Ultrasonic surgery system

Abstract

An ultrasonic instrument includes a tip and a driver coupled to the tip, the driver configured to vibrate the tip to ablate tissue of a target site in response to receiving an AC drive signal from a power source. The locator is configured to generate location data indicative of a pose of the ultrasonic instrument in a known coordinate system. A control system coupled to the power source and the locator is configured to generate a virtual boundary associated with the tumor tissue region in a known coordinate system based on a received medical image including the tumor tissue region, track a pose of the ultrasound instrument in the known coordinate system based on the localization data, and setting an AC drive signal generated by the power supply to induce a first pulsed ultrasound energy in the tip based on the tracked pose of the ultrasound instrument and the virtual boundary.

Description

[0001] Related Applications

[0002] This application claims priority to and all benefits of U.S. Provisional Patent Application No. 63 / 362,598, filed on April 6, 2022, U.S. Provisional Patent Application No. 63 / 362,599, filed on April 6, 2022, and U.S. Provisional Patent Application No. 63 / 413,223, filed on October 4, 2022. The disclosure of each of these applications is incorporated herein by reference in its entirety. Background Art

[0003] Ultrasonic surgical instruments are often used to remove tissue in areas with limited visibility, which makes it difficult for surgeons to distinguish between the target tissue to be removed and the surrounding tissue that is expected to remain intact. This limited visibility can also make it difficult to determine whether the target tissue has been completely removed. Summary of the invention

[0004] In one aspect, an ultrasonic surgical system includes: an ultrasonic instrument having a tip and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue from a target site; a power supply coupled to the ultrasonic instrument and configured to generate an AC drive signal supplied to the driver; a positioner configured to generate positioning data indicating a posture of the ultrasonic instrument in a known coordinate system; and a control system coupled to the power supply and the positioner. The control system is configured to: receive a medical image of a target site including a tumor tissue region; generate a virtual boundary associated with the tumor tissue region in the known coordinate system based on the medical image; track the posture of the ultrasonic instrument in the known coordinate system based on the positioning data; and set the AC drive signal generated by the power supply to induce a first pulse of ultrasonic energy in the tip based on the tracked posture of the ultrasonic instrument and the virtual boundary.

[0005] In another aspect, an ultrasonic surgical system includes: an ultrasonic instrument having a tip and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue from a target site; a power source coupled to the ultrasonic instrument and configured to generate an AC drive signal supplied to the driver; a positioner configured to generate positioning data indicating a pose of the ultrasonic instrument in a known coordinate system; and a control system coupled to the power source and the positioner. The control system is configured to: receive a medical image of a target site including a first tissue region to be ablated; based on the medical image, generate a virtual boundary associated with the first tissue region in the known coordinate system; based on the positioning data, track the pose of the ultrasonic instrument in the known coordinate system; and based on the tracked pose of the ultrasonic instrument relative to the virtual boundary in the known coordinate system, set the AC drive signal generated by the power source to induce a first pulse of ultrasonic energy in the tip.

[0006] In yet another aspect, an ultrasonic surgical system includes: an ultrasonic instrument having a tip and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue from a target site; a power source coupled to the ultrasonic instrument and configured to generate an AC drive signal supplied to the driver; a positioner configured to generate positioning data indicating a posture of the ultrasonic instrument in a known coordinate system; and a control system coupled to the power source and the positioner. The control system is configured to: receive a medical image of a target site including a soft tissue region and a hard tissue region; generate a virtual boundary between the soft tissue region and the hard tissue region in a known coordinate system based on the medical image; track the posture of the ultrasonic instrument in the known coordinate system based on the positioning data; determine whether the ultrasonic instrument is in the hard tissue region or the soft tissue region based on the posture of the ultrasonic instrument tracked in the known coordinate system relative to the virtual boundary; and generate a first AC drive signal in response to determining that the ultrasonic instrument is in the soft tissue region, the first AC drive signal inducing a first pulse of ultrasonic energy in the ultrasonic instrument, the first pulse of ultrasonic energy may include a plurality of first ultrasonic energy pulses, the plurality of first ultrasonic energy pulses being generated by a first pulse of ultrasonic energy in the first most The ultrasonic instrument is configured to: first, generate an AC drive signal that induces second pulsed ultrasonic energy in the ultrasonic instrument, and then generate a second AC drive signal that induces second pulsed ultrasonic energy in the ultrasonic instrument. The second pulsed ultrasonic energy may include a plurality of second ultrasonic energy pulses that are separated by ultrasonic energy at a second minimum ultrasonic energy level that lasts for a third time period, and each second ultrasonic energy pulse reaches a peak value at the maximum ultrasonic energy level set for the ultrasonic instrument for a second time period that is less than each first time period; and in response to determining that the ultrasonic instrument is within a hard tissue area, generate a second AC drive signal that induces second pulsed ultrasonic energy in the ultrasonic instrument. The second pulsed ultrasonic energy may include a plurality of second ultrasonic energy pulses that are separated by ultrasonic energy at a second minimum ultrasonic energy level that lasts for a third time period, and each second ultrasonic energy pulse reaches a peak value at the maximum ultrasonic energy level for a fourth time period that is greater than or equal to each third time period.

[0007] In yet another aspect, an ultrasonic surgical system includes an ultrasonic instrument having a tip and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue from a target site; a power source coupled to the ultrasonic instrument and configured to generate an AC drive signal supplied to the driver; a sampling element coupled to the ultrasonic instrument and including at least one optical fiber configured to collect fluorescence emitted from tissue; and a control system coupled to the power source and the sampling element. The control system is configured to: detect a tissue type that the tip of the ultrasonic instrument is contacting based on the fluorescence; and based on the detected tissue type, set the AC drive signal generated by the power source to induce a first pulse of ultrasonic energy in the tip.

[0008] In yet another aspect, an ultrasonic surgical system includes an ultrasonic instrument having a tip and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue from a target site; a sampling element coupled to the ultrasonic instrument and including at least one optical fiber configured to collect fluorescence emitted from the tissue; and one or more controllers. The one or more controllers are configured to: determine a first tissue characteristic of the tissue that the operative end of the tip is contacting indicated by the collected fluorescence; determine a characteristic of the AC drive signal supplied to the ultrasonic instrument that corresponds to the collected fluorescence indicating the first tissue characteristic; determine a second tissue characteristic of the tissue that the operative end of the tip is contacting indicated by the characteristic of the AC drive signal; and display at least one indicator corresponding to the first and second tissue characteristics.

[0009] In yet another aspect, an ultrasonic surgical system includes an ultrasonic instrument having a tip and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue from a target site; a sampling element coupled to the ultrasonic instrument and including at least one optical fiber configured to collect fluorescence emitted from the tissue; and one or more controllers. The one or more controllers are configured to: determine a first tissue characteristic of the tissue that the operative end of the tip is contacting indicated by the collected fluorescence; determine a characteristic of the AC drive signal supplied to the ultrasonic instrument, the AC drive signal corresponding to the collected fluorescence indicating the first tissue characteristic; determine a second tissue characteristic of the tissue that the operative end of the tip is contacting indicated by the characteristic of the AC drive signal; determine whether the first tissue characteristic is inconsistent with the second tissue characteristic; and indicate a system error in response to determining that the first tissue characteristic is inconsistent with the second tissue characteristic.

[0010] In yet another aspect, an ultrasonic surgical system includes an ultrasonic instrument having an aspiration path, a tip, and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue from a target site, a sampling element coupled to the ultrasonic instrument and including at least one optical fiber configured to collect fluorescence emitted from the tissue, and one or more controllers, a sensor coupled to the aspiration path to measure characteristics of resected tissue moving through the aspiration path, and a control system. The control system is configured to: determine a first tissue characteristic of tissue being contacted by the tip operating end indicated by the collected fluorescence; determine a second tissue characteristic of the resected tissue moving through the aspiration path indicated by the sensor; determine a resection status based on the first and second tissue characteristics; and display the resection status. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1An ultrasonic surgical system is shown that includes a communicatively coupled ultrasonic tool system, a tissue detection system, a navigation system, and an imaging system.

[0012] Figure 2 Shown are an ultrasound tool system and a tissue detection system communicatively coupled.

[0013] Figure 3 An ultrasonic instrument of an ultrasonic tool system is shown.

[0014] Figure 4 Components that may be incorporated into a console of an ultrasonic tool system are shown.

[0015] Figure 5 Components of an ultrasonic instrument that may be incorporated into an ultrasonic tool system are shown.

[0016] Fig. 6A and 6B A circuit representing the flow of current through an ultrasonic instrument of an ultrasonic tool system is shown.

[0017] Fig. 7A and 7B A pulse profile that may be induced in an ultrasonic instrument of an ultrasonic tool system is shown.

[0018] Fig. 8A and 8B Additional pulse profiles that may be induced in an ultrasonic instrument of an ultrasonic tool system are shown.

[0019] Fig. 9A and 9B Other pulse profiles that may be induced in an ultrasonic instrument of an ultrasonic tool system are shown.

[0020] Fig.10 A modulated waveform that may be generated by a console of an ultrasonic tool system to induce pulsed ultrasonic energy in an ultrasonic instrument of the ultrasonic tool system is shown.

[0021] Fig.11 A basic AC signal that may be generated by a console of an ultrasonic tool system to induce pulsed ultrasonic energy in an ultrasonic instrument of the ultrasonic tool system is shown.

[0022] Fig. 12A and 12B An AC signal is shown that may be generated by a console of an ultrasonic tool system to induce pulsed ultrasonic energy in an ultrasonic instrument of the ultrasonic tool system.

[0023] Fig.13 A method of inducing pulsed ultrasonic energy in an ultrasonic instrument is shown.

[0024] Fig.14A method of providing tactile feedback to a physician manipulating an ultrasonic instrument by inducing pulsed ultrasonic energy in the ultrasonic instrument is shown.

[0025] Fig.15 A graph is shown that may be used to provide tactile feedback to a physician operating an ultrasonic instrument by varying the pulse frequency of pulsed ultrasonic energy induced in the ultrasonic instrument in relation to an applied load.

[0026] Fig.16 A graph is shown representing providing tactile feedback to a physician manipulating an ultrasonic instrument by enabling and disabling pulsed ultrasonic energy in the ultrasonic instrument in relation to an applied load.

[0027] Fig.17 Components that may be incorporated into a tissue detection system for detecting characteristics of tissue contacted by an ultrasonic instrument are shown.

[0028] Fig.18 Components that may be incorporated into a navigation system for tracking an ultrasonic instrument during a surgical procedure are shown.

[0029] Fig.19 A processing architecture that may be implemented by an ultrasonic surgical system is shown.

[0030] Fig. 20 A method of operating an ultrasonic instrument based on a tracked pose of the ultrasonic instrument relative to a patient's anatomy is presented.

[0031] Fig.21 Shown are virtual boundaries and regions that may be generated to control the operation of an ultrasonic instrument during a brain tumor resection surgery.

[0032] Fig. 22 Shown are virtual boundaries and regions that may be generated to control the operation of an ultrasonic instrument during spinal fusion surgery.

[0033] Fig.23 A method of operating an ultrasonic instrument based on tissue characteristics detected by a tissue detection system coupled to the ultrasonic instrument is presented.

[0034] Fig.24 A tissue detection method is shown that combines data from both an ultrasonic tool system and a tissue detection system.

[0035] Figures 25A to 25D A graphical user interface (GUI) that may be used to indicate tissue characteristics detected by a communicatively coupled ultrasound tool system and tissue detection system is shown.

[0036] Fig.26 A tissue detection method is presented that combines data from each of a communicatively coupled ultrasound tool system, a tissue detection system, and a navigation system.

[0037] Fig. 27 A GUI is shown that may be used to indicate tissue features detected by each of the communicatively coupled ultrasound tool system, tissue detection system, and navigation system.

[0038] Fig.28 A method of using data from an ultrasound tool system to track the resection status of a surgical procedure is shown. DETAILED DESCRIPTION

[0039] Figure 1 An ultrasonic surgical system 10 is shown for ablating patient tissue using ultrasonic energy during a surgical procedure and for simultaneously detecting features of contacted tissue and / or tracking the position of one or more objects during the surgical procedure to provide surgical guidance. The surgical system 10 may include an ultrasonic tool system 12, a tissue detection system 13, a navigation system 14, and an imaging system 15. As explained in more detail below, the systems 12, 13, 14, 15 may be communicatively coupled to each other to facilitate the features of the surgical system 10 described herein. In some embodiments, at least one of the tissue detection system 13, the navigation system 14, or the imaging system 15 may be omitted from the surgical system 10.

[0040] refer to Figure 2 and 3 , the ultrasonic tool system 12 may include an ultrasonic console 16 and an ultrasonic instrument 18. The ultrasonic instrument 18 may include a tip 20 having a tip head 22 (also referred to as an operating end 22), which is configured to contact and treat patient tissue. During operation, the ultrasonic console 16 may generate an AC drive signal and supply it to the ultrasonic instrument 18, which induces ultrasonic energy in the ultrasonic instrument 18, thereby causing the tip head 22 to vibrate rapidly. The physician may then position the vibrating tip head 22 on the patient tissue to ablate the contacted tissue. The frequency, amplitude, and speed of the vibration of the tip 20 may correspond to the frequency, amplitude, and speed of the induced ultrasonic energy, which in turn may correspond to the frequency, amplitude, and speed of the AC drive signal.

[0041] The ultrasonic instrument 18 may include a handpiece 24 for grasping by a physician to guide and manipulate the ultrasonic instrument 18 against patient tissue. The tip 20 may be detachably coupled to the handpiece 24 so that the handpiece 24 can be used with different interchangeable tips 20. Different tips 20 detachably coupled to the handpiece 24 may be configured for different types of (surgical) procedures. Some tips 20 detachably coupled to the handpiece 24 may be configured for ablating soft tissues, for example by causing cavitation in such tissues. The tip 20 configured for ablating soft tissues may define a lumen for providing suction at the surgical site through the tip 20. Some tips 20 detachably coupled to the handpiece may be configured for ablating hard tissues, such as fibrous tissue and bone. The tip 20 configured for ablating hard tissues may have a tip head 22 feature, which is formed with a size designed to remove tissue teeth or flutes by cutting action. The tip 20 detachably coupled to the handpiece 24 may also have different lengths for providing access to the patient's anatomical structures at different depths. Some tips 20 that are removably attachable to a hand piece 24 may be designed to vibrate only longitudinally at their tip ends 22, while other tips 20 that are removably attachable to a hand piece 24 may be designed to vibrate not only longitudinally but also torsionally and / or substantially torsionally at their tip ends 22. As described in more detail below, the surgical system 10 may be configured to consider a given tip 20 that is attached to a hand piece 24 when detecting features of tissue that the tip 20 contacts.

[0042] The hand piece 24 may form a proximal end of the ultrasonic instrument 18, and the tip 20 coupled to the hand piece 24 may form a distal end of the ultrasonic instrument 18. "Proximal" may be understood as toward a physician holding the ultrasonic instrument 18 and away from tissue to which the tip 20 is applied, while "distal" may be understood as away from the physician and toward tissue to which the tip 20 of the ultrasonic instrument 18 is applied.

[0043] The handpiece 24 may include a housing 26 that defines a handle for the physician to grasp and manipulate the ultrasonic instrument 18. The housing 26 may also define a void that accommodates a transducer 28. The transducer 28 may include one or more drivers 30, such as one or more piezoelectric crystals. The drivers 30 may be disc-shaped and may be stacked end-to-end (end-to-end) within the housing 26. Each driver 30 may be formed of a material that expands and contracts instantaneously along the longitudinal axis of the driver 30 (i.e., the axis extending between the proximal and distal faces of the driver 30) when an alternating current is applied. It is further contemplated that the driver 30 may be implemented as one or more magnetostrictive elements. An insulating disk may be disposed between adjacent drivers 30 and tightly abuts the adjacent drivers.

[0044] The transducer 28 may also include a tube 32 that may extend through the colinear longitudinal axis of the driver 30 (and the insulating disk, if present). To this end, each of the drivers 30 (and the insulating disks) may include an internal through hole through which the tube 32 extends. A proximal mass may be attached to the proximally directed face of the driver 30 located proximal to the proximal side and may be fixedly attached to the exposed proximal end section of the tube 32. In one example, the tube 32 may be threaded at least at the proximal end section, and the proximal mass may be a nut threaded thereon.

[0045] The handpiece 24 may also include a flare 34 at least partially disposed within the void defined by the housing 26. The flare 34 may be coupled to the distal end of the transducer 28. The flare 34 may be constructed of a rigid steel alloy, titanium, or similar material. In operation, the flare 34 may oscillate as the transducer 28 expands and contracts. The flare 34 may be removably coupled to the transducer 28. For example, the proximal end of the flare 34 may include a male threaded connector, and the distal end of the transducer 28 may include a corresponding female threaded connector. Alternatively, the transducer 28 and the flare 34 may be permanently coupled by welding, bonding, or a similar bonding process. The handpiece 24 may be configured such that the stack of drivers 30 is compressed between the proximal mass and the flare 34.

[0046] The tip 20 can be removably coupled to the flare 34. For example, the distal end of the flare 34 can include a threaded coupler configured to engage with corresponding threads on the proximal end of the tip 20. It is further contemplated that other coupling methods can be employed to removably couple the tip 20 to the flare 34. For example, the distal end of the flare 34 can include features that allow for a snap-fit ​​engagement with the tip 20.

[0047] The ultrasonic instrument 18 can be removably coupled to the ultrasound console 16 via a cable 36. One end of the cable 36 can be permanently connected to the proximal end of the housing 26 of the ultrasonic instrument 18, and the other end of the cable 36 can include an adapter 38 that corresponds to a socket 40 of the ultrasound console 16. The socket 40 can be shaped to receive the adapter 38 and can include electrical contacts that correspond to the electrical contacts of the adapter 38, so that when the adapter 38 is fully seated in the socket 40, an electrical connection is formed between the ultrasonic instrument 18 and the ultrasound console 16.

[0048] When the ultrasonic instrument 18 is actuated, the ultrasound console 16 may generate an AC drive signal and supply it to the ultrasonic instrument 18 via the cable 36. Applying the AC drive signal to the ultrasonic instrument 18 may induce ultrasonic energy in the ultrasonic instrument 18 and, in turn, may cause the tip 20 of the ultrasonic instrument 18 to vibrate.

[0049] More specifically, the ultrasonic instrument 18 can be designed so that the AC drive signal from the ultrasound console 16 is applied in parallel to each driver 30 of the transducer 28, which can cause the drivers 30 to expand and contract simultaneously along the longitudinal axis of the transducer 28 according to the AC drive signal. The length of the stack of drivers 30 can be between 1 and 5 centimeters. The distance or amplitude that the driver 30 moves on a single expansion / contraction cycle can be between 0.01 and 10 microns.

[0050] The flared portion 34 may be configured to amplify this movement. Thus, the distal end of the flared portion 34 and (by extension) the tip 20 may each move back and forth along its longitudinal axis between a fully retracted position and a fully extended position, thereby generating a longitudinal vibratory motion. In some examples, the maximum peak-to-peak vibration of the tip 22 (representing a single movement from the fully retracted position to the fully extended position) may be 1000 microns, or 500 microns, or 300 microns. As previously described, some tips 20 that are removably connectable to the handpiece 24 may be configured to vibrate not only longitudinally but also torsionally and / or substantially torsionally at their tip 22. Such a tip 20 may include features along its length, such as a spiral groove, that are configured to convert a longitudinal vibration applied to the proximal end of the tip 20 into a vibration at the tip 22 having both a longitudinal component and a torsional component and / or substantially only a torsional component.

[0051] To help reduce heat generation during operation, the ultrasonic instrument 18 can define an irrigation path for supplying irrigation fluid to the distal region of the tip 20 (e.g., the tip 22) and the surgical site. For example, the ultrasonic instrument 18 can include an irrigation sleeve 42 that is adapted to be arranged around the tip 20 and detachably coupled to the handpiece 24 (e.g., the housing 26 of the handpiece 24) for supplying irrigation fluid to at least the distal region of the tip 20 and the surgical site.

[0052] The irrigation sleeve 42 may include a sleeve body 44 having open proximal and distal ends and defining a lumen 46 extending between the open proximal and distal ends. The sleeve body 44 may be adapted to be coupled to the handpiece 24 (e.g., the housing 26 of the handpiece 24) such that the tip 20 extends through the lumen 46 and out of the open distal end of the sleeve body 44. For example, the proximal end of the sleeve body 44 may be formed with a coupling feature for releasably coupling the sleeve body 44 to the distal end of the housing 26. When disposed on the tip 20 and coupled to the housing 26, the sleeve body 44 may be radially spaced from the tip 20 and may be longitudinally spaced away from the tip 22, as described above. The dimensions of the components of the ultrasonic instrument 18 may be designed such that the tip 20 does not contact the irrigation sleeve 42 during normal operation.

[0053] During operation of the ultrasonic instrument 18, an irrigation fluid may flow from the hand piece 24 into the gap between the tip 20 and the cannula body 44, and then out of the open distal end of the cannula body 44. More specifically, the hand piece 24 may include an irrigation conduit 48 that passes through the housing 26 from the proximal end to the distal end of the hand piece 24. The proximal end of the irrigation conduit 48 may be coupled to a connector 50 of the ultrasonic instrument 18 that extends from the proximal end of the hand piece 24 to receive an irrigation line 52. The irrigation line 52 may be coupled to a fluid supply source 54 via a cassette 56 that may be inserted into a corresponding slot 58 of the ultrasound console 16. During operation of the surgical system 10, a pump of the ultrasound console 16 may operate the cassette 56 to draw fluid from the fluid supply source 54 into the irrigation line 52, and then into the irrigation conduit 48.

[0054] The irrigation cannula 42 may similarly include an irrigation conduit 60 in fluid communication with the lumen 46 defined by the cannula body 44. The irrigation conduit 60 may extend from a proximal region of the cannula body 44 and extend adjacent to the lumen 46 to an orifice 62 formed in a wall of the lumen 46. The orifice 62 may be positioned in an intermediate portion of the lumen 46 between the proximal and distal ends of the lumen 46 and may be configured to supply irrigation fluid from the irrigation conduit 60 into a gap between the tip 20 and the cannula body 44. When the irrigation cannula 42 is coupled to the handpiece 24, the proximal end of the irrigation conduit 60 of the irrigation cannula 42 may be adapted to fluidly engage the distal end of the irrigation conduit 48 of the handpiece 24.

[0055] Thus, during operation of the ultrasonic instrument 18, irrigation fluid may flow from the fluid supply 54, through the irrigation line 52, the connector 50, and the conduits 48, 60, and out of the orifice 62 into the lumen 46. This irrigation fluid may then flow distally along the lumen 46 and out of the open distal end of the cannula body 44. In an alternative example, the irrigation cannula 42 is not configured to receive irrigation fluid from the handpiece 24, but may include a connector in fluid communication with the irrigation conduit 60, and the connector is disposed on the outer surface of the cannula body 44 for receiving the irrigation line 52 extending outside the handpiece 24. In this case, during operation of the ultrasonic instrument 18, the irrigation fluid may similarly flow through the gap between the tip 20 and the cannula body 44 via the connector and out of the open distal end of the cannula body 44.

[0056] The ultrasonic instrument 18 may also define a suction path for providing suction at a distal region of the tip 20 (e.g., the tip 22). For example, the tube 32 of the transducer 28 may define a lumen extending from a proximal end to a distal end of the transducer 28 to establish a fluid passage through the transducer 28. The flared portion 34 may similarly define a lumen extending from a proximal end to a distal end of the flared portion 34 to establish a fluid passage through the flared portion 34, and the tip 20 may also define a lumen extending from a proximal end to a distal end of the tip 20 to establish a fluid passage through the tip 20. In general, these lumens may form at least a portion of a suction path extending from a distal region of the tip 20 to a proximal region of the handpiece 24.

[0057] The ultrasonic instrument 18 may also include a connector 64 that is coupled to the tube 32 and extends proximally from a proximal region of the handpiece 24 for receiving a suction line 66. During a surgical procedure, suction may be applied to the fluid path defined by the tube 32, the flared portion 34, and the tip 20 via the connector 64 and the suction line 66 to draw irrigation fluid applied to the surgical site and debris entrained in the fluid from the surgical procedure toward and out of the proximal end of the handpiece 24. More specifically, the ultrasound console 16 may include a vacuum pump that is in fluid communication with a waste canister 70 via a cassette 56 inserted into the ultrasound console 16, wherein when the cassette 56 is inserted into the ultrasound console 16, the waste canister 70 is separately placed in fluid communication with the fluid passage defined by the tube 32, the flared portion 34, and the tip 20, for example, via the fluid passage defined by the connector 64, the suction line 66, and the cassette 56. In this way, the vacuum pump can apply suction to the fluid passage defined by the tube 32, flared portion 34, and tip 20 via the waste canister 70, the cassette 56, the suction line 66, and the connector 64, thereby drawing material from the surgical site through the fluid passage into the waste canister 70. The suction can also serve to pull tissue toward the tip 22, which can increase the effectiveness of the tip 20 in treating the patient's tissue.

[0058] The ultrasonic tool system 12 may also include one or more sensors associated with the aspiration path for measuring one or more characteristics of the resected tissue moving through the path. As described in more detail below, the surgical system 10 may be configured to use the information generated by these sensors to track the resection status of the surgical procedure.

[0059] For example, a portion of the suction channel between the waste tank 70 and the ultrasonic instrument 18 can pass through the suction sensor 72 of the ultrasound console 16. The suction sensor 72 can be configured to generate data indicating the presence and volume of the patient's tissue passing through the suction path. In some instances, the suction sensor 72 may include a flow sensor. Additionally or alternatively, the suction sensor 72 may include a scanner for scanning the tissue passing through the suction path and generating corresponding data indicating the characteristics of the tissue (e.g., the size, volume, and / or type of the tissue). For example, the scanner may include an IR transceiver and / or a fluorescent emitter / collector, such as similar to that described below, each of which can be configured to excite the resected tissue passing through the suction path with light, and then collect the light signal emitted by the tissue due to the excitation, for determining one or more of the above-mentioned tissue features. In some instances, the target tissue can be dyed to have different optical properties before the surgical procedure so that the suction sensor 72 can distinguish between the resected tissue corresponding to the target tissue and the resected tissue corresponding to the non-target tissue. Additionally or alternatively, sensors associated with the suction path may include a weight sensor 73 configured to generate data indicative of the weight of resected patient tissue that has passed through the suction path and deposited into the waste canister 70 .

[0060] The ultrasound console 16 may also include a display 74 for presenting information to the physician. Non-limiting examples of the information presented may include an identification of the ultrasonic instrument 18 (or more specifically the handpiece 24 and / or the tip 20) currently connected to the ultrasound console 16, and the operating status of the ultrasonic tool system 12 and / or the surgical system 10. The display 74 may be a touch screen display that enables the physician to provide input to the ultrasound console 16, such as through on-screen control elements. The physician may interact with the on-screen control elements to set operating parameters of the ultrasonic tool system 12, such as the maximum ultrasonic energy level, suction level, and irrigation level of the ultrasonic instrument 18.

[0061] The ultrasonic tool system 12 may further include one or more actuation devices coupled to the ultrasound console 16. Each of these actuation devices, when activated by a physician, may cause the ultrasound console 16 to generate an AC drive signal and supply it to the ultrasonic instrument 18, which induces ultrasonic energy in the ultrasonic instrument 18 according to set operating parameters and causes the tip 20 of the ultrasonic instrument 18 to vibrate accordingly.

[0062] For example, the one or more actuation devices may include a foot pedal 76. The foot pedal 76 may be wirelessly connected to the ultrasound console 16, for example, via an adapter 78 connected to the ultrasound console 16. When depressed, the foot pedal 76 may be switched from an inactive position to an active position, and an actuation signal indicative of the depression may be sent to the ultrasound console 16 accordingly. In some examples, the actuation signal sent may vary with the degree to which the foot pedal 76 is depressed, so that the physician may change the ultrasonic energy level induced in the ultrasonic instrument 18 through the foot pedal 76 until a set maximum ultrasonic energy level is reached. In response to receiving the actuation signal, the ultrasound console 16 may generate and supply an AC drive signal to the ultrasound instrument 18, which causes the tip 20 to vibrate according to the current setting of the ultrasound console 16 and / or the degree of depression indicated by the actuation signal.

[0063] The ultrasound tool system 12 may also include a remote control 80 coupled to the ultrasound console 16. Similar to the touch screen display 74, the remote control 80 may include physician-selectable elements for providing input to the ultrasound console 16. For example, the remote control 80 may include buttons for setting operating parameters of the ultrasound tool system 12, such as the maximum ultrasound energy level, suction level, and irrigation level of the ultrasonic instrument 18. The remote control 80 may also include a power button for turning the ultrasound console 16 on and off. Additionally or alternatively, the ultrasound console 16 may include an integrated power button 82 for turning the ultrasound console 16 on and off.

[0064] Still refer to Figure 2 and 3 , the tissue detection system 13 may be communicatively coupled to the ultrasonic tool system 12, such as via a cable 84 connecting the ultrasound console 16 of the ultrasonic tool system 12 with a tissue detection console 86 of the tissue detection system 13. The tissue detection system 13 may be configured to detect the type of tissue contacted by the tip 20 of the ultrasonic instrument 18, and may be configured to cooperate with the ultrasonic tool system 12 to control the operation of the surgical system 10, or more specifically, the operation of the ultrasonic instrument 18, based on the type of tissue detected.

[0065] The tissue detection system 13 may include a tissue detection console 86 and a sampling element 88. The sampling element 88 may be connected to the tissue detection console 86, for example, by a connector 90 that is integrated with the sampling element 88 and inserted into a corresponding socket 92 of the tissue detection console 86. The sampling element 88 may be coupled to the ultrasonic instrument 18, for example, along the length of the handpiece 24 and / or the irrigation sleeve 42, as shown in the illustrated example. For example, but not limited to, the sampling element 88 may be coupled to the ultrasonic instrument 18 using an adhesive (e.g., in the form of a sticker or glue) or by one or more fixing elements wrapped around the ultrasonic instrument 18 and the sampling element 88, which are periodically spaced along the length of the ultrasonic instrument 18.

[0066] The sampling element 88 may include an excitation fiber 94, and may include a detection indicator 96. During a surgical procedure, the tissue detection console 86 may be configured to illuminate tissue adjacent to the operative end 22 of the tip 20 or contacted by the operative end 22 of the tip 20 with excitation light through the excitation fiber 94. To this end, the excitation fiber 94 may extend the length of the sampling element 88 so that when the sampling element 88 is coupled to the ultrasonic instrument 18, a distal region 98 of the excitation fiber 94 is adjacent to the operative end 22 of the tip 20 to allow excitation light to be delivered to tissue adjacent to the operative end 22 of the tip 20 or contacted by the operative end 22 of the tip 20. As shown in the illustrated example, the sampling element 88 may be coupled to the ultrasonic instrument 18 in a manner that does not directly contact the distal portion of the tip 20 and the sampling element 88. For example, the sampling element 88 may terminate near a portion of the irrigation sleeve 42 that is adjacent to the operative end 22 of the tip 20. In another example, the sampling element 88 may extend beyond the irrigation sleeve 42, but be arranged so that there is sufficient empty space between the operative end 22 of the tip 20 and the sampling element 88 to prevent contact therebetween.

[0067] In response to irradiation with excitation light of a given wavelength, different tissues may exhibit different levels and / or different wavelengths of fluorescence. For example, before a surgical procedure involving the removal of tumor tissue, aminovaleric acid (5-ALA) may be administered to a patient a few hours before surgery. 5-ALA is a compound naturally present in the hemoglobin synthesis pathway. In cancer cells, hemoglobin synthesis is disrupted and the pathway stagnates at an intermediate compound called protoporphyrin IX (PPIX). When irradiated with excitation light of a specific wavelength (e.g., blue light) from an excitation optical fiber 94, tumor cells containing PPIX may absorb the excitation light and emit fluorescence with unique optical characteristics (e.g., red fluorescence at a minimum intensity level), thereby indicating the presence of tumor cells. As another example, indocyanine green (ICG) may be administered to a patient before surgery, which may bind to plasma proteins in the blood. When irradiated with excitation light of a specific wavelength (e.g., near-infrared light), ICG may emit fluorescence with unique optimal characteristics (e.g., near-infrared fluorescence at a minimum intensity level), thereby indicating the presence of blood vessels. Other fluorophores that can be excited to detect various types of tissues include Hyperiicin and Hexvix.

[0068] Thus, the tissue detection console 86 may be configured to illuminate tissue adjacent to the operating end 22 of the tip 20 or contacted by the operating end 22 of the tip 20 with one or more wavelengths of excitation light through the excitation fiber 94, and then collect fluorescence emitted from the illuminated tissue through the excitation fiber 94. In an alternative example, the tissue detection system 13 may include a separate optical fiber for collecting the emitted fluorescence, which may be incorporated into a separate collection element extending in parallel with the sampling element 88 and connected to the socket 99 of the tissue detection console 86. In either configuration, the tissue detection console 86, such as through an integrated spectrometer, may be configured to convert the collected light into an electrical signal interpreted by the tissue detection console 86. The electrical signal may indicate the intensity of various fluorophores contained in the collected light, and the tissue detection console 86 may be configured to analyze the electrical signal to determine at least one feature of the tissue adjacent to or contacting the operating end 22 of the tip 20 of the ultrasonic instrument 18 indicated by the electrical signal, such as the type of tissue. For example, the tissue detection console 86 may be configured to compare the intensity of the red fluorescence indicated by the electrical signal with a minimum intensity threshold associated with tumor tissue. In response to the comparison indicating that the intensity of the red fluorescence is greater than or equal to the minimum intensity threshold, the tissue detection console 86 can be configured to determine that the operating end 22 of the tip 20 of the ultrasonic instrument 18 is currently in contact with tumor tissue. Otherwise, the tissue detection console 86 can be configured to determine that the operating end 22 of the tip 20 of the ultrasonic instrument 18 is currently in contact with non-tumor tissue.

[0069] In response to determining that a tissue feature indicative of a given tissue type is present, the tissue detection console 86 can be configured to generate an activation signal that causes the detection indicator 96 to illuminate, thereby providing a real-time indication of the presence of the given tissue type to the healthcare practitioner. As shown in the illustrated example, the detection indicator 96 can be illuminated by an indicator fiber 100 that extends the length of the sampling element 88 as does the excitation fiber 94. The detection indicator 96 can be located near or proximal to the distal portion of the sampling element 88 to ensure that the physician can see the detection indicator 96 when resecting tissue. The detection indicator 96 can be transparent and can correspond to a removed portion of a sheath of the sampling element 88. In one example, the sampling element 88 can include a coaxial optical fiber having a central core and an outer channel covered by a sheath. The excitation fiber 94 can be disposed within the central core, and the indicator fiber 100 can be disposed within the outer channel. A portion of the sheath 102 of the sampling element 88 can be removed so that the indicator fiber 100 can emit light through the sidewall of the outer channel to illuminate the detection indicator 96.

