WO2025213145A1

WO2025213145A1 - Surgical navigation system

Info

Publication number: WO2025213145A1
Application number: PCT/US2025/023329
Authority: WO
Inventors: Per Bergman; Ryan Cleveland; Scott Ryan DE NOBLE; Jonathan FINCKE; Jad KAOUK; John-Michael SUNGAR; Douglas TEANY
Original assignee: Method Ai Inc
Current assignee: Method Ai Inc
Priority date: 2024-04-05
Filing date: 2025-04-04
Publication date: 2025-10-09
Anticipated expiration: 2026-10-05

Abstract

A surgical navigation system includes an elongated medical device (EMD) dimensioned to pass through a urethra. The EMD includes a distal atraumatic tip and carries an ultrasound transducer to acoustically couple with regions along and about the urethra to output ultrasound data for regions along and about of the urethra.

Description

SURGICAL NAVIGATION SYSTEM

BACKGROUND

[0001] Prostate surgeries, or prostatectomies, are often “radical” procedures in that they involve the complete removal of a patient’s prostate. The prostate is surrounded by and fascially connected to multiple sensitive or critical anatomical structures such as veins, arteries, and nerves. A particular example of such a critical anatomical structure is a neurovascular bundle that extends along the prostrate and that controls continence and erectile functions. Regions about the prostate are also highly perfused with a large number of blood meaning that damage to such regions may result in the discharge and spread of blood which may present additional challenges for the prostatectomy.

BRIEF DESCRIPTION OF THE DRAWINGS

[0002] Figure 1 is a diagram madly illustrating portions of the surgical navigation system.

[0003] Figures 2A, 2B and 2C straight different example surgical approaches for laparoscopic prostatectomies.

[0004] Figure 3 is a flow diagram illustrating an example trans-vesical approach for laparoscopic prostatectomy.

[0005] Figure 4 is a sectional view illustrating an example laparoscopic prostatectomy using intra-urethral imaging.

[0006] Figures 5A, 5B and and 5C are diagrams illustrating example usage of intraurethral ultrasound imaging during steps of a laparoscopic prostatectomy procedure.

[0007] Figure 6 is a diagram illustrating example critical structures during dissection of the prostate.

[0008] Figure 7 is is a diagram illustrating ligationis of prostatic pedacles prior to dissection.

[0009] Figure 8 is a perspective view illustrating portions of an example navigation probe for the surgical navigation system of Figure 1 . [00010] Figure 9 is an exploded perspective view illustrating portions of an example probe for the surgical navigation system of Figure 1.

[00011] Figure 10 is a perspective view illustrating portions of an example navigation probe for the surgical navigation system of Figure 1.

[00012] Figure 11 is a side view illustrating portions of an example navigation probe for the surgical navigation system of Figure 1 .

[00013] Figure 12 is a fragmentary perspective view illustrating portions of the example navigation probe of Figure 11 having an example gripping feature engaged by an example grasping device.

[00014] Figure 13 is an enlarged fragmentary perspective view illustrating the gripping feature of Figure 12 engaged by the example grasping device.

[00015] Figure 14 is an enlarged fragmentary perspective view illustrating the example navigation probe of Figure 11 with an alternative gripping feature be engaged by an example grasping device.

[00016] Figure 15 is a perspective view illustrating portions of an example navigation probe for use with the surgical navigation system of Figure 1 and having an example removable distal tip.

[00017] Figure 16 is a perspective view illustrating portions of an example navigation probe for use with the example surgical navigation system of 1 and having an example mechanism removably securing an example distal tip

[00018] Figure 17 is a sectional view of the example mechanism of Figure 16.

[00019] Figure 18 is a perspective view illustrating portions of the distal tip of

Figure 15.

[00020] Figure 19 is a fragmentary perspective view illustrating portions of an example navigation probe for use with the example surgical navigation system of Figure 1 and having a connection mechanism removably securing an example distal tip.

[00021] Figure 20 is a fragmentary perspective view illustrating portions of the example connection mechanism of Figure 19. [00022] Figure 21 is a perspective view illustrating portions of an example navigation probe for use with the surgical navigation system of Figure 1 and comprising a removable handle.

[00023] Figure 22 is a perspective view illustrating portions of an example navigation probe for use with the surgical navigation system of Figure 1 and comprising a removable handle and a removable distal tip.

[00024] Figure 23 is a side view illustrating portions of an example navigation probe for use with the example surgical navigation system of 1 and having example markings.

[00025] Figure 24 is a top view illustrating portions of the example navigation probe of Figure 23.

[00026] Figure 25 is an end view illustrating portions of the example navigation probe of Figure 23.

[00027] Figure 26 is a cross-sectional view of an example navigation probe for use with the surgical navigation system of Figure 1 and extending within a urethra.

[00028] Figure 27 is a cross-sectional view of an example navigation probe for use with the surgical navigation system of Figure 1 and extending within a urethra and having an example lumen.

[00029] Figure 28 is a sectional view of an example navigation probe for use with the example surgical navigation system of Figure 1 and having an example proximal lumen.

[00030] Figure 29 is a sectional view of an example navigation probe for use with the example surgical navigation system of Figure 1 and having an example distal lumen.

[00031] Figure 30 is a sectional view of an example navigation probe for use with the example surgical navigation system of Figure 1 and having an example transducer pressing device in a retracted disengaged state.

[00032] Figure 31 is a sectional view of an example navigation probe of Figure 30 with the example transducer pressing device in an extended engaged state. [00033] Figure 32 is a sectional view of an example navigation probe for use with the example surgical navigation system of Figure 1 and having an example inflatable transducer pressing device in a retracted disengaged state.

[00034] Figure 33 is a sectional view of an example navigation probe of Figure 32 with the example inflatable transducer pressing device in an extended engaged state.

[00035] Figure 34 is a sectional view of an example navigation probe for use with the example surgical navigation system of Figure 1 and having an example mechanical anchor device in a retracted disengaged state.

[00036] Figure 35 is a sectional view of an example navigation probe of Figure 34 with the example mechanical anchor device in an extended engaged state.

[00037] Figure 36 is a sectional view of an example navigation probe for use with the example surgical navigation system of Figure 1 and having an vacuum anchor device.

[00038] Figure 37 is a sectional view of an example navigation probe for use with the example surgical navigation system of Figure 1 and having an example transducer pressing device in a retracted disengaged state.

[00039] Figure 38 is an enlarged cross-sectional view illustrating portions of the example probe of Figure 37 in the retracted disengaged state.

[00040] Figure 39 is a sectional view of an example navigation probe of Figure 37 with the example transducer pressing device in an extended engaged state.

[00041] Figure 40 is an enlarged cross-sectional view illustrating portions of the example probe of Figure 39 in the extended engaged state.

[00042] Figure 41 is a perspective view illustrating portions of an example navigation probe for use with the example surgical navigation system of Figure 1 and having an internal rotatable ultrasound transducer with portions transparently illustrated.

[00043] Figure 42 is a fragmentary perspective view of portions of the example navigation probe of Figure 41 . [00044] Figure 43 is a fragmentary perspective view illustrating portions of an example rotary drive of the example navigation probe of Figure 41 .

[00045] Figure 44 is a cross-sectional view illustrating portions of the example rotary drive shown in Figure 43.

[00046] Figure 45 is a perspective view illustrating portions of an example navigation probe for use with the example surgical navigation system of Figure 1 and having a rotatable ultrasound sensor supporting medial portion and distal tip.

[00047] Figure 46 is a fragmentary perspective view illustrating portions of an example drive mechanism for rotating the rotatable ultrasound sensor supporting medial portion and distal tip.

[00048] Figure 47 is a cross-sectional view of the example rotary drive of the example navigation probe of Figure 46.

[00049] Figure 48 is a fragmentary perspective view illustrating rotation of the rotatable ultrasound sensor supporting medial portion distal tip of the example navigation probe of Figure 46.

[00050] Figure 49 is a perspective view illustrating portions of an example navigation probe for use in the example surgical navigation system of Figure 1 and having a translatable and rotatable ultrasound transducer in a retracted position.

[00051] Figure 50 is an enlarged top perspective view illustrating portions of the example navigation probe of Figure 49 with portions transparently illustrated.

[00052] Figure 51 is an enlarged bottom perspective view of a portion of the example navigation probe of Figure 49 with portions transparently illustrated.

[00053] Figure 52 is a perspective view with the translatable rotatable ultrasound transducer in an extended position.

[00054] Figure 53 is a perspective view illustrating portions of an example navigation probe for use in the example surgical navigation system of Figure 1 and having an example drape clamp.

[00055] Figure 54 is a perspective view of the example navigation probe of Figure 53 with portions transparently illustrated. [00056] Figure 55 is a perspective view illustrating portions of an example patient table supported holder supporting an example navigation probe as part of the surgical navigation system of Figure 1 .

[00057] Figure 56 is a perspective view illustrating portions of the example holder of Figure 55 supporting the example navigation probe.

[00058] Figure 57 is a perspective view filtering portions of an example leg mounted holder supporting an example navigation probe as part of the surgical navigation system of Figure 1 .

[00059] Figure 58 is a diagram illustrating an example surgical navigation system during a prostatectomy.

[00060] Figure 59 is an enlarged sectional view of the example surgical navigation system of Figure 58 illustrating urethral insertion of portions of an example navigation probe.

[00061] Figure 60 is a diagram illustrating of an example display of the system of Figure 58 presenting a guiding image depicting example surgical guide graphics based upon ultrasound data acquired by the example navigation probe.

DETAILED DESCRIPTION

[00062] Disclosed are example surgical navigation systems which provide enhanced navigation and/or vision of regions about and along the prostate during prostate surgery to reduce the likelihood of impact to critical structures of the organ or anatomy from being damaged. The example prostate surgery navigation systems improves the outcomes of the procedure by improving visualization to help ensure complete removal of cancerous tissue in and around the prostate organ and by reducing the likelihood of injury critical structures , such as the neurovascular bundles the extends along the prostate.

[00063] The treatment of prostatic cancer includes surveillance only, ablation, radiation, and surgery. Laparoscopic surgery is common for prostatic cancer, with a high prevalence of robotic assisted laparoscopic surgeries. Laparoscopic surgeries are challenged with limited real-time subsurface visualization of the tissue and structures that are important during the surgery. [00064] For purposes of this disclosure, the term “processing unit” shall mean a presently developed or future developed computing hardware that executes sequences of instructions contained in a non-transitory memory. Execution of the sequences of instructions causes the processing unit to perform steps such as generating control signals. The instructions may be loaded in a random access memory (RAM) for execution by the processing unit from a read only memory (ROM), a mass storage device, or some other persistent storage. In other embodiments, hard wired circuitry may be used in place of or in combination with software instructions to implement the functions described. For example, a controller may be embodied as part of one or more application-specific integrated circuits (ASICs). Unless otherwise specifically noted, the controller is not limited to any specific combination of hardware circuitry and software, nor to any particular source for the instructions executed by the processing unit.

[00065] For purposes of this disclosure, unless otherwise explicitly set forth, the recitation of a “processor”, “processing unit” and “processing resource” in the specification, independent claims or dependent claims shall mean at least one processor or at least one processing unit. The at least one processor or processing unit may comprise multiple individual processors or processing units at a single [00066] For purposes of this disclosure, the term “coupled” shall mean the joining of two members directly or indirectly to one another. Such joining may be stationary in nature or movable in nature. Such joining may be achieved with the two members, or the two members and any additional intermediate members being integrally formed as a single unitary body with one another or with the two members or the two members and any additional intermediate member being attached to one another. Such joining may be permanent in nature or alternatively may be removable or releasable in nature. The term “operably coupled” shall mean that two members are directly or indirectly joined such that motion may be transmitted from one member to the other member directly or via intermediate members. The term “fluidly coupled” shall mean that two or more fluid transmitting volumes are connected directly to one another or are connected to one another by intermediate volumes or spaces such that fluid may flow from one volume into the other volume. [00067] For purposes of this disclosure, the phrase “configured to” denotes an actual state of configuration that fundamentally ties the stated function/use to the physical characteristics of the feature proceeding the phrase “configured to”.

[00068] For purposes of this disclosure, the term “releasably” or “removably” with respect to an attachment or coupling of two structures means that the two structures may be repeatedly connected and disconnected to and from one another without material damage to either of the two structures or their functioning.

[00069] For purposes of this disclosure, unless explicitly recited to the contrary, the determination of something “based on” or “based upon” certain information or factors means that the determination is made as a result of or using at least such information or factors; it does not necessarily mean that the determination is made solely using such information or factors. For purposes of this disclosure, unless explicitly recited to the contrary, an action or response “based on” or “based upon” certain information or factors means that the action is in response to or as a result of such information or factors; it does not necessarily mean that the action results solely in response to such information or factors.

[00070] For purposes of this disclosure, unless explicitly recited to the contrary, recitations reciting that signals “indicate” a value or state means that such signals either directly indicate a value, measurement or state, or indirectly indicate a value, measurement or state. Signals that indirectly indicate a value, measure or state may serve as an input to an algorithm or calculation applied by a processing unit to output the value, measurement or state. In some circumstances, signals may indirectly indicate a value, measurement or state, wherein such signals, when serving as input along with other signals to an algorithm or calculation applied by the processing unit may result in the output or determination by the processing unit of the value, measurement or state.

[00071] For purposes of this disclosure, a “graphic” refers to computer generated content. Although the shape, size or color of a “graphic” may be based upon sensed data, a graphic is not a direct output of the data itself nor is it simply an output of the data that is merely attenuated or that is merely modified to reduce noise. For example, the display of ultrasound echoes, even when modified to reduce noise or speckle is not a “graphic” for the purposes of this disclosure.

[00072] Figure 1 illustrates portions of an example surgical navigation system in form of an imaging system 10 configured to capture images of an organ 20 (shown as a prostate). In the example illustrated, imaging system 10 captures the images of the prostate 20, prostatic tumor 22, and surrounding tissue and organs (such as bladder 24) to facilitate the removal of the prostate 20 or the tumor 22. In addition, imaging system 10 may be utilized to diagnose prostatic cancer or used for imaging of other organs. As shown by Figure 1 , imaging system 10 compromises an ultrasound probe 40 inserted through the urethra 26 to visualize the prostate 20 from within the prostate. The probe comprises of an elongated medical device (EMD) 30, a handle 32, and a connector 34. The EMD comprises a proximal section 60, a medial section 62 containing a transducer 66, and a distal tip 64. In the illustrated embodiment the probe is connected to a controller 36 via a connector 34. The probe handle may be removable connected to position holder 38 to maintain the position of the probe relative to the patient.

[00073] Figure 1 further illustrates the use of a robotic laparoscopic system compromised of a robotic controller 50 with a laparoscopic surgical tool 52, endoscope 56 connected to an endoscope controller 58. The endoscope and the surgical tool are positioned within the abdomen through respective percutaneous access devices 54-1 and 54-1 , such as trocars. Robotic laparoscopic surgery systems typically have up to three surgical tools, equipped with graspers, scissors, or the like. In some embodiments, the surgery system accesses the abdomen via multiple access devices. In other embodiments the surgery system accesses the abdomen via a single access device/port.

[00074] The probe 40 compromises an atraumatic tip 64, a medial portion 62 and a proximal portion 60. The atraumatic tip 64 facilitates the insertion of the probe into the urethra from the penis into the prostate, and beyond into the bladder 24. The medial portion contains an ultrasound transducer 66 designed to provide real-time volume ultrasound with a field of view 68 sufficient to visualize the critical structures in and around the prostate. [00075] The example surgical guidance systems display a guiding image 74 of a target region during a surgical procedure. In the example illustrated the guiding image 74 is presented alongside on a larger display 70 alongside an endoscopic image 76. The guiding image includes at least one surgical guide graphic 75. The surgical guide graphics comprise computer-generated representation such as computer-generated lines, symbols or other computer-generated graphics that may guide movement of a surgical tool during a surgical procedure. The computer- generated graphics that serve as guides are generated based upon ultrasound data acquired by an ultrasound sensor positioned within a patient's anatomy. Rather than having to interpret a raw ultrasound image, the physician is presented with an enhanced representation of a target region being operated upon and may be additionally provided with other graphic representations that assist in guiding movement and positioning of a surgical tool during a surgery.

[00076] Prostatic cancers are classified by how large the tumor is, its level of progression/spread to adjacent anatomy, and its progression/spread to other organs. In today’s surgical practice, it is common to perform a radical prostatectomy, thereby removing the whole prostate. The proposed surgical navigation system provides real-time ultrasound guidance to compliment the endoscopic view, without the need for fusion with pre-operative images (such as magnetic resonance imaging (MRI) or computed tomography (CT)). The visualization of critical structures, such as bladder neck, prostate capsule, prostate apex, neurovascular bundles, etc. will aid the surgeon in performing the procedure with better outcomes. The use of volume ultrasound has the potential to facilitate partial prostatectomy by visualizing the subsurface tumor specifically for smaller tumors without progression/spread to adjacent tissue or organs.

[00077] Figures 2A-C illustrates common surgical approaches for laparoscopic prostatectomies. Figure 2A illustrates trans-peritoneal and extra-peritoneal conventional approach. The endoscope 56 and surgical tool 52 are using an anterior abdominal entry, facilitated by percutaneous access port 54, and the prostate base is accessed using an anterior bladder path 80 . Figure 2B illustrates retzius sparing approach, showing the endoscope 56 and surgical tool 52 with an anterior abdominal entry, using a percutaneous access port 54, and posterior bladder path 82 to the prostate base. Figure 2C illustrates a trans-vesical approach showing the endoscope 56 and surgical tool 52 with an anterior abdominal entry into the bladder 24 via a percutaneous access port 54 to access the prostate base.

[00078] An overview of the trans-vesical approach is described by the method 100 shown in Figure 3. As indicated by block 110, Bladder Neck Incision, where the bladder neck is accessed, and incision made to separate prostate and bladder. As indicated by block 111 , Posterior Prostate, Vas Deferens, & Seminal Vesicle Dissection, the posterior prostate fascia is dissected. Vas Deferens (VD) and seminal vesicles are dissected and ligated; and both seminal vesicles may be removed during procedure. Dissection does not continue to prostatic pedicles at this point. As indicated by block 112, Anterior & Lateral Prostate Dissection, the anterior prostate fascia is dissected to just before the apex taking care not to injure the dorsal vein complex. Endopelvic fascia is exposed and dissected bi-laterally. This simplifies access to the neurovascular bundle and prostatic pedicles. As indicated by block 113, Pedicle & Neurovascular Bundle Dissection, the posterior prostate dissection continues with separation of the neurovascular bundle and clipping and ligation of the nerve and vascular pedicles. This is repeated bilaterally. The posterior fascia dissection is completed. As indicated by block 114, Dorsal Vein Control & Apical Dissection, the Dorsal vein is encircled and clamped with a micro-suture prior to ligation. After suture knotting and dorsal vein control, the vein is ligated, and dissection of the prostate apex is performed. As indicated by block 115, Urethral Dissection, the apex dissection is completed with transection of the urethra. Any remaining posterior plane connections to the prostate are dissected at this point. As indicated by block 116, Urethro-vesical Anastomosis, the urethra and bladder opening are sutured together to complete the drainage pathway from the bladder.

[00079] Figure 4 illustrates the principle of using intra-urethral imaging for prostatectomy procedures. The imaging system 10 may be utilized to visualize key steps of the procedure. The ultrasound probe 40 is inserted into the urethra 26 through the penis 120. The atraumatic tip facilitates insertion through the urethra 26 transversing the anterior angulate bend, also known as the prostatic urethral angle 27, and allows the insertion of the probe into the bladder 24 while limiting risk of harm to tissue. From the position in the bladder, the incision of the bladder neck 130 can be visualized, as can the prostatic base 122. As the procedure continues, the probe can be withdrawn to visualize the posterior prostate, vas deferens 132, and seminal vesicle 134 dissection. From there the probe can also visualize the pedicle and neurovascular bundle dissection; and the dorsal vein control and apical dissection. Depending on the size of the prostate, the probe may need to be retracted further to aid in the visualization of the urethral dissection. Finally, the probe can be manipulated by the bedside assistant during the urethra-vesical anastomosis for structural and location visualization support.

[00080] Figures 5A-C illustrate the use of the surgical navigation system in key steps of the procedure. Figure 5A illustrates the probe 40 inserted through the penis 120 and the urethra 26 until the atraumatic tip is in the bladder 24. From this position, the bladder neck 130, and the prostate base 122 can be visualized. Furthermore, the surrounding tissue and structure can be visualized during dissection, such as rectum 126 and seminal vesicles 134. Figure 5B illustrates the probe position after the prostate base 122 and the prostate apex 124 have been ligated from the bladder and urethra. The atraumatic tip may be grasped by the robotic grasper in order to control and manipulate the prostate during these steps. Finally, Figure 5C illustrates the suturing or the remaining urethra to the bladder to create urethro-vesical anastomosis.

[00081] Figure 6 illustrates the critical structures during the dissection of the prostate. As discussed above, it is beneficial to avoid damage to such critical structures to improve the outcomes of the procedure. As shown in Figure 6, the prostate base 122 has already been separated from the bladder neck 130. The robotic graspers 52 can grasp and manipulate the atraumatic tip 64 to gain access to the sides of the prostate 20. Using the ultrasound transducer in the medial section 62, other critical structures may be visualized during the procedure, such as the dorsal vein complex 156, prostate capsule 21. The rectum 126 and the neurovascular bundle 150, can be avoided when dissecting the prostate and ligating the prostate pedicles 152. Finally, the prostate apex 124 can be visualized before ligation from the urethra.

[00082] Figure 7 is a close-up view illustrating the ligation of the prostatic pedicles 152 prior to the dissection of the prostate. The neurovascular bundle 150 branches into the prostatic pedicles 152, which is comprised of nerves 160, arterial vessel 162, venous vessel 164.

[00083] Figure 8 illustrates an embodiment of the probe 40, suitable for intra- urethral imaging of the prostate. The probe may consist of three segments, the atraumatic tip 64, the medial section containing the ultrasound transducer 66, and the proximal portion 60. The flexible interconnect scheme is routed through the proximal portion 60 to the handle 32. In the handle 32, the flexible interconnect scheme connects to a multi-channel ultrasound coax cable 33 connected to the system connector 34. As described in Figure 1 , the system connector 34 is connected to the controller 36.

