Devices, systems, and methods for transvaginal ultrasound-guided hysteroscopic surgery

Abstract

An ultrasound device includes a frame and an ultrasound sensor assembly. The frame includes first and second rails spaced apart relative to each other and a longitudinal segment defining a longitudinal axis. The longitudinal segment has a distal end portion. The ultrasound sensor assembly is configured to enable ultrasound imaging of a field of view and is attached to the distal end portion of the longitudinal segment of the frame and is oriented such that the field of view is disposed at an oblique angle relative to the longitudinal axis. A surgical system is also provided that includes the ultrasound device and a surgical instrument insertable through the ultrasound device.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 958,045, filed January 7, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to hysteroscopy, and more specifically, to apparatus, systems, and methods for transvaginal ultrasound-guided hysteroscopic surgery. Background Technology

[0004] Transvaginal hysteroscopy encompasses both intrauterine procedures (e.g., procedures performed within the uterine cavity) and intramural procedures (e.g., procedures performed within the uterine wall). Intrauterine procedures may require different methods and / or instruments than intramural procedures, and vice versa. Even within the same category, hysteroscopic procedures may require different methods and / or instruments, depending on factors such as the procedure to be performed, the patient's anatomy, the techniques used, and / or other considerations. Summary of the Invention

[0005] As used herein, the term "distal" refers to the portion described as being farther from the user, while the term "proximal" refers to the portion described as being closer to the user. Furthermore, to a degree of consistency, any or all of the aspects detailed herein may be used in conjunction with any or all of the other aspects detailed herein.

[0006] A hysteroscopy system is provided according to various aspects of this disclosure, comprising an ultrasound device and a hysteroscope. The ultrasound device includes: a proximal body; an axis extending distally from the proximal body; and an ultrasound sensor assembly configured to enable ultrasound imaging. The ultrasound sensor assembly is disposed at a distal portion of the axis and oriented toward a distally facing surface of the distal portion of the axis. The hysteroscope is configured to be removably inserted at least partially through a lumen defined by the ultrasound device. The hysteroscope includes optics configured to enable visualization from the distal portion of the hysteroscope.

[0007] In one aspect of this disclosure, the system further includes a working instrument configured to be removably inserted at least partially through a working channel defined for passage through the hysteroscope. The working instrument may be a tissue resection device.

[0008] In another aspect of this disclosure, at least the shaft defines the lumen, which extends longitudinally through the shaft to an open distal end of the lumen located at the distal portion of the shaft.

[0009] In another aspect of this disclosure, the distal portion of the shaft includes a distal foot that extends distally beyond the open distal end of the lumen. The distal foot defines the distally facing surface.

[0010] In another aspect of this disclosure, the distal-facing surface at least partially surrounds the open distal end of the lumen.

[0011] In yet another aspect of this disclosure, the distal surface is at least one of being convex, conical, or curved.

[0012] In another aspect of this disclosure, the ultrasonic device further includes a movable sheath movable relative to the axis. The movable sheath defines, in such respects, a lumen extending through the sheath.

[0013] In another aspect of this disclosure, the movable sleeve is coupled to the shaft via a pin-slot mechanism configured to allow the movable sleeve to pivot and slide relative to the shaft.

[0014] The hysteroscopic ultrasound apparatus according to this disclosure includes: a proximal body; an axis extending distally from the proximal body; and an ultrasound sensor assembly. At least the axis defines a lumen extending longitudinally through the axis to an open distal end located at a distal portion of the axis. The ultrasound sensor assembly is disposed at the distal portion of the axis and oriented toward a distally facing surface of the distal portion of the axis. The ultrasound sensor assembly is configured to enable ultrasound imaging.

[0015] In one aspect of this disclosure, the shaft and the proximal body cooperate to define the lumen.

[0016] In another aspect of this disclosure, the distal portion of the shaft includes a distal foot that extends distally beyond the open distal end of the lumen. The distal foot defines the distally facing surface in these respects.

[0017] In another aspect of this disclosure, the distal-facing surface at least partially surrounds the open distal end of the lumen.

[0018] In another aspect of this disclosure, the distal surface is at least one of being convex, conical, or curved.

[0019] In another aspect of this disclosure, at least a portion of the distal-facing surface is angled relative to the longitudinal axis defined through the lumen.

[0020] In another aspect of this disclosure, the distal end face of the distal portion of the shaft is asymmetrical.

[0021] Another hysteroscopic ultrasound device according to this disclosure includes: a proximal body; a shaft extending distally from the proximal body to a distal portion of the shaft; an ultrasound sensor assembly; and a movable sheath. The ultrasound sensor assembly is disposed at the distal portion of the shaft and oriented toward a distally facing surface of the distal portion of the shaft. The ultrasound sensor assembly is configured to enable ultrasound imaging. The movable sheath is coupled to the shaft such that the movable sheath is pivotable at least relative to the shaft. The movable sheath defines a lumen through which a surgical instrument is configured to at least partially receive surgical instruments. In an angularly positioned location of the movable sheath relative to the shaft, the longitudinal axis of the movable sheath is angled relative to the longitudinal axis of the shaft.

[0022] In one aspect of this disclosure, the movable sheath is configured to pivot and translate relative to the axis.

[0023] In another aspect of this disclosure, the movable sheath is connected to the shaft via a pin and slot mechanism.

[0024] In another aspect of this disclosure, the movable sheath is movable from a linear positioning to an angular positioning, in which the longitudinal axis of the movable sheath is positioned in a substantially coaxial orientation relative to the longitudinal axis of the shaft.

[0025] The ultrasonic apparatus according to this disclosure includes a frame and an ultrasonic sensor assembly. The frame includes a first guide rail and a second guide rail spaced apart from each other and defines a longitudinal section, the longitudinal section defining a longitudinal axis and having a distal portion. The ultrasonic sensor assembly is configured to enable ultrasonic imaging of a field of view, is attached to the distal portion of the longitudinal section of the frame, and is oriented such that the field of view is positioned at an angle relative to the longitudinal axis.

[0026] In one aspect of this disclosure, the frame further includes an upright section and a curved portion, the upright section being arranged at an angle relative to the longitudinal section, the curved portion interconnecting the proximal portions of the upright section and the longitudinal section.

[0027] In another aspect of this disclosure, the ultrasound device further includes at least one spacer disposed between the first guide rail and the second guide rail, configured to fix the first guide rail and the second guide rail to each other and maintain the distance between the first guide rail and the second guide rail.

[0028] In another aspect of this disclosure, the at least one spacer includes a distal spacer that is integrally formed with the ultrasonic sensor assembly and is disposed at the distal portion of the longitudinal segment of the frame.

[0029] In another aspect of this disclosure, the first guide rail and the second guide rail are substantially parallel plates.

[0030] In yet another aspect of this disclosure, the ultrasound device further includes a sterile barrier disposed around at least a portion of the longitudinal segment of the ultrasound sensor assembly and the frame.

[0031] In another aspect of this disclosure, the ultrasonic sensor assembly may be separable from the distal portion of the longitudinal segment of the frame. In this respect, a sterile barrier is provided that may be positioned around the ultrasonic sensor assembly. The ultrasonic sensor assembly, surrounded by the sterile barrier, may be attached to the distal portion of the longitudinal segment of the frame.

[0032] In another aspect of this disclosure, the ultrasound device further includes a locking mechanism disposed between the first guide rail and the second guide rail and configured to selectively lock a surgical instrument, such as a hysteroscope configured to house a working instrument extending between the first guide rail and the second guide rail, in a fixed position and orientation relative to the locking mechanism.

[0033] In yet another aspect of this disclosure, the first guide rail and the second guide rail are interconnected by a backspan that is a portion of the length of the longitudinal segment of the frame, the backspan being less than the length of the longitudinal segment of the frame.

[0034] The surgical system provided according to this disclosure includes an ultrasound device according to the foregoing or any other aspect herein, and a surgical instrument, such as a hysteroscope configured to house a working instrument passing through it, the surgical instrument being configured to be inserted between a first guide rail and a second guide rail of the frame, whereby the first guide rail and the second guide rail constrain the lateral movement of the surgical instrument.

[0035] In one aspect of this disclosure, the surgical instrument can be inserted at the curved portion of the frame or at the upright section of the frame between the first guide rail and the second guide rail of the frame in an orientation parallel or coaxial with the longitudinal axis of the longitudinal section of the frame.

[0036] In another aspect of this disclosure, when the surgical instrument is inserted between the first guide rail and the second guide rail, the first guide rail and the second guide rail constrain the lateral movement of the surgical instrument, while allowing the surgical instrument to translate axially, rotate axially, and tilt vertically.

[0037] In another aspect of this disclosure, a sterile barrier is disposed around at least a portion of the longitudinal segment of the frame of the ultrasound sensor assembly and the ultrasound device, while the surgical instrument remains outside the sterile barrier when inserted between the first and second guide rails.

[0038] In another aspect of this disclosure, the ultrasound device further includes a locking mechanism disposed between the first guide rail and the second guide rail and configured to selectively lock the surgical instrument located between the first guide rail and the second guide rail in a fixed position and orientation relative to the locking mechanism.

[0039] Another surgical system according to this disclosure includes an ultrasound device and a surgical instrument. The ultrasound device includes an axis and an ultrasound sensor assembly. The axis has a body defining a longitudinal axis and including a lumen extending coaxially through the body. The ultrasound sensor assembly is configured to enable ultrasound imaging of a field of view. The ultrasound sensor assembly is positioned at a distal portion of the body of the axis, offset relative to the longitudinal axis, and oriented such that the field of view is offset relative to the longitudinal axis. The surgical instrument is configured to be removably inserted through the lumen of the body of the axis and extends distally from the distal portion of the body of the axis.

[0040] In one aspect of this disclosure, the shaft further includes a foot that extends distally from the body. In this respect, the ultrasonic sensor assembly can be housed within the foot.

[0041] In another aspect of this disclosure, the shaft further includes a leg and a foot, the leg extending distally from the body and the foot positioned at the distal end of the leg. In these aspects, the ultrasonic sensor assembly may be housed within the foot.

[0042] In another aspect of this disclosure, when the surgical instrument is inserted through the lumen and extends distally from the distal portion of the body, a ring-shaped volume is defined between the innermost surface of the foot and the outermost surface of the surgical instrument. In these respects, the ultrasound device is rotatable about the surgical instrument inserted through the ultrasound device while maintaining the ring-shaped volume, regardless of the rotational orientation of the ultrasound device relative to the surgical instrument.

