Surgical probes for tissue resection with robotic arms

Abstract

To provide surgical probes for tissue resection with robotic arms.SOLUTION: An energy source is coupled to a probe mounted on a robotic arm, and a processor is configured with instructions to release energy to resect tissue in coordination with movement of the robotic arm and probe. The tissue can be resected in accordance with a defined tissue resection volume that can be determined based on images of a patient. The probe can be moved to a plurality of positions with movement of a distal end of the robotic arm, and tissue can be resected in accordance with a treatment plan. The distal end of the robotic arm can be configured to move to a plurality of locations and orientations to provide an appropriate position and orientation of the probe tip and energy source. The processor can be configured with instructions to pivot the probe at a location of decreasing tissue movement near the pivot such as an internal location of the patient.SELECTED DRAWING: None

Description

[Technical Field]

[0001] (Related Applications) This application claims priority to U.S. Patent Application No. 16 / 939,972, filed July 27, 2020, which claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 62 / 933,721, entitled "Surgical Probes for Tissue Resection with Robotic Arms," ​​filed November 11, 2019, the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] Previous methods and devices for resecting tissue may not be ideal in at least some respects. While robotic arms have been used for surgical procedures, previous surgical instruments coupled to the robotic arms may not be ideal in at least some cases. For example, at least some of the previous surgical instruments coupled to the robotic arms may non-selectively resect tissue in at least some cases. Previous surgical instruments may also be somewhat more complex than would be ideal when mounted on a robotic arm.

[0003] Previous robotic arms have been used in which an operator uses a controller to move surgical instruments on the robotic arm to perform surgical procedures, but at least some of the previous approaches do not ideally use imaging and image guidance to guide the probe to the target site where tissue is to be removed.

[0004] In light of the above, improved systems, methods, and devices for improved tissue ablation would be beneficial. Summary of the Invention [Means for solving the problem]

[0005] The disclosed systems, methods, and devices can be used to provide improved surgical procedures. In some embodiments, an energy source is coupled to a probe mounted on a robotic arm, and a processor is configured with instructions for emitting energy to selectively ablate tissue in coordination with movement of the robotic arm and probe. The tissue can be ablated according to a defined tissue ablation volume, which can be determined based on images of the patient. The probe is moved to multiple positions with movement of the distal end of the robotic arm, and the tissue can be ablated according to a treatment plan. The distal end of the robotic arm can be configured to move to multiple locations and orientations to provide appropriate positions and orientations for the probe tip and energy source. In some embodiments, the processor is configured with instructions for pivoting the probe at a location that reduces tissue movement near the pivot axis, and the pivot location can comprise a location internal to the patient. In some embodiments, the energy source of the treatment probe is configured to rotate while the distal end of the robotic arm remains in a fixed location and orientation. Alternatively, the robotic arm can be configured to rotate to rotate the energy source about the extension axis of the treatment probe.

[0006] In some embodiments, a probe coupled to the distal end of the robotic arm includes an irrigation lumen, an aspiration lumen, an endoscope, and an energy source. The irrigation and aspiration lumens can be used to provide a beneficial environment where tissue is removed. In some embodiments, an enclosure, such as a cup, includes an opening for receiving the treatment probe, and the enclosure includes a barrier material to contain the fluid provided by the aspiration lumen. The present invention provides, for example, the following. (Item 1) 1. An apparatus for tissue ablation, said apparatus comprising: A robotic arm, a treatment probe including an energy source coupled to the robotic arm; a processor coupled to the robotic arm for positioning the probe; The device is provided with: (Item 2) Item 1, wherein the robotic arm is configured to position the energy source with a position and orientation for ablating tissue by moving the proximal end of the probe with three or more degrees of freedom, and optionally, the energy source comprises a water jet. (Item 3) Item 10. The apparatus of item 1, wherein the robotic arm is configured to position the energy source by moving the proximal end of the probe. (Item 4) Item 4. The apparatus of item 3, wherein the treatment probe comprises a rigid treatment probe. (Item 5) Item 10. The apparatus of item 1, wherein the robotic arm is configured to rotate the probe about an extension axis extending along the probe. (Item 6) Item 10. The apparatus of item 1, wherein the treatment probe is configured to rotate about an extension axis of the probe while the orientation of the robotic arm remains fixed. (Item 7) Item 10. The apparatus of item 1, wherein the energy source comprises a water jet directed transversely to the extension axis of the probe and emits the water jet at a side of the probe. (Item 8) Item 10. The device of item 1, wherein the energy source comprises a water jet directed along an extension axis of the probe, and emits the water jet toward the tissue in a direction along the extension axis. (Item 9) Item 10. The device of item 1, wherein the treatment probe comprises an irrigation lumen, an endoscope, a high-pressure lumen coupled to a water jet, and a suction lumen for removing excised tissue. (Item 10) Item 10. The device of item 1, wherein the treatment probe comprises an irrigation lumen, an endoscope, a high-pressure lumen coupled to a nozzle for emitting a water jet, an ultrasound transducer, and a suction lumen for removing excised tissue. (Item 11) 2. The device of claim 1, wherein the energy source comprises a water jet, emitting the water jet from an orifice at a flow rate to remove glandular tissue faster than collagenous tissue, and optionally, the collagenous tissue comprises vascular tissue. (Item 12) 12. The apparatus of claim 11, wherein the processor comprises instructions for ablating the tissue with multiple successive layers, each of the multiple successive layers being ablated using a scanning pattern of the water jet. (Item 13) Item 13. The apparatus of item 12, wherein the processor is configured with instructions to move a distal end of the arm, the movement corresponding to the scanning pattern for each of the plurality of layers. (Item 14) Item 14. The apparatus of item 13, wherein the processor is configured with instructions to advance the probe for ablation of a subsequent layer by moving the distal end of the arm. (Item 15) Item 14. The apparatus of item 13, wherein the processor is configured with instructions to increase the flow rate of the water jet for ablation of subsequent layers. (Item 16) Item 10. The device of item 1, wherein the processor is configured with instructions to advance the probe along a tissue resection boundary by moving a distal end of the arm, and the processor is configured to orient the distal end of the arm to orient the probe so as to extend along the tissue resection boundary. (Item 17) 10. The device of claim 1, further comprising an enclosure comprising a barrier material to provide a fluid-filled environment on the surface of the tissue. (Item 18) Item 18. The device of item 17, wherein the enclosure comprises an opening for receiving the treatment probe. (Item 19) 20. The apparatus of claim 17, wherein the processor comprises instructions for pivoting the treatment probe adjacent an opening of the enclosure sized to receive the treatment probe. (Item 20) 20. The apparatus of claim 17, wherein the treatment probe comprises a lumen extending into the enclosure through an opening and sized to provide a fluid into the enclosure, and the treatment probe comprises a suction lumen extending into the enclosure and sized to remove tissue ablation products. (Item 21) Item 10. The apparatus of item 1, wherein the treatment probe comprises an elongated probe sized to extend from an incision in the patient's skin to the organ. (Item 22) Item 10. The apparatus of item 1, wherein the treatment probe comprises an elongated probe sized to extend from an external orifice to an organ. (Item 23) Item 10. The apparatus of item 1, wherein the processor is configured with instructions to move and orient the distal end of the arm to pivot the probe between the proximal end of the probe and the distal end of the probe to reduce probe movement about a pivot axis. (Item 24) 24. The apparatus of claim 23, wherein the processor is configured with instructions to receive input corresponding to a location of a blood vessel, and the processor is configured with instructions to pivot the probe at a location away from the blood vessel. (Item 25) 24. The apparatus of claim 23, wherein the processor is configured with instructions to receive input corresponding to a location near the pubic bone, the processor being configured with instructions to pivot the probe at the location to reduce movement of the probe near the pubic bone. (Item 26) 2. The device of claim 1, wherein the treatment probe comprises an elongated probe sized to extend from the opening of the urethra to the prostate, and the processor is configured with instructions to pivot the probe at a location near one or more of the verumontanum of the prostate, the external sphincter of the urethra, or a location between the verumontanum and the external sphincter. (Item 27) Item 10. The device of item 1, wherein a portion of the probe proximal to the pivot location is configured to move in an opposite direction to a distal end of the probe, and optionally, an external opening to the urethra moves in an opposite direction to the distal end of the probe. (Item 28) Item 10. The apparatus of item 1, wherein the probe comprises a deflectable tip portion. (Item 29) Item 29. The device of item 28, wherein the deflectable tip portion comprises a flexible tip portion. (Item 30) 29. The device of item 28, wherein the deflectable tip is configured to separate the glandular tissue from the capsular tissue along the tissue interface. (Item 31) Item 29. The device of item 28, wherein the deflectable tip is configured to deflect in response to a user input to the processor, and optionally the deflectable tip comprises a plurality of elongated elements for deflecting the tip in response to the user input. (Item 32) Item 29. The device of item 28, wherein the deflectable tip comprises a lumen and a nozzle for emitting a fluid stream, optionally the lumen comprising a high pressure lumen and the fluid stream comprising a water jet emitted from the nozzle. (Item 33) Item 1, wherein the probe is configured for insertion into one or more of the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testes, bladder, ears, nose, mouth, bone marrow, adipose tissue, muscle, glandular and mucosal tissue, spinal cord and nerve tissue, soft tissue such as cartilage, hard biological tissue such as teeth, bone, and body lumens and passageways such as sinuses, ureters, colon, esophagus, pulmonary passageways, blood vessels, and throat. (Item 34) Item 10. The apparatus of item 1, wherein the processor comprises instructions for presenting an image of an organ to a user on a display, receiving input from the user, and identifying one or more of a tissue resection boundary, an area of ​​tissue to be resected, or an area of ​​tissue that should not be resected, and optionally, the area of ​​tissue that should not be resected is within the boundary of the tissue to be resected. (Item 35) Item 10. The apparatus of item 1, wherein the processor comprises instructions for providing a plurality of images to a user, the plurality of images comprising a plurality of tomographic image slices, and the processor is configured to receive input from the user regarding the plurality of images and generate one or more of a 3D tissue resection boundary, a 3D region of tissue to be resected, or a 3D region of tissue that should not be resected, and optionally, the 3D region of tissue that should not be resected is within the 3D boundary of the tissue to be resected. (Item 36) Item 10. The apparatus of item 1, wherein the processor comprises instructions for receiving a plurality of images of a patient, the plurality of images comprising a plurality of tomographic image slices, and the processor is configured to identify one or more of a tissue resection boundary, an area of ​​tissue to be resected, or an area of ​​tissue that should not be resected, and optionally, the area of ​​tissue that should not be resected is within the boundary of the tissue to be resected in the plurality of images. (Item 37) Item 37. The apparatus of item 36, wherein the processor is configured with instructions for generating one or more of a 3D tissue resection boundary, a 3D region of tissue to be resected, or a 3D region of tissue that should not be resected, and optionally, the 3D region of tissue that should not be resected is within the 3D boundary of the tissue to be resected. (Item 38) 38. A method, the method comprising providing or using a device according to any one of items 1-37.