[00084] The example surgical navigation systems provide “navigation” and visualization of regions along and about the prostate, as well as the volume within the prostate that may include pathological tissue, from within the prostate using an ultrasound transducer. The ultrasound transducer may be any form of conventionally known ultrasound transducers such as a transducer using quadrature array technology, an ASIC or other ultrasound technology. Because the ultrasound transducer captures ultrasound data from regions about and along the prostate while the ultrasound transducer resides within the prostate, the distance between the transducer and regions of interest about along the prostate is reduced, facilitating enhanced ultrasound data resolution.

[00085] The volume ultrasound field of view (FOV) 68 shown in Figure 8, can be specified by the elevation FOV angle 70, the azimuthal FOV 72, and the penetration 74. In order to visualize the prostate and the critical structures for prostatectomies from within the urethra, the penetration should be greater than 30 mm. Use of the system is simplified if the elevation FOV is large, as in greater than 80 degrees or greater than 90 degrees, as the need to rotationally reposition the transducer is less. Finally, the azimuthal FOV should be30 mm or larger to allow viewing the length of the prostate without needing to reposition.

[00086] To allow visualizing small critical structures or surgical instruments, the resolution should be equal or less than 2 mm. The contrast should be less than -3dB at the penetration depth to allow visualization of the various critical structures. Most importantly, to allow the system to provide real-time guidance to the surgeon during the procedure, the volume frame rate should be higher than 1 Hz, preferably higher than 5 Hz.

[00087] Ultrasound imaging technology uses ultrasound transducers for imaging in the medical field and for many other applications. Image quality, resolution, imaging depth, as well as 3D and volume imaging may be essential performance requirements for particular applications. However, complexity, cost, size and shape of the ultrasound transducers are also important factors that may limit a given ultrasound imaging technology from being useful.

[00088] Ultrasound imaging technology may employ mechanically scanned 1 D arrays, 2D ultrasound arrays connected to application specific integrated circuits (ASICs), and 2D row column arrays to realize a 3D and/or volume ultrasound imaging systems. The arrays are typically made from piezoelectric materials, capacitive micromachined ultrasound transducer (CMUT) elements, piezoelectric micromachined ultrasound transducer (PMUT) elements and optoacoustic source and receiver elements. More recently, there have been efforts to develop row column arrays using electrostricter arrays to form volume images.

[00089] These 3D ultrasound imaging techniques have many drawbacks; mechanical motion-based systems are hard to mass produce, have low volume imaging rates and can suffer from reliability issues. ASIC based systems are difficult to fabricate, expensive to develop, and can have overheating issues which can be further exacerbated at higher frequencies. 2D arrays of CMUT and PMUT elements with integrated ASICs reduce many of the cost and fabrication challenges seen with conventional 2D arrays (Lead Zirconate Titanate (PZT) based) with ASICs by allowing the entire fabrication of the arrays and ASIC to be done in one chip microfabrication process, however, the imaging and reliability performance of the CMLIT and PMIIT elements has yet to match that of conventional PZT arrays. This performance gap has prevented strong adoption of CMLIT and PMIIT arrays in practice. Row column arrays (RCA’s) using typical piezo ceramic overcome the issues of mechanical motion and ASIC based 3D/volume imaging systems, but they have a limited field of view that is restricted to imaging directly in front of the active aperture. Adding lenses to these RCAs can make the field of view larger but image quality and penetration depth can suffer. Further, the 90-degree field of views (FOV’s) achieved with ASICs or mechanical systems is unlikely to be matched by RCAs with lenses. RCAs can also be fabricated with CMLIT and/or PMIIT elements, however the performance gap relative to PZT materials remains for RCA array architectures as well.

[00090] The shortcomings of these common 3D and volume imaging approaches can be addressed by fabricating RCAs from materials or elements that can have their acoustic transducing properties varied by an external action (e.g. electromagnetic (EM) field, voltage, current etc.). Such examples of these materials or elements are CMLIT and PMIIT cells and electrostrictive (i.e. relaxor) materials. All three of these example element types have transducing properties that are proportional to the voltage applied to the element. This property of the elements enables unique transmit and receive beamforming approaches that can yield large FOV volumes with real time frame/volume rates without any mechanical motion. Previous works with CMLIT arrays in particular have shown that volumes can be acquired with these RCA architectures. Despite the promising developments with CMLIT and PMIIT RCA’s they still struggle to gain adoptions due to their performance shortcoming relative to standard array elements (PZT pillars).

[00091] Existing techniques for forming volumes with RCAs with electrostrictive elements require either data acquisition rates and 3D/volume image formation rates that are prohibitively slow for most clinical applications or the presence of dedicated electronic circuitry on or in very close proximity to the array to realize fast 3D/Volume imaging which prohibit miniaturization of these arrays for many applications (e.g. surgical procedures, NDT applications in tight spaces etc.). This electronic circuitry primarily consists of switches or other components needed to ground elements where they are intended to have zero transducing capacity. In the case of electrostricter materials this would correspond to elements that have a zero-bias applied to them.

[00092] Figure 9 illustrates an embodiment of an EMD forming part of the probe. The medial section 62 houses the transducer 66 which is formed by an ultrasound transducer stack 200. The flexible interconnect 210 connects the ultrasound transducer to an interposer circuit board 212 which allows the connection to the ultrasound coax cable 33. In some embodiments the flexible interconnect is comprised of one or more flexible circuit boards. In other embodiments, the flexible interconnect is comprised of a micro coax cable. The flexible interconnect 210 is routed through the proximal section 60 to the interposer circuit board 212. The assembly is completed by connecting the distal section 64, the medial section 62, the proximal section 60, and the handle 32.

[00093] Figure 10 illustrates a detailed exploded view of one example of transducer 66 comprised the ultrasound transducer stack 200. A row column ultrasound transducer composite 202 is connected to the flexible interconnect 210. A matching layer 204 is bonded to the face of the composite and a coupler 206 is bonded to the matching layer to closely match the sound speed of the tissue. The composite 202 has a backing 208 bonded to the back side to attenuate ultrasonic energy and reduce any near field artifacts. In other implementations, transducer 66 may have other architectures or configurations.

[00094] In some implementations, controller 36 may comprise a beam former and an image processor. Functioning as a beam former, controller 36 may include a plurality of channels for generating transmit waveforms and/or receiving echoes or acoustic signals. Relative delays and/or apodization focus the transmit waveforms or received signals for forming beams. The beam former provided by controller 36 may be connected to the top and bottom electrodes of the array of composite 202 to individually activate the ultrasound transducers of imaging device 200.

[00095] Functioning as an image processor and beamformer, controller 36 receives element data from the ultrasound transducers. Based upon the element data received from different portions of the array of ultrasound transducers, controller 36 may determine multiple different two-dimensional images. Element data refers to data that is based upon generated transmit waveforms and corresponding sensed or receiving acoustic echoes or signals, a transmit/receive pair or operation. Each of the two-dimensional images may be based upon a single set of element data resulting from a single transmit and receive phase from the beam former using a particular portion of the array of ultrasound transducers or may result from a combination of multiple sets of element data (or their corresponding intermediate images) resulting from multiple transmit and receive phases from the beam former using the particular portion of the array of ultrasound transducers. Controller 36 may combine the multiple different two-dimensional images to form the volume image.

[00096] To achieve the performance requirements for FOV and resolution, the ultrasound transducer may have a center frequency of 6-10 MHz, and have an aperture of 3 by 10 mm. The number of signal elements may range from 48-64, with the bias element ranging from 64-128.

[00097] The example surgical navigation systems utilize an EMD to position the ultrasound transducer into the interior of the prostate using a natural body orifice connected to a natural lumen, the urethra. As result, in some implementations, the prostate surgery may be less invasive or may involve less cutting or incisions, or more precise with the imaging provided. The EMD may be in the form of an elongated shaft, cylinder or tube. The ultrasound transducer may be mounted to the EMD, contained within a housing of the EMD or integrally formed as part of the EMD. The EMD is dimensioned for being moved through the urethra and positioning the ultrasound transducer in portions of the urethra that extend through and reside within the prostate. In some implementations, the EMD may have an outer diameter less than or equal to 10 mm in some implementations, less than or equal to 8 mm. Such dimensions facilitate more comfort to the patient as the EMD and the carried transducer are moved through the urethra,

[00098] The EMD is further configured to facilitate passage through the urethra with different segments or portions having different degrees of softness, flexibility and stiffness. For example, EMD may comprise an elongate cylinder, tube or shaft having a flexible or semi-flexible proximal portion to facilitate bending to accommodate turns or bends in the urethra, a soft and potentially flexible tip, such as atraumatic tip to facilitate guidance of the EMD through the urethra and to avoid damage to the urethra, and a stiffer or more rigid portion between the proximal portion and the tip or end portion for stably supporting an ultrasound transducer.

[00099] In some implementations, the distal tip, such as the atraumatic tip may be releasably coupled to the remainder of the EMD by a bayonet attachment configuration, a threaded screw configuration, a snap-lock or the like, facilitating repair, replacement or exchange of the distal tip. In some implementations, the proximal portion of the EMD and the supported ultrasound transducer may be removably coupled to the handle. A high-density electrical interconnect system/connector or plug may be used to removably couple the proximal portion to the handle, facilitating repair, replacement or exchange of the medial ultrasound transducer supporting portion. Such a configuration may facilitate cleaning, sterilization and reuse of the portion of the EMD that supports the ultrasound transducer. In some implementations, the distal tip may be disposable.

[000100] In some implementations, the distal tip of the EMD, which projects or extends distally of the ultrasound transducer is configured to be gripped or grasped by a surgical tool. During prostate surgery, the prostate may be severed from the adjacent bladder, permitting the distal tip of the EMD to be moved through and beyond the formed opening of the urethra, providing access to the distal tip. Manipulation of the distal tip of the EMD facilitates positioning and manipulation of the prostate without requiring direct grasping of the prostate itself which could exaggerate bleeding or impact the prostate and expose cancer. In such implementations, the distal tip may include grip features, such as openings, recesses or projections to facilitate such gripping and manipulation. In some implementations, the grip feature may comprise portions of the distal tip that are formed by a compressible or high coefficient material suitable for the grasping tool. The ultrasound transducer may be axially located along the EMD at a location such that the transducer may reside within the urethra within the prostate while a sufficient extent of the EMD extends out of the prostate for providing a sufficient gripping length. In some implementations, the EMD may have a length of at least 1 mm and in some implementations, at least 5 mm distally beyond the ultrasound transducer. [000101] In some implementations, the outer diameter of the EMD, especially in regions along and adjacent either end of the ultrasound transducer has a diameter or is otherwise shaped and dimensioned such that the ultrasound transducer is placed in contact with interior surfaces of the urethra that resides within the prostate. Said another way, those regions of the EMD supporting the ultrasound transducer in the ultrasound transducer itself have an outer dimension or diameter closely matches the interior diameter of the urethra in those regions inside the prostate. Such close conformal physical contact facilitates enhanced acoustic coupling with urethra and the surrounding prostate tissue. As a result, enhanced resolution and enhanced quality ultrasound data may be obtained for those regions extending along and about the periphery of the prostate.

[000102] In some implementations, the EMD, especially those portions supporting the ultrasound transducer, may have smaller dimensions than that of the internal natural lumen provided by the urethra to facilitate easier passage of the EMD through and within the urethra with less discomfort to the patient. In some implementations, such acoustic coupling may rely upon fluid within the urethra. In other implementations, to ensure enhanced acoustic coupling between the ultrasound transducer in the tissue of the urethra and prostate, the EMD may further provide or support an ultrasound transducer pressing device. The pressing device is a device configured to apply side or radial force to the EMD so as to press the ultrasound transducer into conformal physical contact with interior surfaces of the urethra. The pressing device may be configured to be selectively actuated between a smaller default state facilitating passage through the urethra, and an enlarged or pressing state to press the ultrasound transducer against the interior surface of the urethra.

[000103] In some implementations, the ultrasound transducer pressing device may comprise an inflatable body or a balloon supported by the EMD on a side opposite to that of the ultrasound transducer. The balloon may be selectively inflated through an inflation lumen to an enlarged state such that the balloon presses against the first internal side of the urethra while forcing and pressing the ultrasound transducer into close conformal physical contact with a second internal side of the urethra that is opposite to the first internal side of the urethra. The inflation lumen may selectively transmit the fluid such as a gas or a liquid. Control over the delivery of the inflation fluid may be controlled with an inflation device (controlled by controller or manually by a physician) which selectively delivers pressurized inflation fluid supplied by pump and reservoir.

[000104] In other implementations, the ultrasound transducer pressing device may comprise other forms of local force supplying actuators. For example, the ultrasound transducer pressing device may comprise an electro-mechanical actuator. In some implementations, the ultrasound transducer pressing device may comprise an electromechanical actuator in the form of a shape changing material which changes shape or dimension in response to an applied electrical current (a piezo material). In some implementations, the ultrasound transducer pressing device may comprise a mechanical pressing device which is moved using hydraulic or pneumatic pressure.

[000105] In some implementations, the EMD may include one or more additional internal or integrated passages or lumens. The additional lumen may be used as a fluid lumen for delivering fluid to a bladder or to hydraulicly actuate an ultrasound transducer pressing device or for facilitating the removal of fluid from or the supply of fluid to regions proximate to the prostate. In some implementations, the integrated lumen may terminate at an opening proximal the ultrasound transducer to facilitate therapy or biopsies. In some implementations, integrated lumen may extend to the ultrasound transducer or may extend axially across and distally beyond the ultrasound transducer.

[000106] Once the EMD is initially inserted into the urethra and may be necessary to adjust the positioning of the EMD to relocate or reorient the ultrasound sensor/transducer. Disclosed are various examples of how the axial or angular positioning of the transducer may be adjusted once positioned within the urethra. In some implementations, the handle (connected to the EMD at its proximal end) is fixed to the EMD such that translation of the handle relative to the urethra (and the prostate) likewise results in translation of the EMD and the transducer relative to the urethra and the prostate. Similarly, rotation of the handle relative to the urethra results in rotation of the EMD and the transducer relative to the urethra and the prostate.

[000107] Disclosed are example implementations of a probe that facilitate rotation of the ultrasound sensor/transducer within and relative to the urethra while the handle is stationary (not correspondingly rotated). “Rotation” refers to movement about the central axis or longitudinal axis of the EMD. In one implementation, the transducer within the EMD is connected to the handle by joint that facilitates rotation of the transducer relative to the urethra. In some implementations, the joint facilitates rotation of a portion or an entirety of the EMD relative to the handle. In some implementations, the joint facilitates rotation of the transducer (and its housing or support) within the EMD relative to the EMD and the handle.

[000108] In some implementations, the joint is located so as to be external to the urethra when the transducer is positioned within the urethra and is also positioned internal to the prostate. In some implementations, the joint is located at or within the handle itself. In yet other implementations, the joint is located along the EMD so as to reside within the urethra when the transducer is positioned within the urethra and is also positioned internal to the prostate.

[000109] In some implementations, the probe may include at least one cable extending along the EMD and having a first end connected to a manual interface supported by the handle and a second end coupled to the transducer such that pulling or pushing of the cable results in rotation of the transducer relative to the handle. In some implementations, the cable may comprise a Bowden cable extending along the EMD. In some implementations, the probe may include a pair of push-pull cables. In some implementations, rotation of the manual interface supported by the handle whines and unwinds the push-pull cables to rotate the transducer clockwise or counterclockwise.

[000110] In some implementations, the spring, such as a torsion spring, and be used to resi liently biases the transducer to a default angular position, wherein pushing or pulling of the at least one cable works against the bias to rotate the transducer to a different angular orientation. In some implementations, the at least one cable is coupled to the transducers us to rotate the transducer within the EMD relative to those portions of the EMD both proximal to and distal to the transducer. In some implementations, the at least one cable is coupled to the transducer on a proximal side of the transducer, wherein pushing or pulling of the at least one cable rotates the transducer and a distal portion of the EMD relative to portions of the EMD on a proximal side of the transducer. In some implementations, pushing and/or pulling of the at least one cable may be carried out manually or may be carried out by manually or electronically initiating an electric motor that is operably coupled to the at least one cable to push or pull the at least one cable. For example, the electrical motor may be operably coupled to a spool to wind or unwind the at least one cable to push or pull the at least one cable to achieve rotation of the transducer. [000111] Disclosed are example implementations of a probe that comprises a flexible shaft, tube or cable having a first end coupled to the transducer and a second end connected to a manual interface carried by the handle such that rotation of the manual interface rotates the transducer within the urethra relative to the urethra. In some implementations, the manual interface may comprise a knob, spoke, disc, dial or the like which is rotatable about an axis parallel to or coinciding with an adjacent portion of the longitudinal axis of the flexible shaft, tube or cable. For example, the flexible shaft, tube or cable may be connected to the manual interface on a first axial end of the handle, extending through a second axial end of the handle and further to the transducer. In some implementations, the manual interface may be rotatable about an axis that is substantially perpendicular to the longitudinal axis of adjacent portions of the flexible shaft, tube or cable. In such implementations, the rotational movement of the manual interface may be transmitted to the flexible shaft, tube or cable by a pair of intermeshing bevel gears. In some implementations, additional gears, belt and pulley arrangements of the like may operably coupled to the manual interface to the flexible shaft, tube or cable such that rotational adjustment of the transducer is proportional to but does not directly correspond to rotation of the manual interface. In some implementations, the flexible shaft, tube or cable may alternatively be rotated by a powered mechanism, such as an electric motor which initiates such rotation or terminate such rotation in response to manual input or electronic control.

[000112] In some implementations, the flexible shaft, tube or cable longitudinally extends within the EMD, being rotatable relative to the surrounding tubular portions of the EMD. In implementations where a flexible tube is used, the flexible to may serve as part of the housing supporting the transducer. In such implementations, the flexible housing may include an aperture or open window opposite to the sensing face of the transducer. In each of the disclosed implementations, a fluid coupling medium may be disposed between the sensing face of the transducer and internal walls of the EMD to enhance sensing performance.

[000113] Disclosed are example probes that facilitate selective and independent rotation and translation of the ultrasound sensor/transducer within and relative to the urethra. In some implementations, the manual interface that is operably coupled to the transducer is both rotatably and translationally supported by the handle. Rotation of the manual interface results in rotation of the transducer relative to the urethra.

Translation of the manual interface results in translation of the transducer relative to the urethra. Such rotation and translation may be independently performed and are not linked. In some implementations, rather than the manual interface being manually manipulated, the same structural interface may be manipulated under power from a powered actuator, such as one or more electric motors (and associated gears or other transmissions) which may be controlled in response to manual input or electronic control input.

[000114] In some implementations, the surgical navigation system may further utilize and comprise an optical sensor such as an endoscope. The endoscope may be located so as to capture images of regions about and along the prostate during the surgical procedure. Images output by the optical sensor may facilitate viewing of portions of the probe and is positioning with respect to the urethra or with respect to the bladder. In some implementations, portions of the probe may be viewed directly by the eyes of a physician, such as during a laparoscopic surgery or procedure.

[000115] In such implementations, the distal tip of the EMD may have easily discernible color, distinguished from blood in other organ tissue colors to facilitate optical recognition such that the distance and may serve as a landmark indicating the positioning (urethra insertion depth) of the EMD thereby the positioning of the transducer. For example, the entire distal tip may have an outer surface provided with a color or a graphic pattern that is visually distinguishable from the remaining portions of the EMD. In some implementations, the distal tip of the EMD may be provided with a bright fluorescent color, such as white or yellow or further distinguishing from surrounding blood and tissue.

[000116] In some implementations, the distal tip may be provided with longitudinal or axially spaced gradations or markers. Such gradations or markers may more precisely indicate the relative positioning of the EMD with respect to the urethra. In some implementations, such gradation markers may be spaced along EMD similar to the fashion of markings on a ruler. In some implementations, such gradation markers may be spaced in increments of no greater than 10 mm. In some implementations, the elongate medical device includes at least five individual axially spaced gradation markers. The gradation markers may partially extend around the circumference of the EMD or may completely circumscribe the EMD to form depth “rings”.

[000117] In some implementations, different gradation markers may be provided with different marking thicknesses, color, shapes or other characteristics to indicate depth milestones or length milestones from the end of the EMD. For example, although the markings may be spaced in increments of 5 mm, The markings at each 10 mm distance may have a different color, thickness or the like. In some implementations, some or all of the individual gradation markers may also be associated with alphanumeric text visible along the outer surface of the EMD, wherein the text indicates the exact measurement from an end of the EMD to the particular individual gradation marking. In some implementations, such gradation markers may continue proximally beyond the distal tip, across regions of the EMD containing the ultrasound transducer.

[000118] In some implementations, the distal tip of the EMD may further include other markings or surface shapes that visually indicate the angular orientation of the EMD. For example, in some implementations, a single marking, such as a continuous or broken line, may extend along an outer surface of the EMD directly opposite to a circumferential or transverse center of the transducer (a 12 o’clock angular position, wherein transverse center of the transducer is at the 6 o’clock angular position). In some implementations, additional or alternative markings may be utilized to indicate the angular orientation of positioning of the EMD. For example, recesses, notches, protuberances or visible markings may be provided at the 12 o’clock, 3 o’clock, 6 o’clock and 9 o’clock positions on the exterior of the distal tip. In some implementations, marking may be visibly distinct from other markings to allow visible identification of a particular marking. The visible distinction between such marks may be provided by different colors, brightness is, line thickness, line patterns or the like.

[000119] In some implementations, the EMD may be provided with external visible markings at indicate the location, length, width and field of view of the transducer. In some implementations, the EMD may comprise axial transducer markings formed or placed upon the EMD so as to indicate the positioning of the transducer. Such axial transducer markings may comprise a first marking axially aligned with distal end of transducer, a second marking axially aligned with a proximal end of transducer 66, and a third marking axially aligned with a center of transducer. In some implementations, such markings may merely indicate a proximal end or distal end of the transducer.

[000120] In some implementations, the exterior of the elongate medical device may be provided with angular transducer markings that visibly indicate the angular position or orientation of transducer about longitudinal axis. The angular transducer marking may comprise a 12 o’clock angular transducer marking, a 9 o’clock angular transducer marking and a 3 o’clock angular transducer marking. A particular marking may be located directly opposite to and aligned with a circumferential center or a transverse center of transducer on an opposite side of EMD.