[0070] The indicator optical fiber 100 can be connected to receive light from an excitation source integrated with the tissue detection console 86, the wavelength of which is different from the wavelength of the excitation light used to illuminate the tissue. In response to detecting a tissue feature indicating a given tissue type, the tissue detection console 86 can be configured to transmit light along the indicator optical fiber 100 through the excitation source of the tissue detection console 86 to illuminate the detection indicator 96. In some examples, the detection indicator 96 can be illuminated with light of different colors depending on the detected tissue features. For example, the tissue detection console 86 can be configured to control the excitation source (e.g., one or more LEDs) to emit green light (e.g., wavelength of about 520-564nm) from the detection indicator 96 when a PPIX fluorophore above a threshold is detected, and emit yellow light (e.g., wavelength of about 565-590nm) from the detection indicator 96 when an ICG fluorophore above a threshold is detected.

[0071] The tissue detection console 86 may similarly include a display 104 for presenting information to the physician. A non-limiting example of the information presented may include identification of tissue features detected by the tissue detection system 13. The display 104 may be a touch screen display that enables the physician to provide input to the tissue detection console 86, such as through control elements on the screen. The physician may interact with the control elements on the screen to set operating parameters of the tissue detection system 13, such as ablation target tissue types (e.g., tumor tissue) and / or features of ablation target tissue types (e.g., minimum values ​​and types of fluorophores corresponding to the tissue). In this way, the tissue detection console 86 may illuminate the detection indicator 96 in a particular manner in response to determining that the operating end 22 of the tip 20 is contacting or adjacent to tissue corresponding to the set tissue type and / or feature.

[0072] As described above, the tissue detection system 13 can communicate with the ultrasonic tool system 12. For example, such communication can be established through an electrical port 106 integrated with the tissue detection console 86, and the cable 84 can extend from the electrical port 106 to a corresponding electrical port 107 of the ultrasonic console 16. Alternatively, the communication link between the consoles 16, 86 can be established wirelessly.

[0073] The tissue detection system 13 and the ultrasonic tool system 12 may be configured to cooperate to adjust the operation of the surgical system 10, or more specifically, the operation of the ultrasonic instrument 18. For example, similar to the tissue detection console 86, the ultrasonic console 16 may be configured to monitor one or more characteristics of the tissue contacted by the operating end 22 of the tip 20. More specifically, the characteristics of the AC drive signal supplied to the ultrasonic instrument 18 to vibrate the tip 20 may indicate the characteristics of the tissue contacted by the operating end 22 of the tip 20, such as the mechanical impedance (e.g., stiffness) of the contacted tissue. Therefore, the ultrasonic console 16 may be configured to monitor one or more characteristics of the AC drive signal and determine at least one characteristic of the tissue contacted by the operating end 22 of the tip 20 based on the one or more characteristics monitored. In addition to displaying at least one indicator corresponding to the tissue characteristics determined by the ultrasonic tool system 12 and the tissue detection system 13 (e.g., on one or more of the displays 74, 104), the tissue detection system 13 and / or the ultrasonic tool system 12 may also be configured to determine whether the tissue characteristics determined by the systems 12, 13 are inconsistent. If so, the tissue detection system 13 and / or the ultrasonic tool system 12 can be configured to trigger a system error, which can include preventing operation of the ultrasonic instrument 18 until the surgical system 10 is restarted via user input. These and other functions of the surgical system 10 will be described in more detail below.

[0074] Figure 4 Components that may be integrated with the ultrasound console 16 are shown. The console 16 may include an ultrasound controller 112, a signal generator 114, a transformer 116, and a console storage device 118. In general, the signal generator 114 and the transformer 116 may form a power supply for the console 16, which is configured to generate an AC drive signal supplied to the driver 30 of the ultrasonic instrument 18, and the output of these components is regulated by the ultrasound controller 112.

[0075] The ultrasound controller 112 may include a processor 120 and a memory 122. The processor 120 may include one or more devices selected from the following: a microprocessor, a microcontroller, a digital signal processor, a microcomputer, a central processing unit, a field programmable gate array, a programmable logic device, a state machine, a logic circuit, an analog circuit, a digital circuit, and / or any other device that manipulates signals (analog or digital) based on operating instructions (e.g., from the console storage device 118) that are read into the memory 122 and executed. The memory 122 may include a single memory device or multiple memory devices, including, but not limited to, read-only memory (ROM), random access memory (RAM), volatile memory, non-volatile memory, static random access memory (SRAM), dynamic random access memory (DRAM), flash memory, cache memory, and / or any other device capable of storing information. The console storage device 118 may include one or more persistent data storage devices, such as a hard drive, an optical drive, a tape drive, a non-volatile solid-state device, and / or any other device capable of persistently storing information. Although shown as being separate from the ultrasound controller 112 in the illustrated example, the console storage device 118 may additionally or alternatively be included in the ultrasound controller 112 , such as in communication with the processor 120 .

[0076] The ultrasound controller 112 may be configured to implement the functions, features, processes, and methods of the console 16 described herein. More specifically, the processor 120 of the ultrasound controller 112 may operate under the control of a software program 123 embodied by computer executable instructions, which may reside in the console storage device 118 and be read into the memory 122 for execution by the processor 120. The computer executable instructions may be compiled or interpreted by a variety of programming languages ​​and / or technologies, including, but not limited to, Java, C, C++, C#, Objective C, Fortran, Pascal, Java Script, Python, Perl, and PL / SQL, either alone or in combination. The computer executable instructions may be configured to cause the processor 120 to implement the functions, features, processes, and methods of the console 16 described herein when executed by the processor 120. In this way, the ultrasound controller 112 (or more specifically the processor 120) may be configured to implement the functions, features, processes, and methods of the console 16 described herein.

[0077] For example, the ultrasonic controller 112, for example, when the processor 120 executes the software program 123, can be configured to control the level of ultrasonic energy induced in the ultrasonic instrument 18 by adjusting the AC drive signal supplied from the console 16 to the ultrasonic instrument 18, and accordingly control the vibration of the tip 20. More specifically, during the operation of the ultrasonic tool system 12, the ultrasonic controller 112 can be configured to output one or more control signals to the signal generator 114, which control signals correspond to the target AC drive signal to be supplied from the console 16 to the ultrasonic instrument 18. The signal generator 114 can be configured to responsively generate an AC signal on the primary winding 124 of the transformer 116, for example, using direct digital synthesis (DDS) and one or more amplifiers. The AC signal can be proportional to the target AC drive signal indicated by the one or more control signals, and thus can induce the target AC drive signal on the secondary winding 126 of the transformer 116, and the secondary winding 126 of the transformer 116 can be coupled to the ultrasonic instrument 18, for example, via an electrical contact 128.

[0078] refer to Figure 5 , the electrical contacts 128 can be integrated with the socket 40 of the console 16. The corresponding electrical contacts 130 can be integral with the adapter 38 of the cable 36. The electrical contacts 130 can also be electrically connected to opposite ends of each driver 30 of the ultrasonic instrument 18. When the adapter 38 is fully seated in the socket 40, the electrical contacts 128, 130 can be aligned and electrically connected, so that the AC drive signal generated on the secondary winding 126 of the transformer 116 can be applied to each driver 30 to induce ultrasonic energy in the ultrasonic instrument 18 and cause vibration of the tip 20 accordingly.

[0079] Fig. 6A and 6B FIG. 1 shows a circuit through which current flows through the ultrasonic instrument 18 when an AC drive signal is supplied from the console 16 to the ultrasonic instrument 18. As shown in the example shown, the current i of the supplied AC drive signal is S It can be decomposed into two components: the current i applied to the driver 30 of the ultrasonic instrument 18 O and the equivalent current i applied to the mechanical components of the ultrasonic instrument 18 M (also referred to herein as "mechanical current i M ”). The mechanical components of the ultrasonic instrument 18 may include those components that vibrate in response to a supplied AC drive signal to treat patient tissue, such as, but not limited to, the driver 30, tube 32, horn 34, tip 20, and proximal mass described above.

[0080] The impedance Z provided by the driver 30 O may be mainly capacitive. Therefore, the driver 30 may be ODuring operation of the ultrasonic instrument 18, the capacitance C of the driver 30 O The capacitance C of the driver 30 may remain substantially constant and may therefore be determined and provided to the console 16 prior to operation (e.g., when the ultrasonic instrument 18 is connected to the console 16) in order to adapt the operation of the console 16 to the specific handpiece 24 of the ultrasonic instrument 18. Additionally or alternatively, the console 16 may be configured to periodically measure the capacitance C of the driver 30 during operation of the ultrasonic instrument 18. O , to achieve higher accuracy.

[0081] The equivalent impedance Z provided by the mechanical components of the ultrasonic instrument 18 M (also referred to herein as "mechanical impedance Z M ”) may include inductive components, resistive components and capacitive components. Therefore, these mechanical components can be represented by an inductor L M The inductor and resistor are R M The resistor and capacitor are C M The inductor L M , resistor R M and capacitor C M The resistance R M (also referred to as "mechanical resistance R M ”) can vary as a function of the load applied to the tip 20 (e.g., by the contacted patient tissue and / or the irrigation fluid provided via the irrigation cannula 42). In other words, the mechanical impedance Z M , or more specifically the mechanical resistance R M , may vary based on the hardness of the tissue to which the tip 20 is applied, and / or based on the force with which the physician applies the ultrasonic instrument 18 to the tissue, and / or based on the flow rate of the irrigation fluid flowing through the cannula 42.

[0082] The ultrasonic energy induced in the ultrasonic instrument 18 and the corresponding vibration of the tip 20 can be related to the mechanical current i M For example, the frequency of the vibration of the tip 22 can be equal to the mechanical current i M The peak-to-peak displacement of the tip 22 in micrometers may be approximately the mechanical current i in milliamperes when the ultrasonic instrument 18 is operated in a resonant state. M 180% to 220% of the amplitude of the tip 20, depending on the gain of the tip 20. For example, a mechanical current i at the resonant frequency of the ultrasonic instrument 18 and with an amplitude of 150 mA M The tip head 22 of a given tip 20 may be caused to vibrate back and forth along a travel path of approximately 330 microns.

[0083] Thus, the ultrasonic controller 112 can induce vibrations having a target frequency and displacement level in the tip 20 by generating a control signal to the signal generator 114, which causes the signal generator 114 to supply an AC drive signal to the ultrasonic instrument 18 that induces a mechanical current i having a target frequency and an amplitude corresponding to the target displacement level in the ultrasonic instrument 18. M To this end, the ultrasonic controller 112 may be configured to implement two control loops to induce the target vibration in the tip 20, namely, for regulating the mechanical current i induced in the ultrasonic instrument 18 by the AC drive signal. M The control loop for adjusting the frequency of the AC drive signal and the mechanical current i induced in the ultrasonic instrument 18 M Each control loop may include a PID controller for efficiently regulating the AC drive signal to achieve the desired value, and the iteration cycle time may be approximately 400 microseconds.

[0084] Using Ohm's law, the ultrasonic controller 112 may be configured to calculate the mechanical current i induced in the ultrasonic instrument 18 using the following equation: M Level:

[0085] i M =i S -j2πfC O v S (1)

[0086] Among them, i S is the current of the AC drive signal supplied to the ultrasonic instrument 18, f is the frequency of the AC drive signal, C O is the capacitance of the driver 30, and v S is the voltage of the AC drive signal. An explanation of equation (1) is provided in applicant's U.S. Patent No. 10,016,209, the contents of which are incorporated herein by reference in their entirety. Assuming that the frequency f of the AC drive signal has been previously set to achieve the desired vibration characteristics (e.g., resonance) of the ultrasonic instrument 18, the ultrasonic controller 112 may adjust the AC drive signal by setting the voltage v of the AC drive signal to S The target level of mechanical current i is obtained by making equation (1) M , thereby inducing the target level of mechanical current i M And accordingly induces the target vibration of the tip 20.

[0087] As described above, a characteristic associated with the ultrasonic instrument 18 is the mechanical resonant frequency of the ultrasonic instrument 18. The mechanical resonant frequency is the frequency at which the distal end of the tip 20 experiences a peak range of vibratory motion. In other words, assuming other electrical characteristics remain constant, at the resonant frequency, the tip 20 experiences motion that is greater in magnitude than would occur if the driver 30 were vibrating at a frequency less than or greater than the resonant frequency. For a longitudinally vibrating tip 20, the peak range can be understood as the maximum front-to-back distance of the distal end of the tip 20.

[0088] Applicant's U.S. Patent No. 10,016,209 also discloses a means for tracking the resonant frequency of the ultrasonic instrument 18, which may change during operation of the ultrasonic instrument 18. Specifically, when the current i O With mechanical current i M When the real part of the ratio of is substantially equal to zero, the ultrasonic instrument 18 may be considered to be operating in a resonant state. Therefore, the ultrasonic controller 112 may be configured to determine the resonant frequency of the ultrasonic instrument 18 by determining the value of the frequency f of the AC drive signal such that the following equation holds true:

[0089]

[0090] where i S is the current of the AC drive signal supplied to the ultrasonic instrument 18, C O is the capacitance of the driver 30. In response to determining the resonant frequency of the ultrasonic instrument 18, for example using equation (2), the ultrasonic controller 112 may be configured to set the frequency of the AC drive signal to the determined resonant frequency, thereby operating the ultrasonic instrument 18 in a resonant state.

[0091] The ultrasonic controller 112 may also be configured to track and set the frequency of the AC drive signal based on other vibration characteristics inherent to the ultrasonic instrument 18, such as the anti-resonance frequency of the ultrasonic instrument 18. In this case, the ultrasonic controller 112 may be configured to determine the value of the frequency f such that the left side of equation (2) is substantially equal to one.

[0092] When the frequency of the AC drive signal is adjusted to follow the target vibration characteristics (e.g., resonance) of the ultrasonic instrument 18, the mechanical current i M The level of may vary. Therefore, in order to induce the target ultrasonic energy in the ultrasonic instrument 18, the ultrasonic controller 112 may be configured to repeatedly alternate between or perform both of the following two operations in parallel: the operation of adjusting the frequency of the AC drive signal based on equation (2) and setting the voltage v of the AC drive signal S Let the mechanical current i calculated according to equation (1) M Operation corresponding to the target ultrasound energy.

[0093] For this purpose, refer again to Figure 4 , the ultrasound controller 112 may be configured to receive feedback data corresponding to the AC drive signal supplied to the ultrasonic instrument 18, such as through one or more sensors integrated with the console 16. The ultrasound controller 112 may then be configured to induce target ultrasonic energy in the ultrasonic instrument 18 and correspondingly induce target vibrations of the tip 20 based on the received data, such as by feeding the received data to a controller that adjusts the frequency and voltage v of the AC drive signal using equations (1) and (2), respectively. S in the circuit.

[0094] More specifically, the console 16 may include a voltage V for measuring the AC drive signal supplied to the ultrasonic instrument 18. S The sensor may include a ticklercoil 132 adjacent to or integrated with the transformer 116. The ticklercoil 132 may be connected to a voltage measurement circuit 134 of the console 16, which in turn may be connected to the ultrasound controller 112. The signal across the ticklercoil 132 may be compared to the voltage v of the AC drive signal supplied to the ultrasonic instrument 18. S Based on the signal across the feedback coil 132, the voltage measurement circuit 134 can generate and send to the ultrasonic controller 112 a voltage v representing the AC drive signal supplied to the ultrasonic instrument 18. S Therefore, the ultrasound controller 112 can be configured to measure the voltage v of the AC drive signal via the voltage measurement circuit 134 and the feedback coil 132. S , and based on this, a control signal for adjusting the AC drive signal is generated.

[0095] The console 16 may also include a current meter for measuring the AC drive signal supplied to the ultrasonic instrument 18. S The sensor may include a coil 136 disposed in close proximity to one of the conductors extending from the secondary winding 126 of the transformer 116 to the ultrasonic instrument 18. The coil 136 may be connected to a current measurement circuit 138 of the console 16, which in turn may be connected to the ultrasonic controller 112. The signal across the coil 136 may be compared to the current i of the AC drive signal supplied to the ultrasonic instrument 18. S Based on the signal across the coil 136 , the current measurement circuit 138 can generate and send to the ultrasonic controller 112 a current i representing the AC drive signal supplied to the ultrasonic instrument 18 . S Thus, the ultrasonic controller 112 may be configured to measure the current i of the AC drive signal via the current measurement circuit 138 and the coil 136. S, and based on this, a control signal for adjusting the AC drive signal is generated.

[0096] In addition to the software program 123 embodied by computer executable instructions, the console storage device 118 may store data that supports the functions, features, processes, and methods of the console 16 described herein. For example, the console storage device 118 may include data defining one or more pulse profiles (pulsing profiles, pulse configurations, pulse curves) 140 for inducing pulsed ultrasonic energy in the ultrasonic instrument 18 as described in more detail below, and may include tissue type data 142. The tissue type data 142 (also described in more detail below) may associate different types of tissue with different characteristics of the ultrasonic instrument 18, or more specifically, with different characteristics of the AC drive signal supplied to the ultrasonic instrument 18, which indicate that the operating end 22 of the ultrasonic instrument 18 is contacting that type of tissue.

[0097] In order to efficiently ablate tissue, the ultrasound console 12 (or more specifically the ultrasound controller 112) can cause the tip 20 of the ultrasonic instrument 18 to vibrate at a relatively high speed. For example, at full power, the ultrasound console 12 can cause the tip 20 to vibrate at a frequency between 20 and 40 kHz and a peak-to-peak displacement of about 300 microns. Although the vibration of the tip 20 at this speed can enable the ultrasonic instrument 18 to emulsify hard tissues such as fibrous tissue and bone, the tip 20 undergoing a large number of vibration cycles during operation and maintaining this speed may also generate a large amount of heat in the ultrasonic instrument 18 and at the surgical site. This heat may affect the operation of the ultrasonic instrument 18 and increase trauma to surrounding tissues that are desired to remain intact.

[0098] However, when the tip 20 is vibrated at a constant speed to remove hard tissue, the amount of removal caused by each vibration cycle of the tip 20 may not be equal. In addition, a large number of vibration cycles may only increase the heat generation at the surgical site without actually removing any tissue. Therefore, it is possible to reduce the generation of heat while maintaining an effective removal rate of hard tissue by periodically reducing the ultrasonic energy induced in the ultrasonic instrument 18 (for example, according to one of the predefined pulse profiles 140 stored in the ultrasound console storage device 118). In some examples, the pulse profile 140 can be similar to those described in the applicant's PCT Publication No. WO2022 / 072903 A1, the contents of which are hereby incorporated by reference in their entirety.

[0099] Each pulse profile 140 can define a distribution pattern of ultrasonic energy to be induced in the ultrasonic instrument 18, wherein the ultrasonic energy distribution pattern includes a number of ultrasonic energy pulses peaking at a maximum ultrasonic energy level set for the ultrasonic instrument 18 and separated by ultrasonic energy periods at a minimum ultrasonic energy level set for the ultrasonic instrument 18. In some examples, the maximum ultrasonic energy level can be set by a physician, and the minimum ultrasonic energy level can be defined by the pulse profile relative to the maximum ultrasonic energy level.

[0100] The ultrasonic energy induced in the ultrasonic instrument 18 may cause the tip 20 to vibrate at a frequency, amplitude, and velocity corresponding to the induced ultrasonic energy, which in turn may correspond to the frequency, amplitude, and velocity of the AC drive signal. For a given pulse profile 140, a peak vibration amplitude and velocity may occur in the tip 20 when a maximum ultrasonic energy level is induced in the ultrasonic instrument 18, which may be set to a level sufficient to ablate the type of target tissue. The periodic reduction of the ultrasonic energy induced in the ultrasonic instrument 18 according to the pulse profile 140 may cause the vibration amplitude and velocity of the tip 20 to be periodically reduced from the peak amplitude and velocity, which may reduce heat generation in the ultrasonic instrument 18 and at the surgical site while maintaining an acceptable ablation rate. In other words, relative to maintaining the ultrasonic energy induced in the ultrasonic instrument 18 at the set maximum ultrasonic energy level, implementing a given pulse profile 140 may reduce the number of vibration cycles in which the tip 20 moves at the peak velocity, thereby reducing the generation of frictional heat.

[0101] In addition to reducing heat generation when cutting hard tissue, periodically reducing the ultrasonic energy induced in the ultrasonic instrument 18 according to the predefined pulse profile 140 can achieve finer resection control when applying the tip 20 to certain tissues (e.g., soft tissue) by causing the induced tip 20 vibration to slow the resection rate of harder tissues while substantially maintaining the resection rate of softer tissues. In other words, the predefined pulse profile 140 can provide improved tissue selectivity.

[0102] Different pulse profiles 140 may be designed for different situations, such as ablating certain types of tissue and / or providing the physician with increased tactile feedback when cutting hard tissue such as bone. In some examples, the physician may select a desired pulse profile 140 to operate the ultrasonic instrument 18, such as by interacting with the display 74 of the console 16. In response to receiving a selection of a given pulse profile 140, the ultrasound controller 112 may be configured to retrieve the pulse profile 140 from the console storage device 118 and then generate and supply an AC drive signal to the ultrasonic instrument 18, which induces ultrasonic energy in the tip 20 according to the extracted pulse profile 140.

[0103] Each pulse profile 140 stored in the console storage device 118 may be configured to induce ultrasonic energy in the ultrasonic instrument 18 including a series of ultrasonic energy pulses. More specifically, each pulse profile 140 may indicate a target level of ultrasonic energy induced in the ultrasonic instrument 18 that varies as a function of time, thereby forming a series of ultrasonic energy pulses that peak at a maximum ultrasonic energy level determined for the ultrasonic instrument 18 and are separated by ultrasonic energy at a minimum ultrasonic energy level determined for the ultrasonic instrument 18. For example, each pulse profile 140 may indicate a target level of an upper envelope of induced ultrasonic energy that varies as a function of time, or may indicate a target RMS value of induced ultrasonic energy as a function of time. To achieve a given pulse profile 140, the ultrasonic controller 112 may be configured to generate and supply an AC drive signal to the ultrasonic instrument 18 that induces ultrasonic energy in the ultrasonic instrument 18 according to the varying target level indicated by the given pulse profile 140.

[0104] Each pulse profile 140 stored in the console memory device 118 may include one or more pulse parameter settings specific to the pulse profile 140. The pulse parameters may be used by the ultrasound controller 112 to adjust the ultrasonic energy pulses induced in the ultrasonic instrument 18, and may include, for example, but not limited to, one or more of the following: a factor for determining a minimum ultrasonic energy level of the induced pulsed ultrasonic energy, a pulse shape, a duty cycle, and a pulse frequency.

[0105] The minimum energy factor of each pulse profile 140 may define the minimum ultrasonic energy level of the pulsed ultrasonic energy induced in the ultrasonic instrument 18 as a function of the maximum ultrasonic energy level set for the ultrasonic instrument 18. More specifically, each pulse profile 140 may be configured to induce in the ultrasonic instrument 18 ultrasonic energy including a series of ultrasonic energy pulses peaking at the maximum ultrasonic energy level set for the ultrasonic instrument 18 and separated by ultrasonic energy at the minimum ultrasonic energy level set for the ultrasonic instrument 18. The maximum ultrasonic energy level of each ultrasonic energy pulse may correspond to a vibration of maximum amplitude and velocity in the tip 20, and the minimum ultrasonic energy level may correspond to a vibration of minimum amplitude and velocity in the tip 20. The maximum ultrasonic energy level may be set by a physician, for example, to a level sufficient to ablate the target tissue, while the minimum ultrasonic energy level may be specific to the pulse profile 140 being implemented. The minimum energy factor may indicate a ratio of the maximum ultrasonic energy level set for the ultrasonic instrument 18 to be used as the minimum ultrasonic energy level, and may differ between pulse profiles 140. Thus, given a set maximum ultrasonic energy level, each pulse profile 140 can be configured to induce in the ultrasonic instrument 18 ultrasonic energy pulses that peak at the maximum ultrasonic energy level and are separated by ultrasonic energy at different minimum ultrasonic energy levels specific to the pulse profile 140.

[0106] The pulse shape of each pulse profile 140 may define the shape of the dynamic portion (also referred to as a "transition / switching ultrasonic energy period") of each cycle of pulsed ultrasonic energy induced according to the pulse profile 140. Specifically, each ultrasonic energy pulse induced in the ultrasonic instrument 18 may be defined by the ultrasonic energy transitioning from a minimum ultrasonic energy level set for the ultrasonic instrument 18 to a maximum ultrasonic energy level set for the ultrasonic instrument 18, and then transitioning from the maximum ultrasonic energy level back to the minimum ultrasonic energy level. The period of time during which the ultrasonic energy in each cycle of the induced ultrasonic energy transitions between the minimum and maximum ultrasonic energy levels may be referred to as the dynamic portion of the cycle, and may be defined by the pulse shape of the currently selected pulse profile 140. In other words, the transition between the maximum and minimum ultrasonic energy levels is not arbitrarily formed by the inherent electrical characteristics of the ultrasonic tool system 12, but rather such transition may be specifically controlled to follow a predefined transition function corresponding to the pulse shape of the applied pulse profile 140. As an example, the pulse shape of a given pulse profile 140 can be a Hann shape corresponding to a Hann wave transfer function, a square shape corresponding to a square wave transfer function, a triangle shape corresponding to a triangle wave transfer function, a ramping sawtooth shape corresponding to a ramping sawtooth wave transfer function, a ramping down sawtooth shape corresponding to a ramping down sawtooth shape transfer function, or an inverse (opposite) form of any of these pulse shapes.

[0107] For each cycle of pulsed ultrasonic energy induced in the ultrasonic instrument 18 according to the pulse profile 140, the duty cycle of each pulse profile 140 may indicate the duration of the dynamic portion of the cycle relative to the total duration of the cycle. For a pulse profile 140 having a 100% duty cycle, the dynamic portion of each cycle of the induced ultrasonic energy may be the entire duration of the cycle. In this case, the ultrasonic energy level induced by the pulse profile 140 may be considered to be constantly switching. In other words, the ultrasonic energy induced by the pulse profile 140 having a 100% duty cycle may reach the maximum and minimum ultrasonic energy levels only for a moment (e.g., less than 1 millisecond) and then switch to the other of the maximum and minimum ultrasonic energy levels, for example, according to the pulse shape of the pulse profile 140. In contrast, for a pulse profile 140 associated with a duty cycle of less than 100%, the duration of the dynamic portion of each cycle of the induced ultrasonic energy may be a portion of the duration of the entire cycle corresponding to the duty cycle. The remainder of each cycle (referred to as the constant portion of the cycle) may be occupied by a period of ultrasonic energy maintained at a constant level (e.g., the maximum or minimum ultrasonic energy level).

[0108] The pulse frequency of each pulse profile 140 may indicate the frequency of the ultrasonic energy pulses induced in the ultrasonic instrument 18. Although the resonant frequency of the ultrasonic instrument 18 may be between 10 and 40 kHz, the pulse frequency may be much lower, such as less than 100 Hz. For example, for a given pulse profile 140, a pulse frequency of 50 Hz will be used to induce ultrasonic energy in the ultrasonic instrument 18 including ultrasonic energy pulses occurring once every 20 milliseconds.

[0109] As previously described, the ultrasonic energy induced in the ultrasonic instrument 18, and accordingly the vibration of the tip 20 of the ultrasonic instrument 18, may be related to the mechanical current i induced in the ultrasonic instrument 18. M Thus, each pulse profile 140 may refer to a pulse pattern of ultrasonic energy induced in the ultrasonic instrument 18 or a mechanical current i induced in the ultrasonic instrument 18. M In other words, the maximum ultrasonic energy level set for the ultrasonic instrument 18 can be defined by the corresponding maximum mechanical current i set for the ultrasonic instrument 18. M To express this, the minimum ultrasonic energy level set for the ultrasonic instrument 18 can be expressed as the corresponding minimum mechanical current i set for the ultrasonic instrument 18. M To express.

[0110] In some embodiments, the console 16 can be configured to operate the ultrasonic instrument 18 in multiple ablation modes, such as a soft tissue ablation mode for ablating soft tissue, and a hard tissue ablation mode for ablating hard tissue such as fibrous tissue and bone. In this case, the console storage device 118 can be configured to store one or more different pulse profiles 140 for each mode, wherein the pulse parameters of each pulse profile 140 include parameters indicating whether the pulse profile 140 is associated with the soft tissue ablation mode or the hard tissue ablation mode.

[0111] Fig. 7A FIG. 1 shows a pulse pattern of a soft tissue pulse profile 144 associated with a soft tissue ablation mode that may be stored by the console 16 , and FIG. Figure 7B A pulse pattern of a hard tissue pulse profile 146 associated with a hard tissue ablation mode that may be stored by the console 16 is shown. In other words, in response to determining that the ultrasonic instrument 18 is set to operate in a soft tissue ablation mode, the console 16 may be configured to make the soft tissue pulse profile 144 available for user selection, and in response to determining that the ultrasonic instrument 18 is set to operate in a hard tissue ablation mode, the console 16 may be configured to make the hard tissue pulse profile 146 available for user selection. The console 16 may be configured to determine whether the ultrasonic tool system 12 is set to operate in a soft tissue ablation mode or in a hard tissue ablation mode in response to corresponding user input and / or based on data read from the ultrasonic instrument 18, as described in more detail below.

[0112] Fig. 7A and 7B Each also illustrates a constant energy profile 148 that may be induced in the ultrasonic instrument 18, such as when the pulse mode is disabled by the physician via the display 74 of the console 16, or when the console 16 determines that the tip 20 currently coupled to the console 16 cannot be activated with a pulse.

[0113] Fig. 7A and 7B The constant energy profile 148 shown in FIG. 14A can be configured to maintain the ultrasonic energy induced in the ultrasonic instrument 18 at a constant ultrasonic energy level, such as a maximum ultrasonic energy level set for the ultrasonic instrument 18. In other words, when the constant energy profile 148 is applied, the ultrasonic controller 112 can be configured to generate and supply an AC drive signal to the ultrasonic instrument 18, which will induce a mechanical current i in the ultrasonic instrument 18 that is maintained at a constant level (e.g., a constant level corresponding to the maximum ultrasonic energy level set for the ultrasonic instrument 18). M .

[0114] The maximum ultrasonic energy level of the ultrasonic instrument 18 can be set based on a power setting selected by the physician, which indicates a percentage of the global ultrasonic energy limit of the ultrasonic instrument 18. The maximum ultrasonic energy level can also be adjusted downward from the ultrasonic energy level indicated by the power setting selected by the physician in relation to the position of the foot pedal 76. Specifically, the console 16 can be configured to linearly increase the maximum ultrasonic energy level from a minimum value (e.g., zero) to the level indicated by the power setting selected by the physician when the foot pedal 76 is moved from a fully undepressed position to a fully depressed position. Therefore, the maximum ultrasonic energy level set for the ultrasonic instrument 18 may change during the surgical procedure in relation to changes in the physician's power setting selection and / or the depression level of the foot pedal 76.

[0115] Fig. 7A and 7B The 100% line shown in may correspond to a set maximum ultrasonic energy level. As described above, continued operation of the ultrasonic instrument 18 at the maximum ultrasonic energy level may result in unnecessary heating of the ultrasonic instrument 18 and the surgical site, and may increase potential trauma to surrounding tissue that is desired to remain intact.

[0116] refer to Fig. 7A , each of the soft tissue pulse profiles 144 can be configured so that the ultrasonic energy induced in the ultrasonic instrument 18 includes a plurality of ultrasonic energy pulses separated by ultrasonic energy time periods at a minimum ultrasonic energy level of the ultrasonic instrument 18 determined according to the soft tissue pulse profile 144, wherein each ultrasonic energy pulse is defined by a Hann wave and reaches a peak at a maximum ultrasonic energy level.

[0117] The dynamic period of the pulsed ultrasonic energy induced by each soft tissue pulse profile 144 may correspond to the period during which the induced ultrasonic energy switches from a minimum ultrasonic energy level to a maximum ultrasonic energy level and then returns to the minimum ultrasonic energy level set according to the soft tissue pulse profile 144. In other words, the dynamic portion of the soft tissue pulse profile 144 may correspond to an ultrasonic energy pulse of the induced ultrasonic energy. Fig. 7A The pulse shape parameters of each of the soft tissue pulse profiles 144 shown in FIG. 1 , which define the shape of the dynamic portion of the ultrasound energy induced by the soft tissue pulse profile 144 , may be set to a Hann pulse shape.

[0118] As shown in the illustrated example, the soft tissue pulse profile 144A can have a 100% duty cycle, and therefore, the dynamic portion of each cycle of the ultrasonic energy induced according to the soft tissue pulse profile 144A can extend the entire cycle. In contrast, the soft tissue pulse profiles 144B to 144E can each have a duty cycle of less than 100%. Therefore, the dynamic portion of each cycle of the ultrasonic energy induced according to the soft tissue pulse profiles 144B to 144E can extend only a portion of the cycle, while the remainder of the cycle is a constant ultrasonic energy portion, in which the ultrasonic energy is maintained at a minimum ultrasonic energy level for a considerable period of time. The duration of the constant ultrasonic energy portion can vary depending on the selected soft tissue pulse profile 144. For example, for some soft tissue pulse profiles 144, the duration may be greater than or equal to two milliseconds, while for other soft tissue pulse profiles 144, the duration may be greater than or equal to five milliseconds.

[0119] For example, the duty cycle associated with the soft tissue pulse profile 144B may be 90%. Assume that each soft tissue pulse profile 144 has Fig. 7A Assuming a 50 Hz pulse frequency as shown, the soft tissue pulse profile 144B can be configured to induce ultrasonic energy pulses such that each ultrasonic energy pulse has a duration of 18 milliseconds and these ultrasonic energy pulses are separated by constant ultrasonic energy periods at the minimum ultrasonic energy level, and the duration of each constant ultrasonic energy period is 2 milliseconds. As another example, the duty cycle associated with the soft tissue pulse profile 144C can be 80%. Assuming a pulse frequency of 50 Hz, the soft tissue pulse profile 144C can be configured to induce ultrasonic energy pulses in the ultrasonic instrument 18 such that each ultrasonic energy pulse has a duration of 16 milliseconds and these ultrasonic energy pulses are separated by constant ultrasonic energy periods at the minimum ultrasonic energy level, and the duration of each ultrasonic energy period is 4 milliseconds. As another example, the duty cycle associated with the soft tissue pulse profile 144E can be 50%. Assuming a pulse frequency of 50 Hz, the soft tissue pulse profile 144E may be configured to induce in the ultrasonic instrument 18 ultrasonic energy pulses each having a duration of 10 milliseconds and separated by periods of constant ultrasonic energy at a minimum ultrasonic energy level, each having a duration of 10 milliseconds. Fig. 7A In the example shown, the duration of each significant period of ultrasonic energy maintained at the minimum ultrasonic energy level may be greater than or equal to 2 milliseconds (eg, greater than or equal to 4 milliseconds, greater than or equal to 10 milliseconds).

[0120] like Fig. 7AAs shown, each soft tissue pulse profile 144 may also include a variation factor for determining the minimum ultrasonic energy level of the ultrasonic instrument 18 relative to the maximum ultrasonic energy level set for the ultrasonic instrument 18. For example, the factor of the soft tissue pulse profile 144A may be 80%, indicating that when the soft tissue pulse profile 144A is selected, the minimum ultrasonic level of the ultrasonic instrument 18 should be set to 80% of the maximum ultrasonic energy level. Conversely, the factor of the soft tissue pulse profile 144C may be 40%, indicating that when the soft tissue pulse profile 144C is selected, the minimum ultrasonic level of the ultrasonic instrument 18 should be set to 40% of the maximum ultrasonic energy level.