[0007] (Incorporated by reference) All patents, applications, and publications referenced and identified herein are incorporated by reference in their entirety and shall be considered incorporated by reference in their entirety even if referenced elsewhere in this application. [Brief explanation of the drawings]

[0008] A better understanding of the features, advantages, and principles of the present disclosure will be obtained by reference to the following detailed description and accompanying drawings that set forth illustrative embodiments.

[0009] [Figure 1] FIG. 1 shows a front view of a system for performing tissue ablation in a patient, according to some embodiments.

[0010] [Figure 2] FIG. 2 diagrammatically illustrates a system for performing tissue ablation in a patient, according to some embodiments.

[0011] [Figure 3] 3A and 3B show perspective views of a common base or mount for supporting one or more robotic arms, according to some embodiments.

[0012] [Figure 4A] 4A and 4B illustrate perspective and side views, respectively, of a system for performing tissue ablation on a patient comprising a mobile base, according to some embodiments. [Figure 4B] 4A and 4B illustrate perspective and side views, respectively, of a system for performing tissue ablation on a patient comprising a mobile base, according to some embodiments.

[0013] [Figure 5A] FIG. 5A shows a treatment probe coupled to a robotic arm, where the distal end of the robotic arm is configured to move the proximal end of the treatment probe with six degrees of freedom, according to some embodiments.

[0014] [Figure 5B] FIG. 5B shows a treatment probe coupled to a robotic arm as in FIG. 5A, with the distal end portion of the treatment probe equipped with a deflectable tip, according to some embodiments.

[0015] [Figure 5C] FIG. 5C shows a probe pivoting around a location, according to some embodiments.

[0016] [Figure 6] FIG. 6 illustrates a treatment probe coupled to the distal end of a robotic arm, where the treatment probe is equipped with one or more of irrigation, suction, a robotic energy source, or a camera, according to some embodiments.

[0017] [Figure 7A] FIG. 7A shows a tissue ablation profile, according to some embodiments.

[0018] [Figure 7B] FIG. 7B shows a tissue ablation profile for removing tissue away from a tumor, according to some embodiments.

[0019] [Figure 7C] FIG. 7C shows a 3D tissue ablation profile around a tumor to remove tissue away from the tumor, according to some embodiments.

[0020] [Figure 7D] FIG. 7D shows a cone-shaped tissue ablation profile for removing tissue away from a tumor, according to some embodiments.

[0021] [Figure 8] FIG. 8 shows a treatment probe with a rotating energy source coupled to the distal end of a robotic arm such as in FIG. 5, according to some embodiments.

[0022] [Figure 9] 9-12B illustrate a method of tissue ablation using a water jet, according to some embodiments. [Figure 10] 9-12B illustrate a method of tissue ablation using a water jet, according to some embodiments. [Figure 11]9-12B illustrate a method of tissue ablation using a water jet, according to some embodiments. [Figure 12] 9-12B illustrate a method of tissue ablation using a water jet, according to some embodiments.

[0023] [Figure 13] FIG. 13 illustrates selective tissue ablation and removal of unwanted tissue from an organ for 3D tissue removal using 3D volumetric imaging, according to some embodiments.

[0024] [Figure 14] FIG. 14 shows an image of the right and middle hepatic veins of the liver shown on a display for 3D tissue removal using 3D volumetric imaging, according to some embodiments.

[0025] [Figure 15] FIG. 15 shows an image of a hemangioma of the liver shown on a display for 3D tissue removal using 3D volumetric imaging, according to some embodiments.

[0026] [Figure 16] FIG. 16 shows an image of a liver cancer tumor shown on a display for 3D tissue removal away from the tumor using 3D volumetric imaging, according to some embodiments.

[0027] [Figure 17] FIG. 17 shows cirrhotic liver tissue for removal shown on a display for 3D tissue removal using 3D volumetric imaging, according to some embodiments.

[0028] [Figure 18] FIG. 18 shows a CT scan of liver tissue shown on a display for 3D tissue removal using 3D volumetric imaging, according to some embodiments.

[0029] [Figure 19]19A, 19B, 19C, and 19D show MRI of the liver shown on a display for 3D tissue removal using 3D volumetric imaging, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0030] The following detailed description provides a deeper 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.

[0031] Embodiments of the present disclosure provide improved methods and devices for performing tissue ablation, such as prostate tissue ablation. The methods and devices disclosed herein are well suited to many types of surgical procedures and can be incorporated into many previous systems and methods. While some embodiments of the present disclosure are directed to transurethral treatment of the prostate, some aspects of the present disclosure may also be used to treat and modify other tissues and associated organs. These other tissues and associated organs include, but are not limited to, the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testes, bladder, ears, nose, mouth, bone marrow, adipose tissue, muscle, glandular and mucosal tissue, spinal cord and nerve tissue, soft tissues such as cartilage, hard biological tissues such as teeth and bone, and body lumens and passageways such as sinuses, ureters, colon, esophagus, pulmonary passageways, blood vessels, and throat. The devices disclosed herein can be inserted through existing body lumens or through openings created in body tissue.

