Fiducial system for probe tracking and identification

Abstract

A system for determining the position or orientation of a probe across a drape can include a fiducial assembly that can be coupled to the probe through the drape. The fiducial assembly can include a base, a coupling attached to the base that can be configured to couple the fiducial assembly to the probe across the drape, and one or more fiducials attached to the base. Coupling the fiducial to the probe across the drape can allow a sterile fiducial to be coupled to a non-sterile probe and to determine the position and orientation of the probe based on an image from the fiducial on the sterile side of the drape. In some embodiments, the fiducial is aligned with the elongate axis of the probe with a predetermined offset and orientation relative to the elongate axis of the probe.

Description

[Background technology]

[0001] (cross reference) This application claims the benefit of the filing date of U.S. Patent Application No. 18 / 051,414, filed October 31, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] (background) Previous approaches to locating and aligning surgical probes may be sub-ideal in at least some respects. Research related to the present disclosure suggests that misalignment of surgical probes in previous approaches may result in cutting and treating tissue with less precision and, in at least some cases, be somewhat more invasive than would be ideal. At least some of the previous approaches may align the imaging element and treatment probe with less precision than would be ideal, which may lead to sub-ideal tissue treatment. While robotics approaches can provide alignment using computer control, at least some previous robotics systems may not align the probe inserted into the patient with the anatomical structure as precisely as would be ideal. While treatment using fiducials has been proposed, previous approaches may, at least in some cases, provide sub-ideal adjustment and positioning of the imaging probe and surgical probe. In some previous approaches, surgical drapes may potentially interfere with the use of fiducials, at least in some cases. Summary of the Invention [Means for solving the problem]

[0003] The presently disclosed probes, systems, and methods relate to improved alignment of probes, in some embodiments, imaging probes and treatment probes and associated energy sources. The presently disclosed fiducial assembly may include a coupling portion configured to couple to the probe across a drape for maintaining a sterile surgical field when the coupling portion is connected to the probe, and a fiducial used to determine one or more of the probe's position or orientation. In some embodiments, the fiducial is used to determine the position and orientation at the probe, which may include a six-degree-of-freedom attitude of the probe. In some embodiments, the fiducial system includes a fiducial assembly that may be coupled to the probe through a drape, such as a sterile surgical drape. In some embodiments, the fiducial assembly is aligned with the elongate axis of the probe with a predetermined offset and orientation relative to the elongate axis of the probe. The fiducial assembly may include a base, a coupling portion attached to the base, the coupling portion configured to couple the fiducial assembly to the probe across the surgical drape, and one or more fiducials attached to the base. In some embodiments, the fiducial is aligned with the elongate axis of the probe at a predetermined offset and orientation relative to the elongate axis of the probe. The offset can be configured in many ways and can include one or more of an angular offset, a radial offset, a longitudinal offset, or a pitch or yaw offset relative to the axis of the probe. In some embodiments, the fiducial is coupled to the probe at a predetermined longitudinal offset from the distal tip of the probe so that the position and orientation of the fiducial can be used to determine the position and orientation of the distal tip of the probe. Coupling the fiducial to the probe across a drape can allow the sterile fiducial to be coupled to a non-sterile probe or non-sterile instrument driver to determine the position and orientation of the probe across the drape based on an image of the fiducial on the sterile side of the drape while maintaining a sterile surgical field.

[0004] In some embodiments, the system may include a sterile probe configured to be positioned on the sterile side of a surgical drape and a non-sterile instrument driver configured to couple to the probe. In some embodiments, the instrument driver is positioned on the non-sterile side of the drape, and the sterile probe and instrument driver are configured to couple to one another across the surgical drape. In some embodiments, the system may include one or more sterile fiducials in a fixed spatial relationship with a sterile portion of the probe. In some embodiments, the one or more sterile fiducials are attached to the sterile probe. Alternatively, or in combination, one or more fiducials can be connected to the non-sterile instrument driver across the drape, in which case the position and orientation of the probe is determined in response to the position and orientation of the fiducials on the instrument driver.

[0005] In some embodiments, a method of using a fiducial with a drape includes coupling a probe having an elongate shaft and an elongate axis to an arm, covering the probe with a drape, and coupling a fiducial assembly to the probe through the drape, the drape being between the fiducial assembly and the probe. While the fiducial assembly can be configured in many ways, in some embodiments, the fiducial assembly includes a base, a coupling attached to the base and configured to traverse the drape to couple the fiducial assembly to the probe, and one or more fiducials attached to the base.

[0006] In some embodiments, a method of using the drape includes covering a non-sterile instrument driver with the drape and coupling a sterile probe to the instrument driver, with the surgical drape therebetween, and one or more sterile fiducials coupled to the sterile probe in fixed, specific relationship with a sterile portion of the surgical probe.

[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 that sets forth illustrative embodiments and the accompanying drawings.

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

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

[0011] [Figure 3A] FIG. 3A shows a top view of a probe arrangement according to some embodiments of the present disclosure.

[0012] [Figure 3B] FIG. 3B shows a sagittal view of probe placement according to some embodiments of the present disclosure.

[0013] [Figure 3C] FIG. 3C shows a perspective view of a probe arrangement according to some embodiments of the present disclosure.

[0014] [Figure 3D] FIG. 3D illustrates the treatment probe axis and the imaging probe axis skewed at an angle 330 relative to one another such that the treatment probe and the imaging probe do not extend along a common plane according to some embodiments of the present disclosure.

[0015] [Figure 4] FIG. 4 illustrates a probe, such as an imaging probe, a dockable fiducial assembly, and a drape according to some embodiments of the present disclosure.

[0016] [Figure 5] FIG. 5 illustrates a fiducial assembly and one or more cameras coupled to a probe across a drape according to some embodiments of the present disclosure.

[0017] [Figure 6] FIG. 6 illustrates a surgical probe and fiducial assembly being used during a surgical procedure according to some embodiments of the present disclosure.

[0018] [Figure 7] FIG. 7 illustrates a surgical probe and fiducial being used with a sterile drape during a surgical procedure according to some embodiments of the present disclosure.

[0019] [Figure 8] FIG. 8 illustrates a surgical probe with a fiducial according to some embodiments of the present disclosure.

[0020] [Figure 9A] FIG. 9A illustrates a surgical probe with a dockable base according to some embodiments of the present disclosure.

[0021] [Figure 9B] FIG. 9B illustrates a surgical probe with a dockable base according to some embodiments of the present disclosure.

[0022] [Figure 10A] FIG. 10A illustrates a surgical probe with two-dimensional fiducials according to some embodiments of the present disclosure.

[0023] [Figure 10B] FIG. 10B illustrates a surgical probe with two-dimensional fiducials according to some embodiments of the present disclosure.

[0024] [Figure 11] FIG. 11 illustrates multiple fiducials within the field of view of one or more cameras, where a first one or more fiducials are coupled to a first probe and a second one or more fiducials are coupled to a second probe.

[0025] [Figure 12] FIG. 12 illustrates a fiducial method according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0026] 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.

[0027] The systems and methods of the present disclosure are well suited for use with many probes and diagnostic and surgical procedures. While reference is made to therapeutic probes equipped with energy sources for prostate surgery and transrectal ultrasound ("TRUS") probes, the present disclosure also applies to many types of tissues, organs, cavities, and lumens, such as the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testes, bladder, ear, nose, mouth, tumors, cancers, soft tissues such as bone marrow, adipose tissue, muscle, glandular and mucosal tissue, spinal and nervous tissue, cartilage, hard biological tissues such as teeth, bones, and lumens, such as vascular cavities, nasal cavities and nostrils, sinuses, colon, urethral cavity, gastric cavity, and airways. , esophageal cavity, transesophageal, intestinal cavity, anal cavity, vaginal cavity, transabdominal, abdominal cavity, throat, airways, lung passages, and in surgical procedures such as kidney surgery, ureter surgery, kidney stone, prostate surgery, tumor surgery, cancer surgery, brain surgery, heart surgery, eye surgery, conjunctival surgery, liver surgery, gallbladder surgery, bladder surgery, spinal surgery, orthopedic surgery, arthroscopic surgery, liposuction, colonoscopy, intubation, minimally invasive incision, minimally invasive surgery, and others.

[0028] The systems and methods of the present disclosure are well suited for combination with previous probes, such as imaging and therapy probes. Examples of such probes include, for example, laser therapy probes, water jet probes, RF therapy probes, radiation therapy probes, ultrasound therapy probes, phacoemulsification probes, imaging probes, endoscopic probes, resecting endoscope probes, ultrasound imaging probes, A-scan ultrasound probes, B-scan ultrasound probes, 3D ultrasound probes, Doppler ultrasound probes, transrectal ultrasound probes, transrectal ultrasound probes, sagittal ultrasound imaging probes, transverse ultrasound imaging probes, and transverse and sagittal ultrasound imaging probes.

[0029] The systems, methods, and devices of the present disclosure are highly suitable for combination with many previous surgical procedures, such as hydrojet enucleation of the prostate, transurethral resection of the prostate (TURP), holmium laser enucleation of the prostate (HOLEP), prostate brachytherapy, and surgical robotics systems and automated surgical procedures. The following patent applications describe examples of systems, methods, probes, and procedures suitable for incorporation according to the present disclosure: PCT / US2013 / 028441, filed February 28, 2013, entitled "AUTOMATED IMAGE-GUIDED TISSUE RESECTION AND TREATMENT," published as WO2013 / 130895; PCT / US2014 / 054412, filed September 5, 2014, entitled "AUTOMATED IMAGE-GUIDED TISSUE RESECTION AND TREATMENT," published as WO2015 / 035249; PCT / US2014 / 054412, filed September 5, 2015, entitled "PHYSICIAN-CONTROLLED TISSUE RESECTION INTEGRATED WITH TREATMENT MAPPING OF TARGET ORGAN"; PCT Application No. PCT / US2015 / 048695, filed June 21, 2019, entitled "ARTIFICIAL INTELLIGENCE FOR ROBOTIC SURGERY," published on December 26, 2019, as WO2019246580A1; PCT Application No. PCT / US2019 / 038574, filed March 9, 2020, entitled "ROBOTIC ARMS AND METHODS FOR TISSUE RESECTION AND IMAGING," published on November 4, 2020, as WO / 2020 / 181290; PCT Application No. PCT / US2020 / 021756, filed November 4, 2020, entitled "SURGICAL PROBES FOR TISSUE RESECTION WITH ROBOTIC No. PCT / US2020 / 058884, filed June 23, 2021, entitled "INTEGRATION OF ARMS" and published as WO / 2021 / 096741;No. PCT / US2021 / 070760, entitled "ROBOTIC ARMS WITH SURGICAL PROBES," published as WO / 2021 / 263276, and No. PCT / US2021 / 038175, filed June 21, 2021, entitled "SYSTEMS AND METHODS FOR DEFINING AND MODIFYING RANGE OF MOTION OF PROBE USED IN PATIENT TREATMENT," published as WO / 2021 / 262565 (the entire disclosures of which are incorporated herein by reference).