[0043] In another aspect of this disclosure, the field of view is offset at an oblique angle relative to the longitudinal axis; in other aspects, it is offset at an acute angle relative to the longitudinal axis.

[0044] In another aspect of this disclosure, the ultrasonic sensor assembly is oriented toward the distal surface of the shaft, which at least partially surrounds the open distal end of the lumen.

[0045] In another aspect of this disclosure, the ultrasonic sensor assembly is oriented toward the distal surface of the axis, which includes at least one of a convex, tapered, or curved surface portion.

[0046] In another aspect of this disclosure, the ultrasonic sensor assembly is oriented toward the distal surface of the axis, and the distal surface is angled relative to the longitudinal axis.

[0047] Bias assemblies can be configured in various ways. The bias assembly is configured to connect the ultrasound device to the surgical instrument and to bias the ultrasound device distally around and relative to the surgical instrument.

[0048] In various respects, the biasing assembly may include: a locking collar configured to securely engage around the surgical instrument; an outer sleeve configured to retractably receive the shaft; and a biasing member disposed between the locking collar and the shaft to bias the shaft distally.

[0049] In some aspects, an inflatable balloon may be provided, which is disposed around the body of the axis. In these aspects, the ultrasound device may further include a fluid outlet opening located distal to the inflatable balloon.

[0050] The surgical methods provided according to various aspects of this disclosure include: transvaginally inserting an ultrasound device to position the ultrasound sensor assembly of the ultrasound device near the cervix of the uterus; and inserting a surgical instrument through the lumen of the ultrasound device, through the cervix, and into the uterus.

[0051] In various respects, positioning the ultrasound sensor assembly near the external cervix of the uterus includes positioning the ultrasound sensor assembly in contact with the vaginal fornix.

[0052] In various respects, the method further includes generating an ultrasound image of at least a portion of the uterus using the ultrasound sensor assembly.

[0053] In various respects, the method further includes locking the surgical instrument in a fixed position relative to the ultrasound device.

[0054] In various respects, the method further comprises inserting a working instrument through the surgical instrument and into the uterus.

[0055] In various respects, the method further includes rotating the ultrasound device around the cervix. Attached Figure Description

[0056] The above and other aspects and features of this disclosure will become more apparent when considered in conjunction with the accompanying drawings, in view of the following detailed description, wherein like reference numerals identify similar or identical elements.

[0057] Figure 1 This is an exploded perspective view of the hysteroscopic system according to this disclosure;

[0058] Figure 2 yes Figure 1 A perspective view of the distal portion of the ultrasound device in a hysteroscopic system;

[0059] Figure 3 yes Figure 1 A perspective view of another configuration of the distal portion of the ultrasound device in a hysteroscopic system;

[0060] Figure 4 yes Figure 1 A perspective view of the distal portion of the ultrasound device of the hysteroscopic system in another configuration;

[0061] Figure 5 yes Figure 1 A side view of a hysteroscopic system positioned inside the vagina for performing procedures on or inside the uterus;

[0062] Figure 6 It is configured to be with Figure 1 A side view of another ultrasound device used in conjunction with the hysteroscopic system;

[0063] Figure 7 yes Figure 6 A side view of an ultrasound device positioned inside the vagina for performing surgery on or inside the uterus using a hysteroscope and working instruments.

[0064] Figure 8 It is configured to be with Figure 1 A side view of another ultrasound device used in conjunction with the hysteroscopic system;

[0065] Figure 9 This is a perspective view of another ultrasound device, which includes a hysteroscope operably housed within the ultrasound device.

[0066] Figures 10A-10C It is a demonstration Figure 9 The device was positioned near the cervix and gradually inserted. Figure 9 A perspective view of an ultrasound device through which a hysteroscope passes through the cervix and enters the uterus;

[0067] Figure 11A yes Figure 9 A perspective view of the proximal portion of an ultrasound device, which includes a locking mechanism;

[0068] Figure 11B yes Figure 9 A top view of the proximal portion of an ultrasound device, which includes Figure 11A Locking mechanism;

[0069] Figure 11C and 11D for Figure 9 A proximal view of an ultrasound device, which includes Figure 11A The locking mechanism includes a hysteroscope that is operably housed in the ultrasound device in both the unlocked and locked states.

[0070] Figure 12A This is an exploded perspective view of another ultrasound device according to the present disclosure, which includes a sterile barrier disposed above its ultrasound sensor assembly;

[0071] Figure 12B yes Figure 12A Exploded transverse cross-sectional view of the adapter assembly of the ultrasonic device;

[0072] Figures 13A-13D It is a top view that progressively shows the method of sealing a sterile barrier above an ultrasound device;

[0073] Figure 14A This is a side view of another ultrasound device according to the present disclosure, which includes a hysteroscope operatively housed within the ultrasound device;

[0074] Figure 14B and 14C These are transverse cross-sectional views taken from the section lines “14B-14B” and “14C-14C” across section 14A, respectively.

[0075] Figure 15 yes Figure 14A A side view of the distal portion of an ultrasound device, which includes a sterile barrier disposed around the ultrasound device;

[0076] Figure 16 yes Figure 14A A side view of an ultrasound device, which includes a sterile barrier positioned around the ultrasound device and a hysteroscope inserted and operatively positioned relative to the ultrasound device.

[0077] Figure 17A This is a perspective view of another ultrasound device, which includes a hysteroscope and working instruments inserted into the ultrasound device;

[0078] Figure 17B yes Figure 17A A perspective view of an ultrasound device positioned near the cervix, wherein the hysteroscope and working instruments extend through the cervix and into the uterus;

[0079] Figure 18 This is a perspective view of another ultrasound device positioned near the cervix, in which the hysteroscope and working instruments extend through the cervix and into the uterus;

[0080] Figure 19 This is a perspective view of another ultrasound device positioned near the cervix, wherein the hysteroscope and working instruments extend through the cervix and into the uterus; and

[0081] Figure 20 This is a schematic illustration of an exemplary robotic surgical system configured for use with this disclosure. Detailed Implementation

[0082] refer to Figure 1 The hysteroscopic system provided according to this disclosure is generally indicated by reference numeral 10 and includes working instruments 100, such as tissue resection devices, ablation devices, biopsy devices, etc.; a hysteroscope 200; and an ultrasound device 300. The ultrasound device 300 is configured for transvaginal insertion into a location near or abutting the cervix. The hysteroscope 200 is configured to pass through the ultrasound device 300 and the cervix into the uterus. The working instruments 100 are configured to pass through the hysteroscope 200 into the uterus to perform surgical procedures within the uterine cavity and / or uterine wall.

[0083] As mentioned above, the working instrument 100 may be a tissue resection device, an ablation device, a biopsy device, or other suitable working instrument configured for use on or inside the uterus. For example, with respect to a tissue resection device, the working instrument 100 includes a housing 110, a shaft 120, a cutting member 130, a drive mechanism 140, an outlet port 150, and a cable 160. The housing 110 houses the drive mechanism 140 and serves as a handle for allowing a user to grip the working instrument 100. The drive mechanism 140 includes a motor and is operatively coupled to the cutting member 130 to drive the cutting member 130 to rotate and / or translate relative to the shaft 120. The drive mechanism 140 is adapted to be connected via the cable 160 to a control unit (not shown) to power and control the motor; however, the working instrument 100 may alternatively be powered by a battery or manually. A suction source (not shown) may also be provided, incorporated into the control unit (not shown) or any other suitable vacuum-generating mechanism, to facilitate the extraction of fluids, tissues, and debris through the working instrument 100 and the outflow tube, as detailed below.

[0084] The shaft 120 of the working instrument 100 extends distally from the housing 110 and is fixed relative to the housing 110 in any embodiment, but other configurations are contemplated. The shaft 120 defines a window extending through the sidewall of the shaft toward its distal end to provide access to a cutting member 130, which is rotatably and / or translationally disposed within the shaft 120 and, as noted above, operatively coupled to a drive mechanism 140. The cutting member 130 defines an opening providing access to its interior and may include a serrated cutting edge around the opening, but other suitable cutting edge configurations are contemplated. Alternatively or additionally, the shaft 120 may include a cutting edge defined as a window around the shaft.

[0085] In the use of the working instrument 100, upon activation, tissue is aspirated through the window of shaft 120 and into the opening of cutting member 130. As the tissue is aspirated into the opening of cutting member 130, it is removed by rotation and / or translation of cutting member 130 relative to shaft 120, thereby allowing the removed tissue, along with fluid and debris, to be aspirated proximally through cutting member 130. The removed tissue, along with fluid and debris, is aspirated proximally through cutting member 130, through outlet port 150 and outlet tube (not shown), and ultimately into one or more collection tanks (not shown) of the fluid management system.

[0086] Continue to refer to Figure 1The hysteroscope 200 includes an elongated tubular member 202 and a proximal body 240. The elongated tubular member 202 of the hysteroscope 200 defines a working channel 204, which is configured to receive a working instrument, such as working instrument 100, passing through the working channel. The working channel 204 can also serve as a fluid inflow (or outflow) channel. Alternatively or additionally, a separate fluid inflow (or outflow) channel may be provided. The elongated tubular member 202 further includes an optics 210 extending through the elongated tubular member to enable visualization at the distal end of the elongated tubular member 202.

[0087] The proximal body 240 of the hysteroscope 200 includes a housing 242, a lamp post 244, a valve 246, and an arm 248. The lamp post 244 extends from the housing 242 and is configured to be connected to a light source, for example, to illuminate the distal end of the elongated tubular member 202 via one or more fiber optic bundles (not shown) coupled to the lamp post 244 and extending through the elongated tubular member 202. The valve 246 is arranged in fluid communication with the working channel 204 and is configured to allow fluid to selectively flow into and / or out of the working channel 204. Multiple valves may also be provided in a configuration providing multiple flow channels. The arm 248 is configured to be connected to an imaging device, such as a camera, to capture images received by the optics 210, thereby enabling the display of video images of the internal surgical site captured by the optics 210.

[0088] Still referencing Figure 1 The ultrasound device 300 includes a proximal body 310, a shaft 320 extending distally from the proximal body 310, and an ultrasound sensor assembly 330 disposed at a distal portion 324 of the shaft 320. The ultrasound device 300 further includes a longitudinal lumen 340 defined through the proximal body 310 and the shaft 320 and including an open proximal end 342 and an open distal end 344. The longitudinal lumen 340 may be coaxial with the longitudinal axis defined through the shaft 320, or may be offset and / or angled relative to the longitudinal axis. The longitudinal lumen 340 is configured to allow at least a portion of an endoscope device, such as an elongated tubular member 202 of a hysteroscope 200, to pass through the longitudinal lumen, such that a distal portion of the elongated tubular member 202 extends through the open distal end 344 of the longitudinal lumen 340 and distally from the shaft 320. The longitudinal lumen 340 may be additionally or alternatively configured to allow other instruments, such as one or more working instruments, to pass through the longitudinal lumen.

