Tissue protection system and method
The system uses real-time imaging to adjust energy delivery and probe placement, addressing collateral tissue damage in ablation procedures by minimizing adverse effects on non-target tissues through precise alignment and energy control.
Patent Information
- Application Number
- JP2025543851
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-02-01
- Filing Date
- 2024-01-30
- Publication Date
- 2026-02-05
AI Technical Summary
Conventional tissue ablation methods using energy sources often result in undesirable collateral effects on adjacent tissues due to misalignment of probes or unpredictable tissue reactions, leading to potential damage and functional impairment of non-target tissues.
A system and method that incorporates an imaging device to monitor the effect of energy delivery on a second tissue, adjusting the energy and probe placement based on real-time image data to minimize adverse effects on adjacent tissues.
Enhances the precision of tissue ablation by reducing collateral damage to non-target tissues through real-time imaging and adjustment of energy delivery, ensuring targeted treatment with minimized impact on surrounding tissues.
Smart Images

Figure 2026504384000001_ABST
Abstract
Description
[Background technology]
[0001] Related Applications This application claims the benefit of the filing date of U.S. Patent Application No. 18 / 163,164, filed February 1, 2023, which is incorporated by reference in its entirety.
[0002] background Conventional approaches to tissue ablation using energy sources may not be ideal in at least some respects. Research related to the present disclosure suggests that conventional approaches to treating a first tissue using an energy source may have undesirable effects on a second tissue. For example, while some types of energy may be effective in treating a first tissue, the energy treating the first tissue may have collateral effects on the second tissue that may at least partially reduce the functionality of the second tissue. Also, in some instances, treating tissue in a first organ may have collateral effects on a second organ.
[0003] This collateral effect can occur in many ways, such as an undesirable amount of energy or less-than-ideal alignment of the probe with the tissue structure. Probes can be used to treat many types of tissues and organs, and as they function in the context of this disclosure, it is suggested that misalignment of the probe can result in unintended effects on tissues distant from the probe. Furthermore, if the treated tissue reacts in an unpredictable manner, the energy source may, at least in some cases, have a collateral effect on a second tissue. For example, in prostate tissue surgery, the vermontanum and the trigone of the bladder are tissue structures that can potentially be altered during surgery, at least in some cases with undesirable consequences. The trigone of the bladder is sensitive to stretch and sends signals to the brain to empty the bladder. However, damage to the trigone can create a sensation that the bladder should be emptied even when it is not, potentially resulting in patient discomfort. The vermontanum of the prostate is related to sexual function, and damage to the vermontanum can, at least in some instances, result in decreased male sexual function.
[0004] In light of the above, it would be desirable to have improved surgical systems and methods that ameliorate at least some of the aforementioned limitations of the prior art. Summary of the Invention [Means for solving the problem]
[0005] overview The systems and methods of the present disclosure provide improved treatment of tissue with an energy source while reducing potentially undesirable effects on other tissues. In some embodiments, a probe is configured to deliver energy to a first tissue and an imaging device is configured to image a second tissue. Image data from the second tissue is processed to evaluate the effect of the energy source on the second tissue. In some embodiments, the image data from the second tissue is used to adjust the energy to the first tissue, for example, by increasing or decreasing the energy to the second tissue. In some embodiments, image data from one or more of the first tissue or the second tissue is used to evaluate the placement of the probe in the first tissue, and the placement of the probe in the first tissue is adjusted to reduce tissue changes in the second tissue associated with the probe placement in the first tissue. In some embodiments, the probe is coupled to a force sensor to measure tissue traction on the probe, which can reduce potentially undesirable effects on the second tissue.
[0006] Incorporation by Reference All patents, applications, and publications referred to and identified herein are incorporated herein by reference in their entirety and shall be considered to be incorporated by reference in their entirety even if referred to elsewhere in this application. [Brief explanation of the drawings]
[0007] A better understanding of the features, advantages, and principles of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments and the accompanying drawings.
[0008] [Figure 1] FIG. 1 shows a front view of a system for performing tissue ablation in a patient, according to some embodiments of the present disclosure.
[0009] [Figure 2]FIG. 2 illustrates a schematic diagram of a system for performing tissue ablation in a patient, according to some embodiments.
[0010] [Figure 3A] FIG. 3A shows a top view of an array of probes, according to some embodiments.
[0011] [Figure 3B] FIG. 3B shows a longitudinal view, such as a sagittal view, of an array of probes, according to some embodiments.
[0012] [Figure 3C] FIG. 3C shows a perspective view of an array of probes, according to some embodiments.
[0013] [Figure 4] FIG. 4 illustrates treatment of a patient, according to some embodiments.
[0014] [Figure 5] FIG. 5 illustrates a probe placed in a first tissue and a response of a second tissue to the probe placed in the first tissue, according to some embodiments.
[0015] [Figure 6] FIG. 6 shows an image of a treatment probe having identifiable tissue structures that can be processed to determine the position and location of the tissue structures, according to some embodiments.
[0016] [Figure 7] FIG. 7 shows identified tissue structures on an image of a patient shown on a display during treatment, according to some embodiments.
[0017] [Figure 8] FIG. 8 shows an arm coupled to a probe having a sensor configured to measure tissue traction on the probe in response to placement of the probe, according to some embodiments.
[0018] [Figure 9A] 9A-9C show user interface screens of the system having one or more transverse images of tissue and a treatment profile. [Figure 9B] 9A-9C show user interface screens of the system having one or more transverse images of tissue and a treatment profile. [Figure 9C] 9A-9C show user interface screens of the system having one or more transverse images of tissue and a treatment profile.
[0019] [Figure 10] FIG. 10 shows a user interface screen of a system having a longitudinal image, such as a sagittal image of tissue, and a treatment profile, according to some embodiments.
[0020] [Figure 11] FIG. 11 illustrates a method of treating a first tissue and adjusting the treatment based on a response of a second tissue to the treatment of the first tissue, according to some embodiments.
[0021] [Figure 12] FIG. 12 illustrates a method of adjusting a probe placed in a first tissue in response to stretching of a second tissue, according to some embodiments.
[0022] [Figure 13] FIG. 13 illustrates a method for measuring forces associated with tissue traction on a probe and adjusting the probe in response to tissue traction on the probe, according to some embodiments.
[0023] [Figure 14] FIG. 14 illustrates a two-dimensional convolutional neural network, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION
[0024] Detailed Description The following detailed description provides a better understanding of the features and advantages of the invention described in this disclosure in accordance with the embodiments disclosed herein. While the detailed description includes many specific embodiments, these are provided by way of example only and should not be construed as limiting the scope of the invention disclosed herein.
[0025] The systems and methods of the present disclosure are well suited for use in many probes and diagnostic and surgical procedures. While reference is made to therapeutic probes comprising energy sources and transrectal ultrasound ("TRUS") probes for prostate surgery, the present disclosure also applies to many types of tissues, organs, cavities, and lumens, such as the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testes, bladder, ears, nose, mouth, tumors, cancers, soft tissues such as bone marrow, adipose tissue, muscle, glandular and mucosal tissue, spinal cord and nerve tissue, cartilage, hard biological tissues such as teeth, bones, and lumens, such as blood vessel lumens, nasal lumens, and sinuses. It is well suited for use in many types of probes inserted into the nasal cavity, colon, urethral lumen, gastric lumen, airway, esophageal lumen, transesophageal lumen, intestinal lumen, anal lumen, vaginal lumen, transperitoneal lumen, abdominal cavity, throat, airway, lung passages, as well as in surgeries such as kidney surgery, ureter surgery, kidney stone surgery, prostate surgery, tumor surgery, cancer surgery, brain surgery, heart surgery, eye surgery, conjunctival surgery, liver surgery, gallbladder surgery, bladder surgery, spine surgery, orthopedic surgery, arthroscopic surgery, liposuction, colonoscopy, intubation, minimally invasive incision, minimally invasive surgery, etc.
[0026] The systems and methods of the present disclosure are well suited for combination with conventional probes, such as imaging and therapy probes, including, for example, laser therapy probes, water jet probes, RF therapy probes, radiation therapy probes, ultrasound therapy probes, phacoemulsification probes, imaging probes, endoscopic probes, resectoscope probes, ultrasound imaging probes, A-scan ultrasound probes, B-scan ultrasound probes, 3D ultrasound probes, Doppler ultrasound probes, transrectal ultrasound probes, transvaginal ultrasound probes, longitudinal ultrasound imaging probes, sagittal ultrasound imaging probes, transverse ultrasound imaging probes, and transverse and longitudinal (e.g., sagittal) ultrasound imaging probes.
[0027] The one or more images described herein can be generated in many ways and may include one or more of a longitudinal image, a sagittal image, a parasagittal image, or a transverse image. In some embodiments, the longitudinal image includes an image generated using an elongated imaging probe, where the longitudinal image extends along a plane corresponding to the elongated axis of the imaging probe, and the transverse image extends along a plane transverse to the elongated axis of the probe, e.g., substantially perpendicular to the elongated axis of the probe and the corresponding longitudinal image. The elongated probe can be inserted into the patient in any suitable orientation. In some embodiments, the probe is inserted into the patient substantially along the patient's midline, whereby the longitudinal image corresponds to a sagittal image of the patient. In some embodiments, the elongated imaging probe includes a TRUS probe, and the longitudinal image includes a sagittal image, although other probes having different orientations can be used to generate images in accordance with the present disclosure. While reference is made to an ultrasound probe inserted into the patient, in some embodiments, the imaging device includes an external imaging probe, where the longitudinal and transverse images can refer to one or more arrays of the external imaging probe. In some embodiments, the one or more images are generated from a 3D tomographic image dataset, such as a Digital Imaging and Communications in Medicine (DICOM) image dataset.
[0028] The systems, methods, and devices of the present disclosure are well suited for combination with many conventional surgical procedures, such as water jet removal of the prostate, transurethral resection of the prostate (TURP), holmium laser removal of the prostate (HOLEP), prostate brachytherapy, as well as with surgical robotic systems and automated surgical procedures. The following patent applications describe examples of systems, methods, probes, and procedures suitable for incorporation according to the present disclosure: International Application No. PCT / US2013 / 028441, entitled "AUTOMATED IMAGE-GUIDED TISSUE RESECTION AND TREATMENT," filed February 28, 2013, published as WO 2013 / 130895; International Application No. PCT / US2014 / 054412, entitled "AUTOMATED IMAGE-GUIDED TISSUE RESECTION AND TREATMENT," filed September 5, 2014, published as WO 2015 / 035249; and International Application No. PCT / US2016037137, entitled "PHYSICIAN-CONTROLLED TISSUE RESECTION INTEGRATED WITH TREATMENT MAPPING OF TARGET ORGAN," filed September 5, 2015, published as WO 2016037137, the entire disclosures of which are incorporated herein by reference. International application PCT / US2015 / 048695, entitled "ARTIFICIAL INTELLIGENCE FOR ROBOTIC SURGERY," filed June 21, 2019, published on December 26, 2019 as WO 2019246580; International application PCT / US2020 / 021756, entitled "ROBOTIC ARMS AND METHODS FOR TISSUE RESECTION AND IMAGING," filed March 9, 2020, published on March 9, 2020 as WO 2020 / 181290;International Application No. PCT / US2020 / 058884, entitled "SURGICAL PROBES FOR TISSUE RESECTION WITH ROBOTIC ARMS," filed November 4, 2020, published as WO 2021 / 096741; International Application No. PCT / US2021 / 070760, entitled "INTEGRATION OF ROBOTIC ARMS WITH SURGICAL PROBES," filed June 23, 2021, published as WO 2021 / 263276; and International Application No. PCT / US2021 / 038175, entitled "SYSTEMS AND METHODS FOR DEFINING AND MODIFYING RANGE OF MOTION OF PROBE USED IN PATIENT TREATMENT," filed June 21, 2021, published as WO 2021 / 262565.
[0029] Some embodiments provide improved positional accuracy for energy source placement. The energy source may include any suitable energy source, such as one or more of an electrode, a loop electrode, a laser source, a thermal energy source, a mechanical energy source, a mechanical shear, an ultrasound probe, a cavitation ultrasound probe, a water jet (e.g., a fixed-pressure water jet), a plasma source, a steam source, a morcellator, a transurethral needle, a photoablation source, a radiation energy source, a microwave energy source, or a water jet ejection source. The energy source may be combined with other treatments and compounds, such as photochemical treatments. The imaging probe may include any suitable probe, such as an endoscopic probe, a resectoscope probe, an ultrasound imaging probe, an A-scan ultrasound probe, a B-scan ultrasound probe, a Doppler ultrasound probe, a transrectal ultrasound probe, a transvaginal ultrasound probe, a sagittal ultrasound imaging probe, a transverse ultrasound imaging probe, and a transverse and sagittal ultrasound imaging probe.
[0030] FIG. 1 illustrates an exemplary embodiment of a system 400 for performing treatment on a patient. The system 400 may include a treatment probe 450 as described herein and an imaging probe 460 as described herein. The treatment probe 450 may be coupled to a first arm 442, and the imaging probe 460 may be coupled to a second arm 444. One or both of the first arm 442 and the second arm 444 may comprise a robotic arm, the movement of which may be controlled by one or more computing devices operably coupled to the arm. The treatment probe 450 may comprise a device for removing target tissue from a target site within a patient. The treatment probe 450 may be configured to deliver sufficient energy to the target tissue to remove the target tissue from the treatment probe 450, and the energy source may include any suitable energy source described herein. For example, the treatment probe 450 may include an electrosurgical ablation device, a laser ablation device, a transurethral needle ablation device, a water jet ablation device, a steam ablation device, a high-intensity focused ultrasound (HIFU) device, or any combination thereof. The imaging probe 460 may be configured to deliver sufficient energy to the target tissue to image the target tissue from the imaging probe 460. The imaging probe 460 may comprise, for example, an ultrasound probe, a magnetic resonance probe, an endoscope, or a fluoroscopy probe. The first arm 442 and the second arm 444 may be configured to be independently adjustable, adjustable according to a fixed relationship, adjustable according to a user-selected relationship, independently lockable, simultaneously lockable, or any combination thereof. The first arm 442 and the second arm 444 may have multiple degrees of freedom, e.g., six degrees of freedom, for manipulating the treatment probe 450 and the imaging probe 460, respectively. The treatment system 400 may be used to perform tissue ablation in a patient's organ, such as the prostate gland of the patient. The patient may be positioned on a patient support 449, such as a bed, table, chair, or platform.The treatment probe 450 may be inserted into a patient's target site along an entry axis coincident with the treatment probe's elongated axis 451. For example, the treatment probe 450 may be configured for insertion into the patient's urethra to position the treatment probe's energy delivery region within the patient's prostate. The imaging probe 460 may be inserted into the patient at the patient's target site or adjacent to the target site along an entry axis coincident with the imaging probe's elongated axis 461. For example, the imaging probe 460 may include a transrectal ultrasound (TRUS) probe configured for insertion into the patient's rectum to view the patient's prostate and surrounding tissue. As shown in FIG. 1 , the first arm 442 and the second arm 444 may be covered with sterile drapes to provide a sterile operating environment, keep the robotic arms clean, and reduce the risk of damaging the robotic arms. Further details regarding the various components of system 400 suitable for incorporation with the embodiments disclosed herein can be found in U.S. Pat. No. 7,882,841, U.S. Pat. No. 8,814,921, U.S. Pat. No. 9,364,251, and WO 2013 / 130895, the entire disclosures of which are incorporated herein by reference.
[0031] FIG. 2 schematically illustrates an embodiment of a system 400 for performing tissue ablation on a patient. The system 400 may include a treatment probe 450 as described herein and, optionally, an imaging probe 460. The treatment probe 450 is coupled to a console 420 and a linkage 430. The linkage 430 may include one or more components of a robotic arm 442. The imaging probe 460 is coupled to an imaging console 490. The imaging probe may be coupled to a second robotic arm 444, for example. The patient treatment probe 450 and the imaging probe 460 can be coupled to a common base 440. The patient is supported by a patient support 449. The treatment probe 450 is coupled to the base 440 by a first arm 442. The imaging probe 460 is coupled to the base 440 by a second arm 444. As described in further detail herein, one or both of the first arm 442 and the second arm 444 may comprise a robotic arm whose movement may be controlled by one or more computing devices operably coupled to the arm.
[0032] Although a common base is referenced, the robotic arms may be coupled to a bed rail, a console, or any suitable support structure to support the base of the robotic arms.
[0033] In some embodiments, the system 400 includes a user input device 496 coupled to the processor 423 for a user to manipulate a surgical instrument on a robotic arm. The user input device 496 can be located in any suitable location, e.g., on a console, on a robotic arm, or on a mobile base, and there may be one, two, three, four, or more user input devices used with the system 400 to provide either redundant means of input, unique input commands, or a combination. In some embodiments, the user input device includes a controller for moving the end of a treatment or imaging probe with movement in response to mechanical movement of the user input device. The end of the probe can be shown on the display 425, and the user can manipulate the end of the probe. For example, the user input device may include a six-degrees-of-freedom input controller that allows the user to move the input device in six degrees of freedom, with the distal end of the probe moving in response to movement of the controller. In some embodiments, the six degrees of freedom include three translational degrees of freedom and three rotational degrees of freedom. The processor can be configured with instructions for probe control, for example, to switch between automatic image-guided processing by an energy source and processing by an energy source via user movement of the user input device.
[0034] The patient is positioned on a patient support 449, allowing the treatment probe 450 and ultrasound probe 460 to be inserted into the patient. The patient can be positioned in one or more of a number of positions, such as prone, supine, upright, or inclined. In some embodiments, the patient is positioned in a lithotomy position, e.g., stirrups may be used. In some 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 anterior side of the patient, and the imaging probe can be inserted transrectally into the patient's intestine from the posterior side of the patient. The treatment probe and imaging probe can be positioned on the patient with one or more of urethral tissue, urethral wall tissue, prostate tissue, intestinal tissue, or intestinal wall tissue extending between them.
[0035] The treatment probe 450 and the imaging probe 460 can be inserted into a patient in one or more of a number of ways. During insertion, each of the first and second arms of the treatment or imaging probe may have a substantially unlocked configuration so that the probe can be desirably rotated and translated to insert the probe into the patient. Once the probe is inserted into 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 a number of ways, such as parallel, skewed, horizontal, oblique, or non-parallel. To map imaging probe image data to the treatment probe coordinate reference space, it can 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.
[0036] In some embodiments, the treatment probe 450 is coupled to the imaging probe 460 for aligning the treatment with the probe 450 based on images from the imaging probe 460. Coupling can be achieved using a common base 440 as shown. Alternatively, or in combination, the treatment probe and / or the imaging probe may include magnets for aligning and holding the probe through the patient's tissue. In some embodiments, the first arm 442 is a movable, lockable arm so that the treatment probe 450 can be positioned at a desired location on the patient. Once the probe 450 is positioned at a desired location on the patient, the first arm 442 can be locked with an arm lock 427. The imaging probe can be coupled to the base 440 using a second arm 444 that can be used to adjust the alignment of the imaging probe when the treatment probe is locked in place. The second arm 444 can comprise a lockable and movable arm, for example, under the control of an imaging system or console and user interface. The movable arm 444 can be micro-actuated so that the imaging probe 460 can be adjusted with small movements, such as millimeters, relative to the treatment probe 450.
[0037] In some embodiments, the therapy probe 450 and the imaging probe 460 are coupled to angle sensors so that therapy can be controlled based on the alignment of the imaging probe 460 and the therapy probe 450. A first angle sensor 495 may be coupled to the therapy probe 450 by a support 438. A second angle sensor 497 may be 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 goniometers, accelerometers, and combinations thereof. In some embodiments, the first angle sensor 495 comprises a three-dimensional accelerometer for determining the orientation of the therapy probe 450 in three dimensions. In some embodiments, the second angle sensor 497 comprises a three-dimensional accelerometer for determining the orientation of the imaging probe 460 in three dimensions. Alternatively, or in combination, the first angle sensor 495 may comprise a goniometer for determining the angle of the therapy probe 450 along the elongated axis 451 of the therapy probe. The second angle sensor 497 may comprise a goniometer for determining the angle of the imaging probe 460 along the elongated axis 461 of the imaging probe 460. The first angle sensor 495 is coupled to the controller 424 of the treatment console 420. The second angle sensor 497 of the imaging probe is coupled to the processor 492 of the imaging console 490. Alternatively or in combination, the second angle sensor 497 may be coupled to the controller 424 of the treatment console 420.
