodily organ with the corresponding measured dimensions. The ablation devices and systems may automatically prevent the tissue ablation procedure from starting or may

automatically halt the procedure if the measured dimensions are not within certain thresholds. Exemplary tissue ablation devices may include circuitry configured to store calibration information for the ablation device, and the circuitry may provide calibration instructions to a coupled ablation energy generator or other controller. The ablation devices and systems may be calibrated to more accurately measure the dimensions of the bodily organ.

[0012] An aspect of the present disclosure provides tissue ablation apparatuses for ablating an inner wall of a bodily organ. An exemplary tissue ablation apparatus may comprise an outer shaft, an inner shaft, an expandable ablation member coupled to one or more of the outer or inner shaft, a first sensor, and a second sensor. The outer and inner shaft may be translatable relative to one another to shift the expandable ablation member between a collapsed configuration and an expanded configuration. The first sensor may be configured to detect a width of the expandable ablation member. A width of the bodily organ may be determined based on the detected width of the expandable ablation member when the expandable ablation member is advanced into the bodily organ and expanded. The second sensor may be configured to detect a length of the expandable ablation member advanced into the bodily organ. A length of the bodily organ may be determined based on the detected length.

[0013] The first sensor may comprise a linear encoder coupled to one or more of the inner or outer shafts to measure translation of the inner and outer shafts relative to one another. The width of the expandable ablation member may be determined based on the measured translation.

[0014] The expandable ablation member may comprise an expandable frame. The expandable frame may be coupled to the outer and inner shafts such that translation of the shafts shifts the expandable frame between expanded and collapsed configurations. The first sensor may comprise a strain gauge coupled to the expandable frame to measure a shape change of the expandable frame. The width of the expandable ablation member may be determined based on the measured shape change. The first sensor may comprise one or more electronic sensors coupled to the expandable frame to measure one or more of a length or width of the expandable frame. The one or more electronic sensors may comprise one or more of a photonic sensor, a resistive sensor, an impedance sensor, a capacitance sensor, an electro-magnetic sensor, a Hall effect sensor, a potentiometer, or a strain-gauge.

[0015] The second sensor may comprise a linear encoder coupled to one or more of the inner or outer shafts to measure a distance between a distal end of the expandable ablation member and an entry point of the expandable ablation member into the bodily organ.

[0016] The exemplary tissue ablation apparatus may further comprise a third sensor. The third sensor may be configured to measure one or more of temperature, humidity, ablation member impedance, tissue impedance, oxygenation, tissue oxygenation, blood oxygenation, or blood pressure. The third sensor may be detachably coupled to one or more of the expandable ablation member, the inner shaft, or the outer shaft. The exemplary tissue ablation apparatus may further comprise a transmitter configured to transmit a parameter detected by the third sensor to an external controller. The transmitter may be configured to transmit the parameter to the external controller wirelessly or through a wired connection.

[0017] The expandable ablation member may comprise one or more ablation electrodes.

[0018] The exemplary tissue ablation apparatus may further comprise a user interface configured to show one or more of the measured width or length of the bodily organ. The exemplary tissue ablation apparatus may further comprise a handle coupled to a proximal end of one or more of the inner or outer shafts, wherein the handle comprises the user interface.

[0019] The exemplary tissue ablation apparatus may further comprise a transmitter configured to transmit one or more of the measured width or length of the bodily organ to an external controller. The transmitter may be configured to transmit the one or more of the measured width or length to the external controller wirelessly or through a wired connection. The transmitter may be coupled to one or more of the sensors.

[0020] Another aspect of the present disclosure provides methods of ablating an inner wall of a bodily organ. In an exemplary method, a tissue ablation apparatus comprising an expandable ablation member may be provided. The expandable ablation member may be advanced into the bodily organ and expanded. A width of the expandable ablation member expanded within the bodily organ may be automatically measured. A width of the bodily organ may be determined in response to the measured width of the expandable ablation member. A distance between a distal end of the expandable ablation member and an entry point of the expandable ablation member advanced into the bodily organ may be automatically measured. A length of the bodily organ may be determined in response to the measured distance.

[0021] The tissue ablation apparatus may comprise an outer shaft and an inner shaft translatable relative to one another to shift the expandable ablation member between a collapsed configuration and an expanded configuration. To automatically measure the width of the expandable ablation member, the translation of the inner and outer shafts relative to one another may be automatically measured such as with a linear encoder.

[0022] The expandable ablation member may comprise an expandable frame. The expandable frame may be coupled to the outer and inner shafts such that translation of the shafts shifts the expandable frame between expanded and collapsed configurations. To automatically measure the width of the expandable ablation member, one or more of a shape change, a length, or a width of the expandable frame may be automatically measured such as with one or more of a a photonic sensor, resistive sensor, an impedance sensor, a capacitance sensor, an electro-magnetic sensor, a Hall effect sensor, a potentiometer, or a strain-gauge. [0023] The tissue ablation apparatus may comprise a shaft having a distal end coupled to the expandable ablation member. To automatically measure the distance between the distal end of the expandable ablation member and an entry point of the expandable ablation member width of the expandable ablation member, a position of an opening of the bodily organ relative to the shaft may be automatically measured. The position of the opening of the bodily organ relative to the shaft may be measured with a linear encoder.