[0030] In some embodiments, improved positional accuracy is provided for placement of the energy source and imaging probe. The energy source may comprise any suitable energy source, such as an electrode, a loop electrode, a laser source, mechanical shear, an ultrasound probe, a cavitation ultrasound probe, a water jet (e.g., a fixed-pressure water jet), plasma, steam, a morcellator, a transurethral needle, photoablation, or water jet ejection. The energy source may be combined with other treatments and compounds, such as photochemotherapeutic agents. The imaging probe may comprise any suitable probe, such as an endoscopic probe, a resecting endoscopic probe, an ultrasound imaging probe, an A-scan ultrasound probe, a B-scan ultrasound probe, a Doppler ultrasound probe, a transrectal ultrasound probe, a transvaginal ultrasound probe, a sagittal ultrasound imaging probe, a transverse ultrasound imaging probe, and a transverse and sagittal ultrasound imaging probe.

[0031] The probes comprising the energy sources and the imaging probes can be configured in many ways, and each may comprise one or more fiducials for determining the position and orientation of the respective probe.

[0032] FIG. 1 illustrates an exemplary embodiment of a system 400 for performing treatment on a patient. The system 400 may include a treatment probe 450 as described herein and an imaging probe 460 as described herein. The treatment probe 450 may be coupled to a first arm 442, and the imaging probe 460 may be coupled to a second arm 444. One or both of the first arm 442 and the second arm 444 may include a robotic arm whose movement may be controlled by one or more computing devices operably coupled to the arm. 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 remove 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, a steam ablation device, a high-intensity focused ultrasound (HIFU) device, or any combination thereof. The imaging probe 460 may be configured to deliver sufficient energy to the target tissue to image the target tissue. 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 coinciding with the treatment probe's elongated axis 451.For example, the treatment probe 450 may be configured for insertion into the patient's urethra to position the treatment probe's energy delivery region within the patient's prostate. The imaging probe 460 may be inserted into the patient along an entry axis coincident with the imaging probe's elongated 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 view the patient's prostate and surrounding tissue. As shown in FIG. 1 , the first arm 442 and the second arm 444 may be covered with sterile drapes to provide a sterile operating environment, keep the robotic arms clean, and reduce the risk of damaging the robotic arms. Further details regarding the various components of system 400 suitable for incorporation with embodiments as disclosed herein may be found in U.S. Pat. Nos. 7,882,841, 8,814,921, 9,364,251, and PCT Publication No. WO2013 / 130895, the entire disclosures of which are incorporated herein by reference.

[0033] FIG. 2 schematically illustrates an embodiment of a system 400 for performing tissue ablation on a patient. The system 400 may include a treatment probe 450 as described herein and 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 whose movement may be controlled by one or more computing devices operably coupled to the arm, as described in further detail herein.

[0034] 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.

[0035] 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. The user input device 496 can be located in any suitable location, for example, on a console, a robotic arm, or a mobile base, and there can be one, two, three, four, or more user input devices used in conjunction with the system 400 to provide either redundant means of input, unique input commands, or a combination. In some embodiments, the user input device includes a controller for moving the end of the 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, allowing the user to move the input device in six degrees of freedom, with the distal end of the probe moving in response to movement of the controller. In some embodiments, the six degrees of freedom include three translational degrees of freedom and three rotational degrees of freedom. The processor can be configured with instructions for probe control to be switched between automatic image-guided therapy with the energy source and therapy with the energy source, for example, with user movement of a user input device.

[0036] 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 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.

[0037] 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, oblique, 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 the imaging probe image data to the treatment probe coordinate reference space. Having the 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.

[0038] In some embodiments, the treatment probe 450 is coupled to the imaging probe 460 to align the treatment 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 can 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. When the probe 450 is positioned at a desired location on 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 probe under control of, for example, the imaging system, or a console and user interface. The movable arm 444 may be finely actuated so that the imaging probe 460 may be adjusted relative to the treatment probe 450 with movements as small as, for example, one millimeter.

[0039] 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 elongated axis 451 of the therapy probe. The second angle sensor 497 may comprise a goniometer for determining the angle of the imaging probe 460 along the elongated axis 461 of the imaging probe 460. The first angle sensor 495 is coupled to the controller 424 of the treatment console 420. The second angle sensor 497 of the imaging probe is coupled to the processor 492 of the imaging console 490. Alternatively, or in combination, the second angle sensor 497 may be coupled to the controller 424 of the treatment console 420.

[0040] The console 420 includes a display 425 that is coupled to a processor system of components used to control the treatment probe 450. The console 420 includes a processor 423 having a memory 421. Communications circuitry 422 is coupled to the processor 423 and the controller 424. The communications circuitry 422 is coupled to the imaging console 490 via the imaging console's communications circuitry 494. 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.

[0041] Optionally, the console 420 may include components of an endoscope 426 coupled to anchors 24 of the treatment probe 450. The endoscope 426 may include components of the console 420 and an endoscope insertable with the treatment probe 450 to treat a patient.

[0042] In some embodiments, the console 420 comprises impedance sensor circuitry 220 coupled to an energy source to measure the impedance of tissue being treated with energy from the energy source. In some embodiments, the energy source comprises electrodes, the electrodes comprising an impedance sensor. In some embodiments, the processor is configured with instructions for adjusting the amount of energy from the energy source in response to the amount of impedance. In some embodiments, the processor is configured with instructions for adjusting the amount of deflection of the extension from the elongate shaft and the offset of the energy source in response to the impedance.

[0043] In some embodiments, the console 420 includes force sensor circuitry 210 coupled to a force sensor on the treatment probe. The force sensor is coupled to the extension and can measure, for example, tissue resistance associated with deflection of the extension. In some embodiments, the force sensor is coupled to the linkage and measures tissue resistance associated with movement of the energy source away from the elongate shaft. In some embodiments, the force sensor is coupled to the energy source and measures tissue resistance associated with the positioning distance of the energy source from the elongate shaft. In some embodiments, the force sensor is configured to measure tissue resistance associated with the amount of energy delivery from the energy source.

[0044] Optionally, console 420 may include one or more modules operably coupled with treatment probe 450 for controlling aspects of treatment with 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 light 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 as well as user control over the surgical procedure.

[0046] The treatment probe 450 may include an anchor 24. The anchor 24 can anchor the distal end of the probe 450 while energy is delivered to the energy delivery region 20 using the probe 450. In some embodiments, the probe includes a first energy source 250, which can be offset from the probe's elongated shaft 451 with an offset 252, a distance to treat tissue, for example, with deflection of the extension as described herein. The processor can be configured with instructions to perform 3D volumetric ablation of tissue using rotation, translation, and offset of the energy source 250 in response to computer control. The probe 450 can include a second energy source as described herein, such as a nozzle 200.

[0047] The treatment probe 450 may be coupled to the first arm 442 using a linkage 430. The linkage 430 may comprise 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 comprise a first portion 432, a second portion 434, and a third portion 436. The first portion 432 may comprise a substantially fixed, anchoring portion. The substantially fixed, anchoring portion 432 may be fixed to a support 438. The support 438 may comprise a reference frame for the linkage 430. The support 438 may comprise a rigid chassis or frame or housing for rigidly or firmly coupling the first arm 442 to the treatment probe 450. The first portion 432 can remain substantially fixed, while the second portion 434 and the third portion 436 can move to direct energy from the probe 450 to the patient. The first portion 432 may be fixed a substantially constant 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 delivered. The first portion 432 may include a linear actuator for precisely positioning a second energy source, such as a high-pressure nozzle 200, within the energy delivery region 20 at a desired axial location along the elongated axis 451 of the treatment probe 450. Additional actuators and linkages may be provided and operably coupled to the processor to offset, rotate, and translate the first energy source 250 as described herein.

[0048] The elongated shaft 451 of the treatment probe 450 generally extends between a proximal portion of the probe 450 near the linkage 430 and a distal end having an attached anchor 24. The third portion 436 can control a rotation angle 453 about the elongated shaft 451. During treatment of a patient, a distance 439 between the energy delivery region 20 and the first portion 432 of the linkage can vary with reference to the anchor 24. The distance 439 can be adjusted using probe translation 418 in response to computer control to set a target location along the elongated shaft 451 of the treatment probe. In some embodiments, the first portion of the linkage remains fixed, while the second portion 434 adjusts the position of the energy delivery region 20 along the shaft 451. The third portion 436 of the linkage adjusts the angle 453 about the shaft in response to the controller 424 so that the distance along the axis in the treatment angle can be controlled very precisely with reference 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 light 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 circuitry 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 to accurately position 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, one or more of the treatment probe or 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 as described herein 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 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 specific functional requirements for controlling movement of the treatment probe relative to 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 others.

[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, in response to 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 can be established), and / or position information of the treatment probe and / or imaging probe from one or more sensors coupled to the probe and / or robotic arm.

[0053] 3A, 3B, and 3C show top, sagittal, and perspective views, respectively, of a probe arrangement for use in treating tissue. In particular, FIGS. 3A, 3B, and 3C show a relative arrangement, including the position and orientation, of a treatment probe 450 relative to the position and orientation of an imaging probe 460, for treating tissue, such as prostate tissue. The imaging probe 460 can be configured to generate transverse images, such as transverse ultrasound image 310, and one or more sagittal images, such as one or more sagittal ultrasound images 320. In some embodiments, the energy source of the treatment probe 450 is moved about a rotational angle 453 and a translational movement 418 so that the tissue to be treated and the energy source are within the field of view of the imaging probe 460.

[0054] As shown in the top view of Figure 3A, the treatment probe axis 451 and the imaging probe axis 461 are positioned in a substantially coplanar configuration such that the imaging probe and the treatment probe extend along a common plane. As shown in the top view of Figure 3B and the perspective view of Figure 3C, the treatment probe axis 451 and the imaging probe axis 461 are positioned in a substantially coplanar but non-parallel configuration such that the imaging probe and the treatment probe extend substantially along a common plane, which allows the imaging probe to image the treatment probe along the length of translation 418 for sagittal plane images, such as real-time sagittal plane images. In some embodiments, the treatment probe and the imaging probe are positioned in a substantially coplanar configuration, and the ultrasound probe is rotated to rotate the sagittal plane view of the imaging probe to image the treatment probe along the length of the sagittal plane view. Referring again to FIG. 3A, the imaging probe 460 can be rotated an angle 336 about the elongated axis 461 so that the sagittal plane view of the imaging probe is aligned with, for example, the elongated axis 451 of the treatment probe, and the treatment probe 450 can be aligned so that it is within the sagittal plane view.