[0038] The console 420 includes a display 425 coupled to a processor system in components used to control the treatment probe 450. The console 420 includes a processor 423 having a memory 421. A communication circuit 422 is coupled to the processor 423 and a controller 424. The communication circuit 422 is coupled to the imaging console 490 via a communication circuit 494 of the imaging console. An arm lock 427 of the console 420 may couple to the first arm 442 to lock the first arm or may allow the first arm to move freely to allow the probe 450 to be inserted into the patient.
[0039] Optionally, the console 420 may include components of an endoscope 426 coupled to the anchor 24 of the treatment probe 450. The endoscope 426 may include components of the console 420 and an endoscope through which the treatment probe 450 can be inserted to treat the patient.
[0040] In some embodiments, the console 420 includes an impedance sensor circuit 220 coupled to the energy source to measure the impedance of tissue treated with energy from the energy source. In some embodiments, the energy source includes electrodes, and the electrodes include an impedance sensor. In some embodiments, the processor is configured with instructions for adjusting the amount of energy from the energy source in response to the amount of impedance. In some embodiments, the processor is configured with instructions for adjusting the amount of deflection of the extension and the offset of the energy source from the elongate shaft in response to the impedance.
[0041] In some embodiments, the console 420 includes a force sensor circuit 210 coupled to a force sensor on the treatment probe. The force sensor can be coupled to the extension, for example, to measure tissue resistance associated with deflection of the extension. In some embodiments, the force sensor is coupled to the link to measure tissue resistance associated with movement of the energy source away from the elongate shaft. In some embodiments, the force sensor is coupled to the energy source to measure tissue resistance associated with positioning distance of the energy source from the elongate shaft. In some embodiments, the force sensor is configured to measure tissue resistance associated with energy delivery from the energy source.
[0042] Optionally, the console 420 may include one or more modules operably coupled with the treatment probe 450 to control aspects of treatment by the treatment probe. For example, the console 420 may include one or more of an energy source 22 for providing energy to the treatment probe, a balloon inflation control 26 for affecting inflation of a balloon used to anchor the treatment probe to the target treatment site, an injection / irrigation control 28 for controlling injection and irrigation of the probe, an aspiration control 30 for controlling suction by the probe, an air insufflation control 32 for controlling air insufflation of the target treatment site (e.g., the prostate), or a light source 33, such as an infrared, visible, or ultraviolet light source, for providing light energy to the treatment probe.
[0043] The processor, controller, and control electronics and circuitry may include one or more of many suitable components, such as one or more processors, one or more field programmable gate arrays (FPGAs), and one or more memory storage devices. In some embodiments, the control electronics controls a graphic user interface (hereinafter "GUI") control panel to provide pre-treatment planning according to user-specified treatment parameters and to provide user control over the surgical procedure.
[0044] The treatment probe 450 may include an anchor 24. The anchor 24 can anchor the distal end of the probe 450 while energy is delivered by the probe 450 to the energy delivery region 20. In some embodiments, the probe includes a first energy source 250 that can be offset from an elongated shaft 451, the probe having an offset 252 that is a distance for treating tissue, for example, by deflection of an extension as described herein. The processor can be configured with instructions for performing 3D volumetric ablation of tissue using rotation, translation, and offset of the energy source 250 in response to computer control. The probe 450 may include a second energy source as described herein, such as a nozzle 200.
[0045] The treatment probe 450 may be coupled to the first arm 442 by a linkage 430. The linkage 430 may comprise components for moving the energy delivery region 20 to a desired target location on the patient, for example, based on an image of the patient. The linkage 430 may comprise a first portion 432, a second portion 434, and a third portion 436. The first portion 432 may comprise a substantially fixed anchor portion. The substantially fixed anchor portion 432 may be fixed to a support 438. The support 438 may comprise a reference frame for the linkage 430. The support 438 may comprise a rigid chassis or frame or housing for rigidly and securely coupling the first arm 442 to the treatment probe 450. The first portion 432 may remain substantially fixed, while the second portion 434 and the third portion 436 may move to direct energy from the probe 450 to the patient. The first portion 432 may be fixed at a substantially constant distance 437 relative to the anchor 24. The substantially fixed distance 437 between the anchor 24 and the fixed first portion 432 of the linkage allows for precise placement of the treatment. The first portion 432 may comprise a linear actuator for precisely positioning a second energy source, such as a high-pressure nozzle 200, within the energy delivery region 20 at a desired axial location along the elongated axis 451 of the treatment probe 450. Additional actuators and linkages may be provided and operably coupled to the processor to offset, rotate, and translate the first energy source 250, as described herein.
[0046] The elongated shaft 451 of the treatment probe 450 generally extends between a proximal portion of the probe 450 near the linkage 430 and a distal end having the anchor 24 attached thereto. The third portion 436 can control a rotation angle 453 about the elongated shaft 451. During treatment of a patient, a distance 439 between the energy delivery region 20 and the first portion 432 of the linkage can vary relative to the anchor 24. The distance 439 may be adjusted by probe translation 418 in response to computer control to set a target location along the elongated shaft 451 of the treatment probe. In some embodiments, the first portion of the linkage remains fixed, and the second portion 434 adjusts the position of the energy delivery region 20 along the shaft 451. The third portion 436 of the linkage adjusts the angle 453 about the shaft in response to the controller 424 so that the distance along the axis at the angle of treatment can be controlled very precisely relative 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 so that the distance from the linkage 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 with one or more forms of energy, such as mechanical energy from a jet, electrical energy from an electrode, or light energy from a light source, such as a laser source. The light source may include infrared light, visible light, or ultraviolet light. The energy delivery region 20 can be moved under the control of the linkage 430 to deliver the intended form of energy to the patient's target tissue.
[0047] The imaging console 490 may include a memory 493, a communication circuit 494, and a processor 492. The processor 492 in corresponding circuitry is coupled to the imaging probe 460. An arm controller 491 is coupled to the arm 444 for accurately positioning the imaging probe 460. The imaging console may further include a display 425.
[0048] To facilitate precise control of the treatment probe and / or imaging probe during patient treatment, one or more treatment or imaging probes may be coupled to a robotic, computer-controllable arm. For example, with reference to the system 400 shown in FIG. 2 , one or both of the first arm 442 coupled to the treatment probe 450 and the second arm 444 coupled to the imaging probe 460 may comprise a robotic, computer-controllable arm as described herein. The robotic arm may be operably coupled to one or more computing devices configured to control movement of the robotic arm. For example, the first robotic arm 442 may be operably coupled to the processor 423 of the console 420, or the second robotic arm 444 may be operably coupled to the processor 492 of the imaging console 490 and / or the processor 423 of the console 420. One or more computing devices, such as the processors 423 and 492, may include computer-executable instructions for controlling movement of one or more robotic arms. The first and second robotic arms may be substantially similar in configuration and function, or may be different to accommodate particular functional requirements for controlling movement of the treatment probe relative to movement of the imaging probe.
[0049] The robotic arm may include six or more joints to allow the arm to move under computer control. Suitable robotic arms are commercially available from several manufacturers, such as RoboDK Inc., Kinova Inc., and several other manufacturers.
[0050] One or more computing devices operably coupled to the first and second robotic arms may be configured to automatically control the movement of the treatment probe and / or imaging probe. For example, the robotic arms may be configured to automatically adjust the position and / or orientation of the treatment probe and / or imaging probe during treatment of a patient according to one or more preprogrammed parameters. The robotic arms may be configured to automatically move the treatment probe and / or imaging probe along a preplanned or programmed treatment or scan profile, which may be stored in the memory of the one or more computing devices. Alternatively, or in addition to automatically adjusting the robotic arms, the one or more computing devices may be configured to control the movement of the treatment probe and / or imaging probe in response to user input, for example, through a graphical user interface of the treatment device. Alternatively, or in addition to automatic adjustment of the robotic arm, one or more computing devices may be configured to control movement of the treatment probe and / or imaging probe in response to real-time positioning information, for example, in response to anatomical structures recognized in one or more images captured by an imaging probe or other imaging source (from which a range of allowable movement of the treatment probe and / or imaging probe can be established) and / or position information of the treatment probe and / or imaging probe from one or more sensors coupled to the probe and / or robotic arm.
[0051] 3A, 3B, and 3C show top, longitudinal (e.g., sagittal), and oblique views, respectively, of a probe arrangement for use in treating tissue. In particular, FIGS. 3A, 3B, and 3C show a relative arrangement, including the position and orientation, of a treatment probe 450 relative to the position and orientation of an imaging probe 460 for treatment of tissue, such as prostate tissue. The imaging probe 460 can be configured to generate one or more longitudinal images, such as a transverse image, e.g., a transverse ultrasound image 310, and one or more longitudinal (e.g., sagittal) ultrasound images 320. In some embodiments, the energy source of the treatment probe 450 moves at a rotational angle 453 and a translational angle 418, such that the treated tissue and the energy source are within the field of view of the imaging probe 460.
[0052] As shown in the top view of FIG. 3A , the treatment probe axis 451 and the imaging probe axis 461 are positioned in a substantially coplanar configuration, whereby the imaging probe and the treatment probe extend along a common plane. As shown in the top view of FIG. 3B and the perspective view of FIG. 3C , the treatment probe axis 451 and the imaging probe axis 461 are positioned in a substantially coplanar but non-parallel configuration, whereby the imaging probe and the treatment probe extend along a substantially common plane, enabling the imaging probe to image the treatment probe along the length of translation 418 with one or more longitudinal images, such as real-time longitudinal images, e.g., real-time sagittal images. In some embodiments, the treatment probe and the imaging probe are arranged in a substantially coplanar configuration, and the ultrasound probe rotates to rotate the longitudinal (e.g., sagittal) field of view of the imaging probe to image the treatment probe along the length of the longitudinal field of view. Referring again to FIG. 3A, the imaging probe 460 can be rotated about the elongated axis 461 by angle 336 to align the treatment probe 450 to be within the sagittal field of view, so that, for example, the sagittal field of view of the imaging probe is aligned with the elongated axis 451 of the treatment probe.
[0053] One or more of the treatment probe or the imaging probe can be moved to adjust the alignment between the imaging probe and the treatment probe. In some embodiments, a proximal portion of the treatment probe moves from a first position to a second position. Referring again to FIG. 3B , the treatment probe 450 can be moved from a first position 332 to a second position 334 to adjust the alignment between the probes, for example, based on data from one or more reference points as described herein.
[0054] In some embodiments, the imaging probe 460 and the therapy probe 450 are aligned to be substantially coplanar with one another within a margin of error so that the imaging probe 460 can image the therapy probe 450 and the therapy probe's energy source during treatment with the therapy probe located within the imaging probe's field of view, such as a longitudinal (e.g., sagittal) image field. In some embodiments, the therapy probe is aligned with the imaging probe such that the therapy probe is visible along the length of the imaging probe's longitudinal (e.g., sagittal) view.
[0055] In some embodiments, the imaging probe 460 and the treatment probe 450 may be somewhat misaligned, e.g., beyond a margin of error, such that, for example, a portion of the imaging probe extends beyond the longitudinal (e.g., sagittal) field of view, causing the treatment probe to disappear from a portion of the longitudinal (e.g., sagittal) image. In some embodiments, this may result in the imaging probe 460 not imaging a portion of the treatment in the longitudinal (e.g., sagittal) image. In some embodiments, the treatment probe 450 and the imaging probe 460 may be arranged in a substantially oblique orientation as described herein, e.g., outside a margin of error, such that the treatment probe extends outside the longitudinal (e.g., sagittal) field of view of the imaging probe but is within the field of view of the lateral image of the imaging probe. In such embodiments, the treatment can be monitored in real time using the lateral image, and the imaging probe moves to maintain the energy source and simultaneously treated tissue within the lateral field of view of the imaging probe. In some embodiments, the cross-sectional view of the tissue and energy source can be less sensitive to alignment between the two probes, and the imaging probe can be moved, for example synchronously, with the energy source to image the tissue and energy source during treatment.
[0056] FIG. 4 illustrates the treatment of patient tissue. A treatment probe 450 may be inserted into a patient lumen, such as along the patient's urethra, to treat a distal portion of the treatment area with an energy source. In some embodiments, the treatment probe 450 includes an exhaust port 472 that can be coupled to a suction source as described herein. In some embodiments, the treatment probe 450 is configured to emit energy from the energy source 250, and the treatment probe may include an energy treatment probe 470 configured to emit energy from the energy source 250 in rotation and translation as described herein. In some embodiments, the energy source of the treatment probe 470 is configured to rotate and translate relative to other components of the treatment probe 451, such as a suction port. A treatment profile 474 is shown by the dotted line. As shown, an ablation procedure is initiated and the energy treatment probe 470 moves proximally from the distal end of the treatment profile 474, thereby removing tissue from a distal portion of the distal treatment area according to the treatment profile 474. In some embodiments, the suction port actively aspirates fluids and tissue products during the procedure and may include a component of a fluid management system. In some embodiments, the energy source of the energy treatment probe rotates an angle and translates along a specified length of the treatment profile according to a treatment profile presented on a user interface, hi some embodiments, the ablation depth is controlled according to the treatment profile based on user input to the user interface.
[0057] The first tissue treated with the energy source may include any suitable tissue as described herein, such as a first organ of tissue, and the second tissue imaged at the first tissue may include any suitable tissue as described herein, such as a tissue of a second organ. For example, the first tissue may include tissue of the prostate gland 510, and the second tissue may include tissue of the bladder 520. In some embodiments, the prostate gland 510 includes a middle lobe 512, the distal portion of which extends into the bladder 520 to include an intravesical prostatic protrusion 514. In some embodiments, the bladder 520 includes a wall 522 and trigone tissue 524. In some embodiments, the trigone tissue includes tissue in a region of the bladder tissue generally defined by the entrance of the ureters into the bladder at two ureteral orifices and the opening of the urethra into the bladder at an internal urethral orifice. In some embodiments, the second tissue includes a wall of tissue, such as the bladder wall 522. The edge of the second tissue may include a profile 526 that can be monitored, e.g., imaged, in real time while the first tissue is being treated to assess the effect of the energy source on the second tissue, e.g., the trigone, from treatment of the first tissue, e.g., the prostate.
[0058] The imaging device used to generate the image may include any suitable imaging device as described herein, but in some embodiments, the imaging device includes a real-time ultrasound imaging device such as a probe having a frame rate in the range of about 5 hertz (Hz) to about 250 Hz and a latency time from when imaging energy is emitted from the imaging device until an image is shown on a display in the range of about 10 milliseconds (ms) to about 1000 ms.
[0059] While the second tissue can be monitored in many ways, in some embodiments, the second tissue includes a structure in the image that has sufficient contrast to identify the structure of the second tissue. In some embodiments, the tissue structure includes a tissue wall, such as a wall of an organ such as the bladder. Data from the image of the tissue structure can be processed to determine information from the tissue structure, such as one or more of the tissue structure's shape profile, contrast, gradient, movement, or blur. In some embodiments, the tissue structure includes a surface profile 526 of the second tissue that moves with movement 530 in response to the energy source treating the first tissue. In some embodiments, the surface profile 526 moves from a first profile to a second profile 532 and a third profile 534, which can be sequentially viewed in a real-time image of the second tissue. Movement of the second tissue in response to treatment of the first tissue may include, for example, one or more of stretching, compression, rotation, translation, flexure, or deformation. In some embodiments, the processor is configured to detect movement of the second tissue in response to treatment of the first tissue and adjust the energy source.
[0060] 4 and elsewhere herein, the terms "proximal" and "distal" are from the perspective of the surgical system. Thus, the distal end of the treatment probe is the portion of the probe that is inserted furthest into the patient.
[0061] FIG. 5 illustrates a probe 450 positioned in a first tissue, such as the prostate gland 510, and the response of a second tissue, such as a bladder wall 522, to the probe being positioned in the first tissue. The probe 450 and the probe's elongated shaft 451 are shown positioned in a position 550 adjusted to reduce the response of the second tissue to the placement of the probe 450 in the first tissue. In some embodiments, engagement of the probe with the first tissue, such as the prostate gland 510, can result in tension or compression of the second tissue, such as the bladder wall 522, which moves the second tissue away from its natural position and orientation relative to the other tissue. The initial position and orientation of the probe's elongated shaft is shown by dashed line 540. With the probe positioned in the first tissue, e.g., the prostate gland, the position of the second tissue, such as the tissue of the bladder wall 522, can change in response to the placement of the probe, as shown by dashed line 542. In some embodiments, placement of the probe in the first tissue results in tenting of the second tissue, such that the surface profile of the second tissue appears elevated in one or more images of the second tissue, such as a series of real-time images of the second tissue. Alternatively, the second tissue may appear compressed in the one or more images. The one or more images may include any suitable image as described herein, such as, for example, one or more longitudinal (e.g., sagittal) images 320, or one or more lateral images 310, and combinations thereof. In some embodiments, the one or more images include multiple lateral images, such as a series of lateral images to detect lateral stretching of the tissue from the first side of the probe toward the second side of the probe.
[0062] A processor as described herein can be configured to process image data to generate an output for moving the probe in response to one or more of an image of the probe or force sensor data related to tissue engagement of the probe as described herein. In some embodiments, the output includes a user interface, such as a display, for providing instructions to a user for adjusting the position of the probe. Alternatively, or in combination, the output may include instructions to a robotic arm to adjust the position of the probe. In some embodiments, the output instructions for moving the robotic arm are combined with a first user input to confirm the movement of the probe before moving the probe with the robotic arm and to confirm that the repositioned probe is suitable based on a second user input. While reference is made to a robotic arm, the probe can be manually adjusted, for example, by user manipulation of the proximal end of the probe.
[0063] 6 shows an image 610 of a treatment probe 451 having identifiable tissue structures that can be processed to determine the position, location, size, shape, and contour of the tissue structures as described herein. The image 610 can be shown on a display 425 as described herein. The identifiable tissue structures shown in the image on the display can include any suitable tissue structures as described herein. In some embodiments, the one or more tissue structures include, for example, one or more of the prostate gland 510, the median lobe 512, the intravesical prostatic protrusion 514, the bladder 520, the bladder wall 522, the edge of the bladder wall between the wall 522 and the interior of the bladder 520, the trigone tissue 524, or the vermont 650 of the prostate gland 510. One or more of the identified tissue structures can be shown on the display. In some embodiments, an initial profile of one or more identified structures may be highlighted on the display at a first time, for example using a first modification to pixels of a first image, and as treatment progresses, the one or more structures may be shown on the display at a second time using a second modification to pixels of a second image, which may allow the user to visualize the progress of treatment and make adjustments when useful.
[0064] The image 610 may include one or more images of the tissue shown on the display, such as a real-time image of the tissue and probe. The one or more images may be generated using any suitable imaging device as described herein, such as, for example, a transrectal ultrasound probe. The one or more images may include, for example, one or more longitudinal, sagittal, or transverse images. A treatment profile 474 may be overlaid on the one or more images, and the treatment profile may include, for example, a three-dimensional treatment profile. In some embodiments, a reticle 620 is overlaid on the image of the tissue to indicate the relative scale of the tissue shown on the display in relation to the tissue and treatment profile 474. The reticle 620 may include a radially extending component 622 extending away from the elongated axis of the treatment probe 450 and a longitudinally extending component 624 extending along the elongated axis of the treatment probe 450. The treatment profile 472 may comprise a radial component 632 corresponding to the distance away from the energy source and the elongate axis of the probe and a longitudinal component 634 corresponding to the distance along the elongate axis of the probe, which may correspond to the position of the energy source along the elongate axis during treatment. In some embodiments, the processor is configured with instructions to overlay a treatment marker 640 on the image of the tissue, the marker corresponding to the longitudinal position of the energy source along the treatment axis.
[0065] While the treatment profile can be generated in many ways, in some embodiments, the treatment profile comprises a three-dimensional (3D) treatment profile generated from multiple images, such as a treatment profile generated from a longitudinal image, such as a sagittal image, and multiple transverse images. In some embodiments, the 3D treatment profile comprises a 3D volumetric tissue removal profile. An example of a user interface for generating a three-dimensional treatment profile from transverse and longitudinal (e.g., sagittal) images is described in International Application No. PCT / US2019 / 038574, filed June 21, 2019, entitled "ARTIFICIAL INTELLIGENCE FOR ROBOTIC SURGERY," which was published on December 26, 2019, as International Publication No. WO 2019246580, the entire disclosure of which was previously incorporated herein by reference.