[000121] In some implementations, markings may be provided to indicate the field-of-view of the transducer. In some implementations, such field-of-view markings may be provided on an axial face of the distal tip and may have the shape of a cone or triangle indicating the outward widening field-of-view for the transducer. In the example illustrated, the triangle or cone serving as the marking has an apex aligned with a circumferential or transverse center of the transducer and a widened portion or base facing in the same direction as a field-of-view of the transducer and opposite corners or edges corresponding to the circumferential or transverse edges of the transducer. In other implementations, the field-of-view marking may have other shapes and configurations.

[000122] Once the EMD and the transducer have been appropriately positioned within the urethra, it may be beneficial to secure and retain such positioning. In some implementations, various forms of an anchor or anchors may be provided to rotationally and axially secure the EMD directly to interior surfaces of the urethra. In some implementations, inflatable bodies or balloons may be provided along an exterior of the EMDs. In some implementations, the inflatable bodies or balloons have outer non-stretching flexible walls that expand upon inflation. In some implementations, the outer flexible walls are resiliently flexible so as to stretch and expand in response to sufficient internal fluid pressure and so as to automatically shrink and retract in response to a reduction in internal fluid pressure.

[000123] In some implementations, an inflatable body may continuously extend 360° about the longitudinal axis of the EMD. In some implementations, the inflatable body may be formed by multiple consecutive or spaced inflatable chambers. In some implementations, the inflatable body may comprise a pair of bodies that face in opposite directions along opposite portions of the EMD. In some implementations, the inflatable body may be located in close proximity to those portions of the EMD containing or supporting the transducer to more reliably secure positioning of the transducer. In some implementations, the inflatable body may be located on a proximal side of the transducer such at any inf lation/deflation lumens extending along the EMD do not occupy volume over opposite the transducer.

[000124] Inflation and deflation of the inflatable body may be carried out using a pump which supplies or withdraws a fluid, such as a gas or a liquid (e.g., saline solution). The inflatable bodies may be selectively inflated so as to press either directly against internal surfaces of the urethra or so as to press against an outer flexible portion of the EMD which is, in turn, pressed and flexed radially outwardly into frictional engagement with internal surfaces of the urethra, anchoring the EMD relative to the urethra. Deflation of the inflatable body may cause the inflatable body to be less taut/rigid or to shrink in size to facilitate repositioning of the elongate medical device within the urethra.

[000125] In some implementations, the EMD may comprise external vacuum ports which are fluidically coupled to an external pump or vacuum source by fluid lumens extending along the EMD. In some implementations, a vacuum for may continuously extend 360° about the longitudinal axis of the EMD. In some implementations, an array of vacuum ports may be provided along the exterior of the EMD. In some implementations, the vacuum ports may be located in close proximity to those portions of the EMD containing or supporting the transducer to more reliably secure positioning of the transducer. In some implementations, the vacuum ports may be located on a proximal side of the transducer such that any vacuum applying lumens extending along the EMD do not occupy volume over opposite the transducer.

[000126] The application of vacuum to such ports through the one or more internal lumens cause those internal portions of the urethra adjacent the ports to be drawn and held against the EMD. The vacuum may be maintained for so long as retention is needed. Release of the vacuum may facilitate repositioning of the EMD with respect to the urethra.

[000127] In some implementations, the EMD may comprise mechanically actuated anchors that either directly engage internal surfaces of the urethra or outwardly press flexible portions of the EMD into frictional engagement with internal portions of the urethra to anchor the EMD. For example, the EMD may house internal press bars having heads that pivot between retracted positions and extended positions, wherein the heads are resil iently biased by a spring or the like to the retracted position. When the heads are in the retracted positions, the EMD may be repositioned within the urethra. When the heads are in the extended positions, the heads directly or indirectly press against internal sides of the urethra to anchor the EMD directly to and within the urethra. A rod, cable or the like may be used to move a cam against the spring bias to move the heads to the extended positions. [000128] In some implementations, rather than discrete anchors, larger portions of the EMD may be selectively expanded for anchoring. For example, longer portions of the EMD may have an outer wall formed from a resiliently flexible material, wherein a fluid may be pumped to controllably and selectively inflate portions of the EMD proximate the outer wall to expand the outer wall to increase the overall outer diameter of the EMD for anchoring the EMD directly within the urethra. Withdrawal of the inflation fluid results in the resiliently flexible outer wall and the outer diameter of the EMD shrinking to once again facilitate repositioning of the EMD with respect to the urethra.

[000129] In some implementations, the EMD may be anchored relative to the urethra external to the urethra, external to the patient. In some implementations, a handle connected to the EMD may include a clamp configured for securement to a drape or other garment worn by a patient during a surgical procedure. The plan may pinch the drape or garment to hold the handle and the EMD in a relatively stationary position with respect to the urethra during a surgical procedure. In some implementations, a holder may be configured for releasable securement to the leg of a patient during a surgical procedure, wherein the holder surrounds, grips, partially encloses or is otherwise directly connected to the handle to retain the EMD (and the transducer) relative to the urethra.

[000130] Rather than being mounted to the leg of a patient during a surgical procedure, in some implementations, the holder may be releasably mounted to infrastructure such as a patient table, a cart, a stand or a robotic mechanism position near the patient during the surgical procedure. In some implementations, the holder may include a base that mounts to the infrastructure and brackets that engage opposite end portions of the handle. In some implementations, the brackets may be movably supported relative to the base. In some implementations, one or both of the brackets may be movable relative to the other of the brackets to accommodate differently sized handles.

[000131] In some implementations, the holder may additionally comprise a structure configured to grip or hold the penis during the surgical procedure. The penis holder may assist in retaining positioning of the urethra relative to the probe. In some implementations, the penis holder may be slidable or otherwise movable relative to the base of the holder to provide adjustable positioning of the penis holder.

[000132] In some implementations, the surgical navigation system may comprise a controller formed by a processor and a non-transitory computer-readable medium containing instructions for directing the processor to carry out ultrasound data acquisition, processing and analysis. The controller may utilize a trained machine learning system or network to further facilitate analysis of ultrasound data. The controller may output control signals to a display that presents an image based upon the captured ultrasound data in those regions along and about the prostate. The controller may output control signals that cause the display to present guidance to a physician with respect to manipulation of one or more surgical tools based upon the acquired and analyzed ultrasound data.

[000133] In some implementations, the controller may output control signals that cause the display to present guidance to a physician with respect to manipulation of the probe. For example, the controller may be configured to assess the current positioning of the probe (based at least in part upon the ultrasound data) and output guidance instructing the physician to manually translate the EMD and/or transducer within and with respect to the urethra and/or rotate the EMD and/or the transducer within the urethra. The guidance may be presented in the form of a graphic representing the probe within the urethra and arrows indicating suggested manual repositioning of the probe.

[000134] In some implementations, the controller may further be configured to identify, in some implementations highlight, critical anatomical structures adjacent to and along the prostate. In some implementations, the controller may be configured to display or otherwise provide the physician with guidance as to positioning of the cutting or excision surgical tool to reduce potential damage to the critical anatomical structures. In some implementations, the controller may output control signals causing display to present to a physician a recommended path for the surgical tool during cutting or excision. In some implementations, nerves, veins and arteries may be clipped following separation from the prostate, wherein the controller may be configured to identify such structures and may be configured to cause the display to present graphical representations of such veins, arteries and nerves and their respective positions or locations to facilitate such clipping.

[000135] In some implementations, the controller may cause a display to present a guiding image based at least in part upon ultrasound data acquired from the pro in the transducer within the urethra. In some implementations, the controller may output control signals causing the display to overlay multiple surgical guide graphics on the current ultrasound image that is based upon signals from transducer/ultrasound sensor. In some implementations, regions distant from the target region are either attenuated or modified so as not to depict speckle or ultrasound echoes.

[000136] In some implementations, the controller may overlay multiple surgical guide graphics (SGGs) in the form of a sensor graphic, a prostate capsule surface graphic, a tumor surface graphic, a rectum surface graphic, a neurovascular bundle (NVB) surface graphic, pedicle graphics, a NVB caution zone, an inner guide rail, an outer guide rail, a recommended excision path, an excision tool position, and excision tool path history, and excision tool trajectory, and a tool path correction indicator. The sensor graphic comprises a graphic generated and added by the controller that indicates the current position and orientation of the ultrasound sensor. In some implementations, the sensor graphic is represented by a transparent outline of the transducer. In some implementations, the sensor graphic may be omitted.

[000137] The prostate surface graphic comprises a system generated graphic that indicates the outer surface of the prostate capsule or prostate. The controller may determine the outer surface of the prostate by segmenting all the voxels of the three-dimensional volumetric image based upon signals received from ultrasound transduce. In some implementations, the controller carries out segmentation (computer vision processing) on less than an entirety of the ultrasound image to determine an estimate for the actual edge or outer surface of prostate. For example, in some implementations, the controller may utilize a machine learning network that is configured to first identify a particular segmentation zone for subsequent segmentation in the larger ultrasound image. Once a segmentation zone has been identified, the controller carries out the segmentation only on those voxels within the segmentation zone to determine an estimate for the actual edge of the prostate. By limiting segmentation to the machine learning segmentation zone, computing bandwidth is conserved.

[000138] In yet other implementations, the controller may prompt a physician to input or otherwise identify the segmentation zone directly. For example, the presentation on display may initially comprise a depiction of the ultrasound image from three different orthogonal axes or viewpoints based on signals from senso. A physician or user, based on his or her experience, may utilize a stylus, mouse or other input device to outline or demarcate a segmentation zone on the ultrasound image(s) presented on display. In the example illustrated, the physician annotates the ultrasound image by identifying or marking an inner boundary and an outer boundary for the segmentation zone in each of the three orthogonal views. In some implementations, rather than specifically marking both an inner boundary and the outer boundary for the segmentation zone, the physician may utilize a wider marking line (a wider marker, stylus, or highlighter), wherein an inner edge of the wider line serves as the inner boundary of the segmentation zone and the outer edge of the wider line serves as the outer boundary of the segmentation zone. In the example illustrated, presentation further provides a three-dimensional depiction of the marked inner boundary and outer boundary of the defined segmentation zone. In other implementations, the three-dimensional representation may be omitted.

[000139] This annotation of the target region on the display by the user physician may occur prior to initiation of the surgical procedure and prior to the generation of any surgical guide graphics or their use to generate a guiding image, alone or overlaid upon an ultrasound image. In some implementations, the physician or other user may utilize an input device to identify an initial user estimate for the boundary of the prostate surface, wherein this initial estimate is utilized to determine a segmentation zone for the segmentation of the outer edge estimate for the prostate.

[000140] Upon determining the target region, the surface or boundary of the prostate, the controller may generate a graphic in the form of a line or outline of the surface of the prostate. In the example illustrated, the controller further fills in the outline with a color and opacity chosen so as to render the entire graphic representation of the prostate and its outer surface more discernible or visible on the guiding image. In the illustrated example, the line or outline and the filled in interior of the outline are overlaid onto the underlying ultrasound image, covering underlying portions of the ultrasound image. In some implementations, the interior of the outline may alternatively be transparent to facilitate viewing of portions of the ultrasound image within the interior. As indicated above, in some implementations, the guiding image may omit any underlying ultrasound image, being composed solely of system generated graphics that represent the target region, the prostate and its boundary, as well as other guiding graphics.

[000141] The tumor surface graphic comprises a system generated graphic that indicates the outer surface of the tumor. The controller may determine the outer surface of the tumor in a fashion similar to that described above with respect to the determination of the surface of the prostate. Based upon this determination, The controller generates a line corresponding to the surface of the tumor. In some implementations, the interior of the line may be opaque or provided with a color to better demarcate the tumor. As the entire prostate is removed during a radical prostatectomy, in some implementations, the tumor surface graphic and the determination of the boundary of tumor may be omitted.

[000142] The rectum surface graphic comprises a system or controller generated graphic indicating the boundary or surface of the rectum, especially those portions of the rectum surface proximate to the neurovascular bundle or the pedicles extending to the prostate. The rectum surface graphic may be generated based upon a determined surface of the rectum by the controller using signals from sensor controller may determine the surface of the rectum in a manner fashion similar to that described above with respect to the determination of the surface of prostate. In some implementations, rectum surface graphic may be omitted.

[000143] The neurovascular bundle (NVB) surface graphic comprises a system or controller generated graphic indicating an estimated boundary of the neurovascular bundle, especially those boundaries most proximate to prostate. The controller may determine or estimate the boundary of the neurovascular bundle in a fashion or manner similar to that described above with respect to the determination of the surface of the prostate, using segmentation.

[000144] In some implementations, the controller may determine or estimate the boundary of the neurovascular bundle using Doppler to detect blood flow through the vasculatures of the neurovascular bundle and/or to detect blood flow through the vasculatures of the pedicles branch out or extend from the neurovascular bundle towards the prostate. In some implementations, the controller may utilize Doppler to detect blood flow through the vasculatures of the neurovascular bundle and/or to detect blood flow through the vasculatures of the pedicles to identify the general vicinity of the neurovascular bundle and/or pedicles, the determined general vicinity (such as a predefined region or distance outward from the determined vasculatures) may then being used by controller to establish a zone in which controller carries out segmentation to estimate the surface of the neurovascular bundle and to generate the neurovascular bundle graphic. In some implementations, Doppler may be used to detect bidirectional blood flow to identify the NVB or the pedicles extending from the NVB. Doppler may likewise be used to detect blood flow to identify vasculature branches to identify surfaces of the NVB or those of the prostate, between which an excision path may be formulated by the controller. In some implementations, such as where a recommended cutting path or inner/outer boundaries are provided, the neurovascular bundle graphic may be omitted.

[000145] The pedicle graphics comprise system or controller generated graphics depicting estimated boundaries of pedicles. The pedicle graphic may be determined by the controller in a manner fashion similar to the determination of the estimated boundaries for the neurovascular bundle as described above. In some implementations, the determination of the boundaries of pedicles 756 and/or the generation of pedicle graphic may be omitted.

[000146] The NVB caution zone graphic comprises a system generated graphic identifying a boundary about critical structures that are to be avoided and not intercepted by the tool path. In some implementations, the NVB caution zone graphic is generated at a location so as to extend around or encompass junctions of the determined pedicles and the determined or estimated surface of the neurovascular bundle. In some implementations, the NVB caution zone is generated and displayed at a location so as to extend around the NVB graphic, without any underlying echo or ultrasound image. In yet other implementations, the NVB caution zone graphic may be presented without the NVB graphic, wherein the nerve caution zone graphic is located so as to extend around portions of the underlying ultrasound image (those particular echoes identified as being from the vasculature). In such circumstances, the physician is notified as to general regions (regions within the caution zone) to avoid without an added graphic indicating the specific path of the nerve. In still other implementations, the NVB caution zone graphic may be presented without either nerve graphic or an underlying ultrasound image. In some implementations, the NVB caution zone may be omitted. In some implementations, both the NVB graphic and the NVB caution zone may be omitted.

[000147] The inner guard rail comprises a system generated graphic that indicates a recommended boundary which is not to be crossed by a cutting tool so as to increase the likelihood that no portion of the prostate and the tumor will remain following the surgical procedure. The location and shape of the inner guide rail may be dependent upon the shape and location of the determined boundary of the prostate surface graphic. The distance between the inner guide rail and the estimated boundary of prostate (or the prostate boundary graphic) may be based upon a degree of confidence of system in the accuracy of the estimate for the boundary of prostate. The less precise or less accurate the estimate for the boundary of prostate is the greater the distance between the inner guard rail and the estimated boundary of prostate.

[000148] In the example illustrated, the inner guard rail comprises a generated line having a shape that follows or matches the estimated outer shape of the tumor’s surface. The inner guard rail has peaks and valleys corresponding to the peaks and valleys of the prostate surface graphic. In other implementations, the generated line or shape serving as inner boundary may be smoothened, omitting any peaks and valleys or including peaks and valleys of a lower amplitude. In the example illustrated, the region between the prostate surface graphic and graphic is filled with a color different than that of the prostate surface graphic or the fill color of the prostate surface graphic identifying the prostate. The color may be chosen so as to be more visually discernible in the guiding image and to indicate or provide a warning that this region is not to be intercepted by the path of the cutting tool. In other implementations, the regions between graphic 761 and the inner guard rail graphic may be void of any augmented color or may have transparency to permit viewing of the underlying ultrasound image echoes.

[000149] The outer guide rail graphic extends about inner guard rail graphic. The outer guide rail or outer guide rail graphic comprises a system generated graphic that indicates an outer boundary for the path of the cutting tool. One of the purposes of outer guide rail is to recommend a certain degree of proximity of the cutting tool path relative to the estimated position of the prostate so as to preserve healthy tissue. The outer guide rail further provides a recommended boundary which is not to be crossed by a cutting tool so as to increase the likelihood that no portion of the neurovascular bundle or the rectum will be intersected by the cutting tool path. The location and shape of the outer guide rail may be dependent upon the shape and location of the determined boundary of neurovascular bundle and rectum. The distance between the outer guide rail and the estimated boundary of neurovascular bundle (or the NVB surface graphic) may be based upon a degree of confidence of system in the accuracy of the estimate for the boundary of NVB. The less precise or less accurate the estimate for the boundary of NVB is, the greater the distance between the outer guide rail and the estimated boundary of NVB (or the NVB graphic). In the example illustrated, the region between the inner guide rail and outer guard rail is transparent to permit viewing of the echoes of the underlying ultrasound image (when provided). In some implementations, outer guard rail may be omitted.

[000150] The recommended excision path or excision path graphic comprises a graphic that indicates a recommended path for the excision tool. A surgeon or physician may be advised to attempt to control or move the surgical tool sets to trace the recommended excision path. In circumstances where guiding image includes the inner guide rail, the recommended excision path may closely follow the inner guide rail. In circumstances where the guiding image includes the outer guard rail, the recommended excision path may lie within the outer guide rail. In some implementations, the recommended excision path may lie between the inner guide rail and the outer guide rail. In some implementations, the recommended excision path may provide a more feasible or practical path for the excision while maintaining acceptable removal of the prostate. In the example illustrated, the inner guard rail includes a series of undulations which may be difficult to match with movement of the excision tool. The recommended excision path is smoother and more continuous, potentially offering more attainable objective for control of the excision tool. In some implementations, the recommended excision path may be omitted.

[000151] In some implementations, the controller may differentiate those portions of the path that have already been completed from those portions of the recommended path yet to be traced. In the example illustrated, those portions of a recommended path for which the tool has already passed are indicated with a first style while those portions of the recommended excision path that have yet to be passed or for which the opportunity for tracing still exists are depicted by the style. In such a fashion, the user or the system may ascertain how much of the recommended path remains.

[000152] The excision tool position comprises a graphic indicating the current position of the excision tool. In some implementations, the graphic represents or symbolizes the tool itself. In some implementations the graphic represents or symbolizes a cutting tip of the tool. The position of the graphic indicating current excision tool position may change from frame to frame as the tool is being moved during a surgical procedure.

[000153] In some implementations, the controller may determine the current position of the excision tool based upon the ultrasound data or ultrasound image. For example, during excision, gaps or separations of tissue created by the excision tool may result in brighter echoes. Machine learning can be utilized to identify such brighter echoes and associate them with the current position of the excision tool. The position of the brighter echoes, corresponding to the current position of the excision tool, may be correlated to the particular position or location in the guiding image. In other implementations, the position of the cutting or excision tool can be identified as the temporal difference from a previous frame, where the ultrasound signal has changed as a function of the cutting action. In some implementations, the excision tool position may be omitted.

[000154] The excision tool path history comprises a graphic indicating the completed or historical path of the excision tool. As described above, the controller may track the movement of the excision tool based upon ultrasound data or echoes. The historical positions of the excision tool may be stored and then utilized by the controller to generate a graphic indicating the historical path. In some implementations, the temporal nature of the historical path may be visibly indicated. For example, in some implementations, older portions of the historical tool path may be differently presented. Older portions of the historical tool path may fade or become less bright as time passes and/or as the distance between the historical portions of the path and current tool position grows. In some implementations, the excision tool path history may be omitted.

[000155] The excision tool trajectory comprises a graphic generated by the controller displayed on guiding image, wherein the graphic provides an estimation of the future trajectory of the excision tool given the most recent path being taken by the excision tool. For example, the controller may utilize historical positions with excision tool over a predefined period of time prior to the excision tool reaching its current position using this information, the controller may determine a future predicted vector for the excision tool unless the excision tool is redirected. In some implementations, the excision tool trajectory may be omitted.

[000156] The tool path correction indicator comprises a visual or audible indication that indicates or suggests, to a user, healthcare provider, physician or the like, movement of the surgical tool, such as a cutting tool, so as to put the tool back on track, back on the recommended path or trajectory for the cutting tool. The controller generates the tool path correction indicator based upon the current position of the tool and the previously determined recommended cutting path or tool path. In some implementations, the controller generates tool path correction indicator additionally based upon the current or most recent historical speed or rate at which the cutting tool is being moved. The correction indicator may also be directed to take into account any critical structure, or its caution zone, to return to the recommended cutting path. In the example illustrated, the tool path correction indicator comprises a visual indicator in the form of an arrow generated and depicted on the display by the controller.

[000157] In some implementations, other visible indicators may be presented. In some implementations, the tool path correction indicator may be in the form of an audible indicator. For example, the controller may cause an auditory device to emit a sound, wherein the sound changes to indicate a recommended change in direction of the tool or changes based on the proximity of the tool to the recommended tool path. In some implementations, the tool path correction indicator may be implemented in conjunction with excision tool position. For example, the color, design, brightness or the like of the graphic representing the current excision tool position may change to indicate a recommended change in direction of the tool or may change based on the proximity of the tool to the recommended tool path. In some implementations, the tool path correction indicator may be in the form of both a visual indication and an audible indication. In some implementations, tool path correction indicator may be omitted.