[0032] The disclosed methods and devices are well suited for treating many types of tissue using an energy source. The tissue may include soft tissue, such as glandular or capsular tissue, or hard tissue, such as bone or obstructions like kidney stones. The energy source may include one or more of the following: a laser beam, a water jet, an electrode, ultrasound, high-intensity focused ultrasound, mechanical vibration, radiofrequency (RF) energy, an ultrasound transducer, microwave energy, cavitation energy, such as a cavitation-forming water jet or ultrasonic cavitation, radiation, such as ionizing radiation from a radioisotope, or ion energy from an ionizing electrode, or plasma energy from a plasma electrode. The disclosed methods and devices are well suited for, for example, performing lithotripsy and destroying kidney stones. The disclosed methods and devices are well suited for treatment with radiation, such as a radioisotope on a treatment probe. Radiation therapy can be delivered onto the probe, removed using the probe, or implanted from the treatment probe, for example, for the treatment of cancer.

[0033] In some embodiments, the image-guided therapy system includes a therapy probe and an imaging probe. The imaging probe can be configured to provide images of the target site while the therapy probe performs ablation of the target tissue. Each of the therapy probe and the imaging probe can be coupled to a robotic arm under the control of one or more computing devices to enable more precisely controlled movement of one or both of the arms and to improve the safety and efficiency of therapy using the therapy system.

[0034] FIG. 1 illustrates an exemplary embodiment of a system 400 for performing tissue ablation in a patient. The system 400 may include a treatment probe 450 and an imaging probe 460. 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 arms. The treatment probe 450 may include a device for removing target tissue from a target site within a patient. The treatment probe 450 may be configured to deliver sufficient energy from the treatment probe 450 to the target tissue to ablate the target tissue. 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, an ultrasound ablation transducer, or any combination thereof. The imaging probe 460 may be configured to deliver sufficient energy to the target tissue to image the target tissue. 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 patient's prostate. 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 target site on the patient along an entry axis that coincides with the treatment probe's extension 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 along an entry axis coincident with the imaging probe's extension axis 461 at or adjacent to the patient's target site. For example, the imaging probe 460 may comprise a transrectal ultrasound (TRUS) probe configured for insertion into the patient's rectum to visualize 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 embodiments as disclosed herein may 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 PCT Publication No. WO2013 / 130895, the entire disclosures of which are incorporated herein by reference.

[0035] FIG. 2 schematically illustrates an exemplary embodiment of a system 400 for performing tissue ablation on a patient. The system 400 includes a treatment probe 450 and may optionally include 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 using a patient support 449. The treatment probe 450 is coupled to the base 440 using a first arm 442. The imaging probe 460 is coupled to the base 440 using 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, as described in further detail herein.

[0036] Although a common base is referenced, the robotic arms can be coupled to a bed rail, a console, or any suitable support structure to support the base of the robotic arms.

[0037] 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 the robotic arm. In some embodiments, the user input device includes a controller for moving the end of a treatment or imaging probe 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 can include a six-degrees-of-freedom input controller that allows the user to move the input device in six degrees of freedom, such that the distal end of the probe moves 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 to switch between automated image-guided therapy using an energy source and therapy using an energy source, for example, by user movement of the user input device.

[0038] The patient is positioned on a patient support 449 so that the treatment probe 450 and the ultrasound probe 460 can be inserted into the patient. The patient can be positioned in one or more of 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 can 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 front of the patient, and the imaging probe can be inserted transrectally into the patient's intestine from the back of the patient. The treatment probe and the imaging probe can be positioned within the patient with one or more of urethral tissue, urethral wall tissue, prostate tissue, intestinal tissue, or intestinal wall tissue extending between them.

[0039] The treatment probe 450 and the imaging probe 460 can be inserted into a patient in one or more of many ways. During insertion, each of the first and second arms can have a substantially unlocked configuration so that the treatment or imaging probe can be rotated and translated as desired to insert the probe into the patient. When the probe is inserted at a 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 many ways, such as parallel, twisted, horizontal, oblique, or non-parallel. It can be useful to determine the orientation of the probe using an angle sensor as described herein to map imaging probe image data to the treatment probe coordinate reference. Having tissue image data mapped 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.

[0040] In some embodiments, the treatment probe 450 is coupled to the imaging probe 460 to align the treatment with the probe 450 based on images from the imaging probe 460. 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 to hold the probe in alignment through the patient's tissue. In some embodiments, the first arm 442 is a movable and lockable arm so that the treatment probe 450 can be positioned at a desired location within the patient. Once the probe 450 is positioned at a desired location within the patient, the first arm 442 can be locked using an arm lock 427. The imaging probe can be coupled to the base 440 using a second arm 444, which can be used to adjust the alignment of the imaging probe when the treatment probe is locked in place. The second arm 444 can include a lockable and movable arm, for example, under the control of the imaging system, or a console and user interface. The movable arm 444 may be finely actuated so that the imaging probe 440 may be adjusted relative to the treatment probe 450 with movements as small as, for example, one millimeter.

[0041] 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 using the 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 therapy probe's extension axis 451. The second angle sensor 497 may comprise a goniometer for determining the angle of the imaging probe 460 along the extension 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.

[0042] The console 420 includes a display 425 that is coupled to a processor system and 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 the controller 422. 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 can be coupled to the first arm 442 to lock the first arm or to allow the first arm to be freely movable for inserting the probe 450 into a patient.

[0043] Optionally, the console 420 may include components of an endoscope 426 that are coupled to anchors 24 of the treatment probe 450. The endoscope 426 may include components of the console 420 and an endoscope that is insertable with the treatment probe 450 to treat a patient.

[0044] Optionally, console 420 may include one or more modules operably coupled to treatment probe 450 to control aspects of treatment using the treatment probe. For example, 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 at 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 insufflation control 32 for controlling 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 optical energy to the treatment probe.

[0045] 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-procedure planning according to user-defined treatment parameters and to provide user control over the surgical procedure.

[0046] The treatment probe 450 may include an anchor 24. The anchor 24 may anchor the distal end of the probe 450 while energy is delivered to the energy delivery region 20 with the probe 450. The probe 450 may include a nozzle 200.

[0047] The treatment probe 450 may be coupled to the first arm 442 using a linkage 430. The linkage 430 may include components for moving the energy delivery region 20 to a desired target location on a patient, for example, based on an image of the patient. The linkage 430 may include a first portion 432, a second portion 434, and a third portion 436. The first portion 432 may include a substantially fixed anchor portion. The substantially fixed anchor portion 432 may be fixed to a support 438. The support 438 may include a reference frame for the linkage 430. The support 438 may include a rigid chassis or frame or housing for rigidly or firmly 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 a substantially fixed distance 437 to the anchor 24. The substantially fixed distance 437 between the anchor 24 and the fixed first portion 432 of the linkage allows the treatment to be precisely placed. The first portion 424 may include a linear actuator for precisely positioning the high-pressure nozzle 200 within the energy delivery region 20 at a desired axial location along the extension axis 451 of the treatment probe 450.

[0048] The extension axis 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 an attached anchor 24. The third portion 436 can control a rotation angle 453 about the extension axis 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 can be adjusted in a manner 418 responsive to a computer control to set a target location along the extension axis 451 of the treatment probe relative to the anchor 24. While the first portion of the linkage remains fixed, the second portion 434 adjusts the position of the energy delivery region 20 along the axis 451. The third portion 436 of the linkage adjusts the angle 453 about the axis 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 comprise 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 optical energy from a light source, such as a laser source. The light source may comprise infrared, visible, or ultraviolet light. The energy delivery region 20 can be moved under the control of the linkage 430, such as to deliver the intended form of energy to the patient's target tissue.

[0049] 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 precisely positioning the imaging probe 460. The imaging console may further include a display 425.

[0050] To facilitate precise control of the treatment probe and / or imaging probe during patient treatment, each of the treatment probe and imaging probe 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. 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 to the processor 423 of the console 420. One or more computing devices, such as the processors 423 and 492, may comprise computer-executable instructions for controlling movement of one or more robotic arms. The first and second robotic arms may be substantially similar in structure and function, or they may differ to accommodate the specific functional requirements for controlling the movement of the treatment probe versus the imaging probe.