[0121] refer to Figure 7B , each hard tissue pulse profile 146 may be configured to induce in the ultrasonic instrument 18 ultrasonic energy comprising a plurality of ultrasonic energy pulses separated by ultrasonic energy at a minimum ultrasonic energy level of the ultrasonic instrument 18 determined according to the hard tissue pulse profile 146, wherein each ultrasonic energy pulse peaks at a maximum ultrasonic energy level set for the ultrasonic instrument 18. In contrast to the soft tissue pulse profile 144, the dynamic period of the pulsed ultrasonic energy induced by each hard tissue pulse profile 146 may correspond to a period of time during which the induced ultrasonic energy transitions from the maximum ultrasonic energy level set for the ultrasonic instrument 18 to the minimum ultrasonic energy level set according to the hard tissue pulse profile 146 and back to the maximum ultrasonic energy level. In other words, the dynamic portion of the hard tissue pulse profile 146 may correspond to the adjacent edges of each pair of adjacent ultrasonic energy pulses of the induced ultrasonic energy. Thus, Figure 7B The pulse shape parameters of each hard tissue pulse profile 146 shown in (which may define the shape of the dynamic portion of the ultrasound energy induced by the hard tissue pulse profile 146) may be set to an inverted Hann pulse shape, corresponding to an inverted Hann wave of the dynamic portion. Alternatively, because the hard tissue pulse profiles 146 are respectively associated with hard tissue ablation modes, the pulse shape of each hard tissue pulse profile 146 may indicate an uninverted form of the desired shape (e.g., a Hann shape), and the ultrasound controller 112 may be configured to invert the shape when induced pulsed ultrasound energy based on the console 16 being set to operate in the hard tissue ablation mode.

[0122] As shown in the illustrated example, the hard tissue pulse profile 146A may have a duty cycle of 100%, and therefore, the dynamic portion of each cycle of the ultrasonic energy induced according to the hard tissue pulse profile 146A may extend the entire cycle. In contrast, the hard tissue pulse profiles 146A to 146E may each have a duty cycle of less than 100%. Therefore, the dynamic portion of each cycle of the ultrasonic energy induced according to the hard tissue pulse profiles 146B to 146E may extend only a portion of the cycle, while the remainder of the cycle is a constant ultrasonic energy portion, in which the ultrasonic energy is maintained at the set maximum ultrasonic energy level for a considerable period of time. In other words, the constant ultrasonic energy period induced by each hard tissue pulse profile 146 (e.g., pulse profiles 146B to 146E) associated with a duty cycle of less than 100% may correspond to the period of time during which the ultrasonic energy is maintained at the maximum ultrasonic energy level at the peak of each pulse. The duration of the constant ultrasonic energy portion may vary depending on the selected hard tissue pulse profile 146. For example, for some hard tissue pulse profiles 146, the duration may be greater than or equal to two milliseconds, while for other hard tissue pulse profiles 146, the duration may be greater than or equal to five milliseconds.

[0123] For example, the duty cycle associated with hard tissue pulse profile 146B may be 90%. Assume that each hard tissue pulse profile 146 has Figure 7B Assuming a pulse frequency of 50 Hz as shown, the pulse profile 146B can be configured to induce such ultrasonic energy: the duration between the adjoining edges of each pair of adjacent pulses is 18 milliseconds, and each ultrasonic energy pulse peaks at the maximum ultrasonic energy level and lasts for 2 milliseconds. As another example, the duty cycle of the pulse profile 146C can be 80%. Assuming a pulse frequency of 50 Hz, the pulse profile 146C can be configured to induce ultrasonic energy in the ultrasonic instrument 18 including ultrasonic energy pulses, wherein each ultrasonic energy pulse peaks at the maximum ultrasonic energy level set for the ultrasonic instrument 18 and includes an ultrasonic energy period of 4 milliseconds maintained at the maximum ultrasonic energy level, wherein each constant ultrasonic energy period is separated by a dynamic ultrasonic energy period of 16 milliseconds each. As another example, the duty cycle of the pulse profile 146E can be 50%. Assuming a pulse frequency of 50 Hz, the pulse profile 146E may be configured to induce ultrasonic energy in the ultrasonic instrument 18 that includes ultrasonic energy pulses, wherein each ultrasonic energy pulse peaks at a maximum ultrasonic energy level set for the ultrasonic instrument 18 and includes a constant ultrasonic energy period of 10 milliseconds in duration at the maximum ultrasonic energy level, wherein each constant ultrasonic energy period is separated by dynamic ultrasonic energy periods of 10 milliseconds in duration. Figure 7BIn the example shown, the duration of each significant period during which the ultrasonic energy is maintained at the maximum ultrasonic energy level may be greater than or equal to 2 milliseconds (eg, 4 milliseconds, 10 milliseconds).

[0124] like Figure 7B As shown, each hard tissue pulse profile 146 may also include a variation factor for determining the minimum ultrasonic energy level of the ultrasonic instrument 18 relative to the maximum ultrasonic energy level set for the ultrasonic instrument 18. For example, the factor of the hard tissue pulse profile 146A may be 80%, indicating that when the hard tissue pulse profile 146A is selected, the value of the minimum ultrasonic level of the ultrasonic instrument 18 should be set to 80% of the maximum ultrasonic energy level. Conversely, the factor of the hard tissue pulse profile 146C may be 40%, indicating that when the pulse profile 146C is selected, the value of the minimum ultrasonic level of the ultrasonic instrument 18 should be set to 40% of the maximum ultrasonic energy level.

[0125] Different pulse profiles 144, 146 can provide different operating characteristics, such as different levels of tissue selectivity, temperature control, and tactile feedback. The preferred level of these operating characteristics may depend on the physician's personal preference and the type of tissue to be ablated. The level of these operating characteristics provided by each pulse profile 144, 146 can be a function of the duty cycle, minimum ultrasound energy level, and pulse frequency of the pulse profile 144, 146.

[0126] For example, Fig. 7A Each of the soft tissue pulse profiles 144 shown in has different factors for determining the minimum ultrasonic energy level and different duty cycles. Assuming that other pulse parameters of the soft tissue pulse profile 144 remain unchanged, the lower the minimum ultrasonic energy level defined by a given soft tissue pulse profile 144 relative to another soft tissue pulse profile 144, the lower the average amplitude and speed of vibration of the tip 20 that may be caused by the given soft tissue pulse profile 144. Similarly, assuming that other pulse parameters of the soft tissue pulse profile 144 remain unchanged, the lower the duty cycle of a given soft tissue pulse profile 144 relative to another soft tissue pulse profile 144, the lower the average amplitude and speed of vibration of the tip 20 that may be caused by the given pulse profile 144.

[0127] The lower the average amplitude and velocity of the vibration of the tip 20 caused by a given soft tissue pulse profile 144, the less efficient the vibration of the tip 20 is in resecting harder tissue, thereby providing increased tissue selectivity, and the less heat the ultrasonic instrument 18 generates when resecting tissue. In other words, the lower the average amplitude and velocity of the vibration of the tip 20 caused by a given soft tissue pulse profile 144, the greater the ratio of tissue preservation rate of non-target harder tissue to resection rate of softer target tissue can be provided.

[0128] Furthermore, assuming that other pulse parameters of the soft tissue pulse profile 144 remain unchanged, the lower the minimum ultrasonic energy level defined by a given soft tissue pulse profile 144 relative to another soft tissue pulse profile 144, the more tactile feedback a physician holding the ultrasonic instrument 18 feels from the ultrasonic energy induced in the ultrasonic instrument 18 according to the given soft tissue pulse profile 144. Similarly, assuming that other pulse parameters of the soft tissue pulse profile 144 remain unchanged, the lower the duty cycle defined by a given soft tissue pulse profile 144 relative to another soft tissue pulse profile 144, the more tactile feedback a physician holding the ultrasonic instrument 18 feels from the ultrasonic energy induced in the ultrasonic instrument 18 according to the given soft tissue pulse profile 144.

[0129] like Fig. 7A As shown, each soft tissue pulse profile 144 can be associated with a different pulse control level (e.g., lvl 1 to lvl 5), which can be selected by a physician (e.g., using the display 74 of the console 16) to cause the console 16 to induce ultrasonic energy in the ultrasonic instrument 18 according to the soft tissue pulse profile 144. In some examples, these pulse control levels can be assigned to the soft tissue pulse profiles 144 so that each incremental pulse control level is associated with a soft tissue pulse profile 144 that provides increased tissue selectivity, increased temperature control, and / or increased tactile feedback. More specifically, as Fig. 7A As shown, each selectable pulse control level can be associated with a soft tissue pulse profile 144 that defines a lower minimum ultrasonic energy level and / or a lower duty cycle than the soft tissue pulse profile associated with the previous selectable pulse control level. Thus, a lower selectable pulse control level in the sequence can be associated with a soft tissue pulse profile 144 that is configured to ablate more tissue types, or more particularly, harder tissue, than a soft tissue pulse profile associated with a higher pulse control level in the sequence. A lower selectable pulse control level in the sequence can also be associated with a soft tissue pulse profile 144 that is configured to provide less tactile feedback than a soft tissue pulse profile associated with a higher pulse control level in the sequence.

[0130] Sorting the soft tissue pulse profiles 144 in this manner can provide an intuitive means by which a physician can select a soft tissue pulse profile 144 that corresponds to the physician's desired operating characteristics. Specifically, the physician can request increased tissue selectivity and temperature control of the ultrasonic instrument 18 and / or can request increased tactile feedback by selecting a relatively higher pulse control level, and can request decreased tissue selectivity and temperature control and / or can request decreased tactile feedback by selecting a relatively lower pulse control level.

[0131] same Figure 7B Each hard tissue pulse profile 146 shown in FIG. 1 also defines a different minimum energy factor and duty cycle. Assuming that other pulse parameters of the hard tissue pulse profile 146 remain constant, the lower the minimum ultrasonic energy level defined by a given hard tissue pulse profile 146 relative to another hard tissue pulse profile 146, the lower the average amplitude and velocity of the vibration of the tip 20 that the given hard tissue pulse profile 146 may cause. The lower the average amplitude and velocity of the vibration of the tip 20 caused by a given hard tissue pulse profile 146, the more temperature control that the given pulse profile 146 can provide.

[0132] Furthermore, assuming that other pulse parameters of the hard tissue pulse profile 146 remain constant, the lower the minimum ultrasonic energy level defined for a given hard tissue pulse profile 146 relative to another hard tissue pulse profile 146, the more tactile feedback can be provided to the physician from the ultrasonic energy induced in the ultrasonic instrument 18 according to the hard tissue pulse profile 146, such as when placing the vibrating tip 20 on different tissues. Similarly, assuming that other pulse parameters of the hard tissue pulse profile 146 remain constant, the lower the duty cycle defined for a given hard tissue pulse profile 146 relative to another hard tissue pulse profile 146, the more tactile feedback can be provided to the physician from the ultrasonic energy induced in the ultrasonic instrument 18 according to the hard tissue pulse profile 146, such as when placing the vibrating tip 20 on different tissues.

[0133] The more tactile feedback the physician can feel, the more the physician may feel the ultrasonic energy pulses, which can encourage the physician to make back-and-forth motions with the ultrasonic instrument 18, which is often desirable when cutting hard tissue. In addition, because certain tissues (e.g., soft tissue) can provide increased dampening of vibrations felt by the physician relative to other tissues, the more tactile feedback the physician feels, the more the physician may notice when the tip 20 penetrates hard tissue or inadvertently contacts soft tissue during a surgical procedure. Tactile feedback can also be used to indicate to the physician that the physician is applying a preferred amount of force to the ultrasonic instrument 18, as described in more detail below.

[0134] Furthermore, assuming that other pulse parameters of the hard tissue pulse profile 146 remain unchanged, the lower the minimum ultrasonic energy level defined by a given hard tissue pulse profile 146 relative to another hard tissue pulse profile 146, the more likely the tip 20 will stall as the load applied to the tip 20 increases, which may help reduce undesirable ablation and / or necrosis of non-target tissue.

[0135] like Figure 7BAs shown, each hard tissue pulse profile 146 can be associated with a different pulse control level (e.g., lvl 1 to lvl 5), which can be selected by a physician (e.g., using the display 74 of the console 16) to cause the console 16 to induce ultrasonic energy in the ultrasonic instrument 18 according to the hard tissue pulse profile 146. In some examples, these pulse control levels can be assigned to the hard tissue pulse profiles 146 so that each incremental pulse control level is associated with a hard tissue pulse profile 146 that provides increased tactile feedback and / or a greater likelihood of stalling. More specifically, each selectable pulse control level can be associated with a hard tissue pulse profile 146 that defines a lower minimum ultrasonic energy level and / or a lower duty cycle than the hard tissue pulse profile associated with the previous selectable pulse control level. The lower selectable pulse control levels in the sequence can be associated with a hard tissue pulse profile 146 that is configured to provide less tactile feedback than the hard tissue pulse profile associated with the higher pulse control level in the sequence. A selectable pulse control level lower in the sequence may also be associated with a hard tissue pulse profile 146 configured to provide less stall potential than a pulse control level higher in the sequence.

[0136] Ordering the hard tissue pulse profiles 146 in this manner can provide an intuitive means by which a physician can select a hard tissue pulse profile 146 that corresponds to the physician's desired operating characteristics. For example, the physician can request a higher level of tactile feedback and / or stall likelihood by selecting a higher pulse control level in the order, and can request a reduced level of tactile feedback and / or stall likelihood by selecting a lower pulse control level in the order.

[0137] Further references Figure 7B , assuming that other pulse parameters of the hard tissue pulse profile 146 remain unchanged, the lower the minimum ultrasonic energy level defined by a given hard tissue pulse profile 146 relative to another hard tissue pulse profile 146, the lower the average displacement and velocity of the tip 20 that can be caused by the given hard tissue pulse profile 146. This lower average displacement and velocity may reduce the resection rate of the ultrasonic instrument 18 when operating on hard tissue. In order to help maintain the desired resection rate, as shown in FIG. Figure 7BAs further shown, each incremental pulse control level can also be associated with a hard tissue pulse profile 146 that defines a reduced duty cycle relative to the hard tissue pulse profile 146 associated with the previous pulse control level. This configuration can be used to increase the period of time in which the ultrasonic energy induced by each hard tissue pulse profile 146 is maintained at the maximum ultrasonic energy level set for the ultrasonic instrument 18, and accordingly can increase the average displacement and velocity of the tip 20 induced by the hard tissue pulse profile 146.

[0138] Fig. 7A and 7B Each of the pulse profiles 144, 146 shown in the figure has the same pulse frequency, i.e., 50 Hz. In an alternative example, two or more of the soft tissue pulse profiles 144 defined by the ultrasonic tool system 12 may have different pulse frequencies, and likewise two or more of the hard tissue pulse profiles 146 defined by the ultrasonic tool system 12 may have different pulse frequencies.

[0139] As an example, Fig. 8A Soft tissue pulse profiles 144F to 144J are shown, which are respectively associated with different selectable pulse control levels (lvl1 to lvl5), such that the soft tissue pulse profile 144 associated with each incremental pulse control level provides a lower minimum ultrasonic energy level, a lower duty cycle, and a higher pulse frequency than the soft tissue pulse profile 144 associated with the previous pulse control level. For example, the soft tissue pulse profiles 144F to 144J can have pulse frequencies of 30 Hz, 35 Hz, 45 Hz, 50 Hz, and 55 Hz, respectively. Assuming that other pulse parameters of the soft tissue pulse profiles 144 remain unchanged, the greater the pulse frequency defined by a given soft tissue pulse profile 144 relative to another soft tissue pulse profile 144, the more tactile feedback a physician holding the ultrasonic instrument 18 will feel from the ultrasonic energy induced in the ultrasonic instrument 18 according to the given soft tissue pulse profile 144. Therefore, in addition to each incremental tissue pulse profile 144 providing increased tissue selectivity and temperature control, Fig. 8A The difference in the level of tactile feedback provided between each pair of adjacent soft tissue pulse profiles 144 may be greater than Fig. 7A The difference in tactile feedback level between a pair of adjacent soft tissue pulse profiles 144 corresponding thereto.

[0140] As yet another example, Figure 8BHard tissue pulse profiles 146F to 146J are shown, each associated with a different selectable pulse control level (lvl 1 to lvl 5), such that the hard tissue pulse profile 146 associated with each incremental pulse control level has a lower minimum ultrasonic energy level, a lower duty cycle, and a higher pulse frequency than the hard tissue pulse profile 146 associated with the previous pulse control level. For example, the hard tissue pulse profiles 146F to 146J may have pulse frequencies of 20 Hz, 25 Hz, 30 Hz, 35 Hz, and 40 Hz, respectively. Assuming that other pulse parameters of the hard tissue pulse profiles 146 remain unchanged, the greater the pulse frequency defined by a given hard tissue pulse profile 146 relative to another hard tissue pulse profile 146, the more tactile feedback a physician holding the ultrasonic instrument will feel from the ultrasonic energy induced in the ultrasonic instrument 18 according to the given hard tissue pulse profile 146. Thus, in addition to providing a greater likelihood of stalling with each incremental hard tissue pulse profile 146, Figure 8B The difference in the level of tactile feedback provided between each pair of adjacent hard tissue pulse profiles 146 may be greater than Figure 7B The difference in tactile feedback level between a pair of adjacent hard tissue pulse profiles 146 corresponding thereto.

[0141] As shown in the previous example, the different pulse profiles 144, 146 defined by the ultrasonic tool system 12 may include different duty cycles. In an alternative example, the ultrasonic tool system 12 may be configured to implement pulse profiles 144, 146 having the same duty cycle. For example, Fig. 9A Soft tissue pulse profiles 144K-144O are shown, each associated with a different selectable pulse control level (lvl 1 to lvl 5), such that the soft tissue pulse profile 144 associated with each incremental pulse control level has a lower minimum ultrasonic energy level, a higher pulse frequency, and a duty cycle (e.g., 100%) than the soft tissue pulse profile 144 associated with the previous pulse control level. In this case, each incremental soft tissue pulse profile 144 may continue to provide increased tissue selectivity, temperature control, and tactile feedback, but to a lesser extent than the previous pulse control level. Fig. 8A The corresponding soft tissue pulse profile 144 is shown in FIG. As a corollary, Fig. 8A The ablation rate of each soft tissue pulse profile 144 shown in FIG. 144 with a duty cycle less than 100% may be less than Fig. 9A The corresponding soft tissue pulse profile 144 is shown in .

[0142] Similarly, Fig. 9BHard tissue pulse profiles 146K-146O are shown, each associated with a different pulse control level (lvl1 to lvl 5), such that the hard tissue pulse profile 146 associated with each incremental pulse control level has a lower minimum ultrasonic energy level, a higher pulse frequency, and the same duty cycle (e.g., 100%) as the hard tissue pulse profile 146 associated with the previous pulse control level. In this case, each incremental hard tissue pulse profile 146 may continue to provide increased tactile feedback and stall probability, but the degree of tactile feedback provided by each hard tissue pulse profile 146 may be less than Figure 8B As a corollary, Figure 8B The ablation rate of each hard tissue pulse profile 146 with a duty cycle less than 100% shown in FIG. 1 may be greater than Fig. 9B The resection rate of the corresponding hard tissue pulse profile 146 shown in ( Fig. 9B The hard tissue pulse profile 146 shown in FIG. Figure 8B The corresponding hard tissue pulse profile 146 can provide increased cutting and temperature control.

[0143] In some embodiments, the ultrasonic tool system 12 can store a set of soft tissue pulse profiles 144 and a set of hard tissue pulse profiles 146, wherein the two sets of pulse profiles vary with respect to each other with the same pulse parameters. For example, the stored soft tissue pulse profiles 144 can differ in minimum energy factor, duty cycle, and pulse frequency (e.g., Fig. 8A ), and the stored hard tissue pulse profile 146 may similarly be varied with the same pulse parameters (e.g., Figure 8B Alternatively, the pulse parameters of the set of soft tissue pulse profiles 144 may vary from the pulse parameters of the set of hard tissue pulse profiles 146. For example, the soft tissue pulse profiles 144 may differ in minimum energy factor, duty cycle, and pulse frequency (e.g., Fig. 8A ), the hard tissue pulse profile 146 may differ in minimum energy factor and pulse frequency, rather than duty cycle (e.g., Fig. 9B ).in other words, Fig. 7A , 8A The set of soft tissue pulse profiles 144 of any one of 9A and 9A may be combined with Figure 7B , 8B The set of hard tissue pulse profiles 146 of any of 9B are stored within and implemented by the ultrasonic tool system 12 .

[0144] Some of the above exemplary pulse profiles 144, 146 (e.g., those at the highest pulse control levels) may have minimum energy factors corresponding to minimum ultrasound energy levels near zero, such as Fig. 7A , 7B , 8A and 9A. However, as shown in the illustrated example, the minimum energy factor of these pulse profiles 144, 146 can be set so that the minimum ultrasonic energy level does not drop all the way to zero, but is slightly above zero. This is done so that the ultrasonic energy induced in the ultrasonic instrument 18 does not reach a level at which the console 16 cannot track the resonant frequency of the ultrasonic instrument 18. In other words, the minimum ultrasonic level defined by these pulse profiles 144, 146 can be set so that the vibration induced in the tip 20 has an amplitude sufficient for the console 16 to detect the vibration and track the resonant frequency of the ultrasonic instrument 18. For example, the minimum energy factor of these pulse profiles 144, 146 can be set so that the peak-to-peak vibration of the tip 22 corresponding to the minimum ultrasonic energy level is greater than 5 microns and less than 20 microns, for example, about 10 microns. In other words, the minimum energy factor of these pulse profiles 144, 146 can be set to 3% or more, and / or so that the minimum mechanical current i induced in the ultrasonic instrument 18 is less than 10 microns. M Greater than 2 mA and less than 10 mA, for example, about 5 mA.

[0145] In response to the selection of a given pulse profile 140, the ultrasound controller 112 can be configured to cause the console 16 to generate and supply an AC drive signal to the ultrasonic instrument 18, which induces ultrasonic energy in the ultrasonic instrument 18 according to the selected pulse profile 140. Specifically, referring again to Figure 4 , the ultrasonic controller 112 can be configured to transmit one or more control signals to the signal generator 114, so that the signal generator 114 generates an AC signal corresponding to the selected pulse profile 140 on the primary winding 124, or more specifically, induces an AC drive signal on the secondary winding 126, which in turn induces ultrasonic energy in the ultrasonic instrument 18 according to the selected pulse profile 140.

[0146] For example, in response to receiving a selection of a given pulse profile 140, the ultrasound controller 112 may be configured to extract the pulse profile 140, or more specifically, the pulse parameter settings of the pulse profile 140, from the console storage device 118. The ultrasound controller 112 may also be configured to generate and store a modulation waveform corresponding to the extracted pulse profile 140, for example, in a modulation DDS 150 of the signal generator 114. The modulation DDS 150 may include a memory device for storing a sample array filled with values ​​forming a modulation waveform. The modulation waveform may extend between zero and one, inclusive, and may have a shape and length corresponding to one cycle of the pulse pattern represented by the selected pulse profile 140.

[0147] More specifically, the modulating waveform can include an instance of a transfer function associated with the pulse shape parameter settings of the selected pulse profile 140, the transfer function extending from zero and peaking at 1. If the selected pulse profile 140 has a 100% duty cycle, then the transfer function can extend across the entire modulating waveform. If not, then the transfer function can extend along a portion of the modulating waveform such that the length of the transfer function corresponds to the duty cycle relative to the length of the modulating waveform. In this case, the remainder of the modulating waveform can be a constant period of time maintained at a constant value (e.g., zero or one). For example, if the selected pulse profile 140 is Fig. 7A , 8A or the soft tissue pulse profile 144 shown in 9A, the remainder may be set to zero if the selected pulse profile 140 is Figure 7B , 8B or the hard tissue pulse profile 146 shown in 9B, the remaining portion may be set to one. As an example, Fig.10 Shows the selected Fig. 7A The soft tissue pulse profile 144E shown in FIG. 1 is a modulated waveform that may be generated and stored by the ultrasound controller 112 .

[0148] In response to actuation of the ultrasonic instrument 18 (e.g., by depressing the foot pedal 76), the ultrasonic controller 112 may be configured to send a target ultrasonic frequency to the signal generator 114, or more specifically, to the basic DDS 152 of the signal generator 114. The basic DDS 152 may store an array of samples that form a sinusoidal waveform having a frequency greater than or equal to the maximum ultrasonic frequency that may be supplied to the ultrasonic instrument 18. Based on the array of samples, the basic DDS 152 may be configured to generate a basic AC signal 154. The basic AC signal 154 may be a sinusoidal signal having a frequency equal to the target ultrasonic frequency indicated by the ultrasonic controller 112, and may have a substantially constant amplitude, such as unity.

[0149] Initially, the target ultrasonic frequency sent by the ultrasonic controller 112 may be a predefined target frequency that may be read from the ultrasonic instrument 18, as described in more detail below. Thereafter, the ultrasonic controller 112 may be configured to implement a loop for tracking a frequency corresponding to a target vibration characteristic (e.g., resonance) of the ultrasonic instrument 18, as described above, and send a control signal to the base DDS 152 that adjusts the frequency of the base AC signal 154 generated by the base DDS 152 based on the tracked frequency. Fig.11 A basic AC signal 154A that may be produced by a basic DDS 152 is shown.

[0150] In addition, when the ultrasonic instrument 18 is actuated, the ultrasonic controller 112 can be configured to determine the maximum and minimum ultrasonic energy levels of the induced ultrasonic energy, as described above. The ultrasonic controller 112 can then be configured to implement a cycle for adjusting the amplitude of the ultrasonic energy induced in the ultrasonic instrument 18 according to the selected pulse profile 140, for example by adjusting the mechanical current i induced in the ultrasonic instrument 18 according to the selected pulse profile 140. M . Iterations of this loop may be used to determine a target ultrasonic energy waveform of the induced ultrasonic energy based on the maximum and minimum ultrasonic energy levels, and to generate an AC drive signal based on the target ultrasonic energy waveform. Specifically, the ultrasonic controller 112 may be configured to determine a scalar based on the determined maximum ultrasonic energy level and the determined minimum ultrasonic energy level, multiply the modulated waveform by the scalar, and add the determined minimum ultrasonic energy level to the result of the multiplication to generate the target ultrasonic energy waveform. The ultrasonic controller 112 may then be configured to compare the target ultrasonic energy waveform with the ultrasonic energy induced in the ultrasonic instrument 18 to determine an error therebetween, and to adjust the base AC signal 154 using the scalar 156 to minimize the error, for example using a PID controller.

[0151] At a more granular level, for each iteration of the loop, the ultrasonic controller 112 may be configured to determine a target ultrasonic energy level for the ultrasonic instrument 18 based on the maximum and minimum ultrasonic energy levels of the sensed ultrasonic energy, such as a target mechanical current i M In the form of a value. Specifically, the ultrasound controller 112 can be configured to determine a scalar based on the maximum and minimum ultrasonic energy levels, for example by determining the difference between them. The ultrasound controller 112 can then be configured to extract a sample from the sample array of the modulation DDS 150 and multiply the modulated waveform sample by the scalar. The ultrasound controller 112 can then subtract the minimum ultrasonic energy level from the multiplied product to generate a target ultrasonic energy level for the ultrasonic instrument 18, or more specifically, a target mechanical current i M .

[0152] While determining the target ultrasonic energy level, the ultrasonic controller 112 may be configured to determine the ultrasonic energy level induced in the ultrasonic instrument 18, for example by calculating the mechanical current i based on feedback data corresponding to the supplied AC drive signal as described above. M The ultrasonic controller 112 may then be configured to compare the target ultrasonic energy level with the determined ultrasonic energy level induced in the ultrasonic instrument 18 and determine an error therebetween, and generate a voltage scalar 156 that, when multiplied by the base AC signal 154, may minimize the error, for example using a PID controller.

[0153] For each iteration of the loop, the ultrasound controller 112 may extract a sample value from the modulation waveform sample array according to the order of the samples in the array. The sample rate at which the ultrasound controller 112 extracts sample values ​​from the modulation waveform sample array may depend on the size of the modulation waveform array relative to the pulse frequency of the selected pulse profile 140 and the time of each iteration of the loop, which may be 400 microseconds in one example. For example, if the size of the modulation waveform sample array multiplied by the cycle time is equal to the period represented by the pulse frequency, then for each iteration of the loop, the ultrasound controller 112 may extract the sample value that immediately follows the previously extracted sample value in the modulation waveform array. Conversely, if the size of the modulation waveform sample array multiplied by the cycle time is greater than the period represented by the pulse frequency, then the ultrasound controller 112 may extract samples at a relatively faster sampling rate, such as by skipping (some) samples in the array (e.g., extracting one out of every five samples). As another example, if the size of the modulated waveform sample array multiplied by the cycle time is less than the period represented by the pulse frequency, the ultrasound controller 112 may extract samples at a relatively slower sampling rate, such as by performing multiple iterations of the cycle using a given sample. As explained in more detail below, the ultrasound controller 112 may be configured to adjust the pulse frequency during a surgical procedure, such as in a manner related to the load applied to the ultrasonic instrument 18, which in turn may cause the ultrasound controller 112 to adjust the sampling rate.

[0154] As previously described, during a surgical procedure, the maximum ultrasonic energy level and the corresponding minimum ultrasonic energy level of the induced pulsed ultrasonic energy may change, for example, due to the physician adjusting the set power level and / or the depression level of the foot pedal 76. It should be understood that the above algorithm enables the console 16 to account for such changes without changing the modulation waveform stored in the modulation DDS 150, thereby improving the responsiveness of the system.

[0155] The signal generator 114 may also include a multiplier 158 configured to receive the base AC signal 154 and multiply it by the generated scalar 156 to generate a modulated AC signal 160. The modulated AC signal 160 may be sent to a D / A converter 162 and then through an amplifier 164, which may receive a power signal from a power supply 165 regulated by the ultrasound controller 112. The amplifier 164 may generate a corresponding AC signal on the primary winding 124 of the transformer 116. As an example, the amplifier 164 and the power supply 165 may be configured as described in Applicant's U.S. Patent No. 10,449,570, the contents of which are incorporated herein by reference in their entirety.

[0156] The AC signal on the primary winding 124 may induce an AC drive signal on the secondary winding 126, which in turn may induce ultrasonic energy in the ultrasonic instrument 18 according to the selected pulse profile 140. In other words, the AC signal on the primary winding 124 may induce an AC drive signal on the secondary winding 126, which in turn may induce ultrasonic energy in the ultrasonic instrument 18 that includes a plurality of ultrasonic energy pulses, each pulse peaking at a maximum ultrasonic energy level determined for the ultrasonic instrument 18, and the ultrasonic energy pulses being separated by ultrasonic energy at a minimum ultrasonic energy level defined according to the selected pulse profile 140. Fig. 12A The AC signal 165A that the signal generator 114 can generate on the primary winding 124 is shown, for example, when the Fig. 7A Soft tissue pulse profile 144E is shown. Fig. 12B Another AC signal 165B that the signal generator 114 can generate on the primary winding 124 is shown, for example, when selecting Figure 7B Soft tissue pulse profile 144A is shown.

[0157] In an alternative embodiment, the base DDS 152 may be configured to generate a base AC signal 154 to have a tracked ultrasonic frequency indicated by the ultrasonic controller 112 and an amplitude corresponding to the maximum ultrasonic energy level set for the ultrasonic instrument 18. Specifically, the ultrasonic controller 112 may be configured to implement a loop that determines the error between the determined maximum ultrasonic energy level and the measured ultrasonic energy level induced in the ultrasonic instrument, and provides a scalar that minimizes the error to the base DDS 152. In this case, the modulated waveform generated and stored in the modulation DDS 150 may extend between one and the minimum energy factor of the selected pulse profile 140. The signal generator 114 may then be configured to multiply the base AC signal 154 with the modulated waveform to generate the modulated AC signal 160 described above.

[0158] Reference again Figure 4 and Figure 5The console 16 may also include a memory reader 166 for communicating with one or more electronic memory storage devices integrated with the ultrasonic instrument 18. The ultrasonic instrument 18 may include one or more electronic memory storage devices for storing data identifying the ultrasonic instrument 18 (or more specifically the handpiece 24 and / or the tip 20) and defining operating parameter settings specific to the ultrasonic instrument 18 (or more specifically to the handpiece 24 and / or the tip 20). Non-limiting examples of such operating parameters may include a maximum drive current of the AC drive signal, a mechanical current i M The one or more memory devices integrated with the ultrasonic instrument 18 may also indicate whether the tip 20 coupled to the handpiece 24 is configured to ablate soft tissue or hard tissue, and may indicate one or more pulse profiles 140 specific to the tip 20.

[0159] For example, the handpiece 24 of the ultrasonic instrument 18 may include a handpiece (HP) memory 168 disposed therein. As non-limiting examples, the HP memory 168 may be an EPROM, an EEPROM, or an RFID tag. In response to coupling the ultrasonic instrument 18 to the console 16, the ultrasonic controller 112 may be configured to read data stored in the HP memory 168 using the memory reader 166 and adjust the operation of the console 16 based on the data. More specifically, the console 16 may include a communication interface, such as a coil 170, connected to the memory reader 166. The coil 170 may be integrated with the socket 40 of the console 16. The HP memory 168 may be similarly connected to the coil 172, which may be integrated with the adapter 38 of the cable 36. When the ultrasonic instrument 18 is connected to the console 16 via the cable 36, the coils 170, 172 may be aligned and able to inductively exchange signals. Then, the ultrasonic controller 112 may be configured to read data from the HP memory 168 and write data to the HP memory 168 via the coils 170, 172.

[0160] The memory reader 166 may be configured to convert the signals on the coil 170 into data signals readable by the ultrasound controller 112. The memory reader 166 may also be configured to receive data from the ultrasound controller 112 to be written to the HP memory 168 and to generate signals on the coil 170 that cause the data to be written to the HP memory 168. The structure of the memory reader 166 may complement the structure of the HP memory 168. Thus, continuing with the above non-limiting example, the memory reader 166 may be a component capable of reading and writing data from an EPROM, an EEPROM, or an RFID tag.

[0161] In addition to or in lieu of the HP memory 168, the ultrasonic instrument 18 may include a tip memory 174. As described above, the tip 20 may be detachable from the handpiece 24 so that the handpiece 24 may be used with interchangeable tips 20, and different tips 20 may have different operating limitations and intended uses. For example, some tips 20 may be configured for ablating soft tissue, while other tips 20 may be configured for ablating hard tissue, such as fibrous tissue and bone. Thus, the HP memory 168 may store data identifying the handpiece 24 and operating parameter settings specific to the handpiece 24, including the capacitance C0 of the driver 30, and the tip memory 174 may store data identifying the tip 20 currently connected to the handpiece 24 and operating parameter settings specific to the tip 20, including whether the tip 20 is configured to ablate soft tissue or cut hard tissue (e.g., bone), and / or pulse parameter settings specific to the pulse profile 140 of the tip 20. Because the tip 20 and irrigation cannula 42 may be released together as a single package, the tip memory 174 may be disposed in the irrigation cannula 42, or more specifically in the cannula body 44. The tip memory 174 may be the same type of memory as the HP memory 168 (e.g., EPROM, EEPROM, or RFID tag).