[000158] In some implementations, the controller may be configured to automatically enter a zoom mode based upon an estimated distance between the current tool position and the recommended tool path and/or the current estimated distance or spacing between the current tool position and either or both of the prostate and a critical structure such as the NVB or the rectum. For example, as a current position of the tool approaches or sufficiently close (less than a predefined distance threshold) to a critical structure, the controller may automatically adjust the guiding image or may automatically overlay an additional smaller window or depiction so as to zoom in on the current position of the tool. In such implementations, the person controlling the path of the tool may be given a more precise visual for guidance between narrow gaps between a critical structure, it's caution zone when presented) and the organ, target region (tumor) or recommended tool path. In some implementations, the controller may automatically output a notice to the operator or user and/or may automatically pause or suggest pausing of the procedure to allow the controller to adjust the various display graphics, to adjust the calculations and/or to allow the operator to appreciate the circumstances and any controller output recommendations.

[000159] The ultrasound data acquired by the transducer may be three- dimensional or volumetric. As a result, the ultrasound image generated or corresponding to the ultrasound data is also three-dimensional in nature, permitting the ultrasound image to be reoriented or rotated for different viewpoints or perspectives. In the example illustrated, each of the above surgical guide graphics are three-dimensional in nature, generated or provided with three-dimensional coordinates. As result, the guiding image may be rotated to provide the viewer/user with different viewpoints or perspectives. In implementations where the guiding image comprises the one or more graphics overlaid upon an underlying ultrasound image, both the ultrasound image and the overlying graphics may be rotated in three dimensions. In implementations where the guiding image omits any underlying ultrasound image, the surgical guide graphics may still be rotated in three dimensions.

[000160] In some implementations, the controller may automatically rotate the guiding image in three dimensions to provide the viewer with an enhanced view of the current position of the excision tool relative to the portion of the ultrasound image bonding to the prostate and/or the guide graphics representing the surface of the prostate. For example, in some implementations, the controller may automatically rotate guiding image as the excision tool moves about or along the surface of prostate to maintain the same initial perspective or viewing angle initially chosen by the user. In some implementations, the viewing angle of guiding image is moved in unison with the movement of the excision tool about the tumor. In some implementations, the controller may automatically rotate guiding image to maintain a normal viewing angle (90°) of the tumor surface (tumor guide graphic) and the excision tool position guide graphic from a side of the tumor.

[000161] Ultrasound echoes may indicate a particular anatomical shape or edge, wherein a graphic may be used to represent the anatomical shape or edge indicated by the ultrasound echoes. In such circumstances where the graphic corresponds to the anatomical shape or edge indicated by the ultrasound echoes, the graphic may comprise a line having a thickness greater than that of the line or edge indicated by the ultrasound echo in the ultrasound image. In implementations where the graphic is overlaid on top of an ultrasound image on the display such that lines or edges of the graphic trace or overlay lines or edges in the ultrasound image, the lines or edges of the graphic may have a thickness greater than that of the underlying lines or edges of the ultrasound image. In implementations where the graphic is overlaid on top of an ultrasound image such that lines or edges of the graphic trace underlying lines or edges of the ultrasound image, the lines or edges of the ultrasound image may have a brightness, shade or color different or distinct from that of the underlying lines or edges of the underlying echoes of the ultrasound image.

[000162] In some implementations, the graphic that overlies and traces portions of the underlying echoes of the ultrasound image may be brighter, thicker and size or have a different color to more clearly demarcate such edges, lines or boundaries. The graphic may likewise have a different color, shade or a different brightness as compared to other portions of the underlying ultrasound image not covered up or traced by the graphic.

[000163] In addition to more clearly identifying and demarcating particular anatomical structures (such as organ boundaries, tumor boundaries, critical structures, such as the boundaries of an organ such as a wreck to him, and organ such as a prostate, a neurovascular bundle, a tumor, a pedicle, connective tissue and the like), a graphic may likewise graphically indicate information that is derived from data, such as ultrasound data. For example, a graphic may be generated to indicate a particular vector, a particular path, a particular zone, a particular region or the like which is not directly indicated by the data (ultrasound echoes) itself but wherein the direction, size, shape or the like of the graphic is derived or based upon what the data or ultrasound echoes indicate. For purposes of this disclosure, a critical structure means any anatomical structure that may impact on the functioning of the organ during surgery or post-surgery. A critical structure may be in the form of healthy tissue.

[000164] Examples of such graphics include an estimated surface of the prostate, an estimated surface of a tumor on the prostate, an estimated surface of a wreck to him proximate the prostate, an estimated surface of a neurovascular bundle between the rectum and the prostate, an estimated surface of an ejaculatory duct. proximate the prostate and the rectum, the estimated boundaries or surfaces of pentacles (vasculature and nerves extending from or near the neurovascular bundle and the prostate), a recommended excision path; a recommended inner excision boundary; a recommended pair of excision guide rails; a caution zone encompassing a critical structure (such as the neurovascular bundle or the rectum) to be avoided during excision, and a recommended caution zone encompassing portions of the neurovascular bundle or the rectum to be avoided during excision. In some implementations, graphics may represent or indicate the current positioning of a surgical tool. In some implementations, the graphics may represent or indicate the prior path of the surgical tool as well as the future trajectory of the surgical tool.

[000165] Figure 8 is a perspective view illustrating portions of an example surgical navigation system 10 in use during prostate surgery or a prostatectomy. Figure 8 illustrates an example navigation probe 840 while extending through a urethra and extending through and beyond an example prostate. The prostate and the urethra are not shown for the purposes of illustration. As shown by Figure 8, the navigation probe 840 comprises an EMD 30 supporting an ultrasound transducer 66. The EMD 30 is in the form of a shaft, rod or tube pass through the urethra so as to position the ultrasound transducer 66 within the urethra and within the prostate 20. The ultrasound transducer 66 extends along a particular side of the EMD 30. In other implementations, the ultrasound transducer 66 may extend about a greater portion of the EMD 30 example illustrated, the ultrasound transducer 66 is illustrated as having a field-of-view 68 sufficiently large so as to capture ultrasound data from regions along and about the exterior or periphery of the prostate. In some implementations, ultrasound transducer 66 may comprise or utilize quadrature array technology. In other implementations, ultrasound transducer 66 may comprise an ASIC, a wobbler, or utilize other ultrasound technology.

[000166] In the example illustrated, the field of view (FOV) 68 can be specified by the elevation FOV angle 70, the azimuthal FOV 72, and the penetration 74. In order to visualize the prostate and the critical structures for prostatectomies from within the urethra, the penetration should be greater than 30 mm. Use of the system is simplified if the elevation FOV 70 is large, as in greater than 80 degrees or greater than 90 degrees, as the need to rotationally reposition the transducer is less. Finally, the azimuthal FOV 72 should be 30 mm or larger to allow viewing the length of the prostate without needing to reposition.. In such implementations, the ultrasound transducer may have a resolution of less than 2 mm, in some implementations less than 1 mm. In some implementations, the ultrasound transducer has a center frequency of at least 6 MHz and less than or equal to 12 MHz, nominally 8 to 10 MHz. In some implementations, the EMD 30 has a diameter of less than or equal to 10 mm in some implementations, less than or equal to 8 mm.

[000167] As further shown by Figure 8, the EMD 30 may have a distal tip 64. The distal tip 64 may be formed from a softer flexible material. The distal tip 64 may include a gripping feature 42 to facilitate grasping directly or indirectly by a manual a robotically controlled surgical tool. In some implementation, at least portions of the distal tip may be sufficiently soft or provided with a high friction surface (rough or serrated surface or specific material) to facilitate grasping. Such portions may be demarcated by color or other indicia. In those regions proximate from the end of distal tip 64 and across those portions of the EMD 30 supporting transducer 66 may have a uniform dimension or diameter. In some implementations, the distal tip 64 may distantly taper to facilitate insertion into and along the urethra.

[000168] Figure 11 illustrates navigation probe 1040, one example of navigation probe 840 shown in Figure 8. Navigation probe 1040 comprises EMD 1030 supporting ultrasound transducer 66 (described above). EMD 1030 is composed of multiple segments or sections having different qualities to facilitate passage through and along the urethra. In the example illustrated, EMD 1030 comprises a proximal segment or portion 1060, a distal portion or tip 1064 and a medial portion 1062. Proximal portion 1060 extends from and is connected to a handle 1032 (schematically illustrated). Proximal portion 1060 may be flexible to facilitate bending as EMD 1030 passes through the bends or turns of the urethra to the prostate. Tip 1064 may be flexible and/or soft and may be tapered as described above with respect to tip 1064. In some implementations, the tip or distal portion 1064 has a length of at least 5 mm and in some implementations within a range of 5 to 50 mm.

[000169] Medial portion 1062 supports ultrasound transducer 66. Medial portion 1062 may be stiffer as compared to proximal portion 1060 and distal tip 1064. Such stiffness provides stability for the ultrasound transducer 66. In some implementations, proximal portion 1060 may be formed from material such as steel, polycarbonate, TEXIN 70A having axial stiffnesses of (@1 M (m/N) 1 E -07, 8E-06 and 6E-02, respectively, and bending stiffnesses (@1m (radian/Nm) of 2E-02, 2E+00 and 1 E+03, respectively. In some implementations, distal portion 1064 may be formed from a materials such as polycarbonate, TEXIN 70A and TEXIN 30A having axial stiffnesses of (@1 M (m/N) 8E-06, 6E-02, and 2E-02 respectively, and bending stiffnesses (@1 m (radian/Nm) of 2E+00, 1 E+03, and 5E+03, respectively. The TEXIN materials are thermoplastic polyurethanes which are commercially available from Covestro. In some implementations, the medial portion 1062 may be formed from steel having an axial stiffness of (@1 M (m/N) 1 E -07 and a bending stiffness of (@1 m (radian/Nm) of 2E-02.

[000170] As with tip 64, tip 1064 may include a gripping feature 1042 such as a recess, opening, or projection facilitate gripping of distal tip 1064. In some importations tip 1064 has a length so as to project beyond and past the prostate to facilitate gripping the manipulation of EMD 1030 while medial portion 1062 resides within the prostate. Figures 12 and 13 illustrate the grasping of distal tip 1264 by an example grasping tool in the form of an example fenestrated grasper 1252. In particular, distal tip 1264 comprises an aperture 1214 sized for receiving one of the jaws 1216, wherein the jaws 1216 are brought together or closed to grip the distal tip 1264 for manipulating the EMD 1030 of probe 1040. In some instances, tip 1264 may be gripped with the jaws 1216 gripping about the circumferential sides of distal tip 1264. In some implementations, tip 1264 may be gripped by other grasping devices. In some implementations, the aperture 1214 may be omitted.

[000171] Figure 14 illustrates probe 1400 having a distal tip 1464, an alternative to tip 1264 described above. Distal tip 1464 is similar to distal tip of 1264 except the distal portion or tip 1464 comprises alternative gripping feature 1442. Gripping feature 1442 comprises various protuberances, buds, bumps, knobs or nubbins 1444 configured for being grasped by jaws 1216. In the example illustrated, each of nubbins 1444 is sized to be received within the fenestrations 1448 provided in jaws 1216. As result, grasper 1252 may grip any of such nubbins 1444 at various locations in a secure manner for manipulation of tip 1464 and probe 1040.

[000172] In the example illustrated, gripping feature 1442 comprises a distally projecting post 1450 that extends along the longitudinal axis 1451 of tip 1464. Gripping feature 1442 further comprises a first pair 1454 of oppositely extending nubbins 1444 that extend along a first axis 1455 perpendicular to the longitudinal axis 1451 of tip 1464 and a second pair 1458 of oppositely extending nubbins 1444 that extend along a second axis 1459 of tip 1464 that is perpendicular to longitudinal axis 1451 and that is also perpendicular to the first axis 1455. As result, tip 1464 may be grasped at various angles or positions using the fenestrations 1448 provided in jaws 1216. In the example illustrated, the nubbins 1444 do not project beyond the outer diameter of the remainder of tip 1464 to facilitate easier passage through the urethra. In other implementations, one or both of the pairs of nubbins 1444 may be omitted. In some implementations, additional nubbins 1444 may be provided along post 1450.

[000173] Figure 15 is a side view illustrating portions of an example navigation probe 1540 which may be used as part of system 10 described above. Navigation probe 1540 is similar to navigation probe 1040 described above except that probe 1540 comprises EMD 1530 having a distal tip 1564 that is removably coupled to a medial portion 1562. Medial portion 1562 is similar to medial portion 1062 described above in that it supports transducer 66 and that the distal tip is releasably secured or removably coupled to the medial portion of the probe 1540. Such removable coupling may be achieved by a bayonet connection, a screw connection, a snap fit or lock connection, a magnet connection or other types of connections. As a result, distal tip 1564 may be separated for repair or replacement. Different distal tips 1564 having different lengths, softness or different gripping features may be exchanged depending upon the gripping tool being used, physician preferences or particular characteristics of the patient. [000174] Figures 16-17 illustrate portions of an example navigation probe 1640 which may be used as part of system 10 described above. Navigation probe 1640 is similar to navigation probe 1540 described above except that probe 1640 is specifically illustrated as comprising a distal tip 1664 that is removably coupled to the medial portion 1662 by a push, twist and release/lock mechanism 1610 (sometimes also referred to as a threaded locking mechanism, a twist-and-lock mechanism, bayonet coupling, an interlocking system or a push-and-twist connector). Locking mechanism 1610 is located axially between medial portion 1662 and tip 1664. As shown by Figure 17, mechanism 1610 comprises locking cap 1612, locking hub 1614 and spring 1616.

[000175] Locking cap 1612 comprises a structure secured to an interior of tip 1664 at the proximal end of tip 1664. Locking cap 1612 has an interior 1618, and interior axial face 1619 and a plurality of spaced locking tabs 1620 (shown in Figure 18). Interior 1618 is sized to receive spring 1616 with an axial end of the spring 1616 captured withing a recess of face 1619, capturing spring 1616 between face 1619 and an axial end of hub 1614. Locking tabs 1620 extend inwardly from the interior sides of cap 1612 into the interior 1618 and are configured to engage hub 1614 to axially retain cap 1612 and tip 1664 to hub 1614 (absent applied releasing push and twist force being applied to either of tip 1664 or hub 1614).

[000176] Locking hub 1614 extends from a distal end of medial portion 1662 and releasably engages locking cap 1612. In some implementations, locking hub 1614 is integrally formed as part of a single unitary body with the distal end of medial portion 1662. In other implementations, hub 1614 is mounted to the distal end of medial portion 1662.

[000177] Locking hub 1614 comprises post 1623 having an axial face 1624, channels 1626 (two of which are shown) and locking tabs 1628. Axial face 1626 is located on the distal end of hub 1614 and bears against an axial end of spring 1616. [000178] Channels 1626 extend along the outer sides of post 1623 of hub 1614 from axial face 1624 between locking tabs 1628. Each of channels 1626 is sized to slidably receive a respective one of tabs 1620, at the same time, for axial movement along such channels 1626. In the example illustrated, hub 1614 comprises three channels 1626 angularly spaced 120° apart from one another about hub 1614 for receiving three tabs 1620, respectively, angularly spaced 120° apart from one another about the Interior 1618 of cap 1612. In other implementations, cap 1612 and hub 1614 may utilize other cooperating channels 1626 and locking tabs 1620.

[000179] Locking tabs 1628 comprise protuberances that project outwardly from post 1623. Locking tabs 1628 are sized to be axially passable from a proximal end to a distal end of locking tabs 1620, circumferentially between locking tabs 1620. To secure tip 1664 to medial portion 1662, post 1623 is inserted into interior 1618 of cap 1612 with the locking tabs 1620 aligned with the respective channel 1626 and with locking tabs 1628 positioned between locking tabs 1620. Tip 1664 and medial portion 1662 are axially moved towards one another, compressing spring 1616 (a compression spring) between faces 1624 and 1619 while moving locking tabs 1620 along channel 1626 to a proximal side of locking tabs 1628. While spring 1616 is compressed and while locking tabs 1620 are on a proximal side of locking tabs 1628, one or both of tip 1664 and medial portion 1662 are twisted or rotated about the longitudinal axis of post 1623 to position locking tabs 1620 behind and on a proximal side of respective locking tabs 1628. At such time, the force being used to press tip 1664 and medial portion 1662 towards one another may be stopped, wherein spring 1616 resiliently biases tip 1664 away from hub 1614 in the direction indicated by arrow 1625, frictionally retaining locking tabs 1620 against locking tabs 1628. As a result, tip 1664 is releasably but axially secured to medial portion 1662 by mechanism 1610.

[000180] In the example illustrated, the spring 1616 is a compression spring that resiliently biases locking cap 1612 in a direction away from locking hub 1614 by sufficient force such that sufficient friction exists holding the two members together such that locking cap 1612 and locking hub 1614 remain axially connected (tabs 1620 and 1628 do not separate from one another) and do not rotate relative to one another in response to the typical forces applied to probe 1600 as it is inserted and passed through the urethra and as it is rotated within the urethra to reposition the transducer 66. In other implementations, the above described configuration of locking mechanism 1610 may be reversed. For example, locking cap 1612 and locking hub 1614 may alternatively be connected to or formed as part of medial portion 1662 and tip 1664, respectively.

[000181] Figures 19 and 20 illustrate distal portions of an example navigation probe 1740 which may be used as part of system 10 described above. Navigation probe 1740 is similar to navigation probe 1540 described above except that probe 1740 is specifically illustrated as comprising a distal tip 1764 that is removably coupled to the medial portion 1762 luer locking mechanism 1710. Locking mechanism 1710 is located axially between medial portion 1762 and tip 1764. Locking mechanism 1710 comprises locking cap 1712 and locking hub 1714.

[000182] As shown by Figure 19, locking cap 1712 comprise a member secured to an interior of tip 1764 on a proximal axial end of tip 1764. Locking cap 1712 comprises an internal threaded bore 1716 having internal threads 1718. As shown by Figure 20, locking hub 1714 comprises a post 1720 extending from a distal end of medial portion 1762 and having external threads 1722. Post 1720 is sized to be received within bore 1716, where the external threads 1722 threadably engage and interfere with the internal threads 1718, providing a friction lock, securing tip 1764 to medial portion 1762.

[000183] Figure 21 is a side view illustrating portions of an example navigation probe 1840 which may be used as part of system 10 described above. Navigation probe 1840 is similar to navigation probe 1040 described above except that probe 1840 comprises EMD 1830 which is removably coupled to handle 1832. Such removable coupling may be achieved by a high-density electrical interconnect system/connector or plug may be used to removably couple the proximal portion to the handle. As result, the EMD 1830 or the handle 1832 may be separated for repair or replacement. Different EMDs 1830 having different lengths, softness, different gripping features or different transducer characteristics may be releasably mounted to handle 1832 depending upon the gripping tool being used, physician preferences or particular characteristics of the patient. Likewise, different handles 1832 may be mounted to EMD 1830.

[000184] Figure 22 is a side view illustrating portions of an example navigation probe 1940 which may be used as part of system 10 described above. Navigation probe 1940 is similar to navigation probe 1540, 1640 or 1740, described above except that the EMD 1530, 1630, 1730 is removably and releasably connected to handle 1832. Such removable coupling may be achieved by a high-density electrical interconnect system/connector or plug may be used to removably couple the proximal portion to the handle. As result, the EMD 1530, 1630, 1730 or the handle 1832 may be separated for repair or replacement. Different EMDs 1530, 1630, 1730 having different lengths, softness, different gripping features or different transducer characteristics may be releasably mounted to handle 1032 depending upon the gripping tool being used, physician preferences or particular characteristics of the patient. Likewise, different handles 1032 may be mounted to EMDs 1530, 1630, 1730.

[000185] As discussed above, during some surgical procedures, the distal tip of the navigation probe may be viewable, either by a physician or other persons or by an optical sensor, such as optical sensor 56. Figures 23-25 illustrate the provision of various gradations or markings to visibly indicate both translational and rotational positioning of transducer 66 while at least portions of the probe are received within the urethra. It should be appreciated that each of the various examples of markings shown in Figures 23-25 may be utilized on any of the above or below described navigation probes such as those probes described for use in system 10, with probes 1040 (with either of the gripping features 1042 or 1442), 1540, 1640, 1740, 1840 or 1940.

[000186] Figures 23-25 illustrate distal portions of an example probe 2040. Probe 2040 comprises handle 1032 (described above), proximal portion 1060 (described above), distal tip 2064 and medial portion 2062. Proximal portion 1060 is connected to handle 1032 as described above with respect to probes 1640 and 1740.

[000187] Distal tip 2064 may be similar to any of distal tips 1064, 1164, 1264, 1464 or 1764 described above. In some implementations, distal tip 2064 is a part of or fixed to medial portion 2062 (as with probe 1040). In some implementations, distal tip 2064 is releasably or removably connected to medial portion 2062, such as described above with respect to any of probes 1540, 1640, or 1740. In the example illustrated, distal tip 2064 comprises a gripping or grasping feature, such as feature 1042 described above. In other implementations, distal tip 2064 may omit gripping or grasping feature or may alternatively comprise the grasping feature 1442 described above with respect to probe 1440.

[000188] Probe 2040 may be similar to any of probes 1040, 1440,1540, 1640, 1740, 1840, or 1940 except that probe 2040 additionally comprises distal markings 2070, axial transducer markings 2072, angular transducer marking(s) 2074 and field- of-view marking 2076. Distal markings 2060 comprise markings formed or placed upon distal tip 2064, wherein such markings 2070 are spaced along the longitudinal axis 2071 of EMD 2030. Markings 2070 may be visibly ascertained to indicate or allow the determination of the positioning of EMD 2030 and transducer 66 within the urethra.

[000189] Axial transducer markings 2072 are formed or placed upon medial portion 2062 so as to indicate the positioning of the transducer 66. In the example illustrated, axial transducer markings 2072 comprise a first marking 2072-1 axially aligned with distal end of transducer 66, a second marking 2072-2 axially aligned with a proximal end of transducer 66, and a third marking 2072-3 axially aligned with a center of transducer 66 along axis 2071 . In the example illustrated, markings 2072 may comprise additional individual markings (similar to markings on a ruler). In some implementations, one or more of markings 2072 may be omitted. For example, in some implementations, just marking 2072-3 may be provided. In some implementations, marking 2072-3 may be omitted. In some implementations, a single wider marking 2072-1 may be provided, wherein marking 2072-1 has a first edge axially aligned with the proximal end of transducer 66 and a second opposite edge axially aligned with the distal end of transducer 66.