[0051] The robotic arm may have six, seven, 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.

[0052] 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 patient treatment 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 on the memory of the one or more computing devices. As an alternative to, or in addition to, automatic adjustment of 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. As an alternative to, 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, anatomical structures recognized in one or more images captured by an imaging probe or other imaging source (from which an acceptable range of motion for the treatment probe and / or imaging probe may 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.

[0053] 3A and 3B show exemplary embodiments of a common base or mount 440 for supporting one or more robotic arms of an image-guided therapy system as disclosed herein. FIG. 3A shows a patient support 449 including one or more rails 452. The patient support 449 may include a surgical table or platform. One or more robotic arms associated with one or more of the treatment probes or imaging probes may be mounted to the rails 452 such that the rails function as the common base 440. FIG. 3B shows the common base 440 including a floor stand 454 configured to couple to a first robotic arm connected to a treatment probe and / or a second robotic arm connected to an imaging probe. The floor stand 454 may be positioned between the patient's legs during a therapy procedure.

[0054] 4A and 4B illustrate an exemplary embodiment of a treatment system 400 as described herein that includes a mobile base 470. FIG. 4A is a front view of the treatment system 400, and FIG. 4B is a side view thereof. The treatment system 400 includes a treatment probe 450 coupled to a first robotic arm 442 and an imaging probe 460 coupled to a second robotic arm 444. The first robotic arm 442 and the second robotic arm 444 each include a proximal end and a distal end, the distal ends coupled to the treatment probe 450 and the imaging probe 460, respectively, and the proximal ends coupled to a common base 440 that includes the mobile base 470. The first robotic arm 442 may include a first arm coupling structure 504 for coupling to the treatment probe 450, and the second robotic arm 442 may include a second arm coupling structure 505 for coupling to the imaging probe 460. The treatment probe 450 may be coupled to the distal end of the first robotic arm 442 via a mounting device 500, which may include a linkage configured to effect movement (e.g., rotation, translation, pitch, etc.) of the treatment probe as described herein. The coupling of the treatment probe 450 to the first robotic arm 442 may be fixed, releasable, or user-adjustable. Similarly, the coupling of the imaging probe 460 to the second robotic arm 444 may be fixed, releasable, or user-adjustable.

[0055] The first robotic arm 442 may articulate at one or more first arm joints 443. The imaging arm 444 may articulate at one or more second arm joints 445. Each arm joint 443 or 445 may be operatively coupled to a computer-controllable actuator, such as a stepper motor, for affecting movement at the joint. Each arm joint 443 or 445 may comprise one of a variety of kinematic joints, including, but not limited to, a rectangular, revolute, parallel cylinder, cylindrical, spherical, planar, edge slider, cylindrical slider, point slider, spherical slider, or cross-cylinder joint, or any combination thereof. Furthermore, each arm joint 443 or 445 may comprise a linear, orthogonal, revolute, torsional, or rotary joint, or any combination thereof.

[0056] The system 400 may further include a console 420 as described herein, which may be supported by a mobile support 480 separate from the mobile base 470. The console 420 may be operably coupled to the mobile base 470 via a power and communication cable 475 to enable control of a treatment probe 450 coupled to the mobile base via a first robotic arm. The treatment console 420 includes a processor and memory having stored thereon computer-executable instructions for execution by the processor to control various modules or functions of the treatment console, such as an energy source, an infusion / irrigation control, an aspiration control, and other components as described herein with reference to FIG. 2. The treatment console 420 may further include a display 425 in communication with the processor. The display 425 may be configured to display one or more of the following: subject vital signs, such as heart rate, respiratory rate, temperature, blood pressure, oxygen saturation, or any physiological parameter, or any combination thereof; the status of the procedure; one or more pre-captured images or a series of images of the treatment site from one or more views, one or more real-time images or a series of images of the treatment site from one or more views obtained by the imaging probe 460; a set of treatment parameters, including, but not limited to, the treatment mode, such as cut or coagulation, the intensity of the treatment, the time elapsed during treatment, the time remaining during treatment, the depth of treatment, the area or volume of the treatment site that has been treated, the area of ​​the treatment site that will be treated, the area or volume of the treatment site that will not be treated, location information for the treatment probe 450 or the imaging probe 460, or both; treatment adjustment controls, such as means for adjusting the depth of treatment, the intensity of treatment, the location and / or orientation of the treatment probe 450, the imaging depth, or the location and / or orientation of the imaging probe 460, or any combination thereof; or system configuration parameters.

[0057] The mobile base 470 may further comprise one or more computing devices for controlling the movement of one or more robotic arms. For example, the mobile base may comprise a processor and a memory having computer-executable instructions stored thereon for execution by the one or more processors. The memory may have instructions stored thereon for operating one or more robotic arms coupled to the mobile base. The processor may be operably coupled to the robotic arms via suitable electromechanical components to affect the movement of the robotic arms. For example, each of one or more joints of the robotic arms may comprise a stepper motor, and the processor may be operably coupled to the stepper motor at each joint to actuate the motor by specified increments in specified directions. Alternatively, the one or more robotic arms may be operatively coupled to one or more processors of the console 420 or a separate imaging console (such as the imaging console 490 shown in FIG. 2), and the one or more console processors may be configured to execute instructions for controlling the movement of the one or more robotic arms and may communicate the instructions to the robotic arms via communications circuitry (such as the communications circuitry 422 of the console 420 or the communications circuitry 494 of the console 490 shown in FIG. 2). The computer-executable instructions for controlling the movement of the robotic arms may be pre-programmed and stored on memory, or may be provided by a user via one or more user inputs prior to or during treatment of a patient using the treatment system.

[0058] One or more computing devices operably coupled to the first and / or second robotic arms may be configured to control movement of the arms to adjust the pitch, yaw, roll, and / or linear position of the treatment probe and / or imaging probe along the target site.

[0059] The mobile base 470 may include one or more user input devices to allow a user to control the movement of the robotic arms under computer command. For example, as shown in FIGS. 4A and 4B , the mobile base may include a keyboard 474 and / or a footswitch 471 operably coupled to the mobile base via a footswitch cable 472. The keyboard 474 and footswitch 471 may be configured independently or in combination to control the movement of the first robotic arm 442 and / or the second robotic arm 444, for example, via articulation of one or both robotic arms at one or more joints. The keyboard and footswitch may communicate with one or more processors configured to control the movement of the robotic arms. When a user inputs commands into the keyboard and / or footswitch, the user commands can be received by the one or more processors and converted into electrical signals, which can be transmitted to one or more computer-controllable actuators operably coupled to one or more robotic arms. The keyboard and / or footswitch may control the movement of one or both arms towards or away from a treatment position, a position of interest, a predetermined location, or a user-defined location, or any combination thereof.

[0060] Optionally, the keyboard 474 and footswitch 471 may be configured to independently or in combination to control the operation of the treatment probe 450 and / or the imaging probe 460. For example, the keyboard 474 and / or footswitch 471 may be configured to start, stop, pause, or resume treatment with the treatment probe. The keyboard 474 and / or footswitch 471 may be configured to initiate imaging or to freeze, save, or display on the display 425 an image or sequence of images previously or currently acquired by the imaging probe.

[0061] The mobile base 470 and mobile support 480 of the console 420 may be independently positionable around a patient supported by a patient support 449, such as a platform. For example, the mobile base 470 supporting the first and second robotic arms and the treatment and imaging probes may be positioned between the patient's legs, while the mobile support 480 carrying the console 420 and display 425 may be positioned to the side of the patient, such as near the patient's torso. The mobile base 470 or mobile support 480 may include one or more movable elements, such as multiple wheels, that allow the base or support to move. The mobile base 470 may be covered with sterile draping throughout the treatment procedure to prevent contamination and fluid ingress.