[0162] In response to the ultrasonic instrument 18 being connected to the console 16, the ultrasonic controller 112 may be configured to read the data stored in the HP memory 168 and the tip memory 174 using the memory reader 166 and adapt the operation of the console 16 to the specific handpiece 24 and tip 20 combination coupled to the console 16. The tip memory 174 may include the same settings for the operating parameters as the HP memory 168. If the settings (also referred to as values) for a given operating parameter differ between the HP memory 168 and the tip memory 174, the ultrasonic controller 112 may be configured to manage the operation of the ultrasonic instrument 18 using the more restrictive value. Additionally or alternatively, in the event that both the HP memory 168 and the tip memory 174 include values ​​for the same operating parameter, the ultrasonic controller 112 may be configured to manage the operation of the ultrasonic instrument 18 with respect to the operating parameter based on a combination of the values ​​stored in these memories (e.g., summing the values, averaging the values).

[0163] Similar to the HP memory 168, the ultrasound controller 112 can read data from and write data to the tip memory 174 through the memory reader 166 and the coil 170. Specifically, the handpiece 24 may include two conductors 176 extending from the proximal end to the distal end of the handpiece 24. The proximal end of the conductor 176 may be coupled to the coil 172, which may be integrally formed with the adapter 38 of the cable 36. The distal end of the conductor 176 may be coupled to another coil 178 disposed at the distal end of the handpiece 24. The corresponding coil 180 may be disposed at the proximal end of the irrigation sleeve 42, or more specifically, at the proximal end of the sleeve body 44. When the irrigation sleeve 42 is disposed around the tip 20 and assembled to the handpiece 24, the coils 178, 180 may be aligned and able to inductively exchange signals. When the handpiece 24 is connected to the console 16 via the cable 36, the coils 170, 172 may also be aligned and able to inductively exchange signals. The ultrasound controller 112 may then read data from and write data to the tip memory 174 via inductive communication provided by the coils 170 , 172 and the coils 178 , 180 through the conductor 176 .

[0164] In some embodiments, the tip memory 174 may store data indicating pulse profiles 140 specific to the tip 20, rather than storing the pulse profiles 140 in advance in the console storage device 118. For example, if the tip 20 is designed for ablating soft tissue, the tip memory 174 may store one or more soft tissue pulse profiles 144 specific to the tip 20. Alternatively, if the tip 20 is designed for ablating hard tissue, the tip memory 174 may store one or more hard tissue pulse profiles 146 specific to the tip 20. In either case, in response to the ultrasonic instrument 18 being coupled to the console 16, the ultrasound controller 112 may be configured to read the pulse profile 140 from the tip memory 174 and store it in the console storage device 118 and / or the memory 122 for user selection.

[0165] The ultrasound controller 112 may also be coupled and configured to drive the display 74 of the console 16. Specifically, the ultrasound controller 112 may be configured to generate information and user interface (UI) components for presentation on the display 74. Such information displayed on the display 74 may include information identifying the handpiece 24 and the tip 20 and information describing the operating state of the ultrasonic tool system 12. When the display 74 is a touch screen display, the ultrasound controller 112 may also be configured to cause the display 74 to depict images of buttons and other physician-selectable components. By interacting with the buttons and other physician-selectable components, the physician may set desired operating parameters of the ultrasonic tool system 12, such as those described herein.

[0166] Fig.13 A process 200 is shown for controlling vibrations of the ultrasonic instrument 18 according to the selected pulse profile 140. The console 16 (or more specifically the ultrasound controller 112) may be configured to implement the process 200, such as when executing software 123 embodied by computer executable instructions residing in the console storage device 118.

[0167] In block 202, a maximum ultrasonic energy level of the induced ultrasonic energy may be determined. The maximum ultrasonic energy level may define a maximum mechanical current i of the ultrasonic instrument 18. M , and accordingly, the maximum amplitude and speed of the vibration of the tip 20 can be defined. The maximum ultrasonic energy level of the ultrasonic instrument 18 can be based on the maximum ultrasonic energy level that the ultrasonic instrument 18 is rated to accommodate, also referred to herein as the maximum capable ultrasonic energy level or global ultrasonic energy limit of the ultrasonic instrument 18, which can also be determined by the mechanical current i M Definitions. The console 16 may be configured to read the maximum capable ultrasonic energy level of the ultrasonic instrument 18 from the ultrasonic instrument 18 (or more specifically from the HP memory 168 and / or the tip memory 174 ) in response to the ultrasonic instrument 18 being connected to the console 16 .

[0168] The maximum ultrasonic energy level determined in block 202 may also be based on a power setting of the ultrasonic instrument 18 input by the physician. For example, the physician may interact with the display 74 or remote control 80 of the ultrasonic tool system 12 to input a power setting of the ultrasonic instrument 18, which may indicate a percentage of the maximum capable ultrasonic energy level that limits the driving of the ultrasonic instrument 18. In response to receiving the percentage, the ultrasonic controller 112 may be configured to determine the maximum ultrasonic energy level of the ultrasonic instrument 18 by applying the percentage to the maximum capable ultrasonic energy level. In some examples, the ultrasonic controller 112 may also determine the maximum ultrasonic energy level based on the depression angle of the foot pedal 76. Specifically, the depression angle of the foot pedal 76 may indicate to the ultrasonic controller 112 the percentage of the ultrasonic energy level corresponding to the power setting input by the user to be used as the maximum ultrasonic energy level.

[0169] The physician can set the power setting and / or maximum ultrasonic energy level of the ultrasonic instrument 18 according to the physician's personal preferences and the type of target tissue to be ablated. As an example, for a given surgical procedure, the physician can ablate certain types of soft tissues through cavitation technology while avoiding ablation of other types of soft tissues. In this case, the physician can set the console 16 to limit the operation of the ultrasonic instrument 18 to an ultrasonic energy level that causes cavitation of the target tissue type while avoiding cavitation of other tissue types. For example, with respect to brain surgery, the physician may want to ablate one or more of the dura mater, vascular wall, arachnoid, pia mater, white matter, or gray matter tissue while leaving other types of tissue intact. When the ultrasonic energy induced in the ultrasonic instrument 18 is approximately 27% of the maximum capable ultrasonic energy level of the ultrasonic instrument 18, the ultrasonic instrument 18 can play a role in cavitating these types of tissues. Therefore, the physician can set the console 16 to limit the operation of the ultrasonic instrument 18 to 30% of the maximum capable ultrasonic energy level of the ultrasonic instrument 18.

[0170] Combining a physician-selected power setting and / or maximum ultrasound energy level with one of the pulse profiles 140 can further help reduce potential trauma to tissue types that are desired to remain intact. Fig. 7A, when the console 16 is set to limit the operation of the ultrasonic instrument 18 to 30% of the maximum capable ultrasonic energy level of the ultrasonic instrument 18, the maximum ultrasonic energy level induced by each soft tissue pulse profile 144 (as indicated by the 100% line) may correspond to 30% of the maximum capable ultrasonic energy level of the ultrasonic instrument 18. In this case, each soft tissue pulse profile 144 may function to cavitate the target tissue when the ultrasonic energy induced by the soft tissue pulse profile 144 is equal to or greater than a “cavitation threshold” near the maximum ultrasonic energy level of the soft tissue pulse profile 144, which, as described above, may correspond to 27% of the maximum capable ultrasonic energy level of the ultrasonic instrument 18. Fig. 7A The minimum ultrasound energy level induced by each soft tissue pulse profile 144 shown in FIG. 1 may be below the cavitation threshold. In this way, each soft tissue pulse profile 144 may periodically induce ultrasound energy sufficient to induce cavitation in the target tissue, and may induce reduced ultrasound energy levels in between, which act to reduce temperature and ablation of tissue types that are desired to remain intact.

[0171] Reference again Fig.13 , in block 204, it may be determined whether the ultrasonic instrument 18 has pulse mode enabled. Specifically, the physician may interact with the console 16 to enable and disable the pulse mode, such as using the display 74 or the remote control 80, and the ultrasound controller 112 may be configured to make this determination based on the physician settings provided. In response to determining that the pulse mode is not enabled (the "No" branch of block 204), in block 206, the console 16 may be set to operate the ultrasonic instrument 18 in a continuous mode, such as according to the constant energy profile 148 described above. Specifically, when the ultrasonic instrument 18 is actuated, the ultrasound controller 112 may be configured to generate and supply an AC drive signal to the ultrasonic instrument, the ultrasonic energy induced in the ultrasonic instrument 18 by the AC drive signal being maintained at the determined maximum ultrasonic energy level of the ultrasonic instrument 18.

[0172] Additionally or alternatively, determining whether the pulse mode is enabled may include determining whether the tip 20 itself can be activated with a pulse. Specifically, some tips 20 that are releasably coupled to the handpiece 24 may be configured to operate only in a continuous mode. Whether the tip 20 can be activated with a pulse may be indicated as data specific to the tip 20 stored in the tip memory 174. Therefore, in response to the ultrasonic instrument 18 being coupled to the console 16, the ultrasonic controller 112 may be configured to read the data from the tip memory 174 and determine whether the tip 20 currently coupled to the handpiece 24 can be activated with a pulse. In some instances, the data stored in the tip memory 174 may directly indicate whether the tip 20 can be activated with a pulse. In other examples, the tip memory 174 may indicate the type of tip, such as by an identifier specific to the tip 20, and the ultrasonic controller 112 may be configured to query the data corresponding to the tip type stored in the console storage device 118 to determine whether the tip 20 can be activated with a pulse. If not, the ultrasonic controller 112 may be configured to enable the physician to disable the option and set the console 16 to operate the ultrasonic instrument 18 in a continuous mode, as described above.

[0173] Alternatively, in response to determining that the tip 20 can be activated with a pulse and / or a pulse mode has been selected (the "yes" branch of block 204), in block 208, it can be determined whether the ultrasonic instrument 18 should be operated in a soft tissue ablation mode or a hard tissue ablation mode. As previously described, each mode can be associated with a set of different pulse profiles 140 designed specifically for that mode. The physician can set the console 16 to either mode using a user interface associated with the console 16 (e.g., the display 74 or the remote control 80), and the ultrasound controller 112 can be configured to make this determination based on the physician settings provided.

[0174] Optionally, the tip memory 174 published with the current tip 20 connected to the handpiece 24 of the ultrasonic instrument 18 may include data indicating whether the tip 20 is configured for soft tissue ablation or configured for hard tissue ablation. The data stored in the tip memory 174 may directly indicate whether the tip 20 is configured for soft tissue ablation or for hard tissue ablation, or may indicate a type of tip 20 corresponding to data stored in the console storage device 118, which indicates whether the tip type is for soft tissue ablation or hard tissue ablation. The console 16 may be configured to read such data from the tip memory 174 when the ultrasonic instrument 18 is connected to the console 16, as described above, to determine whether the ultrasonic instrument 18 should be operated in a soft tissue ablation mode or in a hard tissue ablation mode.

[0175] In response to determining that the ultrasonic instrument 18 is to be operated in a soft tissue ablation mode (the "soft tissue" branch of block 208), in block 210, the console 16 may be set to operate in the soft tissue ablation mode. For example, the ultrasound controller 112 may be configured to set a flag in the console storage device 118 and / or the memory 122 corresponding to the console 16 being set to the soft tissue ablation mode. In response to determining that the ultrasonic instrument 18 is to be operated in a hard tissue ablation mode (the "hard tissue" branch of block 208), in block 212, the console 16 may be set to operate in the hard tissue ablation mode. For example, the ultrasound controller 112 may be configured to set a flag in the console storage device 118 and / or the memory 122 corresponding to the console 16 being set to the hard tissue ablation mode.

[0176] In block 214, a physician-selected pulse profile 140 associated with the currently set ablation mode may be received. As previously described, the console storage device 118 may store a number of soft tissue pulse profiles 144 associated with the soft tissue ablation mode and a number of hard tissue pulse profiles 146 associated with the hard tissue ablation mode. The different soft tissue pulse profiles 144 associated with the soft tissue ablation mode may be sorted, for example, according to a user-selectable pulse control level assigned to the soft tissue pulse profiles 144, so that each incremental soft tissue pulse profile 144 provides increased tissue selectivity, temperature control, and / or tactile feedback, and the different hard tissue pulse profiles 146 associated with the hard tissue ablation mode may be sorted, for example, according to a user-selectable pulse control level assigned to the hard tissue pulse profiles 146, so that each incremental hard tissue pulse profile 146 provides increased tactile feedback and / or increased stalling probability about the tissue being contacted and the amount of force applied by the physician with the ultrasonic instrument 18. Thus, the physician may select one of the pulse profiles 140 associated with the currently set ablation mode of the console 16 by selecting a pulse control level of the pulse profile 140 (eg, via the display 74 or remote control 80 ) based on the physician's desired operating characteristics of the ultrasonic device 18 .

[0177] In block 216, in response to receiving a physician selection of one of the pulse profiles 140 associated with a set ablation mode of the console 16, a pulse parameter setting associated with the selected pulse profile 140 may be determined, such as by the ultrasound controller 112 querying the console memory device 118 based on the selected pulse profile 140. Alternatively, the ultrasound controller 112 may be configured to determine such a pulse parameter setting based on data read from the tip memory 174, which may store pulse parameter settings for the pulse profile 140 that are specific to the tip 20 and are available for user selection when the ultrasonic instrument 18 is connected to the console 16.

[0178] In block 218, one or more system parameters may be set based on the extracted pulse parameter settings and / or the set ablation mode. For example, the ultrasound controller 112 may be configured to determine a minimum ultrasound energy level for the ultrasound instrument 18 based on the determined pulse parameter settings (or more specifically, based on a minimum energy factor indicated by the determined parameter settings).

[0179] As yet another example, because crushing soft tissue generally does not require as much crushing power as crushing hard tissue such as bone, if the selected pulse profile 140 corresponds to a soft tissue ablation mode, the ultrasound controller 112 may be configured to reduce the available power, for example by setting the voltage limit (or limit) of the AC drive signal to a lower value. Specifically, if the selected pulse profile 140 corresponds to the soft tissue ablation mode, the ultrasound controller 112 may be configured to set the voltage limit of the AC drive signal to a relatively low value (e.g., 600 volts peak), and if the selected pulse profile 140 corresponds to the hard tissue ablation mode, the ultrasound controller 112 may be configured to set the voltage limit of the AC drive signal to a relatively high value (e.g., 1200 volts peak). Alternatively, each pulse profile 140 may include a pulse parameter setting specific to that pulse profile 140 that indicates to the user the voltage limit of that pulse profile 140.

[0180] As yet another example, the mechanical current i of the ultrasonic tool system 12 M The rate of change limit (or limiter) can adjust the control console 16 from the previously sensed mechanical current i M To induce a new target mechanical current i M How fast can it be. The mechanical current i used when operating in continuous ultrasonic energy mode M The rate of change limit may not be fast enough for the pulse mode, and therefore, the ultrasonic controller 112 may be configured to set the mechanical current i to 100 in response to the ultrasonic tool system 12 being set to the pulse mode and a pulse profile 140 being selected. M The rate of change limit is set to a high value. For a given pulse profile 140, the mechanical current i M The rate of change limit may depend on the pulse shape, pulse frequency, and duty cycle of the pulse profile 140. Thus, in response to selecting a given pulse profile 140, the ultrasound controller 112 may be configured to set the mechanical current i based on these parameters. M Rate of change limiting, for example by using equations or storing different values ​​of these parameters associating different mechanical currents i M The rate of change limit is associated with the data.

[0181] As another example, during operation of the ultrasonic instrument 18, the voltage of the power signal supplied by the power supply 165 may vary based on the voltage induced on the primary winding 124 to enable the amplifier 164 to produce a desired AC signal on the primary winding 124. To improve the responsiveness of the system, the ultrasonic controller 112 may be configured to adjust the voltage of the signal supplied by the power supply 165 to the amplifier 164 based on the voltage to be produced on the primary winding 124, rather than or in addition to using a PID controller of the power supply 165 that waits for a feedback signal indicating a varying voltage. The regulation of the voltage of the signal supplied by the power supply 165 may be subject to a positive rate of change limit, and the ultrasonic controller 112 may be configured to implement a higher rate of change limit (e.g., two times) on the signal when operating in a pulsed mode than in a continuous energy mode.

[0182] In some examples, such as when the console 16 is set to operate in a hard tissue ablation mode, rather than setting the maximum ultrasound energy level of the ultrasound device 18 to be equal to the level set by the physician (e.g., via the user power setting and the foot pedal 76), the ultrasound controller 112 can be configured to determine the maximum ultrasound energy level of the ultrasound device 18 to be greater than the level set by the physician and to make the average ultrasound energy level induced in the ultrasound device 18 according to the selected pulse profile 140 substantially equal to the level set by the physician. This technique can result in higher ablation rates and higher minimum ultrasound energy levels for each pulse profile 140, which can help prevent excessive stalling when treating hard tissue such as bone.

[0183] In block 220, an AC drive signal may be generated and supplied to the ultrasonic instrument 18 based on the determined maximum and minimum ultrasonic energy levels and other pulse parameter settings of the selected pulse profile 140 as described above. Specifically, the AC drive signal may be set according to the duty cycle and pulse frequency of the selected pulse profile 140 so as to induce ultrasonic energy in the ultrasonic instrument 18 having a plurality of ultrasonic energy pulses peaking at a maximum ultrasonic energy level and separated by ultrasonic energy at a minimum ultrasonic energy level.

[0184] As an example, in response to selecting a soft tissue pulse profile 144 having a duty cycle less than 100% (e.g., Fig. 7A Soft tissue pulse profiles 144B to 144E, Fig. 8AThe console 16 may be configured to generate an AC drive signal that induces ultrasonic energy in the ultrasonic instrument 18, including ultrasonic energy pulses that peak at a set maximum ultrasonic energy level and are separated by a substantial period (e.g., a period greater than or equal to 2 milliseconds) at a minimum ultrasonic energy level. The duration of each ultrasonic energy pulse relative to the duration of each cycle of the induced ultrasonic energy may correspond to a duty cycle associated with the selected soft tissue pulse profile 144.

[0185] As another example, in response to selecting a hard tissue pulse profile 146 associated with a duty cycle less than 100% (eg, Figure 7B The pulse profiles 146B to 146E and Figure 8B The console 16 may be configured to generate an AC drive signal to induce in the ultrasonic instrument 18 ultrasonic energy comprising ultrasonic energy pulses that peak at a maximum ultrasonic energy level and are separated by instantaneous periods of ultrasonic energy at a minimum ultrasonic energy level (e.g., less than 1 millisecond). The peak of each ultrasonic energy pulse may include a substantial period (e.g., a period greater than or equal to 2 milliseconds) at the maximum ultrasonic energy level. The duration between each pair of adjacent edges of adjacent ultrasonic energy pulses may correspond to the duty cycle associated with the selected hard tissue pulse profile 146.

[0186] As yet another example, in response to selecting a pulse profile 140 having a 100% duty cycle (e.g., Fig. 7A The pulse profile 144A, Fig. 8A 144F, Fig. 9A 144K-144O, Figure 7B 146A, Figure 8B 146F and Fig. 9B 146K-146O), the console 16 may be configured to generate an AC drive signal that induces ultrasonic energy in the ultrasonic instrument 18 that includes ultrasonic energy pulses separated by instantaneous periods (e.g., less than one millisecond) at a minimum ultrasonic energy level, each ultrasonic energy pulse instantaneously peaking (e.g., less than one millisecond) at a maximum ultrasonic energy level. In other words, the ultrasonic energy level induced in the ultrasonic instrument 18 may be considered to be constantly fluctuating.

[0187] In some embodiments, when pulsed ultrasonic energy is induced in the ultrasonic instrument 18, the console 16 can display a switching element that enables the physician to quickly switch between inducing pulsed ultrasonic energy according to the currently selected pulse profile 140 and inducing ultrasonic energy in the ultrasonic instrument 18 according to a continuous ultrasonic energy mode (e.g., according to a constant energy profile 148) without, for example, having to stop the ultrasonic instrument 18 or cycle through each pulse control level to disable pulses. This feature can enable the physician to briefly increase the fragmentation power, for example if the physician encounters tissue that is difficult to ablate at the current settings, and then quickly return to pulsed ultrasonic energy.

[0188] Fig.14 A method 250 is shown that uses ultrasonic energy pulses induced in an ultrasonic instrument 18 to provide tactile feedback to a physician to indicate whether the physician is providing an optimal amount of pressure to the ultrasonic instrument 18. When a physician applies the vibrating tip 20 of the ultrasonic instrument 18 to tissue such as bone, the pressure applied by the physician to the ultrasonic instrument 18 may affect the effectiveness of the tip 20 in removing tissue. If the physician applies too little pressure, the tip 20 may not effectively remove tissue, and if the physician applies too much pressure, the tip 20 may ablate tissue that is desired to remain intact and / or may stall. The console 16 (or more specifically the ultrasound controller 112) can be configured to implement the method 250 to provide tactile feedback to the physician to indicate whether the pressure the physician is applying is too little, too much, or is more accurate.

[0189] In block 252, target ultrasonic energy may be induced in the ultrasonic instrument 18, for example, according to an ultrasonic energy profile selected by the physician. For example, if one of the pulse profiles 140 is selected to be induced in the ultrasonic instrument 18, the console 16 may be configured to induce pulsed ultrasonic energy in the ultrasonic instrument 18 according to the selected pulse profile 140 as the target ultrasonic energy, wherein the ultrasonic energy pulses occur at a default pulse frequency (e.g., 50 Hz). In some examples, each pulse profile 140 may define a default pulse frequency specific to the pulse profile 140. Alternatively, the console 16 may be configured to use the same default pulse frequency for each pulse profile 140. Conversely, if the physician disables the pulse mode, the console 16 may be configured to induce continuous ultrasonic energy (e.g., according to a constant energy profile 148) in the ultrasonic instrument 18 as the target ultrasonic energy.

[0190] In block 254, the load applied to the ultrasonic instrument 18, or more specifically, the mechanical components of the ultrasonic instrument 18, may be monitored. The magnitude of the load applied to the mechanical components of the ultrasonic instrument 18 may be related to the physical properties of the tissue contacted by the tip 20 and the force applied by the physician to the ultrasonic instrument 18. When the physician applies increasing pressure to the ultrasonic instrument 18, the load applied to the mechanical components may increase, and when the physician applies decreasing pressure to the ultrasonic instrument 18, the load applied to the mechanical components may decrease.

[0191] The ultrasonic controller 112 may be configured to monitor the load applied to the ultrasonic instrument 18 by calculating a load measurement value indicative of the extent of the applied load. In some examples, the load measurement value may be the mechanical impedance Z exhibited by the ultrasonic instrument 18 during operation. M Or mechanical resistance R M , which may increase or decrease with the load applied to the mechanical components of the ultrasonic instrument 18. More specifically, referring again to Fig. 6A and 6B When the ultrasonic instrument 18 is operated in a resonant state (e.g., the fundamental frequency of the AC drive signal corresponding to the frequency of the fundamental AC signal 154 of the signal generator 114 is substantially equal to the resonant frequency of the ultrasonic instrument 18), the mechanical impedance Z of the ultrasonic instrument 18 M The inductance component L M and the capacitance component C M Therefore, when the ultrasonic instrument 18 is operated in a resonant state, the mechanical impedance Z of the ultrasonic instrument 18 is M It can be equal to the mechanical resistance R of the ultrasonic instrument 18 M , the resistance can be based on the mechanical current i of the AC drive signal M and voltage v S Calculated using Ohm's law.

[0192] Therefore, the ultrasonic controller 112 can be configured to determine the load measurement value of the ultrasonic instrument 18 by: when the ultrasonic instrument 18 is operating in a resonant state, based on the mechanical current i M (determined, for example, using equation (1) above) and the voltage v of the AC drive signal S The mechanical resistance R of the ultrasonic instrument 18 is calculated (e.g., measured using the voltage measurement circuit 90) M According to Ohm's law, the mechanical impedance Z of the ultrasonic instrument 18 is M Can be equal to the driving voltage v S Divided by the mechanical current i M Because the mechanical impedance Z in the resonant state M Can be equal to the mechanical resistance R M, so the console 16 can be configured to operate the ultrasonic instrument 18 in a resonant state by applying the drive voltage v S Divided by the mechanical current i M To calculate the mechanical resistance R M .

[0193] As another example, the load measurement value may be the voltage v of the AC drive signal. S , for example, using voltage measurement circuit 90. As previously described, console 16 may be configured to adjust the voltage v of the AC drive signal S , so as to induce a target mechanical current i in the ultrasonic instrument 18 M The mechanical current i of the ultrasonic instrument 18 during operation M The mechanical impedance Z of the ultrasonic instrument 18 can be M Or mechanical resistance R M Therefore, during operation, the voltage v of the AC drive signal S The mechanical impedance Z of the ultrasonic instrument 18 can be M Or mechanical resistance R M Varies accordingly, and may accordingly increase or decrease with the load applied to the mechanical components of the ultrasonic instrument 18 .

[0194] Reference again Fig.14 , in block 256, it may be determined whether an optimal load is being applied to the ultrasonic instrument 18 (or more specifically to a mechanical component of the ultrasonic instrument 18). To this end, the console 16 may be configured to determine whether the monitored applied load is within a target range defined by a predefined lower load threshold level (TH1) and a predefined upper load threshold level (TH2). More specifically, the console 16 may be configured to determine whether the monitored applied load is greater than or equal to the lower threshold level (TH1) and / or less than or equal to the upper threshold level (TH2). As previously described, the applied load may be related to the magnitude of pressure applied by the physician to the ultrasonic instrument 18. A monitored applied load less than the lower threshold level TH1 may indicate that the pressure provided by the physician is less than the optimal pressure for resecting tissue, while a monitored applied load greater than the upper threshold level TH2 may indicate that the pressure provided by the physician is greater than the optimal pressure for resecting tissue. If the monitored applied load is within the target range, the console 16 may be configured to determine that an optimal load is being applied to the ultrasonic instrument 18 (the "yes" branch of block 256).

[0195] The console 16 may be configured to determine whether the monitored applied load is within the target range by being configured to determine whether the load measurement value defining the monitored applied load is within the target range. Thus, the lower threshold TH1 and the upper threshold TH2 may be defined in units of the load measurement value. For example, if the load measurement value corresponds to the voltage v of the AC drive signal S , the lower threshold level TH1 and the upper threshold level TH2 may be defined by voltage thresholds in volts. Alternatively, if the load measurement corresponds to the mechanical impedance Z of the ultrasonic instrument 18 M Or mechanical resistance R M , the lower threshold level TH1 and the upper threshold level TH2 may be defined by a mechanical impedance threshold or a mechanical resistance threshold in ohms, respectively. For example, but not limited to, when the load measurement value corresponds to the mechanical resistance R of the ultrasonic instrument 18 M When the lower threshold level TH1 may be 2000 ohms, the upper threshold level TH2 may be 5000 ohms.

[0196] In some embodiments, the ultrasonic controller 112 may be configured to calibrate the load measurement before determining whether the load measurement is within a target range, for example, based on the level (e.g., flow rate) of the irrigation fluid provided via the cannula 42 (which may be set by the physician and / or monitored by the console 16), and / or based on the type of tissue contacted by the operative end 22 of the tip 20 (which may be detected as described in more detail below). More specifically, each of these items may affect the load on the mechanical components of the ultrasonic instrument 18 and increase or decrease the load measurement accordingly. Therefore, the console memory 118 may store data indicating the value by which the load measurement is offset (e.g., reduced) for different irrigation fluid settings / measurements (values) and / or different types of contacted tissue detected, for the purpose of standardizing or normalizing the load measurement. Additionally or alternatively, such data may be written in a memory device (e.g., the tip memory 174) of the ultrasonic instrument 18 and read by the ultrasonic controller 112 when the ultrasonic instrument 18 is connected to the console 16. Additionally or alternatively, the ultrasound controller 112 can be configured to determine the offset normalization value by instructing the physician to vibrate the tip 20 in free air prior to a surgical procedure and / or without irrigation and measuring corresponding load measurements during such vibration for use as an offset value for normalizing the load measurements later in the surgical procedure.

[0197] In response to determining that the monitored applied load is optimal (the "yes" branch of block 256), the method 250 may return to block 252 to continue inducing target ultrasonic energy in the ultrasonic instrument 18, monitoring the applied load, and determining whether the monitored applied load is optimal. In response to determining that the monitored applied load is not optimal (e.g., the monitored applied load is less than the lower threshold level TH1 or greater than the upper threshold level TH2) (the "no" branch of block 256), in block 258, tactile feedback indicating this situation may be provided to the physician.

[0198] For example, in response to determining that the monitored applied load is less than the lower threshold level TH1, the console 16 may be configured to induce pulsed ultrasonic energy having a relatively high or low pulse frequency in the ultrasonic instrument 18, and in response to determining that the monitored applied load is greater than the upper threshold level TH2, the console 16 may be configured to induce pulsed ultrasonic energy having the other of the relatively high or low pulse frequencies in the ultrasonic instrument 18. For example, but not limitation, in response to determining that the monitored applied load is less than the lower threshold level TH1, the console 16 may be configured to induce pulsed ultrasonic energy having a relatively high pulse frequency of 60 Hz in the ultrasonic instrument 18, and in response to determining that the monitored applied load is greater than the upper threshold level TH2, the console 16 may be configured to induce pulsed ultrasonic energy having a relatively low pulse frequency of 10 Hz in the ultrasonic instrument 18. In this example, when the pressure provided by the physician is too small (e.g., the monitored applied load is less than the lower threshold level TH1), the physician may feel that the pulses in the ultrasonic instrument 18 are relatively fast, and when the pressure provided by the physician is too large (e.g., the monitored applied load is greater than the upper threshold level TH2), the physician may feel that the pulses in the ultrasonic instrument 18 are relatively slow.

[0199] If the target ultrasonic energy sensed in block 252 is pulsed ultrasonic energy corresponding to the pulse profile 140, then in block 258, in response to determining that the monitored applied load is less than the lower threshold level TH1, the console 16 may be configured to sense pulsed ultrasonic energy in the ultrasonic instrument 18 according to the selected pulse profile 140, but at a pulse frequency greater than (or less than) a default pulse frequency associated with the selected pulse profile 140. In other words, the console 16 may be configured to sense a relatively high (or relatively low) pulse frequency. Similarly, in response to determining that the monitored applied load is greater than the upper threshold level TH2, the console 16 may be configured to sense pulsed ultrasonic energy in the ultrasonic instrument 18 according to the selected pulse profile 140, but at a pulse frequency less than (or greater than) a default pulse frequency associated with the selected pulse profile 140. In other words, the console 16 may be configured to sense a relatively low (or relatively high) pulse frequency.

[0200] In an alternative embodiment, if the target ultrasonic energy sensed in block 252 is pulsed ultrasonic energy corresponding to the pulse profile 140, then in response to determining that the monitored applied load is less than the lower threshold level TH1 or greater than the upper threshold level TH2, the console 16 may be configured to switch to sensing ultrasonic energy maintained at a substantially constant value, such as maintained at a maximum ultrasonic energy level determined for the ultrasonic instrument 18 (e.g., the constant energy profile 148, Fig. 7A ).

[0201] In contrast, if the target ultrasonic energy is substantially constant ultrasonic energy, then in block 258, in response to determining that the monitored applied load is less than the lower threshold level TH1 or greater than the upper threshold level TH2, the console 16 can be configured to switch to inducing pulsed ultrasonic energy in the ultrasonic instrument 18, for example, according to one of the pulse profiles 140, wherein the pulse frequency is equal to a default pulse frequency associated with the pulse profile 140, or is equal to a relatively high or low pulse frequency as described above.

[0202] More specifically, assuming that the target ultrasonic energy is substantially constant ultrasonic energy, in response to determining in block 256 that the monitored applied load is less than the lower threshold level TH1 or greater than the upper threshold level TH2, in block 258, the console 16 may be configured to determine whether the currently connected tip 20 is configured to ablate hard tissue or to ablate soft tissue, for example based on a setting provided by a user or data read from the tip memory 174. The console 16 may then be configured to sense one of the soft tissue pulse profiles 144 in response to determining that the tip 20 is configured for ablation of soft tissue, and sense one of the pulse profiles 146 in response to determining that the tip 20 is configured for cutting bone.

[0203] The pulse frequency of the induced pulsed ultrasonic energy can be set to a default pulse frequency associated with the pulse profile 140 (e.g., 50 Hz), or can be set based on whether the monitored applied load is determined to be less than the lower threshold level TH1 or greater than the upper threshold level TH2, as described above. For example, in response to determining that the monitored applied load is less than the lower threshold level TH1, the console 16 can be configured to induce a relatively high pulse frequency (e.g., 60 Hz), and in response to determining that the monitored applied load is greater than the upper threshold level TH2, the console 16 can be configured to induce a relatively low pulse frequency (e.g., 10 Hz), and vice versa.

[0204] After block 258, the method 250 may return to block 254 to continue monitoring and comparing the applied load to the target range to determine whether the applied load is optimal. In response to determining that the monitored applied load becomes optimal (e.g., becomes greater than or equal to the lower threshold level TH1 and less than or equal to the upper threshold level TH2) (the "yes" branch of block 256), the method 250 may return to block 252, where the target ultrasonic energy may be induced in the ultrasonic instrument 18 again to indicate to the physician that the optimal amount of pressure is being applied. In other words, the console 16 may induce ultrasonic energy in the ultrasonic instrument 18 corresponding to the ultrasonic energy profile and related settings selected by the physician.

[0205] For example, if the physician has selected one of the pulse profiles 140 to be induced in the ultrasonic instrument 18 as the target ultrasonic energy, the console 16 can be configured to induce the selected pulse profile 140 at a pulse frequency equal to the default pulse frequency associated with the pulse profile 140. Alternatively, if the physician has selected a constant energy profile 148 to be induced in the ultrasonic instrument 18, the console 16 can be configured to induce constant ultrasonic energy in the ultrasonic instrument 18. In either case, the physician can be able to feel the restoration of the target ultrasonic energy in the ultrasonic instrument 18 and associate this restoration with an indication that the physician is providing an optimal pressure to the ultrasonic instrument 18.

[0206] In some examples, each pulse profile 140 can be associated with a pulse frequency range between a relatively high pulse frequency and a relatively low pulse frequency to sense that the magnitude of the monitored applied load is within a target range. In other words, when the monitored applied load changes within the target range, the console 16 can be configured to determine a pulse frequency that changes in correlation with the degree of change in the monitored applied load and sense the changed pulse frequency in the ultrasonic instrument 18.

[0207] For example, refer to Fig.15 , the console storage device 118 or the tip memory 174 may store data defining a graph 270 that relates various load measurements between the lower threshold level TH1 and the upper threshold level TH2 to a unique pulse frequency induced in the ultrasonic instrument 18 when the load measurement occurs. For example, the data may indicate a lower threshold level TH1 272, a relatively high pulse frequency 274 associated with the lower threshold level TH1 272, an upper threshold level TH2 276, a relatively low pulse frequency 278 associated with the upper threshold level TH2 276, and a transfer function 280. Fig.15 In the example shown, the load measurement is provided in ohms. In alternative examples, the load measurement may be provided in other units, such as volts as described above.

[0208] At load measurement values ​​between the lower threshold level TH1 272 and the upper threshold level TH2 276, the conversion function 280 may extend from a relatively high pulse frequency 274 associated with the lower threshold level TH1 272 to a relatively low pulse frequency 278 associated with the upper threshold level TH2 276. In other words, the conversion function 280 may associate a unique pulse frequency with each load measurement value that is greater than or equal to the lower threshold level TH1 272 and less than or equal to the upper threshold level TH2 276. The conversion function 280 may be a decreasing function, such as a linear function with a negative slope, such that the associated pulse frequency decreases as the load measurement value increases.

