Artificial intelligence for robotic surgery

Abstract

To provide artificial intelligence suitable for robotic surgical procedures. [Solution] The apparatus for robotic surgery comprises a processor configured to receive patient data from the patient being treated, receive surgical robotics data for each of the multiple patients being treated, and output a treatment plan for the patient to be treated in response to the patient data and surgical robotics data. This approach has the advantage of adapting to individual differences between patients and surgical system parameters to provide improved treatment outcomes.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Application No. 62 / 688,349, filed on June 21, 2018, entitled "ARTIFICIAL INTELLIGENCE FOR SURGICAL ROBOTIC SURGERY", the entire disclosure of which is incorporated herein by reference.

[0002] The subject matter of this application is related to PCT / US2015 / 048695, filed on September 4, 2015, entitled "PHYSICIAN CONTROLLED TISSUE RESECTION INTEGRATED WITH TREATMENT MAPPING OF TARGET ORGAN IMAGES", PCT / US2015 / 048687, filed on September 4, 2015, entitled "GENE ANALYSIS AND GENERATION OF STEM CELL METHODS AND APPARATUS", PCT / US2015 / 038605, filed on June 30, 2015, entitled "FLUID JET TISSUE RESECTION AND COLD COAGULATION (AQUABLATION) METHODS AND APPARATUS", PCT / US2015 / 037521, filed on June 24, 2015, entitled "TISSUE SAMPLING AND CANCER TREATMENT METHODS AND APPARATUS", and PCT / US2014 / 054412, filed on September 5, 2015, entitled "AUTOMATED IMAGE - GUIDED TISSUE RESECTION AND TREATMENT", the entire disclosures of which are incorporated herein by reference.

Background Art

[0003] Surgical robotics has led to new surgical techniques and improvements to previous ones. However, previous methods and devices for robotic surgery may be sub-ideal in at least some aspects. For example, previous approaches may be sub-ideal in addressing individual differences such as tissue ablation rates and healing. Additionally, extra factors such as surgical setting time and treatment time may be related to outcomes and can be sub-ideal in addressing using previous methods and devices.

[0004] At least some previous surgical procedures may be near-ideal for customizing surgical procedures to suit the specific desires of individual patients. For example, in prostate surgery, such as surgery for benign prostatic hyperplasia (BPH), there may be a trade-off between the effectiveness of the procedure and the possible side effects. Prostate surgery may typically involve cutting or ablating BPH tissue near delicate tissue structures such as the seminal cumulus, which are important for male sexual function. Research related to this disclosure suggests that determining the location and amount of BPH tissue to be removed in relation to patient-specific preferences may be helpful.

[0005] Based on the above, improved methods and devices for surgical procedures would be useful. Ideally, such methods and devices would improve upon at least some of the shortcomings of previous procedures. [Overview of the Initiative] [Means for solving the problem]

[0006] In the first aspect, the device for robotic surgery comprises a processor configured with instructions that receive patient data from the patient being treated, receive surgical robotics data for each of the multiple patients being treated, and output a treatment plan for the patient to be treated in response to the patient data and surgical robotics data. This approach has the advantage of adapting to individual differences between patients and surgical system parameters to provide improved treatment outcomes. The present invention provides, for example, the following: (Item 1) A device for robotic surgery, wherein the device is A processor, wherein the processor is Receiving patient data for each of multiple patients being treated, wherein the data for each of the multiple patients being treated comprises one or more of the following: patient demographic data, section profiles of the tissue to be removed, actual profiles of the tissue to be removed, target volume of the tissue to be removed, actual volume of the tissue to be removed, or the ratio of the amount of tissue targeted for removal to the amount to be removed. The method involves receiving surgical robotics data for each of the aforementioned multiple patients being treated, wherein the surgical robotics data includes multiple treatment parameters recorded during treatment, treatment time, setup time, imaging time, time the treatment probe moves, multiple locations and orientations of the treatment probe, multiple images of the tissue, multiple images of the tissue comprising the treatment probe, or the intensity of the energy source for removing the tissue. In response to the aforementioned patient data and surgical robotics data, output a treatment plan for the patient to be treated. A processor, which consists of instructions for performing that task. A device equipped with the following features. (Item 2) The apparatus according to item 1, further comprising receiving adjustments to the treatment plan of the patient to be treated, wherein the adjustments to the treatment plan of the patient to be treated include adjustments to one or more of the following: the cutting profile of the tissue to be removed, the actual profile of the tissue to be removed, the target volume of the tissue to be removed, the actual volume of the tissue to be removed, the treatment time, the setup time, the imaging time, the time the treatment probe moves, the intensity of the energy source for removing the tissue, or the ratio of the amount of tissue targeted for removal to the amount to be removed. (Item 3) The apparatus according to item 2, wherein the cutting profile comprises multiple locations having multiple angular coordinates centered on a treatment axis, multiple corresponding axial coordinates along the axis, and multiple radial distances from the axis, and adjustment of the cutting profile includes adjustment of the multiple angular coordinates centered on the treatment axis, the multiple corresponding axial coordinates along the axis, or the multiple radial distances from the axis. (Item 4) The apparatus according to item 1, wherein the processor is configured to display an initial dissection profile superimposed on an image of the tissue to be excised on a display, and to display an adjusted dissection profile on an image of the tissue to be treated. (Item 5) The apparatus according to item 1, wherein the plurality of treatment parameters recorded during treatment include a measured treatment time, a measured setup time, a measured imaging time, a measured time during which the treatment probe moves, a measured intensity of the energy source for tissue removal, a plurality of recorded positions of the treatment probe, a plurality of recorded images of the tissue during treatment, a plurality of recorded orientations of the treatment probe, and a plurality of tissue images corresponding to each of the plurality of recorded positions and orientations. (Item 6) The apparatus according to item 5, wherein the plurality of treatment parameters recorded during treatment comprises a plurality of sequentially arranged data frames, each of which comprises an image of the tissue, an image of the treatment probe positioned relative to the tissue being treated, the position of the treatment probe, the orientation of the treatment probe, or the energy of the treatment probe, and optionally, each of the plurality of sequentially arranged data frames corresponds to a substantially fixed time interval between each of the plurality of frames. (Item 7) The apparatus according to any one of the items, wherein the patient demographic data relating to each of the plurality of patients and the patient to be treated comprises one or more of the following: patient age, weight, sex, obesity index, race, geography, diet, or family structure. (Item 8) The apparatus according to item 1, wherein the intensity of the energy source comprises water jet intensity, light beam intensity, radio frequency energy intensity, ionizing radiation intensity, stereotactic radiation intensity, or ultrasonic energy intensity. (Item 9) The apparatus according to item 1, wherein a treatment plan for the patient to be treated, in response to the patient data and the surgical robotics data, is determined using processor instructions that include one or more of artificial intelligence or machine learning. (Item 10) The apparatus according to item 9, wherein the treatment plan is determined using the artificial intelligence processor instructions, the artificial intelligence processor instructions comprising one or more of the following: machine learning, search and mathematical optimization, artificial neural networks, statistics, probability, support vector machine learning, clustering of data sets, image classification, or image segmentation. (Item 11) The apparatus according to item 9, wherein the treatment plan is determined using the machine learning processor instructions, the machine learning processor instructions comprising one or more of the following: decision tree learning, association rule learning, artificial neural networks, deep learning, inductive logic programming, support vector machines, clustering, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, sparse dictionary learning, genetic algorithms, rule-based machine learning, or a learning classifier system. (Item 12) The apparatus according to item 11, wherein the instructions further cause the processor to receive human interaction, provide input, and use one or more of several AI tools to select an AI approach, select visualizations of different recommended treatment plans, or change the importance of the data used to generate the treatment plans. (Item 13) The apparatus according to any one of the items, wherein the artificial intelligence or machine learning is trained on patient data for each of the multiple patients to be treated and surgical robotics data for each of the multiple patients to be treated, and the treatment plan for the patient to be treated is determined in response to the artificial intelligence or machine learning trained in response to the patient data to be treated and the surgical robotics data. (Item 14) The apparatus according to any one of the preceding items, wherein the target volume of the tissue to be removed comprises the total volume of the tissue targeted for removal, and the actual volume of the tissue to be removed comprises the actual total volume of the tissue to be removed. (Item 15) The apparatus according to any one of the above items, wherein the artificial intelligence ("AI") or machine learning is configured to train the AI ​​or machine learning algorithm on multiple treatment plans and patient outcomes (optionally, based on physician or patient-reported information) for multiple patients to be treated, and to determine a treatment plan for the patient to be treated. (Item 16) The apparatus according to item 15, wherein the multiple treatment plans to be treated are coupled to corresponding outcomes having one or more of a quality of life score, sexual function, treatment endurance, or flow rate, and the AI ​​or machine learning is configured to provide a semi-automatic plan and optimize the treatment contour based on the patient's prostate biostructure of the patient to be treated. (Item 17) The outcome data of the multiple patients being treated is used as input to train the AI ​​or machine learning classifier, optionally comprising one or more of the following: hemoglobin loss, complications, pain score, time to return to work, urinary flow data, catheter insertion time, hospitalization, days to optional adjustment, hemostasis method, sexual function measurement, balloon model, balloon technique, catheter tension, Foley catheter tension, catheter tension device method, surgical case record, anesthesia used, use of analgesics, or pre- and post-procedure urodynamics, optionally configured the AI ​​or machine learning to perform calculations, determine an adjusted treatment plan, and refine critical outcome measurement, optionally comprising the adjusted treatment plan, an adjusted treatment profile, optionally comprising the adjusted treatment profile, the apparatus according to any one of the above items. (Item 18) The apparatus according to any one of the items, wherein the AI ​​or machine learning is trained to automatically adjust the penetration depth based on image recognition of imaging parameters of tissue images of a patient between treatments, in response to the AI ​​or machine learning being trained on multiple patients being treated, and optionally the automatic adjustment has an intended penetration depth compared to the actual penetration depth, and the AI ​​or machine learning is configured to automatically adjust the cutting profile if there is a mismatch, or to vary the intensity of the source based on tissue density. (Item 19) The apparatus according to item 18, wherein the cutting profile is adjusted in response to values ​​of biomechanical tissue parameters measured from the patient. (Item 20) The apparatus according to any one of the above items, wherein the AI ​​or machine learning is trained using reference data comprising a library of many ultrasound images from charts with peer-reviewed identification of identifiable organ tissue surfaces and anatomical features such as the prostatic capsule, bladder neck, sphincter, seminal cumulus, duct, middle lobe, lateral lobe, etc., the AI ​​or machine learning is configured to provide physician-assisted guidance to the patient to be treated in response to data of the patient to be treated, and the AI ​​or machine learning is trained using the reference data. (Item 21) An apparatus for determining a tissue removal profile for prostate surgery of a patient having seminal hills, said apparatus comprising: A processor, said processor comprising: Displaying an image of the prostate; Displaying a tissue removal profile on said image of the prostate; Displaying one or more of an effectiveness parameter, a probability of reduction of sexual function, or a probability of retreatment of the prostate using said cutting profile and said image of the prostate A processor configured with instructions for performing the above; An apparatus comprising the above. (Item 22) The apparatus according to Item 21, wherein said processor comprises instructions for receiving a digital signature from said patient for approving one or more of said effectiveness parameter, said probability of reduction of sexual function, or said probability of retreatment. (Item 23) The apparatus according to Item 22, wherein said processor comprises instructions for displaying said digital signature together with one or more of said image of the prostate, said cutting profile, said effectiveness parameter, said probability of reduction of sexual function, or said probability of retreatment. (Item 24) An apparatus for determining a treatment plan for prostate surgery of a patient having seminal hills, said apparatus comprising: A processor, said processor comprising: Receiving user input comprising a sexual importance parameter corresponding to the importance of sexual activity for said patient and an acceptance parameter corresponding to the tolerance of said patient for a second prostate surgery of said patient; Outputting the aforementioned treatment plan, the treatment plan comprising instructions for removing tissue up to a distance from the seminal cumulus, wherein the distance is further from the seminal cumulus when the sexual importance parameter corresponds to an increase in the importance of sexual activity and the acceptance parameter corresponds to an increase in acceptance of the second prostatectomy, and the distance is closer to the seminal cumulus when the sexual activity parameter corresponds to a decrease in the importance of sexual activity and acceptance of the second prostatectomy. A processor, which consists of instructions for performing that task. A device equipped with the following features. (Item 25) The apparatus according to item 24, wherein the treatment plan comprises a tissue removal profile, and the processor comprises instructions for generating the tissue removal profile in response to the user input. (Item 26) The apparatus according to item 25, wherein the tissue removal profile comprises the distance to the spermatic duct, the distance increasing with increasing importance and tolerability, and decreasing with decreasing importance and tolerability. (Item 27) The apparatus according to item 24, wherein the processor comprises an instruction to display a tissue removal profile on the image of the prostate, and optionally the image comprises an image of the patient's prostate. (Item 28) The apparatus described in item 27 includes one or more of the following images: ultrasound imaging, magnetic resonance imaging, computed tomography (CT) scan imaging, or cystoscopy imaging. (Item 29) The apparatus described in item 28, wherein the ultrasonic imaging includes one or more of pulsed ultrasound, echo ultrasound, Doppler ultrasound, or shear wave elastic imaging. (Item 30) The apparatus according to item 27, wherein the image of the prostate includes one or more sagittal or transverse images of the prostate. (Item 31) The apparatus according to item 30, wherein the image of the prostate further comprises one or more of the following: parasagittal, coronal, paracoronal, or three-dimensional images. (Item 32) The apparatus according to item 27, wherein the image comprises the spermatic cumulus of the prostate, and optionally, the spermatic cumulus of the prostate comprises an image of the patient's spermatic cumulus. (Item 33) The apparatus according to item 27, wherein the processor provides instructions for moving the removal profile shown on the display further away from the genitals in response to increased importance and increased tolerance, and closer to the genitals in response to decreased importance and increased tolerance. (Item 34) The apparatus according to item 24, wherein the processor comprises a command to receive a ranking parameter corresponding to a ranking of the importance of the sexual act in relation to the acceptance of the second prostate surgery, the distance to the cumulus increases with increasing importance of the sexual act and decreasing acceptance of the second prostate surgery in response to the ranking parameter indicating that the sexual act corresponds to an importance greater than the acceptance of the second prostate surgery, and the distance to the cumulus decreases with increasing importance of the sexual act and decreasing acceptance of the second prostate surgery in response to the ranking parameter indicating that the sexual act corresponds to an importance less than the acceptance of the second procedure. (Item 35) The apparatus according to item 24, wherein the processor comprises instructions for generating a first prostate tissue removal profile in response to the first importance of sexual intercourse and the first acceptance of the second prostate surgery, and a second prostate tissue removal profile in response to the second sexual importance of sexual intercourse and the second acceptance of the second prostate surgery. (Item 36) The apparatus according to item 35, wherein the first prostate tissue removal profile comprises a first distance to the seminal cumulus along the first prostate tissue removal profile, and the second prostate tissue removal profile comprises a second distance to the seminal cumulus along the second prostate tissue removal profile. (Item 37) The apparatus according to item 36, wherein the first distance is greater than the second distance when the first importance and first tolerance are less than the second importance and second tolerance, and the first distance is less than the second distance when the first importance and first tolerance are less than the second importance and second tolerance. (Item 38) The apparatus according to item 37, wherein the processor generates a treatment command for moving an energy source in accordance with the treatment plan, and in response to the user inputting the first importance and first acceptance or the second importance and second acceptance, the command to remove the prostate tissue to the first distance or the second distance. (Item 39) A device for excising tissue from a patient's organs, wherein the device is The display and A processor operably coupled to the display, wherein the processor is Receiving one or more of the safety or efficacy parameters relating to the aforementioned patient, Receiving images of the aforementioned organs, Determining the resection profile of the organ in response to the aforementioned image and one or more of the aforementioned safety or efficacy parameters, The excision profile is displayed on the aforementioned display along with the aforementioned image. A processor and A device equipped with the following features. (Item 40) The apparatus according to item 39, wherein the organ has a delicate tissue structure, the excision profile comprises a protective zone, and the protective zone of the removal profile is determined in response to an image of the organ and one or more of the safety profile or the efficacy profile. (Item 41) The apparatus according to item 40, wherein the organ comprises a prostate gland, and the delicate tissue structure comprises the spermatic cumulus of the prostate gland. (Item 42) The aforementioned delicate tissue structure comprises cancerous tissue, as described in item 40. (Item 43) The apparatus according to item 40, wherein the protective zone is one of a plurality of protective zones, and the plurality of protective zones of the removal profile are determined in response to at least one or more of the image of the organ and the safety profile or the efficacy profile. (Item 44) The apparatus according to item 43, wherein one or more of the aforementioned protective zones are associated with an excision profile determined at least partially on the basis of avoiding damage to delicate tissue structures or avoiding damage to pathogenic tissue. (Item 45) The apparatus according to item 40, wherein images of the organ are displayed on the display in sagittal and transverse views along with the resection profile, and the resection profile comprises a three-dimensional stereoscopic resection profile. (Item 46) The apparatus according to item 40, wherein the processor is configured to include commands for displaying an image of the organ together with the resection profile in one or more of the following: sagittal, parasagittal, transverse, coronal, paracoronal, or three-dimensional images. (Item 47) The apparatus according to item 46, wherein the processor is configured to include instructions for displaying the safety parameters and the effectiveness parameters on the display. (Item 48) The apparatus according to item 46, wherein the processor is configured to receive user input, adjust the excision profile shown on the display, generate an adjusted excision profile, and, in response to the user-adjusted excision profile, determine a second value of one or more safety or efficacy parameters on the display. (Item 49) The apparatus according to item 39, wherein the processor is configured to include instructions for displaying the safety parameters and the effectiveness parameters on the display. (Item 50) The apparatus according to item 39, wherein the processor is configured with instructions for displaying a value for a target safety parameter, a value for a target efficacy parameter, a modified safety parameter, and a modified efficacy parameter, the modified safety parameter and the modified efficacy parameter being updated in real time in response to the user modifying the excision profile and displayed on the display. (Item 51) The apparatus according to item 39, wherein the organ comprises a prostate gland, and the processor comprises instructions for identifying the location of the spermatic cumulus of the prostate gland. (Item 52) The apparatus described in item 39, wherein the imaging of the organ includes one or more of the following: tissue boundary recognition, tissue surface recognition, tissue differentiation detection, fluorescence fluoroscopy, CT scan imaging, magnetic resonance imaging, radioactivity detection, or radiopaque imaging. (Item 53) A device for excising tissue from a patient's organs, wherein the device is The display and A processor operably coupled to the display, wherein the processor is Receiving images of the aforementioned organs, Receiving the resection profile of the aforementioned organ, Displaying the value of one or more of the safety parameters or efficacy parameters in response to the excision profile and the image. A processor and A device equipped with the following features. (Item 54) The apparatus according to item 53, wherein the organ comprises a delicate tissue structure, and the processor is configured with instructions to determine the location of the delicate tissue structure in relation to the excision profile, and to display a value of one or more of the safety parameters or the efficacy parameters in response to the location of the delicate tissue structure and the excision profile. (Item 55) The apparatus according to item 54, wherein the organ comprises a prostate gland, and the delicate tissue structure comprises the spermatic cumulus of the prostate gland. (Item 56) The aforementioned delicate tissue structure comprises cancerous tissue, as described in item 54. (Item 57) The apparatus according to item 54, wherein the excision profile comprises one or more protective zones determined at least in part on one or more of the following: reducing damage to the delicate tissue structure or avoiding damage to the pathogenic tissue. (Item 58) The apparatus according to item 53, wherein images of the organ are displayed on the display in sagittal and transverse views along with the resection profile, and the resection profile comprises a three-dimensional stereoscopic resection profile. (Item 59) The apparatus according to item 53, wherein the processor is configured to include commands for displaying images of the organ superimposed on the resection profile in sagittal and transverse views. (Item 60) The apparatus according to item 59, wherein the processor is configured to include instructions for displaying the safety parameters and the effectiveness parameters on the display. (Item 61) The apparatus according to item 53, wherein the processor is configured to receive user input, adjust the excision profile shown on the display, generate an adjusted excision profile, and, in response to the user-adjusted excision profile, determine a second value of one or more safety or efficacy parameters on the display. (Item 62) The apparatus according to item 53, wherein the processor is configured to include instructions for displaying the safety parameters and the effectiveness parameters on the display. (Item 63) The apparatus according to item 53, wherein the processor is configured with instructions for displaying a value for a target safety parameter, a value for a target efficacy parameter, a modified safety parameter, and a modified efficacy parameter, the modified safety parameter and the modified efficacy parameter being updated in real time in response to the user modifying the excision profile and displayed on the display. (Item 64) The apparatus according to item 53, wherein the organ comprises a prostate gland, and the processor comprises instructions for identifying the location of the spermatic cumulus of the prostate gland. (Item 65) The apparatus according to any one of the above items, comprising a cutting profile. (Item 66) The apparatus according to any one of the preceding items, wherein the energy source for excising tissue to the excision profile comprises one or more of the following: mechanical energy, water jet, electromagnetic energy, laser energy, radio frequency (RF) energy, radiotherapy (RT) energy, ultrasonic energy, steam, water vapor energy, superheated steam energy, or steam energy. (Item 67) The device according to any one of the above items, wherein the patient data comprises one or more of the following: tensile strength, modulus of elasticity, elasticity, vascular distribution, biomarker data, drug history, or genetic data. (Item 68) The apparatus according to any one of the items, wherein the processor is configured with instructions for the user to select one or more parameters used to determine one or more of the following: safety parameter values, efficacy parameter values, or proposed tissue resection profiles. (Item 69) The apparatus according to any one of the above items, wherein the processor is configured to allow a user to plan a surgical procedure on a first display remotely from the surgical system, to store parameters relating to the planned surgical procedure, and to provide the parameters to the processor which is operably coupled to the display of the surgical system. (Item 70) A method for robotic surgery, comprising the step of performing a step of a processor instruction as described in any one of the preceding items. (Integrated by reference)

[0007] All publications, patents, and patent applications described herein are incorporated herein by reference to the same extent as each individual publication, patent, or patent application is specifically and individually indicated to be incorporated by reference. [Brief explanation of the drawing]

[0008] Novel features of the present invention are described in detail in the appended claims. A deeper understanding of the features and advantages of the present invention can be obtained by referring to the following embodiments for carrying out the invention, which describe illustrative embodiments in which the principles of the present invention are utilized, and to the accompanying drawings.

[0009] [Figure 1] Figure 1 is a schematic diagram of a device suitable for performing intraurethral prostate tissue reduction, according to several embodiments.

[0010] [Figure 2A] Figures 2A-2D illustrate the use of the device shown in Figure 1 during prostate tissue reduction surgery. [Figure 2B] Figures 2A-2D illustrate the use of the device shown in Figure 1 during prostate tissue reduction surgery. [Figure 2C] Figures 2A-2D illustrate the use of the device shown in Figure 1 during prostate tissue reduction surgery. [Figure 2D] Figures 2A-2D illustrate the use of the device shown in Figure 1 during prostate tissue reduction surgery.

[0011] [Figure 3A] Figures 3A and 3B show systems for treating patients according to several embodiments. [Figure 3B]Figures 3A and 3B show systems for treating patients according to several embodiments.

[0012] [Figure 4A] Figure 4A shows pressure regulation at the surgical site using substantially constant pressure and variable flow rate in several embodiments.

[0013] [Figure 4B] Figure 4B illustrates flow control at a surgical site using a pump that provides a substantially fixed fluid flow rate and substantially constant pressure, according to several embodiments.

[0014] [Figure 5A] Figure 5A shows suitable organs for incorporation in various embodiments.

[0015] [Figure 5B] Figure 5B shows the prostate gland of Figure 5A treated with the device according to many embodiments.

[0016] [Figure 6A] Figure 6A shows the excision inflammation area visible to the human eye in several embodiments.

[0017] [Figure 6B] Figure 6B shows a high-speed image of the excised inflammation area as shown in Figure 6A.

[0018] [Figure 7] Figure 7 shows sweeps of multiple scattered pulses and excision jets that provide smooth, controlled tissue erosion at multiple overlapping locations, according to several embodiments.

[0019] [Figure 8A] Figure 8A shows mounting devices according to several embodiments.

[0020] [Figure 8B] Figure 8B shows the components of the mounting device.

[0021] [Figure 8C] Figure 8C shows a component of a mounting device with a coupling in a partially retracted position, and an extension carrier comprising an energy source extending through the coupling toward the distal end of the extension support.

[0022] [Figure 8D] Figure 8D shows the distal portion of an extension tube having an extension support and a connecting portion mounted thereon.

[0023] [Figure 8E] Figures 8E1-8E4 show the joints according to several embodiments.

[0024] [Figure 8F] Figure 8F shows a bottom view of the carriage according to several embodiments.