[000190] Angular transducer markings 2074 comprise markings that visibly indicate the angular position or orientation of transducer 66 about axis 2071 . In the example illustrated, the angular transducer marking 2074 comprise a 12 o’clock angular transducer marking 1764-1. Marking 2074-1 longitudinally extends along axis 2071 directly opposite to and aligned with a circumferential center or a transverse center of transducer 66 on an opposite side of device 2030. In some implementations, marking 2074-1 extend along an entirety of the axial length of medial portion 2062 and distal portion 2064. In other implementations, marking 2074-1 may alternatively have a shorter length, comprising a continuous or broken line having ends that coincide with or are aligned with the axial ends of transducer 66 so as to indicate the axial extent of transducer 66.

[000191] Field-of-view mark 2076 comprises a marking visible from the axial distal end on device 2030 that indicates the field-of-view of transducer 66. In the example illustrated, marking 2076 is provided on an axial face of tip 2064 and has a shape of a cone or triangle indicating the outward widening field-of-view for transducer 66. In the example illustrated, the triangle or cone serving as marking 2076 has an apex aligned with a circumferential or transverse center of transducer 66 and a widened portion or base facing in the same direction as a field-of-view of transducer 66 and opposite comers or edges corresponding to the circumferential or transverse edges of transducer 66. In other implementations, field-of-view marking 2076 may have other shapes and configurations.

[000192] Although probe 2040 is illustrated as including each of such markings, in other implementations, 2040 may omit one or more such markings. Such markings may be formed by printing, painting or coating upon surfaces of device 2030. Such markings may be formed by molding materials of different color. Such markings may be formed by indentations or protuberances molded or cut into surfaces of device 2030. Different markings may be provided with different colors, line thicknesses, brightnesses, shapes, line patterns or the like. In some implementations, the markings may comprise a bright fluorescent color, such as white or yellow for further distinguishing from surrounding blood and tissue. In some implementations, such markings may comprise lines extending completely about axis 2071 . In some implementations, such markings may only partially extend about axis 2071. In some implementations, such markings may comprise dots, arrowheads or other shapes. In some implementations, the axial ends of transducer 66 may be indicated by large rings of different color or other different attributes. For example, axially long ring (a wide ring) of a first color may distally extend from a distal end of transducer 66 to the end of tip 2064 and axially along ring (a wide ring) of a second color may proximally extend from a proximal end of transducer 66, wherein a third ring of a third color has axial ends coinciding with the axial ends of transducer 66.

[000193] Figures 26 and 27 illustrate probe 2140 with medial portion 2162 and transducer 66 positioned within a urethra 26, and in some implementations, within prostate 20. Probe 2140 may be similar to any of the above described probes. In the example shown in Figure 26, medial portion 2162 omits any lumens and supports ultrasound transducer 66. As shown by Figure 26, medial portion 2162 has a diameter or is otherwise dimensioned so as to support ultrasound transducer 66 in close conformal physical contact with the interior surface of urethra 26. In some implementations, medial portion 2162 has a diameter that closely matches the internal diameter of urethra 26. In some implementations, medial portion 2162 may be slightly larger than urethra 26 for frictional contact with the interior surfaces of urethra 26. In some implementations, medial portion 2162 has a diameter of no greater than 10 mm, and in some implementations, no greater than 8 mm for patient comfort. Because medial portion 2162 supports ultrasound transducer 66 and is in physical contact with the interior surface of urethra 26, to provide transducer 66 with enhanced acoustic coupling with respect to urethra 26, prostate 20 and the anatomical critical structures connected to the outer surfaces of prostate 20.

[000194] Figure 27 is a cross-sectional view of an example medial portion 2262 of an example EMD 2230 of an example navigation probe 2240 positioned within urethra 26, and in some implementations, within prostate 20. EMD 2230 is similar to EMD 2030 except that device 2230 comprises an integrated passageway or lumen 2282. Lumen 2282 is offset or asymmetric with respect to the centerline of EMD 1802. In some implementations, lumen 2282 may be a fluid lumen for the supply of fluid to an inflatable bladder or a hydraulic or pneumatic ultrasound transducer pressing device. In yet other implementations, lumen 2282 may be provided for the supply or withdrawal of fluid to and from regions about prostate 20. In other implementations, the lumen may be used to provide therapy or to perform biopsies. [000195] Figure 28 is a sectional view illustrating portions of an example navigation probe 2340 which may be utilized as part of surgical navigation systems 10 described above. Navigation probe 2340 may have a construction similar to that of any of probes 1040, and 1540-2040, wherein navigation probe 2340 comprises an elongate medical device 2330 comprising a handle 1032 (shown and described above), a proximal portion 2360, a distal tip 2364. Proximal portion 2360 is connected to handle 1032 as described above with respect to probes 1840 and 1940.

[000196] Distal tip 2364 may be similar to any of distal tips 1064-2064 described above. In some implementations, distal tip 2364 is a part of or fixed to medial portion 2362 (as with probe 1040). In some implementations, distal tip 2354 is releasably or removably connected to medial portion 2352, such as by the mechanisms described above with respect to any of probes 1540- 2040. In the example illustrated, distal tip 2364 comprises a gripping or grasping feature, such as feature 1042 described above. In other implementations, distal tip 2364 may omit gripping or grasping feature or may alternatively comprise the grasping feature 1442 described above with respect to probe 1440. In some implementations, distal tip 2354 may additionally comprise distal markings 2070, axial transducer markings 2072, angular transducer marking(s) 2074 and field-of-view marking 2076 (described above with respect to probe 2040).

[000197] As specifically shown by Figure 28, ultrasound transducer 66 is electrically connected to controller 36 by a transmission line or cable 210 for the receipt of power and control signals as well as for the transmission of ultrasound data. Probe 2340 additionally comprises a proximal lumen 2382. Proximal lumen 2382 comprises a passageway that extends within and through proximal portion 2360 and those portions of medial portion 2362 on a proximal side of transducer 66. Proximal lumen 2382 facilitates the transmission of fluids either to the proximal side of transducer 66 or from the proximal side of transducer 66 from and to regions outside the urethra. In the example illustrated, proximal lumen 2382 has a port 2384 on a proximal side of transducer 66, facing in the same direction that transducer 66 faces. In other implementations, proximal lumen 2382 may include a larger number of ports for the discharge or receipt of fluids, wherein such ports may face in other directions. [000198] Figure 29 is a sectional view illustrating portions of an example navigation probe 2440 which may be utilized as part of surgical navigation systems 10 described above. Probe 2440 is similar to probe 2340 except that probe 2440 comprises distal lumen 2482 in place of proximal lumen 2382. For example, probe 2440 may additionally have any of the various features or configurations described above with respect to the various probes 1040 and 1240-2040. Those remaining components of probe 2440 which correspond to components of probe 2340 are numbered similarly.

[000199] Distal lumen 2482 comprises a passageway that extends within and through proximal portion 2360 and those portions of medial portion 2362 to the distal side of transducer 66. Distal lumen 2482 facilitates the transmission of fluids either to the distal side of transducer 66 or from the distal side of transducer 66 from and to regions outside the urethra. In the example illustrated, distal lumen 2482 has a port 2484 on a distal side of transducer 66, facing in the same direction that transducer 66 faces. In other implementations, distal lumen 2482 may include a larger number of ports for the discharge or receipt of fluids, wherein such ports may face in other directions.

[000200] Figures 30 and 31 are sectional views illustrating portions of an example navigation probe 2540 positioned within the interior of urethra 26, and in some implementations, extending within prostate 20. Figure 30 illustrates navigation probe 2540 in a transport state while Figure 30 illustrates navigation probe 2540 in an acoustically coupled, ultrasound data capturing state.

[000201] As shown by Figures 30 and 31 , navigation probe 2540 is similar to navigation probe 2040 except that probe 2540 comprises a transducer pressing device 2580. For example, probe 2540 may additionally have any of the various features or configurations described above with respect to the various probes and 1040-2040. In some implementations, probe 2540 may additionally comprise the proximal lumen 2382 described above with respect to probe 2340. Those remaining components of probe 2540 which correspond to components of probe 1740 are numbered similarly. [000202] As with the above-described navigation probes, navigation probe 2140 which may be utilized as part of surgical navigation system 10 described above. Navigation probe 2540 comprises EMD 2530 (including ultrasound transducer 66), inflation lumen 2582 and ultrasound pressing device 2584 in the form of an inflatable body 2586 such as a balloon. EMD 2530 a proximal portion 2560, a distal tip 2564. Proximal portion 2560 is connected to handle 1032 as described above with respect to probes 1840 and 1940.

[000203] EMD 2530 is fixedly connected to or releasably connected to handle 1032 (described above) and may have any of the configurations described above with respect to EMDs above. Although not illustrated, ultrasound transducer 66 is electrically connected to controller 36 (shown in Figure 1 ) for the receipt of power and control signals as well as for the transmission of ultrasound data.

[000204] Inflatable body 2586 is supported along an exterior of EMD 2530 opposite to the side along which ultrasound transducer66 extends and faces. Inflatable body 2586 is selectively inflated and deflated by the supply or withdrawal of pressurized fluid 2588 through inflation lumen 2582. In some implementations, the inflation fluid may comprise a gas, such as air. In other implementations, the inflation fluid may comprise a liquid, such as saline. The supply of inflation fluid 2588 may be regulated with an inflation device.

[000205] As shown by Figure 30, in the uninflated state, inflatable body or balloon 2586 facilitates movement of navigation probe 2540 through urethra 26. As shown by Figure 31 , inflation of inflatable body 2586 increases the size of body 2586 so as to bear against the first side of urethra 26, pressing ultrasound transducer 66 towards against a second opposite side of urethra 26. As a result, ultrasound transducer 66 is brought into close conformal physical contact with the opposite side of the urethra 26 for enhanced acoustical coupling for enhanced ultrasound data acquisition from those portions along urethra 26.

[000206] Figure 32 is a sectional view illustrating portions of an example navigation probe 2640. As with all of the above-described navigation probes, navigation probe 2640 may be utilized as part of surgical navigation system 10 described above. Navigation probe 2640 comprises EMD 2630 (including ultrasound transducer 66) and electromechanical pressing device 2680. EMD 2630 a proximal portion 2660, a distal tip 2664. Proximal portion 2660 is connected to handle 1032 as described above with respect to probes 1840 and 1940.

[000207] EMD 2630 may have any of the configurations described above with respect to the EMDs. Ultrasound transducer 66 is electrically connected to controller 36 (shown in Figure 1 ) for the receipt of power and control signals as well as for the transmission of ultrasound data by the electrical power/transmission lines 2682.

[000208] In some implementations, the ultrasound transducer pressing device 2680 may comprise an electromechanical actuator in the form of a shape changing material which changes shape or dimension in response to an applied electrical current (a piezo material). In some implementations, the ultrasound transducer pressing device may comprise a mechanical pressing device which is moved using hydraulic or pneumatic pressure.

[000209] As shown by Figure 32, in the un-deployed state, device 2680 is flush with our recessed from the outer surfaces of EMD 2630, facilitating movement of navigation probe 2640 through urethra 26. As shown by Figure 33, upon receiving a stimulus, such as electrical current or a hydraulic or pneumatic supply, device 2680 changes shape and/or size so as to directly bear against the first side of urethra 26 or expand portions of a flexible outer wall portion of device 2630 so as to bear against the first side of urethra 26, pressing ultrasound transducer 66 (and intervening portions of medial portion 2662 against a second opposite side of urethra 26. As a result, ultrasound transducer 66 is brought into close conformal physical contact with the opposite side of the urethra 26 for enhanced acoustical coupling for enhanced ultrasound data acquisition from those portions along urethra 26.

[000210] Figures 34 and 35 are sectional views illustrating portions of an example navigation probe 2740 positioned within the interior of urethra 26, and in some implementations, extending within prostate 20. Figure 34 illustrates navigation probe 2740 in a transport state while 35 illustrates navigation 2740 anchored in place within urethra 26. As shown by Figure 34 and Figure 35, navigation probe 2740 is similar to navigation probe 2040 except that probe 2740 comprises an extendable and retractable anchor 2780. For example, probe 2740 may additionally have any of the various features or configurations described above with respect to the various probes 1040-2040. Those remaining components of probe 2740 which correspond to components of probe 2040 are numbered similarly. As with the above-described navigation probes, navigation probe 2700 which may be utilized as part of surgical navigation system 10 described above. Navigation probe 2740 comprises EMD 2730 (including ultrasound transducer 66), inflation lumen 2782 and anchor 2780 in the form of an inflatable body 2784 such as a balloon. EMD 2730 further comprises proximal portion 2762, medial portion 2762 and distal portion 2764 which have proximal portion 1060, medial portion 1062 and distal portion 1064, respectively, described above.

[000211] EMD 2730 is fixedly connected to or releasably connected to handle 1032 (described above) and may have any of the configurations described above with respect to EMDs above. Although not illustrated, ultrasound transducer 66 is electrically connected to controller 36 (shown in Figure 1) for the receipt of power and control signals as well as for the transmission of ultrasound data.

[000212] Inflatable body 2784, configured to serve as the anchor 2780, and is supported along an exterior of EMD 2730 on a proximal longitudinal side of ultrasound transducer 66. Inflatable body 2784 is configured to be selectively inflated and deflated by the supply or withdrawal of pressurized fluid 2786 through inflation lumen 2782. In some implementations, the inflation fluid may comprise a gas, such as air, or may comprise a liquid, such as saline. The supply of inflation fluid 2786 may be regulated with an inflation device.

[000213] As shown by Figure 34, in the uninflated state, inflatable body or balloon 2784 is flush with the outer circumference or outer surface of device 2730 to facilitate movement of navigation probe 2740 through urethra 26. As shown by Figure 35, inflation of inflatable body 2784 increases the size of body 2784 so as to project outwardly beyond the outer circumference or outer surface of device 2730 so as to bear against opposite internal sides of urethra 26, anchoring device 2730 in place relative to urethra 26. Each of the probes 2340-2840 comprise EMD’s having proximal portion, medial portion, and distal portion which have constructions similar to those of proximal portion 1060, medial portion 1062 and distal portion 1064, respectively, described above. For example, each of the distal portion may comprise a distal atraumatic tip.

[000214] Figure 36 is a sectional view illustrating portions of an example navigation probe 2840 positioned within the interior of urethra 26, and in some implementations, extending within prostate 20. Figure 36 illustrates navigation probe 2840 in a translatable state, facilitating translation of probe 2840 along and within urethra 26. Navigation probe 2840 is similar to navigation probe 2040 except that probe 2840 comprises vacuum ports 2880 supplied with a vacuum passage 2882. For example, probe 2840 may additionally have any of the various features or configurations described above with respect to the various probes 1040-2040. Those remaining components of probe 2840 which correspond to components of probe 2040 are numbered similarly. As with the above-described navigation probes, navigation probe 2840 which may be utilized as part of surgical navigation system 10 described above. Navigation probe 2840 comprises EMD 2830, ultrasound transducer and the aforementioned vacuum ports 2880 and vacuum passage 2882.

[000215] EMD 2830 is fixedly connected to or releasably connected to handle 1032 (described above) and may have any of the configurations described above with respect to EMDs above. Although not illustrated, ultrasound transducer 66 is electrically connected to controller 36 (shown in Figure 1) for the receipt of power and control signals as well as for the transmission of ultrasound data.

[000216] Vacuum ports 2880 comprise at least one port in pneumatic connection with vacuum passage along the exterior side or surface of device 2830 on a proximal longitudinal side of transducer 66. In some implementations, ports 2880 are located on opposite circumferential sides of device 2830. In some implementations, vacuum ports 2880 comprise a series of openings spaced and situated about an outer circumference of device 2830 on a proximal side of transducer 66. Each of such ports is in pneumatic can communication our connection with vacuum passage 2882. [000217] Vacuum passage 2882 comprises one or more lumens extending through device 2030 and connected to a vacuum source, such as a vacuum pump. During positioning of device 2830 within urethra 26, there is no supply of vacuum through passage 2882 to ports 2880. Upon positioning of device 2830 at a selected location within urethra 26, the vacuum source may be actuated, applying a vacuum through passage 2882 to each of ports 2880, wherein the more flexible tissue of the urethra is drawn against and held against ports 2880-to anchor and retain device 2830 in place relative to the urethra.

[000218] Figures 37-40 illustrate another example of how the rotational and/or axial positioning of a probe within the urethra may be fixed against rotation or translation. Figures 37-40 illustrate an example probe 2940. Navigation probe 2900 is similar to navigation probe 2000 except that probe 2940 comprises tube and transducer retention mechanism 2990. For example, probe 2940 may additionally have any of the various features or configurations described above with respect to the various probes 1040 and 1240-2040. Those remaining components of probe 2940 which correspond to components of probe 2040 or any of the other described probes are numbered similarly. As with the above-described navigation probes, navigation probe 2940 which may be utilized as part of surgical navigation system 10 described above. Navigation probe 2940 comprises EMD 2930, ultrasound transducer 66 (described above) and the aforementioned tube and transducer retention mechanism 2990.

[000219] EMD 2930 is fixedly connected to or releasably connected to handle 1032 (described above) and may have any of the configurations described above with respect to EMDs above. Although not illustrated, ultrasound transducer 66 is electrically connected to controller 36 (shown in Figure 1 ) for the receipt of power and control signals as well as for the transmission of ultrasound data.

[000220] Tube and transducer retention mechanism 2990 facilitates selective radial and axial retention of EMD 2930 and transducer 66. Retention mechanism 2990 comprises housing 2992, press bars 2994, cam 2996, bias 3003, and actuation rod 2998. Housing 2992 is fixed to EMD 2802. Housing 2892 may be bonded, glued or fused to EMD 2002. Housing 2992 pivotably supports ends of press bars 2994. In the example illustrated, housing 2992 comprises a circumferential channel 2993 that captures spherical ends 2995 of bars 2994, retaining bars 2994, permitting bars 2994 to pivot towards and away from the longitudinal axis of tube 2966. Housing 2992 further slidably retains cam 2996 for axial movement along axis 3004. [000221] Press bars 2994 extend proximally from channel 2993, terminating at individual heads 2997. In the example illustrated, portions of tube 2966 adjacent office to heads 2997 are resil iently flexible such that such portions may be resi liently pressed outwardly by press bars 2994 into frictional engagement with the internal surfaces of the urethra.

[000222] As shown by Figures 37 and 38, release of rod 2998 permits bias/spring 3003 to move cam 2996 to a distal position such that end 3001 is opposite to the heads 2997 of bars 2994, retracted from the internal side of the flexible portion of the tube forming a portion of EMD 2930, permitting tube of the EMD 2930 and the transducer 66 to be rotated and/or translated. As shown by Figures 39 and 40, proximal movement of rod 2998 moves cam 2996 in a proximal direction (towards handle 3232 1032), against bias 3003 (shown as an elastomeric O-ring or other annular spring) such that the wider end 3002 of cam 2996 bears against heads 2997 of bars 2994 to press heads 2997 against the interior sides of the EMD 2930 to such an extent that outer surfaces of the tube of the EMD 2930 are pressed against internal surfaces of the urethra, frictionally engaging the urethra to retain the EMD 2930 and the supported transducer 66 and inhibit subsequent rotation and/or translation. In some implementations, handle 32321032 may include an L-shaped slot, permitting the rod 2998 to be moved along the longitudinal length of the L-shaped slot and then slid sideways for retention in a proximal position to retain cam 2996 in the proximal position and to retain the heads 2997 and their tube retaining positions.

[000223] Figures 41-42 illustrate portions of an example navigation probe 3040 which facilitates selected rotation of a transducer within the EMD while the EMD is stationary or, in some implementations anchored, within the urethra (as described above). As with the above-described navigation probes, navigation probe 3040 may be utilized as part of surgical navigation system 10 described above. Navigation probe 3040 comprises handle 3032, EMD 3030, distal plug 3070, proximal plug 3072, transducer housing 3074, ultrasound transducer 66, and rotary drive 3050. [000224] Handle 3032 is an example implementation of handle 1032 described above. In the example illustrated, handle 3032 has a bulbous shape to facilitate being manually grasped. Handle 3032 may have other shapes and configurations. [000225] EMD 3030 extends distally from handle 3032 and comprises proximal portion 3060, distal tip 2506 and medial portion 2508. Proximal portion 3060 is similar to proximal portion 1060 or 1960 described above. Proximal portion 3060 extends from and is connected to a handle 3032. Proximal portion 3060 may be flexible to facilitate bending as EMD 3030 passes through the bends or turns of the urethra to the prostate.

[000226] Tip 3064 may be flexible and/or soft and may be tapered as described above with respect to tip 1064. In some implementations, distal tip 3064 has a length of at least 5 mm and in some implementations within a range of 5 to 50 mm. in some implementations, tip 3064 is fixedly connected to medial portion 3062. In other implementations, tip 3064 is removably or releasably connected to medial portion 3062, wherein tip 3064 and medial portion 3062 have the connection mechanisms shown and described above with respect to probes 1640 or 1740. In the example illustrated, distal tip 3064 is illustrated as having grasping feature 1042. In other implementations, distal tip 3064 may alternatively comprise a different grasping feature, such as grasping feature 1442 described above. In the example illustrated, distal tip 3064 further comprises distal markings 2070, axial transducer markings 2072, angular transducer marking(s) 2074 and field-of-view marking 2076 (described above).

[000227] Medial portion 3062 supports ultrasound transducer 66. Medial portion 3062 may be stiffer as compared to proximal portion 3060 and distal tip 3064. Such stiffness provides stability for the ultrasound transducer 66. In some implementations, proximal portion 3060 may be formed from material such as steel, polycarbonate, and TEXIN 70A as described above with respect to medial portion 1062.

[000228] Distal plug 3070 cooperates with proximal plug 3072 to contain a fluid coupling medium 3063 within an interior of medial portion 3062, between transducer 66 and an outer wall of medial portion 3062. Distal plug 3070 occludes an open axial end of medial portion 2508 to inhibit flow of the coupling medium out of the chamber that is formed between plugs 3070 and 3072. Fluid coupling medium 3063 occupies spacing between the lens of transducer 66 and the outer tube forming medial portion 3062, facilitating rotation of the transducer 66 within the outer tube of medial portion 3062.