[0024] One or more of temperature, humidity, ablation member impedance, tissue impedance, oxygenation, tissue oxygenation, blood oxygenation, or blood pressure may be measured. One or more ablation parameters of the tissue ablation apparatus in response to the measured one or more of temperature, humidity, ablation member impedance, tissue impedance, oxygenation, tissue oxygenation, blood oxygenation, or blood pressure may be automatically modified, such as based on one or more of the measured parameters. The inner wall of the bodily organ may be ablated after the one or more ablation parameters have been automatically modified and/or as the one or more ablation parameters are automatically modified. The measured one or more of temperature, humidity, ablation member impedance, tissue impedance, oxygenation, tissue oxygenation, blood oxygenation, or blood pressure may be transmitted to an external controller. The measured one or more of temperature, humidity, ablation member impedance, tissue impedance, oxygenation, tissue oxygenation, blood oxygenation, or blood pressure may be transmitted to the external controller wirelessly or through a wired connection.

[0025] One or more ablation parameters of the tissue ablation apparatus may be automatically modified in response to one or more of the determined width or length of the bodily organ. The inner wall of the bodily organ may be ablated after the one or more ablation parameters have been automatically modified or as the one or more ablation parameters is automatically modified.

[0026] One or more of the determined width or length of the bodily organ may be transmitted to an external controller. The determined width or length of the bodily organ may be transmitted to the external controller wirelessly or through a wired connection.

[0027] One or more of the determined width or length of the bodily organ may be displayed on a user interface. The user interface may be on one or more of the handle of the tissue ablation apparatus or an external controller in communication with the tissue ablation apparatus. The one more of the determined width or length of the bodily organ may be displayed on the user interface as a virtual representation of the bodily organ. The bodily organ may comprise a uterus and the inner wall may comprise a uterine wall. [0028] Another aspect of the present disclosure provides tissue ablation apparatuses for ablating an inner wall of a bodily organ. An exemplary tissue ablation apparatus may comprise a shaft, an expandable ablation member, a handle, and calibration circuitry. The shaft may have a proximal end and a distal end. The expandable ablation member may be coupled to the distal end of the shaft. The handle may be coupled to the proximal end of the shaft and configured to operate the expandable ablation member to ablate tissue. The calibration circuitry may be configured to store calibration information for the tissue ablation apparatus and communicate said information to an external controller.

[0029] The calibration circuitry may be disposed within the handle. The exemplary tissue ablation apparatus may further comprise a transmitter coupled to the calibration circuitry to transmit the calibration information to the external controller. The transmitter may be configured to transmit the calibration information to the external controller wirelessly or through a wired connection. The transmitter may be configured to transmit the calibration information to the external controller through a wired connection.

[0030] The external controller may be configured to provide ablation energy to the expandable ablation member and adjust the ablation energy in response to the calibration information received from the transmitter. The external controller may be configured to adjust the ablation energy provided to the expandable ablation member as the expandable ablation member is ablating tissue.

[0031] The calibration circuitry may be coupled to one or more sensors coupled to one or more of the shaft or expandable ablation member. The one or more sensors may be configured to detect or measure one or more of a width of the expandable ablation member, a length of the expandable ablation member, an insertion depth of the expandable ablation member, tissue impedance, tissue temperature, expandable ablation member temperature, humidity,

oxygenation, tissue oxygenation, blood oxygenation, or blood pressure. The calibration information may comprise calibration information for one or more of width detection with the expandable ablation member, insertion depth measurement with the expandable ablation member, tissue impedance measurement, tissue temperature measurement, expandable ablation member temperature measurement, humidity measurement, gas measurement, chemical measurement, oxygen measurement, carbon dioxide measurement, or pH measurement.

[0032] Another aspect of the present disclosure provides methods of ablating tissue within a bodily organ. In an exemplary method, a tissue ablation apparatus and an external controller may be coupled to one another. Calibration information transmitted from the tissue ablation apparatus may be received with the external controller. The calibration information may be stored within calibration circuitry of the tissue ablation apparatus. An ablation energy generator may be adjusted based on the received calibration information. The ablation energy generator may be coupled to the tissue ablation apparatus. The tissue may be ablated with the tissue ablation apparatus with energy generated by the ablation energy generator as adjusted based on the calibration information.

[0033] The calibration circuitry may be disposed within a handle of the tissue ablation apparatus. The calibration circuitry may be transmitted from the tissue ablation apparatus to the external controller wirelessly. The calibration circuitry may be transmitted from the tissue ablation apparatus to the external controller through a wired connection.

[0034] The energy generated by the ablation energy generator may be adjusted as the tissue is being ablated. The one or more sensors of the tissue ablation apparatus may detect or measure one or more parameters, and the external controller may receive the detected or measured one or more parameters and adjust the ablation energy generator in response. The one or more sensors may be configured to detect or measure one or more of a width of the expandable ablation member, a length of the expandable ablation member, an insertion depth of the expandable ablation member, tissue impedance, tissue temperature, expandable ablation member temperature, humidity, oxygenation, tissue oxygenation, blood oxygenation, or blood pressure. The calibration information may comprise calibration information for one or more of width detection with the expandable ablation member, insertion depth measurement with the expandable ablation member, tissue impedance measurement, tissue temperature measurement, expandable ablation member temperature measurement, humidity measurement, gas

measurement, chemical measurement, oxygen measurement, carbon dioxide measurement, or pH measurement.