[0055] One or more of the treatment probe or the imaging probe can be moved to adjust the alignment between the imaging probe and the treatment probe. In some embodiments, a proximal portion of the treatment probe is moved from a first position to a second position. Referring again to FIG. 3B , the treatment probe 450 can be moved from a first position 332 to a second position 334 to adjust the alignment between the probes, for example, based on data from one or more fiducials, as described herein.

[0056] In some embodiments, the imaging probe 460 and the therapy probe 450 are aligned to be substantially coplanar with one another, within a tolerance of error, such that the imaging probe 460 can image the therapy probe 450 and the therapy probe's energy source during treatment, with the therapy probe positioned within the imaging probe's field of view, such as a sagittal image field. In some embodiments, the therapy probe is aligned with the imaging probe such that the therapy probe is visible along the length of the imaging probe's sagittal field of view.

[0057] In some embodiments, the imaging probe 460 and the therapy probe 450 may be misaligned somewhat beyond a margin of error, such that, for example, the therapy probe may disappear from a portion of the sagittal image because a portion of the imaging probe extends beyond the sagittal field of view. In some embodiments, this may result in the imaging probe 460 not imaging a portion of the therapy for the sagittal image. In some embodiments, the therapy probe 450 and the imaging probe 460 may be positioned at a substantially oblique orientation, outside of a margin of error, such that, for example, the therapy probe extends outside the sagittal field of view of the imaging probe but is within the field of view of the imaging probe's transverse image, as described herein. In such embodiments, the therapy can be monitored in real time using the transverse image, where the imaging probe is moved to maintain the energy source and the tissue being treated within the transverse field of view of the imaging probe. In some embodiments, the cross-sectional view of the tissue and energy source can reduce sensitivity to alignment between the two probes, and the imaging probe can be moved along with the energy source, e.g., synchronously, to image the tissue and energy source during treatment.

[0058] FIG. 3D shows the treatment probe axis 451 and the imaging probe axis 461 skewed at an angle 330 relative to one another so that the treatment probe and the imaging probe do not extend along a common plane. This skew angle can be reduced by adjusting the treatment probe, the imaging probe, or both. One or more fiducials, as described herein, can be used to adjust one or more of the probes to reduce the skew angle between them. The amount of acceptable skew may depend on several factors, such as the field of view of the imaging probe and the length of tissue being treated with one or more of the rotating or translating energy sources. In some embodiments, the tolerance for error in the skew angle is, for example, any one of 10 degrees or less, 5 degrees or less, 3 degrees or less, 2 degrees or less, or 1 degree or less. In some embodiments, the tolerance for alignment error corresponds to the sagittal field of view of the imaging probe and the skew angle between the imaging probe and the treatment probe. When the treatment probe and imaging probe are aligned within a tolerance of error, the treatment probe is located within the sagittal field of view along the translation length of the treatment and can be viewed in one or more real-time sagittal images along the length of the sagittal field of view. When the treatment probe and imaging probe are aligned outside the tolerance of error, a portion of the treatment probe may be located outside the sagittal field of view and may disappear from a portion of the image along the length of the sagittal field of view. In such an embodiment, transverse imaging can be used to view the treatment in real time, as described herein.

[0059] In some embodiments, one or more of the positions or orientations of one or more of the imaging probe 460 or the therapy probe 450 may be determined using one or more fiducials located on one or more of the probes, as described herein. One or more of the positions or orientations of the one or more fiducials can be used to provide instructions to a user for moving one or more of the probes.

[0060] 4 and 5 show a probe, such as imaging probe 460, a dockable fiducial assembly 350, and a sterile drape 370. Fiducial assembly 350 may be coupled to imaging probe 460 across drape 370. Fiducial assembly 350 may include a fiducial tree 354 extending from a base 352. Fiducial tree 354 may include one or more extensions extending from base 352 and / or each other to provide support for one or more fiducials 359. In some embodiments, fiducial tree 354 may include a trunk 356 and multiple branches 358. A probe, such as imaging probe 460, may include a first portion 466 configured to remain outside the patient and a second portion 468 configured for insertion into the patient. In some embodiments, fiducial assembly 350 is coupled to a housing of first portion 466. In some embodiments, the proximal portion 466 coupled to the fiducial assembly 350 remains outside the patient when the distal portion 468 is inserted into the patient. In some embodiments, a drape material is positioned between the fiducial assembly 350 and the proximal portion 466 of the probe to maintain a sterile surgical field.

[0061] As depicted in FIG. 4 , fiducial assembly 350 may include a plurality of at least three fiducials 359 arranged on a tree 354. While reference is made to a fiducial tree, any suitable structure, such as a triangle, square, or polygon, can be used to support one or more fiducials, with any suitable structure having one or more fiducials at suitable locations thereon. In some embodiments, the at least three fiducials 359 may be arranged to define a plane, for example, rather than along a common line, and may comprise a two-dimensional fiducial pattern, as described herein. By arranging the fiducials to define a plane, one or more of a single camera, a stereoscopic camera, or multiple cameras with different positions may be used to capture images of the fiducials 359. Differences in the location of the fiducials 359 in images captured from one or more cameras may be used to determine the position and orientation of the fiducials, e.g., the pose of the one or more fiducials. In some embodiments, the plurality of three or more fiducials may be positioned to define a plane and a two-dimensional fiducial, and may comprise any suitable combination of fiducials, such as a two-dimensional pattern. In some embodiments, the two-dimensional fiducials are used to determine the position and orientation of the probe, e.g., the six degrees of freedom (6DOF) pose of the probe. The position and orientation of the two-dimensional fiducials can be determined from one or more images of the two-dimensional fiducials, as will be understood by those skilled in the art of machine vision and robotics.

[0062] When the fiducials 359 are in a known three-dimensional relationship with respect to the surgical probe to which they are attached, the position and orientation of the surgical probe can be determined based on the position and orientation of the fiducials. In some embodiments, one or more of the fiducials 359 include an offset 355 relative to a probe structure, such as the base 352 or the probe surface or the elongate shaft 461, which can be used to determine the position and orientation of the probe based on the position and orientation and offset 355 of the one or more fiducials. In some embodiments, the offset 355 corresponds to the radial distance of the one or more fiducials 359 from the elongate shaft 461 of the probe. In some embodiments, one or more of the fiducials 359 include an offset 357 along the elongate shaft 461 relative to a structure of the probe 460, such as the distal tip 353, which can allow the position and orientation of a structure of the probe to be determined in response to the position and orientation of the fiducials and the offset 357 along the elongate shaft. In some embodiments, the position and orientation of the probe, i.e., the probe pose, is determined in response to the position and orientation of one or more reference points measured using one or more cameras, an offset 357 along the elongate axis, and an offset 355 lateral to the elongate axis 461.

[0063] The fiducials 359 may comprise passive fiducials that reflect or scatter light that is then captured by a camera system as described herein, such as a stereoscopic camera system, to determine the location and orientation of the fiducials. In some embodiments, the fiducials may comprise reflectors. Alternatively, or in combination, the fiducials may have a contrasting color that contrasts with the surgical operating room. In some embodiments, the fiducials may comprise active fiducials that emit light that is then captured by a camera system as described herein. In some embodiments, the fiducials may reflect or emit infrared light or invisible wavelengths of light.

[0064] The fiducials can have many shapes. They can be round, square, triangular, or other shapes. In some embodiments, the fiducials can be spherical, cubic, pyramidal, or another three-dimensional shape. In some embodiments, each of the fiducials 539 of the fiducial assembly 350 can be a different color or can emit light at different wavelengths.

[0065] In some embodiments, the fiducials may comprise light sources, each of which may emit light with a different on / off duty cycle or may have data encoded in light pulses emitted by the light sources for the camera to separate and identify each individual fiducial or set of fiducials from each other individual set of fiducials.

[0066] In some embodiments, fiducial assembly 350 is coupled to a probe, such as imaging probe 460, across a sterile drape 370. Sterile drape 370 separates the sterile field of a surgical field or operating room from the non-sterile field of a surgical field or operating room. Sterile drape 370 can be optically opaque or substantially optically opaque. In some embodiments, a probe or other object on one side of the sterile drape may not be visible from the other side of the sterile drape. Alternatively, or in combination, at least a portion of the drape may include one or more transparent regions to allow viewing through the drape. In some embodiments, at least a portion of the drape is transparent, allowing one or more cameras to view one or more fiducials through the transparent portion of the drape.

[0067] 4 , fiducial assembly 350 is located on the sterile side 372 of sterile drape 370. In some embodiments, sterile side 372 may be located on the side of sterile drape 370 that is visible to the stereoscopic camera system, while non-sterile side 374 of drape 370 may not be visible to the stereoscopic camera system. In some embodiments, fiducial assembly 350 is on the visible side of sterile drape 370, e.g., sterile side 372, and should be coupled to a surgical probe in a known spatial position and orientation relative to one another. While reference is made to one or more cameras being located on the sterile side of the drape, in some embodiments, one or more cameras and one or more fiducials are located on the non-sterile side of the drape such that one or more fiducials can be coupled to a probe without a drape between probe 450 and base 352.

[0068] One or more couplings 351 can couple the fiducial assembly 350 to the probe across the sterile drape 370 in a known position and orientation relative to each other. The couplings can be configured to couple to each other in a single orientation across the drape. For example, in some embodiments, the couplings 351 can be magnetic couplings comprising one or more magnetic materials. In some embodiments, the magnetic couplings comprise rare earth magnets with polarity configured to attract and hold the couplings 351 a on the fiducial assembly to the couplings 351 b on the surgical probe across the drape 370. In some embodiments, the magnetic couplings are arranged to allow one or more fiducials to be installed on the probe in a single orientation. In some embodiments, the couplings can be snaps, such as socket and stud snaps, where the coupling 351 a on the fiducial assembly 350 is either a socket or a stud and the corresponding coupling 351 b on the surgical probe is the other of the socket or stud, whereby the socket receives the stud across the drape and snaps together with the drape therebetween. In some embodiments, the studs and sockets can be configured to take into account the thickness of the drape 370 and the engagement between the studs and sockets. In some embodiments, one or more connectors, such as a stud and socket, are sized to engage with one another with the drape between them without disrupting the sterile barrier of the drape. In some embodiments, the connectors are sized to engage with one another across the drape without disrupting the sterile barrier material of the drape, for example, when one or more connectors engage with one another with the drape between them or when one or more connectors are separated from one another to release the drape.