[0062] FIG. 5A shows a treatment probe 450 coupled to a robotic arm 442, the distal end of which is configured to move the proximal end of the treatment probe as described herein with six degrees of freedom. The treatment probe 450 and the robotic arm 400 may comprise one or more components of the system 400 as described herein. These movements of the proximal end of the probe correspond to movements of an energy source 455 near the distal end of the probe. In some embodiments, the robotic arm comprises six degrees of freedom, and the probe is moved according to instructions from a processor, which may comprise instructions of a programmed treatment plan, or in response to user input controls. The probe tip 462 can be moved to multiple locations to ablate tissue 600 as the robotic arm 442 moves. In some embodiments, an enclosure 602 is placed over the tissue 600 to be ablated to provide a beneficial fluid environment for the tissue 600 for tissue ablation. Alternatively, the probe tip 462 can be inserted through an opening into the patient and into a cavity within the patient, such as an organ 608 as described herein, which can provide a beneficial fluid environment. In some embodiments, the probe comprises a rigid probe, which allows the position of the probe tip 462 to be precisely positioned and oriented in response to the position and orientation of the distal end of the robotic arm. Alternatively, the probe may comprise a flexible probe, in which at least a portion of the probe is flexible. The energy source 455 near the tip 462 of the treatment probe 450 may comprise any energy source 455 as described herein.

[0063] The tissue access site can be accessed in one or more of a number of ways, for example, using open surgical access through an incision, using access through a small incision, or using insertion through an external opening in a body lumen such as the urethra. Access may comprise, for example, access for an open prostatectomy or an open nephrectomy.

[0064] The enclosure 602 may comprise any suitable barrier material, such as plastic, silicone, or other material, that allows a suitable environment to be provided for the tissue 600. In some embodiments, the enclosure 602 comprises a flexible material that can deform and contour to the surface of the tissue 600 on which it is placed.

[0065] FIG. 5B shows a treatment probe 450 coupled to a robotic arm 442 as in FIG. 5A , where the distal end portion of the treatment probe comprises a deflectable tip 462. The treatment probe 450 and the robotic arm 400 may comprise one or more components of the system 400 as described herein. The deflectable tip 462 can be configured in many ways. For example, the deflectable tip 462 may comprise a flexible, elongated tubular member capable of bending and deflecting in response to a patient's internal lumen. In some embodiments, the deflectable tip 462 comprises a controllable tip in which the amount of deflection 604 can be controlled in response to commands. For example, the tip 462 may comprise a pull wire or other elongated element that allows the angle of deflection to be controlled in response to, for example, one or more of a processor, a user interface, or a user input device. In some embodiments, the probe comprises a rigid probe when deflected to a controlled position. The treatment probe 450 can be configured to rotate about its extension axis in combination with movement of the end of the robotic arm as described herein to direct energy to a targeted tissue location. In some embodiments, the probe is configured to deflect its distal end as the probe rotates about its extension axis to direct energy to a targeted tissue location. In some embodiments, the probe includes a rigid deflector to resist force from a water jet emitted from the probe. In some embodiments, the probe includes multiple openings, one opening directed toward the tissue and another water jet directed in the opposite direction, e.g., toward a shield, to provide a force that counteracts the force of the water jet.

[0066] 5C illustrates probe pivoting of the treatment probe 450 about a location 610. The processor can be configured with instructions for pivoting the probe 450 about the pivot location 610, which can comprise any suitable location. For example, the pivot location 610 can correspond to an opening of an enclosure or an opening to an internal body lumen. In some embodiments, the pivot location 610 is near the patient's verumontanum, near the external sphincter of the urethra, or between the verumontanum and the external sphincter. Alternatively, or in combination, in some embodiments, the surgical pivot location 610 corresponds to the pubic bone.

[0067] Although the pivoting movement can be configured in many ways, it can be configured to move the proximal end of the probe along a path 606 to move the probe tip 462 along a corresponding path to direct energy to a targeted tissue location. The proximal end path 606 can define an enclosed volume, and the distal end path 608 can define an enclosed volume around the tissue 600 to be removed to separate the tissue 600 from surrounding tissue, such as an organ 608. For example, the treatment probe can pivot about a pivot location 610 while benign prostatic hyperplasia is being removed from an organ, such as the prostate, using an energy source 455 located within the prostate capsule. Because tissue near the end of the external opening of the urethra is typically flexible near the open end of the urethra, the tissue near the open end of the urethra can move as well as the proximal end of the probe, and the pivot location 610 is between the proximal end of the urethra and the distal end of the probe. In some embodiments, the tissue treatment area, for example the prostate, is scanned using a scanning pattern and the external opening to the urethra moves in a corresponding pattern, with the pivot location 610 between them.

[0068] The deflectable tip 462 of the probe can be used in many ways. For example, the flexible probe tip 462 can be used to separate capsular tissue from glandular tissue using an energy source 455, such as a laser energy source as described herein. In some embodiments, the deflectable probe tip 462 can be used to separate glandular tissue from capsular tissue, for example, to separate the prostate capsule from the prostate glandular tissue. In some embodiments, the probe tip 462 deflects in response to the increased resistance of the capsule to movement compared to the resistance of the glandular tissue. In some embodiments, the probe tip 462 can be controlled by a system operator to move along the interior boundary of the capsule to separate the capsule from the glandular prostate tissue. Research related to embodiments suggests that the capsular tissue is loosely connected to the glandular tissue along the interface between the capsule and the glandular tissue, such that the capsular tissue can be separated from the glandular tissue using mechanical force along the interior of the capsular tissue. In some embodiments, the deflectable tip 462 is configured to deflect under user control, for example, with an elongated element extending along the deflectable tip 462, so that the user can control the amount of deflection 604. The deflectable probe tip 462 may include an energy source 455 as described herein or may transmit mechanical energy to the tip 462 as the tip 462 moves to separate the capsular tissue from the glandular tissue.

[0069] In some embodiments, the probe 450 is placed and pulled over the capsule of the organ 608 to be resected to facilitate separation of the capsule from the glandular tissue.

[0070] FIG. 6 shows a treatment probe 450 coupled to the distal end of a robotic arm such as that in FIG. 5. The treatment probe includes one or more of: a fluid delivery lumen, such as an irrigation lumen 612 and a delivery port; an endoscope 614, such as a camera for viewing the surgical site; an energy delivery channel, such as a robotic water jet device, and an energy source 455, such as a water jet; and an aspiration lumen 618. The probe may include an elongated probe and may extend a distance ranging from about 5 cm to about 50 cm from the proximal end of the probe to the distal end of the probe. An enclosure may be placed over the tissue to fluidly separate the tissue to create a beneficial environment for tissue ablation. For example, the fluid delivery lumen 612 may be connected to a source of a fluid, such as a gas, e.g., CO2, or a liquid, e.g., water or saline. In some embodiments, the energy source 455 includes a water jet emitted from the end of the probe. For example, the energy source 455 may direct energy coaxially aligned with the axis of the energy delivery channel, e.g., in a line out the end of the energy delivery channel. The energy delivery channel may comprise any suitable structure for delivering energy, such as one or more optical fibers for delivering light energy, tubes for delivering water jet energy, wires for electrical energy or cauterization or ultrasonic energy to the treatment site.

[0071] In some embodiments, the treatment probe 450 comprises a substantially linear, rigid probe with water jets emitted from the end of the probe. The water jets 455 can be scanned to selectively ablate tissue in response to movement of the robotic arm. For example, the robotic arm 442 can be configured to move the distal end of the probe in a scanning pattern by moving the proximal end of the probe coupled to the robotic arm. While a robotic arm with six degrees of freedom is referenced, the robotic arm may have fewer degrees of freedom, e.g., three translational degrees of freedom for moving the water jets from the probe in a scanning pattern.

[0072] In some embodiments, one or more ultrasound probes 620 are coupled to the tissue 600. For example, the one or more ultrasound probes 620 may comprise external ultrasound probes that are coupled to the tissue 600 through the patient's skin. Alternatively, the one or more ultrasound probes 600 may comprise probes that are inserted into the patient. The ultrasound probes 600 can be configured to provide, for example, three-dimensional imaging.

[0073] In some embodiments, one or more imaging markers 622 can be placed on the tissue 600 to track movement of the tissue 600 and maintain alignment of the treatment probe 620 with the target tissue.

[0074] In some embodiments, a contrast agent is injected into a blood vessel, such as an artery, to improve imaging of one or more of the tissues or blood vessels.