[0089] The proximal body 310 of the ultrasound device 300 can be configured to include a handle, such as a pistol grip 312, but other handle configurations are also envisioned, including non-handle configurations, such as those for mounting the ultrasound device 300 and / or attaching the ultrasound device 300 to a surgical robotic arm (see [link to documentation]). Figure 20 Cable 350 extends from proximal body 310 to connect ultrasonic sensor assembly 330 of ultrasonic device 300 to ultrasonic console (not shown), for example, via a line (not shown) extending from ultrasonic sensor assembly 330 through shaft 320, proximal body 310 and cable 350.

[0090] The shaft 320 of the ultrasound device 300 is configured for transvaginal insertion into a location near or abutting the cervix, such that the distal end 344 of the longitudinal lumen 340 is oriented toward the cervical canal, allowing the hysteroscope 200 (or other suitable surgical instrument) to pass through the longitudinal lumen 340, exit from the distal end 344, pass through the cervical canal, and enter the uterus. The body portion 322 of the shaft 320 may be defined in a cylindrical configuration and / or the distal portion 324 of the shaft 320 may be tapered, curved, and / or may be otherwise configured non-invasively to facilitate non-invasive insertion.

[0091] The ultrasound sensor assembly 330 includes one or more ultrasound sensors 332, such as ultrasound transducers, for enabling ultrasound imaging of tissues, such as the uterus. Each ultrasound sensor 332 is configured to emit ultrasound waves, such as high-frequency sound waves, and is configured to receive echoes generated by reflections of the ultrasound waves from various tissue structures encountered. The echoes received by each ultrasound sensor 332 are output to an image processing unit (not shown), for example, via a line extending through a shaft 320, a proximal body 310, and a cable 350. In one embodiment, the ultrasound sensor assembly 330 may be configured to perform 2D ultrasound imaging. In other embodiments, the ultrasound sensor assembly 330 includes a plurality of ultrasound sensors 332 forming an ultrasound sensor array that defines a portion of a circle, a portion of a polygon, a partial polygon, a partial arcuate configuration, or other suitable configuration for enabling the reconstruction of 3D ultrasound images for 3D ultrasound imaging. In this way, when activated, the ultrasound sensor assembly 330 enables ultrasound imaging of tissues, such as the cervix, uterus, and / or surrounding tissues.

[0092] Go to Figure 2The distal portion 324 of shaft 320 defines a protruding foot 360 on one side of the open distal end 344 of longitudinal lumen 340, the protruding foot projecting further distally than a distal side portion 370 disposed on the other side of the open distal end 344 of longitudinal lumen 340. The protruding foot 360 defines a curved distally facing surface 362 comprising one or more curved segments. For example, the distally facing surface 362 of the protruding foot 360 may include a recessed surface portion extending distally and outwardly from the distal end 344 of longitudinal lumen 340, followed by a convex surface portion extending distally and outwardly from the recessed surface portion. However, other suitable configurations are also contemplated. Regardless of the specific configuration, an ultrasonic sensor assembly 330 is positioned within the protruding foot 360, wherein the ultrasonic sensor 332 of the ultrasonic sensor assembly is oriented toward the distally facing surface 362 to emit ultrasonic waves from the sensor. The protruding foot 360 is configured to be positioned near or abutting the cervix, so that the ultrasound sensor assembly 330 can be used to image, for example, the cervix, uterus and surrounding tissues.

[0093] refer to Figure 3 In other configurations, the distal portion 424 of shaft 320 defines a distal side portion 470 that surrounds the open distal end 344 of longitudinal lumen 340. The distal side portion 470 is curved to define a radially symmetrical, convex, distally facing surface 472, wherein an annular portion between the open distal end 344 of longitudinal lumen 340 and the outer periphery of the distal portion 424 of shaft 320 protrudes further distally than the portion of surface 472 adjacent to the open distal end 344 of longitudinal lumen 340 and the outer periphery of the distal portion 424 of shaft 320. An ultrasound sensor assembly 430 is positioned at the distal portion 424 of shaft 320 and may extend around a portion or the entire distal side portion 470. Sensors 432 of the ultrasound sensor assembly 430 are oriented toward surface 472 to emit ultrasound waves from the sensors, such that the ultrasound sensor assembly 430 can be used to image, for example, the cervix, uterus, and surrounding tissues.

[0094] refer to Figure 4In other configurations, the distal portion 524 of shaft 320 defines a distal lateral portion 570 surrounding the open distal end 344 of longitudinal lumen 340, the distal lateral portion narrowing radially inward in a proximal-to-distal direction. Thus, the distal lateral portion 570 defines a distally facing surface 572, wherein the portion adjacent to the open distal end 344 of longitudinal lumen 340 protrudes further distally than the portion adjacent to the outer periphery of the distal portion 524 of shaft 320. An ultrasound sensor assembly 530 is positioned at the distal portion 524 of shaft 320 and may extend annularly about the entire shaft (as shown) or only a portion of the shaft. Sensors 532 of the ultrasound sensor assembly 530 are oriented toward surface 572 to emit ultrasound waves from the sensors, allowing the ultrasound sensor assembly 430 to be used for imaging, for example, the cervix, uterus, and surrounding tissues.

[0095] Go to Figure 5 The diagram illustrates a hysteroscopic system 10 in use, wherein an ultrasound device 300 is inserted transvaginally through the vaginal canal “V”, such that the distal portion 324 of the shaft 320 of the ultrasound device is positioned near or abutting the cervix “C”. In this positioning, more specifically, a protruding foot 360 comprising an ultrasound sensor assembly 330 is positioned near or abutting the cervix “C” to enable ultrasound imaging of a field of view “F1” containing the uterus “U” and surrounding tissues. Further, in this positioning, the open distal end 344 of the longitudinal lumen 340 is oriented using the cervical canal, and an elongated tubular member 202 extends from the cervical canal, through the cervix “C”, and into the uterus “U”. In this manner, the hysteroscope 200 can be used for visualization within the uterus “U”, for example, thereby providing a field of view “F2” for ultrasound imaging or for ultrasound imaging alone. Hysteroscope 200 can also be used to introduce fluid into and / or remove fluid from the uterus “U” and / or to allow working instruments 100, such as tissue resection devices, ablation devices, biopsy devices, etc., to pass through and into the uterus “U” to perform one or more hysteroscopic tasks therein (e.g., within the uterus “U”) or through it (e.g., within the uterine wall). The use of ultrasound imaging of the uterus “U” from outside the uterine cavity and / or visualization of the uterus “U” from inside the uterine cavity provides increased visibility for performing a variety of different hysteroscopic tasks without the need to change instruments supporting different imaging modalities and / or providing different imaging perspectives.

[0096] Figure 6 and 7 Another ultrasonic device 600 provided according to this disclosure is shown. The ultrasonic device 600 includes a proximal body 610, a shaft 620 extending distally from the proximal body 610, an ultrasonic sensor assembly 630 disposed at a distal portion 624 of the shaft 620, and a movable sheath 660.

[0097] The proximal body 610 of the ultrasound device 600 can be configured to include a handle, such as a pistol grip 612, but other handle configurations are also envisioned, including non-handle configurations, such as those for mounting the ultrasound device 600 and / or attaching the ultrasound device 600 to a surgical robotic arm (see [link to documentation]). Figure 20 Cable 650 extends from proximal body 610 to connect ultrasonic sensor assembly 630 of ultrasonic device 600 to ultrasonic console (not shown), for example, via a line (not shown) extending from ultrasonic sensor assembly 630 through shaft 620, proximal body 610 and cable 650.

[0098] The shaft 620 of the ultrasound device 600 is configured for transvaginal insertion into a location near or abutting the cervix, such that the ultrasound sensor assembly 630 is oriented to enable ultrasound imaging of, for example, the cervix, uterus, and surrounding tissues. More specifically, the distal portion 624 of the shaft 620 contains the ultrasound sensor assembly 630. The ultrasound sensor assembly 630 includes one or more ultrasound sensors 632, which are oriented toward the distal surface 672 of the distal portion 624 of the shaft 620, such that the ultrasound sensor assembly 630 can be used to image, for example, the cervix, uterus, and surrounding tissues. The ultrasound sensor assembly 630 can be configured for 2D and / or 3D imaging. The distal surface 672 can define a spherical configuration or any other configuration for facilitating ultrasound imaging, such as those detailed with respect to the ultrasound device described above.

[0099] The shaft 620 of the ultrasonic device 600 further defines a hollow section 626, which is defined by a pair of spaced-apart sidewalls 627 and open top and bottom sides. The hollow section 626 of the shaft 620 is configured to receive a movable sheath 660 therein. A coupling mechanism 680 connects the movable sheath 660 to the shaft 620 such that the movable sheath 660 is movable between a linear positioning and an angular positioning, in which the movable sheath 660 is substantially (e.g., + / - 10%) positioned within and substantially coaxial with the shaft 620, and in which the longitudinal axes of the shaft 620 and the movable sheath 660 are positioned at an angle relative to each other, such that the movable sheath 660 extends from the hollow section 626 of the shaft 620. In linear positioning, the movable sleeve 660 may be completely contained within the outer annular dimension of the shaft 620 (e.g., the largest, smallest, or other outer annular dimension in embodiments where multiple dimensions are provided) so as not to protrude from the shaft. Alternatively, in linear positioning, the movable sleeve 660 may extend radially outward from the outer annular dimension of the shaft 620; in such embodiments, the movable sleeve 660 in linear positioning protrudes radially outward from the shaft 620 by a minimal amount compared to the movable sleeve 660 in angular positioning.

[0100] The coupling mechanism 680 may include, for example, a pin-hole connector that allows the movable sleeve 660 to pivot relative to the shaft 620 while remaining longitudinally fixed. Alternatively, as shown, the coupling mechanism 680 may include a pin-slot connector comprising one or more pins 682 (e.g., a pair of pins 682 extending radially outward from the movable sleeve 660 in opposite directions) that engage one of the shaft 620 or the movable sleeve 660, and one or more slots 684 (e.g., slots 684 defined within each sidewall 627) that receive one or more pins 682 and are defined within the other of the shaft 620 or the movable sleeve 660. In this way, the movable sleeve 660 can slide longitudinally and pivot relative to the shaft 620 between linear and angular positioning. Other suitable coupling mechanisms 680 are also contemplated.