[0066] 7 illustrates identified tissue structures in an image 700 from a patient shown on a display 425 during treatment. The identified tissue structures shown on the image can be enhanced for user viewing, for example, by highlighting or other pixel modification of the image of such markers. In some embodiments, a first tissue, such as the prostate gland 510, is highlighted. Alternatively, or in combination, a boundary 720 of a second tissue, such as a trigone, may be highlighted and identified with markers, such as one or more labels 722.
[0067] In some embodiments, an initial profile of one or more of the first or second tissues is shown on the display 425 and overlaid on subsequent images. For example, an initial profile 710 of an intravesical prostatic protrusion ("IPP") can be shown on the display and overlaid on subsequent images and identified with a marker, such as one or more labels 712. This may allow a user to compare real-time images of the tissue with the initial profile. For example, the treatment markers 740, the image 700, and the initial profile 710 can be used to assess the progress of a treatment. Alternatively, or in combination, an initial profile of a second tissue can be shown on the display and overlaid on subsequent images to assess the effect of a treatment on the second tissue.
[0068] FIG. 8 illustrates an arm 442 coupled to a probe having sensors configured to measure a force 850 from tissue traction on the probe 450 in response to probe placement. In some embodiments, the force 850 includes a first component 850a and a second force component 850b measured by one or more sensors to determine the direction and magnitude of the force exerted by the tissue on the distal portion of the probe. In some embodiments, the second force component 850b corresponds to tissue stretching, such as stretching of a second tissue in response to probe placement on the first tissue as described herein. In some embodiments, the first component 850a corresponds to tissue pulling the probe distally, e.g., away from the handpiece 804, along a direction corresponding to the probe's elongated axis 451. Alternatively, or in combination, the first component 850a may correspond to the probe pushing against the tissue, e.g., by pushing the tissue against the probe along the elongated axis 451. Research related to this disclosure suggests that a natural lumen, such as the urethra, that engages the probe can provide at least some frictional resistance to probe movement. The amount of pulling force applied to the probe can be in the range of about 0 Newtons ("N") to about 12.2 N. In some embodiments, the first force component 850a includes a longitudinal force component and the second force component 850b includes a radial force component. In some embodiments, the first force component is in the range of about 0 N to about 2 N and the second force component is in the range of about 0 N to about 12 N.
[0069] In some embodiments, the processor is configured to provide instructions to the user to adjust the probe in response to an amount of force on the probe, for example, a force greater than about 12 N. In some embodiments, the processor is configured to generate a notification, for example, when the resultant force component is greater than about 6 N. Alternatively, or in combination, the processor can be configured to generate a notification when either force component is greater than, for example, about 5 N. In some embodiments, the processor is configured to provide an indication when a force on the probe along the longitudinal axis of the probe is greater than a first amount or when the radial component is greater than a second amount. For example, the processor can be configured to generate a first indication when the first force component is greater than about 1 N or when the second force component is greater than about 5 N. In some embodiments, the instructions include a first indication when the longitudinal component is greater than the first amount and a second indication when the radial component is greater than the second amount. For example, the processor may be configured to generate a first indication when the amount of longitudinal force is greater than about 2 N and a second indication when the radial force is greater than about 12 N, or to generate a first indication when the longitudinal force is greater than about 1 N and a second indication when the radial force is greater than about 5 N. These values are exemplary, and any suitable values may be used, as will be appreciated by those skilled in the art.
[0070] In some embodiments, the radial component corresponds to an amount of force along a plane transverse to the elongate axis of the probe, e.g., perpendicular to the elongate axis of the probe. In some embodiments, the radial component comprises a combination of force vectors along a plane transverse to the elongate axis of the probe. For example, the force vector may comprise components of a three-dimensional (3D) force vector, where a first force component corresponds to a 3D force vector component along the axis of the probe and a second force component comprises radial components corresponding to second and third 3D force vector components perpendicular to the first 3D force vector component.
[0071] While the force 850 can be measured in many ways, in some embodiments, the force 850 is measured with the probe substantially fixed at a first position. In some embodiments, the probe is moved to a second position to reduce the force from the tissue to the probe. The second position may include a substantially fixed position for measuring the force on the probe at the second position. The force 850 measured at the first and second positions may include one or more force components at each position, such as a first component 850a and a second component 850b.
[0072] In some embodiments, image data is combined with force sensor data to determine whether probe placement is suitable for reducing tissue stretch, as described herein. The image data may include any suitable image data as described herein, such as image data from one or more of a first tissue or a second tissue. In some embodiments, the image data includes image data from a first tissue. Alternatively, or in combination, the image data may include image data from a second tissue, such as a bladder wall, as described herein. In some embodiments, first image data of the tissue acquired before probe placement is compared with second image data acquired after the probe is placed, and data from the comparison is combined with force sensor data to determine whether to adjust the probe.
[0073] The one or more sensors can be calibrated in many ways, but in some embodiments, the one or more sensors are calibrated to measure tissue traction forces exerted on the probe. Alternatively, or in combination, the sensors can be calibrated to measure compressive forces caused by tissue pressing against the probe, as described herein. In some embodiments, force sensor data from the one or more sensors is calibrated to provide a zero force reading when the probe is positioned on the arm in a freestanding configuration. The calibration data may include an offset value for the one or more sensor readings corresponding to the freestanding configuration. The calibration data may be stored in one or more components of the processor, as described herein. The calibration data may include one or more parameters for converting the sensor readings into force values corresponding to the amount of force exerted on the probe, such as the amount of force from the first component and the amount of force from the second component.
[0074] In some embodiments, one or both of the arms coupled to the treatment probe and the imaging probe may include one or more sensors for detecting tissue forces exerted on the one or more probes in response to placement of the one or more probes in tissue. In some embodiments, tissue traction exerted on the probe in response to placement of the probe is measured using one or more sensors located on one or more of the probe, handpiece, or instrument driver, such as a motor pack, as described herein. In some embodiments, tissue engaging the distal portion of the probe responds to placement of the probe with at least one force 850 corresponding to tissue stretching. The at least one force 850 may include one or more components, such as, for example, a force component pulling the probe distally from the handpiece or a radial force component, and combinations thereof.
[0075] 1 and 2 , one or more of the first 442 or second arms 444 may be operably coupled to a force sensor configured to detect tissue traction on one or more probes in response to probe placement. In some embodiments, the arm 442 is coupled to a motor pack 802. The arm 442 may comprise any suitable arm as described herein, such as, for example, a robotic arm or a manually positionable arm. The motor pack 802 may be coupled to a handpiece 804 of the probe 450 to move the probe with one or more wires as described herein.
[0076] Examples of robotic arms and linkages suitable for use in accordance with the present disclosure are described in International Application No. PCT / US2020 / 021756, filed March 9, 2020, entitled "ROBOTIC ARMS AND METHODS FOR TISSUE RESECTION AND IMAGING," published as WO 2020 / 181290, and International Application No. PCT / US2019 / 038574, filed June 21, 2019, entitled "ARTIFICIAL INTELLIGENCE FOR ROBOTIC SURGERY," published December 26, 2019, as WO 2019246580, the entire disclosures of which have been previously incorporated herein by reference.
[0077] According to some embodiments, one or more X-direction force sensors 810, one or more Y-direction force sensors 812, and / or one or more Z-direction force sensors 814 may be provided on the robotic arm 442, the handpiece 804, and / or the probe 450.
[0078] In some embodiments, the handpiece 804 and treatment probe 450 are sterile and configured for single use, while the motor pack 802 and arm 442 comprise non-sterile, reusable components. The handpiece 804 may comprise a linkage for moving the energy source by rotation and translation, for example, as described herein. The sensors for measuring the force on the probe 450 may comprise, for example, one or more sensors located on the motor pack 802 that connect to the arm 804. In some embodiments, one or more X-direction force sensors 810, one or more Y-direction force sensors 812, and one or more Z-direction force sensors 814 are located where the motor pack 802 connects to the arm 442. In some embodiments, the sensors comprise one or more load cells. The sensors may comprise calibrated sensors for measuring tissue force on the probe 450. The sensors can be configured in many ways, but in some embodiments, one or more X-direction force sensors 810 and one or more Y-direction force sensors 812 are configured to measure radial forces in response to tissue traction on the arms, which may include a moment, and the Z-direction force sensor is configured to measure forces along the axis 451 of the probe 450, for example.
[0079] The one or more force sensors may comprise, for example, a strain gauge, a pressure sensor, or a piezoelectric transducer. In some embodiments, the strain gauge comprises any of several configurations of a Wheatstone bridge. A Wheatstone bridge circuit converts small changes in resistance into a measurable voltage difference, which can be equal to the applied force. The force sensor may be coupled to a handpiece, such as any of the handpiece embodiments described herein. In some cases, the one or more force sensors are operably coupled to the imaging probe, the treatment probe, or both.
[0080] In some embodiments, the circuitry for operating the force sensor is insulated and separated from the imaging probe and the treatment probe. This allows the probe to meet any patient leakage current requirements and reduces any noise picked up by the probe, thus improving the signal-to-noise (S / N) of the force sensor. In some embodiments, the signal wires from the force sensor may be twisted together and, if necessary, shielded to maintain signal integrity, improve robustness, and maintain a sufficient S / N ratio. The force sensor may be formed from any suitable material, and in some cases, from a biocompatible material for the portion of the sensor that may come into contact with the patient before, during, or after treatment.
[0081] In some embodiments, one or more force sensors are sized to fit on or within a probe shaft, such as an imaging probe shaft or a therapy probe shaft. The force sensor may be configured with any suitable strain sensitivity "k," which is the proportionality coefficient between relative changes in resistance. Strain sensitivity is dimensionless and is a number called the gauge factor ("GF"). Linear pattern strain gauges may be used to measure unidirectional strain on a handpiece. Conductive signal wires may be bonded to the sensor pads, which carry the signal to an input amplifier. One or more sensors may be bonded to one or more probes on a carrier substrate that may insulate the sensor from any metal in the probe, such as a metal probe shaft.
[0082] Displacement of the handpiece in the Z direction can be detected by a spring and sensor 814. This configuration can be used to slide the entire probe assembly a suitable distance to protect against the probe being pushed into the tissue wall. The probe assembly can be arranged on a sliding carriage 820 that can bounce against a simple spring to provide a constant, known force "K" spring constant. Precise distance measurements of the handpiece, such as the displacement of the carriage, are possible over short distances, such as less than 2 inches, with a suitable arrangement. Other position encoder linear sensors may be used in combination or as an alternative. For example, a linear variable differential transformer (LVDT), an electromechanical sensor used to convert mechanical motion into a variable current, can be used to measure the resistance to the probe's insertion force. An optical encoder or any of several suitable inductive linear encoders can be used. The sensor can measure force based on an inductive linear encoder 824, which may be arranged contactless to ensure high reliability. A high-resolution encoder 824 may be provided for linear resolutions ranging from approximately 15 micrometers for a digital encoder to approximately 54 micrometers for an analog encoder.
[0083] One or more sensors may be provided on one or more robotic arms to measure position, orientation, force, or some other parameter. In some cases, two sensors may be part of the robotic arm assembly and utilized to determine unintended movement. These sensors may be internal encoders located on one or more joints of the robotic arm, or may be an inertial measurement unit (IMU) 822. An IMU is an electronic sensor device that measures and reports one or more parameters, such as force, angular velocity, and / or orientation of the sensor; a combination of accelerometers, gyroscopes, and / or magnetometers may be used. Some IMUs suitable for incorporation into one or more robotic arms may have a full-scale acceleration range of ±2 / ±4 / ±8 / ±16 g (the "g" value for acceleration due to gravity) and a wide angular velocity range of ±125 / ±250 / ±500 / ±1000 / ±2000 / ±4000 degrees per second ("dps"). An IMU can detect forces on a robotic arm and communicate the magnitude and / or direction of the external force to a computing device, such as a robotic control system. One or more IMUs 822 can provide feedback that can be used to control one or more robotic arms to compensate for vibrations, position awareness, and stabilization compensation.
[0084] As described herein, the arm 442 can dock with the probe 450 through the use of sensors to assist in one or more of coarse, medium, and fine positional alignment. For example, the probe may be associated with a beacon 830, such as an IR beacon, and the robotic arm 442 may carry an IR receiver 832 that can detect emissions from the IR beacon 830 for coarse alignment. One or more alignment datums 834 may be associated with the probe 450, and one or more alignment sensors 836 may be associated with the robotic arm 442. The alignment sensors 836 can detect the positions of the alignment datums and thus determine the position of the robotic arm 442 relative to the probe 450, as described herein. In some embodiments, a proximity sensor, such as a Hall Effect sensor or a proximity switch, can be used to detect alignment between the probe and the arm, for example, to engage the probe with the arm and latch the probe to the arm when the arm is manipulated into a suitable position.
[0085] In some embodiments, once treatment is complete, the user can detach the arm from the probe while holding the probe, and the arm will be pulled away from the probe, for example automatically pulled away from the probe.
[0086] In some embodiments, first arm 442 and second arm 444 comprise robotic arms, for example, as shown with reference to Figures 1 and 2. One or more computing devices operably coupled to the robotic arms (such as a processor of console 420 or console 490 as described herein) may include instructions for controlling movement of the robotic arms in response to forces detected by the sensors, for example, to prevent excessive compression or stretching of the anterior tissue and resulting tissue and / or probe damage. In an exemplary use case of the treatment system for prostate tissue ablation, the treatment probe is ideally positioned anteriorly and centrally in the patient's prostatic cavity, but without excessively compressing the anterior prostate gland to prevent inadvertent damage to the urethra / prostate (e.g., excessive tissue bleeding, necrosis, perforation) and / or damage to one or both of the imaging and treatment probes. Similarly, the imaging probe, which may be a TRUS probe, is ideally positioned within the patient's rectum with sufficient anterior compression to observe the prostate and the treatment probe, but without excessively compressing the tissue to avoid inadvertent damage to the rectum (e.g., tissue bleeding or perforation) and / or damage to either or both of the imaging and treatment probes. The treatment probe, the first robotic arm coupled thereto, the imaging probe, and / or the second robotic arm coupled thereto 444 may be provided with force sensors configured to detect anterior compression or stretching of tissue by the probe. The detected force level may be communicated to a processor operably coupled to the robotic arms and compared to a force threshold preprogrammed or stored in the computing system's memory. If the detected force exceeds the threshold, the movement of the robotic arm may be adjusted to move the probe away from the anterior tissue, thereby at least partially relieving the anterior tissue compression or stretching.
[0087] 9A-10 illustrate user interfaces that can be used to adjust tissue treatment of a first tissue based on the response of a second tissue to treatment of the first tissue. The adjustments can be performed, for example, by a user, automatically by processor instructions, or a combination thereof, and the user can view a modified treatment plan, such as a modified treatment profile, overlaid on an image.
[0088] 9A-9C show user interface screens of the system having one or more transverse images of tissue and a treatment profile.
[0089] 9A, there is illustrated a user interface 1700 that can be used with the devices and methods described herein. The user interface 1700 may include two main areas, such as a command area 1702 and a control area 1704. The layout of the illustrated user interface 1700 is exemplary, and any suitable layout or arrangement of information and control inputs may be utilized without departing from the scope of the present invention.
[0090] In instruction area 1702, a user of the system may be alerted and / or prompted for the next treatment step in the sequence of steps. For example, as shown, instruction area 1702 indicates that an imaging device, such as a TRUS probe, is scanning the tissue of one or more organs, such as the prostate, within scanning window 1706. Scanning window 1706 may display the area of the anatomical structure being scanned or to be scanned for the current treatment step, as described below. The views provided include cross-sectional views of the tissue of an organ, such as the prostate, although other views, such as longitudinal and sagittal views, may also be displayed, as described herein.
[0091] The anatomy selection window 1708 provides the user with the ability to select the portion of the anatomy for which to establish a treatment profile. As shown, the user has selected "prostate" as the portion of the anatomy for which to establish a treatment profile.
[0092] In some embodiments, the safety and efficacy parameter window 1750 displays values of one or more safety or efficacy parameters as described herein for a subject in response to the ablation profile and ultrasound image. For example, efficacy value X may include one or more of a target efficacy value or efficacy values determined in response to the ablation profile and the structure of the image. For example, window 1750 may display a target efficacy value determined for a patient in consultation with the patient, as well as a predicted efficacy value generated in response to the ablation profile and the image. Window 1750 may display a target safety value determined for a patient in consultation with the patient, as well as a predicted safety value generated in response to the ablation profile and the image. These values may be determined in real time in response to a treatment profile, such as an ablation profile, and the structure of an image, such as an ultrasound image, shown on the display. The safety parameter may include a value X, and the efficacy parameter may include a value Y.
[0093] As the user adjusts the ablation profile, the X and Y values shown on the display may change. The processor may be configured with instructions for generating an initial ablation profile in response to the ultrasound image and target safety and efficacy values that may have been previously agreed upon by the patient and physician. This initial ablation profile may be provided on the display and adjusted by the user.
[0094] Once a portion of the anatomy is selected, an image corresponding to the selected portion of the anatomy 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 is placed adjacent to the patient's prostate to provide real-time imaging of that area. In the control area 1704 of the user interface 1700, the user can specify the area to be treated. The system is programmed with defaults that help the user select an appropriate treatment plan. For example, if the user selects the prostate, as shown, the control window 1704 initially displays an arc 1710 having an angle 1712 and a radius 1714. The arc 1710 defines a tissue ablation profile in which the area of treatment within the arc 1710 is treated and the area outside the arc 1710 is excluded from treatment. Arc control handles 1716a, 1716b are provided, allowing the user to control each leg of the arc 1710 to adjust the angle 1712. The display indicates the selected angle 1712 and can be used to precisely adjust the angle 1712 to define the appropriate treatment area. The ablation profile initially shown on the display may include 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 to treat the affected area. In some cases, the treatment probe is rotated about its longitudinal axis to direct the treatment energy as described herein. Thus, the treatment area resembles the arc 1710 with a radius 1714 commensurate with the energy intensity. Once the arc control handles 1716A, B are adjusted to define the tissue ablation profile and treatment area, the settings are stored for later use during the procedure and control the degree of rotation of the treatment probe during ablation with energy delivery.
[0095] The user interface 1700 may include a user input 1760 for a user to select parameters of the model used to determine values for one or more of the safety and efficacy parameters disclosed herein. This selection of parameters allows the user to filter out parameters that may be more useful than others and to eliminate parameters that may be less useful than others for a particular patient. For example, if the user believes that a parameter such as age is less useful in predicting outcome, the user can deselect that parameter as an input to the classifier model used to predict outcome. Alternatively, if the user believes that age is a useful parameter, the user can select age as the parameter to be used as an input to the classifier model.
[0096] The user interface 1700 may include a user input 1770 that allows the user to select data to be shown on the display. The data shown on the display may include, for example, visualization data. In some embodiments, the user can select whether to show a proposed treatment profile on the display overlaid with the patient's planned treatment profile after user adjustments. This may be useful for the user to determine how much the patient's planned treatment profile deviates from the profile suggested by the algorithm. The user can select additional types of visualization data to be shown on the display. For example, the user can select the planned trajectory of the energy source for the treatment.
[0097] Referring to FIG. 9B , user interface 1700 shows that a different portion of the anatomy has been selected in an anatomy selection window 1708 within command area 1702. In some embodiments, the different portions of the anatomy correspond to different lateral image locations along a longitudinal or sagittal image, as described herein. As shown, the middle lobe has been selected as a treatment area within anatomy selection window 1708, and control area 1704 has been updated to show imaging, such as one or more lateral images, associated with the middle lobe anatomy. In some embodiments, the one or more images include a series of lateral images, such as a series of real-time images. As previously described, control area 1704 overlays a display of an ablation profile defined by a treatment boundary including an arc 1710. Arc 1710 is customizable by a user manipulating arc control handles 1716A, B, and, optionally, by specifying a radius 1714. Arc 1710 defines an ablation profile and an area of treatment, allowing different ablation profiles and treatment areas to be provided for different anatomical areas. For example, as shown, command area 1702 allows a user to select between the prostate, bladder neck, and median lobe within an anatomy selection window 1708. In some embodiments, a transverse ultrasound image is provided at each location corresponding to the selected tissue. Window 1750 can display a safety parameter X and an efficacy parameter Y, whose values can change in real time, for example, as the user adjusts the ablation profile.