[0069] In some embodiments, coupling portions 351 can be positioned or fixed such that they couple fiducial assembly 350 to the surgical probe in a single orientation. Coupling portions 351 can include one or more support structures, such as protrusions, ribs, indentations, or other structures, to provide stability between the probe and base.

[0070] Referring to FIG. 5 , a fiducial assembly, along with a camera system 502, such as a stereoscopic camera system, is shown coupled to a surgical probe 460 through a surgical drape 370 within a portion of surgical equipment. The camera system 502, along with the fiducial assembly 350 and its corresponding fiducials 359, are located on the sterile side 374 of the drape 370. The camera system 502 may be installed in any suitable location, for example, outside the sterile field. In some embodiments, the camera system 502 is located a sufficient distance from the probe 460 so that it is, for example, outside the sterile field and in a non-sterile location. The camera system may include one or more stereoscopic cameras, a single stereoscopic camera, a single camera, or multiple cameras. The sterile drape 370 may or may not be opaque to the wavelengths of light captured by the stereoscopic camera system 350. The stereoscopic camera system 502 may be positioned within the surgical operating room such that the cameras of the stereoscopic camera system 502 have an unobstructed view of the fiducials 359. In some embodiments, the stereoscopic camera system 502 can include multiple cameras, such as three, four, five, six, or more cameras, positioned at known spatial locations with known fields of view near the surgical field such that the fiducial assemblies 350 and corresponding fiducials 359 are visible to at least two cameras of the stereoscopic camera system 502. In some embodiments, the multiple cameras are positioned at known locations near the surgical field such that the fiducial assemblies 350 and corresponding fiducials 359 are visible to at least two cameras of the stereoscopic camera system during alignment and use of the surgical probe.

[0071] FIG. 6 shows surgical probes 450, 460 and fiducial assembly 350 being used during a surgical procedure on patient 600. A surgical drape is not shown in this figure, but a surgical drape can be positioned between the imaging probe 460 and one or more fiducials 359. The patient 600 is shown lying in a supine position on a patient support 449, which can be a surgical table or other support. One or more arms, such as arms 442, 444, can be coupled to and extend from the patient support 449. In some embodiments, the arms comprise robotic arms. The treatment probe 450 can be coupled to the first arm 442, and the imaging probe 460 can be coupled to the second arm 444. In some embodiments, the first and second arms comprise manually movable arms with brakes to lock the position and orientation of the probes. Alternatively, or in combination, one or both of the first arm 442 and the second arm 444 may comprise a robotic arm, the movement of which may be controlled by one or more computing devices operably coupled to the arm. The treatment probe 450 may comprise a device for removing or otherwise treating target tissue from a target site within a patient. In some embodiments, the treatment probe may be inserted into a patient through the patient's urethra for treatment of the patient's prostate. The energy emitted from the treatment probe 450 may comprise any suitable energy, as described herein. The treatment probe 450 may be configured to deliver energy from the treatment probe 450 to the target tissue with an amount of energy sufficient to ablate the target tissue. For example, the treatment probe 450 may comprise an electrosurgical ablation device, a laser ablation device, a transurethral needle ablation device, a water jet ablation device, a steam ablation device, a high-intensity focused ultrasound (HIFU) device, or any combination thereof.

[0072] The imaging probe 460 can be configured to deliver sufficient energy to the target tissue to image the target tissue. In some embodiments, the imaging probe can be inserted into the patient through the patient's rectum, for example, to image the patient transrectally using a transrectal ultrasound probe. The imaging probe 460 can comprise any suitable probe, such as an ultrasound probe, a magnetic resonance probe, an endoscope, or a fluoroscopy probe. The first arm 442 and the second arm 444 can 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 can each have multiple degrees of freedom, e.g., six or seven degrees of freedom, for each arm, to manipulate the treatment probe 450 and the imaging probe 460. The treatment system 400 can be used to perform tissue ablation within a patient's organ, such as the patient's prostate.

[0073] 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 the patient's target site along an entry axis coincident with the treatment probe's elongated axis 451. For example, the treatment probe 450 may be configured for insertion into the patient's urethra to position the treatment probe's energy delivery region within the patient's prostate. The imaging probe 460 may be inserted into the patient at the target site or adjacent to the patient's target site along an entry axis coincident with the imaging probe's elongated axis 461. 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. Although omitted from FIG. 6 , as discussed herein, the first arm 442 and the second arm 444 may be covered within one or more sterile drapes to provide a sterile operating environment, keep the arms clean, and reduce the risk of damaging the arms.

[0074] The imaging probe 460 includes a fiducial assembly 350. The fiducial assembly 350 is coupled to the imaging probe 460 and includes a fiducial tree extending from a base. The fiducial tree includes extensions extending from the base and providing support for fiducials 359. In the embodiment depicted in FIG. 6 , the fiducial tree may include a trunk and two branches, although other configurations are envisioned, such as each fiducial extending from a corresponding individual extension or multiple fiducials on a single branch. The fiducial assembly 350 includes three fiducials 359 arranged on the tree (one at the intersection of the trunk and branches and one at the distal end of each of the two branches). The fiducials 359 are positioned on the fiducial assembly 350 in a known orientation and in a known three-dimensional relationship to the imaging probe to which they are attached. The known orientation may be based on the shape of the fiducial assembly 350. Based on the known placement, an imaging system such as stereoscopic camera system 502 can be used to image the fiducials and determine the location and orientation of the imaging probe based on the location and orientation of the fiducials and the known spatial relationship between the fiducials and the imaging probe 460. A similar fiducial assembly can be coupled to the treatment probe 450 as discussed herein to determine the location and orientation of the treatment probe 450.

[0075] FIG. 7 shows surgical probes 450, 460 and fiducial assembly 350 being used during a surgical procedure on patient 600, along with surgical drape 370 and patient fiducials 710 and 712. Patient 600 lies supine on patient support 449, which may be a surgical table or other support. One or more arms, such as robotic arms 442, 444, may be coupled to and extend from patient support 449. A sterile drape 370 may be placed over imaging probe 460. Imaging probe 460 may be on the non-sterile side 374 of sterile drape 370. Sterile drape 370 may include a barrier to prevent contaminants from the non-sterile side of the drape from contacting the sterile surgical site. For example, during transrectal ultrasound imaging, the sterile drape may help prevent fecal material from contacting the sterile surgical site.

[0076] The fiducial assembly 350 may be located on the sterile side 372 of the sterile drape 370. The fiducial assembly 350 may be coupled to the imaging probe 460 across the sterile drape 370. In some embodiments, the fiducial assembly 350 may be magnetically or mechanically coupled to the imaging probe in a known spatial relationship on the sterile side 372 of the sterile drape 370. The fiducial assembly 350 includes a fiducial tree extending from a base. The fiducial tree includes extensions that extend from the base and provide support for the fiducials 359. The fiducial assembly 350 includes three fiducials 359 positioned on the tree (one at the intersection of the trunk and branches, and one at the distal end of each of the two branches). The fiducials 359 are positioned on the fiducial assembly 350 in a known spatial arrangement and in a known spatial three-dimensional relationship to the imaging probe to which they are attached. The known spatial arrangement may be based on the shape of the fiducial assembly 350. Using the known placement, an imaging system such as stereoscopic camera system 502 can be used to image the fiducials and determine the location and orientation of the imaging probe based on the location and orientation of the fiducials and the known spatial relationship between the fiducials and the imaging probe 460. A similar fiducial assembly can be coupled to the treatment probe 450 as discussed herein to determine the location and orientation of the treatment probe 450.

[0077] As discussed herein, the imaging probe 460 can be configured to deliver sufficient energy to the target tissue to image the target tissue. The imaging probe can be inserted into the patient through the patient's rectum to image the patient transrectally. The imaging probe 460 can comprise any suitable probe, such as an ultrasound probe, a magnetic resonance probe, an endoscope, or a fluoroscopy probe. The first arm 442 and the second arm 444 can 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 each have multiple degrees of freedom, e.g., six or seven degrees of freedom, to manipulate the treatment probe 450 and the imaging probe 460. The treatment system 400 can be used to perform tissue ablation within a patient's organ, such as the patient's prostate.

[0078] 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 the patient's target site along an entry axis coincident with the treatment probe's elongated axis 451. For example, the treatment probe 450 may be configured for insertion into the patient's urethra to position the treatment probe's energy delivery region within the patient's prostate. The imaging probe 460 may be inserted into the patient along an entry axis coincident with the imaging probe's elongated axis 461 at the target site or at a site 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 view the patient's prostate and surrounding tissue.

[0079] The treatment probe 450 may be coupled to the first arm 442, and the imaging probe 460 may be coupled to the second arm 444. One or both of the first arm 442 and the second arm 444 may comprise a robotic arm, the movement of which may be controlled by one or more computing devices operably coupled to the arm. The treatment probe 450 may comprise a device for removing or otherwise treating target tissue from a target site within a patient. The treatment probe may be inserted into the patient through the patient's urethra for treatment of the patient's prostate gland. 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 comprise an electrosurgical ablation device, a laser ablation device, a transurethral needle ablation device, a water jet ablation device, or any combination thereof.

[0080] In some embodiments, one or more fiducials 710, 712 may be placed on a patient to monitor the patient's movement, position, and orientation during a surgical procedure. The patient monitoring fiducials may be placed on a limb or other portion of the patient's anatomy. For example, a patient fiducial 712 may be placed on a patient's leg, such as the patient's thigh, to monitor the patient's leg movement during treatment. In some embodiments, a single camera may be used to monitor the patient's movement based on the movement of the patient fiducial. The single camera may monitor changes in the position of the fiducial within the image and, for example, determine that the patient has moved based on the movement of the fiducial within the image without determining the three-dimensional spatial position and / or orientation of the fiducial. Alternatively, the patient fiducial may comprise multiple fiducials for determining the patient's position and orientation at the location where the fiducial is placed.

[0081] In some embodiments, one or more patient fiducials 710 may be placed on the patient's torso or hips to monitor movement of the patient's torso and hips during treatment. In some embodiments, a sterile drape 370 may be placed over the patient. In some embodiments, patient fiducials are placed on a sterile drape positioned over the patient's body (such as on a drape covering the patient's torso, hips, or legs). In some embodiments, patient fiducials 710, 720 may comprise a fiducial assembly comprising a frame or base and at least three fiducials in a planar arrangement, as described herein.