[0035] Another aspect of the present disclosure provides controllers for a tissue ablation apparatus. The controller may comprise a display, a receiver, and a processor. The receiver may be for receiving dimensional information for one or more of a bodily organ or an expandable tissue ablation member of the tissue ablation apparatus from the tissue ablation apparatus. The tissue ablation apparatus may be advanced into the bodily organ and deployed to measure the dimensional information. The processor may be coupled to the receiver and the display. The processor may be configured to instruct the display to show a virtual representation of the bodily organ based on the received dimensional information.

[0036] The dimensional information may be determined in response to one or more tissue ablation apparatus measurements comprising one or more of a width of an expandable ablation member of the tissue ablation apparatus, a length of the expandable ablation member of the tissue ablation apparatus, or an insertion depth of the tissue ablation apparatus. The tissue ablation apparatus measurements may be automatically measured using one or more sensors of the tissue ablation apparatus. The virtual representation of the bodily organ may be generated based on one or more of the width of the expandable ablation member, the length of the expandable ablation member, or the insertion depth of the tissue ablation apparatus. The processor may be further configured to instruct the display to numerically show the dimensional information.

[0037] Another aspect of the present disclosure provides methods of guiding tissue ablation within a bodily organ. Dimensional information for one or more of a bodily organ or an expandable tissue ablation member of the tissue ablation apparatus may be received from the tissue ablation apparatus. The tissue ablation apparatus may be advanced into the bodily organ and deployed to measure the dimensional information. Dimensions of the bodily organ may be determined based on the dimensional information. A virtual representation of the bodily organ may be generated and displayed based on the determined dimensions of the bodily organ. The bodily organ may comprise a uterus, for example.

[0038] The dimensional information may be determined in response to one or more tissue ablation apparatus measurements comprising one or more of a width of an expandable ablation member of the tissue ablation apparatus, a length of the expandable ablation member of the tissue ablation apparatus, or an insertion depth of the tissue ablation apparatus. The tissue ablation apparatus measurements may be automatically measured using one or more sensors of the tissue ablation apparatus. The virtual representation of the bodily organ may be generated based on one or more of the width of the expandable ablation member, the length of the expandable ablation member, or the insertion depth of the tissue ablation apparatus. One or more of the dimensional information or the determined dimensions of the bodily organ may be numerically displayed. The determined dimensions of the bodily organ may comprise a length and width of the bodily organ.

[0039] Another aspect of the present disclosure provides controllers for a tissue ablation apparatus. An exemplary controller may comprise an ablation energy generator, a receiver, and a processor. The ablation energy generator may be coupled to the tissue ablation apparatus to provide ablation energy. The receiver may be in communication with the tissue ablation apparatus. The receiver may be configured to receive deployment status from the tissue ablation apparatus. The processor may be coupled to the ablation energy generator and the receiver. The processor may be configured to instruct the ablation energy generator to shut off ablation energy if the tissue ablation apparatus has not deployed to beyond a threshold width. The deployment status may comprise a current width of an expandable tissue ablation member of the tissue ablation apparatus. The deployment status may be automatically determined using one or more sensors of the tissue ablation apparatus, and the one or more sensors may comprise one or more of a linear encoder, a strain gauge, an impedance sensor, a photonic sensor, a resistive sensor, a capacitive sensor, an electro-magnetic sensor, a Hall sensor, or a potentiometer.

[0040] Another aspect of the present disclosure provides methods of ablating tissue within a bodily organ. In an exemplary method, a tissue ablation apparatus comprising an expandable ablation member may be provided. The expandable ablation member may be advanced into the bodily organ and expanded. A width of the expandable ablation member expanded within the bodily organ may be automatically measured. Whether the measured width of the expandable ablation member is above a threshold width may be determined. Ablation energy may be provided to the expandable ablation member if the measured width of the expandable ablation member is above the threshold width. The ablation energy may be shut off if the measured width of the expandable ablation member is below the threshold width. The width of the expandable ablation member may be automatically measured with one or more sensors of the tissue ablation apparatus, and the one or more sensors may comprise one or more of a linear encoder, a strain gauge, an impedance sensor, a photonic sensor, a resistive sensor, a capacitive sensor, an electro-magnetic sensor, a Hall sensor, or a potentiometer.

INCORPORATION BY REFERENCE

[0041] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

[0042] The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the present disclosure are utilized, and the

accompanying drawings of which:

[0043] FIG. 1 A is a schematic diagram of an ablation controller coupled to an ablation probe advanced into a bodily organ, according to many embodiments.

[0044] FIG. IB is a side view of the ablation probe of FIG. 1A coupled to the ablation controller, according to many embodiments. [0045] FIG. 1C is a side view of the distal end of the ablation probe of FIG. 1 A with its expandable ablation member in an expanded configuration, according to many embodiments.

[0046] FIG. ID is a front view of the ablation controller of FIG. 1 A including a display showing a virtual representation of the target bodily organ.

[0047] FIG. 2A is a flow chart of an exemplary method for ablating tissue, according to many embodiments.

[0048] FIG. 2B is a flow chart of an exemplary method for calibrating an ablation probe, according to many embodiments.