[0209] The console 16 may be configured to induce pulsed ultrasonic energy having different pulse frequencies determined based on the above data in the ultrasonic instrument 18. Specifically, assuming that the physician has selected one of the pulse profiles 140 to be induced in the ultrasonic instrument 18, in response to actuation of the ultrasonic instrument 18, the console 16 may be configured to induce pulsed ultrasonic energy in the ultrasonic instrument 18 according to the selected pulse profile 140 and at a pulse frequency equal to a default pulse frequency (e.g., 50 Hz) associated with the selected pulse profile 140. Thereafter, the console 16 may be configured to repeat the following cycle: monitoring the load applied to the mechanical components of the ultrasonic instrument 18, determining an updated pulse frequency induced in the ultrasonic instrument 18 based on the monitored applied load and the graph 270, and generating pulsed ultrasonic energy in the ultrasonic instrument 18 according to the selected pulse profile 140 and the updated pulse frequency.

[0210] For example, assuming that the monitored applied load is the mechanical resistance R of the ultrasonic instrument 18 M Defined, the console 16 may be configured to determine the calculated mechanical resistance R M is less than or equal to the lower threshold level TH1 272, or greater than or equal to the upper threshold level TH2 276, or between the lower threshold level TH1 272 and the upper threshold level TH2 276. In response to determining the mechanical resistance R M is less than or equal to the lower threshold level TH1 272, the console 16 may be configured to set the pulse frequency of the pulsed ultrasonic energy induced in the ultrasonic instrument 18 to a relatively high pulse frequency 274, and in response to determining the mechanical resistance R M is greater than or equal to the upper threshold level TH2 276, the console 16 may be configured to set the pulse frequency of the pulsed ultrasonic energy induced in the ultrasonic instrument 18 to a relatively low pulse frequency 278. In response to determining the mechanical resistance R MBetween the lower threshold level TH1 272 and the upper threshold level TH2 276, the console 16 may be configured to set the pulse frequency of the pulsed ultrasonic energy induced in the ultrasonic instrument 18 to the pulse frequency indicated by the transfer function 280, which is used as the mechanical resistance R M function.

[0211] Thus, when the pressure applied by the physician to the ultrasonic instrument 18 deviates from the specified optimal pressure level (which may be indicated by a load measurement value that is different from a predefined load measurement value (e.g., 3000 ohms) between the lower threshold level TH1 272 and the upper threshold level TH2 276), the pulse frequency of the pulsed ultrasonic energy induced in the ultrasonic instrument 18 may be immediately changed, and to the extent that the applied pressure is different from the specified optimal pressure level. Therefore, the physician may immediately receive tactile feedback indicating a discrepancy with the specified optimal pressure level, and may determine the amount of pressure to be added to or subtracted from the ultrasonic instrument 18 to provide the specified optimal pressure level based on the level of tactile feedback. For example, but not limitation, the predefined load measurement value between the lower threshold level TH1 272 and the upper threshold level TH2 276 corresponding to the specified optimal pressure level may be set to the average of the lower threshold level TH1 272 and the upper threshold level TH2 276, or may be set to a load measurement value corresponding to the average or median of the pulse frequency range defined by the conversion function 280.

[0212] As mentioned above, in Fig.15 In the example shown, the lower threshold level TH1 272 is associated with the relatively high pulse frequency 274, the upper threshold level TH2 276 is associated with the relatively low pulse frequency 278, and the transfer function 280 decreases from the relatively high pulse frequency 274 to the relatively low pulse frequency 278 as the load measurement value increases. As another example, it is contemplated that the lower threshold level TH1 272 may be associated with the relatively low pulse frequency 278, the upper threshold level TH2 276 may be associated with the relatively high pulse frequency 274, and the transfer function 280 may increase from the relatively low pulse frequency 278 to the relatively high pulse frequency 274 as the load measurement value increases.

[0213] In some embodiments, in addition to or in addition to defining a target ultrasonic energy to be induced when the applied load is within the target range, the physician may be able to define a target ultrasonic energy to be induced when the applied load is outside the target range. In this way, in response to determining that the applied load is outside the target range, indicating that the pressure applied by the physician to the ultrasonic instrument 18 may not be the optimal pressure, the console 16 may be configured to induce the target ultrasonic energy outside the range defined by the physician in the ultrasonic instrument 18. Conversely, if the monitored applied load is within the target range, then the physician may be applying the optimal pressure to the ultrasonic instrument 18, and the console 16 may be configured to provide tactile feedback indicating this situation, for example by inducing the target ultrasonic energy within the range also defined by the physician in the ultrasonic instrument 18.

[0214] For example, if the out-of-range target ultrasonic energy induced in the ultrasonic instrument 18 conforms to the above-described constant energy profile 148, the console 16 can be configured to induce pulsed ultrasonic energy in the ultrasonic instrument 18, for example, according to one of the pulse profiles 140 selected by the physician, as the in-range target ultrasonic energy. In this way, in response to the monitored applied load corresponding to the target range, the ultrasonic instrument 18 can begin to exhibit vibrations corresponding to the physician-selected pulse profile 140. If the out-of-range target ultrasonic energy induced in the ultrasonic instrument 18 conforms to one of the pulse profiles 140, then, when the applied load is within the target range, the console 16 can be configured to adjust the pulse frequency of the pulsed ultrasonic energy, for example, by increasing the pulse frequency or decreasing the pulse frequency relative to the pulse frequency of the out-of-range target ultrasonic energy induced in the ultrasonic instrument 18.

[0215] In some examples, the pulse frequency of the pulsed ultrasonic energy induced when the monitored applied load is within the target range may also vary based on the distance between the load measurement value and the lower threshold level TH1 and the distance between the load measurement value and the upper threshold value TH2. For example, in response to the load measurement value moving from a predefined load value between the lower threshold level TH1 and the upper threshold level TH2 to closer to the lower threshold level TH1 or the upper threshold level TH2, the console 16 can be configured to induce a higher pulse frequency. Similarly, in response to the load measurement value moving from the lower threshold level TH1 or the upper threshold level TH2 toward the predefined load value, the console 16 can be configured to induce a lower pulse frequency. This configuration can also be reversed, so that the load measurement value moves from the predefined load value toward the lower threshold value TH1 or the upper threshold value TH2 resulting in a lower pulse frequency, while moving from the lower threshold level TH1 or the upper threshold level TH2 toward the predefined load value results in a higher pulse frequency. The console 16 may be configured to adjust the pulse frequency in this manner according to a transfer function that defines a specific pulse frequency for each load measurement value between the lower threshold level TH1 and the upper threshold level TH2, such as a bell curve function that takes as input the values ​​between the lower threshold level TH1 and the upper threshold level TH2 and reaches a peak at a predefined load value. For example, but not limiting, the predefined load value may be set to the average value of the lower threshold level TH1 and the upper threshold level TH2, or to a load measurement value corresponding to the average or median value of the pulse frequency defined by the transfer function.

[0216] refer to Fig.16 In some embodiments, the console 16 can be configured to operate in different pulse activation modes selectable by the physician that automatically disable and enable pulses based on the monitored load relative to the lower threshold level TH1 and the upper threshold level TH2. For example, in pulse activation mode 1, the console 16 can be configured to sense pulsed ultrasonic energy when the monitored load exceeds or is outside the target range, for example, according to one of the pulse profiles 140 selected by the physician, and sense substantially constant ultrasonic energy when the monitored load is within the target range. Conversely, in pulse activation mode 2, the console 16 can be configured to sense pulsed ultrasonic energy when the monitored load is within the target range, for example, according to one of the pulse profiles 140 selected by the physician, and sense substantially constant ultrasonic energy when the monitored load is outside the target range. Pulse activation mode 0 may correspond to automatic pulse activation being disabled.

[0217] The pulse parameters described above, i.e., the lower threshold level TH1 and the upper threshold level TH2, may be predetermined and stored in the console storage device 118. In some cases, each pulse profile 140 may define a lower threshold level TH1 and an upper threshold level TH2 that are specific to the pulse profile 140. Alternatively, the console 16 may be configured to use the same lower threshold level TH1 and upper threshold level TH2 for each pulse profile 140. In other embodiments, in addition to or in addition to the user-selectable pulse activation mode, each pulse profile 140 may define a specific pulse activation mode (e.g., mode 1 or 2) available for the pulse profile 140, and the physician may select between the defined pulse activation mode or the disabled pulse activation mode when using the pulse profile 140.

[0218] As previously described in the present disclosure, different tips 20 having different operating characteristics may be releasably coupled to the handpiece 24. Because each tip 20 is typically released with an irrigation sleeve 42 specific to the tip 20 to provide further optimization, pulse parameter optimization settings as described above specific to each tip 20 removably coupled to the handpiece 24 may be pre-determined and stored on the tip memory 174 of the irrigation sleeve 42 released with the tip 20. Thereafter, when the ultrasonic instrument 18 including the tip 20 is coupled to the console 16, the console 16 may be configured to read data indicating the set pulse parameters specific to the tip 20 from the tip memory 174 and operate the ultrasonic instrument 18 based on the read data, as described above.

[0219] For example, the data stored on the tip memory 174 for a given tip 20 may indicate one or more pulse profiles 140 that are specific to the tip 20 and that are selectable by the physician. To this end, the data stored on the tip memory 174 may indicate one or more pulse parameter settings that are specific to the tip 20, including one or more of the following: one or more minimum energy factors that are specific to the tip 20, each of which may be associated with a different pulse profile 140 that is specific to the tip 20; one or more duty cycles that are specific to the tip 20, each of which may be associated with a different pulse profile 140 that is specific to the tip 20; one or more pulse frequencies that are specific to the tip 20, each of which may be associated with a different pulse profile 140 that is specific to the tip 20; one or more pulse shapes that are specific to the tip 20, each of which may be associated with a different pulse profile 140 that is specific to the tip 20; and one or more voltage limits that are specific to the tip 20, each of which may be associated with a different pulse profile 140 that is specific to the tip 20.

[0220] The data stored on the tip memory 174 for a given tip 20 may also indicate one or more other pulse parameter settings specific to the tip 20, such as whether the tip 20 is pulse-activatable, whether the tip 20 is a hard tissue ablation tip or a soft tissue ablation tip, a lower threshold level TH1 of the tip 20, an upper threshold level TH2 of the tip 20, and a pulse activation mode of the tip 20. In response to the ultrasonic instrument 18 including the tip 20 being coupled to the console 16, the console 16 may be configured to read the data from the tip memory 174 and utilize the indicated pulse parameter settings, as described above.

[0221] As yet another example, the console storage device 118 may also be configured to store the above-described pulse parameters by tip type. In this case, in response to the ultrasonic instrument 18 being coupled to the console 16, the console 16 may be configured to determine the tip 20 type, for example, based on data indicating the tip type read from the tip memory 174. The console 16 may then be configured to query the console storage device 118 to obtain a pulse parameter setting specific to the tip type and utilize such a pulse parameter setting, as described above.

[0222] Fig.17 Components that may be integrated into a tissue detection console 86 of a tissue detection system 13 are shown. The tissue detection console 86 may include a controller 302, an optical module 304, and a power supply 306. The power supply 306 may be configured to supply power to the other components of the tissue detection console 86 to enable them to operate. The functions of each of the other components will be discussed in more detail below.

[0223] The optical module 304 may include an optical block 308, a spectrometer 310, and one or more excitation sources 312. In response to receiving corresponding instructions from the tissue detection controller 302, the excitation source 312 may illuminate the tissue contacted by the operating end 22 of the tip 20 of the ultrasonic instrument 18 via the excitation optical fiber 94 with excitation light. For example, the excitation source 312 may be configured to emit blue light of about 405 nm or blue light in the range of 400 nm to 500 nm. The excitation source 312 may also be configured to emit excitation light corresponding to other wavelengths, such as wavelengths associated with the rest of the light in the visible spectrum except blue light (e.g., greater than 500 nm but less than 700 nm), wavelengths associated with the ultraviolet spectrum (less than 400 nm), and / or wavelengths associated with the infrared spectrum (greater than 700 nm). The excitation source 312 may also include various types of light sources, including, but not limited to, light emitting diodes (LEDs), pulsed lasers, continuous wave lasers, modulated lasers, and / or filtered white light sources.

[0224] The optical block 308 may include a plurality of optical paths for guiding light between the sampling element 88 and the components of the optical module 304. More specifically, the optical block 308 may include an optical path configured to guide light emitted from the excitation source 312 along the excitation optical fiber 94 and the indicator optical fiber 100, and may also include an optical path configured to guide the fluorescence collected by the excitation optical fiber 94 to the spectrometer 310. The spectrometer 310 may be configured to convert the collected optical signals into electrical signals. More specifically, the spectrometer 310 may be configured to photoelectrically convert each wavelength of the collected optical signal into an electrical signal (also referred to herein as a spectral signal), which may then be provided to the tissue detection controller 302 for analysis.

[0225] The tissue detection controller 302 can be configured to implement the functions, features, and processes of the tissue detection console 86 described herein. More specifically, similar to the ultrasonic controller 112, the tissue detection controller 302 may include a processor 314 and a memory 316, and may include and / or be communicatively coupled to a storage device 318 of the tissue detection console 86, each of which is configured similarly to the configuration described above in conjunction with the ultrasonic controller 112. Similarly, the processor 314 can operate under the control of a software program 317 embodied by computer executable instructions, which, when executed by the processor 314, causes the processor 314 to implement the functions, features, and processes of the tissue detection console 86 described herein. In this way, the tissue detection controller 302 (or more specifically, the processor 314) can be configured to periodically operate the optical module 304 to excite the tissue contacted by the operating end 22 of the tip 20 of the ultrasonic instrument 18, collect fluorescence emitted from the tissue due to the tissue being excited, and convert the collected fluorescence into a spectral signal for analysis.

[0226] The tissue detection controller 302 (or more specifically the processor 314) can also be configured to evaluate the electrical signal to determine the characteristics of the tissue. To this end, the storage device 318 may include tissue (map) data 320, which associates the characteristics of the spectral signal (e.g., frequency, intensity) with various tissue characteristics indicated by the spectral signal, such as the type of tissue (e.g., whether the contacted tissue is considered healthy or unhealthy tumor tissue, and / or whether the tissue corresponds to a blood vessel), which can indicate whether the contacted tissue is an ablation target or a non-target. Therefore, the tissue detection controller 302 (or more specifically the processor 314) can be configured to access the tissue map data 320 to determine the characteristics of the tissue contacted by the tip 20 of the ultrasonic instrument 18 based on the fluorescence collected by the sampling element 88.

[0227] In some examples, the tissue map data 320 may define a plurality of tissue maps associated with different anatomical structures (e.g., brain, spine), each of which associates a characteristic of the spectral signal with a tissue feature in the context of the associated anatomical structure. In this case, the tissue detection controller 302 (or more specifically the processor 314) may be configured to receive an indication of a given patient anatomical structure involved in a surgical procedure (e.g., via user input) and query the tissue map associated with the indicated patient anatomical structure to determine the tissue feature.

[0228] The tissue detection system 13 may include other features and functions, such as, but not limited to, the features and functions described in the applicant's international application PCT / IB2022 / 052294, filed on March 14, 2022, with international publication number WO 2022 / 190076Al, the contents of which are hereby incorporated herein by reference in their entirety.

[0229] like Figure 4 and 17 As shown, the ultrasound controller 112 and the tissue detection controller 302 can be communicatively coupled to each other. In this manner, at least one of the controllers 112, 302 can be configured to send its determined tissue features to the other controller 112, 302 to facilitate display and comparison of tissue features determined by the respective controllers 112, 302. These features are described in more detail with reference to the following methods.

[0230] As mentioned above, refer again Figure 1 , the surgical system 10 may also include a navigation system 14 and an imaging system 15. It will be appreciated from the subsequent description that, among other things, the surgical system 10 may be configured to allow a surgeon to observe, approach, and treat or otherwise manipulate the anatomical structure of a patient P at a target site TS with a high level of control. To this end, imaging data of the target site TS may be acquired by the imaging system 15, and the imaging data may be used to assist the surgeon in observing the anatomical structure of the patient P at or near the target site TS. The imaging data may also be used by the navigation system 14 to facilitate navigation of the ultrasonic instrument 18 relative to the target site TS and to further enhance the tissue detection features described herein.

[0231] exist Figure 1In the illustrative example of , a minimally invasive spinal surgical procedure, such as a posterior lumbar interbody fusion, is being performed on a patient P. It should be understood that this example is intended to be illustrative and that other types of surgical procedures are also contemplated. In this exemplary surgical procedure, an ultrasonic instrument 18 may be employed to ablate intervertebral disc tissue and cartilage endplate tissue. In other examples, the navigation system 14 may be configured to track the position and / or orientation of the ultrasonic instrument 18 when the ultrasonic instrument 18 is operated to cut through a bone (e.g., a skull) or when the ultrasonic instrument 18 is operated to ablate tumor tissue (e.g., tumor tissue in the brain). When the ultrasonic instrument 18 contacts tissue having different characteristics (e.g., non-target (e.g., healthy) tissue and / or target (e.g., tumor) tissue), the surgical system 10 may be configured to associate tissue features determined by the ultrasonic tool system 12 and / or tissue detection system 13 with the tracked position and / or orientation of the ultrasonic instrument 18 to provide the physician with enhanced guidance and additional data points for verifying the accuracy of tissue detection.

[0232] As described above, the imaging system 15 may be used to acquire image data of a patient P, which may be a human or animal patient. Figure 1 As shown in the representative configuration shown, the imaging system 15 can be implemented as an X-ray computed tomography (CT) imaging device. The patient P can be positioned within a central bore 506 of the imaging system 15, and the x-ray source and detector can be rotated around the central bore 506 to obtain raw x-ray imaging data of the patient P. The imaging controller 508 or another suitable controller can be used to process the imaging data to construct three-dimensional imaging data, two-dimensional imaging data, etc., which can be transmitted to the navigation system 14 or otherwise utilized by the navigation system 14.

[0233] Image data may be obtained preoperatively (e.g., before a surgical procedure is performed) and / or intraoperatively (e.g., during a surgical procedure) by positioning the patient P within the central aperture 506 of the imaging system 15. To obtain the imaging data, a portion of the imaging system 15 may be moved relative to a patient support 510 (e.g., an operating table) on which the patient P is positioned while the patient P remains stationary. Here, the patient support 510 may be secured to the imaging system 15, such as by a column 512 mounted to a base 514 of the imaging system 15. A portion of the imaging system 15 (e.g., an O-shaped imaging gantry 516) including at least one imaging component may be supported by an articulated support 518 that may translate along the length of the base 514 on a track 520 to perform an imaging scan of the patient P, and may translate away from the patient P to a remote location to perform a surgical procedure on the patient P.

[0234] An example imaging system 15 that can be used in various configurations is manufactured by Mobius Imaging, LLC. Intraoperative CT system. Examples of X-ray CT imaging devices that can be used in accordance with various configurations of the present disclosure are described in: U.S. Patent No. 10,151,810, entitled “Pivoting Multi-directional X-ray Imaging System with a Pair of Diametrically Opposite Vertical Support Columns Tandemly Movable Along a Stationary Base Support,” U.S. Patent No. 9,962,132, entitled “Multi-directional X-ray Imaging System with Single Support Column,” U.S. Patent No. 9,801,592, entitled “Caster System for Mobile Apparatus,” U.S. Patent No. 9,111,379, entitled “Method and System for X-ray CT Imaging,” U.S. Patent No. 8,118,488, entitled “Mobile Medical Imaging System and Methods,” and U.S. Patent Application Publication No. 2014 / 0275953, entitled “Mobile X-ray Imaging System,” the disclosures of each of which are hereby incorporated by reference in their entirety.

[0235] Although the imaging system 15 is shown as an X-ray CT imaging device, in other configurations, the imaging system 15 may include one or more of an X-ray fluoroscopic imaging device, a magnetic resonance (MR) imaging device, a positron emission tomography (PET) imaging device, a single photon emission computed tomography (SPECT), or an ultrasound imaging device. Other configurations are also contemplated. In some configurations, the imaging system 15 may be a mobile CT device that is not attached to the patient support 510 and may be rotated or otherwise moved over the patient P and the patient support 510 to perform a scan. Examples of mobile CT devices include the Samsung Electronics Co., Ltd. CT Scanners and Medtronic, plc Surgical imaging system. The imaging system 15 may also be a C-arm X-ray fluoroscopy device. In other configurations, the imaging system 15 may be a fixed bore imaging device into which the patient P may be moved, either on a patient support 510 or on a separate patient table configured to slide in and out of the central bore 506. Figure 1The imaging system 15 shown in FIG. 1 is disposed near the patient P in the operating room, but the imaging system 15 may also be disposed remotely, such as in another room or building (eg, in a hospital radiology department).

[0236] The surgical system 10 may employ a navigation system 14 to track the movement of various objects, such as an ultrasonic instrument 18 and (some) portions of the patient P anatomy (e.g., tissue within or near the target site TS), and (some) portions of the imaging system 15 in some configurations. To this end, the navigation system 14 may include a localizer 522 and a navigation controller 524 coupled to the localizer 522. The localizer 522 and the navigation controller 524 may be configured to cooperate to track the position and / or orientation of a tracker 526 disposed in the surgical workspace relative to the object of interest.

[0237] As shown in the example shown, the locator 522 can be an optical locator including a locator camera unit 527. The locator camera unit 527 can include a housing for one or more optical sensors 528 and a locator controller 529 ( Fig.18 ) housing. Each optical sensor 528 may be a separate charge coupled device (CCD) and may be configured to detect light signals of a particular wavelength or a particular frequency band, such as invisible light (e.g., infrared). For example, but not limitation, the optical sensor 528 may be composed of three one-dimensional CCDs, or may be composed of two two-dimensional CCDs. In alternative examples, the optical sensor 528 may be in the form of a CMOS or other suitable sensor.

[0238] Positioner controller 529 ( Fig.18 ) can be configured to operate the optical sensor 528 (e.g., in the direction of the navigation controller 524) and generate locator data based on the optical-based signal received from the optical sensor 528. The locator data can indicate the pixel location of the light signal detected by the optical sensor 528 from the tracker 526, and accordingly, can indicate the position and / or orientation of the tracker 526 in a known coordinate system (e.g., a locator coordinate system LCLZ specific to the locator 522). The locator controller 529 can be coupled and configured to send the locator data to the navigation controller 524 for object tracking, as described in more detail below. Alternatively, the optical sensor 528 and the navigation controller 524 can communicate directly.

[0239] The positioner 522 may be mounted on an adjustable arm to position the optical sensor 528 within the field of view of the tracker 526, ideally with no obstruction to the field of view. The positioner 522 may be adjustable in at least one degree of freedom by rotating about a revolute joint, and may be adjustable about two or more degrees of freedom.

[0240] Each tracker 526 can be attached to an object of interest in the surgical workspace. In general, the object to which each tracker 526 is attached can be rigid and inflexible, such that the object cannot or is unlikely to move or deform relative to the tracker 526 during the surgical procedure. In other words, the spatial relationship between each tracker 526 and the object to which the tracker 526 is attached can remain fixed during the surgical procedure, even though the object moves during the surgical procedure. In this way, in response to determining the position and / or orientation of the tracker 526 in the surgical workspace in a known coordinate system, the navigation controller 524 can infer the position of the object to which the tracker 526 is attached in the known coordinate system based on the determined position and / or orientation of the tracker 526 and the fixed spatial relationship between the tracker 526 and the object.

[0241] Objects tracked by the navigation system 14 (and to which the tracker 526 may therefore be attached) may include patient anatomy and instruments of interest (e.g., the ultrasound instrument 18 and the imaging system 15). Tracked anatomy may include hard tissues such as bone and soft tissues such as skin. Tracked surgical instruments may include retractors, cutting tools, and waste management equipment used in surgical procedures.

[0242] for Figure 1 , the tracker 526 may include a tool tracker 526A for tracking the position and / or orientation of the ultrasonic instrument 18 in a known coordinate system, a patient tracker 526B for tracking the position and / or orientation of the patient and target site TS in a known coordinate system, and an imaging system tracker 526C for tracking the position and / or orientation of at least a portion of the imaging system 15 in a known coordinate system. Additional trackers 526 are also contemplated, such as additional patient trackers and additional trackers for other medical and / or surgical tools.

[0243] The tool tracker 526A and the imaging system tracker 526C are generally depicted and mounted to the frame 516 of the ultrasonic instrument 18 and the imaging system 15, respectively. The patient tracker 526B can be securely attached to different parts of the patient P anatomy (e.g., opposite sides of the ilium) by a mounting assembly configured to releasably engage tissue (e.g., skin, bone). It will be appreciated that the tracker 526 can be securely attached to different types of tracked objects (e.g., discrete bones, tools, pointers, etc.) in a variety of different ways.

[0244] Before the surgical procedure begins, the navigation controller 524 can receive and store data indicating a virtual model of the anatomical structure of interest of the patient P, such as based on a preoperative image of the anatomical structure of interest, which can be generated by the imaging system 15. The preoperative image can be based on an MRI scan, a radiological scan, or a computed tomography (CT) scan of the patient's anatomical structure, and can be used to generate a virtual model of the anatomical structure of interest stored by the surgical navigation system 14. Each virtual model can include a three-dimensional model (e.g., a point cloud, a mesh, CAD) of at least a portion of the anatomical structure, and / or can include a three-dimensional model or other indicator of at least a portion of the anatomical structure (forming at least a portion of the target volume of patient tissue to be treated in the surgical procedure). In addition to or as an alternative to preoperative images, a treatment plan and a virtual model of the anatomical structure of interest can also be developed in the operating room through kinematic studies, skeletal tracking, and other methods. In addition, before the surgical procedure, the navigation controller 524 can receive and store virtual models of other tracked objects of interest in the surgical procedure, such as virtual models of surgical instruments (e.g., ultrasonic instruments 18) and trackers 526 used in the surgical procedure.

[0245] Each virtual model for an object received and stored by the navigation controller 524 may define a three-dimensional coordinate system specific to the object and may indicate coordinates in the three-dimensional coordinate system corresponding to the relative positions of features of the object. For example, the virtual model of a given tracker 526 may indicate coordinates in a three-dimensional coordinate system specific to the tracker 526 that correspond to the relative positions of markers of the tracker 526, as described in more detail below. As yet another example, the virtual model of a given surgical instrument may indicate coordinates in a three-dimensional coordinate system specific to the surgical instrument that correspond to the relative positions of features of a housing of the surgical instrument.

[0246] The navigation controller 524 may also receive and store data defining a fixed spatial relationship between the tracker 526 and the object to which the tracker 526 is attached, and a surgical plan. The spatial relationship may define the position and / or orientation of each tracker 526, or more specifically the position and / or orientation of a marker of each tracker 526 (relative to the object to which the tracker 526 is attached), such as by referencing a virtual model of the object and the tracker 526. For example, the spatial relationship of a given tracker 526 may indicate a position in a coordinate system specific to the object to which the tracker 526 is attached, and vice versa. The surgical plan may identify the patient's anatomical structures involved in the surgical procedure and the target volume of patient tissue to be treated in the surgical procedure, may identify the instruments to be used in the surgical procedure, and may identify the planned trajectories of the instruments and the planned movement of the patient's anatomical structures during the surgical procedure.

[0247] The spatial relationship between the patient tracker 526B and the anatomical structure of the patient P to which it is attached can be determined by known registration techniques, such as point-based registration, in which a calibration tool including a calibration tracker is used to contact points across the anatomical structure being registered. By monitoring the position and / or orientation of the calibration tracker relative to the position and / or orientation of the patient tracker 526B in a known coordinate system (e.g., the locator coordinate system LCLZ) when the calibration tool contacts the point of the anatomical structure, the navigation controller 524 can be configured to determine the position and / or orientation of the anatomical structure relative to the patient tracker 526B based on the known spatial relationship between the contact point of the calibration tool and the calibration tracker. In addition or as an alternative, the navigation controller 524 can be configured to determine the spatial relationship of the patient tracker 526B relative to the anatomical structure of the patient P based on imaging data generated by the imaging system 15, which imaging data can depict the position and / or orientation of the patient tracker 526B and the patient's anatomical structure in the same coordinate system (e.g., the coordinate system of the imaging system 15). Thus, the navigation controller 524 may be configured to determine the spatial relationship of the patient tracker 526B relative to the anatomy of the patient P based on this information of the imaging data.

[0248] During a surgical procedure, the optical sensor 528 of the localizer 522 can detect light signals, such as invisible light signals (e.g., infrared or ultraviolet), emitted from the tracker 526. In response to detecting these light signals, the optical sensor 528 can generate optical-based signals and send them to the localizer controller 529, which can be configured to generate positioning data based on the optical-based signals, the positioning data indicating the pixel location and the direction in which the corresponding optical sensor 528 received the detected light signal. The localizer controller 529 can be configured to send the positioning data to the navigation controller 524, which can then be configured to determine the tracker position and / or orientation data based on the positioning data. The navigation controller 524 can then be configured to determine the object position and / or orientation data based on the determined tracker position and / or orientation and the previously stored fixed spatial relationship between the tracker 526 and the object, which indicates the position and / or orientation of the object to which the tracker 526 is attached.

[0249] like Figure 1As shown in the illustrated example, the navigation controller 524 and the positioner 522 can be supported on a mobile cart 530 that can move relative to the base 514 of the imaging system 15. The mobile cart 530 can also support a user interface (generally indicated at 532) to facilitate the operation of the navigation system 14 by displaying information to a surgeon or another user and / or receiving information from a surgeon or another user. The user interface 532 can be configured to communicate with the navigation controller 524 and can include one or more output devices (e.g., monitors, indicators, display screens, speakers, etc.) to provide information to the surgeon. For example, as shown in the illustrated example, the output device of the user interface 532 can include, but is not limited to, a display 534 suitable for placement outside the sterile field including the surgical workspace, and can include a display 536 suitable for placement within the sterile field. The displays 534, 536 can be adjustably mounted to the mobile cart 530, and can each incorporate touch screen technology to receive user input from a surgeon or other user. Other input devices of the user interface 532 for receiving user input may include, but are not limited to, a keyboard, a mouse, and / or a microphone that enables user input through voice recognition technology.

[0250] In response to determining object position and / or orientation data indicating the position and / or orientation of the tracked object in the known coordinate system, the navigation controller 524 may be configured to display a virtual representation of the relative position and / or orientation of the tracked object to the surgeon or other user of the surgical system 10, such as using images and / or graphical representations of the anatomy of the patient P and the ultrasonic instrument 18 presented on the displays 534, 536. The navigation controller 524 may also be configured to display instructions or request information from the surgeon or other user of the surgical system 10 using the user interface 532.

[0251] Reference now Fig.18 , the trackers 526 attached to the objects in the surgical workspace can each include a known arrangement of markers 540 for emitting light signals detectable by the optical sensor 528. In one example, the trackers 526 can be electrically driven and thus can include an arrangement of electrically driven markers 540, each of which is configured to emit a light signal in response to receiving an electric current through it. As an example, the electrically driven markers 540 can be implemented as light emitting diodes (LEDs) that emit light detectable by the optical sensor 528, such as invisible light (e.g., infrared or ultraviolet light). These trackers 526 can be powered by an internal battery or can have leads to receive power through the navigation controller 524.

[0252] Each electrically driven tracker 526 may also include a tracker controller 542 connected to the electrically driven marker 540 of the tracker 526, which may be configured to control the rate and order in which the electrically driven marker 540 fires, for example, at the direction of the navigation controller 524. Thus, the navigation controller 524 may be in data communication (e.g., wirelessly or via a wired connection) with the tracker controller 542 to cause the electrically driven marker 540 of each tracker 526 to fire. The tracker controller 542 may cause the electrically driven marker 540 of each tracker 526 to fire at different rates and / or times to enable the navigation controller 524 to identify which marker 540 is firing at a given moment. In this way, the navigation controller 524 may associate a given detected light signal with the marker 540 that was firing when the light signal was detected. Alternatively, the tracker controller 542 may cause the markers 540 to fire consecutively and / or simultaneously. In this case, each tracker 526 may include a unique, known arrangement pattern of markers 540, and the navigation controller 524 may be configured to implement a marker assignment algorithm that may include matching light signals detected by different optical sensors 528 that correspond to the same marker 540, triangulating the positions of the markers 540 corresponding to each set of matched light signals, and comparing the triangulated positions to the known tracker marker arrangement pattern to determine which light signals correspond to which markers 540 of the tracker 526.

[0253] Instead of being electrically driven, one or more trackers 526 attached to an object in the surgical workspace may be non-electrically driven, and thus include passive markers 540, such as reflectors that reflect light emitted from a light source near the surgical workspace (e.g., light from the locator 522). The reflected light may then be received and detected by the optical sensor 528 and assigned to the marker 540 as described above.

[0254] The navigation system 14 (or more specifically the locator 522) may have other suitable components or structures not specifically described herein. In addition, any techniques, methods, and / or components described herein with respect to the camera-based navigation system 14 shown in the figures may be implemented or provided for any other configuration of the navigation system 14 described herein. For example, the navigation system 14 may also be based on one or more of inertial tracking, ultrasonic tracking, image-based optical tracking (e.g., using markers defined by patterns, shapes, edges, etc. that can be monitored with a camera), or any combination thereof.

[0255] The navigation controller 524 may be configured to implement the functions, features, and processes of the navigation system 14 described herein. More specifically, similar to the ultrasound controller 112 and the tissue detection controller 302, the navigation controller 524 may include a processor 544 and a memory 546, and may include and / or be communicatively coupled to a storage device 548, each of which may be configured similarly to those described above with respect to the ultrasound controller 112 and the tissue detection controller 302. For example, similarly the processor 544 may operate under the control of a software program 547 embodied by computer executable instructions, such as a positioning engine, a transformer, a navigator, a segmentation tool, and a tissue tracker, each of which will be described in more detail below. The storage device 548 may include data that facilitates the functions, features, and processes of the navigation controller 524 described herein, such as surgical planning data 550, virtual model data 552, and transformation data 554.

[0256] The positioning engine software, when executed, may be configured to receive positioning data from the locator controller 529, and determine tracker position and / or orientation data indicating the position and / or orientation of the tracker 526 in a known coordinate system based on the positioning data, for example by triangulating the position of the marker 540 of each tracker 526 in the known coordinate system based on the above positioning data. The transformer software, when executed, may be configured to determine object position and / or orientation data indicating the position and / or orientation of the object attached to the tracker 526 based on the tracker position and / or orientation data. For example, the stored transformation data 554 may indicate a fixed spatial position between the tracker 526 and the object attached to the tracker 526, which position may be extracted by the transformer and applied to the tracker position and / or orientation data to determine the object position and / or orientation data. The navigator software may be configured to provide navigation guidance based on the determined object position and / or orientation data, or more specifically based on the tracked position and / or orientation of the object attached to the tracker 526 in a known coordinate system. As an example, the navigator may be configured to access a virtual model of the object from virtual model data 552 and display and update a virtual boundary corresponding to the model on user interface 532 to correspond to the relative position of the object indicated by the object position and / or orientation data.