[0082] In some embodiments, the patient fiducial can be configured to allow an imaging system, such as a stereo camera system, to determine the position and orientation of the patient fiducial during treatment. In some embodiments, the patient fiducial can be substantially similar to fiducial assembly 350 described herein. In some embodiments, the interface comprises a first interface that is placed on the patient with, for example, tape, and a second interface on the base that engages the first interface through a sterile drape, as described herein.

[0083] In some embodiments, fiducials as described herein can be used in remote guidance. For example, the fiducial assembly and patient fiducials can be used to determine the position, orientation, and / or movement of a patient during a surgical procedure. This position, orientation, and movement information can be transmitted to a remote medical professional to perform or monitor the procedure and provide feedback or assistance during the procedure.

[0084] FIG. 8 shows a sterile treatment probe 450 with a sterile fiducial 359 coupled to a disposable sterile housing 810 of the single-use disposable treatment probe 450. The fiducial 359 can be directly coupled to or integral with the housing 810, which can include a shell portion 812. The fiducial 359 can extend from a surface of the disposable housing 810, for example, from the shell portion of the housing. In some embodiments, a probe such as treatment probe 460 can include a first portion 456 configured to remain outside the patient and a second portion 458 configured for insertion into the patient. In some embodiments, the fiducial assembly 350 is coupled to the housing of the first portion 466. In some embodiments, the proximal portion 456 coupled to one or more fiducials 359 remains outside the patient when the distal portion 458 is inserted into the patient.

[0085] In some embodiments, the treatment probe 450 includes a handpiece that allows the user to manipulate the treatment probe while the probe is inserted into the patient. In some embodiments, the treatment probe 450 is coupled to a reusable, non-sterile instrument driver 820 supported by an arm, as described herein.

[0086] The instrument driver may comprise any suitable device for driving the probe. In some embodiments, the instrument driver is mounted on the end of an arm, as described herein. In some embodiments, the instrument driver 820 comprises one or more structures for driving the probe. In some embodiments, the one or more structures comprise one or more of a rotatable body, a lever, a pull wire, a gear, a linkage, a motor, a motor pack, or a transmission. While many instrument drivers can be used, examples of instrument drivers and instrument device manipulators suitable for use in accordance with the present disclosure are described in PCT / US2021 / 070760, filed June 23, 2021, entitled "INTEGRATION OF ROBOTIC ARMS WITH SURGICAL PROBES," and published as WO2021263276 (the entire disclosure of which is previously incorporated by reference herein).

[0087] The treatment probe 450 may comprise any suitable treatment probe. In some embodiments, the treatment probe 450 comprises internal gears and linkages, as described herein, that move the energy source in response to rotation of components of the instrument driver 820 to rotate and translate the energy source according to instructions from a processor. While many treatment probes can be used, an example of a suitable treatment probe comprising a handpiece is described in PCT / US2015 / 048695, filed September 5, 2015, entitled "PHYSICIAN CONTROLLED TISSUE RESECTION INTEGRATED WITH TREATMENT MAPPING OF TARGET ORGAN IMAGES," and published as WO2016037137 (the entire disclosure of which is previously incorporated by reference herein).

[0088] As depicted in FIG. 8 , the disposable shell portion of the housing 810 may include at least three fiducials 359 disposed thereon. In some embodiments, the fiducials 359 may be disposed in a plane, as described herein. By locating the fiducials and defining a plane, a stereoscopic camera or multiple cameras having different positions may be used to capture images of the fiducials 359. Differences in the location of the fiducials 359 in images captured from the stereoscopic camera or other cameras may be used to determine the position and orientation of the fiducials, as described herein. When the fiducials 359 are in a known three-dimensional relationship with the surgical probe to which they are attached, the position and orientation of the surgical probe may be determined based on the position and orientation of the fiducials.

[0089] The fiducials 359 may comprise passive fiducials that reflect light that is then captured by the stereoscopic camera system to determine the location and orientation of the fiducials. In some embodiments, the fiducials may be reflective. In some embodiments, the fiducials may not be reflective but may have a contrasting color that contrasts with the surgical suite. In some embodiments, the fiducials may be active fiducials that emit light that is then captured by the stereoscopic camera system. In some embodiments, the fiducials reflect or emit infrared light or invisible wavelengths of light.

[0090] Fiducials can have many shapes. They can be round, square, triangular, or other shapes. In some embodiments, they can be spherical, cubic, pyramidal, or another three-dimensional shape. In some embodiments, each of the fiducials 539 of the fiducial assembly 350 can emit light in a different color or wavelength. In some embodiments, the fiducials can be light sources, each of which can emit light with a different on / off duty cycle or have data encoded in the light pulses emitted by the light sources that allows the camera to separate and identify each individual fiducial or set of fiducials from each other individual set of fiducials.

[0091] In some embodiments, the shell portion of the housing 810 is coupled to the instrument driver 820 across a sterile drape 370. The sterile drape 370 separates a sterile field 372 of the surgical field or operating room from a non-sterile field 374 of the surgical field or operating room. In some embodiments, the sterile drape may include a fenestration 376 for coupling the housing 810 to the instrument driver 820 across the sterile drape. The fenestration 376 may be an opening through the sterile drape 370 from the non-sterile side 374 to the sterile side 372. In some embodiments, a portion of the instrument driver 820 of the surgical probe 450 passes through the fenestration 376 and couples with the sterile disposable shell 810. In some embodiments, the perimeter of the fenestration 376 is captured by the sterile shell 810 and the instrument driver 820 to separate the sterile side 372 from the non-sterile side 374 of the sterile drape 370. In some embodiments, capturing the perimeter of the fenestration 376 closes the fenestration 376 and helps prevent contaminants from passing from the non-sterile side 374 to the sterile side 372 .

[0092] 9A and 9B show a surgical probe 450 with a dockable fiducial assembly 350. The fiducial assembly 350 may be coupled to the instrument driver 820 of the treatment probe 450 across a drape 370. The fiducial assembly 350 may include a fiducial tree 354 extending from a base 352. The fiducial trees 354 may include one or more extensions extending from the base 352 and / or from each other to provide support for the fiducials 359. In some embodiments, the fiducial tree 354 may include a trunk and multiple branches. The fiducial assembly 350 may include at least three fiducials 359 disposed on the tree 354. In some embodiments, the fiducials 359 may be positioned to define a plane, e.g., not extend along a straight line. A stereoscopic camera or multiple cameras with different positions may be used to capture images of the fiducials 359 and determine the position and orientation of the treatment probe 450.

[0093] The fiducials 359 may be passive fiducials for reflecting light that is then captured by the stereoscopic camera system to determine the location and orientation of the fiducials. In some embodiments, the fiducials may be reflective. In some embodiments, the fiducials may not be reflective, but may have a contrasting color that contrasts with the surgical suite. In some embodiments, the fiducials may be active fiducials that emit light that is then captured by the stereoscopic camera system. In some embodiments, the fiducials reflect or emit infrared light or invisible wavelengths of light.

[0094] The fiducials 359 can have many shapes. They can be round, square, triangular, or other shapes. In some embodiments, they can be spherical, cubic, pyramidal, or another three-dimensional shape. In some embodiments, each of the fiducials 539 of the fiducial assembly 350 can emit light in a different color or wavelength. In some embodiments, the fiducials can be light sources, each of which can emit light with a different on / off duty cycle or can have data encoded in the light pulses emitted by the light sources for the camera to separate and identify each individual fiducial or set of fiducials from each other individual set of fiducials.

[0095] In some embodiments, a disposable sterile shell 810 is coupled to an instrument driver 820 across a sterile drape 370. The sterile drape 370 separates a sterile field 372 of a surgical field or operating room from a non-sterile field 374 of a surgical field or operating room. In some embodiments, the sterile drape may include a fenestration 376 for coupling the shell 810 to the instrument driver 820 across the drape. The fenestration 376 may be an opening through the sterile drape 370 from the non-sterile side 374 to the sterile side 372. In some embodiments, a portion of the instrument driver 820 of the treatment probe 450 passes through the fenestration 376 and couples with the sterile disposable shell 810. In some embodiments, the perimeter of the fenestration 376 may be trapped between the sterile shell 810 and the instrument driver 820 to separate the sterile side 372 from the non-sterile side 374 of the sterile drape 370. In some embodiments, capturing the perimeter of the fenestration 376 closes the fenestration 376 and helps prevent contaminants from passing from the non-sterile side 374 to the sterile side 372 .

[0096] In some embodiments, fiducial assembly 350 is coupled to a surgical probe, such as treatment probe 450, across a sterile drape 370. As depicted in Figures 9A and 9B, fiducial assembly 350 is on the sterile side 372 of sterile drape 370.

[0097] One or more couplings 351 can couple the fiducial assembly 350 to the surgical probe in a known position and orientation relative to each other across the sterile drape 370. The couplings can be configured to couple to each other in a single orientation across the drape. For example, in some embodiments, couplings 351 can be magnetic couplings, such as rare earth magnets, with polarity configured to attract and hold couplings 351 a on the fiducial assembly to couplings 351 b on the surgical probe across the drape 370. In some embodiments, the couplings can be snaps, such as socket and stud snaps, where coupling 351 a on the fiducial assembly 350 is either a socket or a stud and the corresponding coupling 351 b on the surgical probe is the other of the socket or stud, whereby the socket receives the stud across the drape and snaps together with the drape located between couplings 351 a and 351 b. In some embodiments, the studs and sockets can be configured to take into account the thickness of the drape 370 and the engagement between the studs and sockets. In some embodiments, one or more connectors, such as a stud and a socket, are sized to engage with each other with the drape between them without disrupting the sterile barrier of the drape. In some embodiments, the connectors are sized to engage with each other across the drape without disrupting the sterile barrier material of the drape, for example, when one or more connectors engage with each other with the drape between them or when one or more connectors are separated from each other to release the drape. In some embodiments, the stud has a diameter greater than the diameter of the socket to which it is connected. In some embodiments, the stud may not interfere with the socket without the drape between them.

[0098] In some embodiments, coupling portions 351 can be positioned or fixed such that they couple fiducial assembly 350 to the surgical probe in a single orientation.