[000229] In implementations where distal tip 2506 is not removable from medial portion 2508, distal plug 3070 may be formed as part of distal tip 3064. In implementations where the distal tip 3064 is separable and removable from medial portion 3062, the mechanism for releasably connecting medial portion 3062 to the distal tip 3064 may extend between the distal end or side of plug 3070, connected to medial portion 3062, and the proximal side of tip 3064. For example, in implementations where medial portion 3062 is releasably connected to distal tip 3064 by a connection mechanism similar to connection mechanism 1610 described above with respect to probe 1600, post 1623 with its channels 1626 and tabs 1628 may distally project from plug 3070 while the distal tip3064 has a hollow axial end containing cap 1612 with its tabs 1620 and spring 1616. In implementations where medial portion 3062 is removably connected by a connection mechanism similar to connection mechanism 1710 of probe 1600, post 1420 and threads 1422 may distally project from plug 3070 while internal portions of distal tip 2506 comprise the internally threaded bore for threadably receiving the post 1420. In yet other implementations, other connection mechanisms may be provided between plug 3070 and the distal tip 3064 to facilitate separation exchange of distal tip 3064 from medial portion 3062.

[000230] In the example illustrated, distal plug 3070 is additionally configured to rotatably support transducer housing 3074 and transducer 66 for rotation about the longitudinal axis 2566 of medial portion 2508. As shown by Figures 34 and 35, distal plug 3070 comprises a main portion 3063 and a longitudinally extending hub 3068. Hub 3068 comprises a cylinder proximally projecting from a proximal side of main portion 363, wherein housing 3074 may rotate about the hub 3068, about the longitudinal axis 3066 of medial portion 3062. [000231] As shown by Figure 43, proximal plug 3072 comprises a disk or other structure occluding the interior of medial portion 3062 on a proximal side of transducer housing 3074 and transducer 66. In some implementations, plug 3072 may be integrally formed as part of a senior unitary body with medial portion 2508. In other implementations, plug 3072 may be mounted within the interior of medial portion 2508. In some implementations, plug 3072 is connected to transducer housing 3074 so as to rotate with transducer housing 3074. In other implementations, by 2562 is fixed and is not connected to transducer housing 3074, such as where transducer housing 3074 is cantilevered from distal plug 3070 or is rotatably supported by other structures extending between housing 3074 and the interior surface of medial portion 3062. Plug 3072 and plug 3070 cooperate to contain and seal the fluid coupling medium 3063 between such plugs.

[000232] Transducer housing 3074 housing supports transducer 66 and is rotatably coupled to distal plug 3070. Transducer 66 comprises an ultrasound transducer similar to transducer 66 described above. As shown by Figure 43, housing 3074 comprises a plate or other structure 3070 having an opening 3076 that slidably receives hub 3068, facilitating rotation of plate 3070 (and the rest of housing 3074) about the axis of hub 368. In addition, housing 3074 further comprises a pair of opposing bearing arms 3078 that proximally project from plate 3070 and that have outer circumferential surfaces having outer radii that match the internal radii of medial portion 3062 to further guide rotation of housing 3074 (and transducer 66) about the axis of hub 3068. In other implementations, housing 3074 and transducer 66 may be rotatably supported within the interior of medial portion 3062 by other mechanisms. In some implementations, housing 3074 may alternatively be rotatably supported by proximal plug 3072 rather than distal plug 3070. In some implementations, proximal plug 3072 may be provided other locations, closer to handle 3032 or as part of handle 3032, wherein the fluid coupling medium 363 would be contained within a larger volume within the EMD 3030.

[000233] As further shown by Figure 44, transducer housing 3074 additionally comprises a ring 3079 distally projecting from and fixedly connected to plate 3070. As with plate 3070, ring 378 extends about and slidably or rotatably receives hub 3068. As will be described hereafter, ring 3079 provides a rotary lever arm for rotating housing 3074 and transducer 66 using rotary drive 3050. In other implementations, structures other than a ring may be used, wherein the other structures rotatably extend about hub 3068 and provide rotational lever arms.

[000234] Rotary drive 3050 comprise a mechanism configured to receive force from a location proximate to handle 3032 and to transmit the force so as to rotate transducer housing 3074 and transducer 66 within and relative to medial portion 2508 to alter the direction or orientation of the field-of-view of transducer 66. Rotary drive 3050 comprises manual interface 3080 (shown in Figure 41 ) and push pull cables 3082-1 , 3082-2 (collectively referred to as cables 3082).

[000235] Manual interface 3080 is connected to each of cables 3082. Manual interface 3080 projects from housing 3032 and is configured to be manually grasped and manipulated so as to pull (placed in tension) one of cables 3082 while concurrently pushing, releasing or discontinuing tension to the other of cables 3082. In the example illustrated, interface 3080 comprises a knob, lever or dial rotatably supported by housing 3032 and connected to ends of cables 3082 such that rotation of interface 3080 winds one of cables 3082 while releasing or unwinding the other of cables 3082.

[000236] Cables 3082 extend from within handle 3032 and from interface 3080 along an interior of device 3030. As shown by Figure 43, cables 3082 pass through an opening 3083 in plug 3072 over and above transducer housing 3074, and through guiding passages 3084 of distal plug 3070. As shown by Figure 44, cable 3082-1 exits its passage 3084, extending counterclockwise about hub 3068 to an end 3086- 1 that is fixed or secured to ring 3079. Likewise, cable 3082-2 exits its passage 3084, extending clockwise about hub 3068 to an end 3086-2 that is fixed or secured to ring 3079. Manual rotation of interface 3080 in a first direction, winding and pulling cable 3082-1 while also unwinding and releasing cable 3082-2 results in ring 3079, housing 3074 and transducer 66 being rotated counterclockwise about axis 3066 (as indicated by arrow 3085-1 in Figure 44). Conversely, manual rotation of interface 3080 in a second opposite direction, winding and pulling cable 3082-2 while also unwinding and releasing cable 3082-1 results in ring 3079, housing 3074 and transducer 66 being rotated counterclockwise about axis 3066 (as indicated by arrow 3085-1 in Figure 44). In some implementations, interface 3080 or ring 3079 may be resiliently biased by one or more torsion springs towards a neutral position, such as a position shown in Figure 44, wherein transducer 66 faces in a direction orthogonal to a plane containing portions of both of cables 3082 that extend over transducer housing 3074.

[000237] Figures 45-48 illustrate portions of an example probe 3140 which also facilitates selected rotation of the medial portion (including the transducer) and the distal tip relative to the proximal portion of the EMD while proximal portions of the EMD is stationary or, in some implementations anchored, within the urethra (as described above). Fluid coupling is not required, since the entire medial portion 3162 and distal portion 3164 are rotated (with the transducer 66 rotating with the medial portion 3162), wherein a lens 206 of the transducer 66 may extend into conformal contact with the outer tube of the medial portion 162. As with the above-described navigation probes, navigation probe 3140 may be utilized as part of surgical navigation system 10 described above.

[000238] Navigation probe 3140 comprises handle 3032, EMD 3130, distal plug 3170, proximal plug 3172, transducer housing 3174, ultrasound transducer 66, and rotary drive 3150. Those components of probe 3140 which correspond to components of probe 3040 are numbered similarly.

[000239] Distal plug 3170 is integrally formed as part of or is connected to the distal region of medial portion 3162 is joined into a hollow axial end of tip 3164 or is otherwise fixed to tip 3164. In some implementations, distal plug 3170 may form part of a connection mechanism releasably connecting distal tip 3164 two medial portion 3162, such as a connection mechanisms described above with respect to probes 1640 and 1740.

[000240] For example, where the distal tip 3164 is separable and removable from medial portion 3162, the mechanism for releasably connecting medial portion 3162 to the distal tip 3164 may extend between the distal end or side of plug 3070, connected to medial portion 3162, and the proximal side of tip 3164. For example, in implementations where medial portion 3162 is releasably connected to distal tip 3164 by a connection mechanism similar to connection mechanism 1610 described above with respect to probe 1640, post 1623 with its channels 1626 and tabs 1628 may distally project from plug 3172 while the distal tip 3164 has a hollow axial end containing cap 1612 with its tabs 1620 and spring 1616. In implementations where medial portion by a connection mechanism similar to connection mechanism 1710 of probe 1740, post 1720 having threads 1722 may distantly project from plug 3170 while internal portions of distal tip 3164 comprise the internally threaded bore for threadably receiving the post 1720.

[000241] Proximal plug 3172 mounts to the distal end of portion 3164. In some implementations, proximal plug 3172 is provided as part of the distal end of proximal portion 3160 or is provided as part of the proximal end of medial portion 3162. In some implementations, proximal plug 3172 may be mounted into the hollow axial end of either proximal portion 3160 or medial portion 3162. As shown by Figure 46, proximal plug 3172 comprises a distally projecting tab 3163 comprising cable guides 3184.

[000242] Transducer housing 3174 housing supports transducer 66 and is rotatably coupled to proximal plug 3172. Transducer 66 comprises an ultrasound transducer similar to transducer 66 described above in Figure 10. As shown by Figure 46, housing 3174 comprises a plate or other structure 3170 having an opening 3176 that receives hub 3168 and, projecting from plug 3165. In addition, housing 3174 further comprises a pair of opposing arms 3178 that distally project from plate 3171 and that have outer circumferential surfaces having outer radii that match the internal radii of medial portion 3162 to further press-fit housing 3174 to the interior medial portion 3162 such that rotation of housing 3174 results in corresponding rotation medial portion 3162 and distal tip 3164.

[000243] As further shown by Figure 47, transducer housing 3174 additionally comprises a ring 3179 proximally projecting from and fixedly connected to plate 3171. As with plate 3171 , ring 3179 extends about and slidably or rotatably receives hub 3168. As will be described hereafter, ring 3179 provides a rotary lever arm for rotating housing 3174 and transducer 66 using rotary drive 3150. In other implementations, structures other than a ring may be used, wherein the other structures rotatably extend about hub 3168 and provide rotational lever arms. [000244] Rotary drive 3150 is similar to rotary drive 3050 described above except that cables 3182 do not extend over or a cross transducer 66, having ends that are connected to ring 3179 of housing 3174 on a proximal end of medial portion 3162. As shown by Figure 47, cable 3182-1 exits its passage 3184, extending counterclockwise about hub 3168 to an end 3186-1 that is fixed or secured to ring 3179. Likewise, cable 3182-2 exits its passage 3184, extending clockwise about hub 3168 to an end 3186-2 that is fixed or secured to ring 3179.

[000245] Manual rotation of interface 3080 (shown in Figure 41 ) in a first direction, winds and pulls cable 3182-1 while also unwinding and releasing cable 3182-2 which results in ring 3179, housing 3174, transducer 66, medial portion 3162, and tip 3164 being rotated clockwise about axis 3166 (as indicated by arrow 3185-1 in Figure 47). Conversely, as shown may Figure 47, manual rotation of interface 3080 in a second opposite direction, winding and pulling cable 3182-2 while also unwinding and releasing cable 3182-1 results in ring 3179, housing 3174, transducer 66, medial portion 3162 and distal tip 3164 being rotated counterclockwise about axis 2666 (as indicated by arrow 3185-2 in Figure 47).

[000246] In some implementations, interface 3080 or ring 3179 may be resiliently biased by one or more torsion springs towards a neutral position, such as a position shown in Figure 46, wherein transducer 66 faces in a direction orthogonal to a plane containing portions of both of cables 3182 that extend along and within proximal portion 3160. In other implementations, housing 3174 (and transducer 66) may be rotatably supported and rotatably supported about hub 3168 such that housing 3174 transducer 66 may be rotated within and relative to medial portion 3162 (similar to the rotation of housing 3074 and transducer 66 in probe 3040), without corresponding rotation of distal tip 3164. In such an implementation, a fluid coupling medium would be positioned between the transducer 66 and the rotating outer tube of medial portion 3162. Because cables 3082 do not extend over and above housing 3174 and transducer 66, additional internal volume or space within medial portion 3108 may be dedicated to the provision of transducer 66 and other electronics.

[000247] Figures 49-52 illustrate portions of navigation probe 3240 which facilitates selected rotation of a transducer within the EMD while the EMD is stationary or, in some implementations anchored, within the urethra (as described above). As with the above-described navigation probes, navigation probe 3240 may be utilized as part of surgical navigation system 10 described above. Navigation probe 3240 comprises handle 3232, EMD 3030, transducer housing 32744, ultrasound transducer 66, and rotary drive 3250. Those components of probe 3240 which correspond to components of probe 3140 are numbered similarly.

[000248] Handle 3232 is similar to handle 3032 except that handle 3232 comprises an elongate longitudinally extending slot 3205 through which a manual interface of rotary drive 3250 extends. As with handle 3032, handle 3232 may have other shapes and configurations. Elongate medical device 3230 comprises an elongate set of end to end hollow tubes or a single hollow to have a different physical properties as described above. The hollow tube forming proximal portion 3260 is fixed to handle 3232. As described above, the distal end of medial portion 3262 may be fixed to distal tip 3264 or may be releasably or removably connected to distal tip 3264 with any of the above-described connection mechanisms. Medial portion 3262 and distal tip 3264 may have a configuration similar to any of the medial portions and distal portions, respectively, described above. For example, distal tip 3264 comprises an atraumatic distal tip. Likewise, the grasping feature 142 may alternatively comprise any of the other above-described grasping features.

[000249] Transducer housing 3274 comprises an elongate internal tube 3286 rotatably and slidably disposed within the outer tubes or tube forming proximal portion 3260 and medial portion 3262. Tube 3286 has a closed axial distal end 3287. Tube 3286 houses and contains transducer 66 and a fluid coupling medium 3289. The fluid coupling medium 3289 extends across the sensing face of transducer 66 and facilitates enhanced sensing by transducer 66.

[000250] In the example illustrated, the fluid coupling medium 3289 may have a predefined volume contained within tube 3286. In some implementations, tube 3286 is connected to a fluid pump and fluid supply or reservoir, wherein a fluid coupling medium is pumped into or circulated through, in and out of the interior of tube 3286. In such implementations, the pumping of the fluid coupling medium into tube 3286 reduces the likelihood of air between transducer 66 and medial portion 3262 due to leakage. In implementations where coupling medium is circulated, such circulation of the fluid coupling medium (mineral oil, saline solution or the like) may additionally cool transducer 66, absorbing heat from transducer 66, wherein the coupling fluid is transmitted through heat exchanger to discharge the heat.

[000251] As shown by Figure 50, tube 3286 comprises a window 3290 opposite to the sensing face of transducer 66. Window 3290 extends to the interior wall of medial portion 3262. Tube 3286 further supports a proximal seal 3270 and a distal seal 3272 on opposite longitudinal sides of window 3290 and the sensing face of transducer 66. Seals 3270 and 3272 provide a liquid or fluid seal between the outer surface of tube 2766 and the internal surface of those tubes or the tube forming the EMD 3230. Seals 3270 and 3272 seal or contain fluid coupling medium 3289 between seals 3270, 3272. In the example illustrated, seals 3270, 3272 comprise elastomeric O-rings. In other implementations, seals 3270, 3272 may comprise other forms of seals, such as gaskets or the like that inhibit the leakage of the fluid coupling medium proximally beyond seal 3270 or distally beyond seal 3272.

[000252] Rotary drive 3250 comprise a mechanism configured to selectively and controllably rotate tube 3286 and the transducer 66 fixed to and carried by tube 3286. Rotary drive 3250 comprises beveled gear 3276, beveled gear 3278 and manual interface 3280. Beveled gear 3276 is fixed to inner tube 3286 so as to rotate with inner tube 3286. Beveled gear 3278 is meshed with gear 3276 and is fixed to manual interface 3280. Manual interface 3280 extends from gear 3278, through slot 3205 and comprises a handle 3282 that is configured to be rotated. Rotation of handle 3282 rotates gear 3278 which rotates gear 3276 to rotate inner tube 3286 and transducer 66.

[000253] In the example illustrated, tube 3286 is axially slidable within the EMD 3230. Gears gear 3278 and interface 3280 are maintained in connection with gear 3276 during translation of tube 3286 and gear 3276. Handle 3232 may be slid along the longitudinal axis of tube 3286, within slot 3285 to axially translate tube 3286 and transducer 66 within EMD 3230. Handle 3282 of interface 3280 may be slid to a proximal position within slot 3205 to position transducer 66 in an axially retracted position shown in Figure 49 while the outer tube or tubes of EMD 3230 remains substantially stationary within the urethra. As shown by Figure 50, handle 3232 of interface 3280 may be slid to a distal position within slot 3205 to position transducer 66 in an axially extended position while the outer tube or tubes of EMD 3230 remains substantially stationary within the urethra. At either of the axially retracted position, the axially extended position or any acts a position therebetween, interface 3280 may be rotated to rotate tube 3286 and transducer 66 about the longitudinal axis of the EMD 3230 while the outer tube or tubes of EMD 3230 remains substantially stationary within the urethra. In other implementations, slot 3205 may be omitted, where interface 3280 extends through a circular opening (rather than elongated slot) such that translation of interface 3280, tube 3286 and of transducer 66 is not facilitated but where rotation of tube 3286 and transducer 66 may still be performed through the rotation of interface 3280. In some implementations, inner tube 3286 may be omitted, wherein the outer tube forming EMD 3230 is fixed to transducer 66 and to bevel gear 3276 such that the entire EMD 3230 and the transducer 66 are rotated together in response to rotation of interface 3280 and are translated in response to movement of interface 3280 along slot 3205. In such implementations, load coupling medium 3289 may be omitted.

[000254] Figures 53-57 illustrate various examples of how the handle of the probe may be externally fixed to inhibit inadvertent or accidental translation or other movement of the probe once positioned within the urethra. Figures 53-54 illustrate portions of an example probe 3340 that may be utilized as part of the surgical navigation system 10 described above. Navigation probe 3340 is similar to probe 3140 except that probe 3340 comprises handle 3332 in place of handle 3132. Those components of probe 3340 which correspond to components of probe 3140 are numbered similarly. Probe 3340 may alternatively be similar to any of the probes described above. [000255] Handle 3332 is similar to handle 3232 except that handle 3332 additionally comprises a drape clamp 3320. Drape clamp 3320 comprises a clamping door 3322 pivotally connected to the remainder of handle 3332. Door 3322 is pivotable between an open position and a locked, clamp position which results in the patient’s drape or garment being pinched and held between door 3322 and the remainder of handle 3332. As result, the patient’s drape is captured between the body of handle 3332 and door 3322 to externally fixed or retain handle 3332 and probe 3340 in place. In some implementations, door 3322 may be releasably secured to the body or housing of handle 3332 by a latch, a magnet, an over center cam, a spring loaded mechanism, or other releasable securement mechanism.

[000256] Figures 55 and 56 illustrate an example infrastructure mounted holder 3400 for externally holding and fixing a probe, such as the illustrated probe 3140 in place. As should be appreciated, holder 3400 may be utilized with any of the abovedescribed navigation probes. Holder 3400 comprises mounts 3404, base 3405, distal handle bracket 3406, proximal handle bracket 3408 and penis holder 3410.

[000257] Mounts 3404 comprise structures configured to be releasably mount and secure Holder 3400 to infrastructure, such as a cart, patient table or the like. In the example illustrated, mounts 3404 are illustrated as being secured to a patient table supporting a patient, using patient table mount 3401 . Mounts 3404 may include threaded bores and bolts, fasteners, screws, clamps or the like for releasable retention and securement to the infrastructure. Mounts 3404 support base 3405.

[000258] Base 3405 supports brackets 3406, 3408 and holder 3410. In the example illustrate, base 3405 slidably supports penis holder 3410 for movement in the direction indicated by arrows 3415. In the example illustrated, base 3405 forms a track or channel receiving brackets 3406, 3408 , along with penis holder 3410 may be translated.

[000259] Brackets 3206 and 3208 are supported by base 3405 and are spaced to at least partially receive portions of handle 3032 (or other handles of other probes) to capture and retain handle 3032 between brackets 3406 and 3408. In the example illustrated, proximal bracket 3406 comprises an opening 3416 that receives the proximal end of handle 3032 while bracket 3408 comprises an opening 3418 smaller than the outer diameter of handle 3032, yet sufficiently large for the proximal portion 3160 of the EMD 3030 to pass therethrough. Opening 3416 is sufficiently large for the power and signal transmitting cables of the retained probe to pass through such openings and to be connected to the controller and display of the systems described above. Due to the shape of handle 3132, handle 3032 is axially retained and captured between brackets 3406 and 3408. In some implementations, one or both of brackets 3406, 3408 may also be slidable along base 3405 and retained at selected spacings to accommodate different probes having differently sized handles. For example, in some implementations, base 3405 and brackets 3406, 3408 may be integrally formed as part of single unitary body to form a sled that is slidable along base 3405 and that is selectively retained in one of a plurality of predefined positions or any one of a continuous range of positions along base 3405 by spring biased pins and detents, clamps or other fasteners.

[000260] Penis holder 3410 is supported by base 3405 and includes an opening 3422 through which a patient’s penis 3424 may extend (as shown in Figure 55) while the EMD 3030 is passed through the urethra of the penis 3424. In some implementations, opening 3422 may have an adjustable size to accommodate different anatomies. In some implementations, the interior of opening 3422 may be lined with a resil iently flexible liner, tube sleeve or balloon.

[000261] Figure 57 illustrates portions of an example holder 3540 secured to the leg of a patient. Holder 3500 is similar to holder 3400 described above except that holder 3500 comprises leg mounting straps 3504 in place of mounts 3404. Those remaining components of holder 3500 which correspond to components of holder 3400 are numbered similarly. Straps 3504 wrap about the leg or thigh of the patient, externally fixing base 3405 of holder 3500 in place. Straps 3504 may have bands which are secured by buckles, hook and loop fasteners, snaps, clips are the like for movement straps 3504 and holder 3500 from the leg of the patient or for adjustment of a length of straps 3504 to accommodate different sized anatomies.

[000262] Figures 58, 59 and 60 illustrate system 10 during an example radical prostatectomy. As shown by Figures 58 and 59, the example navigation probe 40 is positioned within urethra 26 and rotated about its longitudinal axis in increments less than 360 degrees in some implementations, less than 180° such that ultrasound transducer 66 faces prostatic pedicles which are to be dissected and separated from the prostate. The navigation probe 40 shown in such figures may comprise any of the individual navigation probes described above and below, including any of the navigation probes described above.