[0025] [Figure 8G] Figure 8G shows end views of the carriage according to several embodiments.

[0026] [Figure 8H] Figure 8H shows isolated endoscopes in several embodiments.

[0027] [Figure 8I] Figure 8I1 shows a side view of an endoscope according to several embodiments. Figure 8I2 shows a side view along cross section AA as in Figure 8I1. Figure 8I3 shows cross section BB of the endoscope in Figure 8I1. Figure 8I4 shows a top view of an endoscope as in Figure 8I1. Figure 8I5 shows the distal end of an endoscope as in Figure 8I1.

[0028] [Figure 8J] Figure 8J shows the housing of a carriage as described herein.

[0029] [Figure 8K]Figure 8K shows an end view of a mounting device as described herein.

[0030] [Figure 8L] Figure 8L shows the components of the arm configured to connect to the mounting device.

[0031] [Figure 8M] Figure 8M shows an upper view of a mounting device according to several embodiments.

[0032] [Figure 8N] Figure 8N shows the components of the arm according to several embodiments.

[0033] [Figure 8O] Figures 8O1 and 8O2 show the internal structure of the arm component shown in Figure 8N.

[0034] [Figure 8P] Figure 8P shows the chain of mounting devices according to several embodiments.

[0035] [Figure 8Q] Figure 8Q shows the encoder mounted on the proximal end of the carrier.

[0036] [Figure 8R] Figure 8R1 shows encoders according to several embodiments. Figure 8R2 shows a table illustrating the coordinate references of different transitions measured using multiple photodetectors.

[0037] [Figure 8S] Figure 8S shows a suction port on the distal end of the support in several embodiments.

[0038] [Figure 8T] Figure 8T shows a console according to several embodiments.

[0039] [Figure 9A] Figures 9A and 9B show side and top views, respectively, of the alignment of the treatment probe axis with the sagittal plane of the imaging probe in several embodiments. [Figure 9B] Figures 9A and 9B show side and top views, respectively, of the alignment of the treatment probe axis with the sagittal plane of the imaging probe in several embodiments.

[0040] [Figure 9C] Figures 9C and 9D show side and top views, respectively, of a therapeutic probe traversing the sagittal image field of view according to several embodiments. [Figure 9D] Figures 9C and 9D show side and top views, respectively, of a therapeutic probe traversing the sagittal image field of view according to several embodiments.

[0041] [Figure 10A] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10B] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10C] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10D] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10E] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10F] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10G] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10H] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10I] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10J]Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10K] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10L] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10M] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10N] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10O] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10P] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10Q] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10R] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10S] Figures 10A-10T show the treatment screen of the device according to several embodiments. [Figure 10T] Figures 10A-10T show the treatment screen of the device according to several embodiments.

[0042] [Figure 11] Figure 11 shows methods for treating a patient according to several embodiments.

[0043] [Figure 12] Figure 12 shows the maximum tissue penetration depth and flow rate through the nozzle for several embodiments.

[0044] [Figure 13] Figure 13 shows selective removal of a potato, with porcine blood vessels positioned across the potato incision, as a model of selective tissue removal in several embodiments.

[0045] [Figure 14] Figure 14 shows potatoes treated using a predetermined treatment profile and treatment table based on user input, according to several embodiments.

[0046] [Figure 15-1] Figure 15 illustrates several embodiments of methods for treating patients using artificial intelligence or machine learning. [Figure 15-2] Figure 15 illustrates several embodiments of methods for treating patients using artificial intelligence or machine learning.

[0047] [Figure 16] Figure 16 shows a processor system according to several embodiments.

[0048] [Figure 17A] Figures 17A-17C show user interface screens of the device according to several embodiments. [Figure 17B] Figures 17A-17C show user interface screens of the device according to several embodiments. [Figure 17C] Figures 17A-17C show user interface screens of the device according to several embodiments.

[0049] [Figure 18] Figure 18 shows the user interface screen of the device according to several embodiments.

[0050] [Figure 19A] Figures 19A-19D show representations of patient treatment in several embodiments. [Figure 19B] Figures 19A-19D show representations of patient treatment in several embodiments. [Figure 19C] Figures 19A-19D show representations of patient treatment in several embodiments. [Figure 19D]Figures 19A-19D show representations of patient treatment in several embodiments.

[0051] [Figure 20] Figure 20 shows methods for treating a patient according to several embodiments.

[0052] [Figure 21] Figure 21 shows exemplary convolutional neural networks in several embodiments.

[0053] [Figure 22] Figure 22 shows methods for training and using a classifier according to several embodiments. [Modes for carrying out the invention]

[0054] The methods and apparatus disclosed herein are highly suitable for use in combination with many types of surgical procedures and related methods and apparatus, such as prostate surgery. The methods and apparatus disclosed herein can be used to determine suitable therapeutic parameters and are suitable for use in combination with devices that use energy used to treat the prostate, such as mechanical energy, radiotherapy, water jet therapy, radiation therapy, laser ablation, and combinations thereof. The methods and apparatus disclosed herein can be used in combination with surgical robotic systems using therapeutic image guidance, multidimensional imaging, autonomous robots, and ablation such as non-thermal water jet ablation. The methods and apparatus disclosed herein can be used to improve many types of surgical robotic procedures, such as joint-based robotic systems, rotary and oscillating shaft systems, and systems with joints capable of mimicking human movement in response to user input. These systems can rely on image guidance, in which surgical parameters are input into the system prior to treatment. The system can be set up by an operator prior to surgery.

[0055] The systems and methods disclosed herein each comprise multiple sensors capable of measuring and recording the state of robotic system components before, during, and after a surgical procedure, which can be used for analysis to improve surgical techniques and outcomes. For example, a surgical robotic system may comprise multiple parameters related to the state of the system and associated components, such as shaft angle, longitudinal position of the shaft, data related to the energy used to ablate tissue (e.g., pressure or irradiance), real-time ultrasound imaging, and real-time endoscopic imaging (e.g., cystoscopy imaging). Data during treatment can be recorded in real time and used to generate multiple data frames corresponding to the state of the surgical robotic system throughout the treatment. The data frames may correspond to fixed time intervals between frames, e.g., one second, to provide suitable input data for processing using machine learning or artificial intelligence as described herein.

[0056] While embodiments of this disclosure specifically relate to the treatment of the prostate, certain aspects of this disclosure may also be used to treat and modify other organs and tissues such as the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testes, bladder, ears, nose, mouth, bone marrow, adipose tissue, muscle, glandular and mucous tissues, spinal cord and nerve tissue, soft tissues such as cartilage, hard biological tissues such as teeth and bones, and body lumens and passages such as sinuses, ureters, colon, esophagus, pulmonary passages, blood vessels, and throat. The devices disclosed herein may be inserted through existing body lumens or through openings created in body tissues.

[0057] Studies related to the embodiment suggest that input patient data, such as demographic data and imaging data of the organ to be treated, such as the prostate, may be relevant to outcomes, such as the sectional profile of the tissue removed. Biopsy data, if available, may also be helpful in determining appropriate adjustments to the planned surgical treatment.

[0058] This input data can be generated and recorded from many types of surgical systems. The methods and apparatus disclosed herein are highly suitable for use in combination with many applications related to surgical robots, and include PCT / US2015 / 048695, filed on September 4, 2015, titled "PHYSICIAN CONTROLLED TISSUE RESECTION INTEGRATED WITH TREATMENT MAPPING OF TARGET ORGAN IMAGES", PCT / US2015 / 048687, filed on September 4, 2015, titled "GENE ANALYSIS AND GENERATION OF STEM CELL METHODS AND APPARATUS", PCT / US2015 / 038605, filed on June 30, 2015, titled "FLUID JET TISSUE RESECTION AND COLD COAGULATION (AQUABLATION) METHODS AND APPARATUS", and PCT / US2015 / 038605, filed on June 24, 2015, titled "TISSUE SAMPLING AND CANCER Many prior system hardware, processors, and software can be incorporated, such as those described in PCT / US2015 / 037521, titled “TREATMENT METHODS AND APPARATUS,” and PCT / US2014 / 054412, filed on September 5, 2015, titled “AUTOMATED IMAGE-GUIDED TISSUE RESECTION AND TREATMENT” (the full disclosure of which is incorporated above by reference). Many of the components of the AQUABEAM SYSTEM, commercially available from Procept BioRobotics, are very suitable for combinations according to the embodiments disclosed herein.

[0059] The embodiments disclosed herein can be combined in many ways to provide an improved treatment to a patient. Some figures refer to some components, and other figures refer to other components, but each of these components may be considered to be combined with one or more of the other components to provide an improved treatment to a patient.

[0060] As used herein, the terms “proximal” and “distal” in relation to the device refer to the proximal and distal components as they are referenced from the device outside the patient, such that the proximal may refer to the external component of the patient and the distal may refer to the internal component of the patient.

[0061] As used herein, similar words and letters represent similar structures.

[0062] As used herein, the terms “carrier probe” and “therapeutic probe” are used synonymously.

[0063] As used herein, the terms “ablation” and “excision” are used synonymously.

[0064] As used herein, “based on” and “in response to” are used synonymously.

[0065] As used herein, the terms “cutting profile” and “excision profile” are used synonymously.

[0066] The subject matter of Figures 1 to 2D and the corresponding text is incorporated by reference as described in U.S. Application No. 12 / 700,568, filed on 4 February 2010 and published as U.S. Application No. 20110184391, titled "MULTI FLUID TISSUE RESECTION METHODS AND DEVICES," and PCT Application No. PCT / US2011 / 023781, filed on 4 February 2011 and published on 8 November 2011 as WO2011097505, titled "MULTI FLUID TISSUE RESECTION METHODS AND DEVICES" (its full disclosure is incorporated above by reference).

[0067] The methods and apparatus disclosed herein are well suited for combination with many commercially available surgical systems and procedures and may comprise one or more components of the AQUABLATION® surgical system for therapy, which is commercially available from Procept BioRobotics Inc. CORPORATION. In some embodiments disclosed herein, a water jet immersed in saline is used to excise tissue, which is referred to herein as “Aquaablation.”

[0068] Referring to Figure 1, an exemplary prostate tissue reduction device 10 constructed according to the principles of the present invention generally comprises a catheter assembly including a shaft 12 having a distal end 14 and a proximal end 16. The shaft 12 will typically be a polymer extruded material containing one, two, three, or four or more axial lumens extending from a hub 18 at the proximal end 16 to a location near the distal end 14. The shaft 12 will generally have a length in the range of 15 cm to 25 cm and a diameter in the range of 1 mm to 10 mm, usually in the range of 2 mm to 6 mm. The shaft will have sufficient columnar strength so that it can be introduced upward through the male urethra, as will be described in more detail below.

[0069] The shaft includes an energy source located within the energy delivery region 20, in which case the energy source may be one of several specific components, as will be discussed in more detail below. Distal to the energy delivery region, an inflatable anchoring balloon 24 will be located at or very close to the distal end 14 of the shaft. The balloon will be connected to a balloon inflation source 26 through one of the axial lumens, connected via a hub 18. In addition to the energy source 22 and the balloon inflation source 26, the hub may optionally further include connections for an injection / wash source 28, a suction (vacuum) source 30, and / or a blow (pressurized CO2 or other gas) source 32. In exemplary embodiments, the injection or wash source 28 may be connected through an axial lumen (not shown) to one or more delivery ports 34 located proximal to the balloon anchor 24 and distal to the energy delivery region 20. The suction source 30 can be connected to a second port or opening 36, which is typically located proximal to the energy delivery area 20, while the blow source 32 can be connected to an additional port 38, which is similarly typically located proximal to the energy delivery area. The locations of ports 34, 36, and 38 are not critical, but it should be understood that certain locations may provide specific advantages as described herein, and that the lumen and delivery means may be provided by additional catheters, tubes, and equivalents, including, for example, coaxial sleeves, sheaths, and equivalents that may be located along the shaft 12.

[0070] Although this embodiment is described with reference to the human prostate, it should be understood that it can also be used to treat the prostate in general in mammals. Referring here to Figures 2A-2D, the prostate tissue decompression device 10 is introduced through the male urethra U to a region within the prostate P located directly distal to the bladder B. The biostructure is shown in Figure 2A. Once the catheter 10 is positioned so that the anchoring balloon 24 is located just distal to the bladder neck BN (Figure 2B), the balloon can be inflated to preferably occupy substantially the entire interior of the bladder, as shown in Figure 2C. Once the anchoring balloon 24 is inflated, the position of the prostate tissue decompression device 10 will be fixed and stabilized within the urethra U so that the energy delivery region 20 is positioned within the prostate P. It should be understood that the proper positioning of the energy delivery region 20 depends solely on the inflation of the anchoring balloon 24 within the bladder. As the prostate gland is located directly proximal to the bladder neck BN, the delivery area can be appropriately positioned by spacing the distal end of the energy delivery area very close to the proximal end of the balloon, typically within a range of 0 mm to 5 mm, preferably 1 mm to 3 mm. After the anchored balloon 24 is inflated, energy can be delivered into the prostate gland for debulking, as indicated by the arrows in Figure 2. Once energy has been delivered over the desired surface area for a certain period of time, the energy area can be stopped, and the prostate gland will be debulked to relieve pressure on the urethra, as shown in Figure 2D. At that point, a lavage fluid may be delivered through port 34 and aspirated into port 36, as shown in Figure 2D. Optionally, post-treatment, the area may be cauterized using a cauterization balloon and / or stent, which may be positioned using a modified or separate catheter device.

[0071] Figures 3A and 3B show a system for treating a patient according to an embodiment. The system 400 comprises a treatment probe 450 and optionally an imaging probe 460. The treatment probe 450 is coupled to a console 420 and a chain section 430. The imaging probe 460 is coupled to an imaging console 490. The patient treatment probe 450 and the imaging probe 460 can be coupled to a common base 440. The patient is supported using a patient support 449. The treatment probe 450 is coupled to the base 440 using an arm 442. The imaging probe 460 is coupled to the base 440 using an arm 444.

[0072] The patient is positioned on a patient support 449 so that the treatment probe 450 and the ultrasound probe 460 can be inserted into the patient. The patient can be positioned in one or more of many positions, such as prone, supine, upright, or inclined. In many embodiments, the patient is positioned in a lithotomy position, and stirrups may be used, for example. In many embodiments, the treatment probe 450 is inserted into the patient in a first direction on a first side of the patient, and the imaging probe is inserted into the patient in a second direction on a second side of the patient. For example, the treatment probe can be inserted into the patient's urethra from the front of the patient, and the imaging probe can be inserted transrectally into the patient's intestines from the rear of the patient. The treatment probe and imaging probe can be positioned in the patient with one or more of the following extending between them: urethral tissue, urethral wall tissue, prostatic tissue, intestinal tissue, or intestinal wall tissue.

[0073] The treatment probe 450 and the imaging probe 460 can be inserted into the patient in one or more of several ways. During insertion, each arm may have a substantially disengaged configuration so that the probe can be rotated and translated as desired to insert the probe into the patient. When the probe is inserted in the desired location, the arms can be locked. In the locked configuration, the probes can be oriented relative to each other in one or more of several ways, such as parallel, curved, horizontal, oblique, or non-parallel. To map the imaging data of the imaging probe to the treatment probe coordinate reference, it may be useful to determine the orientation of the probe using an angle sensor as described herein. Mapping tissue image data to the treatment probe coordinate reference space can enable precise targeting and treatment of tissue identified for treatment by an operator such as a physician.

[0074] In many embodiments, the treatment probe 450 is coupled to the imaging probe 460 to align the treatment with the probe 450 based on images from the imaging probe 460. The coupling can be achieved using a common base 440 as shown. Alternatively, or in combination, the treatment probe and / or imaging probe may be equipped with magnets to hold the probe in alignment through the patient's tissue. In many embodiments, the arm 442 is a movable and lockable arm so that the treatment probe 450 can be positioned at a desired location within the patient. When the probe 450 is positioned at a desired location in the patient, the arm 442 can be locked using an arm lock 427. The imaging probe can be coupled to the base 440 using an arm 444 and can be used to adjust the alignment of the probe when the treatment probe is locked in place. The arm 444 may be equipped with a lockable and movable probe under the control of, for example, an imaging system or console and user interface. The movable arm 444 may be finely adjustable so that the imaging probe 440 can be adjusted with a small movement of about 1 millimeter in relation to, for example, the treatment probe 450.

[0075] In many embodiments, the treatment probe 450 and the imaging probe 460 are coupled to angle sensors so that the treatment can be controlled based on the alignment of the imaging probe 460 and the treatment probe 450. Angle sensor 495 is coupled to the treatment probe 450 using a support 438. Angle sensor 497 is coupled to the imaging probe 460. The angle sensors may comprise one or more of many types of angle sensors. For example, the angle sensors may comprise a goniometer, an accelerometer, and a combination thereof. In many embodiments, angle sensor 495 comprises a three-dimensional accelerometer for determining the orientation of the treatment probe 450 in three dimensions. In many embodiments, angle sensor 497 comprises a three-dimensional accelerometer for determining the orientation of the imaging probe 460 in three dimensions. Alternatively, or in combination, angle sensor 495 may comprise a goniometer for determining the angle of the treatment probe 450 along the extension axis of the treatment probe. Angle sensor 497 may comprise a goniometer for determining the angle of the imaging probe 460 along the extension axis of the imaging probe 460. The angle sensor 495 is coupled to the controller 424. The angle sensor 497 of the imaging probe is coupled to the processor 492 of the imaging system 490. Alternatively, the angle sensor 497 can also be coupled to the controller 424 in combination.

[0076] The console 420 includes a display 425 coupled to a processor system in the components used to control the treatment probe 450. The console 420 includes a processor 423 having memory 421. A communication circuit 422 is coupled to the processor 423 and the controller 422. The communication circuit 422 is coupled to the imaging system 490. The console 420 includes a component of an endoscope 35 coupled to an anchor 24. An injection and irrigation control 28 is coupled to the probe 450 to control injection and irrigation. A suction control 30 is coupled to the probe 450 to control suction. An endoscope 426 may be a component of the console 420, and the endoscope may be insertable using the probe 450 to treat a patient. An arm lock 427 of the console 420 is coupled to the arm 422 to lock the arm 422 or to allow the arm 422 to move freely to insert the probe 450 into the patient.

[0077] The console 420 may include a pump 419 coupled to a carrier and nozzle as described herein.

[0078] The processor, controller, and control electronics and circuits may include one or more of many preferred components, such as one or more processors, one or more field-programmable gate arrays (FPGAs), and one or more memory storage devices. In many embodiments, the control electronics control a control panel of a graphical user interface (hereinafter referred to as "GUI") to provide pre-procedure planning according to user-defined treatment parameters and to provide user control over the surgery.

[0079] The therapeutic probe 450 includes an anchor 24. The anchor 24 anchors the distal end of the probe 450 while energy is being delivered to the energy delivery area 20 using the probe 450. The probe 450 may include a nozzle 200 as described herein. The probe 450 is coupled to the arm 422 using a chain portion 430.

[0080] The chain section 430 includes components that move the energy delivery area 20 to a desired target location on the patient, for example, based on an image of the patient. The chain section 430 comprises a first section 432, a second section 434, and a third section 436. The first section 432 includes a substantially fixed anchoring section. The substantially fixed anchoring section 432 is fixed to a support 438. The support 438 may include a reference frame for the chain section 430. The support 438 may include a rigid chassis or frame or housing for rigidly or rigidly coupling the arm 442 to the treatment probe 450. While the first section 432 remains substantially fixed, the second section 434 and the third section 436 move to direct energy from the probe 450 to the patient. The first section 437 is fixed at a substantially constant distance 438 from the anchor 24. The substantially fixed distance 437 between the anchor 24 and the fixed first portion 432 of the chain allows the treatment to be precisely positioned. The first portion 424 may include a linear actuator for precisely positioning the high-pressure nozzle within the treatment area 20 at a desired axial position along the extension axis of the probe 450.

[0081] The extension axis of the probe 450 generally extends between the proximal portion of the probe 450 near the chain portion 430 and the distal end having the anchor 24 attached thereto. The third portion 436 controls the rotation angle around the extension axis. During patient treatment, the distance 439 between the treatment area 20 and the fixed portion of the chain portion varies with reference to the anchor 24. The distance 439 is adjusted in response to computer control to set a target location along the extension axis of the treatment probe referenced to the anchor 24. While the first portion of the chain portion remains fixed, the second portion 434 adjusts the position of the treatment area along the axis. The third portion of the chain portion 436 adjusts the angle around the axis in response to the controller 424 so that the distance along the axis at the treatment angle can be controlled very precisely with reference to the anchor 24. The probe 450 may include a rigid member, such as a spine, extending between the support 438 and the anchor 24, such that the distance from the chain portion 430 to the anchor 24 remains substantially constant during treatment. The treatment probe 450 is coupled to a treatment component as described herein to enable treatment using one or more forms of energy, such as mechanical energy from a jet, electrical energy from an electrode, or optical energy from a light source such as a laser source. The light source may be infrared, visible light, or ultraviolet. The energy delivery area 20 can be moved under the control of the chain portion 430, for example, to deliver the intended form of energy to the patient's target tissue.

[0082] The imaging system 490 comprises a memory 493, a communication circuit 494, and a processor 492. The processor 492 in the corresponding circuit is coupled to the imaging probe 460. The arm controller 491 is coupled to the arm 444 to precisely position the imaging probe 460.

[0083] Figure 4A shows pressure regulation of the surgical site using substantially constant pressure and variable flow rate. The saline bag is positioned at a height that provides substantially constant pressure regulation. The saline bag can be positioned at a height corresponding to approximately 50–100 millimeters of mercury (hereinafter "mmHg"). The saline bag is coupled to a lavage port as described herein. A collection bag is coupled to one or more of the lavage port, suction port, or aspiration port as described herein. The collection bag collects the tissue to be removed using a water jet ablation probe 450 as described herein.

[0084] Figure 4B illustrates fluid flow regulation at a surgical site using a pump that provides a substantially fixed fluid flow rate. The pump removes fluid from the surgical site at a substantially fixed flow rate. The pump may comprise, for example, a peristaltic pump. The pump is configured to remove fluid at a rate substantially identical to or greater than the saline flow rate of the water ablation jet in order to prevent pressure buildup at the surgical site. The peristaltic pump can be coupled to the suction port of a manifold, for example, having a tissue removal port 456C as described herein. Providing a pump having a flow rate of at least the flow rate of the tissue ablation jet provides improved suction as ablated tissue that could otherwise block the tissue removal opening, and the channel can be subjected to greater pressure when the pump maintains a substantially fixed flow rate in order to remove material that would otherwise block the channel.

[0085] The irrigation flow from the saline bag may be left open to provide a safety check valve in case the peristaltic pump is not functioning correctly, as it will serve at least two functions: 1) maintain pressure based on the height of the saline bag, and 2) visually the flow entering the bag will appear pink to the individual.

[0086] In alternative embodiments, the pump flow rate includes a variable rate to provide a substantially constant pressure within the patient near the surgical site. Active sensing of the pressure in the treated organ and the variable flow rate of the pump may be provided with a closed-loop pressure regulation system. The pump can be coupled to a sensor, such as a pressure sensor, and the flow rate can be varied to maintain a substantially constant pressure. The pressure sensor can be located in one or more of many locations, such as on the treatment probe, within the suction channel of the probe, within a recess on the outer surface of the probe, on the inner surface of the probe coupled to the surgical site, or near the inlet to the pump on the console.

[0087] Figure 5A shows an organ suitable for incorporation according to an embodiment. The organ may include one or more of the many organs described herein, for example, the prostate gland. In many embodiments, the organ includes, for example, a capsule, tissue contained within the capsule, and a capsular duct and nerves located on the outside of the capsule. In many embodiments, the organ includes the prostate gland. The prostate gland may include, for example, a hypertrophy such as benign prostatic hyperplasia or cancer, and a combination thereof. In many embodiments, the hypertrophic tissue may include tissue located within the patient, where cancer may not be detected. In many embodiments, the capsular duct and nerves extend along the outer surface of the prostate gland. In many embodiments, the hypertrophic tissue may be located on top of the prostate gland. In many embodiments, the hypertrophic tissue may include tissue of unknown specificity in terms of whether the tissue includes cancerous or benign tissue.

[0088] Figure 5B shows the prostate gland of Figure 5A treated with the apparatus according to the embodiment. In many embodiments, prostate tissue is removed according to a tissue removal profile. The tissue removal profile may include a predetermined tissue removal profile based on image-guided tissue removal, for example, as described herein. Alternatively, the tissue removal profile may include a tissue removal profile in which tissue is removed using a handheld tissue removal device. In many embodiments, tissue of an organ such as the prostate is removed into the capsule, for example, to reduce the distance from the tissue removal profile to the outside of the capsule.