[0099] 9B, the fiducial assembly is shown coupled to the surgical probe 460 through a surgical drape 370 within a portion of the surgical equipment along with a stereoscopic camera system 502. The stereoscopic camera system 502, along with the fiducial assembly 350 and its corresponding fiducial 359, may be located on the sterile side 374 of the drape 370. The stereoscopic camera system 502 may be positioned within the surgical operating room such that the cameras of the stereoscopic camera system 502 have an unobstructed view of the fiducial 359.

[0100] 10A and 10B show examples of surgical probes in which one or more fiducials comprise two-dimensional fiducials. In some embodiments, the two-dimensional fiducials can be used to determine the three-dimensional position and orientation of the surgical probe. The two-dimensional fiducials can comprise two-dimensional patterns, such as one or more of a two-dimensional barcode or a QR code. An example of a suitable two-dimensional fiducial is AprilTag, which is commercially available from Apple, Inc.'s App Store and Google Play. The two-dimensional fiducials can be integrated directly into or coupled to the surgical probe, as described herein. For example, as depicted in FIG. 10A , two-dimensional fiducials 359 can be printed or embedded directly onto the sterile shell 810 at a known size and orientation. Two-dimensional fiducials printed directly onto a sterile portion of the surgical probe, such as the sterile shell 810, can be directly viewable by one or more cameras in the operating room. The two-dimensional fiducials can be used to determine the position and orientation of the probe, for example, the six degrees of freedom (6DOF) pose of the probe.

[0101] In some embodiments, the two-dimensional fiducial 359 can be part of the fiducial assembly 350. FIG. 10B depicts the fiducial assembly 350 coupled to the instrument driver 820. The fiducial assembly 350 can include one or more supports that are extensions extending from a base. The extensions can support the two-dimensional fiducial 359. In some embodiments, the two-dimensional fiducial can be printed directly onto the fiducial assembly 350 or formed thereon. As discussed herein, the fiducial assembly 350 can be coupled across the drape 370 to two surgical probes such as those shown and described herein with reference to FIGS. 7, 8, 9A, and 9B.

[0102] The benefit of two-dimensional fiducials is that a single camera can be used to determine the three-dimensional position and orientation of the fiducial and thereby determine the position and orientation of the surgical probe to which the two-dimensional fiducial is attached. In systems using two-dimensional fiducials, the position field of view and other characteristics of the camera system are known along with the size and shape of the fiducial. By using the characteristics of the camera system and the fiducial, an image of the fiducial taken with the camera system can be analyzed to determine the position and orientation of the fiducial. When the spatial relationship between the two-dimensional fiducial and the surgical probe to which it is attached is known, the position and orientation of the surgical probe can also be determined.

[0103] 11 illustrates multiple fiducials within the field of view of one or more cameras, where a first one or more fiducials 359a are coupled to a first probe 450 as described herein and a second one or more fiducials 359b are coupled to a second probe 460 as described herein. In some embodiments, a first fiducial assembly 350a is coupled to the first probe 450 as described herein, and the first fiducial assembly 350a may comprise any suitable components of a fiducial assembly 350, such as a tine, a base, and a coupling, as described herein. In some embodiments, a second fiducial assembly 350b is coupled to the second probe 460 as described herein, and the second fiducial assembly 350b may comprise any suitable components of a fiducial assembly 350, such as a tine, a base, and a coupling, as described herein. The first one or more fiducials 359a may comprise any suitable features of one or more fiducials 359, as described herein. The second one or more fiducials 359b may comprise any suitable characteristics of the one or more fiducials 359 as described herein.

[0104] While the first one or more fiducials and the second one or more fiducials can be configured in many ways, in some embodiments, the first probe 450 comprises a sterile treatment probe and the second probe 460 comprises a non-sterile imaging probe, such as a transrectal imaging probe. In some embodiments, the first one or more fiducials 350a are sterile and are attached to the treatment probe 450, e.g., without a drape between the first one or more fiducials and the treatment probe. In some embodiments, the second one or more fiducials 350b are coupled to the second probe 460 across a drape, e.g., coupled to a housing on the proximal portion 466. In some embodiments, the second fiducial assembly 350b comprises a base 352b that is coupled to the housing of the proximal portion 466 with a drape 370 extending therebetween. The distal portion 468 of the imaging probe is configured to be inserted into a patient as described herein. In some embodiments, the treatment probe 450 is positioned above the imaging probe 450, and the distal portion 458 of the treatment probe 450 is inserted into the patient.

[0105] The first one or more fiducials and the second one or more fiducials can be imaged in any suitable manner, as described herein. Research related to the present disclosure suggests that it may be useful to have the first one or more fiducials and the second one or more fiducials within the field of view of one or more cameras so that both one or more fiducials can be captured within a single image frame. Capturing both the first and second fiducials within the same image frame using the same sensor may reduce errors in determining the relative position and orientation of the probes, for example. This approach can provide relative difference information between the probes, such as the orientation difference between the probes. In some embodiments, determining the relative orientation of the probes is sufficient, which can be used to provide an output to a user for adjusting one or more of the probes, as described herein. In some embodiments, a single camera is used to determine the relative orientation between two probes. In some alternative embodiments, one or more cameras are arranged in a stereoscopic configuration and include a stereoscopic camera or multiple cameras that provide the position and orientation of each of the probes, for example, the position and orientation of each of the six degrees of freedom (6DOF) of the probes.

[0106] In some embodiments, the first one or more fiducials and the second one or more fiducials are imaged using a single camera, and the relative orientation of the first probe and the second probe is determined in response to the locations of the first one or more fiducials and the second one or more fiducials in the one or more images from the camera.

[0107] FIG. 12 illustrates a base point method 1200.

[0108] In step 1205, the patient is placed on a support.

[0109] In step 1210, an imaging probe is placed within the patient.

[0110] In step 1215, the patient is draped.

[0111] In step 1220, a treatment probe is placed within the patient.

[0112] In step 1225, the treatment probe is coupled to the instrument driver across the drape, for example, through an opening in the drape.

[0113] In step 1230, one or more imaging probe fiducials are coupled to the imaging probe across the drape, for example, through the material of the drape.

[0114] In step 1235, one or more treatment probe fiducials are coupled to the treatment probe.

[0115] In step 1240, one or more images of the one or more imaging probe fiducials are captured using one or more cameras as described herein.

[0116] In step 1245, the position of the imaging probe is determined from one or more images.

[0117] In step 1250, the orientation of the imaging probe is determined from one or more images.

[0118] In step 1255, one or more images of the one or more treatment probe fiducials are captured using one or more cameras.

[0119] In step 1260, the position of the treatment probe is determined from one or more images.

[0120] In step 1265, the orientation of the treatment probe is determined from one or more images.

[0121] In step 1270, the difference between the orientation of the imaging probe and the treatment probe is determined.

[0122] In step 1275, the difference between the positions of the imaging probe and the treatment probe is determined.

[0123] In step 1280, instructions are output to the user interface for the user to adjust one or more of the therapy probe or the imaging probe. The instructions may comprise any suitable instructions, such as, for example, one or more of an alert, a notification, a message on the display, a notification on the display, a pop-up screen, a color on the display, an audible alert, or a haptic communication.

[0124] 12 illustrates a method 1200 according to some embodiments, but those skilled in the art will recognize many adaptations and variations. The steps can be performed in any order. Some of the steps can be combined, and some steps may include sub-steps of other steps. Some of the steps can be omitted, and some of the steps can be repeated.

[0125] A processor as described herein may be configured to perform one or more steps of the method 1200.

[0126] 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.

[0127] 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 thereof, or any other suitable storage memory.

[0128] 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), one or more portions thereof, one or more variations or combinations thereof, or any other suitable physical processor. A processor may comprise a distributed processor system, e.g., parallel-running processors, or remote processors such as servers, and combinations thereof.

[0129] 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.

[0130] 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.

[0131] 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 distributed systems.

[0132] 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.

[0133] The various exemplary methods described and / or illustrated herein may 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.

[0134] 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.

[0135] Unless otherwise stated, the terms "connected to" and "coupled to" (and their derivatives) as used in the 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 the 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 the specification and claims shall be synonymous with and have the same meaning as the word "comprising."

[0136] A processor as disclosed herein may be configured with instructions to perform any one or more steps of any method as disclosed herein.

[0137] 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 used to distinguish only 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.

[0138] As used herein, the term "or" is used inclusively to refer to items as alternatives, in combination, or both.

[0139] As used herein, letters such as numbers refer to similar elements.

[0140] This disclosure includes the following numbered appendices:

[0141] Appendix 1. A fiducial system for use with a drape, the fiducial system comprising a fiducial assembly configured to traverse the drape and couple to the probe with a fixed orientation and offset relative to the elongate axis of the probe, the fiducial assembly comprising a base, a coupling portion attached to the base and configured to traverse the drape and couple the fiducial assembly to the probe, and one or more fiducials attached to the base.

[0142] Attachment 2. The fiducial system of any preceding attachment, wherein one or more of the fiducials comprises a two-dimensional fiducial.

[0143] Clause 3. The fiducial system of any preceding clause, wherein the one or more fiducials comprise a two-dimensional array of fiducials.

[0144] Clause 4. The system of any preceding clause, wherein the two-dimensional fiducial comprises a first fiducial, a second fiducial, and a third fiducial arranged along a plane.

[0145] Clause 5. The base system of any preceding clause, wherein the base assembly further comprises a base tree extending from the base, the one or more bases being attached to branches of the base tree.

[0146] Attachment 6. A fiducial system according to any preceding attachment, wherein one or more of the fiducials comprises a light source.

[0147] Attachment 7. The fiducial system of any preceding attachment, wherein one or more fiducials are provided with an optical reflector.

[0148] Appendix 8. A fiducial system according to any preceding appendix, wherein one or more of the fiducials comprises a single two-dimensional fiducial.

[0149] Clause 9. The fiducial system of any preceding clause, wherein the probe comprises one or more of an imaging probe or a therapeutic probe.

[0150] Clause 10. The fiducial system of any preceding clause, wherein the one or more fiducials are configured to be located on a sterile side of the drape and at least a portion of the probe is configured to be located on a non-sterile side of the drape.

[0151] Clause 11. The fiducial system of any preceding clause, wherein the one or more fiducials are configured to be located on a first side of the drape and at least a portion of the surgical probe is configured to be located on a second side of the drape.

[0152] Clause 12. The base system of any preceding clause, wherein the coupling portion couples the surgical drape, the probe, and the base assembly together.

[0153] Clause 13. The fiducial system of any preceding clause, wherein a first portion of the coupling is located on the probe and a second portion of the coupling is located on the fiducial assembly, the first portion being configured to couple to the second portion, and a drape is between the first portion and the second portion.