[0257] The segmentation tool software may be configured to generate one or more virtual boundaries in a known coordinate system and corresponding to the object of interest when executed, for example by applying a segmentation algorithm to the imaging data received from the imaging system 15. The segmentation algorithm may be configured to employ various techniques in machine vision to determine virtual boundaries associated with various objects and / or tissue types within the image represented by the image data. In some examples, the segmentation algorithm may be configured to receive as input the type of surgical procedure to be performed on the target site TS indicated in the medical image and the surgical planning data 550, apply one or more of edge detection, clustering, and other segmentation algorithms calibrated based on the type of surgical procedure to the medical image to identify the boundaries between various objects and tissue types within the image, and generate corresponding virtual boundaries within the image coordinate system specific to the imaging system 15. Additionally or alternatively, the user may be able to interact with the user interface 532 of the navigation system 14 (or the user interface 531 of the imaging system 15) to manually define such virtual boundaries within the image coordinate system and / or manipulate the virtual boundaries generated by the segmentation algorithm described above. The transformer can then be configured to determine the position and / or orientation of these virtual boundaries in a known coordinate system (e.g., locator coordinate system LCLZ) based on: tracker position and / or orientation data indicating the position of the imaging system tracker 526C in the known coordinate system, and transformation data 574 indicating a predefined spatial relationship between the imaging system tracker 526C and a coordinate system specific to the imaging system 15.

[0258] The tissue tracker software, when executed, may be configured to associate the tissue features determined by the ultrasonic tool system 12 and / or tissue detection system 13 with the position and / or orientation of the ultrasonic instrument 18 tracked relative to other tracked objects when determining the tissue features (or more specifically, the position of the operating end 22 of the tip 20 relative to other tracked objects). The tissue tracker software may also be configured to display at least one indicator corresponding to the tissue feature at the determined tracking position in a known coordinate system, and verify whether the determined tissue feature is consistent with the tissue contacted by the ultrasonic instrument 18 as indicated by the positioning data and / or medical image. For example, the surgical planning data 550 may indicate various tissue features associated with the generated virtual boundary, which features may be predetermined in advance, such as by a segmentation tool, and / or input by a surgeon or other user through the user interface 532. Thus, the tissue tracker software can be configured to determine one or more characteristics of the tissue contacted by the operating end 22 of the tip 20 indicated by the surgical planning data 550 based on the tracked position and / or orientation of the ultrasonic instrument 18 relative to the virtual boundary, and compare the determined tissue characteristics with the characteristics determined by the ultrasonic tool system 12 and / or the tissue detection system 13 to verify the consistency therebetween.

[0259] Fig.19 It shows that Figure 1 The processing architecture 560 implemented by the surgical system 10 of the present invention. As shown in the illustrated example, the processing architecture 560 may include a surgical control system 562, a user interface 563 communicatively coupled to the surgical control system 562, and one or more databases 572. The surgical control system 562 may also be operatively coupled to one or more of the ultrasonic instrument 18, the sampling element 88, the positioner 522, and the imaging system 15.

[0260] The surgical control system 562 may generally be configured to adjust the ultrasonic energy induced in the ultrasonic instrument 18 based on the type of tissue contacted by the operating end 22 of the ultrasonic tip 20, for example, to induce pulsed ultrasonic energy, and / or may be configured to verify the tissue detection and / or navigation routines described herein. Specifically, the surgical control system 562 may include one or more of the following or be implemented by one or more of the following: the ultrasonic controller 112 of the ultrasonic tool system 12, the navigation controller 524 of the surgical navigation system 14, the imaging controller 508 of the imaging system 15, and the tissue detection controller 302 of the tissue detection system 13. For example, one or more of the above controllers may each be configured to implement one or more of the functions of the surgical control system 562 described herein, such as when the corresponding software embodied by the computer executable instructions is executed by the controller. In other words, the surgical control system 562 may be distributed on two or more of the above controllers, so that a control system that cooperates with other components of the surgical system 10 to implement various functions, features, methods, and processes of the surgical system 10 described herein may be formed.

[0261] In some examples, the surgical control system 562 may include a software suite that includes a plurality of software programs or modules, each of which is executed on at least one of the above-mentioned controllers. For example, the surgical control system 562 may include an ultrasound module 564 that may be executed on at least the ultrasound controller 112 and / or the navigation controller 524, and when executed, may be configured to adjust the ultrasonic energy induced in the ultrasonic instrument 18, for example, based on the determined type of tissue contacted by the operating end 22 of the ultrasonic tip 20. The surgical control system 562 may also include a navigation module 566 that may be executed on at least the navigation controller 524, and when executed, may be configured to collect positioning data indicating the position and / or orientation of the operating end 22 of the ultrasonic tip 20, and generate tissue contact data based on the medical image of the patient, the tissue contact data indicating the type of tissue that the operating end 22 of the ultrasonic tip 20 is contacting. The surgical control system 562 may also include an imaging module 568 that may be executed by at least the imaging controller 508 and, when executed, may be configured to generate image data defining a medical image of the patient (or, more specifically, a medical image of a target site of the patient). The surgical control system 562 may also include a tissue detection module 570 that may be executed by at least the tissue detection controller 302 and, when executed, may be configured to determine the type of tissue contacted by the operating end 22 of the ultrasonic tip 20, as described in more detail below.

[0262] The one or more databases 572 of the processing architecture 560 can also be implemented by one or more of the console storage device 118 of the ultrasonic tool system 12, the storage device 318 of the tissue detection system 13, and the storage device 548 of the surgical navigation system 14. For example, one or more of the above storage devices can each store at least a portion of the one or more databases 572. In other words, the one or more databases 572 can be distributed in two or more of the above storage devices. The one or more databases 572 can store data used by the surgical control system 562, or more specifically, store data used by each module of the surgical control system 562 to facilitate the functions, features, processes, and methods of the surgical control system 562 described herein. For example, the one or more databases 572 can store one or more of the following: the pulse profile 140 and tissue type data 142 as described above with respect to the ultrasonic tool system 12, the tissue map data 320 as described above with respect to the tissue detection system 13, and the surgical plan data 550, the virtual model data 552, and the transformation data 554 as described above with respect to the navigation system 14.

[0263] The user interface 563 can facilitate the user's interaction with the surgical control system 562. More specifically, the user interface 563 may include one or more output components, such as a display, for presenting information from the surgical control system 562 to the user, and may include one or more input devices, such as a touch screen, for receiving input from the user for the surgical control system 562. For example, the user interface 563 may include one or more of the following: the foot pedal 76, the remote control 80, and the display 74 of the ultrasonic tool system 12, the user interface 532 of the surgical navigation system 14, the user interface 531 of the imaging system 15, and the display 104 of the tissue detection system 13. In other words, the user interface 563 may be distributed in two or more of the above systems.

[0264] Fig. 20 A method 600 is shown for operating the ultrasonic tool system 12 (or more specifically the ultrasonic instrument 18) based on image data generated by the imaging system 15 and positioning data generated by the positioner 522. The method 600 may be implemented by the surgical control system 562, or more specifically, by the navigation controller 524 and / or the ultrasonic controller 112.

[0265] In block 602, a medical image of a patient target site may be received, for example, by the surgical control system 562. For example, the navigation controller 524 may receive image data from the imaging system 15, the image data defining an image of the patient including the target site. According to the surgical plan, the target site may generally include an ablation target tissue region (e.g., a tumor tissue region) and may include a non-ablation target tissue region (e.g., healthy tissue surrounding the tumor tissue).

[0266] In block 603, based on the medical image, one or more virtual boundaries and / or virtual regions associated with the ablation target tissue region may be generated in a known coordinate system (e.g., the localizer coordinate system LCLZ), for example, by the surgical control system 562. As described in more detail below, the surgical control system 562 (or more specifically, the navigation controller 524, for example) may be configured to track the posture of the ultrasonic instrument 18 relative to the virtual boundaries and / or regions in the known coordinate system, and adjust the ultrasonic energy induced in the ultrasonic instrument 18 based thereon.

[0267] For example, the surgical control system 562 (or more specifically the navigation controller 524) can be configured to generate an outer edge virtual boundary corresponding to the boundary or edge of the ablation target tissue, so that the virtual boundary is located between or separates the ablation target tissue area (also referred to as "target tissue" herein) and the non-ablation target tissue area (also referred to as "non-target tissue" herein). In addition to the outer edge virtual boundary, the surgical control system 562 can be configured to generate one or more internal virtual boundaries within the target tissue area, for example at one or more threshold distances from the outer edge virtual boundary. The surgical control system 562 can also be configured to generate one or more virtual areas corresponding to the areas or volumes defined between and / or adjacent to each virtual boundary. As a non-limiting example, each virtual boundary and / or area can be implemented by a line, plane, or surface mesh generated in a known coordinate system (e.g., the locator coordinate system LCLZ).

[0268] In some embodiments, the surgical control system 562 (or more specifically, the navigation controller 524) can be configured to generate the one or more virtual boundaries and / or regions by applying a segmentation algorithm to the received medical image, which can be configured to use various techniques in machine vision to determine the virtual boundaries and / or regions of various tissue types within the image. In some examples, the segmentation algorithm can be configured to receive the type of surgical procedure to be performed on the target site indicated in the medical image and the surgical planning data 550 as input, apply one or more of edge detection, clustering, and other segmentation algorithms calibrated based on the surgical procedure type to the medical image to identify the boundaries and / or regions between various tissue types within the image, and generate corresponding virtual boundaries and / or regions within the image coordinate system associated with the medical image (e.g., a coordinate system specific to the imaging system 15). Segmentation algorithms specific to different surgical procedure types can be generated by an artificial intelligence process. Additionally or alternatively, a user may be able to interact with a user interface 556 connected to the surgical system manager 562, or more specifically with a user interface 532 of the navigation system 14, to manually define virtual boundaries and / or regions within the image coordinate system, and / or manipulate virtual boundaries and / or regions generated by the above-described segmentation algorithm.

[0269] Then, the surgical control system 562 (or more specifically the navigation controller 524 as an example) can be configured to transform the virtual boundary and / or region defined in the image coordinate system associated with the image data to another known coordinate system, such as the localizer coordinate system LCLZ, so as to be able to track the posture of the ultrasonic instrument 18 relative to the boundary and / or region. For example, the navigation controller 524 can be configured to determine the posture of the imaging system tracker 526C in the localizer coordinate system LCLZ. Thereafter, based on the previously stored transformation data 554 indicating the known spatial relationship between the image coordinate system and the coordinate system of the imaging system tracker 526C, the navigation controller 524 can be configured to transform the virtual boundary and / or region from the image coordinate system to the localizer coordinate system LCLZ.

[0270] In block 604, at least one ultrasonic energy profile (e.g., a pulse profile 140 or a constant energy profile 148) may be assigned to each virtual boundary and / or region. For example, the surgical control system 562 (or more specifically, the navigation controller 524) may be configured to assign a pulse profile 140 to each virtual boundary and / or region, such that when the operating end 22 of the ultrasonic tip 20 reaches or crosses the virtual boundary and / or enters the region (as indicated by the positioning data generated by the positioner 522), the AC drive signal supplied to the ultrasonic instrument 18 may be set to induce pulsed ultrasonic energy according to the pulse profile 140 assigned to the virtual boundary and / or region. In this way, when the ultrasonic instrument 18 approaches various tissues (e.g., sensitive or non-target tissues near the target site TS), the ultrasonic instrument 18 can provide different levels of tissue selectivity and / or tactile feedback. In some examples, the ultrasound controller 112 may be configured to determine the available pulse profiles 140 from the console storage device 118 or the tip memory 174 as described above, and send such pulse profiles 140 to the navigation controller 524 for assignment. Other arrangements are also contemplated in which the ultrasound controller 112 is configured to assign pulse profiles 140 to virtual boundaries and / or regions.

[0271] In some embodiments, the surgical control system 562 may be configured such that when the operating end 22 of the ultrasonic tip 20 reaches or crosses a virtual boundary in one direction (e.g., the direction in which the ultrasonic instrument 18 initially reaches or crosses the virtual boundary), the AC drive signal supplied to the ultrasonic instrument 18 may be set to induce pulsed ultrasonic energy according to the pulse profile 140 assigned to the virtual boundary. Conversely, when the operating end 22 of the ultrasonic instrument 18 reaches or crosses the virtual boundary in the opposite direction, the AC drive signal supplied to the ultrasonic instrument 18 may be set to induce such ultrasonic energy, which is the ultrasonic energy induced in the ultrasonic instrument 18 before the initial contact with the virtual boundary. Alternatively, the surgical control system 562 may be configured to assign multiple ultrasonic energy profiles to each virtual boundary relative to the direction of travel, such that when the ultrasonic instrument 18 reaches or crosses the virtual boundary in one direction, the AC drive signal supplied to the ultrasonic instrument 18 may be set to induce ultrasonic energy according to one assigned ultrasonic energy profile (e.g., the pulse profile 140), and when the ultrasonic instrument 18 reaches or crosses the virtual boundary in the opposite direction, the AC drive signal supplied to the ultrasonic instrument 18 may be set to induce ultrasonic energy according to another assigned ultrasonic energy profile (e.g., the pulse profile 140).

[0272] In some examples, the surgical control system 562 (or more specifically the navigation controller 524) can be configured to autonomously assign pulse profiles 140 to virtual boundaries and / or regions, such as the surgical procedure indicated by the surgical planning data 550 and / or the tissue type identified in the medical image by the segmentation algorithm. For virtual regions identified by the segmentation algorithm as containing soft tissue, the surgical control system 562 can be configured to limit the above-mentioned assigned pulse profile 140 to the soft tissue pulse profile 144 associated with the soft tissue ablation u of the ultrasonic tool system 12, and for virtual regions identified by the segmentation algorithm as containing hard tissue, the surgical control system 562 can be configured to limit the above-mentioned assigned pulse profile 140 to the hard tissue pulse profile 146 associated with the hard tissue ablation mode of the ultrasonic tool system 12. Similarly, for virtual boundaries identified by the segmentation algorithm as being within or adjacent to soft tissue, the surgical control system 562 may be configured to limit the above-mentioned assigned pulse profile 140 to a soft tissue pulse profile 144 associated with the soft tissue ablation mode of the ultrasonic tool system 12, and for virtual boundaries identified by the segmentation algorithm as being within or adjacent to hard tissue, the surgical control system 562 may be configured to limit the above-mentioned assigned pulse profile 140 to a hard tissue pulse profile 146 associated with the hard tissue ablation mode of the ultrasonic tool system 12.

[0273] For a virtual boundary identified by the segmentation algorithm as being adjacent to both soft tissue and hard tissue (e.g., representing a boundary between two types of tissue), the surgical control system 562 may be configured to limit the assigned pulse profile 140 based on the surgical planning data 550, or more specifically, based on the planned trajectory of the ultrasonic instrument 18. For example, if the surgical planning data 550 indicates that the operating end 22 of the ultrasonic tip 20 should first reach or cross the virtual boundary in a direction toward the soft tissue side of the boundary, the surgical control system 562 may be configured to limit the assigned pulse profile 140 to a soft tissue pulse profile 144 associated with the soft tissue ablation mode of the ultrasonic tool system 12. Conversely, if the surgical planning data 550 indicates that the operating end 22 of the ultrasonic tip 20 should first reach or cross the virtual boundary in a direction toward the hard tissue side of the boundary, the surgical control system 562 may be configured to limit the assigned pulse profile 140 to a hard tissue pulse profile 146 associated with the hard tissue ablation mode of the ultrasonic tool system 12. In contrast, if multiple pulse profiles 140 can be assigned to each virtual boundary relative to the direction of travel, the surgical control system 562 can be configured to limit the assigned pulse profile 140 to a hard tissue pulse profile 146 associated with the hard tissue ablation mode of the ultrasonic tool system 12 relative to the direction toward the hard tissue side of the virtual boundary, and can be configured to limit the assigned pulse profile 140 to a soft tissue pulse profile 144 associated with the soft tissue ablation mode of the ultrasonic tool system 12 relative to the direction toward the soft tissue side of the virtual boundary.

[0274] Additionally or alternatively, for virtual boundaries and / or regions that are positioned at or outside the edge of the target tissue region according to the surgical plan, the surgical control system 562 (or more specifically, the navigation controller 524, for example) can be configured to assign a pulse profile 140 that provides a relatively high level of tissue selectivity and / or tactile feedback (e.g., pulse control level 4 or 5), so that the AC drive signal can be set to sense ultrasonic energy according to such pulse profile 140 when the operating end 22 of the ultrasonic tip 20 reaches or crosses these virtual boundaries and / or enters these virtual regions from the target tissue region. Conversely, for virtual boundaries and / or regions that are positioned within the target tissue region according to the surgical planning data 550, the surgical control system 562 can be configured to assign an ultrasonic energy profile that provides a relatively low level of tissue selectivity and / or tactile feedback (e.g., pulse control level 3 or lower), so that the AC drive signal can be set to sense ultrasonic energy according to such assigned ultrasonic energy profile when the ultrasonic instrument 18 crosses the inner virtual boundary toward the edge of the target tissue region and / or enters the inner virtual region. In this way, as the operating end 22 moves from within the region to closer to the edge of the target tissue region, the surgical control system 562 (or more specifically the ultrasonic controller 112, for example) can be configured to induce pulsed ultrasonic energy in the ultrasonic instrument 18, which provides the surgeon with increased tissue selectivity and / or tactile feedback, thereby reducing ablation of adjacent non-target tissue areas and / or causing the surgeon to be extra cautious when ablating tissue in the region.

[0275] In some examples, multiple virtual boundaries / regions may be defined within the target tissue region. In this case, the surgical control system 562 (or more specifically the navigation controller 524) may be configured to provide a pulse profile 140 that provides increased tissue selectivity and / or tactile feedback for virtual boundary and / or region assignments as the distance between the virtual boundary / region and the edge of the target tissue region decreases.

[0276] Additionally or alternatively, the surgical control system 562 (or more specifically the navigation controller 524 as an example) can be configured to allow a user to manually assign pulse profiles 140 to various virtual boundaries and / or regions, and / or adjust the assigned pulse profiles 140 set by the surgical control system 562 as described above, for example, through the user interface 563 or more specifically through the user interface 532 of the navigation system 14. The surgical control system 562 (or more specifically the navigation controller 524 as an example) can also be configured to limit the pulse profiles 140 that the user can select for a given boundary and / or region, for example, based on the position of the virtual boundary and / or region relative to hard tissue and soft tissue. For example, if a given boundary and / or region is located within a soft tissue region, the surgical control system 562 can be configured to limit the selectable pulse profiles 140 to pulse profiles corresponding to soft tissue patterns, and if a given boundary and / or region is located within a hard tissue region, the surgical control system 562 can be configured to limit the selectable pulse profiles 140 to pulse profiles corresponding to hard tissue patterns. Additionally or alternatively, if the surgical plan indicates that the surgical procedure is limited to ablating soft tissue or hard tissue, the surgical control system 562 can be configured to limit the selectable pulse profiles 140 to pulse profiles corresponding to soft tissue mode or hard tissue mode as described above.

[0277] In block 606, it may be determined whether to activate the ultrasonic instrument 18, such as by the surgical control system 562. For example, the user may interact with the user interface 563, or more specifically, with the foot pedal 76 of the ultrasonic tool system 12, to provide a command to the surgical control system 562, or more specifically, to the ultrasonic controller 112, to activate the ultrasonic instrument 18. In response to determining that the ultrasonic instrument 18 is to be activated (the "yes" branch of block 606), in block 608, ultrasonic energy may be induced in the ultrasonic instrument 18. More specifically, the surgical control system 562 (or more specifically, the ultrasonic controller 112) may be configured to induce a base ultrasonic energy in the ultrasonic instrument 18. The base ultrasonic energy may be set by the physician, such as by the display 74 of the console 16. In some embodiments, the base ultrasonic energy may correspond to the maximum resection rate desired by the physician for the ultrasonic instrument 18 (e.g., a constant energy profile 148, a pulse profile 140 associated with a relatively low pulse control level).

[0278] In block 610, the pose of the ultrasonic instrument 18 in a known coordinate system may be tracked, for example, based on the positioning data generated by the localizer 522. More specifically, the surgical control system 562 (or more specifically, the navigation controller 524) may be configured to track the pose of the operating end 22 of the ultrasonic tip 20 of the ultrasonic instrument 18 relative to a virtual boundary and / or region in a known coordinate system (e.g., the localizer coordinate system LCLZ).

[0279] In block 612, ultrasonic energy (e.g., pulsed ultrasonic energy) may be induced in the ultrasonic instrument 18 based on the tracked pose of the ultrasonic instrument 18 and the virtual boundaries and / or regions. More specifically, based on the tracked pose of the ultrasonic instrument 18 relative to the virtual boundaries and / or regions, the surgical control system 562 may be configured to set an AC drive signal generated by the power supply of the ultrasonic tool system 12 to induce pulsed ultrasonic energy in the tip 20 of the ultrasonic instrument 18, for example, according to the pulse profile 140 assigned to the virtual boundaries and / or regions. For example, based on the tracked pose of the ultrasonic instrument 18 relative to the virtual boundaries and / or regions, the navigation controller 524 may be configured to determine the assigned pulse profile 140 to be induced in the ultrasonic instrument 18 and send a corresponding message to the ultrasonic controller 112, which may be configured to responsively set an AC drive signal generated by the power supply of the ultrasonic tool system 12 to induce pulsed ultrasonic energy in the tip 20 of the ultrasonic instrument 18 according to the pulse profile 140.

[0280] In one example, a virtual boundary corresponding to the outer edge of the target tissue area can be generated. Based on the posture of the ultrasonic instrument 18 tracked in a known coordinate system relative to the virtual boundary, the surgical control system 562 (or more specifically, the navigation controller 524) can be configured to determine whether the operating end 22 of the tip 20 has reached or crossed the outer edge virtual boundary of the target tissue area. If so, the surgical control system 562 can be configured to set the AC drive signal generated by the power supply of the ultrasonic tool system 12 to induce pulsed ultrasonic energy in the tip 20, for example, according to the pulse profile 140 assigned to the outer edge virtual boundary. For example, the navigation controller 524 can be configured to send a message indicating the assigned pulse profile 140 to the ultrasonic controller 112, and the ultrasonic controller 112 can be configured to responsively set the AC drive signal generated by the power supply of the ultrasonic tool system 12 to induce pulsed ultrasonic energy in the tip 20 according to the pulse profile 140. Conversely, in response to determining that the operative end 22 of the tip 20 is located within the target tissue region, the surgical control system 562 may be configured to set the AC drive signal generated by the power supply of the ultrasonic tool system 12 to induce alternative ultrasonic energy (e.g., basal ultrasonic energy) in the tip 20, such as continuous ultrasonic energy according to a constant energy profile 148 or another, generally lower level pulse profile 140 (e.g., that the surgeon has previously selected via the display 74 of the console 16). In some examples, the induced basal ultrasonic energy may provide less tissue selectivity and / or tactile feedback than any other allocated ultrasonic energy profile, so as to provide a higher resection rate than the other allocated ultrasonic energy profiles.

[0281] As described above, in some examples, at least one virtual boundary may be generated within the target tissue region, wherein the virtual boundary is assigned a different pulse profile 140 and is spaced apart from the outer edge virtual boundary by a threshold distance. Based on the tracked posture of the ultrasonic instrument 18 relative to these virtual boundaries (including the outer edge virtual boundary), the surgical control system 562 may be configured to induce different levels of pulsed ultrasonic energy in the tip 20. For example, based on the tracked posture of the ultrasonic instrument 18 relative to the virtual boundary in a known coordinate system, the surgical control system 562 may be configured to determine whether the operating end 22 of the tip 20 has reached or crossed the outer edge virtual boundary of the target tissue region. If so, the surgical control system 562 may be configured to set an AC drive signal generated by the power supply of the ultrasonic tool system 12 to induce pulsed ultrasonic energy in the tip 20, such as pulsed ultrasonic energy corresponding to the pulse profile 140 assigned to the outer edge virtual boundary, which may be configured to provide a relatively high level of tissue selectivity and / or tactile feedback. For example, the navigation controller 524 may be configured to send a message indicating the assigned pulse profile 140 to the ultrasonic controller 112, and the ultrasonic controller 112 may be configured to set an AC drive signal generated by a power supply of the ultrasonic tool system 12 to induce pulsed ultrasonic energy in the tip 20 according to the indicated pulse profile 140.

[0282] In addition, based on the posture of the ultrasonic instrument 18 tracked in the known coordinate system relative to the virtual boundary, the surgical control system 562 (or more specifically, the navigation controller 524) can be configured to determine whether the operating end 22 of the tip 20 is located in the target tissue area and the distance between the operating end 22 of the tip 20 and the outer edge virtual boundary is less than a threshold distance, which can correspond to the virtual boundary in the target tissue area. In other words, the surgical control system 562 can be configured to determine whether the operating end 22 of the tip 20 is located between the outer edge virtual boundary and the virtual boundary inside the target tissue area. If so, the surgical control system 562 can be configured to set the AC drive signal generated by the power supply to induce other pulsed ultrasonic energy in the tip, for example, according to the pulse profile 140 assigned to the inner virtual boundary, which can be a lower level pulse profile 140 relative to the pulse profile 140 assigned to the outer edge virtual boundary, and thus provide less tissue selectivity and / or tactile feedback.

[0283] In some cases, based on the posture of the ultrasonic instrument 18 tracked in a known coordinate system relative to the outer edge virtual boundary, in response to determining that the operative end 22 of the tip 20 is located within the target tissue area and the distance between the operative end 22 of the tip 20 and the outer edge virtual boundary is greater than a threshold distance associated with the inner virtual boundary, the surgical control system 562 may be configured to set an AC drive signal generated by a power supply of the ultrasonic tool system 12 to induce a basic ultrasonic energy in the tip, which may have been pre-defined by the surgeon via the console 16 as described above.

[0284] As described above, in some cases, multiple internal virtual boundaries can be generated, each having a different threshold distance from the outer edge virtual boundary. For example, but not limiting, the internal virtual boundary can include a first internal virtual boundary at a first threshold distance from the outer edge virtual boundary, and a second internal virtual boundary at a second threshold distance from the outer edge virtual boundary, the second threshold distance being greater than the first threshold distance. In this case, based on the posture of the ultrasonic instrument 18 tracked in the known coordinate system relative to the virtual boundary, the surgical control system 562 can also be configured to determine whether the operating end 22 of the tip 20 is located in the target tissue area and the distance between the operating end 22 of the tip 20 and the outer edge virtual boundary is greater than the first threshold distance and less than the second threshold distance, corresponding to the operating end 22 of the tip 20 being located between the first internal virtual boundary and the second internal virtual boundary. If so, the surgical control system 562 can be configured to set the AC drive signal generated by the power supply to induce pulsed ultrasonic energy in the tip 20 according to the pulse profile 140 assigned to the second internal virtual boundary. The pulsed ultrasonic energy may differ from the pulsed ultrasonic energy sensed when the operative end 22 of the tip 20 is between the first inner virtual boundary and the outer edge virtual boundary, such as by providing a pulse profile 140 that is less tissue selectivity and / or tactile feedback (e.g., a lower level of pulse control).

[0285] Conversely, based on the posture of the ultrasonic instrument 18 tracked in a known coordinate system relative to the outer edge virtual boundary, in response to determining that the operating end 22 of the tip 20 is located within the target tissue area and the distance between the operating end 22 of the tip 20 and the outer edge virtual boundary is greater than a second threshold distance associated with a second inner virtual boundary, the surgical control system 562 may be configured to set an AC drive signal generated by a power supply of the ultrasonic tool system 12 to induce basic ultrasonic energy in the tip 20.

[0286] In block 614, it may be determined whether the ultrasonic instrument 18 is deactivated. For example, the surgeon may interact with the user interface 556 to instruct the surgical control system 562 to deactivate the ultrasonic instrument 18, for example by switching the foot pedal 76 to an inactive position. In response to determining that the ultrasonic instrument 18 is not deactivated (the "No" branch of block 614), the method 600 may return to block 610 to continue tracking the pose of the ultrasonic instrument 18 in a known coordinate system and sensing ultrasonic energy in the ultrasonic instrument 18 accordingly. In response to determining that the ultrasonic instrument 18 is deactivated (the "Yes" branch of block 614), in block 616, the ultrasonic instrument 18 may be deactivated. For example, the surgical control system 562 (or more specifically, the ultrasonic controller 112, for example) may be configured to stop supplying an AC drive signal to the ultrasonic instrument 18. Then, the method 600 may return to block 606 to monitor the reactivation of the ultrasonic instrument 18, as described above.

[0287] Fig.21 A virtual boundary is shown that may be generated for a surgical procedure involving removal of a tumor tissue region 650 from adjacent healthy brain tissue 652. As indicated in the preloaded surgical planning data 550, the procedure may include at least two portions, namely, a hard tissue cutting portion in which the ultrasonic instrument 18 is used to cut through the patient's skull 654, and a soft tissue ablation portion in which the ultrasonic instrument 18 is used to ablate tissue of the tumor tissue region 650. During the hard tissue cutting portion, the surgeon may utilize the hard tissue cutting tip 20 in order to cut through the skull 654 while minimizing the cutting of healthy brain tissue 652. During the soft tissue ablation portion, the surgeon may utilize the soft tissue cutting tip 20 in order to remove tissue from the tumor tissue region 650 and minimize the ablation of healthy brain tissue 652 adjacent to the tumor tissue region 650.

[0288] Compared with the hard tissue cutting part, Fig.21 A defined outer edge virtual boundary 656 is shown corresponding to the inner wall of the skull 654 and to the end of the planned ablation / cutting path of the ultrasonic instrument 18 through the skull 654. Fig.21 Also shown is an inner virtual boundary 658, which can be defined as a threshold distance from the outer edge virtual boundary 656. A virtual region 660 can be defined between the inner virtual boundary 658 and the outer edge virtual boundary 656, and another virtual region 662 can be defined between the start of the planned ablation / cutting path of the ultrasonic instrument 18 through the skull 654 and the inner virtual boundary 658. Each of the virtual boundaries 658, 656 can be associated with a different ultrasonic energy profile, and / or each of the regions 660, 662 can be associated with a different ultrasonic energy profile, so that when the operating end 22 of the tip 20 approaches the end of the planned trajectory through the skull 654, the ultrasonic instrument 18 provides increased tactile feedback.

[0289] In response to receiving an indication to activate the ultrasonic instrument 18 (e.g., by the surgeon actuating the foot pedal 76), the surgical control system 562 may be configured to verify that the tip 20 attached to the hand piece 24 is a bone cutting tip, for example, based on the data stored in the tip memory 174 as described above. For example, the ultrasonic controller 112 may be configured to read data indicating the type of tip 20 from the tip memory 174 and send a message indicating the type of tip 20 to the navigation controller 524, which may then be configured to determine whether a suitable tip 20 is attached based on the surgical planning data 550. If not, the surgical control system 562 may indicate an error (e.g., on the user interface 556) and may prevent the ultrasonic instrument 18 from operating. In response to determining that the bone cutting tip 20 is attached to the hand piece 24, the surgical control system 562 may be configured to set the AC drive signal supplied to the ultrasonic instrument 18 to induce ultrasonic energy (e.g., basal ultrasonic energy) in the tip 20. For example, the navigation controller 524 may be configured to send a signal to the ultrasonic controller 112 to allow activation of the ultrasonic instrument 18. As previously described, the base ultrasonic energy can be continuous ultrasonic energy according to the constant energy profile 148, or pulsed ultrasonic energy according to a hard tissue pulse profile 146 that provides relatively low tactile feedback (e.g., relatively low pulse control levels) previously selected by the surgeon. The surgical control system 562 can be configured to maintain induction of such ultrasonic energy in the ultrasonic instrument 18 when the operating end 22 of the tip 20 is located in the region 662.

[0290] Based on the posture of the ultrasonic instrument 18 tracked in the known coordinate system, the surgical control system 562 (or more specifically the navigation controller 524, for example) can be configured to determine whether the operating end 22 of the tip 20 has reached or crossed the inner virtual boundary 658 and entered the virtual area 660. In other words, the surgical control system 562 can be configured to determine whether the distance between the outer edge virtual boundary 656 and the operating end 22 of the tip 20 is less than or equal to the threshold distance associated with the inner virtual boundary 658. If so, the surgical control system 562 can be configured to set the AC drive signal to induce pulsed ultrasonic energy in the tip 20 of the ultrasonic instrument 18, for example, according to the relatively high level of hard tissue pulse profile 146 (e.g., pulse control level 4) associated with the inner virtual boundary 658 and / or the area 660. As a result of inducing such pulsed ultrasonic energy in the tip 20 of the ultrasonic instrument 18, the ultrasonic instrument 18 can begin to provide tactile feedback with increasing amplitude to alert the surgeon that the operating end 22 of the tip 20 is approaching the inner wall of the skull 654. The surgeon can then reduce the force he or she applies to the ultrasonic instrument 18 and / or the speed at which the ultrasonic instrument 18 moves through the bone based on this increased tactile feedback, which can help the surgeon maintain control as the ultrasonic instrument 18 breaks through the inner wall of the skull 654 and reduce ablation of healthy adjacent tissue.

[0291] Thereafter, based on the pose of the ultrasonic instrument 18 tracked in the known coordinate system, the surgical control system 562 may be configured to determine whether the operating end 22 of the tip 20 has reached or crossed the outer edge virtual boundary 656, indicating that the operating end 22 of the tip 20 has broken through the inner wall of the skull 654. If so, the surgical control system 562 may be configured to set the AC drive signal to induce pulsed ultrasonic energy in the tip 20 of the ultrasonic instrument 18 according to a further higher level of hard tissue pulse profile 146 (e.g., pulse control level 5) associated with the outer edge virtual boundary 656, so as to increase the level of tactile feedback felt by the surgeon to indicate that the operating end 22 of the tip has broken through. Alternatively, the surgical control system 562 may be configured to deactivate the ultrasonic instrument 18. The surgeon may then proceed to manually override the deactivation, such as by moving the ultrasonic instrument 18 backward from its current position, in which case the surgical control system 562 may operate the ultrasonic instrument 18 based on the posture of the operating end 22 of the tip 20 tracked as described above, or, for example, by returning the foot pedal 76 to its inactive position and then moving it back to the active position, in which case the navigation controller 524 may enable the ultrasonic instrument 18 to operate according to the base ultrasonic energy, the hard tissue pulse profile 146 assigned to the inner virtual boundary 658 and / or region 660, or another hard tissue pulse profile 146 selected by the user.

[0292] After completing the bone cutting portion of the procedure, the surgeon may exchange the bone cutting tip 20 for the soft tissue cutting tip 20 and may then indicate that the soft tissue cutting portion is about to begin, such as by depressing the foot pedal 76 and / or interacting with the user interface 532 of the navigation system 14. With respect to the soft tissue ablation portion of the procedure, Fig.21 An outer edge virtual boundary 664 defined as corresponding to the outer boundary of the tumor tissue region 650 and an inner virtual boundary 666 defined as corresponding to a threshold distance from the outer edge virtual boundary 664 are illustrated. A virtual region 668 may be defined between the inner virtual boundary 666 and the outer edge virtual boundary 664, and another virtual region 670 may be defined between the inner virtual boundary 666 and the entry point of the planned ablation / cutting path of the ultrasonic instrument 18 into the tumor tissue region 650. Each of the virtual boundaries 666, 664 may be associated with a different ultrasonic energy profile (e.g., a different soft tissue pulse profile 144), and / or each of the regions 668, 670 may be associated with a different ultrasonic energy profile (e.g., a different soft tissue pulse profile 144), such that when the operating end 22 of the tip 20 is moved closer to the boundary between the tumor tissue region 650 and the adjacent healthy brain tissue 652, the ultrasonic instrument 18 provides increased tactile feedback and / or tissue selectivity.