[0101] The movable sheath 660 can be moved (e.g., pivoted and / or translated) relative to the axis 620 via a coupling mechanism 680, either locally (e.g., by manipulating the movable sheath 660 itself) or remotely (e.g., by manipulating one or more remote actuators (not shown) mounted on the proximal body 610 and associated drive components (not shown, such as shafts, cables, links, etc. interconnecting the remote actuators to the coupling mechanism 680). Further, the movement of the movable sheath 660 relative to the axis 620 via the coupling mechanism 680 can be manual or, for example, powered by one or more motors (not shown) mounted within or otherwise positioned on the proximal body 610.

[0102] The movable sheath 660 defines a longitudinal lumen 662 extending longitudinally from the movable sheath, the longitudinal lumen being sufficient to allow at least a portion of an endoscopic device, such as an elongated tubular member 202 of a hysteroscope 200, to pass through the longitudinal lumen, such that a distal portion of the elongated tubular member 202 extends through an open distal end 664 of the longitudinal lumen 662 and extends distally from the movable sheath 660. The longitudinal lumen 662 may additionally or alternatively be configured to allow other instruments, such as one or more working instruments, to pass through the longitudinal lumen. As an alternative to the linear configuration of the movable sheath 660, the movable sheath 660 may be bent in one or more directions or otherwise configured.

[0103] For details, please refer to the following: Figure 7In use, with the movable sheath 660 positioned in a straight line, the ultrasound device 600 is inserted transvaginally through the vaginal canal “V”, such that the distal portion 624 of the shaft 620 of the ultrasound device is positioned near or abutting the cervix “C”. More specifically, in this positioning, the ultrasound sensor assembly 630 is positioned near or abutting the cervix “C” to enable ultrasound imaging of the uterus “U” and surrounding tissues. With the shaft 620 in this position, the movable sheath 660 can move relative to the shaft 620, for example, pivoting and / or sliding, such that the open distal end 664 of the longitudinal lumen 662 is oriented toward and / or extends through the cervix “C”. In this orientation, the elongated tubular component 202 of the hysteroscope 200 can be inserted through a movable sheath 660, through the cervix “C”, and into the uterus “U”, thereby allowing the hysteroscope 200 to be used for visualization within the uterus “U” along with or separately for ultrasound imaging. The hysteroscope 200 can also be used to introduce fluid into and / or remove fluid from the uterus and / or to allow working instruments 100, such as tissue resection devices, ablation devices, biopsy devices, etc., to pass through and into the uterus “U” to perform one or more hysteroscopic tasks therein (e.g., within the uterus “U”) or through it (e.g., within the uterine wall). The movable configuration of the sheath 660 relative to the axis 620 allows the ultrasound sensor assembly 630 to be positioned in a first orientation to facilitate ultrasound imaging, and allows the sheath 660 (and thus the hysteroscope 200, working instrument 100 or other instruments inserted in the sheath) to be oriented in a second, different, alternative orientation to pass through into the uterus “U” to perform one or more surgical tasks in the uterus.

[0104] Go to Figure 8 Another ultrasonic device 800 is provided according to this disclosure. Ultrasonic device 800 is similar to ultrasonic device 600. Figure 6 and 7 Therefore, the differences will be described in detail below. The ultrasonic device 800 includes a proximal body 810, a shaft 820 extending distally from the proximal body 810, and an ultrasonic sensor assembly 830 disposed at the distal portion 824 of the shaft 820.

[0105] The shaft 820 of the ultrasound device 800 is configured for transvaginal insertion into a location near or abutting the cervix, such that the ultrasound sensor assembly 830 is oriented to enable ultrasound imaging of, for example, the cervix, uterus, and surrounding tissues. The shaft 820 of the ultrasound device 800 defines a hollow segment 826 defined by a pair of spaced-apart sidewalls 827 and open top and bottom sides. The hollow segment 826 of the shaft 820 may extend along a portion of the length of the shaft 820 or substantially the entire length of the shaft 820.

[0106] The hollow section 826 is configured to removably house one or more surgical instruments 860, such as sheaths, hysteroscopes, tissue resection devices, ablation devices, biopsy devices, or other suitable surgical instruments arranged side-by-side or retracting relative to each other. More specifically, the sidewall 827 located on either side of the hollow section 826 is similar to that described above with respect to the ultrasound device 600 ( Figure 6 and 7 As detailed in the description, it guides one or more surgical instruments 860 to insert, slide longitudinally, and / or pivot relative to axis 620, while also allowing interchangeability between different surgical instruments 860. That is, the ultrasound device 800 does not include features like the ultrasound device 600 ( Figure 6 and 7 Such a connecting mechanism allows the surgical instrument 860 to be removably housed within the hollow section 826 of the shaft 820.

[0107] refer to Figure 9 and 10A -10C, another ultrasound device provided according to this disclosure is shown generally as identified by reference numeral 900, comprising a hysteroscope 200 operably inserted through the ultrasound device. Except in the following explicitly contradictory cases, the ultrasound device 900 may include any of the features of the ultrasound device detailed above.

[0108] The ultrasonic device 900 includes a frame 902 and an ultrasonic sensor assembly 930. The frame 902 is formed by a pair of spaced-apart guide rails 904. The guide rails 904 can be configured as plates oriented substantially parallel to each other or extending in any other suitable manner. The guide rails 904 are bent at bends 906 to define a more proximal upright portion 910 and a more distal longitudinal portion 920, which are angled relative to each other. The angle can be from about 60 degrees to about 120 degrees in one configuration, from about 75 degrees to about 105 degrees in another configuration, and from about 90 degrees in yet another configuration. A proximal spacer 912 is disposed between the guide rails 904 at the upright portion 910 of the frame 902, for example, at the proximal end of the upright portion 910, and is secured between the guide rails, for example by pins, bolts, adhesives, overmolding, or any other means, such that the guide rails 904 are fixed to each other and maintain the spacing between the guide rails along the upright portion 910. The distal spacer 922 is disposed between guide rails 904 in the longitudinal portion 920 of the frame 902, for example, at the distal end of the longitudinal portion 920, and is secured between the guide rails, for example by pins, bolts, adhesives, overmolding, or any other means, such that the guide rails 904 are fixed to each other and maintain the spacing between the guide rails along the longitudinal portion 920. Additional or alternative spacers for similar purposes are also contemplated.

[0109] The proximal portion of the upright portion 910 of frame 902 may include a handle (e.g., similar to any of the above configurations) mounted on the proximal portion for manual operation of the ultrasound device 900 and / or may be configured to be mounted on a support arm "SA" of a support device "SD", such as a robotic arm of a surgical system (see [link to documentation]). Figure 20 This eliminates the need for the surgeon to manually manipulate the ultrasound device 900 and / or manually hold the ultrasound device 900 to maintain its position. Suitable mounting hardware “M” may be provided integrally with or attached to the proximal portion of the upright portion 910 for the purpose of releasably engaging the support arm “SA”.

[0110] An ultrasound sensor assembly 930 extends distally from and is secured to the distal end of a longitudinal portion 920 of a frame 902. More specifically, the ultrasound sensor assembly 930 may be formed with, attached to, or otherwise secured relative to a distal spacer 922, such that the distal spacer 922 engages between guide rails 904, also securing the ultrasound sensor assembly 930 relative to the frame 902, or may be secured directly or indirectly relative to the frame 902 in any other suitable manner. The ultrasound sensor assembly 930 includes one or more ultrasound sensors 332, such as ultrasound transducers, which enable ultrasound imaging of tissues, such as the uterus, and more specifically, enable 2D and / or 3D ultrasound imaging. The field of view generated by the ultrasound sensor assembly 930 can be from about 90 degrees to about 180 degrees, and in other configurations from about 120 degrees to about 150 degrees. The ultrasonic sensor assembly 930 can be oriented such that the longitudinal axis defined by the longitudinal portion 920 of the frame 902 extends through the field of view, along the boundary line of the field of view, or deviates from the field of view. In various respects, the ultrasonic sensor assembly 930 is oriented such that the center line extending from the ultrasonic sensor assembly 930 and dividing the field of view is arranged at an angle (in some respects, an acute angle) relative to the longitudinal axis defined by the longitudinal portion 920 of the frame 902. Other ultrasonic devices can be similarly configured, for example, in which the ultrasonic imaging field of view is arranged at an angle (in some respects, an acute angle) relative to the frame or axis of the ultrasonic device.

[0111] Continue to refer to Figure 9 and 10A-10C, the bend 906 of the frame 902 allows the elongated tubular member 202 of the hysteroscope 200 to be inserted between the guide rails 904 in a substantially coaxial or parallel orientation relative to the longitudinal axis defined by the longitudinal portion 920 of the frame 902. Alternatively, the elongated tubular member 202 of the hysteroscope 200 can be inserted between the guide rails 904 at an angle relative to the longitudinal axis. Regardless of the insertion angle, when the elongated tubular member 202 of the hysteroscope 200 extends between the guide rails 904, the guide rails 904 serve to substantially inhibit lateral movement (sliding or tilting) of the elongated tubular member 202 relative to the longitudinal axis defined by the longitudinal portion 920 of the frame 902, while allowing vertical movement (sliding and tilting), axial rotation, and axial sliding of the elongated tubular member 202 relative to the longitudinal axis defined by the longitudinal portion 920 of the frame 902.

[0112] Reference Figures 10A-10C and initially referenced Figure 10A In use, the longitudinal portion 920 of the frame 902 of the ultrasound device 900 can be first inserted through the vaginal canal “V”, such that the ultrasound sensor assembly 930 is positioned near or adjacent to the cervix “C”, enabling ultrasound imaging of the uterus “U” and surrounding tissues, while the upright portion 910 remains outwardly positioned, for example, for manually manipulating the support arm “SA” or fixing it to the support arm (see [link]). Figure 9 The elongated tubular component 202 of the hysteroscope 200 can then be inserted into the guide rail 904 in a substantially coaxial or parallel orientation relative to the longitudinal axis defined by the longitudinal portion 920 of the frame 902. Figure 9 While other suitable insertion orientations are envisioned, the elongated tubular member 202 can be positioned between the guide rails 904 in a coaxial or parallel orientation relative to the longitudinal axis defined by the longitudinal portion 920 of the frame 902 prior to insertion and can be inserted in conjunction with the longitudinal portion 920 of the frame 902. Inserting the elongated tubular member 202 of the hysteroscope 200 in any of these ways significantly reduces the required insertion force and patient discomfort, as the elongated tubular member 202 is positioned within the frame 902 and thus does not interact substantially with tissue at this point.