[0154] Clause 14. The base system of any preceding clause, wherein the coupling comprises a magnetic coupling.

[0155] Clause 15. The anchor system of any preceding clause, wherein the coupling comprises a snap coupling.

[0156] Clause 16. The base system of any preceding clause, wherein the coupling portion comprises a stud portion located on one of the probe or base assembly and a second portion including a socket located on the other of the probe or base assembly.

[0157] Clause 17. The fiducial system of any preceding clause, wherein the coupling portion is configured to couple the fiducial assembly to the probe in a single orientation.

[0158] Clause 18. The fiducial system of any preceding clause, wherein the coupling portion is configured to couple the fiducial assembly to the probe in a single position and a single orientation relative to the probe.

[0159] Clause 19. The fiducial system of any preceding clause, wherein the coupling portion and the one or more fiducials are configured to couple the one or more fiducials to the probe with a fixed offset distance from and a fixed location along the elongate axis.

[0160] Clause 20. The fiducial system of any preceding clause, wherein the fixed location along the elongate axis corresponds to a fixed distance between the fixed location and the distal tip of the probe.

[0161] Clause 21. The fiducial system of any preceding clause, further comprising a processor configured to determine a position and orientation of the probe in response to the positions and orientations of the one or more fiducials.

[0162] Clause 22. The fiducial system of any preceding clause, further comprising one or more cameras coupled to the processor, the one or more cameras having a field of view for generating images of the one or more fiducials coupled to the probes across the drape, the processor configured to process the images and determine positions and orientations of the probes coupled to the one or more fiducials across the drape.

[0163] Clause 23. The fiducial system of any preceding clause, further comprising a second probe comprising a second one or more fiducials within the field of view of the one or more cameras, wherein the processor is configured to determine a position and orientation of the second probe.

[0164] Clause 24. The reference point system of any preceding clause, wherein the one or more cameras comprise a single camera, and wherein the processor is configured to determine a difference between an orientation of the probe and an orientation of a second probe.

[0165] Clause 25. The fiducial system of any preceding clause, further comprising a second probe comprising an orientation sensor coupled to a processor, the processor configured to determine an orientation of the second probe relative to the probe in response to data from the orientation sensor of the second probe and the one or more fiducials.

[0166] Clause 26. The fiducial system of any preceding clause, wherein the probe comprises a transrectal ultrasound probe and the second probe comprises a treatment probe.

[0167] Appendix 27. A system for use with a drape, the system comprising: a probe having a sterile portion configured to be located on the sterile side of the drape; an instrument driver configured to be on the non-sterile side of the surgical drape, the sterile portion and the instrument manipulator being couplable to one another across the surgical drape; and one or more sterile fiducials in a fixed spatial relationship with the sterile portion of the probe.

[0168] Clause 28. The system of any preceding clause, wherein one or more fiducials are couplable to the probe in a fixed, special relationship.

[0169] Attachment 29. A fiducial system as described in any preceding attachment, wherein one or more of the fiducials comprises a two-dimensional fiducial.

[0170] Clause 30. The fiducial system of any preceding clause, wherein the one or more fiducials comprise a two-dimensional array of fiducials.

[0171] Clause 31. The system of reference points of any preceding clause, wherein the two-dimensional reference point comprises a first reference point, a second reference point, and a third reference point disposed along a plane.

[0172] Clause 32. The system of any preceding clause, wherein the base assembly further comprises a base tree extending from the base, the one or more bases being attached to branches of the base tree.

[0173] Clause 33. The system of any preceding clause, wherein one or more of the fiducials comprises a light source.

[0174] Clause 34. The system of any preceding clause, wherein one or more fiducials comprise an optical reflector.

[0175] Attachment 35. The system of any preceding attachment, wherein the one or more fiducials comprise a single two-dimensional fiducial.

[0176] Clause 36. The system of any preceding clause, wherein the one or more fiducials are configured to be located on a sterile side of the surgical drape.

[0177] Clause 37. The system of any preceding clause, wherein the surgical probe comprises one or more of an imaging probe or a treatment probe.

[0178] Clause 38. The system of any preceding clause, wherein a first portion of the one or more couplings is on the surgical probe and a second portion of the one or more couplings is located on the base assembly.

[0179] Clause 39. The system of any preceding clause, wherein one or more couplings comprise magnetic couplings.

[0180] Clause 40. The system of any preceding clause, wherein one or more couplings comprise a snap coupling.

[0181] Clause 41. The system of any preceding clause, wherein the one or more coupling portions comprises a stud portion on one of the surgical probe or fiducial assembly and a second portion including a socket on the other of the surgical probe or fiducial assembly.

[0182] Clause 42. The system of any preceding clause, wherein the one or more couplings are configured to couple the fiducial assembly to the probe in a single orientation.

[0183] Clause 43. The system of any preceding clause, wherein the coupling portion couples the surgical drape, the surgical probe, and the base assembly together.

[0184] Attachment 44. A system according to any preceding attachment, wherein one or more fiducials are attached to the sterile portion.

[0185] Attachment 45. A system according to any preceding attachment, wherein one or more fiducials extend directly from the sterile portion.

[0186] Addendum 46. A system according to any preceding addendum, wherein the one or more base points include three base points in a plane.

[0187] Attachment 47. A system according to any preceding attachment, wherein one or more fiducials are sterilized and integrated with a sterile portion of like material.

[0188] Clause 48. The system of any preceding clause, wherein the one or more fiducials comprise sterile fiducials formed on the sterile portion.

[0189] Attachment 49. The system of any preceding attachment, wherein the one or more fiducials comprise fiducials printed on the sterile portion.

[0190] Addendum 50. The system of any preceding addendum, wherein the sterile portion comprises a sterile shell of the surgical probe, and the one or more fiducials extend from the sterile shell.

[0191] Addendum 51. The system of any preceding addendum, wherein the instrument driver comprises one or more structures for engaging the probe, the one or more structures comprising one or more of a rotatable body, a lever, a pull wire, a gear, a linkage, a motor, a motor pack, or a transmission.

[0192] Addendum 52. The system of any preceding addendum, wherein the probe is configured to traverse a drape with an opening through the drape to couple to the instrument driver.

[0193] Clause 53. The system of any preceding clause, wherein the probe comprises a sterile, single-use, disposable probe and the instrument driver comprises a non-sterile, reusable component.

[0194] Clause 54. The system of any preceding clause, wherein one or more sterilization fiducials are coupled to an instrument driver across the drape.

[0195] Clause 55. The system of any preceding clause, further comprising a processor, the processor configured to determine a position and orientation of the probe in response to the images of the one or more fiducials.

[0196] Addendum 56. A method of using a fiducial with a drape, the method including coupling a probe having an elongated shaft and an elongated axis to an arm, covering the probe with a drape, and coupling a fiducial assembly to the probe across the drape, the drape being between the fiducial assembly and the probe, the fiducial assembly including a base, a coupling attached to the base and configured to couple the fiducial assembly to the probe across the drape, and one or more fiducials attached to the base.

[0197] Clause 57. The method of any preceding clause, further comprising moving the surgical probe under the surgical drape based on an orientation of the probe determined from the origin.

[0198] Clause 58. The method of any preceding clause, wherein the fiducial comprises a light source.

[0199] Clause 59. The method of any preceding clause, wherein the fiducial comprises an optical reflector.

[0200] Clause 60. The method of any preceding clause, wherein the one or more fiducials comprise a single two-dimensional fiducial.

[0201] Clause 61. The method of any preceding clause, wherein the fiducial is coupled to a first side of the surgical drape and at least a portion of the surgical probe is located on a second side of the surgical drape.

[0202] Clause 62. The method of any preceding clause, wherein the probe comprises one or more of an imaging probe or a therapeutic probe.

[0203] Clause 63. The method of any preceding clause, wherein the coupling portion comprises a magnetic coupling portion.

[0204] Clause 64. The method of any preceding clause, wherein the coupling portion is configured to couple the base assembly to the surgical probe in a single orientation.

[0205] Addendum 65. The method of any preceding addendum, wherein the coupling portion couples the surgical drape, the surgical probe, and the base assembly together.

[0206] Appendix 66. A method of using a drape, the method including covering a non-sterile instrument driver with the drape and coupling a sterile probe to the instrument driver, with a surgical drape therebetween, and one or more sterile fiducials coupled to the sterile probe in fixed, specific relationship with a sterile portion of the surgical probe.

[0207] Clause 67. The method of any preceding clause, further comprising inserting a portion of the non-sterile portion of the surgical probe through a fenestrated portion in the surgical drape.

[0208] Clause 68. The method of any preceding clause, further comprising capturing a periphery of the fenestration between a sterile portion and a non-sterile portion of the surgical drape.

[0209] Clause 69. The method of any preceding clause, further comprising moving the surgical probe under the surgical drape based on an orientation of the probe determined from one or more base points.

[0210] Clause 70. The method of any preceding clause, wherein the one or more fiducials are configured to be located on a sterile side of the surgical drape.

[0211] Clause 71. The method of any preceding clause, wherein the one or more fiducials are configured to be located on a first side of the surgical drape and at least a portion of the surgical probe is configured to be located on a second side of the surgical drape.

[0212] Attachment 72. The method of any preceding attachment, wherein one or more fiducials are integral with the sterile portion.

[0213] Attachment 73. The method of any preceding attachment, wherein the one or more fiducials extend directly from the sterile portion.

[0214] Addendum 74. The method of any preceding addendum, wherein the one or more base points include three base points that define a plane.

[0215] Attachment 75. The method of any preceding attachment, wherein one or more fiducials are integrated into the sterile portion.

[0216] Clause 76. The system or method of any one of the preceding clauses, wherein the one or more cameras comprise a stereoscopic camera.

[0217] Clause 77. The system or method of any preceding clause, wherein the one or more cameras comprise a plurality of cameras.

[0218] Clause 78. The system or method of any preceding clause, wherein the one or more cameras comprise a single camera.

[0219] Addendum 79. The system or method of any preceding addendum, wherein the processor is configured to output instructions to the user for adjusting the probe in response to one or more of the position or orientation of the probe.

[0220] 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 invention(s) of the present disclosure shall be defined solely by the scope of the appended claims and their equivalents.

Claims

1. 1. A base system for use with a drape, said base system comprising: a fiducial assembly configured to traverse the drape and couple to the probe with a fixed orientation and offset relative to an elongate axis of the probe; The base assembly includes: A base and a coupling portion attached to the base and configured to traverse the drape to couple the base assembly to the probe; one or more fiducials attached to the base; A base system comprising:

2. The fiducial system of claim 1 , wherein the one or more fiducials comprise two-dimensional fiducials.

3. The fiducial system of claim 2 , wherein the one or more fiducials comprise a two-dimensional array of fiducials.

4. The fiducial system of claim 2 , wherein the two-dimensional fiducials comprise a first fiducial, a second fiducial, and a third fiducial arranged along a plane.