[0098] Similar to the prostate setting, once the middle lobe anatomical structure is selected, an image of the treatment area is shown in control area 1704, such as by a TRUS probe properly positioned to image the anatomical feature of interest, and the user can specify the treatment area for this anatomical feature. Multiple ablation profiles and corresponding treatment areas established by the user can be entered into a user interface provided by the computer, which can store the treatment plan for execution by the surgeon, either by human manipulation of the energy source or by automatic movement of the energy source under processor control using one or more linkages according to the treatment profile as described herein.
[0099] In some embodiments, the processor is configured with instructions for adjusting the treatment profile based on the response of a second tissue to the treatment of the first tissue. In some embodiments, the arc 1710 is adjusted in response to imaging data of a second tissue, such as the trigone of the bladder. For example, if the imaging data during treatment indicates that the second tissue is receiving a greater amount of energy from the treatment of the first tissue than would be useful, the arc can be decreased. Alternatively, or in combination, the radial distance of the treatment profile from the apex 1718 can be adjusted to decrease in response to imaging data from a second tissue, such as the trigone, indicating that the second tissue received a greater amount of energy from the treatment of the first tissue than would be useful. While these adjustments can be performed manually by a user, in some embodiments, the processor is configured with instructions for outputting the adjusted profile. The adjusted profile may be overlaid on a screen for the user to receive, accept, or adjust the adjusted treatment profile with user input, as described herein.
[0100] Referring to FIG. 9C , a user interface 1700 is shown. As shown, in the anatomy selection window 1708, the prostate gland is selected, and the control area 1704 shows real-time imaging data for the selected anatomy. The anatomy selection window 1708 has also been updated to select an option labeled "Adjust Veru Protection Zone" 1720. This refers to a treatment plan designed to protect the verum tanum ("veru") from aggressive ablation. The veru protection zone can be configured in many ways and may include, for example, a butterfly cut profile. In some embodiments, the treatment profile is configured to avoid ablation of tissue at an angle corresponding to the veru protection zone, so as to define a butterfly cut. While referring to the veru protection zone, the protection zone may also include one or more protection zones to protect delicate tissue structures of a second tissue as described herein, such as an ocular tumor or the retina. In some embodiments, the verum tanum 1725 is visible in the lateral image. In some embodiments, Vermontanum is identified with one or more image processing algorithms of an artificial intelligence algorithm as described herein, such as, for example, a convolutional neural network.
[0101] As shown, when the "Adjust Protection Zone" 1720 radio button is selected, a new overlay appears over the control area 1704, defining a veru arc 1722 that is a portion of arc 1710. The veru arc 1722 may share an apex 1718 and a length of radius 1714 with arc 1710. In some embodiments, the radius of arc 1722 is adjusted by the user to decrease the radius of the treatment depth, such as the ablation depth, to reduce the potential for damage to the verum tanum. For example, the depth of treatment of prostate tissue of a first tissue, such as benign prostatic hyperplasia tissue, may be adjusted to reduce the potential for damage to a second tissue, such as the verum tanum ("veru"). In some embodiments, the penetration depth of the tissue ablation profile corresponds to a substantially zero ablation depth within the veru protection zone, although any suitable radial depth from the energy source near the apex may be used. In some embodiments, the user adjusts the penetration depth along arc 1722 to a second location 1727 of reduced depth to reduce the likelihood of potential damage to the veru. In some embodiments, the radial distance from apex 1718 to second location 1727 is adjusted automatically. In some embodiments, the distance is adjusted during treatment, for example automatically or manually, in response to image data of the veru while tissue at another location is being treated as described herein.
[0102] The veru arc 1722 includes a treatment profile that defines an area associated with the veru protection zone 1724. In prostate surgery, as described herein, there may be a risk / benefit trade-off between treatment effectiveness and male sexual function. The aggressiveness of prostatectomy treatment is related to proximity to the vermontanum. Removing tissue near the vermontanum can increase the effectiveness of prostate treatment for benign prostatic hyperplasia. However, the risk of male sexual dysfunction may also increase. A window 1750 providing safety and efficacy parameters may be useful to the user for adjusting the patient's treatment profile to accommodate target safety and efficacy metrics. Similar metrics and adjustments may be provided for other tissues as described herein, such as the bladder trigone and urinary function metrics.
[0103] In some embodiments, the verumtanum is an anatomical landmark near the entrance of the ejaculatory duct into the urethra and may also be called the verumontanum. The verumtanum structure consists of striated muscle fibers of the external sphincter interwoven with smooth muscle tissue from the urethral wall. Some of the embodiments described herein enable targeted, specific treatment of prostate tissue adjacent to the verumtanum. According to the embodiment illustrated in FIGS. 9A-9C, a user can specify ablation profile treatment plans for various areas of a first tissue of a first organ, such as the prostate. For example, a treatment plan can be created that includes specific treatments and profiles for each of the prostate, bladder neck, and middle lobe, as well as specific plans and profiles for the verumtanum area. In some embodiments, specific treatment plans and profiles are developed for the middle lobe of the prostate and the bladder trigone region, which includes the intravesical prostate protrusion, using, for example, transverse images. The treatment profile of a first tissue, such as the middle lobe of the prostate, can be adjusted in response to image data from one or more images of a second tissue, such as one or more images of the verumtanum or the prostate.
[0104] The user can adjust the ablation profile in response to safety and efficacy parameters presented on the display.
[0105] While Figures 9A-9C refer to a display coupled to a surgical system, in some embodiments, similar images and user inputs can be used for remote treatment planning and pre-planning at a remote location away from the surgical instrument, such as in another room or building, which may be in another state or country. A processor can be configured with instructions to allow a user to plan a treatment, and these parameters can be stored and loaded into the processor of the surgical system. For example, diagnostic images of a patient can be generated prior to treatment, such as in an imaging laboratory. The images can be shown on a display to a user on a mobile device, and the user can adjust the treatment profile and other aspects of the treatment. Once accepted, the treatment parameters, e.g., an ablation profile, can be loaded into the surgical instrument.
[0106] 10 shows a user interface screen of the system with a longitudinal (e.g., sagittal) image of tissue and a treatment profile. In some embodiments, user interface 1800 shows a longitudinal (e.g., sagittal) view of the treatment area with anatomically distal organs on the left side of the view. The user interface may include a transverse interface 1700 and a longitudinal (e.g., sagittal) interface 1800 to plan the treatment profile in three dimensions for 3D volumetric tissue removal. This screen displays information from a previously entered treatment plan, such as the rotation angle of the treatment probe 1802, which is 135 degrees in this example, and the ablation depth 1804, which is 24.3 mm in the illustrated example, although any suitable values may be used.
[0107] The user interface 1800 allows for further refinement of the treatment plan by manipulating a 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, such as through one or more algorithms performed on ultrasound imaging, such as image analysis, feature recognition, edge detection, or some other algorithm or combination of algorithms for detecting recommended boundaries of anatomical features and / or ablation profiles and treatment areas.
[0108] The system can present an overlay of information on the ultrasound imaging information, which may include anatomical parts of the organ, instructions, ablation profiles, and other information. In the illustrated user interface 1800, the overlay identifies areas corresponding to a middle lobe region 1810, a bladder neck region 1812, and a mid-prostate region 1814. Each of these identified regions may have a different treatment plan associated with it. For example, the middle lobe region 1810 may have a specified ablation angle, ablation depth, and tissue ablation translation distance that may differ from the treatment plan specific to the bladder neck region 1812 and may also differ from the treatment plan for the mid-prostate region 1814.
[0109] The processor can be configured not only to recognize the tissue structure of various anatomical regions but also to store information regarding recommended and selected treatment plans for each region. For example, information from previous surgeries can be stored in a database corresponding to one or more treatment plans for individual organs or portions of individual organs. This information from previous surgeries 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 including multiple tissue ablation profiles. The recommended ablation profiles can be generated and presented on the display along with predicted safety values X and Y in window 1750. When a treatment plan including multiple ablation profiles is modified by the user, the processor can receive the modified treatment plan, ablation profiles, and ultrasound images and use the trained classifier or neural network to generate updated safety and efficacy parameters shown on display 1750. The trained classifier or neural network can also receive as input patient information such as age, height, weight, symptoms, and other information as described herein when determining the values of the safety and efficacy parameters and generating the treatment plan.
[0110] The user interface 1800 may include controls to allow a user to adjust the treatment plan. For example, a treatment start control 1816, a treatment end control 1818, and a veru zone start control 1820. Any of these controls may be manipulated by the user to modify the ablation profile of the treatment plan. For example, the user may move one or more of the controls to modify the ablation profile, such as by modifying the ablation depth, the location of the ablation start control 1816, or the location of the veru zone start control 1820. Changes made by the user in the user interface 1800 are stored in the memory of an associated computing system for later or concurrent execution during the procedure. In some cases, the procedure is performed by a robotic device that performs the procedure according to ablation boundary limits.
[0111] The user interface 1800 further has informational and / or educational components, such as a procedure walkthrough area 1822 that provides guidance to a user of the system. For example, as shown, the procedure walkthrough 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 TRUS probe 1826.
[0112] The treatment walk-through area further includes creating and / or modifying a treatment plan, such as by providing the user with an opportunity to input and / or modify resection angles 1830, treatment probe registration 1832, and cutting profiles 1834.
[0113] 10 , the setup steps have been completed for the treatment, as indicated by the check marks next to handpiece 1824, TRUS 1826, alignment 1828, angle 1830, and registration 1832. At this stage in the illustrated example, the user still has to complete adjustments to profile 1834. Once the setup and planning steps in user interface 1800 are complete, the user can indicate they are ready to begin treatment by selecting treatment icon 1836, at which point the system may autonomously begin treatment according to the treatment plan.
[0114] Once treatment begins with a treatment profile, the user may make additional adjustments to the treatment profile based on the response of a second tissue to the treatment of the first tissue, as described herein. In some embodiments, the user adjusts the treatment profile from a first treatment profile to a second treatment profile via one or more controls of the user interface. For example, the first treatment profile 1010 may be adjusted to a second treatment profile 1020, and the patient may then be treated with the second treatment profile 1020. In some embodiments, the treatment profile for a first tissue, such as the middle lobe of the prostate, is adjusted relative to a second tissue, such as the bladder wall 522 and trigone tissue 525, although adjustments may be made for any first and second tissues as described herein. In some embodiments, the treatment profile is adjusted relative to profile 526, such as the profile of the bladder inner wall.
[0115] In some embodiments, the first treatment profile includes a first closest distance to the second tissue, the first closest distance defining a first gap between the first treatment profile and the second tissue, and the second treatment profile includes a second closest distance to the second tissue, the second closest distance defining a second gap between the second treatment profile and the second tissue. The first gap may have a different length than the second gap, for example. Referring again to the example shown in FIG. 10 , the first treatment profile 1010 may define a first closest distance to the trigone tissue 524, and the second treatment profile 1020 may define a second closest distance to the trigone tissue 524, the second distance being greater than the first distance. By adjusting the gap distance, the effect of the treatment of the first tissue on the second tissue can be adjusted accordingly. While reference is made to adjustments being made on a user interface, in some embodiments, the adjustments are made automatically by a processor, for example, using appropriate instructions. In some embodiments, the second profile is presented to the user on a display of the user interface for acceptance and modification, and the user has the option of either accepting the first presented processor-generated second profile or modifying the presented second profile and then accepting the user-modified profile.
[0116] Although reference is made to an image-based treatment plan and adjusting a treatment profile based on the image, other approaches are used. In some embodiments, one or more tissue markers can be mapped with another device, such as an endoscope or tissue sensor configured to detect anatomical structures or tissue transitions. Based on the reference anatomical data, the location of the second tissue can be determined based on the location of the reference anatomical marker. In some embodiments, one or more visual markers are identified by the endoscope, and the treatment plan is adjusted by the user in response to the one or more visual markers. The location of the visual markers can be used to estimate the location of the second tissue, such as trigone tissue. In some embodiments, the external sphincter of the urethra is visible from the endoscopic image, and the location of the second tissue, such as the trigone, is estimated from the location of the visual marker, such as the external sphincter. In some embodiments, the tissue marker includes, for example, the bladder opening into the urethra, which can be seen with an endoscope. Although reference is made to determining the location of the bladder opening into the urethra using an endoscope, other methods and devices can also be used. In some embodiments, the urethral opening into the bladder is measured, for example, with one or more of optical measurements, ultrasound, or electrical impedance measurements. In some embodiments, the markers are measured using an impedance probe with two or more electrodes, and the location of the markers corresponds to, for example, a change in impedance. In some embodiments, as the probe passes from the urethra to the opening of the bladder, less tissue engages the electrodes in the opening to the bladder, thereby causing a change in impedance.
[0117] In some embodiments, the handpiece includes one or more markers, such as depth markers, to indicate the location of the energy source or tissue mapping probe. In some embodiments, this information of the depth of the energy source can be used along with other data to determine when the energy source is near a second tissue, such as the trigone. In some embodiments, the handpiece is configured to move the tissue mapping probe in a calibrated translation to determine the depth of the tissue marker, for example, to estimate the location of the second tissue.
[0118] The treatment profile can also be adjusted in response to cancerous tissue, such as a tumor. Research related to the present disclosure suggests that approximately 80% of prostate cancer cases have cancer in the peripheral zone of the prostate, and approximately 20% of prostate cancer cases have cancer located in the transition zone of the prostate. As described herein, the treatment profile can be adjusted in response to, for example, the shape profile of the tumor. In some embodiments, the shape profile is adjusted to selectively treat cancerous regions. Alternatively, the shape profile can be adjusted to reduce the interaction between the energy source and the cancerous region.
[0119] In some cases, the treatment plan may be stored in a database along with other treatment plans and may include data about the patient and the treatment plan, such as the patient's age, weight, height, symptoms, duration of symptoms, diagnosis, previous treatment history, treatment effectiveness, medication history, etc. Previous treatment plans may include data such as angles and ablation profiles of multiple previous treatments for multiple patients and may be stored as previous treatment plan data.
[0120] The past treatment plan data may be analyzed by one or more suitable algorithms, such as those described herein, such as one or more of an artificial intelligence algorithm, supervised machine learning, unsupervised machine learning, a neural network, or a convolutional neural network. In some cases, the past treatment plan data may be analyzed by one or more machine learning algorithms and used to train a classifier. For example, a neural network may analyze the past treatment data to provide a recommended treatment plan for one or more current patients. For example, based on the past treatment data, a neural network may be used to build, train, and deploy a machine learning model, including preparing and labeling the past treatment data, selecting an algorithm, training the model, validating the model, adjusting and optimizing the model, deploying the model, making predictions regarding future treatment plans, and providing treatment plans for current or future patients.
[0121] In some cases, artificial intelligence algorithms such as convolutional neural networks may be implemented to analyze visual data, such as ultrasound imaging from a TRUS probe, and provide feedback to feed into machine learning models. Visual data analysis may include identifying anatomical features along with associated location, size, shape, health, and other information.
[0122] A processor as described herein can be configured with instructions for providing user interfaces, images, and windows, e.g., as described herein with reference to Figures 9A-10. Alternatively, or in combination, the processor can be configured with instructions for adjusting a treatment profile of a first tissue in response to image data from a second tissue, as described herein. In some embodiments, the processor is configured with instructions for overlaying a proposed, modified treatment profile onto an image of the tissue, prompting the user to accept or modify the treatment profile, and then completing the treatment in response to the modified treatment profile.
[0123] FIG. 11 illustrates a method 1100 of treating a first tissue and adjusting the treatment based on a response of a second tissue to the treatment of the first tissue.
[0124] In step 1105, a treatment probe is inserted into the patient to treat a first tissue of the patient. In some embodiments, the treatment probe comprises an energy source. The energy source may include, for example, one or more of an electrode, a loop electrode, a laser source, a mechanical energy source, a mechanical shear, an ultrasound probe, a cavitation ultrasound probe, a water jet, e.g., a fixed pressure water jet, a plasma source, a vapor source, a morcellator, a transurethral needle, a photoablation source, a radiation energy source, a microwave energy source, or a water jet ejection source.
[0125] In step 1110, an imaging device is positioned to image the second tissue and the first tissue. The imaging device may include one or more of an ultrasound transducer array, an external ultrasound transducer array, an ultrasound transducer array on a probe with an energy source, an ultrasound probe, an elongated ultrasound probe sized for placement within a lumen, a transrectal ultrasound probe, a transvaginal ultrasound probe, magnetic resonance imaging, a magnetic resonance probe, an endoscope, or a fluoroscopic imaging device.
[0126] In step 1115, the first tissue and the second tissue are imaged separately, together, or a combination thereof. In some embodiments, the image data includes a series of real-time images. While any suitable acquisition and frame rate can be used, in some embodiments, the series of real-time images includes a frame rate of at least 1 Hertz and a latency of 1 second or less from the time imaging energy is emitted from the imaging device until the image is shown on the display.
[0127] In step 1120, one or more tissue structures of the first tissue are identified and associated data, such as shape data or contrast data, is generated. The associated data may include any suitable data generated by any suitable algorithm as described herein.
[0128] In some embodiments, the anatomical structure of the first tissue structure comprises one or more of a tissue wall, a vesicle, a lumen, a wall of a lumen, a bladder, a wall of the bladder, a bladder neck, a wall of the bladder neck, a ureteral orifice, an internal urethral orifice, an external urethral sphincter, a ureter, a wall of a ureter, a prostate, a lobe of the prostate, an intravesical prostatic protrusion, a capsule of the prostate, an internal and external sphincter, an artery, a wall of an artery, a vein, a wall of a vein, or a lens of an eye.
[0129] In step 1125, one or more tissue structures of the second organization are identified and associated data is generated, which may include any suitable data generated by any suitable algorithm as described herein.
[0130] In some embodiments, the first tissue comprises a first tissue structure, and the second tissue comprises a second tissue structure different from the first tissue structure. The second tissue structure may comprise any suitable tissue, such as one or more of connective tissue, muscle tissue, epithelial tissue, muscular tissue, or an anatomical structure associated with contrast in the image data. In some embodiments, the second tissue structure comprises a second type of tissue adjacent to a third type of tissue or fluid to provide contrast to the image data from the second tissue structure. The fluid may comprise a liquid, such as urine.
[0131] In some embodiments, the anatomical structure of the second tissue structure comprises one or more of a tissue wall, a vesicle, a lumen, a wall of a lumen, a bladder, a wall of the bladder, a neck of the bladder, a wall of the bladder neck, a trigone tissue, a ureteral orifice, an internal urethral orifice, an external urethral sphincter, a ureter, a wall of a ureter, a prostate, a lobe of the prostate, an intravesical prostatic protrusion, a capsule of the prostate, a vermont of the prostate, an internal and external sphincter, an artery, a wall of an artery, a vein, a wall of a vein, and a retina of an eye.
[0132] In some embodiments, the first tissue includes tissue of a first organ and the second tissue includes tissue of a second organ different from the first organ, and the processor is configured to process image data from the tissue of the second organ and output data corresponding to a response of the second tissue to an energy source directed at the tissue of the first organ.
[0133] In some embodiments, the second tissue structure includes a tissue wall facing the first tissue structure, and one or more of the treatment profile, the movement of the energy source, or the energy source are adjusted in response to image data from the tissue wall. The image data from the tissue wall may include, for example, one or more of a shape profile of the tissue wall, a contrast of the tissue wall, a blur of the tissue wall, a movement of the tissue wall, a deflection of the tissue wall, or a distortion of the tissue wall.
[0134] In step 1130, a three-dimensional treatment profile is generated. The three-dimensional treatment profile may include, for example, a three-dimensional treatment profile with associated transverse and longitudinal (e.g., sagittal) images as described herein. The transverse and longitudinal (e.g., sagittal) images may be generated by a user manipulating an imaging probe, such as an ultrasound probe, and capturing transverse images at appropriate locations corresponding to the anatomical structures described herein. Alternatively, or in combination, the associated transverse and longitudinal (e.g., sagittal) images may include 3D images, such as 3D images from a 3D ultrasound probe or other 3D imaging device configured to generate transverse images at predetermined distances along the tissue. In some embodiments, the 3D images include tomographic images.
[0135] In some embodiments, the corresponding movement of the energy source and the amount of energy from the energy source are determined to treat tissue according to a treatment profile, e.g., to ablate tissue to a treatment profile described herein. The energy source can be configured, for example, with one or more of an amount of energy, power, irradiance profile, flow rate, or pressure. The movement of the probe can be configured to provide corresponding rotational and translational movements, such as velocities, to treat tissue according to the treatment profile, e.g., to ablate tissue to a depth of the treatment profile.