[0113] refer to Figure 10BIn the case of inserting the ultrasound device 900 and hysteroscope 200 as detailed above, the hysteroscope 200 can be manipulated relative to the ultrasound device 900 to position the elongated tubular member 202 for insertion through the cervix “C” and into the uterus “U”. This can be accomplished, for example, by tilting the elongated tubular member 202 vertically relative to the frame 902 until the distal end of the elongated tubular member 202 is substantially aligned with the cervix “C”. The ultrasound images provided by the ultrasound device 900 can be used to confirm the correct orientation of the elongated tubular member 202.

[0114] Go to Figure 10C With the elongated tubular member 202 oriented as detailed above, the elongated tubular member 202 can slide distally relative to the frame 902 (maintaining its orientation), such that the distal end of the elongated tubular member 202 extends through the cervix “C” and into the uterus “U” under the guidance of ultrasound imaging provided by the ultrasound device 900. It can then be accessed via the hysteroscope 200 or the working instrument 100 inserted into the uterus. Figure 1 One or more surgical tasks can be performed within the uterine “U”, such as visualization, tissue removal, ablation, biopsy, etc., all of which are guided by ultrasound imaging provided by the ultrasound device 900.

[0115] refer to Figure 11A-11D , combined Figure 9 As detailed above, when the elongated tubular member 202 of the hysteroscope 200 extends between the guide rails 904 of the ultrasound device 900, the guide rails 904 are used to substantially inhibit lateral movement of the elongated tubular member 202 relative to the longitudinal axis defined by the longitudinal portion 920 of the frame 902, while allowing vertical and axial movement (sliding and rotation) of the elongated tubular member 202 relative to the longitudinal axis defined by the longitudinal portion 920 of the frame 902. Therefore, the hysteroscope 200 has multiple degrees of freedom relative to the ultrasound device 900. However, in some cases, it may be desirable, for example, to selectively lock the hysteroscope 200 relative to the ultrasound device 900 when a desired positioning and orientation is achieved. More specifically, a locking mechanism 1100 may be provided to selectively lock the hysteroscope 200 in any suitable positioning and orientation relative to the ultrasound device 900.

[0116] The locking mechanism 1100 is disposed between guide rails 904 of the longitudinal portion 920 of the frame 902 of the ultrasonic device 900 and includes a pair of clamp brackets 1110, an elastic sling 1120 extending between the lower ends 1112a of the clamp brackets 1110, an engagement pin 1130 extending outward from each clamp bracket 1110, and a cam-screw assembly 1140 including a screw 1142 and a cam locking lever 1144. The elastic sling 1120 is formed of an elastic material configured to elastically resist tension of the elastic sling 1120 from one or both ends 1122 of the sling.

[0117] Each clamp bracket 1110 is positioned adjacent to one of the guide rails 904 on the inward-facing surface of the guide rail, toward the proximal end of the longitudinal portion 920 of the frame 902, but other positioning and / or configurations are also contemplated. As mentioned above, a resilient sling 1120 extends toward the distal end of the resilient sling between the lower ends 1112a of the clamp brackets 1110. Support rods 1114 extend proximally from each clamp bracket 1110. One or both support rods 1114 define a threaded connector 1116 at their free proximal portions. In other configurations, the support rods 1114 are omitted and the threaded connector 1116 is defined or positioned on any one or both clamp brackets 1110. The threaded connector 1116 may be the threaded portion of the support rod 1114, the support rod 1114 itself, a male or female threaded assembly attached to the support rod 1114, or any other suitable threaded assembly. In a configuration that provides only one threaded connector 1116, the other support rod 1114 may contain a non-threaded connector, such as a rotatable connector.

[0118] Engaging pin 1130 extends outward from clamp bracket 1110 into hole 1132 defined within the inner surface of guide rail 904. Alternatively, engaging pin 1130 may extend outward from clamp bracket 1110 into an elongated channel defined within and extending longitudinally along the inner surface of longitudinal portion 920 of frame 902, such that in the unlocked state, locking mechanism 1100 can be longitudinally translated along longitudinal portion 920 of frame 902.

[0119] Continue to refer to Figure 11A-11D , combined Figure 9The cam-screw assembly 1140, as mentioned above, includes a screw 1142 and a cam locking lever 1144. The screw 1142 may be mounted on top of one or both guide rails 904 of the longitudinal portion 920 of the frame 902, or may extend through an orifice or longitudinal slot defined within one or both guide rails 904 of the longitudinal portion 920 of the frame 902. In either configuration, the screw 1142 extends laterally relative to the guide rail 904 and engages threadedly with a threaded connector 1116 of the support rod 1114. In a configuration where both support rods 1114 include threaded connectors 1116, the screw 1142 engages threadedly with each of the threaded connectors 1116 in a relative manner, for example, one by a right-hand thread and the other by a left-hand thread. In a configuration where only one support rod 1114 includes a threaded connector 1116, the non-threaded connector of the other support rod 1114 may rotatably and / or slidably house the screw 1142.

[0120] End stop washers 1146 are positioned toward the opposite end of the screw 1142, such that a threaded connector 1116 (and a non-threaded connector, if provided) is positioned between the end stop washers 1146. The end stop washers 1146 are axially fixed to the screw 1142 and are rotatable relative to the screw 1142 or rotatably fixed relative to the screw. In a configuration where the screw 1142 extends through an opening or slot in one or both guide rails 904 defined in the longitudinal portion 920 of the frame 902, one or both end stop washers 1146 may be positioned outside the adjacent guide rail 904.

[0121] A cam locking lever 1144 is pivotally connected via a pivot 1148 to the end portion of a screw 1142, adjacent to one of the end stop washers 1146. The cam locking lever 1144 is positioned outside a guide rail 904 of the longitudinal portion 920 of the frame 902 to allow manual operation by a user. The cam locking lever 1144 defines a cam surface 1145 that extends eccentrically about the pivot 1148, such that in the unlocked position of the cam locking lever 1144, the cam surface 1145 displaces from the adjacent end stop washer 1146, which is related to the rotatable position of the screw 1142 (see [link to relevant documentation]). Figure 11C The unlocked state of the cam locking mechanism corresponds to the locked position of the cam locking lever 1144, and causes the second cam surface 1145 to be pushed to contact the adjacent end stop washer 1146 to apply force to the adjacent end stop washer, which corresponds to the locked state of the cam locking mechanism in which the screw 1142 is inhibited from rotating (see...). Figure 11D Correspondingly, the cam locking lever 1144 can pivot about pivot 1148 between its unlocked and locked positions.

[0122] refer to Figure 11C and 11D In use, the longitudinal portion 920 of the frame 902 of the ultrasonic device 900 is inserted into the positioning as detailed above (see [reference]). Figure 10A In the case of ), the elongated tubular member 202 of the hysteroscope 200 can then be inserted between the guide rails 904 of the frame 902, and more specifically, laterally between the clamp brackets 1110 of the locking mechanism 1100 and vertically between the screw 1142 and the elastic sling 1120 of the locking mechanism 1100. Figure 11C As shown, at this time, the locking mechanism 1100 is positioned in the unlocked state, thereby allowing the insertion of the elongated tubular member 202 through the locking mechanism and manipulation within the locking mechanism to achieve desired orientation and positioning. Alternatively, the elongated tubular member 202 may be positioned between the guide rails 904 and within the locking mechanism 1100 before insertion, and may be inserted in conjunction with the longitudinal portion 920 of the frame 902. In either configuration, the elongated tubular member 202 can be manipulated, for example, distally advanced, rotated, and / or vertically tilted relative to the ultrasound device 900, for example, so that the distal end of the elongated tubular member 202 can be inserted through the cervix “C” and into the uterus “U” to reach the desired positioning and orientation within the uterus (see Figure 10B and 10C The locking mechanism 1100, when in the unlocked state, allows for such advance, rotation, and / or tilting of the elongated tubular member 202.

[0123] Once the desired orientation and positioning of the elongated tubular member 202 are achieved, the locking mechanism 1100 can be switched to a locked state to lock the elongated tubular member 202 in the desired orientation and positioning relative to the ultrasonic device 900. To switch the locking mechanism 1100 to the locked state, the screw 1142 is rotated about its axis to move one or both of the support rods 1114 (depending on whether one or both of the support rods 1114 include a threaded connector 1116) toward the other support rod 1114, thereby pulling the upper ends 1112b of one or both clamp brackets 1110 toward each other to clamp from opposite sides to engage around the elongated tubular member 202, thereby securing the elongated tubular member 202 relative to the locking mechanism 1100. As one or both upper ends 1112b of the clamp brackets 1110 move toward each other, the lower ends 1112a of one or both clamp brackets 1110 move apart, elastically stretching the elastic sling 1120 from opposite ends against the bias of the elastic sling 1120. In this way, the rotation of the screw 1142, along with the configuration of the elastic sling 1120, tilts the clamp brackets 1110 from an orientation relative to the guide rails 904 of the frame 902 and generally parallel to each other to an orientation relative to the guide rails 904 of the frame 902 and angular to each other, in which the upper ends 1112b of the clamp brackets 1110 are relatively closer, while the lower ends 1112a are relatively farther apart. The inclination of the clamp bracket 1110 relative to the guide rail 904 of the frame 902 causes the engagement pin 1130 to be angled within the hole 1132, thereby locking the engagement pin 1130, the clamp bracket 1110, and thus the elongated tubular member 202 relative to the guide rail 904 of the frame 902.

[0124] After the elongated tubular member 202, the locking mechanism 1100, and the ultrasonic device 900 have been secured relative to each other as detailed above, the cam locking lever 1144 can pivot from the unlocked position to the locked position to apply force to the adjacent end stop washers 1146 and thereby secure the locking mechanism 1100 in the locked state, in which the elongated tubular member 202 is maintained in the desired orientation and positioning relative to the ultrasonic device 900. Therefore, the need to manually maintain (or use clamps or other tools) the elongated tubular member 202 in its fixed orientation and positioning relative to the ultrasonic device 900 is eliminated. See also... Figure 1 and 10C In this locked state, the working instrument 100 can be inserted into the uterus “U” via the hysteroscope 200 (if it has not yet been inserted via the hysteroscope) and manipulated in the uterus to perform one or more surgical tasks, all of which are guided by ultrasound imaging provided by the ultrasound device 900.