[0075] In some embodiments, the robotic arm 442 and probe 450 are configured to provide positional accuracy of the probe tip 462 and energy source 455 within a desired tolerance, for example, within about 2 mm of the intended target location of the end of the probe.

[0076] 7A shows a tissue ablation profile 700 for ablating tissue to a depth with a first removal layer. The tissue ablation profile 700 can be generated using instructions on a processor to move the tissue in a scan pattern 702 by moving the proximal end of the robotic arm, moving the tip of the probe and water jet to the appropriate location, and scanning the tissue with the scan pattern 702.

[0077] FIG. 7B shows a tissue ablation profile 700 for removing tissue 600 away from unwanted tissue, such as a tumor, which may comprise a cancerous or benign tumor. Research relevant to the present disclosure suggests that it may be useful to ablate tissue around the tumor boundary, leaving the tumor substantially intact. Other unwanted tissue, such as cirrhotic tissue or other tissue as described herein, can be similarly removed. The tissue ablation profile 700 can be generated using instructions on a processor to move the tissue in a scan pattern 702 by moving the proximal end of the robotic arm and moving the tip of the probe and water jet to appropriate locations around the ablation boundary 704. Once the tissue 600 is ablated around the ablation boundary 704 to separate the tumor from healthy tissue, the unwanted tissue can be removed. While FIG. 7B illustrates tissue ablation along layers of ablation, in some embodiments, the tissue is ablated sequentially, with multiple layers of removal. For example, a first layer can be removed where tissue is ablated up to the ablation boundary 600, and a second ablation layer can be ablated up to a second ablation boundary. For 3D tissue ablation, multiple ablation layers and boundaries 600 can be defined to remove tissue along the 3D boundaries using a 3D tissue ablation profile.

[0078] FIG. 7C shows a 3D tissue ablation profile 700 around a tumor to remove tissue away from the tumor. A probe on a robotic arm can be scanned using a 3D scan pattern 702 in response to instructions from a processor. For example, the proximal end of the probe can be moved with five or six degrees of freedom by moving the robotic arm accordingly to direct an energy source, such as a water jet, at a target tissue site. In some embodiments, the water jet is directed, e.g., substantially linearly, out from the end of the probe aligned with the axis of the probe. The proximal end of the probe can be translated and rotated to provide ablation along a three-dimensional tissue ablation boundary 704. In some embodiments, tissue 600 can be ablated in multiple layers of substantially equal depth, with the probe removing each subsequent layer after tissue has been ablated along the boundary relative to the previous layer. The angle of the probe's extension axis can be tilted at various angles along the tissue ablation boundary 704 to reduce tissue movement associated with the probe, for example, as the probe is inserted further into the tissue along the boundary 704.

[0079] 7D shows a cone-shaped tissue ablation profile 700 for removing tissue 600 away from a tumor. The probe can be moved and aimed along a scan pattern 702 to direct an energy source, e.g., a water jet, along a tissue ablation boundary 704. For example, the probe can be moved in a movement direction 630 to multiple positions and orientations 640 corresponding to the frustum of a cone 632 to ablate a cone ablation boundary 704 using an energy source, e.g., a water jet.

[0080] 8 shows a treatment probe 450 including a rotating energy source 455, such as a water jet, coupled to the distal end of a robotic arm 442. The probe includes one or more components of the probe 450 as described herein with reference to FIG. 5. In some embodiments, the probe includes an ultrasound imaging transducer 620 for imaging tissue ablation using an energy source such as a water jet. In some embodiments, the energy source 455 is configured to move independently relative to the end of the robotic arm, for example, using one or more of rotation, translation, rotational oscillation, or translational oscillation of the energy source relative to the tissue and the end of the robotic arm.

[0081] In some embodiments, an enclosure 602 is placed over the tissue 600 to be excised to provide a beneficial fluid environment for the tissue 600 for tissue excision. The enclosure 602 may comprise any suitable barrier material that allows a suitable environment to be provided for the tissue 600, such as plastic, silicone, or other material. In some embodiments, the enclosure 602 comprises a flexible material that can deform and contour to the surface of the tissue 600 on which it is placed. In some embodiments, the barrier may be a cup or suction cup.

[0082] 9-12B show a method of tissue ablation using a water jet with a robotic arm. In some embodiments, tissue is ablated sequentially into multiple ablation layers using scanning of the water jet at each of the multiple layers.

[0083] 9, tissue 600, such as parenchymal tissue of an organ 608, is visualized using imaging as described herein, such as, for example, using one or more of endoscopic, ultrasound imaging, ultrasound, MRI, or CT scan imaging. The imaging may include visualization of neurovascular bundles, veins, and blood vessels 634. In some embodiments, one or more markers 622 are placed on the tissue 600 to identify tissue movement and align treatment with the tissue.

[0084] In a step as shown in FIG. 10 , tissue resection using energy from energy source 455 is initiated to resect a first layer of tissue 600, such as by initiating parenchymal ablation and creating a depression in the tissue. Tissue can be resected using a low-power energy source, such as a lower-pressure water jet to selectively resect tissue and low pressure to expose and visualize small blood vessels 643. For example, glandular tissue can be selectively resected while vascular tissue remains intact. Examples of selective tissue removal and water jet flow rates to leave vascular tissue substantially intact are described in U.S. Patent No. 10,251,665, filed November 25, 2015, granted April 4, 2019, and entitled “Multifluid Tissue Resection Methods and Devices,” the entire disclosure of which is incorporated herein by reference. The selectively exposed blood vessels can be stapled, clipped, or cauterized.

[0085] In the step shown in FIG. 11, selective tissue ablation using energy from an energy source 455, such as a water jet, for example using jet ablation, follows to expose larger blood vessels 634 within the parenchyma.

[0086] In the step shown in FIG. 12A, non-vascular tissue, such as parenchymal tissue, is selectively resected to expose blood vessels 634, along with a supporting layer of unresected tissue 601, as shown in FIG. 12B. These larger blood vessels 634 can be stapled, cut, or cauterized. Tissue resection can continue through the remaining portion of the organ and the portion of the removed organ. The portion of the organ may comprise a lobe of the organ. The removed portion of the organ may comprise unwanted tissue or tissue suitable for tissue harvesting, e.g., organ donation. In some embodiments, the energy provided by the energy source and the energy source position can be controlled to allow the parenchyma surrounding the blood vessels to be ablated, exposing major blood vessels for dissection of the neurovascular bundle and resulting staple closure of the remaining lobe. The harvested or transplanted lobe can be discarded, and / or anastomosis preparation can be performed.

[0087] Although Figures 9-12B illustrate a method of tissue excision and removal, donor tissue can be transplanted in similar steps to prepare the organ to receive the tissue.

[0088] FIG. 13 illustrates selective tissue ablation and removal of unwanted tissue from an organ using 3D volumetric imaging for 3D tissue ablation. The tissue of the organ can be imaged using volumetric imaging, such as 3D tomography, ultrasound, CT scanning, or MRI imaging. An image of the tissue to be ablated can be shown to the user on the display 425. The user can select and identify the tissue 600 to be ablated, the ablation boundary 704 profile, and the blood vessels 634. For example, the user can use a touchscreen display to input the tissue ablation boundary. By providing multiple screens, the user can identify these structures on each of the multiple screens to define the 3D tissue ablation boundary, the 3D treatment profile, and the 3D shape profile of the tissue that should not be ablated, such as blood vessels, and the scan pattern 702 for tissue ablation.

[0089] 14 shows an ultrasound image of the right hepatic vein (RHV) and middle hepatic vein (MHV) of the liver shown on a display for 3D tissue removal using 3D volumetric imaging. The image can be shown on the display, and a user can input a tissue resection boundary 704 around tissue that should not be resected, including a region 706 of tissue to be resected. In some embodiments, the tissue resection region extends around the boundary of the tissue that should not be resected.

[0090] 15 shows an ultrasound image of a hemangioma in the liver shown on a display for 3D tissue removal using 3D volumetric imaging. The image can be shown on the display and a user can input a tissue removal boundary 704.