[0089] The apparatus for tissue removal may include a nozzle configured to deliver a fluid flow, which may consist of one or more liquids or gases. The liquid fluid flow may consist of, for example, one or more water or saline solution. The liquid fluid flow may exit the nozzle in the form of a liquid ablation jet, causing cavitation in the prostate tissue and dissociating the tissue into multiple fragments. The liquid fluid flow may be discharged into a liquid into which the nozzle is immersed to provide cavitation using a scattering pulse as described herein. The liquid into which the nozzle is immersed may consist of, for example, one or more water or saline solution.

[0090] Figure 6A shows the excision inflammation area visible to the human eye according to the embodiment.

[0091] Figure 6B shows a high-speed image of the excised inflammation area as shown in Figure 6A. The image was captured at a speed of approximately 1 / 400 of a second.

[0092] The data in Figures 6A and 6B show that the excision flame region includes multiple white clouds generated with the excision flow when discharged from the nozzle. Studies of embodiments have shown that cavitation clouds can be dispersed from the jet at characteristic dispersion frequencies. The length 992 of each cloud is related to the dispersion frequency and velocity of the cloud. The relatively cool excision flame region of the jet has a length 990 corresponding to the cutting length of the jet, which can be adjusted to cut tissue to a controlled depth as described herein. In many embodiments, the jet nozzle is positioned at least about a quarter of the length 992 of the dispersion cloud in a non-cutting configuration, as shown in Figure 6B, to allow the dispersion cloud to be substantially formed prior to the cloud striking the tissue. This dispersion of the dispersion cloud to a larger cross-sectional size can also provide improved tissue removal as the cloud can be distributed over a wider area of ​​tissue and can provide improved overlap between jet pulses.

[0093] In addition to the impact pressure of the jet, highly turbulent and invasive regions corresponding to the white clouds in the image substantially contribute to the ablation of tissue as described herein. The white clouds comprise multiple cavitation regions. When pressurized water is injected into the water, small cavitations are generated near the nozzle exit in low-pressure regions within the shear layer. These small cavitations may include cavitation vortices. The cavitation vortices merge with each other to form large discrete cavitation structures that appear as cavitation clouds in the high-speed image. These cavitation clouds provide effective ablation when interacting with tissue. Without being bound by any particular theory, it is thought that cavitation clouds impacting tissue, in combination with high-speed fluids defining the cavitations impacting the tissue, cause substantial erosion of the tissue associated with the cavitation.

[0094] Nozzles and pressures as described herein can be configured to provide a pulsating cloud, for example, by controlling the nozzle angle by those skilled in the art, based on the teachings provided herein. In many embodiments, the nozzle of the fluid delivery element is equipped with a cavitation jet to improve tissue ablation.

[0095] The fluid delivery element nozzles and pressure can be arranged to provide a suitable scattering frequency for tissue removal.

[0096] In many embodiments, the "white cloud" of the "flame region" includes an "encompassed" region in which surrounding water is drawn into or "encompassed" within the jet. Studies of embodiments suggest that fluid encompassion may be related to the dispersion frequency.

[0097] The dispersion frequency and size of the clouds ejected from the jet can be used, according to the embodiment, to provide tissue ablation. The dispersion frequency can be combined with the angular sweep rate of the probe around the longitudinal axis so as to provide overlap in the locations where each cloud interacts with the tissue.

[0098] Figure 7 shows a sweep of multiple scattering pulses 995 and excision jets according to an embodiment, providing smooth, controlled tissue erosion at multiple overlapping locations 997. The scattering frequency can be substantially faster than the pump frequency when the pump is used, so that multiple scattering clouds are provided with each pulse of the pulsating pump. The probe sweep rate may be related to the scattering frequency to provide improved tissue removal, for example, using scattering clouds configured to provide overlapping pulses.

[0099] In many embodiments, the system comprises a pump having a frequency lower than the frequency of the scattering pulses in order to provide multiple scattering pulses for each pump pulse. The pump may have, for example, a pulse repetition rate of at least about 50 Hz in the range of about 50 Hz to about 200 Hz, and the scattering pulses may include a frequency of at least about 500 Hz in the range of about 1 kHz to about 10 kHz.

[0100] While pump pulses have been illustrated, a similar scan of pulsed clouds can be provided using a continuous flow pump.

[0101] The nozzle can consist of one or more of many methods, but in many embodiments the nozzle includes a Strouhull number (hereinafter "St") in the range of about 0.02 to about 0.3, for example, in the range of about 0.10 to about 0.25, and in many embodiments in the range of about 0.14 to about 0.2.

[0102] In many embodiments, the Strouhal number is defined as follows:

[0103] St=(Fshed) * (W) / U

[0104] In the formula, Fshed is the scattering frequency, W is the width of the cavitation jet, and U is the velocity of the jet at the outlet. Those skilled in the art can modify the nozzle as described herein to obtain a scattering frequency suitable for the combination according to the embodiments described herein, and experiments can be carried out to determine a cloud length and scattering frequency suitable for tissue removal.

[0105] A nozzle configuration that provides multiple clouds is suitable for use in conjunction with one or more probes such as those described herein.

[0106] Figure 8A shows an attachment device 800 according to an embodiment. The attachment device is configured to be attached to an arm as described herein. The attachment device comprises one or more components of a surgical system for treating a patient as described herein. In many embodiments, the attachment device comprises a handpiece 802 for the surgeon to manipulate the attachment device using the arm in an unlocked position to insert the distal end of the attachment device into the patient. In many embodiments, the attachment device comprises a chain section 804 having a rotatable body configured to receive rotational torque from the arm as described herein.

[0107] The mounting device comprises a plurality of components that are sized to fit into, for example, a surgical access site in a patient, such as the urethra. The mounting device may comprise, for example, an extension support 806, an extension tube 808, and a connector 814, as described herein. The extension support 806 comprises a rigid support configured for insertion into the patient. The extension support may have a rounded distal end to facilitate insertion into the patient along the access route, in order to expand the pathway and enable and facilitate insertion of the connector. The extension support may have a plurality of suction channels positioned to remove tissue excised from the surgical site. The extension support may have a plurality of channels extending from a suction port 828 to an opening on the distal end of the extension support.

[0108] The extension tube 808 may comprise a telescopic tube having a first distal portion 810 and a second proximal portion 812. The second portion may be larger than the first portion to accommodate the first portion and allow the tube to slide. A coupling 814 on the distal end of the distal portion of the tube can be connected to an endoscope. The endoscope connected to the coupling can be moved proximal and distal, and the length of the extension tube can be shortened and reduced as the coupling moves proximal and distal together with the distal tip 818 of the endoscope.

[0109] The coupling portion 814 may comprise an inclined distal surface 820, or at least one surface molded to facilitate insertion of the coupling portion into the patient. The coupling portion may be positioned adjacent to the distal end of the extension support when the attachment device is inserted into the patient. The endoscope tip 818 can be coupled to the coupling portion using the coupling portion's structure. For example, the coupling portion may comprise an engagement structure molded to receive a corresponding engagement structure on the endoscope tip so that the coupling portion interlocks with the endoscope tip and effectively fits and locks into the endoscope tip. Proximal and distal movement of the endoscope, along with a corresponding decrease or increase in the length of the extension tube, can move the coupling portion proximal and distal.

[0110] The mounting device may include a hub 822 having a lavage port 824 and a suction port 826. The lavage port can be connected to an internal channel of the extension tube to direct a fluid, such as saline solution, to a lavage opening 816 located on the distal end of the extension tube. The lavage opening can provide a fluid, such as saline solution, to the surgical site. Alternatively, a fluid, such as gas, can be provided to the surgical site by blowing. The suction port on the hub can be connected to an opening on the extension support, with a channel extending axially along the extension support.

[0111] The extension tube 808 of the endoscope comprises a first distal portion 810 of the tube and a second proximal portion 812 of the extendable tube. The second proximal portion is larger than the first distal portion to slidably receive the first distal portion, allowing the joint to move proximal and distal with the endoscope.

[0112] The mounting device comprises several structures that allow a user, such as a physician, to adjust the endoscope independently of other components of the device. In many embodiments, the endoscope is coupled to an endoscope carriage 828. The endoscope carriage can be moved forward and backward to move the distal end of the endoscope, which is connected to the coupling, proximal and distal. The mounting device may also include a rack 830 coupled to a pinion gear, which allows the endoscope carriage to be moved proximal and distal as a knob 832 on the endoscope carriage is rotated. The mounting device may also include a rail 834 for engaging with the endoscope carriage, for example, so that the endoscope carriage can slide along the rail as the knob is rotated. In many embodiments, the mounting device includes a connection of a high-voltage cable 836 to a carrier that carries a therapeutic energy source under the control of the chain.

[0113] Figure 8B shows the components of the mounting device 800. The endoscope may comprise a rigid distal portion 838 and a flexible proximal portion 840. The rigid portion of the endoscope may extend from the endoscope carriage 828 to the distal tip of the endoscope. The rigid portion of the endoscope may extend through a seal 842 to seal and contain fluid from the surgical site. The rigid portion of the endoscope may be coupled to the carriage using an engagement structure on the proximal portion of the endoscope. The rigid portion of the endoscope may also be coupled to the coupling using a distal engagement structure located near the tip of the endoscope. The rigid portion of the endoscope extending between the carriage and the coupling provides proximal and distal movement of the coupling and the distal portion of the telescopic tube.

[0114] In many embodiments, the flexible high-pressure saline tube 836 extends to the mounting device and provides pressurized fluid from an external pump.

[0115] In many embodiments, the mounting device is configured to allow the user to remove components of a device such as an endoscope. For example, a carriage release section 844 may be provided on the proximal end of the mounting device, allowing the user to slide the carriage proximal away from the rail to remove the endoscope from the surgical site.

[0116] Figure 8C shows components of a mounting device 800 with a coupling 814 in a partially retracted position, and an extension carrier 846 comprising an energy source 848 extending through the coupling toward the distal end of an extension support 806. In many embodiments, the endoscope tip can be at least partially retracted to visualize the treatment probe 846 within the support. The extension carrier with the treatment probe may have an energy source located above it to direct energy toward the treatment site. The distal portion of the extension tube 808 can be retracted within the proximal portion of the extension tube to allow the coupling, which has the endoscope tip attached thereto, to visualize the treatment site. The coupling can be retracted proximal, for example, by rotating a knob toward the proximal position.

[0117] The extension support 806 can be connected to the extension tube 808 in one or more of several ways to add rigidity. For example, the extension support can be welded to the proximal portion of the extension tube at several locations 850 to add rigidity to the combination of the extension support and the extension tube.

[0118] The welded portion of the extension tube can remain in a fixed position with respect to the extension support when the distal portion of the extension tube slides against the proximal fixed portion of the tube.

[0119] Figure 8D shows the distal portion of an extension tube 808 having an extension support 806 and a connector 814 mounted thereon. The extension support may have a pressure-reducing tip, such as a rounded distal tip 852, to facilitate insertion along a surgical access route, such as through the urethra. The inclined distal surface 820 of the connector can facilitate insertion and push tissue away from the extension support. In many embodiments, the extension support has a recess that is sized to receive a portion of the connector so that the most distal tip of the connector fits into a recess behind the pressure-reducing distal tip. The pressure-reducing distal tip can define an access route for the implantation device into the patient, the inclined distal surface of the connector can follow the pressure-reducing tip, and the tip of the connector can follow the path of the pressure-reducing tip. This combination of the pressure-reducing tip and the inclined distal surface can facilitate insertion.

[0120] An extension tube 808 having multiple openings 816 can move together with a coupling 814. The coupling for receiving the distal tip of the endoscope can be configured in one or more of many ways for receiving the endoscope tip, such as using a channel or slot that receives and locks onto the endoscope. The distal portion of the extension tube may have an opening 854 to receive a fastener from the coupling. A fastener from the coupling extending through the opening of the tube can effectively lock the coupling to the distal end of the tube. The distal end 810 of the tube may have multiple cleaning openings 816. Multiple cleaning openings can move together with the endoscope tip to flush and facilitate visibility using the endoscope tip. The movement of the cleaning openings generally directs the fluid toward the surgical site so that the fluid can be directed. Cleaning openings that move together with the endoscope tip have the advantage of flushing the tip and providing fluid to increase visibility, for example, when the tip of a treatment probe is immersed in the fluid.

[0121] Figures 8E1–8E4 show a coupling 814 according to an embodiment. Figure 8E1 is a cross-sectional end view. Figure 8E2 is a cross-sectional side view. Figure 8E3 is a side view, and Figure 8E4 is an end view. The coupling includes a carrier channel 856 to receive a therapeutic probe on a carrier, as described herein. The carrier channel is sized to allow the carrier, with the therapeutic probe, to slide proximal, distal, and rotationally without interference from the coupling. The carrier channel may include guides to facilitate alignment and positioning and to stabilize the position of the distal end of the carrier, with the energy source. The coupling includes an endoscope channel 858 sized to receive an endoscope. The endoscope channel may be configured to receive an endoscope and an endoscope engagement structure and to engage the endoscope engagement structure with the coupling.

[0122] The side view shown in Figure 8E2 shows the field of view 860 of the endoscope. The field of view of the endoscope may be that of a commercially available endoscope, such as a 70° field of view. The endoscope allows visualization of the surgical site, the extension support, and the therapeutic probe of the carrier from within the endoscope channel. In many embodiments, the inclined surface 820 at the distal end of the junction is inclined at a certain angle to define the field of view along the upper portion of the field of view of the endoscope.

[0123] As shown in Figure 8E3, the coupling portion 814 may include a slot 862 for receiving a projection on the endoscope. The slot may be sized, for example, to allow the projection to enter the slot as the endoscope rotates. Although a slot is shown, the engagement structure of the coupling portion, which receives an engagement structure on the distal end of the rigid portion of the endoscope, can be configured in one or more of many ways, such as a locking structure, a threaded structure, a hub, and threads.

[0124] For example, the endoscope tip may have a leaf spring or similar structure configured to fit into a corresponding capture edge or tip positioned along at least a portion of the inner circumference of the coupling. Using such a mechanism, the user may lock the endoscope tip into the coupling by simply pushing the endoscope tip into the coupling until the leaf spring engages with the capture edge. To allow the endoscope tip to be separated from the coupling, a portion of the inner circumference of the coupling may have an inclined edge configured to allow the leaf spring to slide outward. To separate the endoscope tip from the coupling, the user may rotate the endoscope and pull it out until the leaf spring aligns with the inclined edge.

[0125] Figure 8E3 also shows a projection 855 that extends through the pipe.

[0126] Figure 8E4 shows approximate dimensions of the therapeutic probe carrier 846 and endoscope 866 within the carrier channel 856 and endoscope channel 858, respectively, using dashed lines. The carrier channel and endoscope channel can be sized and spaced apart to provide a gap 868 between the carrier and the endoscope. In many embodiments, the rigid distal tip of the endoscope includes a projection 864 as described herein. The projection extends radially from the rigid distal portion, fits into a slot 862, and can engage with the coupling. In many embodiments, the projection is sized to extend beyond the gap to lock the coupling to the endoscope when the carrier probe, which contains the energy source, extends through the carrier channel. This configuration can facilitate assembly and disassembly of the coupling from the endoscope with the carrier removed, and provides, for example, locking of the coupling with the carrier inserted into the coupling.

[0127] Figure 8F shows a bottom view of the carriage 828 according to an embodiment. The bottom view shows the rigid portion 838 of the endoscope and the flexible portion 840 of the endoscope coupled to the proximal engagement structure 870 of the endoscope. The proximal engagement structure of the endoscope fits into the carriage engagement structure 872 such that the movement of the carriage moves the rigid portion of the endoscope proximal and distal within the engagement structure. The bottom view of the carriage shows a pinion gear 874 that rotates with the knob 832. The pinion gear engages with a rack as described herein. The bottom view also shows a slot 876 on one side of the carriage that receives a rail for a mounting device as described herein. The carriage engagement structure 872 may have a plurality of projections. For example, the plurality of projections may extend on the proximal and distal sides of the carriage to move the endoscope proximal and distal.

[0128] Figure 8G shows an end view of a carriage 828 according to an embodiment. The carriage comprises a plurality of slots 876 that are sized to receive rails for mounting devices. The carriage also comprises a channel 878 that is sized to receive an endoscope.

[0129] The carriages shown in Figures 8F and 8G may be configured to have a low profile to facilitate user handling of the mounting device. For example, the carriage may be configured to have a housing with a relatively short height, and the knob may be molded and sized to have a relatively small diameter and long length (i.e., to facilitate user gripping of the knob).

[0130] Figure 8H shows an isolated endoscope 866 according to an embodiment. The endoscope includes an eyepiece 880, located on the proximal end of the endoscope, which allows a user, such as a surgeon, to view the surgical site from the distal end of the endoscope. The endoscope includes an illumination port 882, which allows a camera, such as a high-resolution camera, to be coupled to the endoscope. The endoscope includes a proximal flexible portion 840 as described herein. The endoscope includes a proximal engagement structure 870, which is located between the flexible proximal portion 838 and the rigid distal portion 840 of the endoscope. The endoscope includes a distal engagement structure 884 as described herein.

[0131] Figure 8I1 shows a side view of the endoscope 866. Figure 8I2 shows a side view along section AA as in Figure 8I1. Figure 8I3 shows section BB of the endoscope in Figure 8I1, which has a structure similar to that shown in section AA. Figure 8I4 shows a top view of the endoscope as in Figure 8I1. Figure 8I5 shows the distal end of the endoscope as in Figure 8I. The endoscope comprises an eyepiece 880, an illumination port 882, a flexible portion 840, a proximal engagement structure 870, a rigid distal portion 838, and a distal end 818 of the endoscope as described herein. Figures 8I2 and 8I3 show cross-sectional views of a structure that provides fixed alignment of the endoscope with respect to the endoscope and engagement structure. For example, the planes shown along sections AA and BB correspond to the maximum dimensions traversing the proximal engagement structure. Having a proximal engagement structure that is fixedly aligned with the endoscope facilitates alignment and ensures an accurate reference system when the endoscope is used. Figure 8I4 in the top view shows the distal engagement structure 884 along the cross section G. Detail G in Figure 8I5 shows the distal engagement structure 884 extending from the distal end as a projection 864.

[0132] In many embodiments, the proximal engagement structure includes a reference structure, such as a maximum transverse dimension, that defines the orientation of the endoscope relative to the mounting device. The maximum transverse dimension of the proximal engagement structure informs the user assembling the device or other individuals of the reference system for the endoscope relative to the mounting device, as described herein. The mounting device may include reference systems for therapeutic and surgical procedures, as described herein. For example, angular rotation of a therapeutic probe around access can be performed relative to the mounting device and components of the mounting device, such as an encoder, as described herein.

[0133] Figure 8J shows a carriage housing 886 as described herein. The carriage housing may comprise, for example, a single part made of injection-molded plastic. The single part can be provided in two ways, such as a pair of parts, to enable the assembly of the carriage housing. For example, referring to Figure 8J, a second housing having the same shape as the first component 888 of the housing may be provided such that two parts snap together across the knob and axle and pinion gear, as described herein, to define the carriage.

[0134] Figure 8K shows an end view of a mounting device 800 as described herein. The mounting device comprises a plurality of rotatable connectors, such as a first rotatable connector 890 and a second rotatable connector 892. The first rotatable connector determines the axial location of an energy source for treating a patient. The second rotatable connector determines the angular location of the energy source with respect to the axis. For example, the energy source may comprise a receptacle mounted on a hypo tube, where the axial location of the receptacle is determined with respect to the first rotatable connector and the angle of the receptacle with respect to the axis is determined with respect to the second rotatable connector. The first and second rotatable connectors can be used to control both rotation and the axial location of the energy source, as described herein. A mounting device with a handpiece may also comprise an electrical connector 894. The electrical connector can be connected to an electrical connector on an arm. The electrical connector can be used to transmit signals to and from the mounting device. Signals transmitted using the electrical connector may include electrical signals from an encoder to a controller away from the mounting device. The mounting device may include a printed circuit board 896 having an electrical connector positioned thereon for connecting the mounting device to an arm. The electrical connector may be a standard connector known in the industry. The printed circuit board may also include the handpiece circuit 898. The circuit may include a processor in non-volatile memory configured to record therapeutic aspects, such as a treatment table as described herein, and mechanical parameters, such as flow rate and pressure. The high-pressure saline tube 836 may include a flexible tube extending into the proximal end of the handpiece.

[0135] Figure 8L shows the components of an arm 900 configured to couple to a mounting device 800. The arm may include a locking mechanical connector 902 configured to couple to the mounting device and lock the mounting device in place. The arm may include a plurality of rotatable connectors 904 configured to engage with rotatable connectors of the mounting device. The arm may also include an electrical connector 906 configured to connect to the mounting device. Although an electrical connector is shown, other connectors such as optical fiber or optical connectors may also be used. The arm may also include a contact sensor 908 that senses contact between the arm and the mounting device.

[0136] The circuitry of the arm and mounting device can be configured in one or more ways of facilitating the connection of the mounting device to the arm. Alternatively, or in combination, the mounting device may be configured to include consumable devices such as single-use devices. In many embodiments, a contact sensor is coupled to a circuit configured to rotate a rotatable connector on the arm in response to the contact sensor engaging with the mounting device. When the contact sensor engages with the mounting device, the rotatable connector rotates back and forth through a predetermined range of motion to enable a meshing connection between the rotatable connector on the arm and the rotatable connector on the mounting device. In many embodiments, the rotatable connector on the arm comprises a plurality of hexagonal sockets, and the mounting device comprises a plurality of hexagonal cross-sectional projections to engage with the sockets on the arm. Alternatively, the sockets and projections can be reversed such that the sockets are provided on the mounting device and the projections are provided on the arm, or a combination thereof. Once the rotatable connector engages with the rotatable connector on the mounting device, the circuitry in the arm can detect the movement with a sensor located on the mounting device and stop the rotation of the rotatable connector in response to the completion of the coupling of the arm to the mounting device.

[0137] Figure 8M shows an upper view of a mounting device 800 according to an embodiment. The upper side of the mounting device may be located opposite, for example, the side having a rack and pinion. The mounting device may comprise a measuring scale 801 and an indicator 803, such as an LED, indicating the location of an energy source on a carrier probe equipped with a treatment probe. In many embodiments, the indicator is mounted on an internal chain that moves axially to treat a patient. This LED indicator on the probe can inform the user of the location of the treatment probe. The measuring scale may comprise one or more of many units and generally comprises a one-to-one scaling with respect to the movement of the probe tip. The measuring scale may comprise units such as centimeters, millimeters, or other units of length.

[0138] Figure 8N shows the components of the arm 900 according to an embodiment. The components of the arm may include an arm mountable component comprising a user input device 910. The user input device may include a first input 912 for increasing the intensity of the energy source and a second input 914 for decreasing the intensity of the energy source. For example, when the energy source comprises a liquid flow, an increase in the intensity of the energy source may include an increased flow rate and / or an increased pressure of the energy source. A decrease in the intensity of the energy source may include, for example, a decreased flow rate or a decreased pressure of the energy source, and a combination thereof.

[0139] Figures 8O2 and 8O1 show the internal structure of the arm component shown in Figure 8N. Figure 8O1 shows the circuit 916 of the lower portion of the component. The circuit can be coupled to a connector 906 that connects to a mounting device. The circuit may comprise one or more of the many known circuit components described herein, such as a processor, a memory such as a random access memory, and a gate array such as a field-programmable gate array. The circuit may comprise one or more of the many known components used to control the motor. Figure 8O2 shows a motor 918 of the arm according to an embodiment. The motor may comprise a known motor component capable of driving surgical instruments. The motor may comprise a shaft that extends to a projection of a rotatable connector as described herein. The motor can engage with the mounting device when the mounting device is connected to the arm.

[0140] A circuit coupled to a connector as shown in Figure 801 can be used to control a motor to position an energy source at an intended axial location and rotation angle around an axis. The circuit may include one or more commands that transmit signals to an encoder located on the mounting device to measure the angular location of the probe as it rotates around the axis. The rotation of the energy source around the axis can be fed back to the circuit, which can drive the energy source to multiple locations according to commands on a treatment table as described herein. By positioning the circuit and motor in a reusable location on the arm, the cost and complexity of the mounting device with the handpiece can be substantially reduced.

[0141] Figure 8P shows a chain section 804 of the mounting device 800 according to an embodiment. The chain section shown in Figure 8P may comprise one or more components configured to direct an energy source to a desired location and angle on the distal end of a carrier 846 equipped with a therapeutic probe. A carrier carrying an energy source near the distal end is coupled to the chain section to control the position and angle of the energy source on the end of the carrier. The carrier may comprise, for example, a hypotube, and the energy source may comprise one or more of the many energy sources described herein. For example, the energy source may comprise a nozzle formed in a material consisting of a receiving stone. The receiving stone on the hypotube can receive a high-pressure fluid from a cable 836. The carrier is connected to a flexible conduit that receives energy along with a medium such as high-pressure saline along a flexible high-pressure tube. The carrier is connected to the chain section so that the carrier translates and rotates in response to commands from the circuit.