[0125] Continue to refer to Figure 11C and 11D In order to unlock the locking mechanism, for example, to enable the removal of the hysteroscope 200, the cam locking lever 1144 is pivoted from the locked position back to the unlocked position, and then the screw 1142 is rotated in the opposite direction to disengage the engagement pin 1130 from the latching engagement in the hole 1132, so that the elastic sling 1120 can elastically return to its rest position and release the clamp bracket 1110 from the engagement around the elongated tubular member 202, thereby again allowing the elongated tubular member 202 to move relative to the locking mechanism 1100 and the ultrasound device 900, for example, sliding proximally or distally, rotating axially and / or tilting vertically.

[0126] Turn Figure 12A and 12B Another ultrasonic device provided according to this disclosure is shown generally as identified by reference numeral 1200. Except where explicitly contradicted below, ultrasonic device 1200 is similar to and may include ultrasonic device 900 detailed above. Figure 9 Therefore, only the ultrasonic device 1200 and ultrasonic device 900 are described in detail below. Figure 9 The differences between them are described in general terms or omitted entirely.

[0127] The ultrasound device 1200 includes a removable assembly 1250 and an adapter 1270. The removable assembly includes an ultrasound sensor assembly 1230, a distal spacer 1222, and a sterile barrier 1260. The removable assembly 1250 further includes a connecting cable 1280 that accommodates one or more wires, enabling connection of the ultrasound sensor assembly 1230 to an ultrasound control console (not shown). The ultrasound sensor assembly 1230 and the distal spacer 1222 may be integrally formed as a single unit, or the distal spacer 1222 may be releasably engaged with the ultrasound sensor assembly 1230. In either configuration, the distal spacer 1222 defines an engagement feature 1223 on its outer surface, such as an arrangement of fins projecting outward from the distal spacer, but alternative or additional features, such as slots, are also contemplated. In a configuration in which the distal spacer 1222 can be releasably engaged with the ultrasonic sensor assembly 1230, various ultrasonic sensor assemblies 1230 and corresponding distal spacers 1222 can be provided, thereby enabling customization, for example, for providing 2D ultrasound, 3D ultrasound, different sensor arrangements, etc.

[0128] A sterile barrier 1260 is configured to surround the ultrasound sensor assembly 1230 and the distal spacer 1222. The sterile barrier 1260 maintains the ultrasound sensor assembly 1230 in a sterile state throughout its use, but does not include the functionality of the ultrasound sensor assembly 1230.

[0129] Adapter 1270 defines an internal receiving region 1272, which includes engagement features 1274 complementary to the engagement features 1223 of the distal spacer 1222, such as complementary arrangements of slots, to facilitate engagement between adapters. More specifically, the internal receiving region 1272 of adapter 1270 is configured to receive and engage the distal spacer 1222 therein, wherein a sterile barrier 1260 is provided between the adapter and the distal spacer to thereby seal the interior of the sterile barrier 1260, thereby maintaining the sterility of the ultrasonic sensor assembly 1230. In some configurations, a positioning screw or other suitable additional engagement features may be provided to facilitate engagement of the distal spacer 1222 with the adapter 1270 and to seal the sterile barrier 1260 between the distal spacer and the adapter.

[0130] The adapter 1270 can be engaged between the rails 1204 of the longitudinal portion 1220 of the frame 1202, for example, by a pair of pins 1276 on either side (only one set of pins is shown) or other suitable releasable engagement mechanism, thereby enabling the ultrasonic sensor assembly 1230 to be releasably secured to the frame 1202, wherein the sterile barrier 1260 seals around the ultrasonic sensor assembly 1230.

[0131] Reference Figures 13A-13D According to this disclosure, a method for forming a sterile housing around an ultrasonic sensor assembly 1330 of an ultrasonic device 1300 is provided. The ultrasonic device 1300 is similar to and may include the ultrasonic device 900 detailed above. Figure 9 Therefore, only the ultrasonic device 1200 and ultrasonic device 900 are described in detail below. Figure 9 The differences between them are described in general terms or omitted entirely.

[0132] Initially, such as Figure 13A and 13BAs shown, a sterile barrier 1360, having an open end 1362 and a proximal end 1364, slides proximally over at least a portion of the ultrasonic sensor assembly 1330 of the ultrasonic device 1300 and the frame 1302 of the ultrasonic device 1300, guided by its open end 1362. The sterile barrier 1360 may surround and enclose the entire ultrasonic device 1300 or a sufficiently distal portion of the ultrasonic device to maintain the sterility of the ultrasonic device 1300 during use. More specifically, in some configurations, the sterile barrier 1360 surrounds and encloses at least a majority of the longitudinal portion 1320 of the frame 1302; in other configurations, the sterile barrier 1360 surrounds and encloses at least a portion of the longitudinal portion 1320 and the upright portion (not shown); in still other configurations, the sterile barrier 1360 surrounds and encloses at least a majority of the longitudinal portion 1320 and the upright portion; and in yet another configuration, the sterile barrier 1360 surrounds and encloses the entire frame 1302.

[0133] refer to Figure 13C After the sterile barrier 1360 is positioned as described above, it is sealed along the sealing line "SL", for example, by heat sealing, ultrasonic sealing, or any other suitable method, to the spaced-apart guide rails 1304 of the sterile barrier 1360 across the frame 1302, for example, the top and bottom laterally extending portions of the longitudinal portion 1320 across the frame 1302. Reference Figure 13D After the seal is formed, or simultaneously with or overlapping with the seal, the sterile barrier 1360 is cut along the seal line "SL", thereby defining a gap body "GV" that exposes the internal body between the spaced guide rails 1304 of the longitudinal portion 1320 of the frame 1302, while maintaining the sterile barrier 1360 in a sealed arrangement around the ultrasound sensor assembly 1330 and each of the guide rails 1304. Thus, a sealed barrier 1360 is formed to maintain at least a portion of the ultrasound sensor assembly 1330 and the spaced guide rails 1304 in a sterile state throughout the use of the ultrasound device 1300, without impairing the insertion of the hysteroscope 200 ( Figure 9 The ability to insert between spaced guide rails 1304 and to manipulate relative to the guide rails.

[0134] Turn Figure 14A-16 According to this disclosure, and configured to enable aseptic sealing of the ultrasonic sensor assembly of the ultrasonic device to maintain sterility during use, another ultrasonic device is shown, generally identified by reference numeral 1400. Ultrasonic device 1400 is similar to and may include the ultrasonic device 900 detailed above. Figure 9 Therefore, only the ultrasonic device 1400 and ultrasonic device 900 are described in detail below. Figure 9 The differences between them are described in general terms or omitted entirely.

[0135] refer to Figures 14A-14C The ultrasonic device 1400 includes a frame 1402 formed by a pair of spaced-apart guide rails 1404, and an ultrasonic sensor assembly 1430 disposed at a distal portion of the frame 1402. The guide rails 1404 are bent at bends 1406 to define a more proximal upright portion 1410 and a more distal longitudinal portion 1420. The longitudinal portion 1420 defines a proximal segment 1424, a distal segment 1426, and a connector segment 1428 disposed between the proximal segment 1424 and the distal segment 1426, respectively. The guide rails 1404 are interconnected by a first rear span 1407 extending across the upper ends of the guide rails along the proximal segment 1424 of the longitudinal portion 1420, such that the proximal segment 1424 of the longitudinal portion 1420 defines an inverted U-shaped configuration (see [link to documentation]). Figure 14B And interconnected by a second rear span 1408 extending along the distal segment 1426 of the longitudinal portion 1420 from the lower segment of the cross rail, such that the distal segment 1426 of the longitudinal portion 1420 defines a U-shaped configuration (see...). Figure 14C Furthermore, one of the guide rails 1404 is discontinuous because it defines the gap "G" along the connector segment 1428 and therefore does not extend along the connector segment 1428; instead, only one of the guide rails 1404 extends along the connector segment 1428 (see also...). Figure 15 ).

[0136] For further reference Figure 15 and 16 The ultrasonic device 1400 is configured to house a sterile barrier 1460 that surrounds and encloses the entire ultrasonic device 1400 or a sufficiently distal portion thereof to maintain the sterility of the ultrasonic device 1400 during use. More specifically, the sterile barrier 1460 is configured to extend proximally from the closed distal end 1464 of the sterile barrier around the ultrasonic sensor assembly 1430, around the distal segment 1426 of the longitudinal portion 1420 of the frame 1402, around the connector segment 1428 of the longitudinal portion 1420 of the frame 1402, and around the proximal segment 1424 of the longitudinal portion 1420 of the frame 1402.

[0137] Although the sterile barrier 1460 surrounds and encloses at least a portion of the longitudinal portion 1420 of the ultrasound sensor assembly 1430 and the frame 1402, the hysteroscope 200 can still be operatively coupled to the ultrasound device 1400 without compromising the sterility of the sterile barrier 1460, without impairing the function of the ultrasound device 1400, and without compromising the function or maneuverability of the hysteroscope 200 relative to the ultrasound device 1400. More specifically, refer to Figure 16To operatively connect the hysteroscope 200 to the longitudinal portion 1420 of the frame 1402, the elongated tubular member 202 of the hysteroscope 200 is first oriented substantially perpendicular to the longitudinal portion 1420 of the frame 1402, and then laterally moved between the guide rails 104 through the gap “G” into the connector segment 1428 of the longitudinal portion 1240 of the frame 1402. A sterile barrier 1460 flexes inward to allow insertion of the elongated tubular member 202 into the frame 1402.

[0138] After the elongated tubular member 202 of the hysteroscope 200 is placed within the connector segment 1428 of the longitudinal portion 1240 of the frame 1402, the elongated tubular member 202 can be, for example, along the... Figure 16 The illustrated orientation is vertically tilted clockwise to a use positioning in which the elongated tubular member 202 is positioned at an angle relative to the longitudinal axis of the frame 1402. From this positioning, the elongated tubular member can be advanced proximally and retracted distally; rotated about the axis of the elongated tubular member; and / or further vertically laid flat for ease of use. When the elongated tubular member 202 is vertically tilted and further vertically tilted, the proximal portion of the elongated tubular member 202 is exposed below the longitudinal portion (see [reference]). Figure 14B The proximal segment 1424 of the longitudinal portion 1420 is entered, while the more distal portion of the elongated tubular member 202 extends from the open upper side of the longitudinal portion (see...). Figure 14C The distal segment 1426 of the longitudinal portion 1420 is entered. The sterile barrier 1460 flexes upward and downward to allow the proximal and distal portions of the elongated tubular member 202 to tilt and insert into the frame 1402, respectively. The elongated tubular member 202 can tilt to a substantially coaxial orientation relative to the longitudinal axis defined by the longitudinal portion 1420 of the frame 1402 without compromising the sterile barrier 1460, but is prevented from tilting substantially beyond the rear spans due to the presence of the first rear span 1407 and the second rear span 1408, respectively.