DETAILED DESCRIPTION

[0049] FIG. 1A shows an ablation control unit 100 coupled to an ablation probe 150. The ablation probe 150 is shown as advanced into the cavity CAV of a bodily organ ORG.

Typically, the bodily organ ORG will be the uterus of a subject, but the ablation probe 150 may be suitable for use with other organs such as the bladder, the heart, the stomach, the small intestines, the large intestines, the colon, to name a few.

[0050] The control unit 100 may comprise a processor 103 to operate the various components and sub-systems of the control unit 100. The control unit 100 may further comprise a user interface 106, which may include user controls 109 and a display 112. The user interface 106 may be integral with the control unit 100 (i.e., held in the same housing) or may comprise external components (i.e., a screen, a mouse, a keyboard, etc.) that are coupled to the enclosure of the control unit 100. The user controls 109 may be operated to adjust various ablation setting and conduct an ablation procedure with the ablation probe 150. The display 112 may be configured to display various ablation parameters and show the progress of the ablation procedure and the status of the ablation probe 150. In some embodiments, the user controls 109 are components of the display 112. For example, the display 112 may comprise a touch-screen display that may show a touch menu which may comprise the user controls 109. The control unit 100 may further comprise ablation energy circuitry 115 to generate ablation energy directed to the ablation probe, a gas source 118 to insufflate the bodily organ ORG through the ablation probe 150 and/or insufflate the probe 150 itself, a vacuum source 119 to draw the bodily organ's cavity CAV (and particularly the inner walls thereof) toward the energy applicator 153, a pressure sensor 121 coupled to the ablation probe 150 to detect one or more gas parameters from the organ ORG and/or the ablation probe 150 itself, and a receiver 124 to receive measurement, calibration, ablation, and other data from the ablation probe 150. In some embodiments, the receiver 124 may comprise a two-way communications unit and include a transmitter to transmit control instructions, calibration data, and/or other data, such as to the ablation probe 150. The ablation energy circuitry 115, the gas source 118, the vacuum source 119, the pressure sensor 121, and the receiver 124 may each be coupled to the processor 103 so that the processor 103 can operate these various components. In some cases, updates and/or upgrades (for example, a firmware upgrade) may be provided to the control unit 100. The control unit 100 may be configured to accept these updates and/or upgrades via a wireless connection (such as through the receiver 124) and/or a wired connection such as through an input port (for example, a USB port).

[0051] The ablation probe 150 may comprise an expandable ablation energy applicator or ablation member 153. As shown in FIG. 1A, the ablation probe 150 may be advanced into the bodily organ ORG such that the expandable ablation member 153 is positioned within its cavity CAV in a collapsed configuration. In some embodiments, the expandable ablation member 153 may be at least partially disposable while the remainder of the ablation probe 150 may be reusable. In some embodiments, the ablation probe 150 is entirely disposable or reusable. The ablation probe 150 may further comprise a shaft assembly 156 which has a distal end coupled to the expandable ablation member 153 and a proximal end coupled to a handle assembly 159.

[0052] The gas source 118 of the control unit 100 may be coupled to the ablation probe 150 through a connection 118a to provide gas (such as C0 ₂ ) to the ablation probe 150 which may provide the gas to insufflate the cavity CAV. The ablation probe 150 may direct gas back to the pressure sensor 121 through a connection 118b. The vacuum source 119 of the control unit 100 may be coupled to the ablation probe 150 through a connection 119a to provide vacuum to attract or pull the cavity CAV to the energy applicator or ablation member 153. The ablation probe 150 may direct the vacuum back to the pressure sensor 121 through a connection 119b The processor 103 may use the pressure sensor 121 to measure the gas backflow from the ablation probe 150 and/or cavity CAV to perform an assessment of the bodily organ ORG. For example, the processor 103 may determine whether pressure within the cavity CAV has failed to achieve a predetermined threshold which may indicate a perforation in the bodily cavity CAV, or if pressure within the cavity CAV has reached and maintained a level above the predetermined threshold over a predetermined period of time, which may indicate a lack of perforations in the bodily cavity CAV. The ablation procedure may be allowed to proceed if no perforations of the bodily cavity CAV are detected. The user interface 106 may provide notification to the user that the bodily cavity CAV may be perforated. The user may choose to halt the ablation procedure and/or the processor 103 may be configured to automatically halt the ablation procedure. In some embodiments, the gas source 118, the vacuum source 119, and the pressure sensor 121 are components of a gas management sub-system of the control unit 100. In some embodiments, one or more of the gas source 118, the vacuum source 119, or the pressure sensor 121 are components of separate sub-systems of the control unit 100 and may be controlled separately by the processor 103.

[0053] The processor 103 may use the pressure sensor 121 to measure the vacuum level from the ablation probe 150 and/or cavity CAV to perform an assessment of the bodily organ ORG. For example, the processor 103 may determine whether vacuum within the cavity CAV has failed to achieve a predetermined threshold which may indicate an improper contact of inner wall of the cavity CAV to the ablation probe 150, or if vacuum within the cavity CAV has reached and maintained a level above the predetermined threshold over a predetermined period of time, which may indicate a proper contact of the inner wall of the bodily cavity CAV to the ablation probe 150. The ablation procedure may be allowed to proceed if proper contact of the bodily cavity CAV is detected. The user interface 106 may provide notification to the user that the bodily cavity CAV may be properly or improperly contacting the probe 150, for example, as detected by a change in impedance and/or change in humidity. The user may choose to halt the ablation procedure and/or the processor 103 may be configured to automatically halt the ablation procedure.