[0142] The chain section comprises a first rotary connector 890 for controlling the Z-axis position of the carrier along the extension axis and a second rotatable connector 892 for controlling the angle of the energy source with respect to the extension axis. The first rotatable connector 890 can be rotatably connected to a plurality of threads 889. Rotation of the threads can drive the chain section proximal and distal, as indicated by arrow 891. When rotated, the threads can guide the carrier 846 to move proximal and distal, as shown. As the carrier moves proximal and distal, the second rotatable connector 892 can slide along the extension structure, such as a hexagonal structure 895. Axial sliding of the carrier can be provided over a therapeutic range, for example, up to about 7 millimeters. The second rotatable connector 892 can be rotated to guide the rotation of the carrier. For example, rotation of the second rotatable connector can cause angular rotation of the carrier, as indicated by rotation arrow 893. The rotation of the second rotatable connector can rotate the gear 805 of the chain section coupled to the carrier 846. The gear of the chain section may be concentric with the carrier so as to guide the rotation of the carrier around the carrier's extension axis. The second rotatable connector may include a second gear concentric with the rotatable connector to guide the rotation of a gear concentric with the carrier. The chain section may include, for example, a free gear between the first gear and the second gear to guide the angular rotation of the energy source with respect to the carrier's extension axis.

[0143] Figure 8Q shows an encoder 807 mounted on the proximal end of carrier 846. The encoder on the proximal end of the carrier can enable precise rotational positioning of the energy source angle. The carrier can be rotated to a target position in response to a signal measured from the encoder. The encoder on the proximal end of the carrier may comprise one or more of many known encoders. In many embodiments, the encoder comprises a Gray encoder configured to provide quadrature measurements. The encoder may be provided on the surface of the carrier, for example, with an annular structure extending from the carrier to provide a precise surface for the encoder to be attached. The photodetector 809 may also be arranged in a line extending along the direction of the carrier probe axis. This can facilitate measurement of the energy source angle and allow the detector to be positioned on the plane of the printed circuit board. The encoder may extend on the surface of the carrier probe, which may comprise a removable carrier treatment probe. The removable carrier treatment probe may extend into a seal as described herein. In many embodiments, the encoder includes a matching structure that can be matched with an energy source supported on the distal tip of the probe to ensure accurate matching during manufacturing. For example, the encoder may have multiple edge transitions, each edge extending axially. One or more of the edges can be pre-configured to match the angle of the energy source extending from the extension axis of the probe. For example, the energy source may extend radially from the axis at the same angle as the edge extends radially from the probe, or be located along the angle of the radial extension from the probe.

[0144] Figure 8R1 shows an encoder 807 according to an embodiment. As shown with the encoder, each edge 811 corresponds to an angular reference with respect to the probe. For example, a 0-degree reference 813 is shown. The 0-degree reference is aligned with an energy source extending from the distal end of the carrier.

[0145] Figure 8R2 shows Table 815, which illustrates the coordinate references for different transitions measured using multiple photodetectors. These positions can be given as absolute positions of the probe within a certain range. Circuits such as those described herein can be configured to interpolate within the positions shown in Figure 8R2. Interpolation can be performed in one or more of many ways. For example, a motor may be equipped with a stepping motor to provide interpolation. Alternatively, a motor may be equipped with an encoder which can be used to provide interpolation.

[0146] In Table 815, the white areas correspond to the steel pipe portion of the encoder, while the black areas correspond to the black plastic pipe portion of the encoder. The steel pipe and the black plastic pipe can form multiple rows distributed along the longitudinal axis of the encoder, each row extending around the circumference of the encoder. Each row can be aligned with a photodetector. For each photodetector A (distal), B, C, and D (proximal), the encoder rotation position corresponding to the white area can correspond to the "on" or "1" binary code, while the encoder rotation position corresponding to the black area can correspond to the "off" or "0" binary code.

[0147] The encoder and photodetector configurations in Figures 8Q, 8R1, and 8R2 are provided as examples only, and many other configurations are possible. For example, Figures 8Q, 8R1, and 8R2 show an encoder having four rows, each row matched to one of four photodetectors, but the encoder may have any number of rows matched to any number of photodetectors in any suitable configuration. The encoder may also have one or more additional rows and additional photodetectors matched to each additional encoder row to increase the encoder resolution and thereby provide more finely adjustable positioning of the motor, and therefore the carrier.

[0148] Figure 8S shows a suction port 817 on the distal end 819 of a support 806 according to an embodiment. The distal end of the support comprises a plurality of ports 817 for aspirating material from the surgical site. The plurality of ports can be sized to receive tissue excised by an energy source 848. The ports can be positioned in a predetermined location to provide a visual guide to the user. For example, the suction ports can be positioned at 1 cm intervals so that the user can easily determine the size and location of the tissue at the target site. The user can also evaluate accuracy and, for example, verify the accuracy of the probe during use. The support may comprise a plurality of ports in a number of, for example, 2 to about 10. The plurality of ports can be located on the underside of the support facing the carrier 846. A concave shape of the support can improve alignment and provide space for receiving the probe. The suction port on the distal end of the support can be fluidly coupled to a suction port on the proximal end of the support (826 in Figure 8A) near the hub, for example, with a channel extending from the port to the plurality of ports. The energy source carrier can slide toward the distal end of the support during treatment. Ports can provide reference structures for determining the location of the carrier relative to the energy source and can help facilitate alignment during treatment. Multiple ports on the distal end of the support can be visualized, for example, using ultrasound, and can be visualized, for example, using a field-of-view endoscope as described herein. Multiple ports can be located between a ball-shaped portion on the distal end and a fixed portion of the tube. As described herein, the carrier probe can be advanced and retracted to the distal end of the support. As shown in Figure 8S, the energy source carrier is shown in the retracted position. The coupling structure 814 that connects the endoscope to the extension tube 808 is also shown in the retracted position. The proximal portion of the tube 812 is shown with the distal portion of the tube 810 received therein, such that a portion of the irrigation port 824 is covered by the proximal portion of the tube. The coupling structure 814 as described herein can be used to advance the extension tube and the endoscope as described herein.The carrier, which includes the energy source, can be moved independently of the endoscope and the connector within the tube, for example. In at least some embodiments, this independent movement can be useful for therapeutic purposes. Alternatively, or in combination, the connector can be positioned across the energy source to act as a shield for the user of the system from the energy source. For example, when the system is initially set up, the connector can be slid across the energy source to block the energy source. In many embodiments, the connector has sufficient mechanical strength to withstand the energy source, and the energy source is configured to excise tissue when the connector is positioned across the energy source, without damaging the connector.

[0149] Figure 8T shows a console 920 according to an embodiment. The console has a user interface with multiple inputs and multiple outputs that allow the user to program the system for treatment. The console has an angle input 922 for increasing the angle and a second angle input 924 for decreasing the angle. The console has a preparation input 926 for preparing the pump. The console has a mode input 928 for setting the mode. The console has a suction input 930 for suction. The console has outputs such as dock configuration 932, arm state 934, and defect state 936. Power can be increased or decreased to an energy source, as shown with plus 938 and minus 940. Inputs for a foot pedal 942 and manual control 944 are shown. The foot pedal may be a standard commercially available foot pedal, and the manual control may have plus and minus controls on the arm as described herein. A high-pressure pipe can be attached to a channel or connector 946 coupled to the high-pressure pump.

[0150] Figures 9A and 9B show side and top views, respectively, of the alignment of the treatment probe axis with the sagittal plane of the imaging probe. Figure 9A shows the treatment probe 450 inclined with respect to the imaging probe 460. The imaging probe has an extension axis 461 that provides an image reference. In many embodiments, the imaging probe has an extension axis. The imaging probe may also have an ultrasound probe having an extension axis that defines at least partially the sagittal image plane 950. In many embodiments, the imaging probe has a sagittal image field of view, and the treatment probe 450 is substantially aligned with the sagittal plane of the imaging probe when the treatment probe is within the sagittal image field of view.

[0151] In this specification, transrectal ultrasound (TRUS) imaging probes are used, but the imaging probe may comprise one or more of many known probes, such as non-TRUS probes, ultrasound probes, magnetic resonance probes, and endoscopes or fluoroscopy probes.

[0152] The user can use images of the treatment probe acquired using the imaging probe to align the treatment probe with the imaging probe. In axial mode, the treatment probe may appear distorted when the imaging probe is not sufficiently aligned with the treatment probe. The distortion of the treatment probe may depend on the cross-sectional shape of the treatment probe. For example, a disc-shaped cross-sectional profile may appear as a distorted crescent shape in axial mode. In sagittal imaging mode, only a portion of the extended probe extending through the sagittal field of view will appear in the image. The user may be prompted to align the probe until sufficient alignment is achieved to visualize the treatment probe in the sagittal image, with the image of the extended treatment probe along the effective axial distance of the probe, e.g., 5 cm, with the blocked distortion of the treatment probe, for example, in axial mode.

[0153] In many embodiments, as shown in Figure 9B, the elongation axis 450 of the elongation therapy probe 450 is substantially aligned with the sagittal image plane 950 when a substantial portion of the elongation therapy probe, for example 5 mm, is visible in the sagittal image.

[0154] Figures 9C and 9D show side and top views of the treatment probe 450 traversing the sagittal image plane 950 field of view, respectively. Users may be prompted to refine the configuration to be similar to, for example, Figures 9A and 9B.

[0155] Residual matching errors may exist that are corrected by processor software instructions in response to the image of the treatment probe measured using the imaging probe. In many embodiments, the extension axis of the treatment probe may appear rotated in the image. System software can be configured to measure the rotation and rotate the image. For example, the user can be trained to view a sagittal image in which the axis of the imaging probe is used as a reference. However, for planning the treatment, the user may be able to visualize the treatment better when the extension axis of the treatment probe appears, for example, horizontally or vertically on the user screen. In many embodiments, the software measures the rotation angle of the treatment probe in an image such as a TRUS image and rotates the image in response to the rotation of the treatment probe. For example, system software may measure the angle of 1 degree of rotation and rotate the image accordingly so that the rotation angle appears to the user as 0 degrees.

[0156] Figures 10A-10T show the treatment screen of the device according to an embodiment.

[0157] Figure 10A shows a preparation verification screen according to an embodiment. The preparation verification screen includes user input for the user to press a continue button upon completion of the preparation. The preparation is performed to prepare the pump, which can be used to provide an energy source such as fluid flow. While a pump is referred to, the energy source may be another energy source, or an alternative energy source such as an electrical energy source. Upon completion of the preparation, the user presses continue.

[0158] Figure 10B shows a docking standby screen according to an embodiment. In Figure 10B, the user is prompted to dock the system. The system can be docked by positioning the mounting part on an arm as described herein. Once the mounting part is docked to the arm, the system automatically proceeds to the next step.

[0159] In many embodiments during the docking step, a rotational coupling of the arm is provided to align the coupling of the arm with a mounting portion comprising the handpiece described herein.

[0160] Figure 10C shows a prompt for the user to confirm that the ultrasound is within the transverse view. The screen can provide a transverse ultrasound image to orient the user and confirm that the ultrasound probe is within the correct transverse view. Once the user has viewed the ultrasound system and confirmed that the ultrasound is within the transverse view, the user interface screen provides a continue button for the user to provide input. Depending on whether the user enters continue, the user will be prompted on the next screen.

[0161] Figure 10D shows the angle selection input screen. The angle selection input screen allows the user to select a treatment angle. The input screen comprises multiple icons, namely a first icon indicating an increased angle and a second icon indicating a decreased angle. The user uses an input device such as a cursor and mouse to increase the angle by clicking the appropriate icon. For example, if the user wishes to increase the angle, the user clicks an icon with an outward-extending arrow to increase the treatment angle. Once the treatment angle is selected, the user can confirm it by pressing a confirmation button. Selecting an angle in the transverse image allows the user to adjust the treatment angle to match the patient's biological structure. The treatment angle can be, for example, in the range of about 1 degree to about 180 degrees. In many embodiments, the treatment angle is in the range of about 10 degrees to about 170 degrees.

[0162] Figure 10E shows the angle selected according to the embodiment. In Figure 10E, for example, a selected angle of 80 degrees is shown. Once the user has selected the desired angle, the user can press the confirmation button and move to the next user input screen.

[0163] Figure 10F shows a prompt for the user to change the ultrasound to a sagittal image. Upon changing the ultrasound to a sagittal image, the user can press a continue button using an input device such as a mouse or touchscreen display. The input presented to the user may display an icon representing a sagittal ultrasound image, orienting the user toward the sagittal image.

[0164] Figure 10G shows the probe scaling user input screen. The probe scaling user input screen can be used to set the probe scale with respect to the ultrasound image. The probe can be seen in the upper right corner of the sagittal image. A line of sight can be placed across removable marks to identify the probe. In many embodiments, the user is prompted to identify the probe tip by placing a line of sight across the probe tip. When the user places a line of sight across the probe tip, the instrument receives a command from the input indicating that the probe tip has been identified.

[0165] When the probe tip is identified, the instrument advances the carrier probe distally.

[0166] Figure 10H shows the carrier probe tip advanced to its distal location. The carrier probe tip can be seen with a marker that identifies the end of the carrier probe tip. The user may be prompted to identify the carrier probe tip in a second configuration. As shown in Figure 10H, the first location of the carrier probe tip is the proximal location, as shown with the marker, and the second location of the carrier probe tip is the distal location, as shown with the second marker.

[0167] The carrier can be configured in one or more of the many methods for performing therapeutic calibration and image-guided delimiting as described herein, but in many embodiments, a probe comprising a support as described herein is used.

[0168] Referring again to Figure 10G, the probe tip can be seen proximal to a substantially different extent, accompanied by an extension support that extends distally. As can be seen from Figure 10H, the probe tip extends a substantial distance closer to the distal end of the extension support as described herein.

[0169] When the user is satisfied with the marker, they can press the accept input to accept the mark. If the user is not satisfied with the mark shown in the image, they can press the erase button and repeat the step to identify the appropriate mark on the probe at the first and second positions.

[0170] As shown in Figure 10I, probe calibration is repeated. The user input screen displays a probe scale icon used to identify the scaling on the probe, and the user again sets a reticle across the probe to mark the start and end positions. According to some embodiments, a total of three comparisons may be required. Depending on the success of completing the probe scale setting multiple times, the scale can be calculated.

[0171] Figure 10J shows a user input screen where the user is informed that the scale has been calculated. The user is then prompted to press the continue button to proceed to the next screen.

[0172] Figure 10K shows an image displayed on the screen for scale verification. The square root can be superimposed on the ultrasound image along with the scale determined by calibration. For example, as shown in Figure 10K, the scale can extend over a distance of 70 millimeters. The calibration and marks used can also be shown along with the square root displayed on the screen. For example, proximal and distal marks can be shown on the screen. When the distance between the proximal and distal locations is approximately 60 millimeters, the display can, for example, show marks at the zero location and the 60-millimeter location. The square root displayed on the ultrasound image is presented to the user, who has the opportunity to accept or reset the scale. If the user chooses to reset the scale, the user is prompted to set the scale again. If the user accepts and confirms the scale, the user is allowed to proceed to the next screen.

[0173] Figure 10L shows an image illustrating a calibration cut according to an embodiment. A calibration cut can be performed to verify the accurate calibration of the system by an initial treatment prior to completing the treatment. The display screen prompts the user with commands. The user is prompted to perform a calibration cut. The user may be notified to press and hold the foot switch to advance the cut, and to lift the foot switch to pause or complete the treatment. As shown in Figure 10L, the root symbol is shown superimposed on the treatment probe. The treatment carrier probe, equipped with a nozzle, can first be aligned to a zero reference, for example, across the spermatic cord as described herein. A jet can be emitted from the nozzle, and the jet can be visualized using ultrasound as described herein, or other imaging techniques such as endoscopy, for example.

[0174] Figure 10M shows an advancing calibration section according to an embodiment. Figure 10M shows an image of the calibration section in real time on the screen. The probe is automatically advanced, and the user is commanded to lift the foot switch to pause or complete the treatment, and the display window indicates that the probe is advancing. The probe can advance according to a treatment profile programmed into the device as described herein. The section may be shown to extend approximately halfway through the treatment, for example, referring to Figure 10M, but the actual image shown to the user in real time may be provided in terms of scale. Images of organs being excised, such as the prostate, as shown in Figure 10M, may help the user determine that the system is precisely set up to complete the treatment first with tissue that is less sensitive to the variability of the treatment.

[0175] Figure 10N shows a calibration section near the distal end of the section. As shown on the ultrasound image, the jet with a cryoflavone area advances to a position of approximately 60 millimeters from the zero reference point. As shown in the real-time image, the tissue is substantially excised by the targeted calibration section. The screen provides input to the user to confirm the treatment, and the user can indicate that the calibration section is complete by pressing the confirmation button. The user is prompted to resume or complete the calibration section. When the user confirms that the calibration section is complete, the user is then provided with the next input screen.

[0176] Figure 10O shows a user interface screen for determining the cutting depth according to an embodiment. The input for determining the cutting depth of the user interface shown on the display allows the user to set the cutting depth. Since scaling of the ultrasound image onto the treatment probe is performed in advance, the pixel coordinate reference of the image can be used to set additional references such as the coordinate reference of the treatment profile. The user is prompted with multiple lines to indicate the cutting depth. A first icon shows vertical arrows, with a first vertical arrow pointing up and a second vertical arrow pointing down, and the user is allowed to slide the image overlay over the cutting profile so that the user can roughly estimate the depth of the calibration cutting. The user may also be provided with another input screen that allows the user to further adjust the calibration cutting measurement. Once the user has confirmed the cutting depth, the user is prompted to proceed to the next user input screen. In many embodiments, the system includes multiple thresholds for determining whether the calibration cutting depth is within an appropriate machine boundary. For example, cutting that is too shallow may prompt the user with a warning, and cutting that is too deep may prompt the user with a similar warning.

[0177] The user interface screen may include several values ​​available to the user. For example, pressure and time may be shown to the user along with the target angle. The user may also be shown procedural steps to complete procedures such as setting steps, including preparing and docking the pump as described herein. The plan may include angles and scales, the cut may include calibration cuts and profiles, and the treatment may include, for example, a treatment profile.

[0178] Figure 10P shows an adjustable profile according to an embodiment. Figure 10P shows a treatment profile molded to the user's biostructure. Using ultrasound images of the prostate or other organs shown to the user, the user can select multiple locations to adjust the treatment. For example, as shown in Figure 10P, the organ to be treated may include a benign prostatic hyperplasia (BPH). The BPH may extend, for example, beyond the bladder neck or within the bladder neck, as shown by the number 9. The narrow constraint of the bladder neck shown in Figure 8 can be adjusted according to the user's biostructure and measurement profile. Figure 10 can then show, for example, the biostructure of the prostate near the capsule, and the user can adjust the cutting profile accordingly. The user is enabled to adjust and confirm the contour. The user is provided with menus and commands to adjust and confirm the contour. The user is told to adjust and confirm the contour boundary and proceed. When the user has confirmed the treatment profile shown on the ultrasound image, the user presses the continue button to proceed.

[0179] Figure 10Q shows the screen for initiating treatment. The screen for initiating treatment allows the user to start treatment. The user is instructed to press start to begin treatment, and is instructed to press and hold the foot switch to advance the cut. Lifting the foot switch can pause treatment. Alternatively, the user can complete treatment. A cut profile adapted based on a profile provided by the user is shown to the user. The target cut profile may consist of an approximation of the intended profile provided by the user. The flame area cut profile can be configured in many ways, but in many embodiments, the jet output can be increased so that the distance of the white flame area and cavitation, as described herein, can extend to a desired target distance.

[0180] In relation to the embodiments shown, the flow rate of the jet can provide a radial distance that can be substantially linearly related to the flow rate of the fluid flowing into the jet. In many embodiments, the surgical site is washed with saline solution, and a fluid flow consisting of saline solution is discharged at high pressure to form multiple splash pulses, as described herein. Since the distance of the white, low-temperature flame region is substantially related to the cutting distance, the user can be provided with a visual input regarding the cutting depth profile. As the cutting depth profile changes, the flow rate of the fluid from the jet can be modified to correspond to the cutting depth profile.

[0181] The cutting depth profile shown in Figure 10Q, including steps, can correspond to steps that vary the flow rate. For example, the flow rate can be set to an arbitrary integer value between 0 and 10, and a calibration cut can be performed at a flow rate of 3 on an arbitrary scale. Based on the user's biostructure and cutting profile, the system software can determine, for example, that a flow rate of 9 is appropriate for the deepest cut, and that a flow rate of 8 can be performed near the bladder neck. Near the proximal and distal ends of the cut, the flow rate can be increased, for example, from a value of about 3 near the distal end of the cut to a value of about 8 corresponding to the tissue within the bladder neck. The flow rate can then be decreased, for example, to about 3. As the treatment probe with the jet is drawn proximal, the pump output can be decreased in accordance with the cutting profile. For example, the pump flow rate on an arbitrary unit can be decreased from a value of about 8 near the proximal end of the cut to a value of about 3.

[0182] Figure 10R illustrates a treatment procedure using a treatment nozzle supported on a probe that is being drawn proximally. Drawing the energy source on the carrier probe proximally allows for tissue resetting, as shown in Figure 10R and other figures. The treatment probe continues to be drawn proximally, with rotation and oscillation of the probe tip, until a predetermined volume of tissue is removed. This removal of a predetermined volume of tissue by the cutting profile can provide highly precise tissue removal. In many embodiments, delicate structures of the prostate, such as the capsule and nerves, can be avoided. In many embodiments, the user-viewed screen can include additional screens that may be helpful. For example, a treatment guide window showing the position of the energy source on the carrier with respect to the treatment axis can be provided. The extension axis of treatment can extend, for example, to about 0-6 millimeters, based on the program. As the energy source is drawn proximally, an indicator showing the current location of the treatment can be displayed on the screen. This indicator displayed on the screen can, and should, in many embodiments correspond to an indicator on the handpiece, as described herein. This redundant information allows the user to verify that the instrument is functioning correctly.

[0183] As described and shown herein, the user may be shown a series of completed steps on the screen, for example, on the right side. For example, the user may be shown the current step as a treatment, and the user may also be shown several preceding steps. Preceding steps may include setting steps such as preparation and docking, as described herein. Preceding steps may include planning, such as setting angles and scales, as described herein. And preceding steps may include steps to define cutting-related parameters such as cutting profiles or calibration and definition of cutting profiles.

[0184] Figure 10S shows the treatment completion screen. In response to the completion of a pre-programmed treatment, the user is presented with the treatment completion screen, and the user has the option to return to adjust the profile to perform additional excision of tissue or to enter an end to move to the next screen.

[0185] Figure 10T shows the screen for exporting data. The user is prompted to export the data. The processor may be provided with instructions to export the procedure data to a non-volatile memory.

[0186] The treatment can be stored in one or more of a number of ways. For example, the treatment can be stored on a non-volatile memory such as a flash drive. Alternatively, or in combination, the attachment device as described herein may include a non-volatile memory for storing the treatment. The stored treatment parameters may include measured sensed parameters such as the pressure of the treatment, the flow rate of the treatment, and the location of the probe during the treatment. The stored treatment parameters may also include, for example, a treatment table. And the treatment table can provide useful information. For example, when compared with the measured location of the probe during the treatment to verify that the treatment is being performed according to the treatment table. When the user presses the next screen, the user is prompted to move to the next stage.

[0187] The user interface screens of FIGS. 10A - 10T are shown as examples of a series of screens according to an embodiment. Those skilled in the art will recognize many variations based on the teachings provided herein. For example, some of the screens can be removed. Other screens can be added. Some of the screens can be combined. Some of the screens may include sub-screens. Further, the screens may be presented in a different order.

[0188] In many embodiments, other alignment screens may be provided. For example, the user may be asked to identify the axes of the treatment probe in order to identify the reference axis of the treatment. The user may be asked to identify marks on the treatment probe in order to determine the translation alignment of the treatment probe axes shown on the screen with the mapped treatment shown on the screen.

[0189] Figure 11 shows a method 1100 for treating a patient in various embodiments.

[0190] In step 1102, an imaging probe having an imaging probe axis is provided.

[0191] In step 1104, a therapeutic probe having a therapeutic probe axis is provided.

[0192] In step 1106, the imaging probe axis is aligned with the treatment probe axis.

[0193] In step 1110, the alignment of the treatment probe axis along the sagittal plane of the imaging probe is verified.

[0194] In step 1112, the residual error is corrected.

[0195] In step 1114, the angle of the treatment probe axis with the imaging probe is measured.

[0196] In step 1116, the image of the patient into which the probe is inserted is rotated in response to the angle.

[0197] In step 1152, the user interface may ask the user whether the preparation of the treatment probe is complete.