[000263] Figure 58 schematically illustrates the surgical tool 52 during an example prostatectomy. Figure 58 illustrates tool 52 being manipulated by a physician 157 who may be controlling a powered actuator 158 (a robotic laparoscopic system) connected to tool 52. In other implementations, tool 52 may be controlled and manipulated by the physician 157 in other manners.

[000264] In the example shown by Figures 58 and 59, the ultrasound transducer 66 of the navigation probe 40 is specifically oriented so as to face the rectum 126, the neurovascular bundle 150 and the prostatic pedicles 152 which extend from the neurovascular bundle 150 to distinct spaced locations along the prostate 20 where they are attached to prostate 20. The pedicles 152 comprise vasculatures and nerves extending from the neurovascular bundle 150 to the prostate 20, providing blood flow to and from the prostate 20 and nerve signals to and from the prostate 20. Each of such structures may be surrounded by associated connective tissue connecting the structures to the prostate 20. The ultrasound transducer 66 captures ultrasound images of such anatomical structures, wherein the ultrasound images are transmitted to controller 36. The probe 40 including ultrasound transducer 66 may comprise any of the above-described navigation probes including any of the example associated EMDs with the above disclosed combination of features or with other combinations of the individual features of the different probes.

[000265] Figure 60 illustrates one example of the views presented by controller 72 and including an example guiding image 74, in the form of guiding image 3800. In the example illustrated, controller 36 outputs control signals causing display 72 to overlay multiple surgical guide graphics 75 on the current ultrasound image that is based upon signals from ultrasound sensor 66. In the example illustrated, regions distant from the target region are either attenuated or modified so as not to depict speckle or ultrasound echoes. [000266] In the example illustrated, controller 3636 overlays multiple surgical guide graphics 75 in the form of sensor graphic 3866, prostate capsule surface graphic 382, tumor surface graphic 3822, rectum surface graphic 3850, neurovascular bundle (NVB) surface graphic 3848, pedicle graphics 3840, NVB caution zone 3845, inner guide rail 3842, outer guide rail 3846, recommended excision path 3844, excision tool position 3857, excision tool path history 3856, excision tool trajectory 3860 and tool path correction indicator 3858. Sensor graphic 3866 comprises a graphic generated and added by controller 3636 that indicates the current position and orientation of the ultrasound sensor 66 with respect to ultrasound data. In the illustrated example, sensor graphic 3866 is represented by a transparent outline of the transducer 66. In some implementations, sensor graphic 3866 may be omitted.

[000267] Prostate surface graphic 3822 comprises a system generated graphic that indicates the outer surface of the prostate capsule 21 or prostate 20. Controller 3636 determines the outer surface of the prostate 20 by segmenting all the voxels of the three-dimensional volumetric image based upon signals received from ultrasound transducer 66, using a machine learning network 3644, or other image processors. In some implementations, controller 3636 carries out segmentation (computer vision processing or machine learning) on less than an entirety of the ultrasound image to determine an estimate for the actual edge or outer surface of prostate 20. For example, in some implementations, controller 3636 may utilize a machine learning network 3644 that is configured to first identify a particular segmentation zone for subsequent segmentation in the larger ultrasound image. Once a segmentation zone has been identified, controller 3636 carries out the segmentation only on those voxels within the segmentation zone to determine an estimate for the actual edge of the prostate 20. By limiting segmentation to the machine learning segmentation zone, computing bandwidth is conserved.

[000268] Controller 3636 may determine or estimate the boundary of other surgical guidance graphics in a fashion or manner similar to that described above with respect to the determination of the surface of the prostate 20, using segmentation. [000269] Once controller 3636 has carried out the segmentation to determine an estimate for the actual edge of the prostate 20, controller 3636 may utilize the estimated edge to later identify coordinates of the estimated edge in a later acquired ultrasound image frame during a surgical procedure despite changes in the ultrasound image or movement of the organ. Controller 36 may determine and store the pattern of the pixels or points corresponding to the shape of the edge. This pattern is stored by controller 3636 and subsequently used by controller 3636 to track or later determine the edge of the prostate 20 without the necessity of carrying out segmentation in later image frames.

[000270] Upon determining the target region, the surface or boundary of prostate 20, controller 3636 generates a graphic 3821 in the form of a line or outline of the surface of the prostate 3820. In the example illustrated, controller 3636 further fills in the outline with a color and opacity chosen so as to render the entire graphic representation of the prostate 20 and its outer surface more discernible or visible on the guiding image 3800. In the illustrated example, the line or outline and the filled in interior of the outline are overlaid onto the underlying ultrasound image, covering underlying portions of the ultrasound image. In some implementations, the interior of the outline may alternatively be transparent to facilitate viewing of portions of the ultrasound image within the interior. As indicated above, in some implementations, the guiding image 3800 may omit any underlying ultrasound image, being composed solely of system generated graphics that represent the target region, the prostate 3820 and its boundary 3821 , as well as other guiding graphics.

[000271] Tumor surface graphic 3822 comprises a system generated graphic that indicates the outer surface of the tumor 22. Based upon this determination, controller 3636 generates a line corresponding to the surface of the tumor 22. In some implementations, the interior of the line may be opaque or provided with a color to better demarcate the tumor graphic 3822. As the entire prostate is removed during a radical prostatectomy, in some implementations, the tumor surface graphic 3822 and the determination of the boundary of tumor 20 may be omitted.

[000272] Rectum surface graphic 3850 comprise a system or controller generated graphic indicating the boundary or surface of the rectum, especially those portions of the rectum surface proximate to the neurovascular bundle or the pedicles extending to the prostate. Rectum surface graphic 3850 may be generated based upon a determined surface of the rectum 126 by controller 3636 using signals from sensor 66. In some implementations, rectum surface graphic 3850 may be omitted. [000273] Neurovascular bundle (NVB) surface graphic 3848 comprise a system or controller generated graphic indicating an estimated boundary of the neurovascular bundle, especially those boundaries most proximate to prostate 20. In some implementations, controller 3636 may determine or estimate the boundary of the neurovascular bundle 150 using doppler to detect blood flow through the vasculatures of the neurovascular bundle 150 and/or to detect blood flow through the vasculatures of the pedicles 152 branch out or extend from the neurovascular bundle 150 towards the prostate 20. In some implementations, controller 3636 may utilize doppler to detect blood flow through the vasculatures of the neurovascular bundle 150 and/or to detect blood flow through the vasculatures of the pedicles 152 to identify the general vicinity of the neurovascular bundle 150 and/or pedicles 152, the determined general vicinity (such as a predefined region or distance outward from the determined vasculatures) may then being used by controller 3636 to establish a zone in which controller 3636 carries out segmentation to estimate the surface of the neurovascular bundle 150 and to generate the neurovascular bundle graphic 3848. In some implementations, such as where a recommended cutting path or inner/outer boundaries are provided, the neurovascular bundle graphic 3848 may be omitted.

[000274] Pedicle graphics 3840 comprise system or controller generated graphics depicting estimated boundaries of pedicles 152. Pedicle graphic 3840 may be determined by controller 3636 in a manner similar to the determination of the estimated boundaries for the neurovascular bundle 150 as described above. In some implementations, the determination of the boundaries of pedicles 152 and/or the generation of pedicle graphic 3840 may be omitted.

[000275] Caution zones, such as the NVB caution zone graphic 3845, comprise a system generated graphic identifying a boundary about critical structures that are to be avoided and not intersected by the tool path. In some implementations, the NVB caution zone graphic 3845 is generated at a location so as to extend around or encompass junctions of the determined pedicles 152 and the determined or estimated surface of the neurovascular bundle 150. In some implementations, the NVB caution zone 3845 is generated and displayed at a location so as to extend around the NVB graphic 3848, without any underlying echo or ultrasound image. In yet other implementations, the NVB caution zone graphic 3845 may be presented without the NVB graphic 3848. In such circumstances, the physician is notified as to general regions (regions within the caution zone) to avoid without an added graphic indicating the specific path of the nerve. In still other implementations, the NVB caution zone graphic 3845 may be presented without an underlying ultrasound image. In some implementations, NVB caution zone 3845 may be omitted. In some implementations, both NVB graphic 3848 and NVB caution zone 3845 may be omitted.

[000276] Inner guard rail 3842 comprises a system generated graphic that indicates a recommended boundary which is not to be crossed by a cutting tool so as to increase the likelihood that no portion of the prostate 20 and the tumor 22 will remain following the surgical procedure. The location and shape of inner guide rail 3842 may be dependent upon the shape and location of the determined boundary of prostate 20. The distance between the inner guide rail 3842 and the estimated boundary of prostate 20 (or the prostate boundary graphic 3822) may be based upon a degree of confidence of system 10 in the accuracy of the estimate for the boundary of prostate 20. The less precise or less accurate the estimate for the boundary of prostate 20 is, the greater the distance between the inner guard rail 3842 and the estimated boundary of prostate 20 (or the graphic 3822).

[000277] In the example illustrated, the inner guard rail 3842 comprises a generated surface or line having a shape that follows or matches the estimated outer shape of the tumor surface. In some embodiments, the inner guard rail 3842 may have peaks and valleys corresponding to the peaks and valleys of graphic 3822. In other implementations, the generated line or shape serving as inner boundary 3842 may be smoothened, omitting any peaks and valleys or including peaks and valleys of a lower amplitude. In some embodiment, the region between graphic 3822 and graphic 3844 is filled with a color different than that of graphic 3822 identifying the prostate 20. The color may be chosen so as to be more visually discernible in the guiding image 74 and to indicate or provide a warning that this region is not to be intercepted by the path of the cutting tool. In other implementations, the regions between graphic 3822 and graphic 3844 may be void of any augmented color or may have transparency to permit viewing of the underlying ultrasound image echoes. [000278] Outer guide rail 3846 extends about inner guard rail 3842. Outer guide rail 3846 comprises a system generated graphic that indicates an outer boundary for the path of the cutting tool. One of the purposes of outer guide rai 13846 is to recommend a certain degree of proximity of the cutting tool path relative to the estimated position of the prostate 20 so as to preserve healthy tissue. Outer guide rail 3846 further provides a recommended boundary which is not to be crossed by a cutting tool so as to increase the likelihood that no portion of the neurovascular bundle 150 or the rectum 126 will be intersected by the cutting tool path. The location and shape of outer guide rail 3846 may be dependent upon the shape and location of the determined boundary of neurovascular bundle 150 and rectum 126. The distance between the outer guide rail 3846 and the estimated boundary of neurovascular bundle 150 (or the NVB surface graphic 3848) may be based upon a degree of confidence of system 10 in the accuracy of the estimate for the boundary of NVB 150. The less precise or less accurate the estimate for the boundary of NVB 150 is, the greater the distance between the outer guide rail 3846 and the estimated boundary of NVB 150 (or the graphic 3848). In the example illustrated, the region between the inner guide rail 3842 and outer guard rail 3846 is transparent to permit viewing of the echoes of the underlying ultrasound image (when provided). In some implementations, outer guard rail 3846 may be omitted.

[000279] Recommended excision path 3844 comprises a graphic that indicates a recommended path for the excision tool. A surgeon or physician 157 may be advised to attempt to control or move the surgical tool to trace the recommended excision path. In circumstances where guiding image 74 includes the inner guide rail 3842, the recommended excision path 3844 may closely follow the inner guide rail. In circumstances where the guiding image 74 includes the outer guard rail 3846, the recommended excision path may lie within the outer guide rail 3846. In some implementations, the recommended excision path 3844 may lie between the inner guide rail and the outer guide rail. In some implementations, the recommended excision path 3844 may provide a more feasible or practical path for the excision while maintaining acceptable removal of the prostate 20. In the example illustrated, the recommended excision path 3844 is smoother and more continuous, potentially offering more attainable objective for control of the excision tool. In some implementations, the recommended excision path 3844 may be omitted.

[000280] In some implementations, controller 3636 may further differentiate those portions of the path that have already been completed from those portions of the recommended path yet to be traced. In the example illustrated, those portions of a recommended path 3844 for which the tool has already passed are indicated with a first style 3856 while those portions of the recommended excision path that have yet to be passed or for which the opportunity for tracing still exists are depicted by the style 3844. In such a fashion, the user or the system may ascertain how much of the recommended path remains.

[000281] The excision tool position 3857 comprises a graphic indicating the current position of the excision tool. In some implementations, the graphic represents or symbolizes the tool itself. In some implementations the graphic represents or symbolizes a cutting tip of the tool. The position of the graphic indicating current excision tool position 3857 may change from frame to frame as the tool is being moved during a surgical procedure.

[000282] In some implementations, controller 3636 may determine the current position of the excision tool based upon the ultrasound data or ultrasound image. For example, during excision, gaps or separations of tissue created by the excision tool may result in brighter echoes. Machine learning can be utilized to identify such brighter echoes and associate them with the current position of the excision tool. The position of the brighter echoes, corresponding to the current position of the excision tool, may be correlated to the particular coordinates or locations in the guiding image 74. In other implementations, the position of the cutting or excision tool can be identified as the temporal difference from a previous frame, where the ultrasound signal has changed as a function of the cutting action. In some implementations, the excision tool position 3857 may be omitted.

[000283] The excision tool path history 3856 comprises a graphic indicating the completed or historical path of the excision tool. As described above, controller 3636 may track the movement of the excision tool based upon ultrasound data or echoes. The historical positions of the excision tool may be stored and then utilized by controller 3636 to generate a graphic indicating the historical path. In some implementations, the temporal nature of the historical path may be visibly indicated. For example, in some implementations, older portions of the historical tool path may be differently presented. Older portions of the historical tool path may fade or become less bright as time passes and/or as the distance between the historical portions of the path and current tool position grows. In some implementations, the excision tool path history 3856 may be omitted.

[000284] The excision tool trajectory 3860 comprises a graphic generated by controller 36 displayed on guiding image 74, wherein the graphic provides an estimation of the future trajectory of the excision tool given the most recent path being taken by the excision tool. For example, controller 3636 may utilize historical positions with excision tool over a predefined period of time prior to the excision tool reaching its current position using this information, controller 3636 may determine a future predicted vector for the excision tool unless the excision tool is redirected. In some implementations, the excision tool trajectory 3860 may be omitted.

[000285] Tool path correction indicator 3858 comprises a visual or audible indication that indicates or suggests, to a user, healthcare provider, physician or the like, movement of the surgical tool, such as a cutting tool, so as to put the tool back on track on the recommended path or trajectory for the cutting tool. Controller 3636 generates the tool path correction indicator 3858 based upon the current position of the tool and the previously determined recommended cutting path or tool path. In some implementations, controller 3636 generates tool path correction indicator 3858 additionally based upon the current or most recent historical speed or rate at which the cutting tool is being moved. The correction indicator 3858 may also be directed to take into account any critical structure, or its caution zone, to return to the recommended cutting path. In the example illustrated, the tool path correction indicator 3858 comprises a visual indicator in the form of an arrow generated and depicted on the display by controller 3636.

[000286] In some implementations, other visible indicators may serve as indicator 3858. In some implementations, indicator 3858 may be in the form of an audible indicator. For example, controller 3636 may cause an auditory device to emit a sound, wherein the sound changes to indicate a recommended change in direction of the tool or changes based on the proximity of the tool to the recommended tool path. In some implementations, indicator 3858 may be implemented in conjunction with excision tool position 3857. For example, the color, design, brightness or the like of the graphic representing the current excision tool position 3857 may change to indicate a recommended change in direction of the tool or may change based on the proximity of the tool to the recommended tool path. In some implementations, indicator 3858 may be in the form of both a visual indication and an audible indication. In some implementations, tool path correction indicator 3858 may be omitted.

[000287] In some implementations, controller 3636 may be configured to enter a zoom mode based upon an estimated distance between the current tool position and the recommended tool path and/or the current estimated distance or spacing between the current tool position and either or both of the prostate 20 and a critical structure such as the NVB 150 or the rectum 126. For example, as a current position of the tool approaches or sufficiently close (less than a predefined distance threshold) to a critical structure, controller 3636 may automatically adjust the guiding image or may automatically overlay an additional smaller window or depiction so as to zoom in on the current position of the tool. In such implementations, the person controlling the path of the tool may be given a more precise visual for guidance between narrow gaps between a critical structure, it's caution zone when presented) and the organ, target region (tumor) or recommended tool path. In some implementations, controller 3636 may automatically output a notice to the operator or user and/or may automatically pause or suggest pausing of the procedure to allow controller 3636 to adjust the various display graphics, to adjust the calculations and/or to allow the operator to appreciate the circumstances and any controller output recommendations.

[000288] The ultrasound data acquired by sensor 66 may be three-dimensional or volumetric. As a result, the ultrasound image generated or corresponding to the ultrasound data is also three-dimensional in nature, permitting the ultrasound image to be reoriented or rotated for different viewpoints or perspectives. In the example illustrated, it should be appreciated that each of the above surgical guide graphics are three-dimensional in nature, generated or provided with three-dimensional coordinates. As result, the guiding image 74 may be rotated to provide the viewer/user with different viewpoints or perspectives. In implementations where the guiding image 74 comprises the one or more graphics overlaid upon an underlying ultrasound image, both the ultrasound image and the overlying graphics may be rotated in three dimensions. In implementations where the guiding image 74 omits any underlying ultrasound image, the surgical guide graphics may still be rotated in three dimensions.

[000289] In some implementations, controller 36 may automatically rotate guiding image 72 in three dimensions to provide the viewer with an enhanced view of the current position of the excision tool relative to the portion of the ultrasound image bonding to the prostate 20 and/or the guide graphics representing the surface of the prostate 3821. For example, in some implementations, controller 3636 may automatically rotate guiding image 72 as the excision tool moves about or long the surface of prostate 20 to maintain the same initial perspective or viewing angle initially chosen by the user. In some implementations, the viewing angle of guiding image 72 is moved in unison with the movement of the excision tool about the tumor. In some implementations, controller 3636 may automatically rotate guiding image 72 to maintain a normal viewing angle (90°) of the prostate surface (prostate surface graphic) and the excision tool position (tool position graphic) from a side of the prostate.

[000290] In some implementations, the user may control the viewing of guiding image. In some implementations, the guide image may be user adjusted using any one of several available user interfaces. The graphical user interfaces may be selected by manual touch (such as with a touchscreen display) or by a mouse or stylus. Once a user input interface has been touched or clicked upon, the finger or mouse/stylus pointer may be tapped or dragged to alter the characteristics of guiding image.

[000291] One example input interface facilitates panning of the guide image. A user may select an icon and then drag his or finger or the pointer to the left, right, up or down to move or center particular portions of guide image on the display. Another example input facilitates inward and outward zooming of the entirety of the current guiding image. Another example input interface facilitates zooming/magnification of a particular portion of guiding image. For example, a user may select the interface and then drag his or finger or a pointer from a first point to a second point to define a rectangle on guiding image, wherein the controller adjusts the guiding image to display what is contained in the rectangle, at a larger scale across display. In this way, a user may select or create a particular window about a particular portion of guiding image for enlargement or magnification.

[000292] Another example input interface facilitates rotation of guiding image, rotation of the various guiding graphics and, when provided, corresponding rotation of the underlying ultrasound image. Such rotation may be made with respect to any arbitrary axes. For example, a user may touch or click upon the interface and then drag the mouse, stylus or his or her fingers in a particular direction across the screen to rotate the guiding image in the corresponding direction. Because the guiding graphics generated or stored with three-dimensional attributes, such rotation may be more readily performed in real-time.

[000293] Another example user input facilitates automatic rotation of guiding image so as to be normal to the surface of the organ from the perspective of the endoscope (from a perspective looking at the backside of the excision tool with the excision tool being positioned between the organ and the image viewpoint). In use, a user may click or touch the interface or select and touch the interface, wherein the controller automatically rotates image. In some implementations, the controller may operate in a mode wherein selection of the user interface causes the controller to automatically rotate guiding image to match the viewing perspective of endoscope. [000294] Another example user input interface facilitates automatic rotation of the guiding image so as to be orthogonal to the surface of the organ from the perspective of the endoscope (from a perspective looking at side of the target region). In use, a user may click or touch the interface or select and touch the interface, wherein the controller automatically rotates the guiding image. In some implementations, the controller may operate in a mode wherein selection of user interface causes the controller to automatically rotate the guiding image to be orthogonal (rotated 90 degrees) to the viewing perspective of the endoscope (when employed).

[000295] Another example user input interface facilitates display of a sectional view of the prostate. In response to a user touching, clicking or otherwise selecting the interface, the controller outputs control signals causing a sectional view of the prostate to be generated based upon the ultrasound data. In some implementations, the outer boundary of the prostate may be represented by a guide graphic. In some implementations, the interior within the boundary may be transparent. In other implementations, the interior within the boundary may be opaque or provided with section lines.

[000296] Another example user input interface facilitates selected attenuation of the ultrasound echoes in the underlying ultrasound image. As indicated above, in some implementations, regions of the underlying ultrasound image distant from the determined location of prostate (distant from the prostate surface guide graphic) be automatically attenuated to such a degree that they are not visible or barely visible. The user interface provides a user with the ability to adjust the brightness of those remaining echoes in the ultrasound image that are illustrated or that are proximate to the tumor. A user may select the interface and drag his or finger or a mouse/stylus pointer to increase or decrease the brightness of the echoes of the underlying ultrasound image.

[000297] Another example user input interface facilitates toggling with respect to what guide graphics are depicted in the guiding image. In other implementations, the interface may include a list of each and every guide graphic, or other guide graphics from which a user may select part of guiding image or removal from guiding image. In some implementations, there may be options where groups of guide graphics are presented.

[000298] In the example illustrated, the controller further outputs control signals causing the display to present a focus window. The focus window comprises an enlarged view of a portion of the guiding image. In the example illustrated, the focus window is overlaid on top of the guiding image. In other implementations, the focus window may be placed to a side, above or below the guiding image. In one example implementation, the focus window is automatically adjusted by the controller so as to center on a region about the current position of the excision tool. As result, the user is automatically provided with an enlarger close of view of the current position of the excision tool. The magnification offered by the focus window may be set as a default percentage.