[0139] refer to Figure 17A and 17B Another ultrasonic device provided under this disclosure is shown, generally identified by reference numeral 1700. Ultrasonic device 1700 is similar to and may include ultrasonic device 300 as detailed above. Figure 1 and 2 Therefore, only the ultrasonic device 1400 and ultrasonic device 300 are described in detail below. Figure 1 and 2 The differences between them are described in general terms or omitted entirely.

[0140] The ultrasound device 1700 includes a proximal body (not shown), a shaft 1720 extending distally from the proximal body, and an ultrasound sensor assembly 1730 disposed at the distal portion of the shaft 1720. In some configurations, the proximal body is omitted. The ultrasound device 1700 further includes a longitudinal lumen 1740 defined through the shaft 1720, the longitudinal lumen being configured to allow at least a portion of an endoscopic device, such as an elongated tubular member 202 of a hysteroscope 200, to pass through. Working instruments, such as an ablation probe 1780, can pass through the elongated tubular member 202 of the hysteroscope 200.

[0141] The main body portion 1722 of shaft 1720 defines a generally cylindrical configuration coaxially disposed around lumen 1740. Shaft 1720 further includes a distal leg 1725 extending distally from its distal portion. The distal leg 1725 defines a foot 1760 at its free end portion. An ultrasound sensor assembly 1730 is disposed within the foot 1760 and, in various respects, can be angled such that the field of view generated by the ultrasound sensor assembly 1730 is centered at a predetermined longitudinal distance from the distal end of shaft 1720 along the longitudinal axis of the shaft, for example, such that the distal end of the elongated tubular member 202 and / or the distal end of the ablation probe 1780 are maintained within the field of view during manipulation within the uterine “U” and / or surrounding tissues. The distal leg 1725 and foot 1760 project distally from the distal end of the body portion 1722 of the shaft 1720 at a location radially offset relative to the longitudinal axis defined by the body portion 1722 of the shaft 1720, such that they define an annular volume between the elongated tubular member 202 (when extending distally through the lumen 1740) and the foot 1760, regardless of the orientation of the ultrasound device 1700 relative to the elongated tubular member 202. The distal leg 1725 and foot 1760 are configured such that the annular volume defines a substantially constant width dimension along at least a portion of the longitudinal distance from the distal end of the body portion 1722 of the shaft 1720 to the distal end of the foot 1760. More specifically, the annular volume may define a substantially constant width along at least 50%, at least 70%, or at least 90% of the longitudinal distance (e.g., within 10%).

[0142] Due to the configuration described above, in which the distal leg 1725 and foot 1760 protrude distally from the distal end of the main body portion 1722 of the shaft 1720 at a radially offset positioning point, when the ultrasonic device 1700 rotates about the elongated tubular member 202, the foot 1760 circumferentially orbits the elongated tubular member 202, thereby maintaining the annular volume between them. In use, as... Figure 17BAs shown, the ultrasound device 1700 can be positioned together with the distal end of the main body portion 1722 of the shaft 1720 to abut against the cervix "C" (so that the elongated tubular member 202 and the ablation probe 1780 can be inserted through the cervix "C" and into the uterus "U"), while the foot 1760 (accommodating the ultrasound sensor assembly 1730) maintains contact with the vaginal fornix "VF". More specifically, the annular volume defined between the elongated tubular member 202 and the legs 1725 and foot 1760 accommodates the portion of the cervix "C" protruding into the vaginal canal "V", thereby allowing the foot 1760 to extend into contact with the vaginal fornix "VF". Maintaining tissue contact ensures proper transmission contact between the ultrasound sensor assembly 1730 and the tissue, thereby facilitating ultrasound imaging. With respect to the ultrasound device 1700 or any other ultrasound device detailed herein, an ultrasound gel can be used to facilitate maintaining proper transmission contact.

[0143] Continue to refer to Figure 17B The ultrasound device 1700 can rotate about the elongated tubular member 202 to position the foot 1760 in contact with different vaginal fornixes “VFs”. These various positioning of the ultrasound device 1700 provides different fields of view and / or viewing angles for facilitating ultrasound imaging, such as for identifying target tissue to be ablated using the ablation probe 1780, or for performing any other surgical tasks. For example, the ultrasound device 1700 can rotate to achieve a desired field of view or view and / or viewing angle, and maintain its proper positioning while performing ablation or other surgical tasks. Alternatively, the ultrasound device 1700 can rotate to various different rotational positions so that an ultrasound console (not shown) can generate and display 3D images of the patient's anatomy. This can be implemented in robotic embodiments (see [link to documentation]). Figure 20 This is achieved through [the system], which allows for easy control of the rotation of the ultrasound device 1700, but a manual implementation is also envisioned. 3D images can be generated for later use or continuously updated during the procedure.

[0144] refer to Figure 18 Another ultrasonic device 1800 according to this disclosure includes a shaft 1820, an ultrasonic sensor assembly 1830, and a biasing assembly 1870. The shaft 1820 and the ultrasonic sensor assembly 1830 may be similar to and include the ultrasonic device 1700. Figure 17A and 17B The features of shaft 1720 and ultrasonic sensor assembly 1730, any of the other configurations detailed herein, or any other suitable configuration are not described in detail below. Therefore, shaft 1820 and ultrasonic sensor assembly 1830 are not described in detail below.

[0145] The biasing assembly 1870 includes: an outer sleeve 1872 configured to retractably receive a proximal portion of the body 1822 of the shaft 1820; a locking collar 1874 disposed at the proximal end of the outer sleeve 1872; a positioning screw 1876 (or other suitable locking element) operably engaged with the locking collar 1874; and a biasing member 1878 (e.g., a coil spring) disposed within the outer sleeve 1872 and extending relative to the locking collar 1874 to the biasing body of the shaft 1820 between the locking collar 1874 and the proximal end face of the body 1822 of the shaft 1820. The body 1822 of the shaft 1820 and / or the outer sleeve 1872 may include a stop feature (not explicitly shown) configured to prevent complete removal and disengagement of the body 1822 of the shaft 1820 from the outer sleeve 1872. Furthermore, the proximal end faces of the outer sleeve 1872, the body 1822, and / or the locking collar 1874 may include end faces for securing the biasing member 1878 or otherwise retaining the biasing member 1878 relative to the proximal end faces of the outer sleeve 1872, the body 1822, and / or the locking collar 1874 (not explicitly shown).

[0146] The shaft 1820 of the ultrasound device 1800 defines a longitudinal lumen 1840 passing through the shaft, the longitudinal lumen being configured to slidably receive at least a portion of an endoscope device, such as the elongated tubular member 202 of a hysteroscope 200. A biasing assembly 1870 similarly defines an internal passage aligned with the lumen 1840 to receive the elongated tubular member 202 passing through the lumen. With the elongated tubular member 202 received by the biasing assembly 1870, a positioning screw 1876 can be tightened through a locking collar 1874 and abut against the elongated tubular member 202 to secure the locking collar 1874 around the elongated tubular member 202. The shaft 1820 and the bias assembly 1870 can be configured such that the locking collar 1874 remains outside the patient's body, while the shaft 1820 extends through the vagina to a position near the cervix "C", thereby enabling the bias assembly 1870 to be selectively locked and unlocked during use with the elongated tubular member 202.

[0147] In use, the ultrasound device 1800 is positioned at the distal end of the body 1822 of the shaft 1820 to abut against the cervix “C” and positioned by the elongated tubular member 202 (and the ablation probe 1780 in the elongated tubular member) to extend through the cervix “C” and into the uterus “U”. Before or after insertion, the positioning screw 1876 can be tightened through the locking collar 1874 and abut against the elongated tubular member 202 to secure the locking collar 1874 around the elongated tubular member 202. In this locked state of the locking collar 1874, the ultrasound device 1800 is operatively connected to the elongated tubular member 202 of the hysteroscope 200, allowing the ultrasound device 1800 and the elongated tubular member 202 to be manipulated as a unit, for example, by a single hand of the user (e.g., manipulating the handle of the hysteroscope 200). Furthermore, in this locked state, the biasing member 1878 biases the body 1822 of the shaft 1820 distally relative to the elongated tubular member 202, such that the foot 1860 of the shaft 1820 is biased distally to contact the vaginal fornix "VF", thereby ensuring proper transmission contact between the ultrasound sensor assembly 1830 and the tissue. More specifically, this allows the elongated tubular member 202 to be further distally advanced into the uterus "U" without applying excessive force to the cervix "C" or vaginal fornix "VF" due to compression of the biasing member 1878 (towards its bias), for example, to facilitate surgical procedures within the uterus. This compression allows the outer sleeve 1872 to slide distally about the body 1822 of the shaft 1820, thereby enabling the elongated tubular member 202 to move distally relative to the shaft 1820. Furthermore, proper transmission contact is maintained between the ultrasound sensor assembly 1830 and the tissue, even when the elongated tubular member 202 is withdrawn proximally from the uterus “U”. That is, when the elongated tubular member 202 is withdrawn proximally, the biasing member 1878 elastically elongates (under its bias) such that even if the elongated tubular member 202 is translated proximally relative to the axis 1820, the axis 1820 remains in contact with the tissue. The length of the outer sleeve 1872 and the length of the biasing member 1878 (in their resting, fully compressed, and / or fully extended positions) determine the permissible amount of distal advance and proximal withdrawal, and can be selected to allow for sufficient distal advance and proximal withdrawal as needed to manipulate the elongated tubular member 202 using the uterus “U” during use.

[0148] refer to Figure 19 According to another ultrasonic device 1900 disclosed herein, a shaft 1920, an ultrasonic sensor assembly 1930, a blocking assembly 1970, and a fluid supply assembly 1990 are included. The ultrasonic device 1900 may be similar to and include the ultrasonic device 1700. Figure 17A and 17BThe features of the ultrasonic device 1900 are as described herein, or any of the features of any other ultrasonic device or any other suitable configuration. Therefore, only the additional features of the ultrasonic device 1900 are described in detail below.

[0149] The occlusion assembly 1970 of the ultrasound device 1900 includes: an inflatable balloon 1972 disposed around a body 1922 about an axis 1920; and an expansion fluid line 1974 fluidly connected to the inflatable balloon 1972 and extending proximally through (or along) the axis 1920 to connect to an expansion fluid source, such as an expansion fluid pump connected to an expansion fluid reservoir (not shown) to allow the inflatable balloon 1972 to selectively inflate and deflate. The inflatable balloon 1972 defines a donut-shaped configuration such that, when the ultrasound device 1900 is positioned within a vaginal canal “V”, the inflatable balloon 1972 can inflate, for example by pumping expansion fluid through the expansion fluid line 1974 into the inflatable balloon 1972, thereby causing the inflatable balloon 1972 to expand to sealably engage the inner wall of the vaginal canal “V” and occlude the vaginal canal “V”.