[0136] In step 1135, the three-dimensional profile is output to a display of a user interface and overlaid on an associated image, such as one or more of the transverse or longitudinal (eg, sagittal) images described herein.
[0137] In step 1140, the three-dimensional treatment profile is adjusted in response to user input.
[0138] In step 1145, energy from the energy source is directed to the first tissue to treat the first tissue. The energy source may be selectively directed to the first tissue and the second tissue by moving the energy source as described herein, such as by one or more of rotating the energy source or translating the energy source. In some embodiments, energy from the energy source is scanned across the first tissue at a scanning rate, and the second tissue moves according to the scanning rate. In some embodiments, the scanning rate includes an angular sweep rate, and the second tissue moves according to the angular sweep rate, whereby the movement of the tissue corresponds to the angular sweep rate. In some embodiments, the energy source comprises a mechanical energy source, such as a water jet, and the tissue moves according to the sweep rate of the water jet. The sweep rate of the energy source may include any suitable sweep rate, but in some embodiments, the sweep rate is within a range of about 1 Hz to about 20 Hz, and the angle of each sweep is within a range of about 20 degrees to about 180 degrees.
[0139] In step 1150, the first tissue is imaged while the energy source treats the first tissue. In some embodiments, the treatment probe is coupled to a first linkage, and an imaging device, such as an ultrasound probe, is coupled to a second linkage. The energy source moves according to a treatment profile, and the imaging device moves with the energy source to maintain the second tissue or one or more of the second tissues within a field of view of the imaging device. In some embodiments, the processor is configured to move the imaging device synchronously with the energy source to maintain the second tissue within a field of view of the imaging device. Alternatively, the processor can be configured to move the imaging device asynchronously with the energy source to maintain the second tissue within a field of view of the imaging device, for example, by incremental movement of the imaging device. In some embodiments, the image data includes multiple lateral images of the treatment probe, the first tissue, and the second tissue, and the imaging device moves to maintain the energy source, the first tissue, and the second tissue within a lateral field of view of the imaging device.
[0140] In step 1155, image data from the image of the first tissue is processed. In some embodiments, the target tissue ablation profile of the first tissue is compared to the measured tissue ablation profile of the first tissue. The comparison of the target tissue ablation profile and the measured tissue ablation profile can be output, for example, from a software module of the processor to a display of a user interface.
[0141] In step 1160, while the energy source is treating the first tissue, the second tissue is imaged.
[0142] In step 1165, image data from an image of the second tissue acquired during treatment of the first tissue is processed.
[0143] In step 1170, the response of the second tissue to the treatment of the first tissue is determined. In some embodiments, the image data from the second tissue structure includes one or more of a shape profile of the second tissue structure, a contrast of the second tissue structure, a blur of the second tissue structure, a movement of the second tissue structure, a deflection of the second tissue structure, or a distortion of the second tissue structure. In some embodiments, the movement of the second tissue is measured in response to energy from the energy source, and one or more of the energy source, the movement of the energy source, or the treatment profile are adjusted in response to the movement of the second tissue.
[0144] In some embodiments, the response of the second tissue to the treatment of the first tissue is assessed by a difference between images taken at different times. In some embodiments, the image data from the second tissue structure includes a first image at a first time and a second image at a second time. The processor is configured to determine, based on the first image and the second image, a response to the energy source directed at the first tissue, which can be assessed, for example, by a change in one or more of the shape profile of the second tissue structure, the contrast of the second tissue structure, the blur of the second tissue structure, the movement of the second tissue structure, the deflection of the second tissue structure, or the distortion of the second tissue structure.
[0145] While any suitable image can be used, in some embodiments, the first image comprises a first longitudinal (e.g., sagittal) image, the second image comprises a second longitudinal (e.g., sagittal) image, and the probe comprises an elongated probe shown extending along the first longitudinal (e.g., sagittal) image and the second longitudinal (e.g., sagittal) image.
[0146] In step 1175, the treatment of the first tissue is correlated with the movement of the second tissue, for example, correlated with the sweep rate of the energy source directed at the first tissue. In some embodiments, the amount of movement of the second tissue corresponds to the sweep rate and is determined from the images. In some embodiments, the movement of the second tissue is correlated with the angular sweep rate of the energy source to determine the effect of the treatment of the first tissue on the second tissue.
[0147] In step 1180, data corresponding to the response of the second tissue to the treatment of the first tissue is output.
[0148] In step 1185, the data from the second organization is output to a user interface for evaluation by a user, such as a healthcare professional.
[0149] In step 1190, user input is received from the user interface, the input relating to output data of the second tissue, such as output data provided to a display of the user interface. In some embodiments, the processor outputs data to the user interface in response to image data from the second tissue, receives input from the user, and adjusts one or more of the treatment profile, movement of the energy source, or energy from the energy source in response to the input from the user. In some embodiments, a proposed, modified treatment profile is generated in the processor and overlaid with one or more images of the tissue described herein.
[0150] In step 1195, the treatment of the first tissue is adjusted based on the response of the second tissue to the treatment of the first tissue. The adjustment may include any suitable adjustment described herein. In some embodiments, the processor is configured to adjust one or more of the energy source or treatment profile of the first tissue structure in response to image data from the second tissue structure.
[0151] In some embodiments, the processor comprises a feedback loop component for adjusting one or more of the treatment profile, the movement of the energy source, or the energy from the energy source in response to image data from the second tissue. The processor can be configured to automatically adjust the treatment in real time. Alternatively, or in combination, the treatment can be adjusted in response to user input.
[0152] In some embodiments, the processor automatically adjusts one or more of the treatment profile, the movement, or the energy from the energy source in response to the image data from the second tissue.
[0153] Treatment can be adjusted in many ways, but in some embodiments the energy source is adjusted in one or more of the following: translation, rotation, translation, angular velocity, translational velocity, energy from the energy source, output from the energy source, pump power, laser power, or power.
[0154] In some embodiments, a first tissue is treated according to a treatment profile, and the treatment profile is adjusted in response to image data from a second tissue. For example, the first tissue can be treated according to a first treatment profile, and the first treatment profile is adjusted in response to image data from the second tissue to generate a second tissue profile.
[0155] In some embodiments, the processor adjusts the energy source in response to the image data from the second tissue to treat the first tissue with reduced interaction between the energy source and the second tissue. Alternatively or in combination, in some embodiments, the processor adjusts the energy source in response to the image data from the second tissue to treat the first tissue with increased interaction between the energy source and the second tissue.
[0156] In step 1199, the first tissue is treated with the adjusted treatment profile.
[0157] 11 illustrates a method 1100 for treating a first tissue and adjusting the treatment based on a second tissue's response to the treatment of the first tissue, according to an embodiment, although one skilled in the art will recognize many adaptations and variations. For example, steps can be performed in any order and may be performed at least partially simultaneously. Some steps can be omitted. Some steps can be repeated. Some steps can be combined. Some steps may include sub-steps of other steps.
[0158] 12 illustrates a method 1200 of adjusting a probe disposed in a first tissue in response to stretching of a second tissue. In some embodiments, for example, the first tissue comprises tissue of a first organ and the second tissue comprises tissue of a second organ.
[0159] Image data from a first tissue of the subject and a second tissue of the subject is acquired in step 1205. The image data may include any suitable image data as described herein.
[0160] In step 1210, a probe is placed within a subject to treat a first tissue of the subject. The first tissue may include any suitable tissue as described herein. In some embodiments, the probe includes an energy source as described herein.
[0161] The position of the probe in the first tissue is fixed in step 1215. In some embodiments, the probe is supported on an arm, and the position of the arm is fixed as described herein.
[0162] In step 1220, image data is acquired from a first tissue of the subject and a second tissue of the subject while the probe is positioned in the subject to treat the first tissue. For example, the image data may be acquired while the probe position is fixed. The image data may include any suitable images and tissue structures as described herein, for example, an image of a wall of the second tissue.
[0163] In step 1230, the image data is processed to identify one or more tissue structures and associated shape data of the second tissue. The one or more tissue structures may include any suitable tissue structure as described herein. The associated shape data may include any data related to shape as described herein, such as, for example, shape profile data, deflection data, or sag height data related to the gradient of the tissue.
[0164] In step 1240, the image data is processed to generate data related to tissue stretching of the second tissue. The image data can be processed in any suitable manner, such as with an artificial intelligence algorithm such as a convolutional neural network, as described herein. In some embodiments, the shape data of the second tissue is compared to reference shape data of the second tissue, such as population reference data. Alternatively, or in combination, shape data from a first image of the tissue structure can be compared to shape data from a second image of the tissue structure to determine changes in the shape data. The first image can include an image before placement of the probe, and the second image can include an image with the probe placed in the first tissue.
[0165] Data related to tissue stretching is output at step 1250. The output may be provided to, for example, a software module or a user interface.
[0166] Data related to tissue stretching is output to a user interface at step 1260. In some embodiments, the output includes one or more of an alert, notification, or message to the user to adjust one or more of the angle, position, or attitude of the probe.
[0167] In step 1270, a probe movement within the first tissue is determined to reduce the stretch of the second tissue. In some embodiments, the movement may include a direction that reduces the stretch of the second tissue and may include movement that moves at least a portion of the probe generally toward the second tissue.
[0168] User input to adjust the probe is received in step 1275. In some embodiments, the proposed movement is provided to a user interface for the user to confirm, and the probe is moved by the robotic arm as described herein.
[0169] In step 1280, the placement of the probe in the first tissue is adjusted to reduce the stretch of the second tissue. The adjustment may include, for example, one or more of the placement, angle, location, or six degrees of freedom (6DOF) pose of the probe in response to data related to the stretch of the probe. The adjustment can be performed, for example, by manual manipulation by a user, a robotic arm, or combinations thereof. In some embodiments, the processor includes instructions, for example, to cause a first module to output data related to the stretch of the second tissue and a second module to receive data related to the stretch of the second tissue and adjust one or more of the angle, location, or 6DOF pose of the probe.
[0170] In step 1285, user input is received confirming the alignment of the probe at the first tissue, which in some embodiments is useful to ensure that the probe is properly aligned for treatment.
[0171] In step 1290, a first tissue of the patient is treated with the probe placement adjusted.
[0172] While FIG. 12 illustrates a method 1200 for adjusting a probe positioned in a first tissue in response to stretching of a second tissue according to an embodiment, those skilled in the art will recognize many adaptations and variations. For example, steps may be performed in any order and may be performed at least partially simultaneously. Some steps may be omitted. Some steps may be repeated. Some steps may be combined. Some steps may include sub-steps of other steps.
[0173] FIG. 13 illustrates a method 1300 for measuring forces associated with tissue traction on a probe and adjusting the probe in response to tissue traction on the probe.
[0174] In step 1305, sensor data is acquired from one or more sensors with the probe position fixed in a freestanding configuration. In some embodiments, this includes a calibration step. In some embodiments, the sensor data is pre-calibrated, for example, before the probe is placed on the patient.
[0175] In step 1310, a probe is placed within a subject to treat a first tissue of the subject.
[0176] The position of the probe in the tissue is fixed in step 1315. In some embodiments, the position of the probe is fixed before measuring the tissue traction on the probe.
[0177] In step 1320, sensor data is received from one or more sensors while the probe is coupled to the arm in a fixed configuration.
[0178] In step 1330, the sensor data is processed.
[0179] In step 1340, the sensor data is processed to generate data related to a first tissue traction on the probe.
[0180] In step 1350, data relating to tissue traction on the probe is output.
[0181] In step 1360, data relating to tissue traction on the probe is output to a user interface.
[0182] In step 1370, the movement of the probe is determined to reduce the tissue traction on the probe.
[0183] In step 1375, user input to adjust the probe is received.
[0184] In step 1380, the placement of the probe in the first tissue is adjusted to the force from the first tissue traction on the probe.
[0185] In step 1385, user input is received confirming adjustment of the probe at the first tissue.
[0186] In step 1390, a first tissue of the patient is treated with the probe placement adjusted.
[0187] While Figure 13 illustrates a method 1300 for measuring forces associated with tissue traction on a probe and adjusting the probe in response to tissue traction on the probe, according to an embodiment, those skilled in the art will recognize many adaptations and variations. For example, steps can be performed in any order and may be performed at least partially simultaneously. Some steps can be omitted. Some steps can be repeated. Some steps can be combined. Some steps may include sub-steps of other steps.
[0188] It is possible to combine any one or more of the steps of method 1100, method 1200, and method 1300. A processor as described herein can be configured to perform any one or more of the steps of method 1100, method 1200, or method 1300 in any suitable combination of steps. In some embodiments, sensor data related to traction of a first tissue on the probe is combined with image data from a second tissue, such as, for example, data related to stretching of the second tissue.
[0189] 14 illustrates artificial intelligence ("AI") algorithms suitable for incorporation according to embodiments of the present disclosure. In some embodiments, the artificial intelligence algorithms include, for example, one or more of image enhancement, image segmentation, neural networks, convolutional neural networks, Transformers, Transformer machine learning models, supervised machine learning, unsupervised machine learning, edge detection, feature recognition, segmentation, 3D model reconstruction, or multi-modality image fusion.
[0190] In some embodiments, the AI algorithm includes a two-dimensional convolutional neural network (CNN) 2100. In some embodiments, the AI, such as a CNN, is configured to identify one or more tissue structures of one or more tissues, process images to identify the tissue structures, and determine the tissue's response to treatment. The tissues may include a first tissue or a second tissue, or a combination thereof, as described herein. A dataset 2102 is first provided, which may include images from previous treatment data from previous patients and treatments. A convolution operation 2104 results in data in a second dataset 2106, which then has a pooling layer 2108 applied to result in a pooled layer 2110 of sub-sampled data to further condense the spatial size of the representation. The sub-sampled data may be convolved 2112 to produce a third dataset 2114, which may further have a pooling layer 2116 applied to provide sub-sampled data 2118. The subsampled 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 to each convolutional layer to provide different types of feature extraction. After a 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, such as by using historical processing data as training data, and validated according to the model's predictions until the model's predictions converge with the real data.
[0191] The trained model can be configured in many ways, but in some embodiments, the trained model is configured to identify tissue structures and output one or more evaluation metrics associated with the tissue structures, such as one or more of shape data or movement data, as described herein.
[0192] As described herein, the computing devices and systems described and / or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions, such as those contained within the modules described herein. In their most basic configurations, these computing devices may each include at least one memory device and at least one physical processor.
[0193] As used herein, the term "memory" or "memory device" generally refers to any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one example, a memory device may store, load, and / or maintain one or more of the modules described herein. Examples of memory devices include, but are not limited to, random access memory (RAM), read-only memory (ROM), flash memory, hard disk drive (HDD), solid-state drive (SSD), optical disk drive, cache, one or more variants or combinations thereof, or any other suitable storage memory.
[0194] Additionally, as used herein, the term "processor" or "physical processor" generally refers to any type or form of hardware-implemented processing unit capable of interpreting and / or executing computer-readable instructions. In one example, a physical processor may access and / or modify one or more modules stored in the memory devices described above. Examples of physical processors include, but are not limited to, a microprocessor, a microcontroller, a central processing unit (CPU), a field programmable gate array (FPGA) implementing a soft-core processor, an application-specific integrated circuit (ASIC), one or more portions thereof, one or more variants or combinations thereof, or any other suitable physical processor. A processor may also include, for example, a distributed processor system operating a parallel processor, or a remote processor such as a server, and combinations thereof.
[0195] While illustrated as separate elements, the method steps described and / or illustrated herein may represent portions of a single application. Additionally, in some embodiments, one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, may cause the computing device to perform one or more tasks, such as method steps.
[0196] Additionally, one or more of the devices described herein may transform data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more of the modules listed herein may execute on a computing device, store data on a computing device, and / or otherwise interact with a computing device, thereby transforming a processor, volatile memory, non-volatile memory, and / or any other portion of a physical computing device from one form of computing device to another form of computing device.
[0197] The term "computer-readable medium," as used herein, generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media include, but are not limited to, transmission-type media, such as carrier waves, and non-transitory media, such as magnetic storage media (e.g., hard disk drives, tape drives, and floppy disks), optical storage media (e.g., compact discs (CDs), digital video discs (DVDs), and BLU-RAY discs), electronic storage media (e.g., solid-state drives and flash media), and other distribution systems.
[0198] Those skilled in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and order of steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, although the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily have to be performed in the order illustrated or discussed.
[0199] The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or may include additional steps in addition to those disclosed. Furthermore, the steps of any method disclosed herein may be combined with any one or more steps of any other method disclosed herein.
[0200] A processor as described herein can be configured to perform one or more steps of any of the methods disclosed herein. Alternatively, or in combination, the processor can be configured to combine one or more steps of one or more of the methods disclosed herein.
[0201] Unless otherwise stated, the terms "connected to" and "coupled to" (and their derivatives) as used in this specification and claims should be interpreted to allow both direct and indirect (i.e., via other elements or components) connections. Additionally, the terms "a" or "an" as used in this specification and claims should be interpreted to mean "at least one." Finally, for ease of use, the terms "including" and "having" (and their derivatives) as used in this specification and claims are interchangeable with the word "comprising" and shall have the same meaning.
[0202] The processors disclosed herein may be configured with instructions to perform any one or more steps of any of the methods disclosed herein.
[0203] It will be understood that terms such as "first," "second," and "third" may be used herein to describe various layers, elements, components, regions, or sections without reference to any particular order or sequence of events. These terms are used merely to distinguish one layer, element, component, region, or section from another layer, element, component, region, or section. A first layer, element, component, region, or section as described herein could be referred to as a second layer, element, component, region, or section without departing from the teachings of the present disclosure.
[0204] As used herein, the term "or" is used inclusively to refer to items in alternative forms and combinations.
[0205] As used herein, letters, such as numbers, refer to like elements.
[0206] As used herein, the term "eg" means, for example.
[0207] This disclosure contains the following numbered clauses:
[0208] Clause 1. A system for treating tissue of a target, the system comprising: a probe having an energy source for directing energy to a first tissue to treat the first tissue; an imaging device configured to acquire image data from the first tissue and a second tissue proximate to the first tissue; and a processor coupled to the energy source and the imaging device, the processor configured to process the image data from the second tissue and output data corresponding to a response of the second tissue to the energy source directed to the first tissue.
[0209] Clause 2. The system of the preceding clause, wherein the processor is configured to adjust one or more of the treatment profile, movement of the energy source, or energy from the energy source in response to image data from the second tissue.
[0210] Clause 3. A system described in any of clauses 1 to 2, wherein the processor is configured to automatically adjust one or more of the treatment profile, movement, or energy from the energy source in response to image data from the second tissue.
[0211] Clause 4. A system described in any of clauses 1 to 3, wherein the processor is configured to output data to a user interface in response to image data from the second tissue, receive input from a user, and adjust one or more of the treatment profile, movement of the energy source, or energy from the energy source in response to the input from the user.
[0212] Clause 5. A system described in any of clauses 1 to 4, wherein the processor comprises a feedback loop component for adjusting one or more of the treatment profile, movement of the energy source, or energy from the energy source in response to image data from the second tissue.
[0213] Clause 6. A system according to any of clauses 1 to 5, wherein the energy source is adjusted in one or more of the following: translation, rotation, translation, angular velocity, translational velocity, energy from the energy source, output from the energy source, pump power, laser power, or electrical power.
[0214] Clause 7. The system of any of clauses 1 to 6, wherein the processor is configured to adjust the energy source in response to image data from the second tissue to reduce interaction between the energy source and the second tissue and treat the first tissue.
[0215] Clause 8. The system of any of clauses 1 to 7, wherein the processor is configured to adjust the energy source in response to image data from the second tissue to increase interaction of the energy source with the second tissue to treat the first tissue.
[0216] Clause 9. The system of any of clauses 1 to 8, wherein the processor is configured to treat a first tissue according to a treatment profile and adjust the treatment profile in response to image data from a second tissue.
[0217] Clause 10. A system described in any of clauses 1 to 9, wherein the processor is configured to treat a first tissue according to a first treatment profile, and the first treatment profile is adjusted in response to image data from a second tissue to generate a second tissue profile.
[0218] Clause 11. A system described in any of clauses 1 to 10, wherein the first treatment profile includes a first closest distance to the second tissue, the first closest distance defining a first gap between the first treatment profile and the second tissue, and the second treatment profile includes a second closest distance to the second tissue, the second closest distance defining a second gap between the second treatment profile and the second tissue, and the first gap is different from the second gap.