5. The base assembly includes: The base system of claim 1 further comprising a base tree extending from the base, the one or more bases being attached to branches of the base tree.

6. The fiducial system of claim 1 , wherein the one or more fiducials include a light source.

7. The fiducial system of claim 1 , wherein the one or more fiducials comprise an optical reflector.

8. The fiducial system of claim 1 , wherein the one or more fiducials comprise a single two-dimensional fiducial.

9. The fiducial system of claim 1 , wherein the probe comprises one or more of an imaging probe or a therapy probe.

10. 10. The fiducial system of claim 1, wherein the one or more fiducials are configured to be located on a sterile side of the drape and at least a portion of the probe is configured to be located on a non-sterile side of the drape.

11. 10. The fiducial system of claim 1, wherein the one or more fiducials are configured to be located on a first side of the drape and at least a portion of the surgical probe is configured to be located on a second side of the drape.

12. The fiducial system of claim 1 , wherein the coupling couples the surgical drape, the probe, and the fiducial assembly together.

13. 10. The fiducial system of claim 1, wherein a first portion of the coupling is located on the probe and a second portion of the coupling is located on the fiducial assembly, the first portion configured to couple to the second portion, and the drape is between the first portion and the second portion.

14. The base system of claim 13 , wherein the coupling comprises a magnetic coupling.

15. The base system of claim 1 , wherein the coupling comprises a snap coupling.

16. 10. The fiducial system of claim 1, wherein the coupling portion comprises a stud portion located on one of the probe or the fiducial assembly and a second portion including a socket located on the other of the probe or the fiducial assembly.

17. The fiducial system of claim 1 , wherein the coupling is configured to couple the fiducial assembly to the probe in a single orientation.

18. 18. The fiducial system of claim 17, wherein the coupling is configured to couple the fiducial assembly to the probe in a single position and in the single orientation relative to the probe.

19. 20. The fiducial system of claim 18, wherein the coupling portion and the one or more fiducials are configured to couple the one or more fiducials to the probe with a fixed offset distance from and a fixed location along the elongate axis.

20. 20. The fiducial system of claim 19, wherein a fixed location along the elongate axis corresponds to a fixed distance between the fixed location and a distal tip of the probe.

21. The fiducial system of claim 1 , further comprising a processor configured to determine a position and orientation of the probe in response to the position and orientation of the one or more fiducials.

22. further comprising one or more cameras coupled to the processor, the one or more cameras having a field of view for generating an image of the one or more fiducials coupled to the probe across the drape; 22. The fiducial system of claim 21, wherein the processor is configured to process the image and determine the position and orientation of the probe coupled to the one or more fiducials across the drape.

23. 23. The fiducial system of claim 22, further comprising a second probe comprising a second one or more fiducials within the field of view of the one or more cameras, the processor configured to determine a position and orientation of the second probe.

24. 24. The reference system of claim 23, wherein the one or more cameras comprise a single camera, and the processor is configured to determine a difference between the orientation of the probe and the orientation of the second probe.

25. 23. The fiducial system of claim 22, further comprising a second probe comprising an orientation sensor coupled to the processor, the processor configured to determine an orientation of the second probe relative to the probe in response to data from the orientation sensor of the second probe and the one or more fiducials.

26. 26. The fiducial system of claim 25, wherein the probe comprises a transrectal ultrasound probe and the second probe comprises a treatment probe.

27. 1. A system for use with a drape, said system comprising: a probe having a sterile portion configured to be positioned on the sterile side of the drape; an instrument driver configured to be on a non-sterile portion of the surgical drape, the sterile portion and the instrument manipulator being connectable to one another across the surgical drape; one or more sterile fiducials in fixed spatial relationship with the sterile portion of the probe; A system comprising:

28. 28. The system of claim 27, wherein the one or more fiducials are bindable to the probe in the fixed special relationship.

29. 30. The fiducial system of claim 28, wherein the one or more fiducials comprise two-dimensional fiducials.

30. 30. The fiducial system of claim 29, wherein the one or more fiducials comprise a two-dimensional array of fiducials.

31. 30. The fiducial system of claim 29, wherein the two-dimensional fiducials comprise a first fiducial, a second fiducial, and a third fiducial disposed along a plane.

32. The base assembly includes:

28. The system of claim 27, further comprising an origin tree extending from the base, the one or more origins being attached to branches of the origin tree.

33. 30. The system of claim 27, wherein the one or more fiducials comprise a light source.

34. 30. The system of claim 27, wherein the one or more fiducials comprise an optical reflector.

35. 30. The system of claim 27, wherein the one or more fiducials comprise a single two-dimensional fiducial.

36. 28. The system of claim 27, wherein the one or more fiducials are configured to be located on a sterile side of the surgical drape.

37. 28. The system of claim 27, wherein the surgical probe comprises one or more of an imaging probe or a therapy probe.

38. 28. The system of claim 27, wherein a first portion of the one or more couplings is on the surgical probe and a second portion of the one or more couplings is located on the fiducial assembly.

39. 40. The system of claim 38, wherein the one or more couplings comprise magnetic couplings.

40. 30. The system of claim 27, wherein the one or more couplings comprise a snap coupling.

41. 28. The system of claim 27, wherein the one or more coupling portions comprise a stud portion on one of the surgical probe or the fiducial assembly and a second portion including a socket on the other of the surgical probe or the fiducial assembly.

42. 28. The system of claim 27, wherein the one or more couplings are configured to couple the fiducial assembly to the probe in a single orientation.

43. 28. The system of claim 27, wherein the coupling couples the surgical drape, the surgical probe, and the fiducial assembly together.

44. 28. The system of claim 27, wherein the one or more fiducials are attached to the sterile portion.

45. 28. The system of claim 27, wherein the one or more fiducials extend directly from the sterile portion.

46. 46. ​​The system of claim 45, wherein the one or more origins include three origins in a plane.

47. 28. The system of claim 27, wherein the one or more fiducials are sterile and integrated with a sterile portion with a similar material.

48. 28. The system of claim 27, wherein the one or more fiducials comprise sterile fiducials formed on the sterile portion.

49. 28. The system of claim 27, wherein the one or more fiducials comprise fiducials printed on the sterile portion.

50. 28. The system of claim 27, wherein the sterile portion comprises a sterile shell of the surgical probe, and the one or more fiducials extend from the sterile shell.

51. 28. The system of claim 27, wherein the instrument driver comprises one or more structures for engaging the probe, the one or more structures comprising one or more of a rotatable body, a lever, a pull wire, a gear, a linkage, a motor, a motor pack, or a transmission.

52. 28. The system of claim 27, wherein the probe is configured to traverse the drape with an opening through the drape to couple to the instrument driver.

53. 28. The system of claim 27, wherein the probe comprises a sterile, single-use, disposable probe and the instrument driver comprises a non-sterile, reusable component.

54. 28. The system of claim 27, wherein the one or more sterilization fiducials are coupled to the instrument driver across the drape.

55. 28. The system of claim 27, further comprising a processor, the processor configured to determine a position and orientation of the probe in response to images of the one or more fiducials.

56. 1. A method for using a fiducial with a drape, the method comprising: coupling a probe having an elongated shaft and an elongated axis to the arm; draping the probe; coupling a fiducial assembly to the probe across the drape; Including, The drape is between the fiducial assembly and the probe, and the fiducial assembly includes: A base and a coupling portion attached to the base and configured to traverse the drape to couple the base assembly to the probe; one or more fiducials attached to the base; The method comprises:

57. 57. The method of claim 56, further comprising moving the surgical probe under the surgical drape based on an orientation of the probe determined from the origin.

58. 57. The method of claim 56, wherein the fiducial comprises a light source.

59. 57. The method of claim 56, wherein the fiducials comprise optical reflectors.

60. 57. The method of claim 56, wherein the one or more fiducials comprise a single two-dimensional fiducial.

61. 57. The method of claim 56, wherein the fiducial is coupled to a first side of the surgical drape and at least a portion of the surgical probe is located on a second side of the surgical drape.

62. 57. The method of claim 56, wherein the probe comprises one or more of an imaging probe or a therapy probe.

63. 57. The method of claim 56, wherein the coupling comprises a magnetic coupling.

64. The method of any one of claims 56-63, wherein the coupling portion is configured to couple the fiducial assembly to the surgical probe in a single orientation.

65. 57. The method of claim 56, wherein the coupling couples the surgical drape, the surgical probe, and the fiducial assembly together.

66. 1. A method of using a drape, the method comprising: draping a non-sterile instrument driver; coupling a sterile probe to said instrument driver; Including, The method wherein the surgical drape is between the sterile probe and the instrument driver, and one or more sterile fiducials are coupled to the sterile probe in fixed, specific relationship with a sterile portion of the surgical probe.

67. 67. The method of claim 66, further comprising inserting a portion of the non-sterile portion of the surgical probe through a fenestrated portion in the surgical drape.

68. 68. The method of claim 67, further comprising capturing a periphery of the fenestration between the sterile portion and the non-sterile portion of the surgical drape.

69. 69. The method of claim 68, further comprising moving the surgical probe under the surgical drape based on an orientation of the probe determined from the one or more origins.

70. 67. The method of claim 66, wherein the one or more fiducials are configured to be located on a sterile side of the surgical drape.

71. 67. The method of claim 66, wherein the one or more fiducials are configured to be located on a first side of the surgical drape and at least a portion of the surgical probe is configured to be located on a second side of the surgical drape.

72. 67. The method of claim 66, wherein the one or more fiducials are integral with the sterile portion.

73. 67. The method of claim 66, wherein the one or more fiducials extend directly from the sterile portion.

74. 74. The method of claim 73, wherein the one or more origins include three origins that define a plane.

75. 67. The method of claim 66, wherein the one or more fiducials are integral to the sterile portion.

76. 10. A system or method according to any preceding claim, wherein the one or more cameras comprise a stereo camera.

77. 10. A system or method according to any preceding claim, wherein the one or more cameras comprise a plurality of cameras.

78. 10. A system or method according to any preceding claim, wherein the one or more cameras comprise a single camera.

79. 10. A system or method according to any preceding claim, wherein a processor is configured to output instructions to a user for adjusting the probe in response to one or more of the position or orientation of the probe.

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