[0198] In step 1154, the user interface may be awaiting docking of the treatment probe with the computer operating the user interface.

[0199] In step 1156, the user interface may confirm with the user that the ultrasound imaging device is imaging the target in a transverse image. In response to such confirmation, the main menu screen of the user interface may be displayed.

[0200] In step 1158, the user interface may allow the user to select a target angle for the treatment probe when performing the cutting procedure. The target angle may vary from 0 to 180 degrees.

[0201] In step 1160, the user interface may confirm the selected cutting angle with the user.

[0202] In step 1162, the user interface may confirm with the user that the ultrasound imaging device is imaging the target in sagittal form.

[0203] In step 1164, the user interface may facilitate the scaling or calibration of the treatment probe by prompting the user to identify the start and end positions of the probe tip as the probe tip advances from a retracted position as indicated by the ultrasound image. The start and end positions may be identified by the placement of start and end markers on the image display portion of the user interface, respectively.

[0204] In step 1166, the user interface may confirm with the user the marked start and end positions of the probe tip as acceptable.

[0205] In step 1168, the user interface may repeatedly identify and accept the start and end positions of the probe tip. In many embodiments, these steps, for example, steps 1166 and 1168, are repeated three times to verify the calibration of the probe tip.

[0206] In step 1170, the user interface may confirm with the user the zooming or calibration of the probe tip.

[0207] In step 1172, the probe tip may perform a calibration cut. The user interface may activate the probe tip and provide an instruction to perform the calibration cut. Alternatively, or in combination, the user interface may operate the treatment probe and provide a menu or sub-menu for performing the calibration cut. The display portion of the user interface may show a sagittal image of the target tissue as the calibration cut is performed. The treatment probe may be paused and resumed during the cutting process.

[0208] In step 1174, the user interface may confirm with the user that the calibration cut is complete.

[0209] In step 1176, the user interface may enable the user to determine and confirm the cut depth of the calibration cut. The user interface may provide a marker for the user to drag and place at the cut location and probe location to confirm the cut depth.

[0210] In step 1178, the user interface may enable the user to adjust and then confirm the contour boundary of the final cut. The user interface may provide one or more markers for the user to drag and place at the desired contour boundary points and modify the contour boundary as desired.

[0211] In step 1180, the treatment probe tip may perform the final cut. The user interface may provide commands to activate the probe tip and perform the final cut. Alternatively, or in combination, the user interface may provide menus or submenus for operating the treatment probe and performing the final cut. The display portion of the user interface may show a sagittal view of the target tissue as the final cut is performed. The treatment probe may be paused and unpaused during the cutting process.

[0212] In step 1182, the treatment may be completed, and the user interface may provide options to repeat and / or modify the treatment, as well as to export the history, parameters, and other information of the treatment performed to a storage medium such as a USB drive, a local data storage device, or a cloud-based storage device.

[0213] The steps of Method 1100 can be combined with the screens shown in Figures 10A-10T.

[0214] The steps described above illustrate a method 1100 for operating a therapeutic probe according to many embodiments, but those skilled in the art will recognize many modifications based on the teachings described herein. The steps may be completed in a different order. Steps may be added or omitted. Some of the steps may include sub-steps. Many of the steps may be repeated as frequently as is beneficial to the treatment.

[0215] For example, steps associated with performing a calibration cut (e.g., corresponding to the screen in Figures 10L-10O and / or steps 1172-1176 of Method 1100) may be omitted. If sufficient data on system performance is available to provide an accurate correlation between system power and the resulting penetration depth of the cut, the calibration step may not be necessary, and the system may be configured to proceed directly to the therapeutic cut.

[0216] One or more steps of Method 1100 may be carried out using a circuit as described herein, for example, one or more of the processors or logic circuits of the systems described herein. The circuit may be programmed to provide one or more steps of Method 1100, and the program may include program instructions stored in computer-readable memory, or programmed steps of logic circuits such as programmable array logic or field-programmable gate arrays, for example, Figure 11 shows a method according to an embodiment. Those skilled in the art will recognize many modifications and adaptations by teaching disclosed herein. For example, steps of the method may be eliminated. Additional steps may be provided. Some of the steps may include substeps. Some of the steps may be repeated. The order of the steps may be changed.

[0217] A processor as described herein can be configured to perform one or more steps of the method of Figure 11 and to provide one or more user interface screens as described herein. In many embodiments, the processor is configured to perform at least a portion of one or more steps in response to user input shown on a display, and the processor may include instructions for generating and displaying user interface screens as described herein.

[0218] The processor may further be configured to record each performed step of the method described herein with respect to Figures 10A-10T and 11. Separate records of use may be maintained for each user or operator of the system, and all operator inputs provided during each step of the method may be recorded. Operator records may be configured to be inaccessible for modification by the operator (e.g., recorded as a read-only file, stored in a restricted access database, backed up to a remote server, etc.). Records of all operator inputs and performed steps can provide improved operator accountability and useful reference data for system improvement and / or troubleshooting.

[0219] experiment

[0220] Figure 12 shows the maximum tissue penetration depth and flow rate through the nozzle according to the embodiment. The maximum penetration depth substantially corresponds to the length of the cavitation bubbles in the jet, which has a "low temperature" aquaablation flame region. The maximum tissue penetration depth of the ablation directly corresponds to the flow rate and, in many embodiments, is linearly related to the flow rate.

[0221] The inset in Figure 12 shows a cut potato as a model of prostate BPH according to an embodiment. The maximum penetration depth of the potato closely corresponds to the maximum cutting depth of the BPH. The potato is shown cut using a nozzle and rotary probe as described herein at 10 different flow settings corresponding to rates ranging from about 50 ml / min to about 250 ml / min. The maximum penetration depth ranges from about 4 mm at 50 ml / min to about 20 mm at about 250 ml / min.

[0222] In many embodiments, the growth and length of the cavitation cloud are a function of the flow rate proportional to the injection pressure, and vice versa, for a well-configured nozzle as described herein. As the pressure increases, the maximum erosion radius appears to increase linearly, which is shown as the maximum penetration depth in Figure 12.

[0223] High-speed cavitation jets can be created by using a known high-pressure pump to propel water through a nozzle in either a continuous or pulsating flow. Regardless of the type of flow generated by the pump, the cavitation phenomenon pulsates due to the unstable nature of vapor cavities, and cavity formation will pulsate even in continuous flow jets as described herein. Without being bound by any particular theory, it is assumed that both pulsating and continuous flow water jets will result in equivalent amounts of material erosion over a given time. In many embodiments, the nozzle geometry is configured to provide the fluid dynamics and cavitation process as described herein. In many embodiments, the nozzle is configured to prevent tight contraction at the water jet outlet, which may be related to cavitation that may occur inside the nozzle itself. In many embodiments, sharp angles further contract the water jet path while separating the water from the walls and concentrating it toward the nozzle centerline, simultaneously reducing the frictional effect caused by the nozzle walls. This results in increased velocity, along with a corresponding pressure drop and vapor cavity formation. The formation of steam cavities will affect the overall fluid dynamics, as their eventual collapse may introduce turbulence and influence the erosion depth. Those skilled in the art can conduct experiments to determine appropriate nozzle geometry and flow rate to provide the tissue removal described herein without requiring excessive experimentation.

[0224] (Aqua ablation)

[0225] Subsurface water jet cutting as described herein has the ability to utilize the cavitation phenomenon to treat patients with benign prostatic hyperplasia (BPH). The jet removes the excess soft tissue growth seen in BPH through pressure pulses and microjet caused by collapsed vapor cavities. The water jet direction can be manipulated by changing the position and orientation of the nozzle of the device, either by translating the nozzle along the anterior-posterior direction or by rotating the nozzle, for example, up to 180 degrees.

[0226] Since vapor cavity formation and its erosion intensity are functions of both injection pressure and fluid dynamics, the depth of the material can be controlled by configuring the pressure and nozzle geometry. Higher injection pressure will result in a faster exit velocity. As discussed herein, the nozzle geometry can further increase the velocity in response to contraction and will affect the degree of pressure drop as the water jet exits through the Venturi effect. These factors can result in a longer distance over which the cavitation cloud can grow and propagate before collapsing and releasing pressure pulses and microjet. The nozzle geometry and pressure settings of the aqua ablation system are optimized to give the user precise control and ensure that the cavitation jet removes only the desired benign tissue growth.

[0227] The images provided herein illustrate, according to embodiments, how tissue erosion depth is a function of pressure. The images show smaller cavitation cloud length and corresponding tissue excision depth for lower injection pressures compared to other images.

[0228] In many embodiments, aquaablation as described herein is capable of removing excessive tissue growth, such as BPH, with the removal and prevention of damage to arteries and veins. The pressure pulses and microjets caused by cavitation exceed the threshold energy required to erode soft tissue growth and can cause minimal damage to other structures, such as blood vessels, which have much higher threshold energies. Repeated concentrated pressure pulses and microjets can cause stress fatigue on the vascular system and lead to bleeding, but aquaablation system algorithms and treatment instructions as described herein are designed and configured to prevent such damage.

[0229] In many embodiments, the formation of harmful embolisms is prevented. Vapor cavity formation can benefit, for example, from microscopic air nuclei already present in the bloodstream. Cavitation can lead to nucleus growth without any additional air being introduced into the system. Furthermore, once the local jet pressure exceeds the vapor pressure, the cavities will collapse, allowing the air pockets to shrink back to their original nucleus size. In many embodiments, embolism formation is prevented as cavitation can rely on and be limited to trace amounts of air from the saline solution surrounding the urethra, and as the jet pressure begins to rise, the vapor cavities dissipate rapidly.

[0230] Aquaablation as described herein utilizes this phenomenon. Its naturally self-limiting erosion radius and unique ability to precisely excise tissue with low injury threshold energy while minimizing damage to nearby structures with denser cellular structures, such as arteries, make aquaablation as described herein a useful surgical tool for treating BPH. Combined with the nearly isothermal nature of cavitation as described herein, it can reduce collateral damage and provide an improved healing and safety profile.

[0231] Figure 13 shows selective potato ablation as a model of selective tissue removal, with porcine vessels positioned across a potato incision. The porcine vessels were positioned on the potato prior to the incision so that they were exposed to a water jet using cavitation in order to remove the potato. Aqua ablation excised a soft potato tissue model, a close surrogate for benign tissue growth seen in BPH, without causing severe damage to the porcine vessels.

[0232] Figure 14 shows potatoes treated using a predetermined treatment profile and treatment table based on user input. (Artificial intelligence and machine learning)

[0233] This disclosure provides patient and surgical robotics data, as well as several embodiments of machine learning, which can be used to train machine learning algorithms, and any type of patient and surgical robotics data as described herein can be used. For example, tissue ablation parameters such as pressure and nozzle type can be used in combination with the type of tissue to be ablated, such as capsular tissue, BPH, or cancerous tissue. Additional parameters include treatment planning profiles such as the radius, angle, and longitudinal position of the cutting profile. This can be combined with real-time imaging from imaging devices such as ultrasound probes, TRUS probes, endoscopes, cystoscopes, and optical imaging devices. The images may include images of tissue structures such as the urethra, bladder neck, and spermatic ducts. The images may include parts of surgical instruments such as rotational and oscillating probes as described herein. The images can be processed using image segmentation to determine, for example, the location of tissue structures and surgical instruments. Artificial intelligence software instructions can be configured to automatically identify tissue structures and surgical instruments and determine their relative locations. The data can be vectorized and input into, for example, a machine learning classifier.

[0234] The tissue structures to be imaged may include any tissue structures as described herein with reference to Figure 5B, for example, the bladder, capsular duct, capsule, nerves, BPH, and capsular tissue.

[0235] Sensor data, position data, and recorded treatment positions may include any of the sensor data, position data, and recorded treatment positions described herein with reference to the components and sensors and elements of Figures 3A and 10A-10R, for example. Recorded data may include, for example, data from the energy source, pump, injection / washing, blowing, endoscope, balloon inflation, suction, light source, arm lock, arm controller, chain section, angle sensor, patient support, or base.

[0236] The treatment data may include, for example, setting data such as the position of the probe relative to multiple structures, allowing a user, such as a physician, to adjust the endoscope independently of other components of the device, as shown in Figures 8A-8T. In many embodiments, the endoscope is coupled to an endoscope carriage or chain section as described herein, with a sensor configured to determine the position of the endoscope on the carriage during setup. The endoscope carriage can be advanced and retracted to move the distal end of the endoscope connected to the coupling section proximal and distal, and these positions can be recorded during setup.

[0237] Treatment data may include any data and images of a planned treatment, for example, as described herein with reference to Figures 10A-10S. Treatment data may include target angle, planned tissue profile, pressure, and other parameters as described herein.

[0238] The treatment data may include, for example, setting data related to the alignment of the surgical treatment probe with the imaging probe, with reference to Figures 9A-9B and 10A-10S. For example, the alignment of the treatment probe axis with the sagittal plane of the imaging probe, as described herein, can be recorded and used as input. The inclination of the extension axis of the treatment probe with respect to the extension axis of the imaging probe, as described herein, can be used as input. The recorded images may include images from the imaging probe having a sagittal image field of view in which the treatment probe is substantially aligned with the sagittal plane of the imaging probe, as described herein, when the treatment probe is in the field of view of the sagittal image. The setting data may include, for example, preparation data, docking data, angle data, scale data, calibration data, section profile data, the corresponding time for one or more of these, and the planned treatment time.

[0239] The planned data can be modified using artificial intelligence or machine learning as described herein. For example, the planned and modified tissue removal profile can be overlaid on an image of the tissue and displayed on a screen as described herein.

[0240] Figure 15 shows a method 1500 for treating a patient using artificial intelligence or machine learning, according to several embodiments. While the method can be implemented in many ways, in some embodiments, patient data is received for each of several patients being treated. The data for each of several patients being treated includes one or more of the following: patient demographic data, section profiles of the tissue to be removed, actual profiles of the tissue to be removed, target volume of the tissue to be removed, actual volume of the tissue to be removed, or the ratio of the amount of tissue targeted for removal to the amount to be removed. Surgical robotics data is also received for each of several patients being treated. The surgical robotics data includes multiple treatment parameters recorded during treatment, treatment time, setup time, imaging time, time the treatment probe moves, multiple locations and orientations of the treatment probe, multiple images of the tissue, multiple images of the tissue each comprising the treatment probe, or the intensity of the energy source for tissue removal. A treatment plan for the patient to be treated is output in response to the patient data and surgical robotics data.

[0241] In step 1505, patient demographic data is recorded for each of the multiple patients being treated. The patient demographic data for each of the multiple patients and for the patient to be treated includes one or more of the following: patient age, weight, sex, or body mass index.

[0242] In step 1510, a treatment plan is recorded for each of the patients being treated. The treatment plan may consist of any of the treatment plans described herein.

[0243] In step 1515, configuration data is recorded from the surgical robot for each of the multiple patients being treated. The configuration data may include any of the configuration data described herein.

[0244] In step 1520, multiple patients are treated individually according to a treatment plan. Patients may be treated using one or more surgical procedure steps as described herein.

[0245] In step 1523, data is recorded between treatments for each of the multiple patients being treated. The recorded data may include images of each of the multiple patients. The recorded data may include a sequence of images, for example, a video of any of the images described herein.

[0246] Multiple treatment parameters recorded during treatment include a measured treatment time, a measured setup time, a measured imaging time, a measured time the treatment probe moves, a measured intensity of the energy source for tissue removal, multiple recorded positions of the treatment probe, multiple recorded images of the tissue during treatment, multiple recorded orientations of the treatment probe, and multiple tissue images corresponding to each of the multiple recorded positions and orientations. Multiple treatment parameters recorded during treatment include multiple sequentially arranged data frames, each of which includes an image of the tissue, an image of the treatment probe positioned relative to the tissue being treated, the position of the treatment probe, the orientation of the treatment probe, or the energy of the treatment probe, and optionally, each of the multiple sequentially arranged data frames corresponds to a substantially fixed time interval between each of the multiple frames.

[0247] In step 1525, sensor data and treatment data from robotic components are recorded, with data corresponding to each of multiple images for each patient being treated. The energy source intensity may be water jet intensity, light beam intensity, radio frequency energy intensity, ionizing radiation intensity, stereotactic radiation intensity, or ultrasonic energy intensity.

[0248] In step 1530, a data frame is generated for each of the multiple patients being treated, from multiple image and sensor data as well as treatment data. The data frame may include image frames corresponding to fixed intervals, such as one second, between frames. Alternatively, or in combination, vectorized data can be generated from the image frames.

[0249] In step 1535, pre-treatment data is received, corresponding to the outcome parameters for each of the multiple patients being treated.

[0250] In step 1540, post-treatment data is received, corresponding to outcome parameters for each of the multiple patients being treated.

[0251] In step 1545, surgical robotics data is received for each patient being treated.

[0252] In step 1550, an artificial intelligence processor instruction or machine learning classifier is trained in response to the received patient and surgical treatment data. The artificial intelligence processor instruction may comprise one or more of the following: machine learning, search and mathematical optimization, artificial neural networks, statistics, probability, support vector machine learning, data clustering, image classification, or image segmentation. The machine learning processor instruction may comprise one or more of the following: decision tree learning, association rule learning, artificial neural networks, deep learning, inductive logic programming, support vector machines, clustering, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, sparse dictionary learning, genetic algorithms, rule-based machine learning, or a learning classifier system.

[0253] In step 1555, the trained artificial intelligence or trained machine learning classifier is validated.

[0254] In step 1560, data on the patients to be treated is input into a trained artificial intelligence or a trained machine learning classifier.

[0255] In step 1565, the treatment plan for the patient to be treated is determined.

[0256] In step 1570, the treatment plan for the patient to be treated is input into a trained artificial intelligence or machine learning classifier.

[0257] In step 1575, the treatment plan is modified in response to a trained artificial intelligence or machine learning classifier. Modification of the treatment plan for the patient to be treated may include adjustment of one or more of the following: the section profile of the tissue to be removed, the actual profile of the tissue to be removed, the target volume of the tissue to be removed, the actual volume of the tissue to be removed, the treatment time, the setup time, the imaging time, the time the treatment probe moves, the intensity of the energy source for tissue removal, or the ratio of the amount of tissue targeted for removal to the amount to be removed. The section profile may have multiple locations, each comprising multiple angular coordinates around the treatment axis, multiple corresponding axial coordinates along the axis, and multiple radial distances from the axis. Modification of the section profile may include adjustment of multiple angular coordinates around the treatment axis, multiple corresponding axial coordinates along the axis, and multiple radial distances from the axis.

[0258] In step 1580, the revised treatment plan is output and received as input into the processor of the surgical robot system.

[0259] In step 1585, the initial and modified cutting profiles are displayed on the image of the tissue to be treated. The initial cutting profile is overlaid on the image of the tissue to be excised on the display, and the modified cutting profile is displayed on the image of the tissue to be treated, for example.

[0260] In step 1590, the patient is treated using the modified treatment plan.

[0261] In step 1595, data from patients being treated with the revised treatment plan is recorded.

[0262] In step 1597, a trained artificial intelligence or trained machine learning classifier is updated in response to patients being treated with the modified treatment plan.

[0263] One or more steps of Method 1500 may be carried out using circuit or processor instructions as described herein, for example, one or more of the processors or logic circuits of the systems described herein. The circuit may be programmed to provide one or more steps of Method 1500, and the program may comprise programmed steps of program instructions or logic circuits stored in computer-readable memory, for example, using programmable array logic or field-programmable gate arrays.

[0264] Figure 15 shows a method according to an embodiment. Those skilled in the art will recognize many modifications and adaptations by the teachings disclosed herein. For example, steps of the method can be eliminated. Additional steps can be provided. Some of the steps may include substeps. Some of the steps can be repeated. The order of the steps can be changed. (Digital processing devices)

[0265] In some embodiments, the platforms, systems, media, and methods described herein involve the use of a digital processing device or the same. In further embodiments, the digital processing device includes one or more hardware central processing units (CPUs) or general-purpose graphics processing units (GPGPUs) that perform the functions of the device. In yet further embodiments, the digital processing device further includes an operating system configured to execute executable instructions. In some embodiments, the digital processing device is optionally connected to a computer network. In further embodiments, the digital processing device is optionally connected to the Internet to access the World Wide Web. In yet further embodiments, the digital processing device is optionally connected to a cloud computing infrastructure. In other embodiments, the digital processing device is optionally connected to an intranet. In other embodiments, the digital processing device is optionally connected to a data storage device.

[0266] According to this specification, suitable digital processing devices, in non-limiting embodiments, include server computers, desktop computers, laptop computers, notebook computers, subnotebook computers, netbook computers, netpad computers, set-top computers, media streaming devices, handheld computers, internet appliances, mobile smartphones, tablet computers, personal digital assistants, video game consoles, and vehicles. Those skilled in the art will recognize that many smartphones are suitable for use in the systems described herein. Those skilled in the art will also recognize that a selection of televisions, video players, and digital music players with optional computer network connectivity are suitable for use in the systems described herein. Suitable tablet computers include those with booklet, slate, and convertible configurations, which are known to those skilled in the art.

[0267] In some embodiments, the digital processing device includes an operating system configured to execute executable instructions. The operating system is software, including programs and data that, for example, manage the device's hardware and provide services for running applications. Those skilled in the art will recognize that, in non-limiting embodiments, preferred server operating systems include FreeBSD, OpenBSD, NetBSD®, Linux®, Apple® Mac OS X Server®, Oracle® Solaris, Windows® Server, and Novell® NetWare®. Those skilled in the art will recognize that, in non-limiting embodiments, preferred personal computer operating systems include UNIX®-like operating systems such as Microsoft® Windows®, Apple® Mac OS X®, UNIX®, and GNU / Linux®. In some embodiments, the operating system is provided by cloud computing. Those skilled in the art will also recognize that suitable mobile smartphone operating systems include, in non-limiting embodiments, Nokia® Symbian® OS, Apple® iOS®, Research In Motion BlackBerry OS®, Google® Android®, Microsoft® Windows® Phone® OS, Microsoft® Windows® Mobile® OS, Linux®, and Palm® WebOS®.Those skilled in the art will also recognize that suitable media streaming device operating systems include, in non-limiting embodiments, Apple TV®, Roku®, Boxee®, Google TV®, Google Chromecast®, Amazon Fire®, and Samsung® HomeSync®. Those skilled in the art will also recognize that suitable video game console operating systems include, in non-limiting embodiments, Sony® PS3®, Sony® PS4®, Microsoft® Xbox 360, Microsoft Xbox One, Nintendo® Wii®, Nintendo® Wii U®, and Ouya®.

[0268] In some embodiments, the device includes a storage and / or memory device. The storage and / or memory device is one or more physical devices used to store data or programs on a temporary or permanent basis. In some embodiments, the device is volatile memory and requires power to maintain the stored information. In some embodiments, the device is non-volatile memory and retains the stored information when the digital processing device is not powered. In further embodiments, the non-volatile memory comprises flash memory. In some embodiments, the non-volatile memory comprises dynamic random access memory (DRAM). In some embodiments, the non-volatile memory comprises ferroelectric random access memory (FRAM®). In some embodiments, the non-volatile memory comprises phase-change random access memory (PRAM). In other embodiments, the device is a storage device that, in non-limiting embodiments, includes CD-ROMs, DVDs, flash memory devices, magnetic disk drives, magnetic tape drives, optical disk drives, and cloud computing-based storage devices. In further embodiments, the storage device and / or memory device is a combination of devices such as those disclosed herein.

[0269] In some embodiments, the digital processing device includes a display for transmitting visual information to the user. In some embodiments, the display is a cathode ray tube (CRT). In some embodiments, the display is a liquid crystal display (LCD). In further embodiments, the display is a thin-film transistor liquid crystal display (TFT-LCD). In some embodiments, the display is an organic light-emitting diode (OLED) display. In various further embodiments, the OLED display is a passive-matrix OLED (PMOLED) or an active-matrix OLED (AMOLED) display. In some embodiments, the display is a plasma display. In other embodiments, the display is a video projector. In yet further embodiments, the display is a combination of devices such as those disclosed herein.

[0270] In some embodiments, the digital processing device includes an input device for receiving information from a user. In some embodiments, the input device is a keyboard. In some embodiments, the input device is a pointing device, including, in non-limiting embodiments, a mouse, trackball, trackpad, joystick, game controller, or stylus. In some embodiments, the input device is a touchscreen or multitouchscreen. In other embodiments, the input device is a microphone for capturing voice or other sound input. In other embodiments, the input device is a video camera or other sensor for capturing motion or visual input. In further embodiments, the input device is Kinect, Leap Motion, or equivalent. In even further embodiments, the input device is a combination of devices such as those disclosed herein.