[0219] Clause 12. The system of any of clauses 1 to 11, wherein the first gap is smaller than the second gap.
[0220] Clause 13. The system of any of clauses 1 to 12, wherein the first gap is larger than the second gap.
[0221] Clause 14. The system of any of clauses 1 to 13, wherein the first treatment profile comprises a three-dimensional ("3D") treatment profile and the second treatment profile comprises a 3D treatment profile.
[0222] Clause 15. The system of any of clauses 1 to 14, wherein the processor is configured to compare a target tissue ablation profile of the first tissue with a measured tissue ablation profile of the first tissue and output a comparison of the target tissue ablation profile and the measured tissue ablation profile.
[0223] Clause 16. The system of any of clauses 1 to 15, wherein the processor is configured to measure movement of the second tissue in response to energy from the energy source and adjust one or more of the energy source, the movement of the energy source, or the treatment profile in response to the movement of the second tissue.
[0224] Clause 17. A system described in any of clauses 1 to 16, wherein the first tissue includes tissue of a first organ and the second tissue includes tissue of a second organ different from the first organ, and the processor is configured to process image data from the tissue of the second organ and output data corresponding to a response of the second tissue to an energy source directed at the tissue of the first organ.
[0225] Clause 18. The system of any of clauses 1 to 17, wherein the first tissue includes a first tissue structure and the second tissue includes a second tissue structure different from the first tissue structure, and the processor is configured to adjust one or more of the energy source or treatment profile of the first tissue structure in response to image data from the second tissue structure.
[0226] Clause 19. The system of any of clauses 1 to 18, wherein the image data from the second tissue structure includes one or more of a shape profile of the second tissue structure, a contrast of the second tissue structure, a blur of the second tissue structure, a movement of the second tissue structure, a deflection of the second tissue structure, or a distortion of the second tissue structure.
[0227] Clause 20. The system of any of clauses 1 to 19, wherein the image data from the second tissue structure includes a first image at a first time and a second image at a second time, and the processor is configured to determine, based on the first image and the second image, a change to one or more of a shape profile of the second tissue structure, a contrast of the second tissue structure, a blur of the second tissue structure, a movement of the second tissue structure, a deflection of the second tissue structure, or a distortion of the second tissue structure in response to the energy source directed at the first tissue.
[0228] Clause 21. The system of any of clauses 1 to 20, wherein the second tissue structure comprises one or more of connective tissue, muscle tissue, epithelial tissue, muscular tissue, or an anatomical structure associated with contrast in the image data.
[0229] Clause 22. A system described in any of clauses 1 to 21, wherein the second tissue structure comprises a second type of tissue adjacent to a third type of tissue or fluid to provide contrast to image data from the second tissue structure, and optionally the fluid comprises a liquid.
[0230] Clause 23. The system of any of clauses 1 to 22, wherein the anatomical structure of the second tissue structure comprises one or more of a tissue wall, a vesicle, a lumen, a wall of a lumen, a bladder, a wall of the bladder, a neck of the bladder, a wall of the bladder neck, a trigone tissue, a ureteral orifice, an internal urethral orifice, an external urethral sphincter, a ureter, a wall of a ureter, a prostate, a lobe of the prostate, an intravesical prostatic protrusion, a capsule of the prostate, a vermontanum of the prostate, an internal and external sphincter, an artery, a wall of an artery, a vein, a wall of a vein, and a retina of the eye.
[0231] Clause 24. The system of any of clauses 1 to 23, wherein the anatomical structure of the first tissue structure comprises one or more of a tissue wall, a vesicle, a lumen, a wall of a lumen, a bladder, a wall of the bladder, a neck of the bladder, a wall of the bladder neck, a ureteral orifice, an internal urethral orifice, an external urethral sphincter, a ureter, a wall of a ureter, a prostate, a lobe of the prostate, an intravesical prostatic protrusion, a capsule of the prostate, an internal and external sphincter, an artery, a wall of an artery, a vein, a wall of a vein, and a lens of an eye.
[0232] Clause 25. A system described in any of clauses 1 to 24, wherein the second tissue structure includes a tissue wall facing the first tissue structure, and the processor is configured to adjust one or more of the treatment profile or energy source in response to image data from the tissue wall.
[0233] Clause 26. A system described in any of clauses 1 to 25, wherein the first tissue structure includes a tissue wall spaced apart from a wall of the second tissue structure, a gap extending therebetween, and the processor is configured with instructions for adjusting one or more of the treatment profile or energy source in response to image data from the wall of the second tissue structure.
[0234] Clause 27. The system of any of clauses 1 to 26, wherein the image data from the tissue wall includes one or more of a shape profile of the tissue wall, a contrast of the tissue wall, a blur of the tissue wall, a movement of the tissue wall, a deflection of the tissue wall, or a distortion of the tissue wall.
[0235] Clause 28. The system of any of clauses 1 to 27, wherein the processor is configured to process image data from one or more of the first tissue or the second tissue using one or more of an artificial intelligence algorithm, image enhancement, image segmentation, a neural network, a convolutional neural network, a Transformer, a Transformer machine learning model, supervised machine learning, unsupervised machine learning, edge detection, feature recognition, segmentation, 3D model reconstruction, or multi-modality image fusion.
[0236] Clause 29. The system of any of clauses 1 to 28, wherein the energy source comprises one or more of an electrode, a loop electrode, a laser source, a mechanical energy source, mechanical shear, an ultrasound probe, a cavitation ultrasound probe, a water jet, e.g., a fixed pressure water jet, a plasma source, a vapor source, a morcellator, a transurethral needle, a photoablation source, a radiation energy source, a microwave energy source, or a water jet ejection source.
[0237] Clause 30. The system of any of clauses 1 to 29, wherein the imaging device comprises one or more of an ultrasound transducer array, an external ultrasound transducer array, an ultrasound transducer array on a probe with an energy source, an ultrasound probe, an elongated ultrasound probe dimensioned for placement within a lumen, a transrectal ultrasound probe, a transvaginal ultrasound probe, magnetic resonance imaging, a magnetic resonance probe, an endoscope, or a fluoroscopic imaging device.
[0238] Clause 31. A system described in any of clauses 1 to 30, wherein the image data comprises one or more of longitudinal image data, sagittal image data, transverse image data, or 3D ultrasound image data, and optionally the image data comprises real-time image data.
[0239] Clause 32. A system described in any of clauses 1 to 31, wherein the image data includes a first image from a first time and a second image from a second time, the first image and the second image showing the probe, a first tissue and a second tissue, and the second tissue moving between the first image and the second image in response to energy delivered to the first tissue.
[0240] Clause 33. A system described in any of clauses 1 to 32, wherein the first image includes a first longitudinal image, the second image includes a second longitudinal image, and the probe includes an elongated probe shown extending along the first longitudinal image and the second longitudinal image.
[0241] Clause 34. A system described in any of clauses 1 to 33, wherein the first longitudinal image includes a first sagittal image, the second longitudinal image includes a second sagittal image, and the elongated probe is shown extending along the first sagittal image and the second sagittal image.
[0242] Clause 35. A system described in any of clauses 1 to 34, wherein the image data includes a series of real-time images, and optionally the series of real-time images includes a frame rate in the range of about 5 hertz (Hz) to about 250 Hz and a latency period from when imaging energy is emitted from the imaging device until the image is shown on the display in the range of about 10 milliseconds (ms) to about 1000 ms.
[0243] Clause 36. A system according to any of clauses 1 to 35, wherein the processor is configured to scan energy from the energy source across the first tissue at a scanning rate, and the second tissue moves according to the scanning rate.
[0244] Clause 37. A system according to any of clauses 1 to 36, wherein the scanning rate comprises an angular sweep rate, and the second tissue moves according to the angular sweep rate.
[0245] Clause 38. A system described in any of clauses 1 to 37, wherein the processor is configured to determine an amount of movement of the second tissue corresponding to the sweep rate, and optionally, the processor is configured to correlate the movement of the second tissue with the angular sweep rate.
[0246] Clause 39. A system described in any of clauses 1 to 38, wherein the sweep rate is in the range of about 0.25 Hz to about 30 Hz and the angle of each sweep is in the range of about 10 degrees to about 240 degrees.
[0247] Clause 40. A system described in any of clauses 1 to 39, wherein the energy source comprises a water jet, the first tissue includes an intravesical lobe of the prostate gland extending at least partially within a portion of the bladder, the second tissue includes trigone tissue, and the processor is configured to process image data from the trigone tissue and output data corresponding to a response of the trigone tissue to energy directed at the intravesical lobe of the prostate gland, and optionally the lobe includes a median lobe of the prostate gland.
[0248] Clause 41. The system of any of clauses 1 to 40, further comprising a linkage coupled to the processor and the energy source for moving the energy source according to a treatment profile.
[0249] Clause 42. A system described in any of clauses 1 to 41, wherein the treatment probe is coupled to a first linkage and the ultrasound device is coupled to a second linkage, and the processor is configured to move the energy source according to a treatment profile and to move the imaging device together with the energy source to maintain the second tissue within the field of view of the imaging device.
[0250] Clause 43. A system according to any of clauses 1 to 42, wherein the processor is configured to move the imaging device in synchronization with the energy source to maintain the second tissue within the field of view of the imaging device.
[0251] Clause 44. A system described in any of clauses 1 to 43, wherein the image data includes multiple lateral images of the treatment probe, the first tissue, and the second tissue, and the processor is configured to move the imaging device to maintain the energy source, the first tissue, and the second tissue within the lateral field of view of the imaging device.
[0252] Clause 45. A method for treating tissue of a target, comprising: directing energy from an energy source to a first tissue to treat the first tissue; acquiring image data from the first tissue and a second tissue proximate to the first tissue using an imaging device; processing the image data from the second tissue using a processor; and outputting data corresponding to a response of the second tissue to the energy source directed to the first tissue.
[0253] Clause 46. The method of clause 45, wherein the processor adjusts one or more of the treatment profile, the movement of the energy source, or the energy from the energy source in response to image data from the second tissue.
[0254] Clause 47. The method of any of clauses 45 to 46, wherein the processor automatically adjusts one or more of the treatment profile, the movement, or the energy from the energy source in response to image data from the second tissue.
[0255] Clause 48. The method of any of clauses 45 to 47, wherein the processor, in response to image data from the second tissue, outputs data to a user interface, receives input from a user, and, in response to the input from the user, adjusts one or more of the treatment profile, movement of the energy source, or energy from the energy source.
[0256] Clause 49. The method of any of clauses 45 to 48, wherein the processor comprises a feedback loop component for adjusting one or more of the treatment profile, movement of the energy source, or energy from the energy source in response to image data from the second tissue.
[0257] Clause 50. The method of any of clauses 45 to 49, wherein the energy source is adjusted in one or more of the following: translation, rotation, translation, angular velocity, translational velocity, energy from the energy source, output from the energy source, pump power, laser power, or electrical power.
[0258] Clause 51. The method of any of clauses 45 to 50, wherein the processor adjusts the energy source in response to image data from the second tissue to treat the first tissue with reduced interaction of the energy source with the second tissue.
[0259] Clause 52. The method of any of clauses 45 to 51, wherein the processor adjusts the energy source in response to image data from the second tissue to increase interaction of the energy source with the second tissue to treat the first tissue.
[0260] Clause 53. The method of any of clauses 45 to 52, wherein a first tissue is treated according to a treatment profile, and the treatment profile is adjusted in response to image data from a second tissue.
[0261] Clause 54. A method according to any of clauses 45 to 53, wherein a first tissue is treated according to a first treatment profile, and the first treatment profile is adjusted in response to image data from a second tissue to generate a second tissue profile.
[0262] Clause 55. The method of any of clauses 45 to 54, wherein the first treatment profile includes a first closest distance to the second tissue, the first closest distance defining a first gap between the first treatment profile and the second tissue, and the second treatment profile includes a second closest distance to the second tissue, the second closest distance defining a second gap between the second treatment profile and the second tissue, and the first gap is different from the second gap.
[0263] Clause 56. The method of any of clauses 45 to 55, wherein the first gap is smaller than the second gap.
[0264] Clause 57. The method of any of clauses 45 to 56, wherein the first gap is larger than the second gap.
[0265] Clause 58. The method of any of clauses 45 to 57, wherein the first treatment profile comprises a three-dimensional ("3D") treatment profile and the second treatment profile comprises a 3D treatment profile.
[0266] Clause 59. The method of any of clauses 45 to 58, wherein the processor is configured to compare the target tissue ablation profile of the first tissue with the measured tissue ablation profile of the first tissue and output a comparison of the target tissue ablation profile and the measured tissue ablation profile.
[0267] Clause 60. The method of any of clauses 45 to 59, wherein movement of the second tissue is measured in response to energy from the energy source, and one or more of the energy source, the movement of the energy source, or the treatment profile is adjusted in response to the movement of the second tissue.
[0268] Clause 61. The method of any of clauses 45 to 60, wherein the first tissue comprises tissue of a first organ and the second tissue comprises tissue of a second organ different from the first organ, and the processor is configured to process image data from the tissue of the second organ and output data corresponding to a response of the second tissue to an energy source directed at the tissue of the first organ.
[0269] Clause 62. The method of any of clauses 45 to 61, wherein the first tissue includes a first tissue structure and the second tissue includes a second tissue structure different from the first tissue structure, and the processor is configured to adjust one or more of the energy source or treatment profile of the first tissue structure in response to image data from the second tissue structure.
[0270] Clause 63. The method of any of clauses 45 to 62, wherein the image data from the second tissue structure includes one or more of a shape profile of the second tissue structure, a contrast of the second tissue structure, a blur of the second tissue structure, a movement of the second tissue structure, a deflection of the second tissue structure, or a distortion of the second tissue structure.
[0271] Clause 64. The method of any of clauses 45 to 63, wherein the image data from the second tissue structure includes a first image at a first time and a second image at a second time, and the processor is configured to determine, based on the first image and the second image, a change to one or more of a shape profile of the second tissue structure, a contrast of the second tissue structure, a blur of the second tissue structure, a movement of the second tissue structure, a deflection of the second tissue structure, or a distortion of the second tissue structure in response to the energy source directed at the first tissue.
[0272] Clause 65. The method of any of clauses 45 to 64, wherein the second tissue structure comprises one or more of connective tissue, muscle tissue, epithelial tissue, muscular tissue, or an anatomical structure associated with contrast in the image data.
[0273] Clause 66. The method of any of clauses 45 to 65, wherein the second tissue structure comprises a second type of tissue adjacent to a third type of tissue or fluid to provide contrast to image data from the second tissue structure, and optionally the fluid comprises a liquid.
[0274] Clause 67. The method of any of clauses 45 to 66, wherein the anatomical structure of the second tissue structure comprises one or more of a tissue wall, a vesicle, a lumen, a wall of a lumen, a bladder, a wall of a bladder, a neck of the bladder, a wall of the bladder neck, a trigone tissue, a ureteral orifice, an internal urethral orifice, an external urethral sphincter, a ureter, a wall of a ureter, a prostate, a lobe of the prostate, an intravesical prostatic protrusion, a capsule of the prostate, a vermontanum of the prostate, an internal and external sphincter, an artery, a wall of an artery, a vein, a wall of a vein, or a retina of an eye.
[0275] Clause 68. The method of any of clauses 45 to 67, wherein the anatomical structure of the first tissue structure comprises one or more of a tissue wall, a vesicle, a lumen, a wall of a lumen, a bladder, a wall of the bladder, a neck of the bladder, a wall of the bladder neck, a ureteral orifice, an internal urethral orifice, an external urethral sphincter, a ureter, a wall of a ureter, a prostate, a lobe of the prostate, an intravesical prostatic protrusion, a capsule of the prostate, an internal and external sphincter, an artery, a wall of an artery, a vein, a wall of a vein, or a lens of an eye.
[0276] Clause 69. The method of any of clauses 45 to 68, wherein the second tissue structure includes a tissue wall facing the first tissue structure, and one or more of the treatment profile, the movement of the energy source, or the energy source are adjusted in response to image data from the tissue wall.
[0277] Clause 70. The method of any of clauses 45 to 69, wherein the first tissue structure includes a tissue wall spaced apart from a wall of the second tissue structure, a gap extending therebetween, and one or more of the treatment profile, the movement of the energy source, or the energy source are adjusted in response to image data from the wall of the second tissue structure.
[0278] Clause 71. The method of any of clauses 45 to 70, wherein the image data from the tissue wall includes one or more of a tissue wall shape profile, tissue wall contrast, tissue wall blur, tissue wall movement, tissue wall deflection, or tissue wall distortion.
[0279] Clause 72. The method of any of clauses 45 to 71, wherein the image data from one or more of the first tissue or the second tissue is processed using one or more of an artificial intelligence algorithm, image enhancement, image segmentation, a neural network, a convolutional neural network, a Transformer, a Transformer machine learning model, supervised machine learning, unsupervised machine learning, edge detection, feature recognition, segmentation, 3D model reconstruction, or multi-modality image fusion.
[0280] Clause 73. The method of any of clauses 45 to 72, wherein the energy source comprises one or more of an electrode, a loop electrode, a laser source, a mechanical energy source, mechanical shear, an ultrasonic probe, a cavitation ultrasonic probe, a water jet, e.g., a fixed pressure water jet, a plasma source, a vapor source, a morcellator, a transurethral needle, a photoablation source, a radiation energy source, a microwave energy source, or a water jet ejection source.
[0281] Clause 74. The method of any of clauses 45 to 73, wherein the imaging device comprises one or more of an ultrasound transducer array, an external ultrasound transducer array, an ultrasound transducer array on a probe with an energy source, an ultrasound probe, an elongated ultrasound probe dimensioned for placement within a lumen, a transrectal ultrasound probe, a transvaginal ultrasound probe, magnetic resonance imaging, a magnetic resonance probe, an endoscope, or a fluoroscopic imaging device.
[0282] Clause 75. The method of any of clauses 45 to 74, wherein the image data comprises one or more of longitudinal image data, sagittal image data, transverse image data, or 3D ultrasound image data, and optionally the image data comprises real-time image data.
[0283] Clause 76. The method of any of clauses 45 to 75, wherein the image data includes a first image from a first time and a second image from a second time, the first image and the second image showing the probe, the first tissue and the second tissue, and the second tissue moving between the first image and the second image in response to energy delivered to the first tissue.
[0284] Clause 77. The method of any of clauses 45 to 76, wherein the first image comprises a first longitudinal image, the second image comprises a second longitudinal image, and the probe comprises an elongated probe shown extending along the first longitudinal image and the second longitudinal image.
[0285] Clause 78. The method of any of clauses 45 to 77, wherein the first longitudinal image comprises a first sagittal image, the second longitudinal image comprises a second sagittal image, and the elongate probe is shown extending along the first sagittal image and the second sagittal image.
[0286] Clause 79. The method of any of clauses 45 to 78, wherein the image data includes a series of real-time images, and optionally the series of real-time images includes a frame rate in the range of about 5 hertz (Hz) to about 250 Hz and a latency period from when imaging energy is emitted from the imaging device until the image is shown on the display in the range of about 10 milliseconds (ms) to about 1000 ms.
[0287] Clause 80. The method of any of clauses 45 to 79, wherein energy from an energy source is scanned across a first tissue at a scanning velocity, and a second tissue moves according to the scanning velocity.
[0288] Clause 81. The method of any of clauses 45 to 80, wherein the scanning rate comprises an angular sweep rate, and the second tissue moves according to the angular sweep rate.
[0289] Clause 82. The method of any of clauses 45 to 81, wherein an amount of movement of the second tissue corresponding to the sweep rate is determined, and optionally the movement of the second tissue is correlated with the angular sweep rate.
[0290] Clause 83. The method of any of clauses 45 to 82, wherein the sweep rate is in the range of about 0.25 Hz to about 30 Hz and the angle of each sweep is in the range of about 10 degrees to about 240 degrees.
[0291] Clause 84. A method according to any of clauses 45 to 83, wherein the energy source comprises a water jet, the first tissue comprises an intravesical lobe of the prostate gland extending at least partially within a portion of the bladder, the second tissue comprises trigone tissue, image data from the trigone tissue is processed, and data output is provided from the processed image data, the output data corresponding to a response of the trigone tissue to energy directed at the intravesical lobe of the prostate gland, and optionally the lobe comprises a median lobe of the prostate gland.
[0292] Clause 85. The method of any of clauses 45 to 84, wherein a linkage coupled to the processor and the energy source moves the energy source according to a treatment profile.