[0293] In response to receiving an indication to activate the ultrasonic instrument 18 as described above, the surgical control system 562 can be configured to verify that the tip 20 attached to the handpiece 24 is a tissue ablation tip, for example based on data stored in the tip memory as described above. If not, the surgical control system 562 can be configured to indicate an error (e.g., on the user interface 556) and prevent the ultrasonic instrument 18 from operating. In response to determining that the soft tissue ablation tip 20 is attached to the handpiece 24, the surgical control system 562 can be configured to set the AC drive signal to induce a base ultrasonic energy in the tip 20, such as continuous ultrasonic energy according to a constant energy profile 148 or a relatively low level soft tissue pulse profile 144 previously selected by the user. The surgical control system 562 can be configured to maintain the induction of such base ablation ultrasonic energy when the operating end 22 of the tip 20 is located in the region 670.

[0294] Based on the posture of the ultrasonic instrument 18 tracked in the known coordinate system, the surgical control system 562 (or more specifically, the navigation controller 524, for example) can be configured to determine whether the operating end 22 of the tip 20 has reached or crossed the inner virtual boundary 666 and entered the area 668. In other words, the surgical control system 562 can be configured to determine whether the distance between the outer edge virtual boundary 664 and the operating end 22 of the tip 20 is less than or equal to the threshold distance associated with the inner virtual boundary 666. If so, the surgical control system 562 can be configured to set the AC drive signal to induce pulsed ultrasonic energy in the tip 20 of the ultrasonic instrument 18, for example, according to the relatively high level of soft tissue pulse profile 144 (e.g., pulse control level 3, 4) associated with the inner virtual boundary 666 and / or the area 668. For example, the navigation controller 524 can be configured to send a corresponding signal indicating the soft tissue pulse profile 144 to the ultrasonic controller 112, and the ultrasonic controller 112 can be configured to responsively set the AC drive signal accordingly. By inducing this pulsed ultrasonic energy in the tip 20 of the ultrasonic instrument 18, the ultrasonic instrument 18 can provide increased tissue selectivity and / or increased tactile feedback to alert the surgeon that the operating end 22 of the tip 20 is approaching the outer wall of the tumor tissue region 650. The surgeon can then be prompted by the increased amplitude tactile feedback and / or increased tissue selectivity to proceed with caution, such as by reducing the force he or she applies to the ultrasonic instrument 18 and / or the speed at which the ultrasonic instrument 18 moves through the tissue, which can help the surgeon maintain control and reduce ablation of healthy brain tissue 652 near the tumor tissue region 650.

[0295] Thereafter, based on the posture of the ultrasonic instrument 18 tracked in the known coordinate system, the surgical control system 562 (or more specifically, the navigation controller 524, for example) may be configured to determine whether the operating end 22 of the tip 20 has reached or crossed the outer edge virtual boundary 656, indicating that the operating end 22 of the tip 20 is adjacent to or in contact with the healthy brain tissue 652. If so, the surgical control system 562 (e.g., via corresponding communications between the navigation controller 524 and the ultrasonic controller 112) may be configured to set the AC drive signal to induce pulsed ultrasonic energy in the tip 20 of the ultrasonic instrument 18 according to a further higher level of soft tissue pulse profile 144 (e.g., pulse control level 5) assigned to the outer edge virtual boundary 664, which may provide increased tissue selectivity and / or provide increased tactile feedback, thereby informing the surgeon of the position of the ultrasonic instrument 18. Alternatively, the surgical control system 562 may be configured to deactivate the ultrasonic instrument 18. The surgeon can then manually override the deactivation, for example by moving the ultrasonic instrument 18 backward from its current position, in which case the surgical control system 562 can operate the ultrasonic instrument 18 based on the posture of the operating end 22 of the tip 20 tracked as described above, or, for example by returning the foot pedal 76 to its inactive position and then moving it back to the active position, in which case the surgical control system 562 can enable the ultrasonic instrument 18 to operate according to the base ultrasonic energy, the soft tissue pulse profile 144 associated with the inner virtual boundary 666 and / or region 668, or another soft tissue pulse profile 144 selected by the physician.

[0296] In some examples, the defined virtual boundaries and / or regions may also include an outer virtual boundary 672 located outside the outer edge virtual boundary 664, for example, located at a defined distance from the outer edge virtual boundary 664, and may include a virtual region 673 defined between the outer edge virtual boundary 664 and the outer virtual boundary 672. The outer virtual boundary 672 and / or region 673 may correspond to an intended ablation margin surrounding the tumor tissue region 650, and thus may define an overall region of ablation target tissue, including both the tumor tissue region 350 and a small amount of healthy brain tissue 652. In this case, the outer virtual boundary 672 may be assigned a soft tissue pulse profile 144 that provides increased tissue selectivity and / or tactile feedback (e.g., a higher level of pulse control) compared to the soft tissue pulse profile 144 assigned to the outer edge virtual boundary 664 and / or the virtual region 673. Thus, the surgical control system 562 can be configured to implement the assigned soft tissue pulse profile 144 so that the ultrasonic instrument 18 provides further increased tissue selectivity and / or tactile feedback when the operating end 22 of the tip 20 enters the region 673 and then reaches the outer virtual boundary 672. Alternatively, the surgical control system 562 can be configured to stop vibration when the operating end 22 of the tip reaches the outer virtual boundary 672.

[0297] Fig. 22 Schematic diagram of virtual boundaries and / or regions that can be generated in a known coordinate system for a spinal fusion surgical procedure. During this surgical procedure, the ultrasonic instrument 18 can be used to ablate tissue between the vertebral bodies 678 of the spine, including the intervertebral disc tissue 674 and the cartilage endplate tissue 676, while minimizing contact with the spinal cord 680 and tissue ablation of the vertebral bodies 678. To this end, Fig. 22 An outer edge virtual boundary 682 corresponding to the outer boundary of the ablation target tissue (including the intervertebral disc tissue 674 and the cartilage endplate tissue 676) is illustrated. Fig. 22Also illustrated is an inner virtual boundary 684 positioned at a threshold distance from a portion of the outer edge virtual boundary 682 adjacent to the spinal cord 680, and a pair of inner virtual boundaries 686 corresponding to the boundary between the intervertebral disc tissue 674 and the cartilage endplate tissue 676. A virtual region 688 may be defined between the inner virtual boundaries 684, 686, a virtual region 690 may be defined between the inner virtual boundary 684 and a portion of the outer edge virtual boundary 682 adjacent to the spinal cord 680 away from the inner virtual boundary 684, and a virtual region 692 may be defined between each inner virtual boundary 686 and a portion of the outer edge virtual boundary 682 adjacent to one of the vertebral bodies 678 away from the inner virtual boundary 686. A different ultrasound energy profile can be assigned to each of the virtual boundaries 682, 684, 686, and / or a different ultrasound energy profile, such as a different soft tissue pulse profile 144, can be assigned to each of the regions 688, 690, 692, so that the ultrasonic instrument 18 provides different levels of tissue selectivity and / or tactile sensation when the operating end 22 of the tip 20 of the ultrasonic instrument 18 moves through different portions of the ablation target tissue.

[0298] More specifically, in response to receiving an indication to begin a procedure, the surgical control system 562 can be configured to verify that the tip 20 attached to the hand piece 24 is a soft tissue ablation tip 20, for example, based on data stored in the tip memory 174 associated with the tip 20 as described above. If not, the surgical control system 562 can indicate an error (e.g., on the user interface 532) and can prevent the ultrasonic instrument 18 from operating. In response to determining that the soft tissue ablation tip 20 is attached to the hand piece 24, the surgical control system 562 can be configured to set the AC drive signal to induce basal ultrasonic energy in the tip 20, for example, continuous ultrasonic energy according to the constant energy profile 148 or the soft tissue pulse profile 144 previously selected by the user. The surgical control system 562 can be configured to continuously sense the basal ablation ultrasonic energy when the operating end 22 of the tip 20 is located within the region 688.

[0299] Based on the tracked pose of the ultrasonic instrument 18 in the known coordinate system, the surgical control system 562 (or more specifically the navigation controller 524, for example) can be configured to determine whether the operating end 22 of the tip 20 has reached or crossed the inner virtual boundary 684 and entered the region 690. In other words, the surgical control system 562 can be configured to determine whether the distance between the portion of the outer edge virtual boundary 682 adjacent to the spinal cord 680 and the operating end 22 of the tip 20 is less than or equal to the threshold distance associated with the inner virtual boundary 684. If so, the surgical control system 562 can be configured to set the AC drive signal to induce pulsed ultrasonic energy in the tip 20 of the ultrasonic instrument 18, for example, according to the soft tissue pulse profile 144 associated with the inner virtual boundary 684 and / or the region 690, and the pulsed ultrasonic energy can be different from the basic ultrasonic energy, for example, by providing increased tissue selectivity and / or tactile feedback (e.g., pulse control level 4). The surgeon can then reduce the force he or she applies to the ultrasonic instrument 18 and / or the speed at which the ultrasonic instrument 18 moves through the tissue based on the increased tactile feedback of the amplitude and / or increased tissue selectivity, which can help the surgeon maintain control and reduce trauma to adjacent non-ablation target tissue and contact with the spinal cord 680.

[0300] Based on the tracked pose of the ultrasonic instrument 18 in the known coordinate system, the surgical control system 562 may also be configured to determine whether the operating end 22 of the tip 20 has reached or crossed the portion of the spinal cord 680 adjacent to the outer edge virtual boundary 682, indicating that the operating end 22 of the tip 20 has broken through the distal end of the intervertebral disc tissue 674. If so, the surgical control system 562 may be configured to set the AC drive signal to induce pulsed ultrasonic energy in the tip 20 of the ultrasonic instrument 18 according to the soft tissue pulse profile 144 associated with the outer edge virtual boundary 682, which may be different from the previously induced soft tissue pulse profile 144 and may provide further tissue selectivity and / or tactile feedback, such as a pulse control level 5). Alternatively, the surgical control system 562 may be configured to deactivate the ultrasonic instrument 18. The surgeon can then manually override the deactivation, for example by moving the ultrasonic instrument 18 backward from its current position, in which case the surgical control system 562 can operate the ultrasonic instrument 18 based on the tracked posture of the operating end 22 of the tip 20 as described above, or, for example by returning the foot pedal 76 to its inactive position and then moving it back to the active position, in which case the surgical control system 562 can enable the ultrasonic instrument 18 to operate according to the base ultrasonic energy, the soft tissue pulse profile 144 assigned to the outer edge virtual boundary 682, or another pulse profile 140 selected by the user.

[0301] Based on the tracked pose of the ultrasonic instrument 18 in the known coordinate system, the surgical control system 562 may also be configured to determine whether the operating end 22 of the tip 20 has reached or crossed one of the internal virtual boundaries 686 from the region 688 into the region 692. If so, the navigation controller 524 may be configured to set the AC drive signal to induce pulsed ultrasonic energy in the tip 20 of the ultrasonic instrument 18, for example, according to the soft tissue pulse profile 144 assigned to the internal virtual boundary 686 and / or the region 692, which pulsed ultrasonic energy may be different from the basic ultrasonic energy by providing increased tissue selectivity and / or tactile feedback (e.g., pulse control level 4). The increased tissue selectivity and / or tactile feedback may alert the surgeon that the operating end 22 of the tip 20 is contacting the cartilage endplate tissue 676 near the vertebral body 678. The surgeon may be prompted by the increased tissue selectivity and / or tactile feedback to reduce the force he or she applies to the ultrasonic instrument 18 and / or the speed at which the ultrasonic instrument 18 moves through the tissue, which may help the surgeon maintain control and reduce trauma to non-ablation target tissue.

[0302] Based on the tracked pose of the ultrasonic instrument 18 in the known coordinate system, the surgical control system 562 may be further configured to determine whether the operating end 22 of the tip 20 has reached or crossed the portion of the adjacent vertebral body 678 of the outer edge virtual boundary 682 from the region 692, indicating that the operating end 22 of the tip 20 is in contact with or close to contacting the vertebral body 678. If so, the surgical control system 562 may be configured to set the AC drive signal to induce pulsed ultrasonic energy in the tip 20 of the ultrasonic instrument 18 according to the soft tissue pulse profile 144 assigned to the portion of the outer edge virtual boundary 682, which pulse profile 144 may be different from the pulse profile 144 assigned to the inner virtual boundary 686 and / or the region 692 (e.g., pulse control level 5) and may provide further tissue selectivity and tactile feedback than the pulse profile 144 (e.g., pulse control level 5) thereof, thereby alerting the surgeon to retract the operating end 22 of the tip 20 from the current position. Alternatively, the navigation controller 524 may be configured to deactivate the ultrasonic instrument 18. The surgeon may then proceed to override the deactivation, for example by moving the ultrasonic instrument 18 backward from its current position, in which case the surgical control system 562 may operate the ultrasonic instrument 18 based on the tracked posture of the operating end 22 of the tip 20 as described above, or by moving the foot pedal 76 to its inactive position and then back to the active position, in which case the surgical control system 562 may enable the ultrasonic instrument 18 to operate according to the base ultrasonic energy, the soft tissue pulse profile 144 corresponding to the outer edge virtual boundary 682, or another soft tissue pulse profile 144 selected by the user.

[0303] Fig.23A method 700 is shown of operating the ultrasonic instrument 18 to resect tissue including one or more tissue types at a target site based on the tissue types detected by the tissue detection system 13. The method 700 may be implemented by the surgical control system 562, or more specifically, by the tissue detection controller 302 and the ultrasonic controller 112 (as examples).

[0304] In block 702, the tissue type in or near the target site can be determined. For example, the physician can interact with the user interface 556, or more specifically, with the display 104 (as an example) of the console 86 of the tissue detection system 13 to select a preloaded tissue type, which can be stored as tissue map data 320 in the tissue detection console storage device 318. Additionally or alternatively, the surgical control system 562 (or more specifically, the tissue detection controller 302) can prompt the physician, for example, through the display 104, to place the distal portion of the sampling element 88 (for example, when the sampling element 88 is coupled to the ultrasonic instrument 18) multiple times near each type of tissue in or near the target site, and / or place the distal portion of the sampling element 88 at multiple locations near each type of tissue.

[0305] In response to receiving an indication from a physician that the sampling element 88 has been positioned adjacent to a given tissue type (e.g., via the display 104), the tissue detection controller 302 can be configured to illuminate tissue adjacent to the distal portion of the sampling element 88 and collect the resulting fluorescence, as described above. For each tissue type to be detected during the surgical procedure, the surgical control system 562 (or more specifically, the tissue detection controller 302) can be configured to analyze the collected fluorescence instances for the tissue type to determine the sample light intensity corresponding to each of the one or more fluorophores associated with the tissue type. The surgical control system 562 can then be configured to generate tissue map data 320 for the tissue type, which indicates a minimum threshold value for each of the one or more fluorophores. For example, but not limited to, the minimum threshold value for each fluorophore can be based on the lowest intensity sample of the fluorophore, or based on the average of a fixed number of lowest intensity samples of the fluorophore. As an example, the tissue detection controller 302 can be configured to determine the minimum intensity threshold for each fluorophore by subtracting a predetermined buffer value from the lowest intensity value or the average.

[0306] At block 704, each tissue type may be assigned an ultrasonic energy profile, such as a constant energy profile 148 or a pulse profile 140. For example, the surgical control system 562 (or more specifically, the tissue detection controller 302 or the ultrasonic controller 112) may be configured to assign a pulse profile 140 to each tissue type, such that when the operating end 22 of the tip 20 of the ultrasonic instrument 18 contacts the type of tissue, the AC drive signal supplied to the ultrasonic instrument 18 is set to induce pulsed ultrasonic energy according to the pulse profile 140 assigned to the tissue type. In this way, the ultrasonic instrument 18 may provide different levels of tissue selectivity and / or tactile feedback when the ultrasonic instrument 18 contacts different types of tissue (e.g., tissue types corresponding to or proximate to sensitive or non-target tissue in or near the target site TS).

[0307] In some embodiments, the surgical control system 562 (or more specifically the tissue detection controller 302 or the ultrasound controller 112 as an example) can be configured to autonomously assign pulse profiles 140, for example based on the determined tissue type, and data included in the tissue map data 320 and / or the tissue type data 142 indicating which pulse profile 140 is assigned to each of the various tissue types. Additionally or alternatively, the surgical control system 562 can be configured to utilize the positioning data generated by the locator 522 to assign pulse profiles 140 as described above. When assigning pulse profiles 140, the surgical control system 562 can also be configured to limit which pulse profiles 140 can be assigned to a given tissue type as described above, for example based on whether the tissue type is hard tissue or soft tissue. Additionally or alternatively, the surgical control system 562 can be configured to enable a user to modify a pulse profile 140 that has been assigned or is to be assigned through the user interface 556.

[0308] At block 706, it may be determined whether to activate the ultrasonic instrument 18. For example, the physician may move the foot pedal 76 from the inactive position to the active position to provide an indication of activating the ultrasonic instrument. In response to determining that the ultrasonic instrument 18 is to be activated (the "yes" branch of block 706), in block 708, ultrasonic energy may be induced in the ultrasonic instrument 18, for example, by the surgical control system 562. For example, the ultrasound controller 112 may be configured to induce a base ultrasonic energy in the ultrasonic instrument 18, which may correspond to an ultrasonic energy profile and power setting selected for the base ultrasonic energy by the physician (e.g., via the display 74 of the console 16).

[0309] In block 710, the type of tissue contacted by the operating end 22 of the tip 20 of the ultrasonic instrument 18 may be detected. For example, the surgical control system 562 (or more specifically, the tissue detection controller 302) may be configured to illuminate the tissue with one or more wavelengths of excitation light through the excitation optical fiber 100, and collect the generated fluorescence through the excitation optical fiber 94 as described above. Based on the fluorescence, the surgical control system 562 (or more specifically, the tissue detection controller 302) may be configured to determine the type of tissue contacted by the operating end 22 of the ultrasonic tip 20.

[0310] In block 712, ultrasonic energy (e.g., pulsed ultrasound) may be induced in the ultrasonic instrument 18 based on the detected tissue type, such as by the surgical control system 562. For example, assuming that a given pulse profile 140 has been assigned to the detected tissue type, the AC drive signal generated by the power supply of the ultrasonic tool system 12 may be set to induce pulsed ultrasonic energy in the tip according to the pulse profile 140. In one example, the tissue detection controller 302 may be configured to send a message indicating the detected tissue type to the ultrasonic controller 112, and the ultrasonic controller 112 may be configured to induce ultrasonic energy in the ultrasonic instrument 18 based on the indicated tissue type, as described above. Alternatively, the tissue detection controller 302 may be configured to determine the ultrasonic energy profile assigned to the detected tissue type and send a message indicating the same to the ultrasonic controller 112 for implementation.

[0311] Examples of inducing ultrasound energy based on the type of tissue being detected can be found in Fig.21. As previously described, the target site TS in the illustrated tumor resection surgery may at least partially include a tumor tissue region 650 and adjacent healthy brain tissue 652. The tumor tissue region 650 may be marked as an ablation target tissue type by the surgical control system 562, while the adjacent healthy brain tissue 652 may be marked as a type of non-ablation target tissue. These tissues may be detected by the surgical control system 562 (or more specifically, taking the tissue detection system 13 as an example), and may be assigned an ultrasonic energy profile, respectively. For example, a constant energy profile 148 or a soft tissue pulse profile 144 (e.g., pulse control level 1) providing relatively low tissue selectivity and / or tactile feedback may be assigned to the ablation target tissue type, and a soft tissue pulse profile 144 providing relatively high tissue selectivity and / or tactile feedback may be assigned to the non-ablation target tissue type. In this way, when the operating end 22 moves from contacting the tumor tissue region 650 to the adjacent healthy brain tissue 652, the ultrasonic instrument 18 may provide increased tissue selectivity, thereby minimizing undesired ablation of the healthy brain tissue 652. The ultrasonic instrument 18 may also provide increased tactile feedback, which may be perceived by the surgeon and indicate to the surgeon that the operating end 22 of the ultrasonic tip 20 is contacting healthy brain tissue 652. The surgeon may take this tactile feedback and / or increase in tissue selectivity as a cue to proceed more carefully.

[0312] In some examples, the target site TS may include a certain type of tissue area in which different ultrasonic energies may need to be sensed. For example, relative to an area of ​​a certain ablation target tissue type adjacent to an area of ​​a non-ablation target tissue type, when the operating end 22 of the ultrasonic tip 20 moves toward the periphery of the area, it may be desirable to sense pulsed ultrasonic energy with increased tissue selectivity and / or tactile feedback. In this way, when the operating end 22 of the ultrasonic tip 20 moves closer to the edge of the area of ​​the ablation target tissue type, the ultrasonic instrument 18 can provide increased tissue selectivity and / or tactile feedback, which can minimize undesired ablation of non-ablation target tissue types and can prompt the physician to position the operating end 22 of the ultrasonic instrument 18 and operate it with caution.

[0313] For example, refer to Fig.21In the example shown in , relative to the tumor tissue region 650, when the operating end 22 of the ultrasonic instrument 18 is located in the central portion (e.g., region 670) of the tumor tissue region 650, it may be desirable to sense ultrasonic energy with relatively less tissue selectivity and / or tactile feedback. On the contrary, in a portion of the tumor tissue region 650 that is close to another tissue type and located between the central portion and the other tissue type, such as a peripheral portion of the tumor tissue region 650, represented by region 668, it may be desirable to sense ultrasonic energy with relatively high tissue selectivity and / or tactile feedback.

[0314] To this end, the central portion of the tumor tissue region 650 may be assigned an ultrasound energy profile with relatively low tissue selectivity and / or tactile feedback, such as a constant energy profile 148 or a relatively low level of soft tissue pulse profile 144 (e.g., pulse control level 1). In contrast, a soft tissue pulse profile 144 providing higher tissue selectivity and / or tactile feedback, such as pulse control level 3 or 4, may be assigned to the peripheral portion of the tumor tissue region 650. A soft tissue pulse profile 144 providing further tissue selectivity and / or tactile feedback, such as pulse control level 5, may be assigned to the healthy brain tissue 652 region.

[0315] Similarly, relative to the healthy brain tissue 652 region, when the operating end 22 of the ultrasonic instrument 18 is located in the portion represented by the region 673 (i.e., the portion of the healthy brain tissue 652 adjacent to the tumor tissue region 650 or within a threshold distance from the tumor tissue region 650), it may be desirable to induce ultrasonic energy with more tissue selectivity and / or tactile feedback than the ultrasonic energy induced in the tumor tissue region 650, and to further increase the tissue selectivity and / or tactile feedback of the induced ultrasonic energy as the operating end 22 of the tip 20 moves further into the healthy brain tissue 652. Therefore, portions of the healthy brain tissue 652 closer to and farther from the tumor tissue region 650 may be assigned a soft tissue pulse profile 144 that provides increased tissue selectivity and / or tactile feedback than that induced in the tumor tissue region 650, such as pulse control levels 4 and 5, respectively.

[0316] In some embodiments, the surgical control system 562 (or more specifically, the tissue detection controller 302) can be configured to determine the position of the operating end 22 of the ultrasonic tip 20 relative to the edge of a certain type of tissue region based on the characteristics of the collected fluorescence. Specifically, for a region of a given type of tissue, the density of the tissue and the density of the fluorophores within the tissue may decrease toward the edge of the region, thereby causing the characteristics of the fluorescence emitted from the region to change when the distal portion of the sampling element 88 moves from the central portion toward the edge of the region. In other words, when the distal portion of the sampling element 88 moves from the central portion to the edge of the region, the intensity of the wavelength of fluorescence specific to the tissue type may change, for example, according to a gradient from a greater intensity to a lesser intensity.

[0317] Thus, in order to detect different portions of a given type of tissue region, the tissue type data 105 stored in the tissue detection console storage device 318 may indicate the following two aspects: a minimum intensity threshold corresponding to the type of tissue, and one or more other intensity thresholds greater than the minimum intensity threshold used to distinguish different portions of the type of tissue region. For example, the one or more other intensity thresholds may include a peripheral intensity threshold, such that if the measured intensity of the fluorescence at the wavelength corresponding to the type of tissue is greater than the minimum intensity threshold and greater than the peripheral intensity threshold, the surgical control system 562 (or more specifically the tissue detection controller 302) may be configured to determine that the operating end 22 of the ultrasonic tip 20 is located within the central portion of the region. Alternatively, if the measured intensity of the fluorescence at the wavelength corresponding to the type of tissue is greater than the minimum intensity threshold and less than or equal to the peripheral intensity threshold, the surgical control system 562 (or more specifically the tissue detection controller 302) may be configured to determine that the operating end 22 of the ultrasonic tip 20 is located in the peripheral portion of the region, which may correspond to the portion of the region within a threshold distance from the edge of the region. In some examples, the tissue type data 105 may also include one or more other intensity threshold values ​​that are greater than the peripheral intensity threshold value and correspond to further zones between the peripheral portion and the central portion of the region. Likewise, a pulse profile 140 may be assigned to each of these zones so that when the operating end 22 of the tip 20 moves through these zones in a direction according to the planned ablation path, the tissue selectivity and / or tactile feedback provided by the ultrasonic instrument 18 increases.

[0318] Additionally or alternatively, the surgical control system 562 (e.g., using the ultrasound controller 112 or the tissue detection controller 302 as an example) can be configured to use the characteristics of the AC drive signal to determine the portion of the region of a given type of tissue where the operating end 22 of the ultrasonic tip 20 is located. Specifically, for a given type of tissue region, the density of the tissue may decrease, and correspondingly, the mechanical impedance (e.g., stiffness) of the tissue may decrease. As described above, the ultrasound controller 112 can be configured to determine the load applied to the ultrasonic instrument 18 based on a load measurement value, which can be a function of the stiffness of the tissue contacted by the operating end 22 of the tip 20...

Claims

1. An ultrasonic surgical tool system, comprising: an ultrasonic instrument comprising an aspiration path, an irrigation path, a tip, and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue at a target site; a power supply coupled to the ultrasonic instrument and configured to generate an AC drive signal supplied to a driver of the ultrasonic instrument; a positioner configured to generate positioning data indicative of a pose of the ultrasonic instrument in a known coordinate system; and A control system is coupled to the power source and the positioner and is configured to: receiving a medical image of a target site including a tumor tissue region; Based on the medical image, a virtual boundary associated with the tumor tissue region is generated in a known coordinate system; Tracking the posture of the ultrasonic instrument in a known coordinate system based on the positioning data; and Based on the tracked pose of the ultrasonic instrument and the virtual boundary, an AC drive signal generated by the power supply is set to induce a first pulse of ultrasonic energy in the tip.

2. The ultrasonic surgical tool system according to claim 1, wherein: The control system is configured to: Determining whether the operating end of the tip has reached or crossed the virtual boundary from the tumor tissue region based on the posture of the ultrasound instrument tracked in the known coordinate system relative to the virtual boundary; and In response to determining that the operative end of the tip has reached or crossed the virtual boundary from the tumor tissue region, an AC drive signal generated by the power supply is set to induce the first pulsed ultrasonic energy in the tip.

3. The ultrasonic surgical tool system according to claim 1 or 2, wherein: The control system is configured to: determining whether the operating end of the tip is located within the tumor tissue region based on the pose of the ultrasound instrument tracked in the known coordinate system relative to the virtual boundary; and In response to determining that the operative end of the tip is located within the tumor tissue region, an AC drive signal generated by the power supply is set to induce continuous ultrasound energy in the tip.

4. The ultrasonic surgical tool system according to any one of claims 1 to 3, wherein: The first pulsed ultrasonic energy includes a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level for a first period of time, each of the first ultrasonic energy pulses reaching a peak at a maximum ultrasonic energy level set for the ultrasonic instrument and lasting for a second period of time less than each of the first period of time.

5. The ultrasonic surgical tool system according to any one of claims 1 to 4, wherein: The first pulsed ultrasonic energy includes a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level, each of the first ultrasonic energy pulses reaching a peak value at a maximum ultrasonic energy level set for the ultrasonic instrument, the first minimum ultrasonic energy level being less than or equal to 5% of the maximum ultrasonic energy level.

6. The ultrasonic surgical tool system according to claim 1, wherein: The control system is configured to: Determining whether the operating end of the tip is located within the tumor tissue region and the distance between the operating end of the tip and the virtual boundary is less than a first threshold distance based on the posture of the ultrasound instrument tracked in the known coordinate system relative to the virtual boundary; and In response to determining that the operative end of the tip is located within the tumor tissue region and the distance between the operative end of the tip and the virtual boundary is less than a first threshold distance, an AC drive signal generated by the power supply is set to induce the first pulsed ultrasonic energy in the tip.

7. The ultrasonic surgical tool system according to claim 6, wherein: The first pulsed ultrasonic energy includes a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level for a first period of time, each of the first ultrasonic energy pulses reaching a peak at a maximum ultrasonic energy level set for the ultrasonic instrument and lasting for a second period of time less than each of the first period of time.

8. The ultrasonic surgical tool system according to claim 6 or 7, wherein: The first pulsed ultrasonic energy includes a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level, each of the first ultrasonic energy pulses reaching a peak value at a maximum ultrasonic energy level set for the ultrasonic instrument, the first minimum ultrasonic energy level being greater than or equal to 10% of the maximum ultrasonic energy level.

9. The ultrasonic surgical tool system according to any one of claims 6 to 8, wherein: The control system is configured to: Based on the posture of the ultrasonic instrument tracked in the known coordinate system relative to the virtual boundary, determining whether the operating end of the tip is located within the tumor tissue region and the distance between the operating end of the tip and the virtual boundary is greater than a first threshold distance; and In response to determining that the operative end of the tip is located within the tumor tissue region and the distance between the operative end of the tip and the virtual boundary is greater than a first threshold distance, an AC drive signal generated by the power supply is set to induce continuous ultrasound energy in the tip.

10. The ultrasonic surgical tool system according to any one of claims 6 to 8, wherein: The first pulsed ultrasonic energy is generated based on a first modulated waveform, and the control system is configured to: Based on the posture of the ultrasonic instrument tracked in the known coordinate system relative to the virtual boundary, determining whether the operating end of the tip is located within the tumor tissue region and the distance between the operating end of the tip and the virtual boundary is greater than a first threshold distance; and In response to determining that the operative end of the tip is located within the tumor tissue region and the distance between the operative end of the tip and the virtual boundary is greater than a first threshold distance, an AC drive signal generated by the power supply is set to induce a second pulsed ultrasonic energy in the tip, the second pulsed ultrasonic energy being generated based on a second modulation waveform different from the first modulation waveform.

11. The ultrasonic surgical tool system according to any one of claims 6 to 8, wherein: The first pulsed ultrasonic energy is generated based on a first modulated waveform, and the control system is configured to: Based on the pose of the ultrasonic instrument tracked in the known coordinate system relative to the virtual boundary, determining whether the operating end of the tip is located within the tumor tissue region and the distance between the operating end of the tip and the virtual boundary is greater than a first threshold distance and less than a second threshold distance; and In response to determining that the operative end of the tip is located within the tumor tissue region and the distance between the operative end of the tip and the virtual boundary is greater than the first threshold distance and less than the second threshold distance, an AC drive signal generated by the power supply is set to induce a second pulsed ultrasonic energy in the tip, the second pulsed ultrasonic energy being generated based on a second modulation waveform different from the first modulation waveform.

12. The ultrasonic surgical tool system according to claim 11, wherein: The control system is configured to: determining, based on a pose of the ultrasound instrument tracked in a known coordinate system relative to the virtual boundary, whether an operating end of the tip is located within the tumor tissue region and a distance between the operating end of the tip and the virtual boundary is greater than a second threshold distance; and In response to determining that the operative end of the tip is within the region of tumor tissue to be removed and the distance between the operative end of the tip and the virtual boundary is greater than a second threshold distance, an AC drive signal generated by the power supply is set to induce continuous ultrasound energy in the tip.

13. The ultrasonic surgical tool system according to any one of claims 10 to 12, wherein: The first pulsed ultrasonic energy comprises a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level, the second pulsed ultrasonic energy comprises a plurality of second ultrasonic energy pulses separated by ultrasonic energy at a second minimum ultrasonic energy level, and the first minimum ultrasonic energy level is less than the second minimum ultrasonic energy level.

14. The ultrasonic surgical tool system according to claim 13, wherein: Each of the first ultrasonic energy pulses and each of the second ultrasonic energy pulses reaches a peak value at a maximum ultrasonic energy level set for the ultrasonic instrument.

15. The ultrasonic surgical tool system according to claim 14, wherein: The first minimum ultrasonic energy level is greater than 10% of the maximum ultrasonic energy level, and the second minimum ultrasonic energy level is greater than 20% of the maximum ultrasonic energy level.

16. The ultrasonic surgical tool system according to claim 14 or 15, wherein: The first ultrasonic energy pulses are separated by ultrasonic energy lasting for a first period of time at a first minimum ultrasonic energy level, and respectively reach a peak at the maximum ultrasonic energy level and last for a second period of time less than each of the first period of time, the second ultrasonic energy pulses are separated by ultrasonic energy lasting for a third period of time at a second minimum ultrasonic energy level, and respectively reach a peak at the maximum ultrasonic energy level and last for a fourth period of time less than each of the third period of time, and each of the first period of time is greater than each of the third period of time.

17. The ultrasonic surgical tool system according to any one of claims 10-16, wherein: The first pulsed ultrasonic energy has a first pulse frequency, and the second pulsed ultrasonic energy has a second pulse frequency that is less than the first pulse frequency.

18. The ultrasonic surgical tool system according to any one of claims 10-17, wherein: The first pulsed ultrasonic energy has a first duty cycle, and the second pulsed ultrasonic energy has a second duty cycle greater than the first duty cycle.

19. The ultrasonic surgical tool system according to any one of claims 6 to 18, wherein: The first pulsed ultrasonic energy is generated based on a first modulated waveform, and the control system is configured to: Based on the pose of the ultrasound instrument tracked in the known coordinate system, determining whether the operating end of the tip has reached or crossed the virtual boundary from the tumor tissue region; and In response to determining that the operating end of the tip has reached or crossed the virtual boundary from the tumor tissue region, an AC drive signal generated by the power supply is set to induce a third pulsed ultrasonic energy in the tip, wherein the third pulsed ultrasonic energy is generated based on a modulation waveform different from the first pulsed ultrasonic energy.

20. The ultrasonic surgical tool system according to claim 19, wherein: The third pulsed ultrasonic energy includes a plurality of third ultrasonic energy pulses separated by ultrasonic energy at a third minimum ultrasonic energy level, each of the third ultrasonic energy pulses reaching a peak value at a maximum ultrasonic energy level set for the ultrasonic instrument, and the third minimum ultrasonic energy level is less than or equal to 5% of the maximum ultrasonic energy level.

21. The ultrasonic surgical tool system according to claim 20, wherein: The first pulsed ultrasonic energy comprises a plurality of first ultrasonic energy pulses spaced apart by ultrasonic energy at a first minimum ultrasonic energy level greater than the third minimum ultrasonic energy level.

22. The ultrasonic surgical tool system according to any one of claims 19-21, wherein: The third pulsed ultrasonic energy comprises a plurality of third ultrasonic energy pulses separated by ultrasonic energy at a third minimum ultrasonic energy level for a fifth period of time, each of the third ultrasonic energy pulses peaking at the maximum ultrasonic energy level and lasting for a sixth period of time less than each fifth period of time.