[0091] 16 shows an ultrasound image of a liver cancer tumor shown on a display for 3D tissue removal using 3D volumetric imaging. The image can be shown on the display and a user can input a tissue removal boundary 704.

[0092] 17 shows cirrhotic liver tissue for removal shown on a display for 3D tissue removal using 3D volumetric imaging. A tissue removal boundary 704 and a tissue removal region 706 are identified by a user on the display. Tissue is removed along the tissue resection boundary, and the cirrhotic tissue can be removed, for example, using water jet ablation or by removing intact portions of the cirrhotic liver that are separated from the non-cirrhotic liver using an energy source.

[0093] 18 shows a CT scan of liver tissue shown on a display for 3D tissue removal using 3D volumetric imaging. The user can input a tissue removal boundary 704 and a tissue removal region 706 around the tissue that should not be removed.

[0094] 19A-D show an MRI of the liver and the ablation boundary 704 of the tissue ablation region shown on a display for 3D tissue removal using 3D volumetric imaging.

[0095] 15-19 show images shown on a display for generating tissue ablation profiles and boundaries. A processor can be configured with instructions for performing volumetric ablation in many ways. For example, the image may comprise a tomographic image, and a user views multiple image slices and identifies one or more of a tissue ablation profile 700, a tissue ablation region 706, or a tissue ablation boundary 704 of tissue that should not be ablated. The boundary of tissue that should not be ablated may be located within the boundary of the tissue ablation region. For each of the multiple slices, the user can identify one or more regions. In some embodiments, an artificial intelligence algorithm, such as a convolutional neural network, can be trained and used to identify one or more boundaries, for example, blood vessel boundaries, from each of the multiple images. From the identified regions for each of the multiple slices, the process can generate one or more of a 3D tissue ablation profile within the boundary of the tissue ablation region, a 3D tissue ablation region, or a 3D tissue ablation boundary of tissue that should not be ablated in 3D. Once the 3D volumetric resection area, tissue resection boundary, and tissue retention area are identified, the processor can be configured with instructions to move the robotic arm to multiple locations and remove tissue as described herein.

[0096] While tissue can be imaged in many ways, in some embodiments, tissue is imaged using ultrasound to identify cancerous tissue, such as ultrasound shear wave elastography. Tissue can be imaged using Doppler ultrasound or 3D Doppler ultrasound to identify blood vessels. The ultrasound transducer can be located, for example, near the tip of the treatment probe 450. Alternatively, or in combination, the ultrasound transducer can be coupled to the patient with another ultrasound probe or an external ultrasound transducer.

[0097] In some embodiments, the fluid released into the organ or fluid-filled enclosure comprises a chemotherapeutic agent, for example, the fluid released using a water jet comprises a chemotherapeutic agent.

[0098] 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.

[0099] The terms "memory" or "memory device" as used herein generally refer 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 drives (HDDs), solid-state drives (SSDs), optical disk drives, caches, variations or combinations of one or more of the same, or any other suitable storage memory.

[0100] Additionally, the term "processor" or "physical processor" as used herein 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 a memory device 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), a portion of one or more of the same, a variation or combination of one or more of the same, or any other suitable physical processor.

[0101] Although illustrated as separate elements, the method steps described and / or illustrated herein may represent parts 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.

[0102] 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, by executing on the computing device, storing data on the computing device, and / or otherwise interacting with the computing device, transform 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.

[0103] 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-type 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.

[0104] Those skilled in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and sequence 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 shown or discussed.

[0105] The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein, or may comprise additional steps in addition to those disclosed. Furthermore, the steps of any method as disclosed herein can be combined with one or more steps of any of any other methods as disclosed herein.

[0106] 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, a processor can be configured to combine one or more steps of one or more methods as disclosed herein.

[0107] Unless otherwise stated, the terms "connected to" and "coupled to" (and their derivatives) as used in this specification and claims shall be interpreted as allowing 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 shall be interpreted as meaning "at least one of." Finally, for ease of use, the terms "including" and "having" (and their derivatives) as used in this specification and claims shall be synonymous with and have the same meaning as the word "comprising."

[0108] A processor as disclosed herein may be configured with instructions to perform any one or more steps of any method as disclosed herein.

[0109] It should be understood that the terms “first,” “second,” “third,” etc. 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 merely used 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.

[0110] As used herein, the term "or" is used inclusively to refer to items as alternatives and in combination.

[0111] As used herein, letters such as numbers refer to like elements.

[0112] This disclosure includes the following numbered appendices:

[0113] Appendix 1. An apparatus for tissue ablation, the apparatus comprising: a robotic arm; a treatment probe having an energy source coupled to the robotic arm; and a processor coupled to the robotic arm for positioning the probe.

[0114] Appendix 2. The apparatus of Appendix 1, wherein the robotic arm is configured to position the energy source with a position and orientation for ablating tissue by moving the proximal end of the probe with three or more degrees of freedom, and optionally, the energy source comprises a water jet.

[0115] Clause 3. The apparatus of Clause 1, wherein the robotic arm is configured to position the energy source by moving the proximal end of the probe.

[0116] Clause 4. The apparatus of clause 3, wherein the treatment probe comprises a rigid treatment probe.

[0117] Clause 5. The apparatus of Clause 1, wherein the robotic arm is configured to rotate the probe about an extension axis extending along the probe.

[0118] Clause 6. The apparatus of Clause 1, wherein the treatment probe is configured to rotate about an axis of extension of the probe while the orientation of the robotic arm remains fixed.

[0119] Clause 7. The apparatus of clause 1, wherein the energy source comprises a water jet directed transverse to the extension axis of the probe, emitting the water jet at a side of the probe.

[0120] Appendix 8. The device of Appendix 1, wherein the energy source comprises a water jet directed along the extension axis of the probe and emits the water jet toward the tissue in a direction along the extension axis.

[0121] Appendix 9. The device of Appendix 1, wherein the treatment probe includes an irrigation lumen, an endoscope, a high-pressure lumen coupled to a water jet, and a suction lumen for removing excised tissue.

[0122] Appendix 10. The device of Appendix 1, wherein the treatment probe includes an irrigation lumen, an endoscope, a high-pressure lumen coupled to a nozzle for emitting a water jet, an ultrasound transducer, and a suction lumen for removing excised tissue.

[0123] Clause 11. The device of Clause 1, wherein the energy source comprises a water jet, emitting the water jet from the orifice at a flow rate to remove glandular tissue faster than collagenous tissue, and optionally, the collagenous tissue comprises vascular tissue.

[0124] Clause 12. The apparatus of clause 11, wherein the processor comprises instructions for removing tissue with multiple successive layers, each of the multiple successive layers being removed using a scanning pattern of water jets.

[0125] Clause 13. The apparatus of Clause 12, wherein the processor is configured with instructions for moving the distal end of the arm, the movement corresponding to a scanning pattern for each of the plurality of layers.

[0126] Clause 14. The apparatus of Clause 13, wherein the processor is configured with instructions for advancing the probe for ablation of a subsequent layer by moving the distal end of the arm.

[0127] Clause 15. The apparatus of Clause 13, wherein the processor is configured with instructions for increasing a flow rate of the water jet for ablation of a subsequent layer.

[0128] Clause 16. The apparatus of Clause 1, wherein the processor is configured with instructions to advance the probe along the tissue ablation boundary by moving the distal end of the arm, and the processor is configured to direct the distal end of the arm to orient the probe so as to extend along the tissue ablation boundary.

[0129] Clause 17. The device of clause 1, further comprising an enclosure comprising a barrier material to provide a fluid-filled environment on the surface of the tissue.

[0130] Clause 18. The device of clause 17, wherein the enclosure comprises an opening for receiving the treatment probe.

[0131] Clause 19. The device of clause 17, wherein the processor comprises instructions for pivoting the treatment probe proximate an opening in the enclosure sized to receive the treatment probe.

[0132] Clause 20. The device of clause 17, wherein the treatment probe comprises a lumen extending into the enclosure through the opening and sized to provide a fluid into the enclosure, and the treatment probe comprises a suction lumen extending into the enclosure and sized to remove tissue ablation products.