[0293] Clause 86. A method according to any of clauses 45 to 85, wherein the treatment probe is coupled to a first linkage, the ultrasound device is coupled to a second linkage, the energy source moves according to a treatment profile, and the imaging device moves with the energy source to maintain the second tissue within the field of view of the imaging device.
[0294] Clause 87. The method of any of clauses 45 to 86, wherein the processor is configured to move the imaging device in synchronization with the energy source to maintain the second tissue within the field of view of the imaging device.
[0295] Clause 88. The method of any of clauses 45 to 87, wherein the image data includes multiple transverse images of the treatment probe, the first tissue, and the second tissue, and the imaging device moves to maintain the energy source, the first tissue, and the second tissue within a transverse field of view of the imaging device.
[0296] Clause 89. A system for treating a subject, the system comprising: a probe having an energy source for directing energy to a first tissue to treat the first tissue; an imaging device configured to acquire image data from the first tissue and a second tissue proximate to the first tissue; and a processor coupled to the energy source and the imaging device, the processor configured to process the image data from the second tissue and output data related to stretching of the second tissue in response to placement of the probe.
[0297] Clause 90. The system of clause 89, wherein the first tissue comprises tissue of a first organ and the second tissue comprises tissue of a second organ.
[0298] Clause 91. A system according to any of clauses 89 to 90, wherein the processor is configured to output data relating to the stretching of the second tissue to a user interface.
[0299] Clause 92. The system of any of clauses 89 to 91, wherein the processor is configured to output one or more of a warning, notification, or message to the user to adjust one or more of the angle, location, or attitude of the probe.
[0300] Clause 93. The system of any of clauses 89 to 92, wherein the processor is configured to receive input from a user relating to the user's response to one or more of the alert, notification, or message.
[0301] Clause 94. The system of any of clauses 89 to 93, wherein the processor is configured to adjust one or more of the probe's placement, angle, location, or six degrees of freedom (6DOF) attitude in response to data relating to extension of the probe.
[0302] Clause 95. The system of any of clauses 89 to 94, further comprising a linkage coupled to the probe and the processor, the linkage configured to adjust one or more of the alignment, angle, location, or 6DOF attitude of the probe.
[0303] Clause 96. A system according to any of clauses 89 to 95, wherein the linkage comprises a linkage of a robotic arm.
[0304] Clause 97. The system of any of clauses 89 to 96, wherein the processor includes instructions for causing the first module to output data related to stretching of the second tissue, and for causing the second module to receive data related to stretching of the second tissue, and for adjusting one or more of the angle, location, or 6DOF attitude of the probe.
[0305] Clause 98. A system according to any of clauses 89 to 97, wherein the processor is configured to output data relating to the stretching of the second tissue to a user interface, receive user input in response to the data provided to the user interface, and adjust one or more of the placement, angle, location or attitude of the probe in response to the user input.
[0306] Clause 99. The system of any of clauses 89 to 98, wherein the first tissue comprises tissue of a first organ and the second tissue comprises tissue of a second organ, and the processor is configured to output data corresponding to stretching of the tissue of the second organ in response to the tissue of the first organ engaging the probe.
[0307] Clause 100. The system of any of clauses 89 to 99, wherein the first tissue includes a first tissue structure detectable in the image data, and the processor is configured to identify the first tissue structure and compare profile data of the first tissue structure with reference profile data to determine stretch of the first tissue.
[0308] Clause 101. The system of any of clauses 89 to 100, wherein the baseline profile data includes data from a first image of the tissue before placement of the probe.
[0309] Clause 102. The system of any of clauses 89 to 101, wherein the first tissue includes a first tissue structure detectable in the image data and the second tissue includes a second tissue structure detectable in the image data.
[0310] Clause 103. The system of any of clauses 89 to 102, wherein the probe is configured to direct an energy source to a first tissue structure, and the processor is configured to identify a second tissue structure and compare profile data of the second tissue structure with reference profile data to determine stretch of the second tissue.
[0311] Clause 104. The system of any of clauses 89 to 103, wherein the baseline profile data includes data from a first image of the tissue before placement of the probe.
[0312] Clause 105. The system of any of clauses 89 to 104, wherein the second tissue structure includes a wall, and the processor is configured to compare the wall profile data with reference wall profile data to determine wall extension.
[0313] Clause 106. The system of any of clauses 89 to 105, further comprising one or more sensors coupled to the probe for detecting force from the probe engaging tissue.
[0314] Clause 107. The system of any of clauses 89 to 106, wherein one or more sensors are configured to detect tissue pulling the probe.
[0315] Clause 108. A system according to any of clauses 89 to 107, wherein the tissue against which the probe is pulled comprises the wall of a lumen.
[0316] Clause 109. A system according to any of clauses 89 to 108, wherein the wall comprises a urethral wall.
[0317] Clause 110. A method for detecting tissue stretching in a subject, the method comprising: acquiring, from an imaging device, image data of a first tissue and a second tissue proximate the first tissue using a probe positioned in the first tissue, the probe comprising an energy source for directing energy to the first tissue to treat the first tissue; and processing, with a processor, the image data from the second tissue to generate output data related to stretching of the second tissue in response to placement of the probe in the first tissue.
[0318] Clause 111. The method of clause 110, wherein the first tissue comprises tissue of a first organ and the second tissue comprises tissue of a second organ.
[0319] Clause 112. The method of any of clauses 110-111, wherein the processor outputs data related to the stretching of the second tissue to a user interface.
[0320] Clause 113. The method of any of clauses 110 to 112, wherein the processor outputs one or more of a warning, notification, or message to the user to adjust one or more of the angle, location, or attitude of the probe.
[0321] Clause 114. The method of any of clauses 110 to 113, wherein the processor receives input from the user relating to the user's response to one or more of the alert, notification, or message.
[0322] Clause 115. The method of any of clauses 110 to 114, wherein one or more of the probe placement, angle, location, or six degrees of freedom (6DOF) attitude is adjusted in response to data related to extension of the probe.
[0323] Clause 116. The method of any of clauses 110 to 115, further comprising a linkage coupled to the probe and the processor, the linkage configured to adjust one or more of the alignment, angle, location, or 6DOF attitude of the probe.
[0324] Clause 117. A method according to any of clauses 110 to 116, wherein the linkage comprises a linkage of a robotic arm.
[0325] Clause 118. The method of any of clauses 110 to 117, including instructions for a processor to cause a first module to output data related to stretching of the second tissue, and a second module to receive data related to stretching of the second tissue, and adjust one or more of the angle, location, or 6DOF attitude of the probe.
[0326] Clause 119. The method of any of clauses 110 to 118, wherein the processor is configured to output data related to the stretching of the second tissue to a user interface, receive user input in response to the data provided to the user interface, and adjust one or more of the placement, angle, location, or attitude of the probe in response to the user input.
[0327] Clause 120. The method of any of clauses 110 to 119, wherein the first tissue comprises tissue of a first organ and the second tissue comprises tissue of a second organ, and the processor is configured to output data corresponding to stretching of the tissue of the second organ in response to the tissue of the first organ engaging the probe.
[0328] Clause 121. The method of any of clauses 110 to 120, wherein the first tissue includes a first tissue structure detectable in the image data, and the processor is configured to identify the first tissue structure and compare profile data of the first tissue structure with reference profile data to determine an elongation of the first tissue.
[0329] Clause 122. The method of any of clauses 110 to 121, wherein the baseline profile data includes data from a first image of the tissue before placement of the probe.
[0330] Clause 123. The method of any of clauses 110 to 122, wherein the first tissue includes a first tissue structure detectable in the image data and the second tissue includes a second tissue structure detectable in the image data.
[0331] Clause 124. The method of any of clauses 110 to 123, wherein the probe is configured to direct an energy source to a first tissue structure, and the processor is configured to identify a second tissue structure and compare profile data of the second tissue structure with reference profile data to determine stretch of the second tissue.
[0332] Clause 125. The method of any of clauses 110 to 124, wherein the baseline profile data includes data from a first image of the tissue before placement of the probe.
[0333] Clause 126. The method of any of clauses 110 to 125, wherein the second tissue structure includes a wall, and the processor is configured to compare the wall profile data with reference wall profile data to determine wall extension.
[0334] Clause 127. The method of any of clauses 110 to 126, wherein one or more sensors coupled to the probe detect force from the probe engaging tissue.
[0335] Clause 128. The method of any of clauses 110-127, wherein one or more sensors detect tissue pulling the probe.
[0336] Clause 129. The method of any of clauses 110 to 128, wherein the tissue against which the probe is retracted comprises the wall of a lumen.
[0337] Clause 130. The method of any of clauses 110 to 129, wherein the wall comprises a urethral wall.
[0338] Clause 131. A system for treating tissue of a subject, comprising: a probe having an energy source for directing energy to the tissue to treat the tissue, the probe being sized for insertion into the subject; an arm coupled to the probe for supporting the probe; one or more sensors coupled to the probe for measuring forces from tissue traction on the probe; and a processor coupled to the one or more sensors, the processor configured to output data related to the forces from tissue traction on the probe to a user interface.
[0339] Clause 132. The system of clause 131, wherein the arm and probe include a fixed orientation when the sensor measures the force and the processor provides the data.
[0340] Clause 133. A system according to any of clauses 131 to 132, wherein the arm comprises a robotic arm.
[0341] Clause 134. A system according to any of clauses 131 to 133, wherein the arm comprises a manually movable arm configured to enable a user to move the arm to reduce the force from tissue traction on the probe.
[0342] Clause 135. A system according to any of clauses 131 to 134, wherein the processor is configured to determine a force vector corresponding to a direction of tissue traction on the probe.
[0343] Clause 136. A method for treating tissue of a subject, the method comprising: receiving data from one or more sensors coupled to a probe to measure forces from tissue traction on the probe, the probe comprising an energy source for directing energy to the tissue to treat the tissue, the probe being supported by an arm with the probe inserted into the subject; and processing the sensor data to output data related to forces from tissue traction on the probe to a user interface.
[0344] Clause 137. The method of clause 136, wherein the arm and probe comprise a fixed position when the one or more sensors measure the force of tissue traction on the probe.
[0345] Clause 138. A method according to any of clauses 136 to 137, wherein the arm comprises a robotic arm.
[0346] Clause 139. The method of any of clauses 136 to 138, wherein the arm comprises a manually movable arm configured to allow a user to move the arm to reduce the force from the tissue to the sensor.
[0347] Clause 140. The method of any of clauses 136 to 139, wherein the processor is configured to determine a vector corresponding to a direction of tissue traction on the probe.
[0348] Clause 141. A computer-readable medium configured to carry out a method according to any preceding claim.
[0349] Clause 142. A system comprising a processor configured to carry out a method according to any preceding claim.
[0350] The embodiments of the present disclosure have been shown and described herein and are provided by way of example only. Those skilled in the art will recognize numerous adaptations, modifications, variations, and substitutions without departing from the scope of the present disclosure. Several alternatives and combinations of the embodiments disclosed herein may be utilized without departing from the scope of the present disclosure and the invention(s) disclosed herein. Accordingly, the scope of the present disclosure is to be defined solely by the scope of the appended claims and their equivalents.
Claims
1. 1. A system for treating tissue of a subject, comprising: a probe including an energy source for directing energy to a first tissue to treat the first tissue; an imaging device configured to acquire image data from the first tissue and a second tissue proximate to the first tissue; a processor coupled to the energy source and the imaging device, the processor configured to process the image data from the second tissue and output data corresponding to a response of the second tissue to the energy source directed at the first tissue; A system comprising:
2. 10. The system of claim 1, wherein the processor is configured to adjust one or more of a treatment profile, movement of the energy source, or the energy from the energy source in response to image data from the second tissue.
3. 3. The system of claim 2, wherein the processor is configured to automatically adjust the one or more of the treatment profile, the movement, or the energy from the energy source in response to the image data from the second tissue.
4. 10. The system of claim 1, wherein the processor is configured to output data to a user interface in response to the image data from the second tissue, receive input from a user, and adjust one or more of a treatment profile, the movement of the energy source, or the energy from the energy source in response to the input from the user.
5. 10. The system of claim 1, wherein the processor comprises feedback loop components for adjusting one or more of a treatment profile, movement of the energy source, or the energy from the energy source in response to the image data from the second tissue.
6. 10. The system of claim 1, wherein the energy source is adjusted in one or more of: translation, rotation, translation, angular velocity, translational velocity, energy from the energy source, output from the energy source, pump power, laser power, or electrical power.
7. 7. The system of claim 6, wherein the processor is configured to adjust the energy source in response to the image data from the second tissue to treat the first tissue with reduced interaction between the energy source and the second tissue.
8. 7. The system of claim 6, wherein the processor is configured to adjust the energy source in response to the image data from the second tissue to increase interaction of the energy source with the second tissue to treat the first tissue.
9. The system of claim 1 , wherein the processor is configured to treat the first tissue according to a treatment profile and to adjust the treatment profile in response to the image data from the second tissue.
10. 10. The system of claim 1, wherein the processor is configured to treat the first tissue according to a first treatment profile, the first treatment profile being adjusted in response to the image data from the second tissue to generate a second tissue profile.
11. 11. The system of claim 10, wherein the first treatment profile includes a first closest distance to the second tissue, the first closest distance defining a first gap between the first treatment profile and the second tissue, and the second treatment profile includes a second closest distance to the second tissue, the second closest distance defining a second gap between the second treatment profile and the second tissue, the first gap being different from the second gap.
12. The system of claim 11 , wherein the first gap is smaller than the second gap.
13. The system of claim 11 , wherein the first gap is larger than the second gap.
14. 11. The system of claim 10, wherein the first treatment profile comprises a three-dimensional ("3D") treatment profile and the second treatment profile comprises a 3D treatment profile.
15. 2. The system of claim 1, wherein the processor is configured to compare a target tissue ablation profile of the first tissue to a measured tissue ablation profile of the first tissue and output a comparison of the target tissue ablation profile and the measured tissue ablation profile.
16. 10. The system of claim 1, wherein the processor is configured to measure movement of the second tissue in response to the energy from the energy source and adjust one or more of the energy source, the movement of the energy source, or the treatment profile in response to the movement of the second tissue.
17. 2. The system of claim 1, wherein the first tissue includes tissue of a first organ and the second tissue includes tissue of a second organ different from the first organ, and the processor is configured to process the image data from the tissue of the second organ and output data corresponding to a response of the second tissue to the energy source directed at the tissue of the first organ.
18. 10. The system of claim 1, wherein the first tissue comprises a first tissue structure and the second tissue comprises a second tissue structure different from the first tissue structure, and the processor is configured to adjust one or more of the energy source or treatment profile of the first tissue structure in response to image data from the second tissue structure.
19. 20. The system of claim 18, wherein the image data from the second tissue structure includes one or more of a shape profile of the second tissue structure, a contrast of the second tissue structure, a blur of the second tissue structure, a movement of the second tissue structure, a bending of the second tissue structure, or a distortion of the second tissue structure.
20. 20. The system of claim 19, wherein the image data from the second tissue structure includes a first image at a first time and a second image at a second time, and the processor is configured to determine, based on the first image and the second image, a change to the one or more of the shape profile of the second tissue structure, the contrast of the second tissue structure, the blur of the second tissue structure, the movement of the second tissue structure, the deflection of the second tissue structure, or the distortion of the second tissue structure in response to the energy source directed at the first tissue.
21. 20. The system of claim 18, wherein the second tissue structure comprises one or more of connective tissue, muscle tissue, epithelial tissue, muscular tissue, or an anatomical structure associated with contrast in the image data.
22. 22. The system of claim 21, wherein the second tissue structure comprises a second type of tissue adjacent to a third type of tissue or fluid to provide the contrast to the image data from the second tissue structure, and optionally the fluid comprises a liquid.
23. 22. The system of claim 21, wherein the anatomical structure of the second tissue structure comprises one or more of a tissue wall, a vesicle, a lumen, a wall of a lumen, a bladder, a wall of a bladder, a bladder neck, a wall of a bladder neck, a trigone tissue, a ureteral orifice, an internal urethral orifice, an external urethral sphincter, a ureter, a wall of a ureter, a prostate, a lobe of a prostate, an intravesical prostatic protrusion, a capsule of a prostate, a vermont of a prostate, an internal and external sphincter, an artery, a wall of an artery, a vein, a wall of a vein, and a retina of an eye.
24. 22. The system of claim 21, wherein the anatomical structure of the first tissue structure comprises one or more of a tissue wall, a vesicle, a lumen, a wall of a lumen, a bladder, a wall of a bladder, a bladder neck, a wall of a bladder neck, a ureteral orifice, an internal urethral orifice, an external urethral sphincter, a ureter, a wall of a ureter, a prostate, a lobe of a prostate, an intravesical prostate protrusion, a capsule of a prostate, an internal and external sphincter, an artery, a wall of an artery, a vein, a wall of a vein, and a lens of an eye.
25. 20. The system of claim 18, wherein the second tissue structure includes a tissue wall facing the first tissue structure, and the processor is configured to adjust the one or more of the treatment profile or the energy source in response to the image data from the tissue wall.
26. 26. The system of claim 25, wherein the first tissue structure includes a tissue wall spaced apart from the wall of the second tissue structure with a gap extending therebetween, and the processor is configured with instructions for adjusting the one or more of the treatment profile or the energy source in response to image data from the wall of the second tissue structure.
27. 26. The system of claim 25, wherein the image data from the tissue wall includes one or more of a shape profile of the tissue wall, a contrast of the tissue wall, a blur of the tissue wall, a movement of the tissue wall, a bending of the tissue wall, or a distortion of the tissue wall.
28. 10. The system of claim 1, wherein the processor is configured to process the image data from one or more of the first tissue or the second tissue with one or more of an artificial intelligence algorithm, image enhancement, image segmentation, a neural network, a convolutional neural network, a Transformer, a Transformer machine learning model, supervised machine learning, unsupervised machine learning, edge detection, feature recognition, segmentation, 3D model reconstruction, or multi-modality image fusion.
29. 10. The system of claim 1, wherein the energy source comprises one or more of an electrode, a loop electrode, a laser source, a mechanical energy source, mechanical shear, an ultrasound probe, a cavitation ultrasound probe, a water jet, e.g., a fixed pressure water jet, a plasma source, a vapor source, a morcellator, a transurethral needle, a photoablation source, a radiation energy source, a microwave energy source, or a water jet ejection source.
30. 10. The system of claim 1, wherein the imaging device comprises one or more of an ultrasound transducer array, an external ultrasound transducer array, an ultrasound transducer array on the probe comprising the energy source, an ultrasound probe, an elongated ultrasound probe sized for placement within a lumen, a transrectal ultrasound probe, a transvaginal ultrasound probe, magnetic resonance imaging, a magnetic resonance probe, an endoscope, or a fluoroscopic imaging device.
31. 10. The system of claim 1, wherein the image data includes one or more of longitudinal image data, sagittal image data, transverse image data, or 3D ultrasound image data, and optionally the image data includes real-time image data.
32. 2. The system of claim 1, wherein the image data includes a first image from a first time and a second image from a second time, the first image and the second image showing the probe, the first tissue and the second tissue, the second tissue moving between the first image and the second image in response to the energy delivered to the first tissue.
33. 33. The system of claim 32, wherein the first image comprises a first longitudinal image, the second image comprises a second longitudinal image, and the probe comprises an elongated probe shown extending along the first longitudinal image and the second longitudinal image.
34. 34. The system of claim 33, wherein the first longitudinal image comprises a first sagittal image, the second longitudinal image comprises a second sagittal image, and the elongate probe is shown extending along the first sagittal image and the second sagittal image.
35. 33. The system of claim 32, wherein the image data includes a series of real-time images, and optionally the series of real-time images includes a frame rate in the range of about 5 hertz (Hz) to about 250 Hz and a latency time from when imaging energy is emitted from the imaging device until an image is shown on the display in the range of about 10 milliseconds (ms) to about 1000 ms.
36. The system of claim 1 , wherein the processor is configured to scan the energy from the energy source across the first tissue at a scan rate, and the second tissue moves according to the scan rate.
37. 37. The system of claim 36, wherein the scan rate comprises an angular sweep rate, and the second tissue moves according to the angular sweep rate.
38. 38. The system of claim 37, wherein the processor is configured to determine an amount of movement of the second tissue corresponding to the sweep rate, and optionally, the processor is configured to correlate the movement of the second tissue with the angular sweep rate.
39. 38. The system of claim 37, wherein the sweep rate is in the range of about 0.25 Hz to about 30 Hz and the angle of each sweep is in the range of about 10 degrees to about 240 degrees.