[0054] The ablation probe 150 may be configured to transmit measurement, calibration, ablation, and other data to the receiver 124 of the control unit 100 through a connection 127. The connection 127 may comprise a wireless or wired connection. For example, wireless communication protocols that may be used by the connection 127 include, but are not limited to, BlueTooth, BlueTooth LE, WiFi, Near-Field Communication (NFC), infrared wireless, radio wave, micro-wave, WiMax, Femtocell, Zigbee, 3G, 4G, 5G, to name a few.

[0055] The ablation probe 150 may further be coupled to the ablation energy circuitry 115 to provide ablation energy to the expandable ablation member 153. The ablation energy circuitry 115 may generate the ablation energy and/or adjust the settings of the generated ablation energy. The ablation energy generated and provided to the ablation probe 150 by the ablation energy circuitry 115 may be adjusted by the ablation energy circuitry 115 as informed by measurement, calibration, ablation, and/or other data from the ablation probe 150 as received by the receiver 124. Typically, the ablation energy comprises radiofrequency (RF) energy, but other types of ablation energy may be used. For example, the ablation probe 150 may ablate tissue using cryoablation, microwave energy, ultrasound energy, thermal energy, optical energy (e.g., laser energy), to name a few. [0056] FIG. IB is a side view of the ablation probe 150 coupled to the control unit 100. The handle assembly 159 may comprise a handle 162 which the user can operate to expand the expandable ablation member 153 at the distal end of the shaft assembly 156. The handle assembly 159 may further comprise calibration circuitry 165 which may store various calibration parameters for the ablation probe 150. The calibration circuitry 165 may store one or more calibration parameters such than every individual ablation probe 150 may be custom calibrated. The handle assembly 159 may further comprise a transmitter 168 which may be coupled to the calibration circuitry 165 as well as one or more sensors of the ablation probe 150. Alternatively or in combination, one or more of the calibration circuitry 165 or the transmitter 168 may be separate from the ablation probe 150, such as by being removably coupled thereto. The transmitter 168 may couple to the ablation control unit 100 and its receiver 124 to transmit one or more of measurement, calibration, ablation, or other data through the connection 127 which may comprise a wired or a wireless connection. In some embodiments, one or more sensors of the ablation probe 150 are directly connected to the transmitter 168 and bypass the calibration circuitry to transmit data to the ablation control unit. For instance, ablation data may be measured directly from the power wires that deliver energy to the probe 150 at the control unit 100. Various wireless communications protocols that may be appropriate for use with the ablation probe transmitter 168 may include, but are not limited to, BlueTooth, BlueTooth LE, WiFi, Near-Field Communication (NFC), infrared wireless, radio wave, micro-wave, WiMax, Femtocell, Zigbee, 3G, 4G, 5G, to name a few. In some embodiments, the transmitter 168 may comprise a two-way communications unit and include a receiver configured to receive control instructions, calibration data, and/or other data, such as from the control unit 100.

[0057] As discussed below and further herein, the onboard calibration circuitry 165 may allow the customization of each ablation probe 150 and its onboard sensors to their optimal operating parameters and the storing of such customization information on the calibration circuitry 165 for use with the ablation control unit 100. In some embodiments, once the calibration and customization information is provided on the calibration circuitry 165 during the manufacturing of the ablation probe 150, further recalibration or altering of this information is disabled to prevent a user from mal -calibrating the ablation probe 150. Alternatively, further recalibration or alteration of the calibration and customization information may be enabled.

[0058] FIG. 1C shows the distal end of the ablation probe 150, including the expandable ablation member 153 in its expanded configuration. In the expanded configuration, the expandable ablation member 153 may assume a bicornual shape suitable for intrauterine ablation, including lateral horn regions to extend toward the fallopian tubes when placed within the uterus. The expanded configuration may have other geometries suitable for different bodily organs as well.

[0059] The shaft assembly 156 may comprise an outer shaft 171 and an inner shaft 174 which may be translated relative to one another to expand the expandable ablation member 153. The expandable ablation member 153 may comprise an internal framework 177 coupled to the shaft assembly 156 such that the translation of the outer and inner shafts 171, 174 may expand the internal framework. The proximal end of the inner and outer shafts 171, 174 may be coupled to the handle assembly 159 such that the user can affect this translation.

[0060] The framework 177 may be covered with an outer membrane 180 which may carry one or more ablation electrodes. For example, the outer membrane 180 may comprise a metallized fabric which may conduct the ablation energy. The metallized fabric may include yarns of conductive material such as silver, gold, platinum, copper, to name a few, and may also include yarns of insulating material which may be expandable, such as spandex. In some embodiments, the outer membrane 180 may be moisture permeable and/or absorbent so as to capture moisture as tissue is ablated, reducing risks of ablation energy being away from the tissue by the moisture generated by the tissue ablation. For example, apertures between the fabric yarns of the outer membrane 180 may provide such moisture permeability and/or absorbance. In some

embodiments, suction may further be applied to the ablation member 153 to draw moisture away from the inner wall of the bodily organ and/or bring the inner wall of the bodily organ in contact with the outer membrane 180, and the negative pressure may be applied through the permeable outer membrane 180.