23. The ultrasonic surgical tool system according to claim 22, wherein: The first pulsed ultrasonic energy includes a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level for a first period of time, each of the first ultrasonic energy pulses reaches a peak value at a maximum ultrasonic energy level set for the ultrasonic instrument and lasts for a second period of time less than each of the first period of time, and each of the first period of time is less than each of the fifth period of time.

24. The ultrasonic surgical tool system according to any one of claims 19-23, wherein: The first pulsed ultrasonic energy has a first pulse frequency, and the third pulsed ultrasonic energy has a third pulse frequency greater than the first pulse frequency.

25. The ultrasonic surgical tool system according to any one of claims 19-24, wherein: The first pulse of ultrasonic energy has a first duty cycle, and the third pulse of ultrasonic energy has a third duty cycle that is less than the first duty cycle.

26. The ultrasonic surgical tool system according to any one of claims 1-25, wherein: The control system is configured to: determining that the positioning data indicates that the tip is vibrating in a region of tumor tissue; determining one or more characteristics of an AC drive signal supplied to the ultrasound instrument corresponding to the positioning data indicating that the tip is vibrating within the tumor tissue region; determining that the one or more characteristics indicate that the tip is not vibrating within a region of tumor tissue; and In response to determining that the one or more features indicate that the tip is not vibrating within the tumor tissue region, a navigation error is determined.

27. The ultrasonic surgical tool system according to claim 26, wherein: The control system is configured to, in response to determining a navigation error, reposition the virtual boundary within the known coordinate system based on the determined one or more characteristics of the AC drive signal.

28. An ultrasonic surgical system, comprising: an ultrasonic instrument comprising an aspiration path, an irrigation path, a tip, and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue from a target site; a power supply coupled to the ultrasonic instrument and configured to generate an AC drive signal supplied to the driver; a positioner configured to generate positioning data indicative of a pose of the ultrasonic instrument in a known coordinate system; and A control system is coupled to the power source and the positioner and is configured to: receiving a medical image of a target site including a first tissue region to be ablated; generating, based on the medical image, a virtual boundary associated with the first tissue region in a known coordinate system; Based on the positioning data, tracking the posture of the ultrasonic instrument in a known coordinate system; and Based on a pose of the ultrasonic instrument tracked in a known coordinate system relative to the virtual boundary, an AC drive signal generated by a power supply is set to induce a first pulse of ultrasonic energy in the tip.

29. The ultrasonic surgical system according to claim 28, wherein: The control system is configured to: determining whether the operating end of the tip has reached or crossed the virtual boundary from the first tissue region based on the pose of the ultrasonic instrument tracked in the known coordinate system relative to the virtual boundary; and In response to determining that the operative end of the tip has reached or crossed the virtual boundary from the first tissue region, an AC drive signal generated by the power supply is set to induce the first pulse of ultrasonic energy in the tip.

30. The ultrasonic surgical system according to any one of claims 28 or 29, wherein: The control system is configured to: determining whether the operative end of the tip is located within the first tissue region based on a pose of the ultrasonic instrument tracked in a known coordinate system relative to the virtual boundary; and In response to determining that the operative end of the tip is located within the first tissue region, an AC drive signal generated by the power supply is set to induce continuous ultrasonic energy in the tip.

31. The ultrasonic surgical system according to any one of claims 28 to 30, wherein: The first pulsed ultrasonic energy includes a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level for a first period of time, each of the first ultrasonic energy pulses reaching a peak at a maximum ultrasonic energy level set for the ultrasonic instrument and lasting for a second period of time less than each of the first period of time.

32. The ultrasonic surgical system according to any one of claims 28 to 31, wherein: The first pulsed ultrasonic energy includes a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level, each of the first ultrasonic energy pulses reaching a peak value at a maximum ultrasonic energy level set for the ultrasonic instrument, the first minimum ultrasonic energy level being less than or equal to 5% of the maximum ultrasonic energy level.

33. The ultrasonic surgical system according to any one of claims 28 to 30, wherein: The first pulsed ultrasonic energy includes a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level for a first period of time, each of the first ultrasonic energy pulses reaching a peak at a maximum ultrasonic energy level set for the ultrasonic instrument and lasting for a second period greater than or equal to each of the first period of time.

34. The ultrasonic surgical system according to any one of claims 28-30 and 33, wherein: The first pulsed ultrasonic energy includes a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level, each of the first ultrasonic energy pulses reaching a peak value at a maximum ultrasonic energy level set for the ultrasonic instrument, the first minimum ultrasonic energy level being less than or equal to 40% of the maximum ultrasonic energy level.

35. The ultrasonic surgical system according to claim 28, wherein: The control system is configured to: determining, based on a pose of the ultrasonic instrument tracked in a known coordinate system relative to the virtual boundary, whether an operative end of the tip is located within the first tissue region and a distance between the operative end of the tip and the virtual boundary is less than a first threshold distance; and In response to determining that the operative end of the tip is within the first tissue region and the distance between the operative end of the tip and the virtual boundary is less than a first threshold distance, an AC drive signal generated by the power supply is set to induce the first pulsed ultrasonic energy in the tip.

36. The ultrasonic surgical system according to claim 35, wherein: The first pulsed ultrasonic energy includes a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level lasting a first period of time, each of the first ultrasonic energy pulses reaching a peak at a maximum ultrasonic energy level set for the ultrasonic instrument and lasting a second period greater than or equal to each of the first period of time.

37. The ultrasonic surgical system according to claim 35 or 36, wherein: The first pulsed ultrasonic energy includes a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level, each of the first ultrasonic energy pulses reaching a peak value at a maximum ultrasonic energy level set for the ultrasonic instrument, the first minimum ultrasonic energy level being greater than or equal to 20% of the maximum ultrasonic energy level.

38. The ultrasonic surgical system according to any one of claims 35-37, wherein: The control system is configured to: determining, based on a pose of the ultrasonic instrument tracked in a known coordinate system relative to the virtual boundary, whether an operative end of the tip is located within the first tissue region and a distance between the operative end of the tip and the virtual boundary is greater than a first threshold distance; and In response to determining that the operative end of the tip is within the first tissue region and the distance between the operative end of the tip and the virtual boundary is greater than a first threshold distance, an AC drive signal generated by the power supply is set to induce continuous ultrasonic energy in the tip.

39. The ultrasonic surgical system according to any one of claims 35-37, wherein: The first pulsed ultrasonic energy is generated based on a first modulated waveform, and the control system is configured to: determining, based on a pose of the ultrasonic instrument tracked in a known coordinate system relative to the virtual boundary, whether an operative end of the tip is located within the first tissue region and a distance between the operative end of the tip and the virtual boundary is greater than a first threshold distance; and In response to determining that the operative end of the tip is within the first tissue region and the distance between the operative end of the tip and the virtual boundary is greater than a first threshold distance, an AC drive signal generated by the power supply is set to induce a second pulsed ultrasonic energy in the tip, the second pulsed ultrasonic energy being generated based on a second modulation waveform different from the first modulation waveform.

40. The ultrasonic surgical system according to any one of claims 35-37, wherein: The first pulsed ultrasonic energy is generated based on a first modulated waveform, and the control system is configured to: Determining, based on a pose of the ultrasonic instrument tracked in a known coordinate system relative to the virtual boundary, whether an operating end of the tip is located within the first tissue region and a distance between the operating end of the tip and the virtual boundary is greater than a first threshold distance and less than a second threshold distance; and In response to determining that the operative end of the tip is within the first tissue region and the distance between the operative end of the tip and the virtual boundary is greater than the first threshold distance and less than the second threshold distance, an AC drive signal generated by the power supply is set to induce a second pulsed ultrasonic energy in the tip, the second pulsed ultrasonic energy being generated based on a second modulation waveform different from the first modulation waveform.

41. The ultrasonic surgical system according to claim 40, wherein: The control system is configured to: determining, based on a pose of the ultrasonic instrument tracked in a known coordinate system relative to the virtual boundary, whether an operative end of the tip is located within the first tissue region and a distance between the operative end of the tip and the virtual boundary is greater than a second threshold distance; and In response to determining that the operative end of the tip is within the first tissue region and the distance between the operative end of the tip and the virtual boundary is greater than a second threshold distance, an AC drive signal generated by the power supply is set to induce continuous ultrasonic energy in the tip.

42. The ultrasonic surgical system according to any one of claims 39-41, wherein: The first pulsed ultrasonic energy comprises a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level, the second pulsed ultrasonic energy comprises a plurality of second ultrasonic energy pulses separated by ultrasonic energy at a second minimum ultrasonic energy level, and the first minimum ultrasonic energy level is less than the second minimum ultrasonic energy level.

43. The ultrasonic surgical system according to claim 42, wherein: Each of the first ultrasonic energy pulses and each of the second ultrasonic energy pulses reaches a peak value at a maximum ultrasonic energy level set for the ultrasonic instrument.

44. The ultrasonic surgical system according to claim 43, wherein: The first minimum ultrasonic energy level is greater than 20% of the maximum ultrasonic energy level, and the second minimum ultrasonic energy level is greater than 30% of the maximum ultrasonic energy level.

45. The ultrasonic surgical system according to claim 43 or 44, wherein: The first ultrasonic energy pulses are separated by ultrasonic energy lasting a first time period at a first minimum ultrasonic energy level, and respectively reach a peak value at the maximum ultrasonic energy level and last for a second time period greater than or equal to each of the first time periods. The second ultrasonic energy pulses are separated by ultrasonic energy lasting a third time period at a second minimum ultrasonic energy level, and respectively reach a peak value at the maximum ultrasonic energy level and last for a fourth time period greater than or equal to each of the third time periods, and each of the second time periods is greater than each of the fourth time periods.

46. ​​The ultrasonic surgical system according to any one of claims 39-45, wherein: The first pulsed ultrasonic energy comprises a first pulse frequency, and the second pulsed ultrasonic energy comprises a second pulse frequency that is less than the first pulse frequency.

47. The ultrasonic surgical system according to any one of claims 39-46, wherein: The first pulsed ultrasonic energy has a first duty cycle, and the second pulsed ultrasonic energy has a second duty cycle that is greater than or equal to the first duty cycle.

48. The ultrasonic surgical system according to any one of claims 35-47, wherein: The control system is configured to: determining whether the operating end of the tip reaches or crosses the virtual boundary based on the pose of the ultrasonic instrument tracked in the known coordinate system relative to the virtual boundary; and In response to determining that the tracked pose of the ultrasonic instrument reaches or crosses the virtual boundary, an AC drive signal generated by the power supply is set to induce a third pulse of ultrasonic energy in the tip that is different from the first pulse of ultrasonic energy.

49. The ultrasonic surgical system according to claim 48, wherein: The third pulsed ultrasonic energy comprises a plurality of third ultrasonic energy pulses spaced apart by ultrasonic energy at a third minimum ultrasonic energy level, and the first pulsed ultrasonic energy comprises a plurality of first ultrasonic energy pulses spaced apart by ultrasonic energy at a first minimum ultrasonic energy level greater than the third minimum ultrasonic energy level.

50. The ultrasonic surgical system according to claim 49, wherein: Each of the first ultrasonic energy pulses and each of the third ultrasonic energy pulses reaches a peak value at the maximum ultrasonic energy level set for the ultrasonic instrument, the third minimum ultrasonic energy level is greater than 20% of the maximum ultrasonic energy level, and / or the first minimum ultrasonic energy level is greater than 30% of the maximum ultrasonic energy level.

51. The ultrasonic surgical system according to claim 49, wherein: Each of the first ultrasonic energy pulses and each of the third ultrasonic energy pulses reaches a peak value at the maximum ultrasonic energy level set for the ultrasonic instrument, the third minimum ultrasonic energy level is less than or equal to 5% of the maximum ultrasonic energy level, and / or the first minimum ultrasonic energy level is greater than 20% of the maximum ultrasonic energy level.

52. The ultrasonic surgical system according to claim 49 or 51, wherein: The third pulsed ultrasonic energy comprises a plurality of third ultrasonic energy pulses separated by ultrasonic energy at a third minimum ultrasonic energy level for a fifth period of time, each of the third ultrasonic energy pulses peaking at a maximum ultrasonic energy level and lasting for a sixth period of time less than each fifth period of time.

53. The ultrasonic surgical system according to claim 52, wherein: The first pulsed ultrasonic energy includes a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level lasting a first period of time, each of the first ultrasonic energy pulses reaching a peak value at a maximum ultrasonic energy level set for the ultrasonic instrument and lasting a second period of time greater than or equal to each of the first period of time, wherein each of the first period of time and / or the second period of time is less than each of the fifth period of time.

54. The ultrasonic surgical system according to any one of claims 48, 49, and 51-53, wherein: The first pulsed ultrasonic energy corresponds to a hard tissue ablation mode of the ultrasonic surgical system.

55. The ultrasonic surgical system according to any one of claims 48, 49, and 51-54, wherein: The third pulsed ultrasonic energy corresponds to a soft tissue ablation mode of the ultrasonic surgical system.

56. The ultrasonic surgical system according to any one of claims 48-50, wherein: The third pulsed ultrasonic energy includes a plurality of third ultrasonic energy pulses separated by ultrasonic energy lasting for a fifth period of time at a third minimum ultrasonic energy level, each of the third ultrasonic energy pulses reaching a peak value at a maximum ultrasonic energy level set for the ultrasonic instrument and lasting for a sixth period of time greater than or equal to each of the fifth period of time.

57. The ultrasonic surgical system according to claim 56, wherein: The first pulsed ultrasonic energy comprises a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level for a first period of time, each of the first ultrasonic energy pulses peaking at the maximum ultrasonic energy level and lasting for a second period of time greater than or equal to each of the first period of time, wherein the second period of time is less than or equal to a sixth period of time.

58. The ultrasonic surgical system according to any one of claims 48-50, 56 and 57, wherein: The first pulse of ultrasonic energy has a first duty cycle, and the third pulse of ultrasonic energy has a third duty cycle that is less than the first duty cycle.

59. The ultrasonic surgical system according to any one of claims 48-58, wherein: The first pulsed ultrasonic energy has a first pulse frequency, and the third pulsed ultrasonic energy has a third pulse frequency greater than the first pulse frequency.

60. The ultrasonic surgical system according to any one of claims 48-59, wherein: The first tissue region is a hard tissue region such as bone, and the virtual boundary corresponds to an end of a planned ablation path of the ultrasonic instrument through the hard tissue region.

61. The ultrasonic surgical system according to any one of claims 48-60, wherein: The first tissue region is a cartilage tissue region adjacent to the second tissue region to be avoided, such as a bone tissue region.

62. An ultrasonic surgical tool system, comprising: an ultrasonic instrument comprising an aspiration path, an irrigation path, a tip, and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue from a target site; a power supply coupled to the ultrasonic instrument and configured to generate an AC drive signal supplied to the driver; a positioner configured to generate positioning data indicative of a pose of the ultrasonic instrument in a known coordinate system; and A control system is coupled to the power source and the positioner and is configured to: receiving a medical image of a target area including a soft tissue region and a hard tissue region; generating a virtual boundary between a soft tissue region and a hard tissue region in a known coordinate system based on the medical image; Based on the positioning data, tracking the posture of the ultrasonic instrument in a known coordinate system; determining whether the ultrasonic instrument is within the hard tissue region or the soft tissue region based on a pose of the ultrasonic instrument tracked in the known coordinate system relative to the virtual boundary; In response to determining that the ultrasonic instrument is within the soft tissue region, generating a first AC drive signal that induces a first pulsed ultrasonic energy in the ultrasonic instrument, the first pulsed ultrasonic energy comprising a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level for a first period of time, each of the first ultrasonic energy pulses peaking at a maximum ultrasonic energy level set for the ultrasonic instrument and lasting for a second period of time less than each of the first periods of time; and In response to determining that the ultrasonic instrument is within a hard tissue region, a second AC drive signal is generated to induce second pulsed ultrasonic energy in the ultrasonic instrument, wherein the second pulsed ultrasonic energy includes a plurality of second ultrasonic energy pulses separated by ultrasonic energy at a second minimum ultrasonic energy level for a third period of time, each of the second ultrasonic energy pulses peaking at the maximum ultrasonic energy level and lasting for a fourth period greater than or equal to each of the third periods of time.

63. An ultrasonic surgical tool system, comprising: an ultrasonic instrument comprising an aspiration path, an irrigation path, a tip, and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue from a target site; a power supply coupled to the ultrasonic instrument and configured to generate an AC drive signal supplied to the driver; a positioner configured to generate positioning data indicative of a pose of the ultrasonic instrument in a known coordinate system; and A control system is coupled to the power source and the positioner and is configured to: receiving a medical image of a target site including a tissue region to be ablated; generating a virtual boundary associated with the tissue region based on the medical image; determining that the positioning data indicates that the tip is vibrating in the tissue region; measuring one or more characteristics of an AC drive signal supplied to the ultrasonic instrument corresponding to the positioning data indicating that the tip is vibrating in the tissue region; determining that the measured one or more characteristics indicate that the tip is not vibrating in the tissue region; and In response to determining that the measured one or more characteristics indicate that the tip is not vibrating in the tissue region, a navigation error is determined.

64. An ultrasonic surgical system, comprising: an ultrasonic instrument comprising an aspiration path, an irrigation path, a tip, and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue at a target site; a power supply coupled to the ultrasonic instrument and configured to generate an AC drive signal supplied to a driver of the ultrasonic instrument; a sampling element coupled to the ultrasonic instrument and comprising at least one optical fiber configured to collect fluorescent light emitted from the tissue; and A control system coupled to the power supply and the sampling element and configured to: Based on the fluorescence, detecting the type of tissue contacted by the tip of the ultrasonic instrument; and Based on the detected tissue type, the AC drive signal produced by the power supply is set to induce a first pulse of ultrasonic energy in the tip.

65. The ultrasonic surgical system according to claim 64, wherein: The target site includes a first type of tissue and a second type of tissue, and the control system is configured to: determining, based on the fluorescence, whether the tip of the ultrasonic instrument is contacting a first type of tissue; and In response to determining that the tip of the ultrasonic instrument is contacting the first type of tissue, an AC drive signal generated by the power supply is set to induce the first pulse of ultrasonic energy in the tip.

66. The ultrasonic surgical system according to claim 65, wherein: The control system is configured to: Based on the fluorescence, determining whether the tip of the ultrasonic instrument is contacting a second type of tissue; and In response to determining that the tip of the ultrasonic instrument is contacting the second type of tissue, an AC drive signal generated by the power supply is set to induce continuous ultrasonic energy in the tip.

67. The ultrasonic surgical system according to claim 65, wherein: The first pulsed ultrasonic energy is generated using a first modulated waveform, and the control system is configured to: Based on the fluorescence, determining whether the tip of the ultrasonic instrument is contacting a second type of tissue; and In response to determining that the tip of the ultrasonic instrument is contacting a second type of tissue, an AC drive signal generated by the power supply is set to induce a second pulse of ultrasonic energy in the tip, the second pulse of ultrasonic energy being generated using a second modulation waveform different from the first modulation waveform.

68. The ultrasonic surgical system according to claim 67, wherein: The target site includes an area of ​​a second type of tissue, the area including a first portion proximate to the first type of tissue, and a second portion, wherein the first portion is located between the second portion and the first type of tissue, and the control system is configured to: determining, based on the fluorescence, whether the tip of the ultrasonic instrument is contacting the first portion; and In response to determining that the tip of the ultrasonic instrument is contacting the first portion, an AC drive signal generated by the power supply is set to induce a second pulse of ultrasonic energy in the tip.

69. The ultrasonic surgical system according to claim 68, wherein: The control system is configured to: determining, based on the fluorescence, whether the tip of the ultrasonic instrument is contacting the second portion; and In response to determining that the tip of the ultrasonic instrument is contacting the second portion, an AC drive signal generated by the power supply is set to induce continuous ultrasonic energy in the tip.

70. The ultrasonic surgical system according to any one of claims 65-69, wherein: The target site includes a second region of the first type of tissue, the second region includes a third portion proximate to the second type of tissue, and a fourth portion, wherein the third portion is located between the second type of tissue and the fourth portion, and the control system is configured to: determining, based on the fluorescence, whether the tip of the ultrasonic instrument is contacting the third portion; and In response to determining that the tip of the ultrasonic instrument is contacting the third portion, an AC drive signal generated by the power supply is set to induce the first pulse of ultrasonic energy in the tip.

71. The ultrasonic surgical system according to claim 70, wherein: The control system is configured to: Based on the fluorescence, determining whether the tip of the ultrasonic instrument is contacting the fourth portion; and In response to determining that the tip of the ultrasonic instrument is contacting the fourth portion, an AC drive signal generated by the power supply is set to deactivate the ultrasonic instrument.

72. The ultrasonic surgical system according to any one of claims 65-69, wherein: The target site includes a second region of the first type of tissue, the second region includes a third portion proximate to the second type of tissue, and a fourth portion, wherein the third portion is located between the second type of tissue and the fourth portion, and the control system is configured to: determining whether the tip of the ultrasonic instrument is contacting the third portion based on the fluorescence; and In response to determining that the tip of the ultrasonic instrument is contacting the third portion, an AC drive signal generated by the power supply is set to induce a third pulse of ultrasonic energy in the tip.

73. The ultrasonic surgical system according to claim 72, wherein: The control system is configured to: Based on the fluorescence, determining whether the tip of the ultrasonic instrument is contacting the fourth portion; and In response to determining that the tip of the ultrasonic instrument is contacting the fourth portion, an AC drive signal generated by the power supply is set to induce the first pulse of ultrasonic energy in the tip.

74. The ultrasonic surgical system according to claim 64, wherein: The target site includes a first type of tissue and a second type of tissue, and the control system is configured to: determining, based on the fluorescence, whether the tip of the ultrasonic instrument is contacting a second type of tissue; and In response to determining that the tip of the ultrasonic instrument is contacting the second type of tissue, an AC drive signal generated by the power supply is set to induce the first pulse of ultrasonic energy in the tip.

75. The ultrasonic surgical system according to claim 74, wherein: The control system is configured to: determining, based on the fluorescence, whether the tip of the ultrasonic instrument is contacting a first type of tissue; and In response to determining that the tip of the ultrasonic instrument is contacting the first type of tissue, the ultrasonic instrument is deactivated.

76. An ultrasonic surgical system according to claim 74 or 75, wherein: The target site includes an area of ​​a second type of tissue, the area including a first portion proximate to the first type of tissue, and a second portion, wherein the first portion is located between the second portion and the first type of tissue, and the control system is configured to: determining, based on the fluorescence, whether the tip of the ultrasonic instrument is contacting the first portion; and In response to determining that the tip of the ultrasonic instrument is contacting the first portion, an AC drive signal generated by the power supply is set to induce the first pulse of ultrasonic energy in the tip.

77. The ultrasonic surgical system according to claim 76, wherein: The control system is configured to: determining, based on the fluorescence, whether the tip of the ultrasonic instrument is contacting the second portion; and In response to determining that the tip of the ultrasonic instrument is contacting the second portion, an AC drive signal generated by the power supply is set to induce continuous ultrasonic energy in the tip.

78. An ultrasonic surgical system according to any one of claims 64-77, wherein: The second type of tissue is ablation target tissue, and the first type of tissue is tissue at least a portion of which is not to be ablated.

79. The ultrasonic surgical system according to any one of claims 64-78, wherein: The second type of tissue is tumor tissue and the first type of tissue is non-tumor tissue.

80. The ultrasonic surgical system according to any one of claims 64-79, wherein: The first pulsed ultrasonic energy comprises a plurality of first ultrasonic energy pulses separated by ultrasonic energy at a first minimum ultrasonic energy level for a first period of time, each of the first ultrasonic energy pulses peaking at a maximum ultrasonic energy level set for the ultrasonic instrument and lasting for a second period of time.

81. The ultrasonic surgical system according to claim 80, wherein: The second period of time is smaller than each of the first periods of time.

82. The ultrasonic surgical system according to claim 80 or 81, wherein: The first minimum ultrasonic energy level is less than or equal to 5% of the maximum ultrasonic energy level.

83. The ultrasonic surgical system according to any one of claims 80-82, as long as it is directly or indirectly dependent on any one of claims 67-73, wherein: The second pulsed ultrasonic energy comprises a plurality of second ultrasonic energy pulses separated by ultrasonic energy at a second minimum ultrasonic energy level for a third period of time, each of the second ultrasonic energy pulses peaking at a maximum ultrasonic energy level set for the ultrasonic instrument and lasting for a fourth period of time.

84. The ultrasonic surgical system according to claim 83, wherein: The fourth time period is smaller than each of the third time periods.

85. The ultrasonic surgical system according to claim 83 or 84, wherein: Each of the third time periods is smaller than each of the first time periods.

86. An ultrasonic surgical system according to any one of claims 83-85, wherein: The second minimum ultrasonic energy level is greater than the first minimum ultrasonic energy level.

87. An ultrasonic surgical system according to any one of claims 83-86, wherein: The second minimum ultrasonic energy level is greater than or equal to 1 μ% of the maximum ultrasonic energy level.

88. An ultrasonic surgical system according to any one of claims 83-87, wherein: The pulse frequency of the first pulsed ultrasonic energy is greater than the pulse frequency of the second pulsed ultrasonic energy.

89. The ultrasonic surgical system according to any one of claims 83-88, wherein: The duty cycle of the first pulsed ultrasonic energy is smaller than the duty cycle of the second pulsed ultrasonic energy.

90. An ultrasonic surgical system according to any one of claims 83-89, as long as it is directly or indirectly dependent on claim 72 or 73, the third pulsed ultrasonic energy includes a plurality of third ultrasonic energy pulses separated by ultrasonic energy lasting for a fifth period of time at a third minimum ultrasonic energy level, each of the third ultrasonic energy pulses reaching a peak at a maximum ultrasonic energy level set for the ultrasonic instrument and lasting for a sixth period of time.

91. The ultrasonic surgical system according to claim 90, wherein: The sixth time period is smaller than each of the fifth time periods.

92. The ultrasonic surgical system according to claim 90 or 91, wherein: Each of the fifth time periods is smaller than each of the first time periods and larger than each of the third time periods.

93. The ultrasonic surgical system according to any one of claims 90-92, wherein: The third minimum ultrasonic energy level is greater than the first minimum ultrasonic energy level and less than the second minimum ultrasonic energy level.

94. The ultrasonic surgical system according to any one of claims 90-93, wherein: The third minimum ultrasonic energy level is greater than or equal to 10% of the maximum ultrasonic energy level, and the second minimum ultrasonic energy level is greater than or equal to 30% of the maximum ultrasonic energy level.

95. The ultrasonic surgical system according to any one of claims 90-94, wherein: The pulse frequency of the third pulsed ultrasonic energy is less than the pulse frequency of the first pulsed ultrasonic energy and greater than the pulse frequency of the second pulsed ultrasonic energy.

96. An ultrasonic surgical system according to any one of claims 90-95, wherein: The duty cycle of the third pulsed ultrasonic energy is greater than the duty cycle of the first pulsed ultrasonic energy and less than the duty cycle of the second pulsed ultrasonic energy.

97. An ultrasonic surgical system according to any one of claims 64-96, and wherein the control system is configured to: determining one or more characteristics of an AC drive signal supplied to the ultrasonic instrument corresponding to the fluorescence indicating that the tip is contacting the first type of tissue; determining that the one or more characteristics indicate that the tip is contacting a second type of tissue different from the first type of tissue; and In response to determining that the one or more features indicate that the tip is contacting a second type of tissue different than the first type of tissue, a surgical error is determined.

98. An ultrasonic surgical system according to any one of claims 64-97, wherein: The fluorescent indicator tip is contacting a first type of tissue, and the ultrasonic surgical system further includes a localizer configured to cooperate with a tracker fixed to the ultrasonic instrument to generate positioning data indicating a pose of the ultrasonic instrument in a known coordinate system, and the control system is further configured to: receiving a medical image of a target site, the target site including ablation target tissue; generating a virtual boundary associated with an ablation target tissue in a known coordinate system based on the medical image; determining, based on the virtual boundary, that the positioning data indicates that the tip of the ultrasonic instrument is contacting the ablation target tissue; and determining that the fluorescence corresponding to the positioning data indicating that the tip of the ultrasound instrument is contacting the ablation target tissue indicates that the tip of the ultrasound instrument is not contacting the ablation target tissue; and In response to determining that the positioning data indicates that the tip of the ultrasound instrument is contacting the ablation target tissue and the fluorescence indicates that the tip of the ultrasound instrument is not contacting the ablation target tissue, a navigation error is determined.

99. The ultrasonic surgical system according to claim 98, wherein: The control system is configured to modify a pose of the virtual boundary in the known coordinate system in response to determining a navigation error.

100. The ultrasonic surgical system according to claim 99, wherein: The control system is configured to store ablation data indicating the position of the tip of an ultrasonic instrument tracked in a known coordinate system and, for each of the positions, an indication based on fluorescence of whether the tip is contacting ablation target tissue, and wherein the control system is configured to modify the position of a virtual boundary in the known coordinate system based on the ablation data.

101. An ultrasonic surgical system, comprising: an ultrasonic instrument comprising an aspiration path, an irrigation path, a tip, and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue at a target site; a sampling element coupled to the ultrasonic instrument, comprising at least one optical fiber configured to collect fluorescent light emitted from tissue contacted by the operative end of the tip; as well as One or more controllers configured to: determining a first tissue characteristic of tissue contacted by the operative end of the tip indicated by the collected fluorescence; determining a characteristic of an AC drive signal supplied to an ultrasonic instrument corresponding to the collected fluorescence indicative of the first tissue characteristic; determining a second tissue characteristic of tissue contacted by the operative end of the tip indicated by the characteristic of the AC drive signal; and At least one indicator corresponding to the first and second tissue characteristics is displayed.

102. The ultrasonic surgical system according to claim 101, wherein: The at least one indicator indicates the type of tissue contacted by the operative end of the tip.

103. The ultrasonic surgical system according to claim 101 or 102, wherein: The at least one indicator indicates whether the tissue contacted by the operative end of the tip is target tissue or non-target tissue.

104. The ultrasonic surgical system according to any one of claims 101-103, wherein: The one or more controllers are configured to: determining whether the first tissue characteristic is inconsistent with the second tissue characteristic; and In response to determining that the first tissue characteristic is inconsistent with the second tissue characteristic, a system error is indicated.

105. The ultrasonic surgical system according to any one of claims 101-104, wherein: The characteristic of the AC drive signal includes a voltage of the AC drive signal.

106. The ultrasonic surgical system according to any one of claims 101-105, wherein: The one or more controllers are configured to: calculating a mechanical resistance presented by the ultrasonic instrument based on characteristics of the AC drive signal; and The at least one indicator is generated based on the mechanical resistance.

107. The ultrasonic surgical system according to claim 106, wherein: The one or more controllers are configured to: determining whether the first tissue characteristic is inconsistent with mechanical resistance; and In response to determining that the first tissue characteristic is inconsistent with the mechanical resistance, a system error is indicated.

108. The ultrasonic surgical system of any one of claims 101-107, further comprising a localizer configured to generate positioning data indicative of a position of an operative end of the tip in a known coordinate system, wherein the one or more controllers are configured to: determining, based on the localization data, a position of an operative end of the tip corresponding to the collected fluorescence indicative of the first tissue feature in a known coordinate system; and At least a portion of the known coordinate system is displayed, wherein the at least one indicator is shown at the determined location.

109. The ultrasonic surgical system according to claim 108, wherein: The one or more controllers are further configured to: receiving a medical image of a target area; generating at least one virtual boundary associated with the target site in a known coordinate system based on the medical image; determining, based on the at least one virtual boundary, a third tissue characteristic of the tissue contacted by the operative end of the tip indicated by the determined position; determining whether the third tissue characteristic is inconsistent with the first tissue characteristic and / or the second tissue characteristic; and In response to determining that the third tissue characteristic is inconsistent with the first tissue characteristic and / or the second tissue characteristic, a system error is indicated.

110. The ultrasonic surgical system according to claim 109, wherein: The one or more controllers are further configured to, in response to determining that the third tissue feature is inconsistent with the first tissue feature and / or the second tissue feature, adjust the position and / or orientation of the at least one virtual boundary in the known coordinate system based on the first tissue feature and / or the second tissue feature.

111. The ultrasonic surgical system according to any one of claims 108-110, wherein: The one or more controllers are configured to: For each of the positions indicated by the positioning data: determining a first tissue characteristic indicated by fluorescence emitted from the tissue and collected by the sampling element corresponding to the localization data indicative of the location; determining a second tissue characteristic indicated by an AC drive signal supplied to the ultrasonic instrument corresponding to the positioning data indicative of the location; and The at least a portion of the known coordinate system is displayed, wherein at each location at least one indicator is shown, the at least one indicator corresponding to the first and second tissue characteristics determined for that location.

112. The ultrasonic surgical system according to any one of claims 101-111, wherein: The target site includes ablation target tissue, and the ultrasonic surgical system also includes a sensor connected to the suction path, the sensor being configured to generate sensor data indicating a fourth tissue characteristic of the resected tissue moving through the suction path, wherein the one or more controllers are configured to track the resection status of the ablation target tissue based on the fourth tissue characteristic and the first tissue characteristic and / or the second tissue characteristic during the surgical procedure.

113. The ultrasonic surgical system according to claim 112, wherein: The fourth tissue characteristic includes the volume and / or weight of the resected tissue moved through the aspiration path.

114. The ultrasonic surgical system according to claim 112 or 113, wherein: The one or more controllers are configured to: tracking a volume of ablation target tissue that has been resected based on the first tissue feature and / or the second tissue feature and based on a fourth tissue feature; and Displays the tracked volume.

115. The ultrasonic surgical system of claim 114, wherein: The one or more controllers are configured to: comparing the tracked volume to a predetermined resection volume; and Based on the comparison, a notification of completion of resection of the ablation target tissue is displayed.

116. An ultrasonic surgical system, comprising: an ultrasonic instrument comprising an aspiration path, an irrigation path, a tip, and a driver coupled to the tip, the driver configured to vibrate the tip in response to receiving an AC drive signal to ablate tissue at a target site; a sampling element coupled to the ultrasonic instrument, comprising at least one optical fiber configured to collect fluorescent light emitted from tissue contacted by the operative end of the tip; and One or more controllers configured to: determining a first tissue characteristic of tissue contacted by the operative end of the tip indicated by the collected fluorescence; determining a characteristic of an AC drive signal supplied to the ultrasonic instrument corresponding to the collected fluorescence indicative of the first tissue characteristic; determining a second tissue characteristic of tissue contacted by the operative end of the tip indicated by the characteristic of the AC drive signal; determining whether the first tissue characteristic is inconsistent with the second tissue characteristic; and In response to determining that the first tissue characteristic is inconsistent with the second tissue characteristic, a system error is indicated.

117. An ultrasonic surgical system, comprising: an ultrasonic instrument comprising an aspiration path, an irrigation path, a tip, and a driver coupled to the tip, the driver configured to vibrate the tip to ablate tissue in response to receiving an AC drive signal; a sampling element coupled to the ultrasonic instrument, comprising at least one optical fiber configured to collect fluorescent light emitted from tissue contacted by the operative end of the tip; and a sensor coupled to the aspiration path for measuring a characteristic of the resected tissue moving through the aspiration path; as well as A control system configured to: determining a first tissue characteristic of tissue contacted by the operative end of the tip indicated by the collected fluorescence; determining a second tissue characteristic of the resected tissue moving through the aspiration path as indicated by the sensor; determining a resection status based on the first and second tissue characteristics; as well as Displays the resection status.

Images