[0133] Clause 21. The apparatus of clause 1, wherein the treatment probe comprises an elongated probe sized to extend from an incision in the patient's skin to the organ.

[0134] Clause 22. The apparatus of clause 1, wherein the treatment probe comprises an elongated probe sized to extend from the external orifice to the organ.

[0135] Addendum 23. The apparatus of Addendum 1, wherein the processor is configured with instructions to move and orient the distal end of the arm to pivot the probe between the proximal end of the probe and the distal end of the probe to reduce probe movement about the pivot axis.

[0136] Clause 24. The apparatus of Clause 23, wherein the processor is configured with instructions to receive input corresponding to a location of the blood vessel, and the processor is configured with instructions to pivot the probe at a location away from the blood vessel.

[0137] Clause 25. The apparatus of Clause 23, wherein the processor is configured with instructions to receive input corresponding to a location near the pubic bone, and the processor is configured with instructions to pivot the probe at the location to reduce probe movement near the pubic bone.

[0138] Appendix 26. The apparatus of Appendix 1, wherein the treatment probe comprises an elongated probe sized to extend from the opening of the urethra to the prostate, and wherein the processor is configured with instructions to pivot the probe at a location near one or more of the verumontanum of the prostate, the external sphincter of the urethra, or a location between the verumontanum and the external sphincter.

[0139] Addendum 27. The device of Addendum 1, wherein a portion of the probe proximal to the pivot location is configured to move in an opposite direction to the distal end of the probe, and optionally, the external opening to the urethra moves in an opposite direction to the distal end of the probe.

[0140] Clause 28. The apparatus of clause 1, wherein the probe comprises a deflectable tip portion.

[0141] Clause 29. The device of clause 28, wherein the deflectable tip portion comprises a flexible tip portion.

[0142] Clause 30. The device of clause 28, wherein the deflectable tip is configured to separate the glandular tissue from the capsular tissue along a tissue interface.

[0143] Clause 31. The device of Clause 28, wherein the deflectable tip is configured to deflect in response to user input to the processor, and optionally, the deflectable tip comprises a plurality of elongated elements for deflecting the tip in response to user input.

[0144] Clause 32. The device of clause 28, wherein the deflectable tip comprises a lumen and a nozzle for emitting a fluid stream, and optionally, the lumen comprises a high-pressure lumen and the fluid stream comprises a water jet emitted from the nozzle.

[0145] Addendum 33. The device of Addendum 1, wherein the probe is configured for insertion into one or more of the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testes, bladder, ears, nose, mouth, bone marrow, adipose tissue, muscle, glandular and mucosal tissue, spinal cord and nerve tissue, soft tissue such as cartilage, hard biological tissue such as teeth, bone, and body lumens and passageways such as sinuses, ureters, colon, esophagus, pulmonary passageways, blood vessels, and throat.

[0146] Appendix 34. The apparatus of Appendix 1, wherein the processor comprises instructions for presenting an image of an organ to a user on a display, receiving input from the user, and identifying one or more of a tissue resection boundary, an area of ​​tissue to be resected, or an area of ​​tissue that should not be resected, optionally, the area of ​​tissue that should not be resected is within the boundary of the tissue to be resected.

[0147] Appendix 35. The apparatus of Appendix 1, wherein the processor comprises instructions for providing a plurality of images to a user, the plurality of images comprising a plurality of tomographic image slices, and the processor is configured to receive input from the user regarding the plurality of images and generate one or more of a 3D tissue resection boundary, a 3D region of tissue to be resected, or a 3D region of tissue that should not be resected, and optionally, the 3D region of tissue that should not be resected is within the 3D boundary of the tissue to be resected.

[0148] Appendix 36. The apparatus of Appendix 1, wherein the processor comprises instructions for receiving a plurality of images of the patient, the plurality of images comprising a plurality of tomographic image slices, and the processor is configured to identify one or more of a tissue resection boundary, an area of ​​tissue to be resected, or an area of ​​tissue that should not be resected, and optionally, the area of ​​tissue that should not be resected is within the boundary of the tissue to be resected in the plurality of images.

[0149] 37. The apparatus of claim 36, wherein the processor is configured with instructions for generating one or more of a 3D tissue resection boundary, a 3D region of tissue to be resected, or a 3D region of tissue that should not be resected, and optionally, the 3D region of tissue that should not be resected is within the 3D boundary of the tissue to be resected.

[0150] Clause 38. A method, the method comprising providing or using an apparatus according to any one of the preceding clauses.

[0151] The embodiments of the present disclosure are 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 substitutions 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 presently disclosed invention(s) shall be defined solely by the scope of the appended claims and their equivalents.

Claims

1. A system for urological endoscopic treatment, wherein the system comprises: A robot arm comprising a distal end and a plurality of articulated joints, wherein the plurality of articulated joints are configured to facilitate the movement of the distal end of the robot arm in a plurality of degrees of freedom, A treatment probe configured to be coupled to the distal end of the robot arm, wherein the treatment probe is configured to perform the urological endoscopic treatment, At least one processor configured to move the robotic arm to position the treatment probe, The at least one processor is equipped with To provide images of the tissue treated by the aforementioned urological endoscopic treatment on a display, In response to receiving a user selection via a user input device for the tissue removal boundary on the image of the tissue, the proximal end of the treatment probe is made to move along a path and move the tip of the treatment probe along a corresponding path around a pivot point located between the proximal end and the distal end of the treatment probe to direct energy to the target tissue location. To provide an image of the tissue and the tissue removal boundary on the display. A system further configured to perform the following actions.

2. The system according to claim 1, wherein the user input device comprises one or more of a touchscreen display, a keyboard, a foot switch, or an input controller having multiple degrees of freedom.

3. The system according to claim 1, wherein the user input device comprises a touchscreen display.

4. The system according to claim 1, wherein the robot arm is configured to rotate the treatment probe about an extension axis that extends along the treatment probe.

5. The system according to claim 1, wherein the treatment probe is configured to rotate around the extension axis of the treatment probe while the posture of the robot arm remains fixed.

6. The system according to claim 1, wherein the treatment probe comprises an irrigation tube lumen and an endoscope.

7. The system according to claim 1, wherein the at least one processor is configured to move the distal end of the robot arm in a scanning pattern.

8. The system according to claim 1, further comprising an inclusion body having a flexible material that can deform and contour relative to the surface of the tissue, wherein the inclusion body is configured to be filled with a fluid.

9. The system according to claim 8, wherein the encapsulating body has an opening configured to receive the therapeutic probe.

10. The system according to claim 8, wherein the at least one processor is configured to rotate the therapeutic probe near an opening in the encapsulation body which is sized to receive the therapeutic probe.

11. The system according to claim 1, wherein the at least one processor is configured to rotate the treatment probe at the rotation location in order to reduce the movement of the treatment probe.

12. The system according to claim 1, wherein the treatment probe comprises an elongated probe sized to extend from an external opening of the urethra, the treatment probe is configured to rotate about the rotation location, and a portion of the treatment probe proximal to the rotation location is configured to move in the opposite direction to the distal end of the treatment probe, thereby moving the external opening to the urethra in the opposite direction to the distal end of the treatment probe.

13. The system according to claim 1, wherein the treatment probe comprises an energy source, the energy source comprising one or more of a laser source, a water jet, an electrode, ultrasound, a mechanical energy source, a radio frequency (RF) energy source, an ultrasonic transducer, a microwave energy source, a cavity formation energy source, a radiation energy source, ion energy, a plasma source, or a transurethral needle, the water jet is directed along the extension axis of the treatment probe to release the water jet toward the tissue in a direction along the extension axis of the treatment probe, and the ultrasonic transducer is configured to image the excised tissue.

14. The system according to claim 1, further comprising an imaging probe.

15. The system according to claim 14, wherein the imaging probe comprises an ultrasonic transducer, and the ultrasonic transducer is configured to image excised tissue.

16. The system according to claim 1, wherein the treatment probe is equipped with a camera.

17. The system according to claim 1, wherein the display is configured to display a plurality of images, and the plurality of images include images of the organization.

18. The system according to claim 17, wherein the plurality of images include real-time images.

Images