[0061] The shaft assembly 156 and the expandable ablation member 153 may comprise various sensors for detecting various ablation parameters. The sensor(s) may detect their respective parameters continuously or discretely. The sensors(s) may be disposed within the expandable ablation member 153 and/or the shaft assembly 156 and may be detached for reuse in at least some cases.

[0062] The expandable ablation member 153 may comprise a first lateral sensor 183a and a second lateral sensor 183 coupled to the lateral horn regions of the expandable ablation member 153. The first and second lateral sensors 183a, 183b may measure impedance between the two sensors. Alternatively or in combination, the first and second lateral sensors 183a, 183b may comprise sensors for one or more of temperature, oxygenation, blood pressure, stress, strain, voltage, resistance, capacitance, distance, etc. For example, the first and second lateral sensors 183a, 183b may comprise Hall sensors capable of sensing a distance between the two sensors and therefore the current width of the expandable ablation member 153 and hence, in many cases, the width of the bodily cavity CAV when the expandable ablation member 153 is expanded therein.

[0063] The expandable ablation member 153 may further comprise a distal sensor 186. The distal sensor 186 may be coupled to the membrane 180. The distal sensor 186 may be configured to measure various parameters such as temperature, oxygenation, blood pressure, stress, strain, voltage, resistance, capacitance, distance, etc. For example, the distal sensor 186 may be a Hall sensor coupled to another Hall sensor at the proximal end of the expandable ablation member 158 and/or the shaft assembly 156 to detect a distance between the two and therefore the current length of the expandable ablation member 153 and hence, in many cases, the length of the bodily cavity CAV when the expandable ablation member 153 is expanded therein. Alternatively or in combination, the distal sensor 186 may comprise a contact sensor configured to measure and provide feedback when the distal tip of the ablation member 150 makes contact with the inner wall of the cavity CAV of the bodily organ ORG, such as the fundus of the uterus.

[0064] The expandable ablation member 153 may further comprise a framework-coupled sensor 186 coupled to the expandable framework 177 of the expandable ablation member 153. The framework-coupled sensor 186 may comprise, for example, a strain gauge coupled to the expandable framework 177 to detect changes in the geometry of the expandable framework 177. The detected changes in geometry may correlate to a degree of expansion of the expandable framework 177 and the current length and width of the expandable ablation member 153. These measured dimensions of the expandable ablation member 153 may, in many cases, correlate with the dimensions of the bodily cavity CAV when the expandable ablation member 153 is fully expanded therewithin. Alternatively or in combination, the framework-coupled sensor may measure various further parameters such as temperature, oxygenation, blood pressure, stress, strain, voltage, resistance, capacitance, distance, etc. The sensors coupled to the framework and/or the outer surface of the expandable ablation member 153 may also detect a geometry or shape of the expandable ablation member 153. For instance, the curvature of the edges of the expandable ablation member 153 may be detected when the expandable ablation member 153 is expanded within the bodily cavity CAV to detect the geometry or shape of the bodily cavity CAV.

[0065] The shaft assembly 156 may comprise one or more sensors as well. For example, the inner shaft 171 may comprise an inner linear encoder 192 and the outer shaft 174 may comprise an inner linear encoder 195. The linear encoders 192, 195 may be used alone or in combination with one another to detect the degree of translation between the inner and outer shafts 171, 174, which may correlate to a degree of expansion of the expandable ablation member 153, including known lengths and widths of the expandable ablation member 153 which may, in many cases, the length of the bodily cavity CAV when the expandable ablation member 153 is expanded therein. The outer linear encoder 195 may also be used to measure of degree of advancement of the ablation probe 150 into the bodily organ ORG. For example, the outer linear encoder 195 may detect the position of the opening of the bodily organ. The length of the bodily organ may be calculated based on this detected position and the detected or known position of the distal end of the ablation probe 150 (for example, the distal probe 186 and/or the known length of the expandable ablation member 153 as correlated to the degree of detected, current expansion of the expandable ablation member 153).

[0066] The various sensors of the expandable ablation member 153 and/or the shaft assembly 156 may be coupled to the one or more of the calibration circuitry 165 or transmitter 168 through connection(s) 198 which may lead from the distally positioned sensors to the proximally positioned calibration circuitry 165 and transmitter 168. Alternatively or in combination, the various sensors may communicate wirelessly to one or more of the calibration circuitry 165, the transmitter 168, or the receiver 124 of the ablation control unit. Various wireless

communications protocols that may be appropriate for use with the sensors may include, but are not limited to, BlueTooth, BlueTooth LE, WiFi, Near-Field Communication (NFC), infrared wireless, radio wave, micro-wave, WiMax, Femtocell, Zigbee, 3G, 4G, 5G, to name a few.