40. 2. The system of claim 1, wherein the energy source comprises a water jet, the first tissue comprises an intravesical lobe of a prostate gland extending at least partially into a portion of the bladder, the second tissue comprises trigone tissue, and the processor is configured to process the image data from the trigone tissue and output data corresponding to a response of the trigone tissue to the energy directed at the intravesical lobe of the prostate gland, and optionally the lobe comprises a middle lobe of the prostate gland.
41. The system of claim 1 , further comprising a linkage coupled to the processor and the energy source for moving the energy source according to the treatment profile.
42. 2. The system of claim 1, wherein the treatment probe is coupled to a first linkage and the ultrasound device is coupled to a second linkage, and the processor is configured to move the energy source according to the treatment profile and to move the imaging device with the energy source to maintain the second tissue within a field of view of the imaging device.
43. 43. The system of claim 42, wherein the processor is configured to move the imaging device in synchronization with the energy source to maintain the second tissue within the field of view of the imaging device.
44. 43. The system of claim 42, wherein the image data includes multiple lateral images of the treatment probe, the first tissue, and the second tissue, and the processor is configured to move the imaging device to maintain the energy source, the first tissue, and the second tissue within a lateral field of view of the imaging device.
45. 1. A method for treating tissue in a subject, comprising: directing energy from an energy source to a first tissue to treat the first tissue; acquiring image data from the first tissue and a second tissue proximate to the first tissue using an imaging device; processing the image data from the second tissue with a processor; and outputting data corresponding to a response of the second tissue to the energy source directed at the first tissue; A method comprising:
46. The method of claim 1 , wherein the processor adjusts one or more of a treatment profile, movement of the energy source, or the energy from the energy source in response to image data from the second tissue.
47. 47. The method of claim 46, wherein the processor automatically adjusts one or more of the treatment profile, the movement, or the energy from the energy source in response to the image data from the second tissue.
48. 10. The method of claim 1, wherein the processor outputs data to a user interface in response to the image data from the second tissue, receives input from the user, and adjusts one or more of a treatment profile, the movement of the energy source, or the energy from the energy source in response to the input from the user.
49. 10. The method of claim 1, wherein the processor comprises feedback loop components for adjusting one or more of a treatment profile, movement of the energy source, or the energy from the energy source in response to the image data from the second tissue.
50. 10. The method of claim 1, wherein the energy source is adjusted in one or more of: translation, rotation, translation, angular velocity, translational velocity, energy from the energy source, power from the energy source, pump power, laser power, or electrical power.
51. 51. The method of claim 50, wherein the processor adjusts the energy source in response to the image data from the second tissue to treat the first tissue with reduced interaction between the energy source and the second tissue.
52. 51. The method of claim 50, wherein the processor adjusts the energy source in response to the image data from the second tissue to increase interaction of the energy source with the second tissue to treat the first tissue.
53. The method of claim 1 , wherein the first tissue is treated according to a treatment profile, and the treatment profile is adjusted in response to the image data from the second tissue.
54. 10. The method of claim 1, wherein the first tissue is treated according to a first treatment profile, and the first treatment profile is adjusted in response to the image data from the second tissue to generate a second tissue profile.
55. 55. The method of claim 54, wherein the first treatment profile includes a first closest distance to the second tissue, the first closest distance defining a first gap between the first treatment profile and the second tissue, and the second treatment profile includes a second closest distance to the second tissue, the second closest distance defining a second gap between the second treatment profile and the second tissue, the first gap being different from the second gap.
56. 56. The method of claim 55, wherein the first gap is smaller than the second gap.
57. 56. The method of claim 55, wherein the first gap is larger than the second gap.
58. 55. The method of claim 54, wherein the first treatment profile comprises a three-dimensional ("3D") treatment profile and the second treatment profile comprises a 3D treatment profile.
59. 2. The method of claim 1, wherein the processor is configured to compare a target tissue ablation profile of the first tissue to a measured tissue ablation profile of the first tissue and output a comparison of the target tissue ablation profile and the measured tissue ablation profile.
60. 10. The method of claim 1, wherein movement of the second tissue is measured in response to the energy from the energy source, and one or more of the energy source, the movement of the energy source, or the treatment profile are adjusted in response to the movement of the second tissue.
61. 2. The method of claim 1, wherein the first tissue includes tissue of a first organ and the second tissue includes tissue of a second organ different from the first organ, and the processor is configured to process the image data from the tissue of the second organ and output data corresponding to a response of the second tissue to the energy source directed at the tissue of the first organ.
62. 10. The method of claim 1, wherein the first tissue comprises a first tissue structure and the second tissue comprises a second tissue structure different from the first tissue structure, and the processor is configured to adjust one or more of the energy source or treatment profile of the first tissue structure in response to the image data from the second tissue structure.
63. 63. The method of claim 62, wherein the image data from the second tissue structure includes one or more of a shape profile of the second tissue structure, a contrast of the second tissue structure, a blur of the second tissue structure, a movement of the second tissue structure, a bending of the second tissue structure, or a distortion of the second tissue structure.
64. 64. The method of claim 63, wherein the image data from the second tissue structure includes a first image at a first time and a second image at a second time, and the processor is configured to determine, based on the first image and the second image, a change to the one or more of the shape profile of the second tissue structure, the contrast of the second tissue structure, the blur of the second tissue structure, the movement of the second tissue structure, the deflection of the second tissue structure, or the distortion of the second tissue structure in response to the energy source directed at the first tissue.
65. 63. The method of claim 62, wherein the second tissue structure comprises one or more of connective tissue, muscle tissue, epithelial tissue, muscular tissue, or an anatomical structure associated with contrast in the image data.
66. 66. The method of claim 65, wherein the second tissue structure comprises a second type of tissue adjacent to a third type of tissue or fluid to provide the contrast to the image data from the second tissue structure, and optionally the fluid comprises a liquid.
67. 66. The method of claim 65, wherein the anatomical structure of the second tissue structure comprises one or more of a tissue wall, a vesicle, a lumen, a wall of a lumen, a bladder, a wall of a bladder, a bladder neck, a wall of a bladder neck, a trigone tissue, a ureteral orifice, an internal urethral orifice, an external urethral sphincter, a ureter, a wall of a ureter, a prostate, a lobe of a prostate, an intravesical prostatic protrusion, a capsule of a prostate, a vermontanum of a prostate, an internal and external sphincter, an artery, a wall of an artery, a vein, a wall of a vein, or a retina of an eye.
68. 66. The method of claim 65, wherein the anatomical structure of the first tissue structure comprises one or more of a tissue wall, a vesicle, a lumen, a wall of a lumen, a bladder, a wall of the bladder, a bladder neck, a wall of the bladder neck, a ureteral orifice, an internal urethral orifice, an external urethral sphincter, a ureter, a wall of a ureter, a prostate, a lobe of the prostate, an intravesical prostatic protrusion, a capsule of the prostate, an internal and external sphincter, an artery, a wall of an artery, a vein, a wall of a vein, or a lens of an eye.
69. 63. The method of claim 62, wherein the second tissue structure includes a tissue wall facing the first tissue structure, and wherein the one or more of the treatment profile, the movement of the energy source, or the energy source are adjusted in response to the image data from the tissue wall.
70. 70. The method of claim 69, wherein the first tissue structure includes a tissue wall spaced apart from the wall of the second tissue structure, a gap extending therebetween, and wherein the one or more of the treatment profile, the movement of the energy source, or the energy source are adjusted in response to image data from the wall of the second tissue structure.
71. 70. The method of claim 69, wherein the image data from the tissue wall includes one or more of a shape profile of the tissue wall, a contrast of the tissue wall, a blur of the tissue wall, a movement of the tissue wall, a bending of the tissue wall, or a distortion of the tissue wall.
72. 46. The method of claim 45, wherein the image data from one or more of the first tissue or the second tissue is processed using one or more of an artificial intelligence algorithm, image enhancement, image segmentation, a neural network, a convolutional neural network, a Transformer, a Transformer machine learning model, supervised machine learning, unsupervised machine learning, edge detection, feature recognition, segmentation, 3D model reconstruction, or multi-modality image fusion.
73. 46. The method of claim 45, wherein the energy source comprises one or more of an electrode, a loop electrode, a laser source, a mechanical energy source, mechanical shear, an ultrasonic probe, a cavitation ultrasonic probe, a water jet, e.g., a fixed pressure water jet, a plasma source, a vapor source, a morcellator, a transurethral needle, a photoablation source, a radiation energy source, a microwave energy source, or a water jet ejection source.
74. 46. The method of claim 45, wherein the imaging device comprises one or more of an ultrasound transducer array, an external ultrasound transducer array, an ultrasound transducer array on the probe comprising the energy source, an ultrasound probe, an elongated ultrasound probe sized for placement within a lumen, a transrectal ultrasound probe, a transvaginal ultrasound probe, magnetic resonance imaging, a magnetic resonance probe, an endoscope, or a fluoroscopic imaging device.
75. 46. The method of claim 45, wherein the image data comprises one or more of longitudinal image data, sagittal image data, lateral image data, or 3D ultrasound image data, and optionally the image data comprises real-time image data.
76. 46. The method of claim 45, wherein the image data includes a first image from a first time and a second image from a second time, the first image and the second image showing the probe, the first tissue and the second tissue, the second tissue moving between the first image and the second image in response to the energy delivered to the first tissue.
77. 77. The method of claim 76, wherein the first image comprises a first longitudinal image, the second image comprises a second longitudinal image, and the probe comprises an elongated probe shown extending along the first longitudinal image and the second longitudinal image.
78. 78. The method of claim 77, wherein the first longitudinal image comprises a first sagittal image and the second longitudinal image comprises a second sagittal image, and the elongate probe is shown extending along the first sagittal image and the second sagittal image.
79. 77. The method of claim 76, wherein the image data comprises a series of real-time images, and optionally the series of real-time images comprises a frame rate in the range of about 5 hertz (Hz) to about 250 Hz and a latency time from when imaging energy is emitted from the imaging device until an image is shown on the display in the range of about 10 milliseconds (ms) to about 1000 ms.
80. 46. The method of claim 45, wherein the energy from the energy source is scanned across the first tissue at a scanning velocity, and the second tissue moves according to the scanning velocity.
81. 81. The method of claim 80, wherein the scanning rate comprises an angular sweep rate, and the second tissue moves according to the angular sweep rate.
82. 82. The method of claim 81, wherein an amount of movement of the second tissue corresponding to the sweep rate is determined, and optionally the movement of the second tissue is correlated with the angular sweep rate.
83. 82. The method of claim 81, wherein the sweep rate is in the range of about 0.25 Hz to about 30 Hz and the angle of each sweep is in the range of about 10 degrees to about 240 degrees.
84. 46. The method of claim 45, wherein the energy source comprises a water jet, the first tissue comprises an intravesical lobe of a prostate gland extending at least partially within a portion of a bladder, the second tissue comprises trigone tissue, the image data from the trigone tissue is processed, and data output is generated from the processed image data, the output data corresponding to a response of the trigone tissue to the energy directed at the intravesical lobe of the prostate gland, and optionally the lobe comprises a middle lobe of the prostate gland.
85. 46. The method of claim 45, wherein a linkage coupled to the processor and the energy source moves the energy source according to the treatment profile.
86. 46. The method of claim 45, wherein the treatment probe is coupled to a first linkage, the ultrasound device is coupled to a second linkage, the energy source is moved according to the treatment profile, and the imaging device moves with the energy source to maintain the second tissue within a field of view of the imaging device.
87. 87. The method of claim 86, wherein the processor is configured to move the imaging device in synchronization with the energy source to maintain the second tissue within the field of view of the imaging device.
88. 87. The method of claim 86, wherein the image data includes multiple lateral images of the treatment probe, the first tissue, and the second tissue, and the imaging device moves to maintain the energy source, the first tissue, and the second tissue within a transverse field of view of the imaging device.
89. 1. A system for treating a subject, comprising: a probe including an energy source for directing energy to a first tissue to treat the first tissue; an imaging device configured to acquire image data from the first tissue and a second tissue proximate to the first tissue; a processor coupled to the energy source and the imaging device, the processor configured to process the image data from the second tissue and output data related to stretching of the second tissue in response to placement of the probe; A system comprising:
90. 90. The system of claim 89, wherein the first tissue comprises tissue of a first organ and the second tissue comprises tissue of a second organ.
91. 90. The system of claim 89, wherein the processor is configured to output the data related to the stretching of the second tissue to a user interface.
92. 92. The system of claim 91, wherein the processor is configured to output one or more of a warning, notification, or message to a user to adjust one or more of an angle, location, or attitude of the probe.
93. 93. The system of claim 92, wherein the processor is configured to receive input from the user related to the user's response to the one or more of the alert, the notification, or the message.
94. 90. The system of claim 89, wherein the processor is configured to adjust one or more of the probe's placement, angle, location, or six degrees of freedom (6 DOF) attitude in response to data related to extension of the probe.
95. 95. The system of claim 94, further comprising a linkage coupled to the probe and the processor, the linkage configured to adjust one or more of the placement, the angle, the location, or the 6 DOF attitude of the probe.
96. 96. The system of claim 95, wherein the linkage comprises a robotic arm linkage.
97. 95. The system of claim 94, wherein the processor includes instructions to cause a first module to output the data related to the stretching of the second tissue and a second module to receive the data related to the stretching of the second tissue and to adjust the one or more of the angle, the location, or the 6 DOF attitude of the probe.
98. 95. The system of claim 94, wherein the processor is configured to output the data related to the stretching of the second tissue to a user interface, receive user input in response to the data provided to the user interface, and adjust one or more of the placement, angle, location, or attitude of the probe in response to the user input.
99. 90. The system of claim 89, wherein the first tissue comprises tissue of a first organ and the second tissue comprises tissue of a second organ, and the processor is configured to output data corresponding to the stretching of the tissue of the second organ in response to the tissue of the first organ engaging the probe.
100. 90. The system of claim 89, wherein the first tissue includes a first tissue structure detectable in the image data, and the processor is configured to identify the first tissue structure and compare profile data of the first tissue structure to reference profile data to determine the stretch of the first tissue.
101. 101. The system of claim 100, wherein the baseline profile data includes data from a first image of the tissue before placement of the probe.
102. 90. The system of claim 89, wherein the first tissue comprises a first tissue structure detectable in the image data and the second tissue comprises a second tissue structure detectable in the image data.
103. 103. The system of claim 102, wherein the probe is configured to direct the energy source to the first tissue structure, and the processor is configured to identify the second tissue structure and compare profile data of the second tissue structure to reference profile data to determine the stretching of the second tissue structure.
104. 104. The system of claim 103, wherein the baseline profile data includes data from a first image of the tissue before placement of the probe.
105. 103. The system of claim 102, wherein the second tissue structure includes a wall, and the processor is configured to compare profile data of the wall with reference wall profile data to determine the stretching of the wall.
106. 90. The system of claim 89, further comprising one or more sensors coupled to the probe for detecting force from the probe engaging the tissue.
107. 100. The system of claim 99, wherein the one or more sensors are configured to detect tissue pulling the probe.
108. 108. The system of claim 107, wherein the tissue that retracts the probe comprises a wall of a lumen.
109. 109. The system of claim 108, wherein the wall comprises a urethral wall.
110. 1. A method for detecting tissue stretch in a subject, comprising: acquiring image data of a first tissue and a second tissue proximate to the first tissue from an imaging device using a probe positioned at the first tissue, the probe including an energy source for directing energy to the first tissue to treat the first tissue; processing, with a processor, the image data from the second tissue to generate output data related to stretching of the second tissue in response to placement of the probe in the first tissue; A method comprising:
111. 111. The method of claim 110, wherein the first tissue comprises tissue of a first organ and the second tissue comprises tissue of a second organ.
112. 111. The method of claim 110, wherein the processor outputs the data related to the stretching of the second tissue to a user interface.
113. 113. The method of claim 112, wherein the processor outputs one or more of a warning, notification, or message to a user to adjust one or more of an angle, location, or attitude of the probe.
114. 114. The method of claim 113, wherein the processor receives input from the user related to the user's response to the one or more of the alert, the notification, or the message.
115. 111. The method of claim 110, wherein one or more of the probe's placement, angle, location, or six degrees of freedom (6 DOF) pose are adjusted in response to the data related to the extension of the probe.
116. 116. The method of claim 115, further comprising a linkage coupled to the probe and the processor, the linkage configured to adjust the one or more of the placement, the angle, the location, or the 6 DOF attitude of the probe.
117. 117. The method of claim 116, wherein the linkage comprises a robotic arm linkage.
118. 116. The method of claim 115, wherein the processor includes instructions to cause a first module to output the data related to the stretching of the second tissue and a second module to receive the data related to the stretching of the second tissue and to adjust one or more of the angle, the location, or the 6 DOF attitude of the probe.
119. 116. The method of claim 115, wherein the processor is configured to output the data related to the stretching of the second tissue to a user interface, receive user input in response to the data provided to the user interface, and adjust one or more of the placement, angle, location, or attitude of the probe in response to the user input.
120. 111. The method of claim 110, wherein the first tissue comprises tissue of a first organ and the second tissue comprises tissue of a second organ, and the processor is configured to output data corresponding to the stretching of the tissue of the second organ in response to the tissue of the first organ engaging the probe.
121. 111. The method of claim 110, wherein the first tissue includes a first tissue structure detectable in the image data, and the processor is configured to identify the first tissue structure and compare profile data of the first tissue structure to reference profile data to determine the stretching of the first tissue.
122. 122. The method of claim 121, wherein the baseline profile data includes data from a first image of the tissue before placement of the probe.
123. 111. The method of claim 110, wherein the first tissue comprises a first tissue structure detectable in the image data and the second tissue comprises a second tissue structure detectable in the image data.
124. 124. The method of claim 123, wherein the probe is configured to direct the energy source to the first tissue structure, and the processor is configured to identify the second tissue structure and compare profile data of the second tissue structure to reference profile data to determine the stretching of the second tissue structure.
125. 125. The method of claim 124, wherein the baseline profile data includes data from a first image of the tissue before placement of the probe.
126. 124. The method of claim 123, wherein the second tissue structure includes a wall, and the processor is configured to compare profile data of the wall with reference wall profile data to determine the stretching of the wall.
127. 111. The method of claim 110, wherein one or more sensors coupled to the probe detect force from the probe engaging the tissue.
128. 124. The method of claim 123, wherein the one or more sensors detect tissue pulling the probe.
129. 129. The method of claim 128, wherein the tissue that retracts the probe comprises a wall of a lumen.
130. 130. The method of claim 129, wherein the wall comprises a urethral wall.
131. 1. A system for treating tissue of a subject, comprising: a probe comprising an energy source for directing energy to the tissue to treat the tissue, the probe being sized for insertion into the subject; an arm coupled to the probe for supporting the probe; one or more sensors coupled to the probe for measuring forces from the tissue traction on the probe; a processor coupled to the one or more sensors, the processor configured to output data related to the force from the tissue traction on the probe to a user interface; A system comprising:
132. 132. The system of claim 131, wherein the arm and the probe comprise a fixed attitude when the sensor measures the force and the processor provides the data.
133. 132. The system of claim 131, wherein the arm comprises a robotic arm.
134. 132. The system of claim 131, wherein the arm comprises a manually movable arm configured to allow a user to move the arm to reduce the force from the tissue traction on the probe.
135. 132. The system of claim 131, wherein the processor is configured to determine a force vector corresponding to a direction of the tissue traction on the probe.
136. 1. A method for treating tissue in a subject, comprising: receiving data from one or more sensors coupled to a probe to measure a force from the tissue traction on the probe, the probe comprising an energy source for directing energy to the tissue to treat the tissue, the probe being supported by an arm while the probe is inserted into the subject; processing the sensor data to output data related to the force from the tissue traction on the probe to a user interface; A method comprising:
137. 137. The method of claim 136, wherein the arm and the probe comprise a fixed position when the one or more sensors measure the force of the tissue traction on the probe.
138. 137. The method of claim 136, wherein the arm comprises a robotic arm.
139. 137. The method of claim 136, wherein the arm comprises a manually movable arm configured to allow a user to move the arm to reduce the force from the tissue to the sensor.
140. 137. The method of claim 136, wherein the processor is configured to determine a vector corresponding to a direction of the tissue traction on the probe.
141. A computer readable medium configured to perform the method of any preceding claim.
142. A system comprising a processor configured to perform the method of any preceding claim.