[0271] Referring to Figure 16, in certain embodiments, the exemplary digital processing device 1601 is programmed or otherwise configured to use artificial intelligence or machine learning to set up, plan, or perform surgical robotic procedures. The device 1601 can adjust various aspects of machine learning and artificial intelligence of this disclosure, such as determining a cutting profile, in response to data of patients to be treated and data from previously treated patients and previous surgical procedures, as described herein. In these embodiments, the digital processing device 1601 includes a central processing unit (CPU, also referred to herein as “processor” and “computer processor”) 1605, which may be a single-core or multi-core processor, or multiple processors for parallel processing. The digital processing device 1601 also includes memory or memory locations 1610 (e.g., random-access memory, read-only memory, flash memory), an electronic storage unit 1615 (e.g., a hard disk), a communication interface 1620 (e.g., a network adapter) for communicating with one or more other systems, and peripheral devices 1625 such as a cache, other memory, data storage devices, and / or an electronic display adapter. The memory 1610, storage unit 1615, interface 1620, and peripheral device 1625 communicate with the CPU 1605 through a communication bus (solid wire) such as a motherboard. The storage unit 1615 may be a data storage unit (or data repository) for storing data. The digital processing device 1601 can be operably coupled to the computer network ("Network") 1630 with the help of the communication interface 1620. The Network 1630 may be the Internet, the Internet and / or an extranet, or an intranet and / or extranet communicating with the Internet. In some cases, the Network 1630 is a telecommunications and / or data network. The Network 1630 may include one or more computer servers that can enable distributed computing such as cloud computing.Network 1630 can implement a peer-to-peer network, which in some cases, with the help of device 1601, may allow devices coupled to device 1601 to behave as either clients or servers.

[0272] Continuing to refer to Figure 16, the CPU 1605 can execute a set of machine-readable instructions, which may be embodied in a program or software. The instructions may be stored in a memory location, such as memory 1610. The instructions can then be directed to the CPU 1605, which may be programmed or otherwise configured to implement the method of this disclosure. Embodiments of operations performed by the CPU 1605 may include fetching, decoding, executing, and writing back. The CPU 1605 may be part of a circuit, such as an integrated circuit. One or more other components of device 1601 may be included in the circuit. In some cases, the circuit is an application-specific integrated circuit (ASIC) or a field-programmable gate array (FPGA).

[0273] Continuing to refer to Figure 16, the storage unit 1615 can store files such as drivers, libraries, and saved programs. The storage unit 1615 can also store user data, such as user preferences and user programs. The digital processing device 1601 may include one or more additional data storage units located externally, such as on a remote server communicating via an intranet or the internet.

[0274] Continuing to refer to Figure 16, the digital processing device 1601 can communicate with one or more remote computer systems through the network 1630. For example, device 1601 can communicate with a user's remote computer system. Embodiments of a remote computer system include personal computers (e.g., portable PCs), slate or tablet PCs (e.g., Apple® iPad®, Samsung® Galaxy Tab), telephones, smartphones (e.g., Apple® iPhone®, Android-enabled devices, Blackberry®), or personal digital assistants.

[0275] The methods described herein can be implemented, for example, via machine-executable code stored on an electronic storage location of a digital processing device 1601, such as memory 1610 or an electronic storage unit 1615. The machine-executable or machine-readable code can be provided in the form of software. During use, the code can be executed by the processor 1605. In some cases, the code can be read from the storage unit 1615 and stored on memory 1610 for easy access by the processor 1605. In some situations, the electronic storage unit 1615 can be omitted, and the machine-executable instructions are stored on memory 1610.

[0276] (Non-transient computer-readable storage medium)

[0277] In some embodiments, the platforms, systems, media, and methods disclosed herein include one or more non-transient computer-readable storage media encoded with a program containing instructions executable by an operating system of a optionally networked digital processing device. In further embodiments, the computer-readable storage medium is a tangible component of the digital processing device. In yet another embodiment, the computer-readable storage medium is optionally removable from the digital processing device. In some embodiments, the computer-readable storage medium includes, in non-limiting embodiments, CD-ROMs, DVDs, flash memory devices, solid-state memory, magnetic disk drives, magnetic tape drives, optical disk drives, cloud computing systems and services, and equivalents. In some cases, the programs and instructions are encoded permanently, substantially permanently, semi-permanently, or non-transiently on the medium.

[0278] (Computer program)

[0279] In some embodiments, the platforms, systems, media, and methods disclosed herein involve the use of at least one computer program or identical thereof. A computer program includes a set of instructions executable on the CPU of a digital processing device, written to perform a specified task. Computer-readable instructions may be implemented as program modules such as functions, objects, application programming interfaces (APIs), data structures, and equivalents, which perform a particular task or implement a particular abstract data type. Based on the disclosures provided herein, those skilled in the art will recognize that computer programs can be written in various versions of various languages.

[0280] The functionality of computer-readable instructions may be combined or distributed as desired within various environments. In some embodiments, a computer program comprises one sequence of instructions. In some embodiments, a computer program comprises multiple sequences of instructions. In some embodiments, a computer program is provided from one location. In other embodiments, a computer program is provided from multiple locations. In various embodiments, a computer program includes one or more software modules. In various embodiments, a computer program includes, in part or in whole, one or more web applications, one or more mobile applications, one or more standalone applications, one or more web browser plugins, extensions, add-ins or add-ons, or a combination thereof.

[0281] (Web application)

[0282] In some embodiments, the computer program includes a web application. Those skilled in the art will recognize, based on the disclosures provided herein, that the web application utilizes, in various embodiments, one or more software frameworks and one or more database systems. In some embodiments, the web application is built on a software framework such as Microsoft® .NET or Ruby on Rails (RoR). In some embodiments, the web application utilizes one or more database systems, including, in non-limiting embodiments, relational, non-relational, object-oriented, associative, and XML database systems. In further embodiments, preferred relational database systems, in non-limiting embodiments, include Microsoft® SQL Server and MySQL. TM, and Oracle®, among others. Those skilled in the art will also recognize that web applications may, in various embodiments, be written in one or more versions of one or more languages. A web application may be written in one or more markup languages, presentation definition languages, client-side scripting languages, server-side coding languages, database query languages, or a combination thereof. In some embodiments, a web application may be written to some extent in a markup language such as Hypertext Markup Language (HTML), Extensible Hypertext Markup Language (XHTML), or Extensible Markup Language (XML). In some embodiments, a web application may be written to some extent in a presentation definition language such as Cascading Style Sheets (CSS). In some embodiments, a web application may be written to some extent in a client-side scripting language such as Asynchronous Javascript® and XML (AJAX), Flash® Actionscript, Javascript®, or Silverlight®. In some embodiments, the web application uses, to some extent, Active Server Pages (ASP), ColdFusion (registered trademark), Perl, Java (registered trademark), Java Server Pages (JSP), Hypertext Preprocessor (PHP), and Python. TMThe web application is written in a server-side coding language such as Ruby, Tcl, Smalltalk, WebDNA®, or Groovy. In some embodiments, the web application is written to some extent in a database query language such as a structured query language (SQL). In some embodiments, the web application integrates with enterprise server products such as IBM® Lotus Domino®. In some embodiments, the web application includes a media player element. In various further embodiments, the media player element utilizes one or more of many preferred multimedia technologies, including, in non-limiting embodiments, Adobe® Flash®, HTML 5, Apple® QuickTime®, Microsoft® Silverlight®, Java®, and Unity®.

[0283] (Mobile application)

[0284] In some embodiments, the computer program includes a mobile application provided to a mobile digital processing device. In some embodiments, the mobile application is provided to the mobile digital processing device at the time it is manufactured. In other embodiments, the mobile application is provided to the mobile digital processing device via a computer network as described herein.

[0285] In light of the disclosures provided herein, mobile applications are created using hardware, languages, and development environments known in the art, and techniques known to those skilled in the art. Those skilled in the art will recognize that mobile applications are written in several languages. Preferred programming languages, in non-limiting embodiments, include C, C++, C#, Objective-C, Java®, Javascript®, Pascal, Object Pascal, and Python. TMThis includes Ruby, VB.NET, WML, and XHTML / HTML with or without CSS, or a combination thereof.

[0286] Suitable mobile application development environments are available from several sources. Commercially available development environments, in non-exclusive examples, include AirplaySDK, alcheMo, Appcelerator®, Celsius, Bedrock, Flash Lite, .NET Compact Framework, Rhomobile, and WorkLight Mobile Platform. Other development environments, in non-exclusive examples, include Lazarus, MobiFlex, MoSync, and Phonegap, which are available free of charge. Mobile device manufacturers also offer, in non-exclusive examples, iPhone® and iPad® (iOS) SDKs, Android SDKs, and Android SDKs. TM We distribute software developer kits, including SDKs, BlackBerry® SDK, BREW SDK, Palm® OS SDK, Symbian SDK, webOS SDK, and Windows® Mobile SDK.

[0287] Those skilled in the art will recognize, in non-limiting embodiments, that several commercial forums are available for the distribution of mobile applications, including Apple® App Store, Google® Play, Chrome WebStore, BlackBerry® App World, App Store for Palm devices, App Catalog for webOS, Windows® Marketplace for mobile devices, Ovi Store for Nokia® devices, Samsung® Apps, and Nintendo® DSi Shop.

[0288] (Standalone application)

[0289] In some embodiments, the computer program includes a standalone application, which is a program launched as an independent computer process, not an add-on to an existing process, such as a plug-in. Those skilled in the art will recognize that standalone applications are often compiled. A compiler is a computer program that translates source code written in a programming language into binary object code, such as assembly language or machine code. Suitable compiled programming languages, in non-limiting embodiments, include C, C++, Objective-C, COBOL, Delphi, Eiffel, Java®, Lisp, and Python. TM This includes Visual Basic and VB.NET, or a combination thereof. Compilation is often performed to create an at least partially executable program. In some embodiments, a computer program includes one or more executable compiled applications.

[0290] (Web browser plugin)

[0291] In some embodiments, a computer program includes web browser plugins (e.g., extensions). In computing, a plugin is one or more software components that add specific functionality to a larger software application. Software application makers support plugins to enable third-party developers to create the ability to extend the application, support the easy addition of new features, and reduce the size of the application. When supported, plugins allow for customization of the functionality of the software application. For example, plugins are commonly used in web browsers to play videos, generate interactivity, scan for viruses, and display specific file types. Those skilled in the art will be familiar with several web browser plugins, including Adobe® Flash® Player, Microsoft® Silverlight®, and Apple® QuickTime®. In some embodiments, a toolbar comprises one or more web browser extensions, add-ins, or add-ons. In some embodiments, a toolbar comprises one or more explorer bars, toolbands, or deskbands.

[0292] In light of the disclosures provided herein, those skilled in the art will recognize that, as non-limiting embodiments, several plugin frameworks are available that enable the development of plugins in a variety of programming languages, including C++, Delphi, Java®, PHP, Python®, and VB.NET, or combinations thereof.

[0293] A web browser (also called an internet browser) is a software application designed for use with a network-connected digital processing device to read, present, and traverse information resources on the World Wide Web. Preferred web browsers, in non-limiting embodiments, include Microsoft® Internet Explorer®, Mozilla® Firefox®, Google® Chrome, Apple® Safari®, Opera Software® Opera®, and KDE Konqueror. In some embodiments, a web browser is a mobile web browser. Mobile web browsers (also called microbrowsers, minibrowsers, and wireless browsers) are designed for use on mobile digital processing devices, in non-limiting embodiments, including handheld computers, tablet computers, netbooks, subnotebook computers, smartphones, music players, personal digital assistants (PDAs), and handheld video game systems. Suitable mobile web browsers, in non-exclusive examples, include the Google® Android® browser, the RIM BlackBerry® browser, Apple® Safari®, Palm® Blazer, Palm® WebOS® browser, Mozilla® Firefox® for mobile, Microsoft® Internet Explorer® Mobile, Amazon® Kindle® Basic Web, Nokia® browser, Opera Software® Opera® Mobile, and Sony® PSP TM Includes browsers.

[0294] (Software module)

[0295] In some embodiments, the platforms, systems, media, and methods disclosed herein involve the use of software, servers, and / or database modules, or the same. In light of the disclosures provided herein, software modules are created using machines, software, and languages ​​known to those skilled in the art, and by techniques known to those skilled in the art. Software modules disclosed herein are implemented in numerous ways. In various embodiments, a software module comprises files, sections of code, programming objects, programming structures, or a combination thereof. In further various embodiments, a software module comprises multiple files, multiple sections of code, multiple programming objects, multiple programming structures, or a combination thereof. In various embodiments, one or more software modules comprise, in non-limiting embodiments, a web application, a mobile application, and a standalone application. In some embodiments, a software module resides within a single computer program or application. In other embodiments, a software module resides within one or more computer programs or applications. In some embodiments, a software module is hosted on a single machine. In other embodiments, a software module is hosted on one or more machines. In further embodiments, a software module is hosted on a cloud computing platform. In some embodiments, the software module is hosted on one or more machines in one location. In other embodiments, the software module is hosted on one or more machines in more than one location.

[0296] (Database)

[0297] In some embodiments, the platforms, systems, media, and methods disclosed herein involve the use of one or more databases or identical databases. In light of the disclosures provided herein, those skilled in the art will recognize that many databases are suitable for storing and retrieving patient and surgical information as described herein. In various embodiments, suitable databases include, in non-limiting embodiments, relational databases, non-relational databases, object-oriented databases, object databases, entity-relational model databases, associative databases, and XML databases. Further non-limiting embodiments include SQL, PostgreSQL, MySQL, Oracle, DB2, and Sybase. In some embodiments, the database is internet-based. In further embodiments, the database is web-based. In even further embodiments, the database is cloud computing-based.

[0298] Patient data for each patient may be stored in a database as described herein and used as input to train a classifier. The patient data may include several fields and images for each patient, and may also include a library of treatments. The patient data may also include patient-specific values ​​for safety and efficacy parameters as described herein.

[0299] (Examples of artificial intelligence, classifiers, neural networks, and associated inputs and user interfaces)

[0300] The effectiveness and durability of patient treatment can be measured in many ways. Treatment durability may correspond to the stability of effectiveness parameters over time. For example, durability parameters may correspond to the patient's urethral patency and urinary flow rate over time after surgery. Many metrics of patient effectiveness can be used, but in some embodiments, the International Prostate Symptom Score ("I-PSS") is used to determine the effectiveness of the procedure. A questionnaire may be provided to the patient before and after treatment, and the results may be used to train an algorithm such as the one described herein. The I-PSS score has seven questions, each with graded responses on a scale of 1 to 5. These graded responses may be used as input to train an algorithm. The questions include incomplete urination, frequent urination, intermittent, urge, weak flow, straining, and nocturia. "Incomplete urination" refers to the feeling that the bladder is not empty. "Frequent urination" refers to how often the subject needs to urinate less than every two hours. "Intermittent" refers to the frequency with which the subject stopped and resumed urination several times during a urination period. "Urgent" refers to the frequency with which the subject found it difficult to postpone urination. "Weak flow" refers to the frequency with which the subject had a weak urine flow. "Straining" refers to the frequency with which the subject needed to strain to begin urination. Nocturia refers to the number of times the subject woke up at night to urinate. The sum of these values ​​can be added together to determine an overall score, with 1-7: mild, 8-19: moderate, and 20-35: severe. The sum can be used as input to algorithms such as classifiers or neural networks as described herein.

[0301] Other tests, such as the United States Urological Association ("AUA") Symptom Index, may also be used.

[0302] Another input to algorithms, such as the International Index of Erectile Function (IIEF-5) Shortened Questionnaire, may be patient outcomes related to sexual function following prostate surgery. The IIEF-5 has five questions related to sexual function, with responses ranging from 1 to 5, where 1 is very low and 5 is very high. The questions concern confidence, firmness, stability, and subjective satisfaction with erections. IIEF-5 scores can be combined to provide a total score. Individual values ​​and / or total scores can be used as input to algorithms, such as those described herein, to train one or more classifiers or neural networks.

[0303] Additional parameters that may be used include one or more of the following: return-to-work time, uroflow rate data, catheter insertion time, catheter tension, Foley catheter tension, or catheter tensioning device method. In urological procedures such as prostate surgery, it may be helpful to place a catheter, such as a Foley catheter, in the patient and maintain uroflow rate. Studies related to this disclosure suggest that applying tension to a catheter placed in the patient's urethra may reduce bleeding and maintain catheter placement. Since catheter insertion can be somewhat uncomfortable for the patient, it may be helpful to shorten catheter insertion time while maintaining urethral patency and reducing bleeding. Since many types of catheter tensioning can be used, it may be helpful to receive the type of catheter tensioning to be used as input. Examples of catheter tensioning include weights, springs, tapes, and other approaches that may be used to apply tension to the catheter.

[0304] The input patient data may include one or more biomechanical parameters from the patient's tissue, such as tissue strain, tissue elasticity, tissue tensile strength, tissue elongation, tissue modulus of elasticity, or tissue homogeneity. These measurements are performed for each patient and can be used as input. For example, an ultrasound probe can be used to measure these parameters, and these parameters may comprise components of the ultrasound probe. For example, an ultrasound probe may be configured to measure tissue using one or more of the following: low-frequency vibration, step, freehand, physiological displacement, radiant force (e.g., displacement, impulse, shear wave, and acoustic emission), or pulsed echo or Doppler ultrasound. An ultrasound probe for measuring tissue parameters may comprise components of a TRUS probe as described herein.

[0305] Alternatively, or in combination, these biomechanical tissue parameters can be determined and provided as inputs, such as physical palpation using measuring tools. In some embodiments, these values ​​can be determined using lookup tables. For example, demographic parameters such as patient age and patient-specific tissue biomechanical parameters can be input into a classifier and used to generate a lookup table for tissue parameters in response to patient demographic data.

[0306] The patient images used as input may include, for example, one or more of the following: tissue boundary recognition, tissue surface recognition, tissue differentiation detection, fluorescence fluoroscopy, CT scan imaging, magnetic resonance imaging, radioactivity detection, or radiopaque imaging. In some embodiments, the images include fluorescence images of the patient's tissue. The fluorescence images may include, for example, images of tissue marked with a fluorescent antibody configured to bind to cancer tissue in order to identify cancer tissue in the image.

[0307] The input patient data may include the identification of cancerous tissue in one or more images of the patient.

[0308] In some embodiments, the processor is configured with instructions for the user to select one or more parameters to be used to determine one or more of the following: safety parameter values, efficacy parameter values, or proposed tissue resection profiles. This can be useful, for example, for a physician to adapt specific preferences based on user experience when they believe that certain demographic parameters or other parameters are not helpful in planning treatment or predicting outcomes.

[0309] In some embodiments, the processor is configured with instructions for a user to plan a surgical procedure on a first display remotely from the surgical system, to store parameters relating to the planned surgical procedure, and to provide the parameters to the processor which is operably coupled to the display of the surgical system. This can help the user to pre-plan surgical procedures. For example, a surgeon can pre-plan a patient treatment and load the parameters of the planned treatment onto the surgical system at a location remote from the surgical site, thereby reducing preparation time at the surgical site.

[0310] In some embodiments, the user is provided with guidance in response to patient data. The user can consider different approaches to different recommended treatment plans based on individual or grouped artificial intelligence (AI) approaches and select visualizations or pre-planning reports. The user can consider the strengths of different algorithms when predicting outcomes such as risk, recovery, persistence, procedure length, specific patient characteristics, or physician characteristics.

[0311] In some embodiments, the user selects, for example, data to be used in conjunction with a chosen algorithm. This allows the user to consider the difficulty and risk of outcome likelihood, for example, with a desired outcome versus risk, for different scenarios.

[0312] While rotational and translational surgical probes are referred to, the methods, apparatus, and artificial intelligence programs disclosed herein are highly suitable for combination with many types of robotic surgical procedures. The robotic system may include a processor operably coupled to a chain section such as a robotic arm. For example, the surgical system may include a robotic arm such as a 5- to 7-degree-of-freedom robotic arm with an end effector. The robotic arm may include joint states that can be recorded along with images of the surgical procedure. The end effector may include an energy source, as described herein, for removing tissue in accordance with the tissue resection profile. The end effector may be present in the stored images as described herein. One or more of the patient data, such as images, chain states, resection profiles, or demographic data, can be recorded in a database comprising a library of patient procedures as described herein, which can be used to train a classifier as described herein. The trained classifier can receive data from individual patients and classifier outputs used to determine treatment parameters as input. Treatment for individual patients can be planned using a user interface as described herein.

[0313] Treatment parameters and safety and efficacy data can be used to train one or more classifiers or neural networks, as described herein with reference to Figure 15, for example. Once trained, the classifiers and / or neural networks can be used to provide information on a display and assist robotic system users, such as surgeons, in determining appropriate tissue resection or cutting profiles.

[0314] The information displayed on the screen may include, for example, safety parameters and efficacy parameters. The system user can adjust the tissue resection profile to provide an appropriate balance between the safety parameters and the efficacy parameters. The safety parameters may include the likelihood of erectile dysfunction at a certain time after surgery, for example, one year after surgery, e.g., a predicted IIE-5 score. The efficacy parameters may include the likelihood of retreatment at a certain time in the future, for example, in the next five years. The efficacy parameters may include a predicted I-PSS score at a certain time in the future, e.g., a predicted I-PSS score in the next five years.

[0315] Displaying these profiles along with associated parameters can help physicians plan treatment with a treatment plan that is acceptable to the patient. For example, some patients may voluntarily tolerate some degree of sexual dysfunction rather than retreatment. Alternatively, some patients may more voluntarily accept retreatment rather than sexual dysfunction.

[0316] In some embodiments, as part of a treatment plan, a physician can present targeted safety and efficacy parameters to a patient on a computer display, which the patient can digitally sign and accept. For example, the display can show the patient a predicted I-PSS score at 5 years and the user a predicted IIEF-5 score at 1 year, which the user can digitally sign and accept. Target parameters can be displayed on the display along with images of the prostate and the patient's digital signature. This data can be stored on a processor as described herein and provided to the physician on the display as part of a treatment planning process as described herein. This data can also be stored as part of a record for the patient, for example, as an electronic medical record ("EMR").

[0317] Referring to Figure 17A, a sample user interface 1700, which can be used in conjunction with the devices and methods described herein, is illustrated. The user interface 1700 may comprise two main areas, such as an instruction area 1702 and a control area 1704. Naturally, the illustrated user interface 1700 layout is illustrative, and any preferred layout or arrangement of information and control inputs can be used without departing from the scope of this specification.

[0318] In the instruction area 1702, the system user may be reminded and / or prompted regarding the next step in a series of steps. For example, as shown in the figure, the instruction area 1702 indicates that an imaging device, such as a TRUS probe, is scanning the prostate within the scan window 1706. The scan window 1706 may display the area of ​​a biological structure that is being scanned or should be scanned for the current procedural step, as will be described later. The provided image is a cross-sectional view of the prostate.

[0319] The biostructure selection window 1708 provides the user with the ability to select a portion of the biostructure to establish a work profile. As shown in the figure, the user selected "prostate" as part of the biostructure to set up the work profile.

[0320] The safety and efficacy parameter window 1750 displays values ​​for one or more safety or efficacy parameters, as described herein, for a subject, in response to the resection profile and ultrasound image. For example, the efficacy value X may comprise one or more of the target efficacy value or efficacy values ​​determined in response to the structure of the resection profile and image. For example, window 1750 may display a target efficacy value determined for the patient in consultation with the patient, and a predicted efficacy value generated in response to the resection profile and image. Window 1750 may also display a target safety value determined for the patient in consultation with the patient, and a predicted safety value generated in response to the resection profile and image. These values ​​can be determined in real time in response to the structure of the resection profile and ultrasound image shown on the display. The safety parameter may comprise a value X, and the efficacy parameter may comprise a value Y. The values ​​of X and Y displayed on the display can change as the user adjusts the resection profile. The processor can be configured with instructions to generate an initial resection profile in response to the ultrasound image and target safety and efficacy values, which may have been agreed upon in advance by the patient and physician. This initial excision profile is provided on the display and can be adjusted by the user.

[0321] As a portion of a biological structure is selected, an image corresponding to the selected portion of the biological structure may be displayed. For example, a real-time image captured by an in-situ imaging system may be displayed. In some cases, a TRUS probe will be placed close to the patient's prostate to provide real-time imaging of the area. In the control area 1704 of the user interface 1700, the user can define the area to be treated. The system is programmed by default to assist the user in selecting an appropriate treatment plan. For example, if the user selects the prostate as shown in the figure, the control window 1704 first displays an arc 1710 having an angle 1712 and a radius 1714. The arc 1710 defines a tissue resection profile in which the area to be treated within the arc 1710 is treated, and the area outside the arc 1710 is excluded from treatment. Arc control handles 1716a and 1716b are provided to allow the user to control each section of the arc 1710 and adjust the angle 1712. The display shows the selected angle 1712, which can be used to precisely adjust the angle 1712 and define the appropriate treatment area. The excision profile initially shown on the display may have a profile determined in response to desired safety and efficacy values. The vertex 1718 of the arc 1710 indicates the placement of the treatment probe. In some cases, the treatment probe provides energy delivery and treats the affected area. In other cases, the treatment probe is rotated about its longitudinal axis to direct the treatment energy as described herein. Thus, the treatment area will be similar to the arc 1710, having a radius 1714 corresponding to the energy intensity. As the arc control handles 1716A,B are adjusted to define the tissue excision profile and treatment area, the settings are stored during the procedure for subsequent use and to control the degree of rotation of the treatment probe during excision with energy delivery.