[0067] FIG. ID shows the display 112 of the control unit 100. The various parameters detected and measured by the various sensors of the ablation probe 150 may be transmitted to the control unit 100 and displayed on the display 112 such as numerically. The display 112 may also generate a virtual representation 130 of the bodily organ ORG based on the dimensions (e.g., length, width, curvature of the edges of the expandable member 153, etc.) automatically measured by the ablation probe 150. The virtual representation 130 may assist the user in mentally visualizing the bodily organ to be ablated. The user may adjust various ablation parameters (e.g., power, time, voltage, probe expansion and position, etc.) based on the parameters shown and the virtual representation 130. Alternatively or in combination, the various ablation parameters may be automatically adjusted based on the automatically measured and calculated parameters. For example, the ablation power may be a function of the dimensions of the bodily organ such as its surface area as determined by its measured length and width, and, in some embodiments, the ablation power may be automatically adjusted as tissue is ablated based on changes to the measured length and width as the ablation procedure is undertaken. The various parameters may be displayed numerically or in the virtual representation before, during, and/or after the ablation procedure. The various parameters and/or the virtual representation 130 may be updated and displayed through the course of the ablation procedure. For example, the progress of an ablation procedure may be indicated by the tissue impedance of the bodily organ ORG as measured by one or more sensors of the ablation probe 150. The measured impedance may be displayed on the display 112 numerically and/or as indicated by the virtual representation 130, such as with a color scheme. For example, the virtual representation 130 may be colored green at the beginning of an ablation procedure before any tissue ablation, gradually turn yellow as the ablation procedure is undertaken and tissue impedance changes, and finally turns red when the ablation procedure is complete and the tissue impedance reaches a particular threshold that indicates complete ablation. The size and/or geometry of the virtual representation 130 may also be dynamically updated in accordance with sensor data from the ablation probe 150 as the ablation procedure is undertaken. While the parameters or detected organ length (LENGTH), detected organ width (WIDTH), ablation power (POWER), current temperature (TEMP.), detected organ area (AREA), time of ablation (TEVIE), and tissue impedance (EVIPEDANCE) and a safety indicator (SAFE) are shown in the display 112 above the virtual representation 130 of the bodily organ ORG in FIG. ID, any number of the same parameters or a different combination of different parameters may be shown and may be shown in any location within the display 112. The safety indicator (SAFE) may indicate whether it is safe to proceed with the ablation procedure and may indicate that it is not, for example, when a lock out is implemented as described herein, the ablation member 153 has not yet expanded to a threshold width, and/or the bodily organ ORG is detected as perforated.

[0068] FIG. 2A shows a flow chart of a method 200 of ablating tissue. The method 200 may be implemented with the ablation control unit 100 and the ablation probe 150 described above.

[0069] In a step 203, an ablation probe may be advanced into a bodily organ. For example, the ablation probe 150 may be advanced into a uterus.

[0070] In a step 206, the ablation member of the ablation probe may be expanded within the bodily organ. For example, the ablation member 156 may be expanded within the cavity CAV.

[0071] In a step 209, the width of the ablation member, such as the ablation member 153, may be measured. The width may be measured before, during, and/or after the expansion of the ablation member.

[0072] In a step 212, the length of the ablation member, such as the ablation member 156, and or the advancement depth of the ablation probe into the bodily cavity, such as the ablation probe 150, may be measured. The length and/or advancement depth may be measured before, during, and/or after the expansion of the ablation member. [0073] In a step 215, the control unit may lockout the ability to ablate tissue if the measured width of the ablation member is below a threshold. The inability of the ablation member, for example the ablation member 153, to expand beyond a threshold width may indicate that the inner wall of the bodily organ is perforated and tissue ablation should not be conducted. For example, if the ablation probe has been perforated by the distal advancement of the ablation probe (e.g., the fundus of the uterus is penetrated by the ablation probe), the expansion of the ablation member may be restricted by the perforation. This lockout scheme may be useful in cases where even after the ablation probe perforates the bodily cavity, the ablation probe seals against the perforation such that various gas flow and pressure test may incorrectly indicate that the bodily cavity is non-perforated. Such situations may occur with patients having a small uterine width, typically less than 25 mm. The combination of the automatic sensor system integrated into the ablation probe and the ablation generator or control unit being programmed to detect small uterine widths can prevent ablation energy delivery to a perforated uterus, thereby preventing patient injuries.

[0074] In a step 218, the measurements of length, width, and others may be transmitted to a controller or the control unit, such as to ablation control unit 100, for example, through the connection 127 described above.

[0075] In a step 221, the ablation settings may be adjusted in accordance with the

measurements. For example, the ablation power may be a function of the dimensions of the bodily organ such as its surface area as determined by its measured length and width.

[0076] In a step 224, a virtual representation of the bodily organ, showing its dimensions, may be generated and displayed, such as with the display 112.

[0077] In a step 227, one or more of the ablation parameters may be displayed, such as with the display 112.

[0078] In a step 230, the tissue may be ablated with the ablation member. For example, the user may operate the ablation member 153 of the ablation probe 150 to ablate the endometrial tissue of the uterus.

[0079] In a step 233, the progress of the ablation may be monitored. For example, the progress of the ablation may be monitored by the various sensors of the ablation probe 150. Parameters such as tissue impedance may be measured to determine a progress of the ablation. The tissue ablation may be complete once a tissue impedance threshold has been reached.

[0080] In a step 236, the parameters of the ablation may be modified based on the monitored progress. For example, ablation power may be varied depending on the progress of the ablation, the measured temperature of the tissue, or the measured dimensions of the bodily cavity as the ablation is undertaken. The ablation parameters may be automatically modified and/or manually modified by the user. In some embodiments, ablation power may be automatically modified and adjusted as tissue is ablated based on changes to the measured length and width and/or tissue impedance as the ablation procedure is undertaken.