[000299] In some implementations, the system may operate in a mode in which the user may control the parameters of the focus window. For example, using interface 3880-3, a user may select what region of guiding image 72 is presented by controller 3636 in the focus window 3862. Using interface 3880-1 , a user may move or slide a transparent window 3852 across guiding image 72 to select or define what is shown in focus window 3862. This selection window may be enlarged or shrunk using interface 3880-2 (or by “pulling” on a corner of the window 3852 to adjust the degree of magnification presented within the focus window 3862. In some implementations, focus window 3862 may be omitted or may be toggled off by the user.

[000300] As further shown by Figure 60, controller 3636 is also configured to provide the user with criteria or feedback during the surgical procedure. In the example illustrated, controller 3636 provides information to the user in the form of confidence level indicator 3872, tool speed 3876, target distance 3870, and progress indicator 3874. Confidence level indicator 3872 visually indicate to a user a confidence level or degree of certainty, as determined by controller 3636, for the estimation or calculation being presented. Confidence level indicator 3872 may indicate the degree of confidence or certainty with respect to a particular estimate for estimates such as the current estimated position of the excision tool as indicated by graphic 3857, the current estimated surface of the target region, such as a surface of the tumor, the current estimated recommended excision path, the current estimated excision tool trajectory, the current estimated inner and size or outer boundaries or guide rails, the current estimated surface of the organ, the current estimated location of a critical structure, the current estimated caution zone for a critical structure such as those about the prostate 20 and/or the NVB 150 or other critical structure and the like. In indication how much reliance should be made are different should be given to the information being presented.

[000301] Confidence level indicator 3872 is in the form of a window providing a numerical indicator. The numerical indicator may be in the form of a percent, such as where hundred percent is 100% confidence level or a scaled a number, such as a number between zero and 10 where 10 is the highest degree of confidence. In some implementations, a color may be used to indicate a degree of confidence. For example, a green color may indicate a level of confidence above a predefined threshold, a yellow color may indicate an intermediate level of confidence that is not satisfy the first threshold, but satisfies a second lower confidence threshold, and a red color may indicate a low level of confidence that fail to satisfy the second lower confidence threshold. In some implementations, confidence levels may be presented for each of the above noted different estimates. Such confidence levels may be concurrently presented on display 250 or the user may be given the option to switch or toggle between different confidence levels for different estimates.

[000302] Confidence level indicator 3872 communicates the degree or level of confidence for an estimate using the visual appearance of the particular guide graphic itself corresponding to estimate for which the level of confidence is being provided. In other words, a particular guide graphic may have a different appearance based upon the current level of confidence for the estimate represented by the particular guide graphic. For example, guide graphic 3857 indicating the current estimate for the position of the excision tool, may change between different colors, brightness levels, flashing frequencies, shapes, sizes, line thickness, line style (dashed or solid) or the like depending upon the level of confidence. Each of the other guide graphics may likewise change in appearance (color, brightness, flashing frequency, shape, size, line thickness, line style) depending upon the level of confidence or degree of confidence currently associated with the estimate being indicated by the guide graphic. In some implementations, a user may select how the appearance is to change to indicate the current degree of confidence. In some implementations, the confidence level indicator 3872 may be omitted.

[000303] Tool speed 3876 indicates the current speed at which the excision tool is being moved, either instantly or over a predefined prior period of time. As noted above, controller 3636 may determine the current position of the excision tool based upon the ultrasound data. Using this information, controller 3636 may calculate and present the rate at which the excision tool is being moved.

[000304] Target distance 3870 indicates the distance between the current position of the excision tool and at least one of the guide graphics that are based upon the determined boundary of the prostate. In the example illustrated, target distance 3870 indicates a distance between the current position of the excision tool and the closest boundary or surface of the prostate 21 , as represented by guide graphic 3821 . In the example illustrated, controller 3636 further presents an additional guide graphic in the form of a distance marker 3854 extending from the estimated current position of the excision tool and the boundary of prostate 20 as represented by guide graphic 3821. In some implementations, this distance marker may be omitted.

[000305] In some implementations, controller 3636 is configured to evaluate or compare the current distance between the current position of the excision tool and the boundary of the prostate 20 and alert the user when the current position of the excision tool is too close to the boundary of the prostate 20 (as represented by guide graphic 3821 ) or the inner guard rail 3840. For example, target distance 3870 may change color, such as red, to indicate a warning or may flash or increase in brightness to alert the user. In some implementations, target distance 3870 may specifically note that the excision tool is too close or has breached the inner guard rail (“guard rail invaded”), in addition to the indicated distance. In some implementations, controller 3636 is configured to evaluate or compare the current distance between the current position of the excision tool and the boundary of the NVB 150 and alert the user when the current position of the excision tool is too close to the boundary of the NVB 150 (as represented by guide graphic 3848) or the outer guard rail 3846. For example, target distance 3870 may change color, such as red, to indicate a warning or may flash or increase in brightness to alert the user. In some implementations, target distance 3870 may specifically note that the excision tool is too close or has breached the inner guard rail (“guard rail invaded”), in addition to the indicated distance. In some implementations, the target distance 3870 may automatically are periodically toggle between indicating the distance (1 ) from the current position of the excision tool to the surface of prostate 3821 or the inner guide rail 3844 and (2) from the current position of the excision tool to the surface of the NVB 3848 of the outer guide rail 3846. In such implementations, the two different measurements may be represented by different colors, fonts or the like such that the viewer can merely tell what distance is being indicated. In some implementations, the user may select which of the two distances are presented by target distance 3870.

[000306] In other implementations or in other user selected modes for system 10, target distance 3870 may indicate the distance between the current position of the excision tool and the recommended excision path as indicated by graphic 3844, the inner guide rail 3842, the outer guard rail 3846, a critical feature, such as represented by guide graphics 3848 and 3850 or the caution zones, such as indicated by graphics 3845.

[000307] Progress indicator 3874 provides an indication of progress towards excision or resection of the prostate or the prostate tumor. Controller 3636 may determine the peripheral size of the prostate to be excised or the length or area of the recommended cutting path. Based upon where the cutting tool 3857 currently resides, controller 3636 may then determine a degree or level of progress towards completion of the excision procedure. In some implementations, a user may select or how the progress is indicated. In a first user selected mode, the progress indicator 3874 may indicate how much of the excision task has been completed. In a second user selected mode, the progress indicator 3874 may alternatively indicate how much of the excision task remains to be performed. The progress may be indicated by presenting a percentage, a pie graph or other visual progress indicating presentations. In some implementations, progress indicator 3874 may be omitted.

[000308] In the illustrated example, guiding image 74 is three-dimensional such that guiding image 74 may be viewed by a physician 157 or other user using a stereoscopic display, or 3D glasses or goggles, to provide the user with a depth perception of the guide graphic 75 representing the prostate or other target region. In other implementations, controller 36 may output control signals causing display 72 to present a guiding image 74 which comprises an isometric view and three different orthogonal two-dimensional views taken along three orthogonal planes of the target region on 3 orthogonal axes.

[000309] In some implementations, the user may control the viewing of guiding image 72. In the example illustrated in Figure 60, system 3600 comprises multiple user input interfaces 3880-1 3880-2 3880-3, 3880-4, 3880-5, 3880-6, 3880-7, 3880-8 and 3880-9 (collectively referred to as interfaces 3880). In the example illustrated, the user input interfaces 3880 are in the form of graphical user interfaces 3880 presented on display 72. The graphical user interfaces 3880 may be selected by manual touch (such as when guiding image 74 is presented on a touchscreen display 72 or by a mouse or stylus. Once a user input interface 3880 has been touched or clicked upon, the finger or mouse/stylus pointer may be tapped or dragged to alter the characteristics of guiding image 74.

[000310] Input interface 3880-1 facilitates panning of image 74. A user may select icon 3880-1 and then drag his or finger or the pointer to the left, right, up or down to move or center particular portions of image 74 on the display 72. Input interface 3880-2 facilitates inward and outward zooming of the entirety of the current guiding image 750. Input interface 3880-3 facilitates zooming/magnification of a particular portion of guiding image 72. For example, a user may select interface 3880-3 and then drag his or finger or a pointer from a first point to a second point to define a rectangle on guiding image 750, controller 3636 adjusts guiding image 74 to display what is contained in the rectangle, at a larger scale across display 72. In this way, a user may select or create a particular window about a particular portion of guiding image 74 for enlargement or magnification. [000311] Input interface 3880-4 facilitates rotation of guiding image 74, rotation of the various guiding graphics and, when provided, corresponding rotation of the underlying ultrasound image. Such rotation may be made with respect to any arbitrary axes. For example, a user may touch or click upon interface 3880-4 and then drag the mouse, stylus or his or her fingers in a particular direction across screen 72 to rotate the guiding image 74 in the corresponding direction. Because the guiding graphics generated or stored with three-dimensional attributes, such rotation may be more readily performed in real-time.

[000312] User input interface 3880-5 facilitates automatic rotation of guiding image 74 so as to be normal to the surface of the organ from the perspective of the endoscope (from a perspective looking at the backside of excision tool with the excision tool being positioned between the organ 24 and the image viewpoint). In use, a user may click or touch interface 3880-5 or select and touch interface 3880-5, wherein controller 3636 automatically rotates image 74. In some implementations, controller 3636 may operate in a mode wherein selection of user interface 3880-5 causes controller 3636 to automatically rotate guiding image 74 to match the viewing perspective of endoscope 56.

[000313] User input interface 3880-6 facilitates automatic rotation of guiding image 74 so as to be orthogonal to the surface of the organ from the perspective of the endoscope (from a perspective looking at side of the target region). In use, a user may click or touch interface 3880-6 or select and touch interface 3880-6, wherein controller 3636 automatically rotates image 74. In some implementations, controller 3636 may operate in a mode wherein selection of user interface 3880-6 causes controller 3636 to automatically rotate guiding image 74 to be orthogonal (rotated 90 degrees) to the viewing perspective of endoscope 56.

[000314] User interface 3880-7 facilitates display of a sectional view of the prostate 624. In response to a user touching, clicking or otherwise selecting interface 3880-7, controller outputs control signals causing a sectional view of the prostate 3820 to be generated based upon the ultrasound data. In some implementations, the outer boundary of the prostate 20 may be represented by guide graphic 3821 . In some implementations, the interior within the boundary may be transparent. In other implementations, the interior within the boundary may be opaque or provided with section lines.

[000315] User interface 3880-8 facilitates selected attenuation of the ultrasound echoes in the underlying ultrasound image 74. As indicated above, in some implementations, regions of the underlying ultrasound image distant from the determined location of prostate 20 (distant from guide graphic be automatically attenuated to such a degree that they are not visible or barely visible. User interface 3880-8 provides a user with the ability to adjust the brightness of those remaining echoes in the ultrasound image that are illustrated or that are proximate to the tumor. A user may select user interface 3880-8 and drag his or finger or a mouse/stylus pointer to increase or decrease the brightness of the echoes of the underlying ultrasound image.

[000316] User interface 3880-9 facilitates toggling with respect to what guide graphics are depicted in guiding image 74. In the example illustrated, the “all” has been selected which results in each of the above-mentioned guide graphics being presented. Alternatively, the user may guide graphics not being presented. In the example illustrated, the user is provided with the option of particular critical features guide graphics, such as a prostate surface graphic 3821 (CF A) and/or rectum graphic 3850 (CF B). As should be appreciated, in other implementations, interface 3880-9 may include a list of each and every guide graphic, or other guide graphics from which a user may select part of guiding image 74 or removal from guiding image 74. In some implementations, there may be options where groups of guide graphics are presented.

Definitions

[000317] Although the claims of the present disclosure are generally directed to a surgical navigation system, the present disclosure is additionally directed to the features set forth in the following definitions.

1 . A surgical navigation system comprising: an EMD dimensioned to pass through a urethra and comprising a distal atraumatic tip; and an ultrasound transducer supported and carried by the EMD so as to acoustically couple with regions along and about the urethra to output ultrasound data for regions along and about of the urethra.

2. The system of definition 1 , wherein the EMD and the ultrasound transducer are configured for rotation within the urethra.

3. The system of definition 1 , wherein the EMD is flexible.

4. The system of definition 1 , wherein the elongated medical has a consistent diameter.

5. The system of definition 1 , where the distal atraumatic tip is removable coupled to a remainder of the EMD.

6. The system of definition 1 , where the distal atraumatic tip has a length greater than 5 mm.

7. The system of definition 1 , wherein the distal atraumatic tip has a color distinct from the elongate medical device.

8. The system of definition 1 , wherein the distal atraumatic tip comprises axially spaced gradations.

9. The system of any definitions 1 , wherein the system has a field of view indicator

10. The system of definition 9, wherein the field of view indicator is selected from a group of field of view indicators consisting of: transducer plane, transducer aperture, and angle.

11 . The system of definition 1 , wherein the atraumatic tip comprises a gripping feature for surgical tools.

12. The system of definition 1 further comprising an ultrasound transducer pressing device supporting carried by the EMD to selectively apply a force to the ultrasound transducer to press the ultrasound transducer against an internal surface of the urethra.

13. The system of definition 12, wherein the ultrasound transducer pressing device is inflatable.

14. The system of definition 1 , wherein the EMD further comprises an integral lumen passing through the EMD. 15. The system of definition 14, wherein the integral lumen axially passes along and across to a distal side of the ultrasound transducer.

16. The system of definition 14, wherein the integral lumen terminates on a proximal side of the ultrasound transducer.

17. The system of definition 1 , wherein the EMD omits an integral lumen.

18. The system of definition 1 , wherein the ultrasound transducer has a f ield-of- view that is at least 30 mm wide, at least 20 mm deep and at least 20 mm long.

19. The system of definition 1 , wherein the ultrasound transducer has a f ield-of- view that is less than 60 mm deep.

20. The system of definition 1 , wherein the ultrasound transducer has a resolution of less than 2 mm.

21 . The system of definition 1 , the ultrasound transducer has a resolution of at least 6 MHz and less than or equal to 12 MHz.

22. The system of definition 1 , wherein the EMD has a diameter less than or equal to 10 mm.

23. The system of definition 1 , wherein the EMD comprises a flexible proximal portion and an inflexible portion along which the ultrasound transducer is supported, the inflexible portion extending between the distal atraumatic distal tip and the flexible proximal portion.

24. The system of definition 1 further comprising: a display; and a controller configured to output control signals causing the display to present a visible image of the regions along and about the urethra based upon the ultrasound data.

25. The system of definition 24, wherein the controller is configured to determine positioning of a tool based upon the ultrasound data and wherein the controller is further configured to output control signals causing the display to present guidance to a physician for manipulating the tool based upon the ultrasound data.

26. The system of definition 1 further comprising a controller configured to determine a path for a surgical tool based upon the ultrasound data. 27. The system of definition 1 further comprising a controller to identify a critical structure proximate a prostate based upon the ultrasound data.

28. The system of definition 27, wherein the critical structure comprises one of more critical structures consisting of: neurovascular bundle, prostate pedicle, prostate capsule, prostate apex, prostate base, bladder neck, rectum, dorsal vein complex, and tumor.

29. The system of any definitions 27 and 28, further comprising a display, wherein the controller is configured to output control signals causing the display a surgical guide graphic representing the critical structure.

30. The system of any of definitions 27 and 28 further comprising a display, wherein the controller is configured to output control signals causing the display to present a caution zone about the critical structure.

31 . The system of any of definitions 27 and 28 further comprising a display, wherein the controller is configured to output control signals causing the display to present a cutting tool path based upon a position of the critical structure.

32. The system of definition 28 further comprising a display, wherein the controller is configured to determine a prostate surface and output control signals causing the display to present an inner guide rail based upon the prostate surface.

33. The system of definition 28, wherein the controller is configured to determine cause the display to present an outer guide rail based upon at least one of a rectum and neurovascular bundle.

34. The system of definition 1 further comprising a controller configured to determine positioning of a surgical tool with respect to the prostate based upon the ultrasound data and further configured to output control signals resulting in repositioning of the elongate medical device and repositioning of the ultrasound transducer based upon the determined positioning of the surgical tool.

35. The system of definition 34, wherein the control signals are configured to cause a display to present a recommendation to a physician to reposition the EMD and the ultrasound transducer based upon the determined positioning of the surgical tool. 36. The system of any definitions 27 and 28 further comprising a trained machine learning network trained to identify the critical structure based upon the ultrasound data.

37. The system of any definitions 27 and 28 wherein the controller identifies the critical structures based upon doppler ultrasound data.

38. The system of any definitions 37, wherein the controller identifies the critical structures based upon bi-directional blood flow using doppler ultrasound data.

39. The system of definition 1 , wherein the elongate medical device comprises at least one anchor on a proximal side of the ultrasound transducer to engage an interior of the urethra to resist rotation and translation within the urethra

40. The system of definition 39, wherein the at least one anchor comprises an anchor portion of the elongate medical device on a proximal side of the ultrasound transducer is selectively expandable from a first outer diameter to a second outer diameter greater than the first outer diameter, the system further comprising an actuator to selectively expand the anchor portion of the elongate medical device.

41 . The system of definition 39, wherein the actuator is configured to inflate the anchor portion to the second outer diameter and deflate the anchor portion to the first outer diameter.

42. The system of definition 39, wherein the anchor portion comprises spaced protuberances projecting along an outer surface of the elongate medical device, each of the protuberances being selectively expandable from the first outer diameter to the second outer diameter.

43. The system of definition 1 further comprising a handle coupled to the elongate medical device, wherein rotation of the handle rotates the ultrasound transducer.

44. The system of definition 1 further comprising a handle, wherein the ultrasound transducer is rotatable relative to the handle.

45. The system of definition 44, wherein the ultrasound transducer is rotatable relative to the handle about a revolute joint in the handle.

46. The system of definition 44, wherein the ultrasound transducer is rotatable about a revolute joint between the handle and the ultrasound transducer. 47. The system of definition 44, wherein the ultrasound transducer is rotatable about a revolute joint located so as to reside within the urethra when the ultrasound transducer is residing within a prostate.

48. The system of any of definitions 44-47 further comprising a member rotatably coupled to the handle and operably coupled to the ultrasound transducer, wherein actuation of the member rotates the ultrasound transducer relative to the handle.

49. The system of any of definitions 43-48, wherein the ultrasound transducer is extendable and retractable relative to and from the handle.

50. The system of any of definitions 44-47 further comprising an extension interface rotatably coupled to the handle and operably coupled to the ultrasound transducer, wherein actuation of the extension interface extends and retracts the ultrasound transducer relative to the handle.

51 . The system of definition 1 further comprising a handle coupled to the elongate medical device, wherein the ultrasound transducer is extendable and retractable relative to and from the handle.

52. The system of definition 51 further comprising an extension interface rotatably coupled to the handle and operably coupled to the ultrasound transducer, wherein rotation of the extension interface extends and retracts the ultrasound transducer relative to the handle.

53. The system of definition 1 further comprising a holder coupled to the elongate medical device to secure the elongate medical device to a stationary body external to the urethra to resist rotation and translation of the elongate medical device.

54. The system of definition 53, wherein the holder is configured to secure the elongate medical device to an anatomical leg of a person while the elongate medical device is extending in the urethra of the person.

55. The system of definition 53, the holder is configured to secure the elongate medical device to a penis through which urethra extends.

56. The system of definition 53, wherein the holder is configured to secure the elongate medical device to a drape worn by a person while the elongate medical device is extending in the urethra of the person. 57. The system of definition 53, wherein the holder is configured to secure the elongate medical device to a robotic mechanism.

58. The system of definition 53, wherein the holder is configured to secure the elongate medical device to a patient table.

[000318] Although the present disclosure has been described with reference to example implementations, workers skilled in the art will recognize that changes may be made in form and detail without departing from the scope of the claimed subject matter. For example, although different example implementations may have been described as including features providing benefits, it is contemplated that the described features may be interchanged with one another or alternatively be combined with one another in the described example implementations or in other alternative implementations. Because the technology of the present disclosure is relatively complex, not all changes in the technology are foreseeable. The present disclosure described with reference to the example implementations and set forth in the following claims is manifestly intended to be as broad as possible. For example, unless specifically otherwise noted, the claims reciting a single particular element also encompass a plurality of such particular elements. The terms “first”, “second”, “third” and so on in the claims merely distinguish different elements and, unless otherwise stated, are not to be specifically associated with a particular order or particular numbering of elements in the disclosure.

Claims

WHAT IS CLAIMED IS:

1 . A surgical navigation system comprising: an elongated medical device (EMD) dimensioned to pass through a urethra and comprising a distal atraumatic tip; and an ultrasound transducer supported and carried by the EMD so as to acoustically couple with regions along and about the urethra to output ultrasound data for regions along and about of the urethra.

2. The system of claim 1 , where the distal atraumatic tip is removable coupled to a remainder of the EMD.

3. The system of claim 1 , wherein the distal atraumatic tip comprises axially spaced gradations.

4. The system of claim 1 , wherein the system has a field of view indicator.

5. The system of claim 1 , wherein the atraumatic tip comprises a gripping feature for surgical tools.

6. The system of claim 1 further comprising: a display; and a controller configured to output control signals causing the display to present a visible image of the regions along and about the urethra based upon the ultrasound data.

7. The system of claim 6, wherein the controller is configured to determine positioning of a tool based upon the ultrasound data and wherein the controller is further configured to output control signals causing the display to present guidance to a physician for manipulating the tool based upon the ultrasound data.

8. The system of claim 1 further comprising a controller configured to determine a path for a surgical tool based upon the ultrasound data.

9. The system of claim 1 further comprising a controller to identify a critical structure proximate a prostate based upon the ultrasound data.

10. The system of claim 9, wherein the critical structure comprises one of more critical structures consisting of: neurovascular bundle, prostate pedicle, prostate capsule, prostate apex, prostate base, bladder neck, rectum, dorsal vein complex, and tumor.

11 . The system of claim 10, wherein the controller is configured to determine cause a display to present an outer guide rail based upon at least one of a rectum and neurovascular bundle.

12. The system of claim 1 further comprising a handle coupled to the elongate medical device, wherein rotation of the handle rotates the ultrasound transducer.

13. The system of claim 1 further comprising a handle, wherein the ultrasound transducer is rotatable relative to the handle.

14. The system of any of claims 12-13, wherein the ultrasound transducer is extendable and retractable relative to and from the handle.

15. The system of claim 1 further comprising a holder coupled to the elongate medical device to secure the elongate medical device to a stationary body external to the urethra to resist rotation and translation of the elongate medical device.