[0150] The fluid supply assembly 1990 includes an infusion fluid conduit 1992 that extends via (or along) axis 1920 to one or more distal openings 1994 located distal to an inflatable balloon 1972. The infusion fluid conduit 1992 is configured to extend proximally to connect to an infusion fluid source, such as an infusion fluid pump connected to an infusion fluid reservoir (not shown), to allow selective infusion fluid to be infused into or withdrawn from the occluded portion of a vaginal canal “V” through the distal openings 1994 of the infusion fluid conduit 1992. As an alternative to the fluid supply assembly 1990 incorporated into the ultrasound device 1900, a separate fluid supply assembly may be used, for example, inserted through a lumen 1940 through axis 1920 of the ultrasound device 1900 or through an elongated tubular member 202 of the hysteroscope 200. Pumping an infusion fluid, such as saline or other suitable fluid, into the closed portion of the vaginal canal “V” provides a transmission medium for transmitting ultrasound from the ultrasound sensor assembly 1930 to the tissue without direct contact between the ultrasound sensor assembly 1930 and the tissue, thereby increasing the positionability of the ultrasound device 1900 to enable ultrasound visualization of, for example, the uterus “U”. This fluid infusion may be used additionally or alternatively for other purposes or may be omitted, thereby providing a stable and maintained position of the ultrasound device 1900 within the patient’s body via the inflatable balloon 1972.

[0151] Go to Figure 20This illustration shows a robotic surgical system 1000 configured for use according to this disclosure. Aspects and features of the robotic surgical system 1000 that are not closely related to the understanding of this disclosure are omitted so as not to obscure the aspects and features of this disclosure with unnecessary detail.

[0152] The robotic surgical system 1000 generally includes: multiple robotic arms 1002, 1003; a control unit 1004; and an operation console 1005 connected to the control unit 1004. The operation console 1005 may include: a display device 1006, specifically configured to display three-dimensional images; and manual input devices 1007, 1008, through which a person, for example a surgeon, can remotely operate the robotic arms 1002, 1003 in a first operating mode. The robotic surgical system 1000 can be configured for minimally invasive use on a patient 1013 lying on a patient table 1012. The robotic surgical system 1000 may further include a database 1014 specifically connected to the control unit 1004, containing, for example, preoperative data stored from the patient 1013 and / or anatomical atlases.

[0153] Each of the robotic arms 1002 and 1003 includes multiple components and mounting devices connected by joints. The mounting devices may be, for example, surgical instruments “ST”. The surgical instruments “ST” may include any of the devices disclosed herein, such as ultrasound devices, hysteroscopes (or endoscopes), working instruments, etc., thereby providing any of the functions detailed above on the robotic surgical system 1000.

[0154] Robotic arms 1002 and 1003 can be driven by an electric actuator, such as a motor, connected to a control unit 1004. The motor can be, for example, a rotary drive motor configured to provide rotary input to perform one or more desired tasks. The control unit 1004, such as a computer, can be configured to activate the motors in a manner specifically through a computer program that causes the robotic arms 1002 and 1003, and the surgical instruments "ST" mounted on the robotic arms, to perform desired movements and / or functions based on corresponding inputs from manual input devices 1007 and 1008, respectively. The control unit 1004 can also be configured to adjust the movement of the robotic arms 1002 and 1003 and / or the motors.

[0155] More specifically, the control device 1004 may control one or more motors based on rotation, for example, by controlling rotational positioning using a rotary positioning encoder (or Hall effect sensor or other suitable rotary positioning detector) associated with the motor, to determine the rotational output from the motor and the rotational input thereby provided. Alternatively or additionally, the control device 1004 may control one or more motors based on torque, current, or any other suitable method.

[0156] While various aspects of this disclosure have been shown in the accompanying drawings, it is not intended to limit this disclosure to these aspects, as it is intended that this disclosure be as broad as permitted in the art and should be interpreted in the same manner. Therefore, the above description should not be construed as restrictive, but merely as illustrative of specific aspects. Those skilled in the art will contemplate other modifications within the scope and spirit of the appended claims.

Claims

1. An ultrasonic device comprising: A frame comprising a first guide rail and a second guide rail spaced apart from each other, the frame defining a longitudinal segment defining a longitudinal axis, the longitudinal segment having a distal portion; as well as An ultrasonic sensor assembly configured to enable ultrasonic imaging of a field of view, the ultrasonic sensor assembly being attached to the distal portion of the longitudinal segment of the frame and oriented such that the field of view is positioned at an angle relative to the longitudinal axis. The ultrasound device also includes a locking mechanism disposed at the proximal portion of the ultrasound device, the locking mechanism being configured to selectively lock a surgical instrument extending between the first guide rail and the second guide rail in a fixed position and orientation relative to the ultrasound device. The locking mechanism is disposed between the first and second guide rails and includes a pair of clamp brackets, a resilient sling extending between the lower ends of the pair of clamp brackets, an engagement pin extending outward from each clamp bracket, and a cam-screw assembly including a screw and a cam locking lever, wherein the engagement pin extends outward from the clamp bracket into a hole defined in the inner surfaces of the first and second guide rails or into an elongated channel defined in the inner surface of the longitudinal section of the frame and extending longitudinally along the inner surface, the screw extends laterally relative to the first and second guide rails, and the cam locking lever is pivotally coupled to an end portion of the screw, wherein the elongated tubular member of the surgical instrument is configured to be inserted laterally between the clamp brackets of the locking mechanism and vertically between the screw and the resilient sling of the locking mechanism.

2. The ultrasound device of claim 1, wherein the frame further includes an upright section arranged at an angle relative to the longitudinal section, wherein the frame defines a bend that interconnects the upright section with a proximal portion of the longitudinal section.

3. The ultrasonic device according to claim 1, further comprising at least one spacer disposed between the first guide rail and the second guide rail, the at least one spacer fixing the first guide rail and the second guide rail to each other and maintaining the distance between the first guide rail and the second guide rail.

4. The ultrasound device of claim 3, wherein the at least one spacer comprises a distal spacer, the distal spacer being integrally formed with the ultrasound sensor assembly and disposed at the distal portion of the longitudinal segment of the frame.

5. The ultrasonic device according to claim 1, wherein the first guide rail and the second guide rail are substantially parallel plates.

6. The ultrasound device of claim 1, further comprising a sterile barrier disposed around at least a portion of the longitudinal segment of the ultrasound sensor assembly and the frame.

7. The ultrasonic device of claim 1, wherein the ultrasonic sensor assembly is separable from the distal portion of the longitudinal segment of the frame.

8. The ultrasound device of claim 7, further comprising a sterile barrier disposed around the ultrasound sensor assembly, wherein the ultrasound sensor assembly with the sterile barrier disposed around it is attachable to the distal portion of the longitudinal segment of the frame.

9. The ultrasound device of claim 1, wherein the first guide rail and the second guide rail are interconnected by a rear span along a portion of the length of the longitudinal segment of the frame, the rear span being less than the length of the longitudinal segment of the frame.

10. A surgical system comprising: An ultrasonic device, the ultrasonic device comprising: A frame comprising a first guide rail and a second guide rail spaced apart from each other, the frame defining a longitudinal segment defining a longitudinal axis, the longitudinal segment having a distal portion; as well as An ultrasonic sensor assembly configured to enable ultrasonic imaging of a field of view, the ultrasonic sensor assembly being attached to the distal portion of the longitudinal segment of the frame and oriented such that the field of view is positioned at an angle relative to the longitudinal axis. as well as A surgical instrument configured to be inserted between a first guide rail and a second guide rail of the frame, wherein the first guide rail and the second guide rail constrain the lateral movement of the surgical instrument. The ultrasound device also includes a locking mechanism disposed at the proximal portion of the ultrasound device, the locking mechanism being configured to selectively lock a surgical instrument extending between the first guide rail and the second guide rail in a fixed position and orientation relative to the ultrasound device. The locking mechanism is disposed between the first and second guide rails and includes a pair of clamp brackets, a resilient sling extending between the lower ends of the pair of clamp brackets, an engagement pin extending outward from each clamp bracket, and a cam-screw assembly including a screw and a cam locking lever, wherein the engagement pin extends outward from the clamp bracket into a hole defined in the inner surfaces of the first and second guide rails or into an elongated channel defined in the inner surface of the longitudinal section of the frame and extending longitudinally along the inner surface, the screw extends laterally relative to the first and second guide rails, and the cam locking lever is pivotally coupled to an end portion of the screw, wherein the elongated tubular member of the surgical instrument is configured to be inserted laterally between the clamp brackets of the locking mechanism and vertically between the screw and the resilient sling of the locking mechanism.

11. The surgical system of claim 10, wherein the frame of the ultrasound device further comprises an upright section and a curved section, the upright section being positioned at an angle relative to the longitudinal section, the curved section interconnecting the proximal portions of the upright section and the longitudinal section.

12. The surgical system of claim 11, wherein the surgical instrument is oriented parallel or coaxial with the longitudinal axis of the longitudinal segment of the frame at the curved portion of the frame or at the upright section of the frame between the first guide rail and the second guide rail of the frame.

13. The surgical system of claim 10, wherein when the surgical instrument is inserted between the first guide rail and the second guide rail, the first guide rail and the second guide rail constrain the lateral movement of the surgical instrument while allowing the surgical instrument to translate axially, rotate axially, and tilt vertically.

14. The surgical system of claim 10, wherein the ultrasound device further comprises at least one spacer disposed between the first guide rail and the second guide rail, the at least one spacer fixing the first guide rail and the second guide rail to each other and maintaining the distance between the first guide rail and the second guide rail.

15. The surgical system of claim 10, wherein the first and second guide rails of the frame of the ultrasound device are substantially parallel plates.

16. The surgical system of claim 10, further comprising a sterile barrier disposed around at least a portion of the longitudinal segment of the ultrasound sensor assembly and the frame.

17. The surgical system of claim 16, wherein the surgical instrument remains outside the sterile barrier when inserted between the first guide rail and the second guide rail.

18. The surgical system of claim 10, wherein the surgical instrument is a hysteroscope, the hysteroscope being configured to house a working instrument passing through the hysteroscope.

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