[0322] The user interface 1700 may include a user input 1760 for the user to select parameters for a model used to determine the values ​​of one or more of the safety and efficacy parameters disclosed herein. This parameter selection can allow the user to choose parameters that may be more useful to a particular patient than others, and to remove parameters that may be less useful. For example, if the user believes that a parameter such as age is not very useful for predicting outcomes, the user can deselect that parameter as input to the classifier model used to predict outcomes. Alternatively, if the user believes that age is a useful parameter, the user can select age as the parameter to be used as input to the classifier model.

[0323] The user interface 1700 may include a user input 1770 for the user to select data to be displayed on the display. The data displayed on the display may include, for example, visualization data. In some embodiments, the user can choose whether to display a proposed treatment profile on the display, superimposed on the patient's planned treatment profile after user adjustment. This may help the user determine the extent to which the planned treatment profile for the patient deviates from the profile suggested by the algorithm. The user can select additional types of visualization data to be displayed on the display. For example, the user can select a planned trajectory of an energy source for treatment.

[0324] Referring to Figure 17B, the user interface 1700 indicates that different parts of the biostructure have been selected within the biostructure selection window 1708 in the command area 1702. As shown, the middle lobe has been selected as the treatment area within the biostructure selection window 1708, and the control area 1704 has been updated to show the image associated with the middle lobe biostructure. As before, the control area 1704 overlays the display of the defined resection profile with the treatment boundary comprising an arc 1710. The arc 1710 is customizable by the user, in some cases by defining a radius 1714 for operating the arc control handles 1716A, B. The arc 1710 can define the resection profile and treatment area and provide different resection profiles and treatment areas for different anatomical areas. For example, as shown, the command area 1702 allows the user to select between the prostate, bladder neck, and middle lobe within the biostructure selection window 1708. Window 1750 can display safety parameter X and efficacy parameter Y, and these values ​​can change in real time as the user adjusts the excision profile.

[0325] Similar to the prostate setting, when the middle lobe biostructure is selected, an image of the treatment area is displayed within the control area 1704 by a TRUS probe or the like, appropriately positioned to image the anatomical feature of interest, allowing the user to define the treatment area for this anatomical feature. Multiple resection profiles and corresponding treatment areas established by the user can be fed into a computer, where the treatment plan can be saved for execution by a surgeon, whether human or robotic.

[0326] Referring to Figure 17C, the user interface 1700 is shown. As illustrated, in the biostructure selection window 1708, the prostate is selected, and the control area 1704 displays real-time imaging data of the selected biostructure. The biostructure selection window 1708 has been further updated to select an option labeled “Adjust spermatic cumulus protection zone” 1720. This refers to a treatment plan designed to protect the spermatic cumulus ("verumontanum" or "veru") from invasive resection. The spermatic cumulus protection zone can be configured in many ways, for example, it may have a butterfly resection profile. While the spermatic cumulus protection zone is referred to, the protection zone may comprise one or more protection zones to protect, for example, a tumor or a delicate tissue structure such as the retina of the eye.

[0327] As shown, once the “Adjust Sperm Protection Zone” radio button 1720 is selected, a new overlay appears across the control area 1704, defining the sperm arc 1722, which is part of the arc 1710. The sperm arc 1722 may share a vertex 1718 and a radius length 1714 with the arc 1710.

[0328] The arc of the cumulus 1722 has a therapeutic profile that defines an area associated with the cumulus protective zone 1724. In prostate surgery, as described herein, a risk / reward trade-off may exist between the effectiveness of the procedure and male sexual function. The invasiveness of prostatectomy is related to proximity to the cumulus. If the tissue is resected closer to the cumulus, the effectiveness of prostate treatment for benign prostatic hyperplasia may increase. However, male sexual dysfunction may also increase. A window 1750 that provides safety and efficacy parameters may help the user to adjust the therapeutic profile for the patient to correspond to targeted safety and efficacy metrics.

[0329] The verumontanum is an anatomical landmark near the opening of the ejaculatory duct into the urethra, and may also be referred to as the seminal colliculus. The structure of the verumontanum consists of striated muscle fibers of the external sphincter, interwoven with smooth muscle tissue from the urethral wall. Some of the embodiments described herein allow for targeted treatment of prostate tissue close to the verumontanum. According to the embodiments illustrated in Figures 17A–17C, the user can define the resection profile of the treatment plan for various areas of the prostate. For example, a treatment plan is created that includes unique treatments for the prostate, bladder neck, and middle lobe, and a unique plan for the area of ​​the verumontanum.

[0330] The user can adjust the excision profile in response to safety and efficacy parameters displayed on the screen.

[0331] Figures 17A-17C refer to displays coupled to a surgical system, but in some embodiments, similar images and user input can be used for remote treatment planning and pre-planning in remote locations away from surgical instruments, such as in another room or building. The processor can be configured with instructions for the user to plan the treatment, and these parameters can be stored and loaded onto the surgical system's processor. For example, a diagnostic image of the patient can be generated prior to treatment, for example, in an imaging room. The image can be shown to the user on a display on a mobile device, and the treatment profile and other aspects of the treatment can be adjusted. Once accepted, the treatment parameters, such as the resection profile, can be loaded onto the surgical instrument.

[0332] Referring to Figure 18, the sagittal user interface 1800 displays a sagittal view of the treatment area with anatomically distal organs on the left side of the figure. The user interface may also include a transverse interface 1700 and a sagittal interface 1800 for planning the treatment profile in three dimensions for 3D tissue removal. This screen displays information from the already entered treatment plan, such as the rotation angle of the treatment probe 1802, which is 135 degrees in this embodiment, and the depth of resection 1804, which is 24.3 mm in the illustrated embodiment.

[0333] The user interface 1800 allows for further refinement of the treatment plan by manipulating the treatment profile 1806. The treatment profile 1806 generally follows an anatomical curve fit 1808 of the area of ​​interest. In some cases, the system can detect anatomical features through one or more algorithms performed on the ultrasound image, such as image analysis, feature recognition, edge detection, or some other algorithm or combination of algorithms, and can detect recommended boundaries of the anatomical features and / or resection profiles as well as recommended boundaries of the treatment area.

[0334] The system can present an overlay of information, which may include anatomical parts of organs, commands, resection profiles, and other information, across ultrasound imaging data. In the illustrated user interface 1800, the overlay identifies areas corresponding to the middle lobe zone 1810, the bladder neck zone 1812, and the intermediate prostate zone 1814. Each of these identified zones may have a different treatment plan associated with it. For example, the middle lobe zone 1810 may have a specified resection angle, resection depth, and tissue resection displacement distance that may differ from the treatment plan for the intermediate prostate zone 1814, and may also differ from the treatment plan specific to the bladder neck zone 1812.

[0335] The processor may be configured not only to recognize various anatomical zones but also to store information on recommended and selected treatment plans for each zone. For example, information from previous surgical procedures may be stored in a database corresponding to one or more treatment plans for individual organs or parts of individual organs. This information from previous surgical procedures can be used to train a classifier or neural network as described herein. The trained classifier or neural network can generate an appropriate recommended treatment plan comprising multiple tissue resection profiles. This recommended resection profile can be generated and presented on the display in window 1750 along with predicted safety values ​​X and Y. As the treatment plan comprising multiple resection profiles is modified by the user, the processor may receive the modified treatment plan, resection profiles, and ultrasound images, and the trained classifier or neural network can be used to generate updated safety and efficacy parameters shown on display 1750. The trained classifier or neural network may also receive patient information as input, such as age, height, weight, symptoms, and other information as described herein, when determining the values ​​of the safety and efficacy parameters and when generating the treatment plan.

[0336] The user interface 1800 may include controls that allow the user to adjust the treatment plan. For example, a treatment start control 1816, a treatment end control 1818, and a spermatic duct zone start control 1820. Any of these controls may be manipulated by the user to modify the resection profile of the treatment plan. For example, the user may modify the resection profile by moving one or more of the controls to modify the depth of resection, the location of the resection start control 1816, or the location of the spermatic duct zone start control 1820. Changes made by the user in the user interface 1800 are stored in the memory of the associated computing system for subsequent execution during the procedure. In some cases, the procedure is performed by a robotic device that performs the procedure according to the resection boundary limits.

[0337] The user interface 1800 further includes information and / or educational components, such as a procedure overview area 1822, which provide guidance to the system's user. For example, as shown, the procedure overview area 1822 includes a list of procedure setup steps for the user to perform, such as positioning the handpiece 1824, positioning the TRUS probe 1826, and aligning the handpiece and the TRUS probe 1826.

[0338] The procedure overview area further includes creating and / or modifying a treatment plan, such as by providing the user with the opportunity to input and / or modify the resection angle 1830, treatment probe alignment 1832, and cutting profile 1834. As shown in Figure 18, the setup step is completed for the procedure, as indicated by check marks next to the handpiece 1824, TRUS 1826, alignment 1828, angle 1830, and alignment 1832. At the current stage in the illustrated embodiment, the user still needs to complete the profile 1834 adjustment. Upon completion of the setup and planning steps in the user interface 1800, the user can indicate that the procedure is ready to begin by selecting the treatment icon 1836, at which point the system may autonomously start the procedure according to the treatment plan.

[0339] In some cases, treatment plans are stored in a database along with other treatment plans and may include data about the patient and treatment plan, such as patient age, weight, height, symptoms, duration of symptoms, diagnosis, past treatment history, treatment effectiveness, medication history, and equivalents. Past treatment plans may include data such as angles and resection profiles for multiple historical treatments for multiple patients and may be stored as historical treatment plan data.

[0340] The historical treatment plan data may be analyzed by one or more suitable algorithms as described herein, such as artificial intelligence algorithms, supervised machine learning, unsupervised machine learning, neural networks, or convolutional neural networks. In some cases, the historical treatment plan data may be analyzed by one or more machine learning algorithms and used to train classifiers. For example, a neural network may analyze the historical treatment data and provide recommended treatment plans for one or more current patients. For example, based on the historical treatment data, a neural network may be used to select algorithms, train models, validate models, synchronize and optimize models, deploy models, make predictions about future treatment plans, and provide treatment plans for current or future patients, including creating and labeling the historical treatment data.

[0341] In some cases, a convolutional neural network may be implemented to analyze visual data, such as ultrasound images from a TRUS probe, and provide feedback to be fed into a machine learning model. Visual data analysis may include steps to identify anatomical features, along with relevant location, size, shape, health, and other information.

[0342] A processor as described herein may be configured with instructions that provide a user interface, images, and windows, for example, as described herein with reference to Figure 17A-18.

[0343] Referring to Figure 19A, the resection procedure is illustrated. As shown, the treatment probe 1902 is inserted through the urethra to the distal portion of the treatment area. When used in the illustrated embodiments of Figures 19A-19D, the terms “proximal” and “distal” refer to the viewpoint of the treatment probe. Thus, the distal end of the treatment probe is the portion of the probe that is inserted the deepest into the patient.

[0344] The treatment probe 1902 includes a suction port 1904 and an energy treatment probe 1906. The treatment area 1908 is indicated by a dotted line in a series of Figures 19A–19D for clarity. As shown in the explanatory diagram, the excision procedure is initiated, and the energy treatment probe 1906 is moved proximal to one end of the treatment area and ablated tissue from the distal portion of the treatment area 1908. The suction port actively aspirates fluid and ablated tissue during the procedure and may be equipped with components of a fluid management system. The energy treatment probe is rotated through an angle and translated along a length defined within the user interface 1800 as described above. Furthermore, the depth of excision is also controlled based on user input into the user interface 1800.

[0345] Referring to Figure 19B, it can be seen that the energy therapy probe 1906 was moved further proximal to ablate a larger volume of tissue. During the translation of the energy therapy probe 1906, the intensity of the resection energy was varied according to the treatment plan so that the resection closely followed the treatment area boundary 1908.

[0346] Referring to Figure 19C, the energy treatment probe 1906 was moved to a position approximately aligned with the proximal edge of the treatment area 1908. The resection energy 1910 can be seen emanating from the energy treatment probe 1906 at a relatively low intensity. In the illustrated treatment plan, it can be seen that the tissue was reserved within the area of ​​the spermatic cumulus 1912. When the user establishes a spermatic cumulus protection zone 1724, as illustrated in Figure 17C, a treatment plan is created to protect this zone from invasive resection. In some cases, the tissue within the spermatic cumulus protection zone 1724 is ablated separately from the surrounding tissue. As shown, the tissue adjacent to the spermatic cumulus 1912 was ablated, but the tissue directly above the spermatic cumulus was not. Resection of the spermatic cumulus protection zone 1724 according to the established treatment plan will leave a wedge-shaped tissue 1914 above the spermatic cumulus 1912. The wedge-shaped tissue 1914 may be ablated according to a unique treatment plan that allows for gradual ablation of the tissue by utilizing multiple sweeps in the translational and rotational directions, and by utilizing relatively low energy intensity from the energy treatment probe 1906, in order to ablate the wedge-shaped tissue 1914.

[0347] In some cases, the tissue on one side of the wedge-shaped tissue 1914 is ablated first, then the tissue on the opposite side of the wedge-shaped tissue 1914 is ablated, and finally the wedge-shaped tissue 1914 is ablated in such a way that it protects the spermatic duct from invasive excision.

[0348] Referring to Figure 19D, the energy therapy probe 1906 continues to move proximal, excising the wedge-shaped tissue 1914 above the seminal duct. While the explanatory diagram shows the wedge-shaped tissue 1914 being ablated in a single parallel stroke of the energy therapy probe 1906, it should be understood that the energy therapy probe 1906 may perform multiple parallel strokes and / or multiple rotational sweeps to adequately remove the wedge-shaped tissue 1914. The suction port 1904 may include multiple ports or channels through which material is removed from the treatment site.

[0349] Figure 20 shows a method for excising tissue.

[0350] In step 2002, the target values ​​for the patient efficacy parameters are received.

[0351] In step 2004, the target values ​​for patient safety parameters are received.

[0352] In step 2006, the patient's demographic parameter values ​​are received.

[0353] In step 2008, a tissue excision profile is generated. This process may be automated, or it may be created or modified by user input, such as by modifying the excision profile of the treatment area. In some embodiments, the excision profile is generated in response to the values ​​of the target safety and efficacy parameters.

[0354] In step 2010, images of the organ to be removed are received.

[0355] In step 2012, the delicate tissue structure of the organ image is identified from the image. This may be based on image feature recognition by applying a convolutional neural network, employing, among other things, one of several preferred image analysis algorithms such as edge detection, feature recognition, segmentation, and 3D model reconstruction.

[0356] In Step 2014, the tissue excision profile is compared to the delicate tissue structure in the image.

[0357] In step 2016, the values ​​for the safety and efficacy parameters are generated using one or more neural networks or classifiers trained on a database as described herein. These values ​​may also be generated using a trained convolutional neural network application that classifies image features, such as using ultrasound imaging.

[0358] In Step 2018, the target value and the generated value are displayed.

[0359] Step 2020 involves adjusting one or more of the resection areas. This may include a step of determining different treatment areas for a single organ, such as determining separate treatment areas for the bladder neck, middle lobe, and intermediate prostate. Determining different treatment zones facilitates the creation of separate treatment plans for each treatment zone.

[0360] In step 2022, the resection angle is adjusted. The treatment angle may be based on an overlay of real-time imaging of the area to be treated, as described herein above with reference to Figures 17A-17C, for example.

[0361] In step 2024, the excision profile is adjusted. This may be done by the user in response to the target value and the value generated shown on the display. The excision profile may be adjusted for one or more treatment areas.

[0362] In step 2026, the delicate tissue structure protection zone is adjusted. The delicate tissue structure protection zone may include, for example, a spermatic cord protection zone.

[0363] In step 2028, updated values ​​for safety and effectiveness parameters are generated and displayed to the user.

[0364] In step 2030, the tissue is excised, for example, away from the protective zone. The energy therapy probe may be translated along its longitudinal axis and, in addition, rotated about its longitudinal axis. The energy therapy probe may move across the tissue within the treatment area in a single pass and ablate the tissue according to the treatment plan, or it may make multiple passes to ablate the tissue according to the treatment plan.

[0365] In step 2032, tissue adjacent to the delicate tissue structure is excised on the first side of the protective zone.

[0366] In step 2034, tissue on the second side of the delicate tissue protection zone may be removed, leaving a wedge-shaped unexcised tissue above delicate tissue structures such as the delicate tissue structures of the spermatic ducts. The tissue may be excised by an energy therapy probe that delivers excision energy to the tissue.

[0367] In step 2036, treatment data is stored, and the treatment database is updated as described herein. One or more classifiers or neural networks may also be updated as described herein.

[0368] Figure 20 shows a method 2000 for excising tissue from organs such as prostate tissue according to several embodiments, but many modifications and adaptations can be made so as will be readily recognizable to those skilled in the art. For example, some of the steps can be repeated, some of the steps can be omitted, and the steps can be carried out in a different order. Other types of tissue, such as those described herein, can also be treated.

[0369] One or more steps of Method 2000 can be combined with Method 1500. For example, a classifier or neural network can be trained using a patient treatment database. Once the classifier or neural network is trained, it can be used to determine safety and efficacy parameters for a patient being treated in response to demographic data, ultrasound images, and equivalents, as described with reference to Method 2000.

[0370] Method 1500 can be used either as an alternative or in combination with a classifier as described herein to train a neural network as described herein.

[0371] A processor as described herein may be configured to perform one or more steps of the methods disclosed herein, such as the steps of Method 1500 and Method 2000.

[0372] Referring to Figure 21, an embodiment of a two-dimensional convolutional neural network 2100 is shown. A dataset 2102 is initially provided, which may include images from historical treatment data from previous patients and procedures. A convolutional operation 2104 yields data in a second dataset 2106, which has a pooling layer 2108 applied to yield a pooled layer 2110 of subsample data to further condense the spatial size of the presentation. The subsample data may be convolved to produce a third dataset 2114, which may have further pooling layers 2116 applied to provide subsample data 2118 2112. The subsample data 2118 may be passed through a first fully connected layer 2120 and a second fully connected layer 2122 to generate a classification matrix output 2124. One or more filters may be applied in each convolutional layer to provide different types of feature extraction. After the model is defined, it may be compiled and feature recognition accuracy may be used as a performance metric. The model may be trained over time by using historical procedure data as training data, validated according to the model's predictions, and validated over time until the model's predictions converge with the true data.

[0373] Figure 22 illustrates a method 2200 for training and using an artificial intelligence or machine learning classifier in several embodiments. While the method can be carried out in many ways, in some embodiments, the classifier is trained to recognize anatomical landmarks and multiple resection profiles associated with those anatomical landmarks. The method includes a step of comparing past patient resection profiles with patient data such as anatomical landmark and outcome data, as well as demographic data, as described herein. The resection profiles may consist of actual past resection profiles superimposed on images from treatment, or generated and proposed profiles based on machine learning algorithms, data point weighting, and patient data, among several input types.

[0374] The dataset may be stored in a database containing historical information, which may include a library of generated and actual historical data. The patient data library may be stored in a database indicated by a unique patient identifier and associated data for each patient, as described herein. The database may include a relational database indicated by a unique patient identifier. The historical data stored for each patient in the database may include robotics data from surgery, images from surgery, preoperative questionnaire data, postoperative questionnaire data, retreatment data, and sexual function data for each patient. The database may contain data from at least 100 patients, and any preferred number of patients, such as at least 1,000 patients, at least 10,000 patients, and in some embodiments, 10,000 to 1,000,000 patients. Based on data input as described herein, the method utilizes an appropriate model and generates predictive outcome data used to train a classifier. A classifier validated with data can be subjected to iterative training. The validated classifier is then used to receive input from actual patients and output useful information, such as proposed resection profiles, in response to values ​​of targeted safety and efficacy parameters as described herein. The input data may comprise patient images, targeted safety and efficacy parameters, and other patient data as described herein. Alternatively, or in combination, the input data may comprise targeted tissue resection profiles and values ​​of predicted safety and efficacy parameters as described herein. In some embodiments, the patient data comprises one or more of each patient's tensile strength, modulus of elasticity, elasticity, vascular distribution, biomarker data, drug history, or genetic data.

[0375] In step 2202, the classifier is trained on multiple anatomical landmarks from multiple images. This may be carried out by one or more image analysis algorithms that enable the classifier, such as a convolutional neural network, to determine the anatomical features present with the image data. The classifier can be trained in many ways, but in some embodiments, a trained professional, such as a radiologist or surgeon, identifies the landmarks and inputs the location and type of the anatomical landmark using a user interface such as a touchpad. The anatomical landmarks may consist of one or more delicate tissue structures, such as the spermatic cumulus, the retina of the eye, or a tumor, as described herein. This training can be completed, for example, with respect to several images from a library of treatments.

[0376] In step 2204, the classifier is trained on multiple excision profiles. The excision profiles may include targeted excision profiles that are superimposed on images, such as those described herein, where the images are stored in a database. Alternatively, or in combination, the classifier can be trained using user input to identify excision profiles from images, such as ultrasound images, as described herein. For example, a therapeutic professional can identify the location and profile of an excision using user input to the image location using an input device such as a touchpad, and the user can train the classifier by drawing lines of the excision profile using the input device.

[0377] In step 2206, the resection profile is compared to anatomical landmarks. For example, the distance between the resection profile and the anatomical landmarks may be compared. The anatomical landmarks may include one or more delicate tissue structures, as described herein, and the distance between the resection profile and the anatomical landmarks, which is compared patient by patient among multiple patients. In some cases, the resection profile includes one or more protective zones to protect sensitive tissue structures, as described herein. The distance from the protective zones to the delicate tissue structures is compared patient by patient.

[0378] In step 2208, the method generates a dataset between the location of an anatomical structure and the resection profile of that structure. This may be based on actual historical data demonstrating the effectiveness of treatment based on the resection profile.

[0379] In step 2210, patient demographic data is received. The patient demographic data may include any of a number of data types that present information about the patient, such as those described herein. In non-limiting embodiments, the demographic data may include information on age, weight, body mass index, medication history, procedure history, flow rate, sexual function, geography, race, symptoms, diet, family structure, and equivalents.

[0380] In step 2212, predicted outcome data is generated and used to train the classifier. For example, the method may generate predicted outcome data that can be compared against actual historical data. If there is a discrepancy between the predicted outcome data and the actual outcome data from the historical data, the classifier may be modified, and training may be iterated until the predicted outcome data matches the actual historical data within a threshold amount.

[0381] In step 2214, the trained classifier is validated. As described, this may be an iterative process of comparing the predicted data to the actual data, and the classifier may be modified until the predicted data converges toward the actual data.

[0382] In step 2216, data from individual patients is received. This may include any of the demographic data described, along with other data types that provide the classifier with sufficient information to generate a resection profile.

[0383] In step 2218, safety and efficacy parameters are generated for each individual patient. These may be based on user input or may be generated automatically based on possible or desired outcomes.

[0384] In step 2220, the proposed resection profile is determined for each individual patient. In other words, based on the input data, the trained classifier generates and outputs a proposed resection profile for each individual patient. The resection profile may be modified as described herein to reduce the amount or aggressiveness of resection in the protective zone or other zones as described herein. Alternatively, the resection profile may be modified to increase the invasiveness of the tissue resection.

[0385] The proposed resection profile, the actual resection profile, and the actual procedural outcome can be stored in a database and used to refine classifiers and other machine learning algorithms. Procedural parameters can be recorded for each procedure and may include any parameters as described herein, such as the measured treatment time, measured setup time, measured imaging time, measured time the treatment probe moves, measured intensity of the energy source for tissue removal, multiple recorded positions of the treatment probe, multiple recorded images of tissue during treatment, multiple recorded orientations of the treatment probe, or one or more of multiple tissue images corresponding to each of the multiple recorded positions and orientations. Multiple treatment parameters recorded during treatment may include multiple sequentially arranged data frames, each of which comprises an image of tissue, an image of the treatment probe positioned relative to the tissue being treated, the position of the treatment probe, the orientation of the treatment probe, or the energy of the treatment probe, and optionally, each of the multiple sequentially arranged data frames corresponds to a substantially fixed time interval between each of the multiple frames. The values ​​of each of these parameters can be stored in a library of multiple patient-specific treatments stored in a database as described herein.