[0081] In a step 239, the tissue ablation may be ended.

[0082] In a step 242, the ablation probe may be retracted and removed from the bodily organ.

[0083] Although the above steps show the method 200 of ablating tissue in accordance with many embodiments, a person of ordinary skill in the art will recognize many variations based on the teaching described herein. The steps may be completed in a different order. Steps may be added or omitted. At least some of the steps may comprise one or more sub-steps. Many of the steps may be repeated as often as beneficial.

[0084] One or more of the steps of the method 200 may be performed with circuitry as described herein, for example, one or more of the processor 103 of the ablation control unit 100 or other processing units of the ablation control unit 100 and/or the ablation probe 150. The circuitry may be programmed to provide one or more of the steps of the method 200, and the program may comprise program instructions stored on a computer readable memory or programmed steps of logic circuitry such as a programmable array logic or a field programmable gate array.

[0085] FIG. 2B shows a flow chart of a method 250 of custom calibrating an individual ablation probe, such as the ablation probe 150. The ablation probes described herein may be factory manufactured and each ablation probe may be custom and individually calibrated such as during or after the manufacturing process.

[0086] In a step 253, an ablation member of an ablation probe may be fully collapsed. For example, the ablation member 153 of the ablation probe 150 may be fully collapsed.

[0087] In a step 256, the dimensions of the ablation member, such as its length and width, may be measured with the ablation member fully collapsed and with external tools.

[0088] In a step 259, the dimensions of the ablation member, such as its length and width, as sensed by the sensors of the ablation probe with the ablation member fully collapsed may be corrected based on the actual measured dimensions of the ablation member from step 256.

[0089] In a step 262, the correctional data to adjust the sensed ablation member dimensions to accurately reflect the actual ablation member dimensions (as determined by external tools) may be stored, such as on the calibration circuitry 165 of the ablation probe 150.

[0090] In a step 265, the ablation member of the ablation probe may be expanded. For example, the ablation member 153 of the ablation probe 150 may be expanded. [0091] In a step 268, the dimensions of the ablation member, such as its length and width, may be measured as the ablation member is expanded and with external tools

[0092] In a step 271, the dimensions of the ablation member, such as its length and width, as sensed by the sensors of the ablation probe as the ablation member is expanded may be corrected based on the actual measured dimensions of the ablation member from step 268. For example, a look-up table may be generated based on the sensor readings and the associated length, width, and surface area of the ablation member.

[0093] In a step 274, the correctional data to adjust the sensed ablation member dimensions to accurately reflect the actual ablation member dimensions (as determined by external tools and over the full course of expansion of the ablation member) may be stored, such as on the calibration circuitry 165 of the ablation probe 150.

[0094] The calibration steps 253 to 274 could be repeated in partial expansions multiple times.

[0095] While calibrating the ablation probe sensors for accurate measurement of ablation member dimensions is described, the ablation probe may also be calibrated for other parameters such as ablation energy, temperature sensing, impedance sensing, to name a few. Individual sensors of the ablation probe may be calibrated individually or in combination with other sensors.

[0096] In a step 277, ablation energy may be activated on the ablation member of the ablation probe. For example, the ablation probe 150 may be coupled to an ablation energy generator generating ablation energy at a known power level, and the ablation energy may be generated and conducted to the ablation member 153 of the ablation probe.

[0097] In a step 280, the ablation energy may be measured such as with one or more external sensors.

[0098] In a step 283, the ablation energy as sensed by the one or more sensors of the ablation member or ablation probe itself may be corrected, for example, based on the measured ablation energy from step 280 and/or the known power level of the ablation energy generator from step 277.

[0099] In a step 286, the correctional or calibration data from step 283 may be stored on the ablation probe such as on the calibration circuitry 165 of the ablation probe 150.

[0100] The various correctional or calibration data on the ablation probe 150 may facilitate further calibration of the ablation probe 150 and/or the ablation control unit 100 as the ablation probe 150 is coupled to the ablation control unit 100. For example, the user may not need to individually calibrate the ablation probe 150 if the calibration probe 150 is already and automatically provided by the probe 150 to the ablation control unit 100. [0101] In a step 289, the ablation probe may be coupled to an ablation energy generator and/or controller, such as the ablation control unit 100.

[0102] In a step 292, the ablation probe may provide various calibration and correctional data to the ablation energy generator and/or controller.

[0103] In a step 295, the ablation probe and/or the ablation energy generator and/or controller may be calibrated based on the provided calibration and correctional data.

[0104] Although the above steps show the method 250 of calibrating an ablation probe in accordance with many embodiments, a person of ordinary skill in the art will recognize many variations based on the teaching described herein. The steps may be completed in a different order. Steps may be added or omitted. At least some of the steps may comprise one or more sub-steps. Many of the steps may be repeated as often as beneficial.

[0105] One or more of the steps of the method 250 may be performed with circuitry as described herein, for example, one or more of the processor 103 of the ablation control unit 100 or other processing units of the ablation control unit 100 and/or the ablation probe 150. The circuitry may be programmed to provide one or more of the steps of the method 250, and the program may comprise program instructions stored on a computer readable memory or programmed steps of logic circuitry such as a programmable array logic or a field programmable gate array.

[0106] While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.