[0386] The artificial intelligence and machine learning systems described may comprise a processor having instructions configured to perform one or more of the following: artificial intelligence, search and mathematical optimization, artificial neural networks, statistics, probability, support vector machine learning, clustering of data sets, image classification, and image segmentation. The instructions may comprise one or more of the following: decision tree learning, association rule learning, artificial neural networks, deep learning, inductive logic programming, support vector machines, clustering, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, sparse dictionary learning, genetic algorithms, rule-based machine learning, or learning classifier systems.

[0387] One or more steps of Method 2200 may be carried out using a processor as described herein. One or more steps of Method 2200 may be carried out using a circuit or processor instruction as described herein, for example, one or more of the processors or logic circuits of the systems described herein. The circuit may be programmed to provide one or more steps of Method 2200, and the program may comprise programmed steps of program instructions or logic circuits stored in computer-readable memory, for example, using a programmable array logic or a field-programmable gate array.

[0388] Figure 22 shows a method according to several embodiments. Those skilled in the art will recognize many modifications and adaptations by the teachings disclosed herein. For example, some of the steps of the method can be eliminated. Additional steps can be provided. Some of the steps may include substeps. Some of the steps can be repeated. The order of the steps can be changed.

[0389] Convolutional neural networks may be used to separate image data, and this or alternative machine learning algorithms may be applied to generate recommended treatment profiles. The machine learning neural network model may be trained over time by utilizing historical treatment data and modifications of the recommended treatment plans output from the model. The result is the generation of recommended treatment plans that improve over time based on the continuous training of the machine learning model.

[0390] The energy source may comprise one or more of the following: mechanical energy, water jet, electromagnetic energy, laser energy, radio frequency (RF) energy, radiotherapy (RT) energy, or ultrasonic energy, steam, water vapor, heated steam, or any other type of suitable energy source for ablating, excising, or removing tissue, and combinations thereof.

[0391] This specification includes the following numbered appendices, which are part of this disclosure.

[0392] (Note 1) A device for robotic surgery, For each patient being treated, patient data is received, and the data for each patient being treated includes one or more of the following: patient demographic data, section profile of the tissue to be removed, actual profile of the tissue to be removed, target volume of the tissue to be removed, actual volume of the tissue to be removed, or ratio of the amount of tissue targeted for removal to the amount to be removed. For each patient being treated, surgical robotics data is received, and the surgical robotics data includes multiple treatment parameters recorded during the treatment, treatment time, setup time, imaging time, time the treatment probe moves, multiple locations and orientations of the treatment probe, multiple images of the tissue, multiple images of the tissue, each of the treatment probes, or the intensity of the energy source for tissue removal. In response to patient data and surgical robotics data, it outputs a treatment plan for the patient to be treated. A processor comprising instructions, Device.

[0393] (Note 2) The apparatus as described in Appendix 1, further comprising instructions for receiving adjustments to the treatment plan of a patient to be treated, the adjustments to the treatment plan of a patient to be treated include adjustments to one or more of the following: the cutting profile of the tissue to be removed, the actual profile of the tissue to be removed, the target volume of the tissue to be removed, the actual volume of the tissue to be removed, the treatment time, the setup time, the imaging time, the time the treatment probe moves, the intensity of the energy source for tissue removal, or the ratio of the amount of tissue targeted for removal to the amount to be removed.

[0394] (Note 3) The cutting profile comprises multiple locations, each having multiple angular coordinates around the treatment axis, multiple corresponding axial coordinates along the axis, and multiple radial distances from the axis, and the adjustment of the cutting profile includes adjustment of multiple angular coordinates around the treatment axis, multiple corresponding axial coordinates along the axis, and multiple radial distances from the axis, as described in Appendix 2.

[0395] (Note 4) The apparatus as described in Appendix 1, comprising a processor that displays an initial dissection profile superimposed on an image of the tissue to be excised on a display, and instructions that display an adjusted dissection profile on an image of the tissue to be treated.

[0396] (Note 5) The apparatus as described in Appendix 1, wherein multiple treatment parameters recorded during treatment include a measured treatment time, a measured setup time, a measured imaging time, a measured time during which the treatment probe moves, a measured intensity of the energy source for tissue removal, multiple recorded positions of the treatment probe, multiple recorded images of the tissue during treatment, multiple recorded orientations of the treatment probe, and multiple tissue images corresponding to each of the multiple recorded positions and orientations.

[0397] (Note 6) The apparatus as described in Appendix 5, wherein multiple treatment parameters recorded during treatment comprise multiple sequentially arranged data frames, each comprising an image of tissue, an image of a treatment probe positioned relative to the tissue being treated, the position of the treatment probe, the orientation of the treatment probe, or the energy of the treatment probe, and optionally, each of the multiple sequentially arranged data frames corresponds to a substantially fixed time interval between each of the frames.

[0398] (Note 7) The device described in any one of the preceding appendices includes patient demographic data for each of multiple patients and for each patient to be treated, comprising one or more of the following: patient age, weight, sex, body mass index, race, geography, diet, or family structure.

[0399] (Note 8) The apparatus as described in Appendix 1, wherein the energy source intensity comprises water jet intensity, light beam intensity, radio frequency energy intensity, ionizing radiation intensity, stereotactic radiation intensity, or ultrasonic energy intensity.

[0400] (Note 9) The apparatus as described in Appendix 1, wherein a treatment plan for a patient to be treated is determined using processor instructions, including one or more of artificial intelligence or machine learning, in response to patient data and surgical robotics data.

[0401] (Note 10) The treatment plan is determined using artificial intelligence processor instructions, the apparatus as described in Appendix 9, wherein the artificial intelligence processor instructions include one or more of the following: machine learning, search and mathematical optimization, artificial neural networks, statistics, probability, support vector machine learning, data clustering, image classification, or image segmentation.

[0402] (Note 11) The treatment plan is determined using machine learning processor instructions, the apparatus as described in Appendix 9, wherein the machine learning processor instructions include one or more of the following: decision tree learning, association rule learning, artificial neural networks, deep learning, inductive logic programming, support vector machines, clustering, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, sparse dictionary learning, genetic algorithms, rule-based machine learning, or a learning classifier system.

[0403] (Note 12) The device as described in Appendix 11, further having the instruction cause the processor to receive human interaction, provide input, and use one or more of several AI tools to select an AI approach, select visualizations of different recommended treatment plans, or change the importance of the data used to generate the treatment plan.

[0404] (Note 13) The apparatus according to any one of the preceding appendices, wherein artificial intelligence or machine learning is trained on patient data for multiple patients to be treated and surgical robotics data for multiple patients to be treated, and the treatment plan for the patient to be treated is determined in response to the artificial intelligence or machine learning, which is trained in response to the patient data to be treated and the surgical robotics data.

[0405] (Note 14) The apparatus according to any one of the preceding appendices, wherein the target volume of tissue to be removed comprises the total volume of tissue targeted for removal, and the actual volume of tissue to be removed comprises the actual total volume of tissue to be removed.

[0406] (Note 15) The apparatus according to any one of the preceding appendices, wherein artificial intelligence ("AI") or machine learning is configured to train an AI or machine learning algorithm on multiple treatment plans and patient outcomes (optionally, based on physician or patient-reported information) for multiple patients to be treated, and to determine a treatment plan for a patient to be treated.

[0407] (Note 16) Multiple treatment plans to be administered are combined with corresponding outcomes, comprising one or more of the following: quality of life score, sexual function, treatment endurance, or flow rate; and AI or machine learning is configured to provide a semi-automatic plan and optimize the treatment contour based on the patient's prostate biostructure, as described in Appendix 15.

[0408] (Note 17) Outcome data from multiple treated patients are used as input to train an AI or machine learning classifier, optionally comprising one or more of the following: hemoglobin loss, complications, pain score, time to return to work, urinary flow data, catheter insertion time, hospitalization, days to optional adjustment, hemostasis method, sexual function measurement, balloon model, balloon technique, catheter tension, Foley catheter tension, catheter tension device method, surgical case record, anesthesia used, analgesic use, or pre- and post-hoc urodynamics, optionally configured for the AI ​​or machine learning to perform calculations, determine an adjusted treatment plan, and refine critical outcome measurement, optionally comprising an adjusted treatment profile, optionally comprising an optimized treatment profile, as described in any one of the preceding appendices.

[0409] (Note 18) The apparatus according to any one of the preceding appendices, wherein the AI ​​or machine learning is trained to automatically adjust the penetration depth based on image recognition of tissue imaging parameters between treatments of a patient, in response to the AI ​​or machine learning being trained on multiple patients being treated, and the automatic adjustment has an intended penetration depth compared to the actual penetration depth, and the AI ​​or machine learning is configured to automatically adjust the cutting profile if there is a mismatch, or to vary the intensity of the source based on tissue density.

[0410] (Note 19) The apparatus described in Appendix 18, in which the cutting profile is adjusted in response to the values ​​of biomechanical tissue parameters measured from the patient.

[0411] (Note 20) The apparatus as described in any one of the preceding appendices, comprising a library of numerous ultrasound images from charts with peer-reviewed identification of identifiable organ tissue surfaces and anatomical features such as the prostatic capsule, bladder neck, sphincter, seminal cumulus, duct, middle lobe, lateral lobe, etc., trained with reference data, the AI ​​or machine learning is configured to provide physician-assisted guidance to the patient to be treated in response to data of the patient to be treated, and the AI ​​or machine learning is trained with reference data.

[0412] (Note 21) A device for determining the tissue removal profile in prostate surgery for patients with spermatic ducts, Display an image of the prostate, Display the tissue removal profile on the prostate image. Display one or more of the following: efficacy parameters, probability of decreased sexual function, or probability of retreatment of the prostate using a dissection profile and prostate imaging. A processor comprising instructions, Device.

[0413] (Note 22) The apparatus as described in Appendix 21, comprising instructions for receiving a digital signature from a patient accepting one or more of the following: efficacy parameters, the probability of decreased sexual function, or the probability of retreatment.

[0414] (Note 23) The apparatus as described in Appendix 22, comprising instructions for displaying a digital signature along with one or more of the following: an image of the prostate, a section profile, efficacy parameters, the probability of decreased sexual function, or the probability of retreatment.

[0415] (Note 24) A device for determining a treatment plan for prostate surgery in patients with spermatic ducts, The system receives user input and includes a sexual importance parameter corresponding to the importance of sexual activity to the patient, and an acceptance parameter corresponding to the patient's tolerance to a second prostate surgery. The system outputs a treatment plan, which includes instructions for removing tissue up to a certain distance from the seminal cumulus. The distance is further from the seminal cumulus when the sexual importance parameter corresponds to an increase in the importance of sexual activity and the acceptance parameter corresponds to an increase in acceptance of a second prostatectomy. The distance is closer to the seminal cumulus when the sexual activity parameter corresponds to a decrease in the importance of sexual activity and acceptance of a second prostatectomy. A processor comprising instructions, Device.

[0416] (Note 25) The apparatus as described in Appendix 24, wherein the treatment plan includes a tissue removal profile, and the processor includes instructions for generating the tissue removal profile in response to user input.

[0417] (Note 26) The tissue removal profile is provided with the distance to the spermatic duct, the distance increasing with increasing importance and tolerability, and decreasing with decreasing importance and tolerability, as described in Appendix 25.

[0418] (Note 27) The device, as described in Appendix 24, includes a processor with instructions to display a tissue removal profile on an image of the prostate, and optionally the image includes an image of the patient's prostate.

[0419] (Note 28) The apparatus described in Appendix 27 includes imaging of one or more of the following: ultrasound imaging, magnetic resonance imaging, computed tomography (CT) scan imaging, or cystoscopy imaging.

[0420] (Note 29) The ultrasound imaging apparatus is as described in Appendix 28, and includes one or more of the following: pulsed ultrasound, echo ultrasound, Doppler ultrasound, or shear wave elastic imaging.

[0421] (Note 30) The apparatus described in Appendix 27 comprises one or more sagittal or transverse images of the prostate gland.

[0422] (Note 31) The apparatus according to Appendix 30, wherein the images of the prostate further include one or more of the following: parasagittal, coronal, paracoronal, or three-dimensional images.

[0423] (Note 32) The device described in Appendix 27 includes images of the prostate gland and, optionally, images of the patient's prostate gland.

[0424] (Note 33) The apparatus as described in Appendix 27, wherein the processor provides instructions for moving the removal profile shown on the display further away from the genus in response to increased importance and increased tolerance, and closer to the genus in response to decreased importance and increased tolerance.

[0425] (Note 34) The device as described in Appendix 24, wherein the processor has a command to receive a ranking parameter corresponding to a ranking of the importance of sexual activity in relation to the acceptance of a second prostatectomy, the distance to the cumulus increases with increasing importance of sexual activity and decreasing acceptance of a second prostatectomy in response to a ranking parameter indicating that sexual activity is of greater importance than the acceptance of a second prostatectomy, and the distance to the cumulus decreases with increasing importance of sexual activity and decreasing acceptance of a second prostatectomy in response to a ranking parameter indicating that sexual activity is of less importance than the acceptance of a second procedure.

[0426] (Note 35) The apparatus as described in Appendix 24, wherein the processor comprises instructions for generating a first prostate tissue removal profile in response to the first importance of sexual intercourse and the first acceptance of a second prostatectomy, and a second prostate tissue removal profile in response to the second sexual importance of sexual intercourse and the second acceptance of a second prostatectomy.

[0427] (Note 36) The apparatus according to Appendix 35, wherein the first prostate tissue removal profile comprises a first distance to the spermatic cumulus along the first prostate tissue removal profile, and the second prostate tissue removal profile comprises a second distance to the spermatic cumulus along the second prostate tissue removal profile.

[0428] (Note 37) The apparatus as described in Appendix 36, wherein the first distance exceeds the second distance when the first importance and first acceptance are less than the second importance and second acceptance, and the first distance is less than the second distance when the first importance and first acceptance are less than the second importance and second acceptance.

[0429] (Note 38) The apparatus according to Appendix 37, wherein the processor generates therapeutic commands for moving an energy source according to a treatment plan, and in response to the user inputting a first importance and first acceptance or a second importance and second acceptance, commands for removing prostate tissue to a first distance or a second distance.

[0430] (Note 39) A device for excising tissue from a patient's organs, The display and A processor that is operablely coupled to a display, If a patient receives one or more of the safety or efficacy parameters, Receive images of organs, The organ resection profile is determined in response to one or more of the image and safety or efficacy parameters. Display the excision profile along with the image on the screen. A processor, which is composed of instructions, A device equipped with the following features.

[0431] (Note 40) The apparatus as described in Appendix 39, wherein the organ has a delicate tissue structure, the excision profile includes a protective zone, and the protective zone of the removal profile is determined in response to one or more of the organ's image and safety profile or efficacy profile.

[0432] (Note 41) The organ comprises a prostate gland, and its delicate tissue structure comprises the seminal cumulus of the prostate, as described in Appendix 40.

[0433] (Note 42) The delicate tissue structure is the device described in Appendix 40, which contains cancerous tissue.

[0434] (Note 43) The apparatus as described in Appendix 40, wherein the protective zone is one of several protective zones, and the multiple protective zones of the removal profile are determined in response to at least one or more of the organ image and safety profile or efficacy profile.

[0435] (Note 44) The apparatus as described in Appendix 43, wherein one or more of the multiple protective zones are associated with the excision profile, determined at least partially on the basis of avoiding damage to delicate tissue structures or avoiding damage to pathogenic tissue.

[0436] (Note 45) The apparatus described in Appendix 40 displays images of the organ along with the resection profile in sagittal and transverse views, and the resection profile includes a three-dimensional stereoscopic resection profile.

[0437] (Note 46) The apparatus as described in Appendix 40, wherein the processor is configured with commands to display an image of the organ along with the resection profile in one or more of the following formats: sagittal, parasagittal, transverse, coronal, paracoronal, or three-dimensional.

[0438] (Note 47) The device described in Appendix 46, wherein the processor is configured with instructions for displaying safety parameters and effectiveness parameters on a display.

[0439] (Note 48) The apparatus as described in Appendix 46, wherein the processor is configured with instructions to receive user input, adjust the excision profile shown on a display, generate the adjusted excision profile, and determine a second value of one or more safety or efficacy parameters on a display in response to the user-adjusted excision profile.

[0440] (Note 49) The device described in Appendix 39, wherein the processor is configured with instructions for displaying safety parameters and effectiveness parameters on a display.

[0441] (Note 50) The apparatus as described in Appendix 39, wherein the processor is configured with instructions to display the values ​​of the target safety parameter, the target efficacy parameter, the adjusted safety parameter, and the adjusted efficacy parameter, the adjusted safety parameter and the adjusted efficacy parameter being updated in real time in response to the user adjusting the excision profile and displayed on the display.

[0442] (Note 51) The apparatus as described in Appendix 39, comprising an organ comprising a prostate gland, and a processor with instructions for identifying the location of the spermatic cumulus of the prostate.

[0443] (Note 52) The apparatus described in Appendix 39 includes one or more of the following methods for imaging organs: tissue boundary recognition, tissue surface recognition, tissue differentiation detection, fluorescence fluoroscopy, CT scan imaging, magnetic resonance imaging, radioactivity detection, or radiopaque imaging.

[0444] (Note 53) A device for excising tissue from a patient's organs, The display and A processor that is operablely coupled to a display, Receive images of organs, Receive the organ resection profile, In response to the excision profile and image, it displays the value of one or more of the safety or efficacy parameters. A processor, which is composed of instructions, A device equipped with the following features.

[0445] (Note 54) The apparatus as described in Appendix 53, wherein the organ has delicate tissue structures, and the processor is configured with instructions to determine the location of the delicate tissue structures in relation to the resection profile, and to display a value of one or more of the safety parameters or efficacy parameters in response to the location of the delicate tissue structures and the removal profile.

[0446] (Note 55) The organ comprises a prostate gland, and its delicate tissue structure comprises the seminal cumulus of the prostate, as described in Appendix 54.

[0447] (Note 56) The delicate tissue structure is the device described in Appendix 54, which contains cancerous tissue.

[0448] (Note 57) The apparatus as described in Appendix 54, comprising one or more protective zones, wherein the excision profile is determined at least partially on one or more of the following: reducing damage to delicate tissue structures or avoiding damage to pathogenic tissue.

[0449] (Note 58) The apparatus described in Appendix 53 displays images of the organ along with the resection profile in sagittal and transverse views, and the resection profile includes a three-dimensional stereoscopic resection profile.

[0450] (Note 59) The apparatus as described in Appendix 53, wherein the processor is configured with instructions to display images of the organ superimposed on the resection profile in sagittal and transverse views.

[0451] (Note 60) The device described in Appendix 59, wherein the processor is configured with instructions for displaying safety parameters and effectiveness parameters on a display.

[0452] (Note 61) The apparatus as described in Appendix 53, wherein the processor is configured with instructions to receive user input, adjust the excision profile shown on the display, generate the adjusted excision profile, and determine a second value of one or more safety or efficacy parameters on the display in response to the user-adjusted excision profile.

[0453] (Note 62) The device described in Appendix 53, wherein the processor is configured with instructions for displaying safety parameters and effectiveness parameters on a display.

[0454] (Note 63) The apparatus as described in Appendix 53, wherein the processor is configured with instructions to display the values ​​of the target safety parameter, the target efficacy parameter, the adjusted safety parameter, and the adjusted efficacy parameter, the adjusted safety parameter and the adjusted efficacy parameter being updated in real time and displayed on the display in response to the user adjusting the excision profile.

[0455] (Note 64) The apparatus as described in Appendix 53, comprising an organ comprising a prostate gland, and a processor with instructions for identifying the location of the spermatic cumulus of the prostate.

[0456] (Note 65) The excision profile is the apparatus according to any one of the above appendices, comprising a cutting profile.

[0457] (Note 66) The apparatus described in any one of the preceding appendices comprises one or more of the following energy sources for excising tissue to the excision profile: mechanical energy, water jet, electromagnetic energy, laser energy, radio frequency (RF) energy, radiotherapy (RT) energy, ultrasonic energy, steam, water vapor energy, superheated steam energy, or steam energy.

[0458] (Note 67) The device according to any one of the preceding appendices, comprising one or more patient data from among tensile strength, elastic modulus, elasticity, vascular distribution, biomarker data, or genetic data.

[0459] (Note 68) The device described in any one of the preceding appendices, wherein the processor is configured with instructions for the user to select one or more parameters used to determine one or more of the following: safety parameter values, efficacy parameter values, or proposed tissue resection profiles.

[0460] (Note 69) The apparatus according to any one of the preceding appendices, wherein the processor is configured to allow a user to plan a surgical procedure on a first display remotely from the surgical system, to store parameters relating to the planned surgical procedure, and to provide the parameters to the processor which is operably coupled to the display of the surgical system.

[0461] (Note 70) A method for robotic surgery, comprising the step of performing a step of a processor instruction as described in any one of the preceding appendices.

[0462] Preferred embodiments of the present invention are shown and described herein, but it will be apparent to those skilled in the art that such embodiments are provided only as examples. Numerous modifications, alterations, and substitutions will be conjured upon those skilled in the art without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be adopted in practicing the present invention. The following claims define the scope of the present invention, and methods and structures within the scope of these claims and their equivalents are intended to be covered thereby.

Claims

1. A device for treating the prostate tissue of a patient, wherein the device is The display and A processor operably coupled to the aforementioned display, Memory equipped with instructions and Equipped with, When the aforementioned instruction is executed by the processor, the device will: Receiving an image of the prostate gland, Based on the aforementioned image, the delicate tissue structure is identified, wherein the delicate tissue structure comprises a bladder. Based on the aforementioned image, the surgical instrument is identified, and the surgical instrument is equipped with an energy source. Using a trained classifier, generate a treatment plan that includes values ​​for safety and efficacy parameters, as well as a tissue removal or tissue excision profile for excising or removing tissue. A device that performs an action.

2. The aforementioned instruction further instructs the device to: The apparatus according to claim 1, which performs the following: determining the location of the delicate tissue structure in relation to the tissue removal profile, and displaying the value of one or more of the safety parameters or the efficacy parameters.

3. The apparatus according to claim 1, wherein the delicate tissue structure comprises the spermatic cumulus of the prostate.

4. The apparatus according to claim 1, wherein the delicate tissue structure comprises cancerous tissue.

5. The apparatus according to claim 2, wherein the tissue removal profile comprises one or more protective zones determined at least in part on reducing damage to the delicate tissue structure or avoiding damage to pathogenic tissue.

6. The apparatus according to claim 1, wherein the trained classifier is a trained neural network.

7. The apparatus according to claim 1, wherein the trained classifier is a trained artificial intelligence network.

8. The aforementioned instruction is given to the device, The apparatus according to claim 1, wherein the trained classifier is used to identify the delicate tissue structure in the image.

9. The apparatus according to claim 1, wherein the tissue removal profile includes a cutting profile.

10. The apparatus according to claim 9, wherein the cutting profile includes a plurality of locations comprising a plurality of angular coordinates centered on the treatment axis, a plurality of corresponding axial coordinates along the treatment axis, and a plurality of radial distances from the treatment axis.

11. The aforementioned instruction further instructs the device to: The apparatus according to claim 10, which adjusts the cutting profile based on user input.

12. The aforementioned instruction is given to the device, The plurality of angular coordinates centered on the aforementioned treatment axis, The plurality of corresponding axial coordinates along the treatment axis, or The plurality of radial distances from the treatment axis The apparatus according to claim 11, which allows adjustment of at least one of the following.

13. The aforementioned instruction is given to the device, The apparatus according to claim 1, wherein a trained convolutional neural network is used to identify the delicate tissue structure.

14. The aforementioned instruction is given to the device, The apparatus according to claim 1, which uses edge detection, feature recognition, or segmentation to identify the delicate tissue structure.

15. The aforementioned instruction is given to the device, The apparatus according to claim 1, which displays the image comprising the prostate gland together with the tissue removal profile in one or more of the following: sagittal, parasagittal, transverse, coronal, paracoronal, or three-dimensional images.

16. The apparatus according to claim 1, wherein the image comprising the prostate includes one or more of the following: tissue boundary identification, tissue surface identification, tissue differentiation detection, fluorescence fluoroscopy, CT scan imaging, magnetic resonance imaging, radioactivity detection, or radiopaque imaging.

17. The apparatus according to claim 5, wherein the prostate gland has a delicate tissue structure, the tissue removal profile has a protective zone, and the protective zone of the tissue removal profile is determined in response to the image comprising the prostate gland and one or more of the safety parameters or the efficacy parameters.

18. The apparatus according to claim 17, wherein the protective zone is one of a plurality of protective zones, and the plurality of protective zones of the tissue removal profile are determined in response to the image comprising the prostate and at least one or more of the safety parameters or the efficacy parameters.

19. The apparatus according to claim 18, wherein one or more of the plurality of protective zones are determined at least in part on the basis of avoiding damage to delicate tissue structures or avoiding damage to pathogenic tissues.

Images