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

Abstract

The ultrasonic device includes a frame and an ultrasonic sensor assembly. The frame includes first and second rails spaced apart from one another and a longitudinal section defining a longitudinal axis. The longitudinal section has a distal end portion. The ultrasonic sensor assembly is configured to enable ultrasonic imaging of a field of view and is attached to the distal end portion of the longitudinal section of the frame and 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 ultrasonic device and a surgical instrument insertable therethrough.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62 / 958,045, filed January 7, 2020, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to devices, systems, and methods for hysteroscopy, and more particularly, for transvaginal ultrasound-guided hysteroscopic surgery. [Background technology]

[0003] Transvaginal hysteroscopy includes 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 approaches and / or instruments compared to intramural procedures, and vice versa. Even within the same category, hysteroscopic procedures may require different approaches and / or instruments depending, for example, on the procedure being performed, the patient's anatomy, the techniques utilized, and / or other considerations. Summary of the Invention [Means for solving the problem]

[0004] As used herein, the term "distal" refers to a portion that is described as being further from the user, while the term "proximal" refers to a portion that is described as being closer to the user. Furthermore, to the extent consistent, any or all of the aspects detailed herein may be used in conjunction with any or all of the other aspects detailed herein.

[0005] According to an aspect of the present disclosure, there is provided a hysteroscopy system including an ultrasound device and a hysteroscope. The ultrasound device includes a proximal body, a shaft 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 end portion of the shaft and oriented toward a distal-facing surface of the distal end portion of the shaft. The hysteroscope is configured to be at least partially removably inserted through a lumen defined by the ultrasound device. The hysteroscope includes an optical system configured to enable visualization from the distal end portion of the hysteroscope.

[0006] In one aspect of the present disclosure, the system further includes a working instrument configured to be at least partially removably inserted through a working channel defined by the hysteroscope. The working instrument may be a tissue resection device.

[0007] In another aspect of the present disclosure, at least the shaft defines a lumen extending longitudinally therethrough to an open distal end of the lumen at a distal end portion of the shaft.

[0008] In yet another aspect of the present disclosure, the distal end portion of the shaft includes a distal foot that extends distally beyond the open distal end of the lumen. The distal foot defines a distally facing surface.

[0009] In yet another aspect of the present disclosure, the distally-facing surface at least partially surrounds the open distal end of the lumen.

[0010] In still yet another aspect of the present disclosure, the distally-facing surface is at least one of convex, conical, or curved.

[0011] In another aspect of the present disclosure, the ultrasound device further includes a movable sheath that is movable relative to the shaft. In such an aspect, the movable sheath defines a lumen therethrough.

[0012] In another aspect of the present disclosure, the movable sheath is coupled to the shaft via a pin and slot mechanism configured to allow the movable sheath to pivot and slide relative to the shaft.

[0013] A hysteroscopic ultrasound device provided in accordance with the present disclosure includes a proximal body, a shaft extending distally from the proximal body, and an ultrasound sensor assembly. At least the shaft defines a lumen extending longitudinally therethrough to an open distal end at the distal end portion of the shaft. The ultrasound sensor assembly is disposed at the distal end portion of the shaft and oriented toward a distal-facing surface of the distal end portion of the shaft. The ultrasound sensor assembly is configured to enable ultrasound imaging.

[0014] In one aspect of the present disclosure, the shaft and proximal body cooperate to define a lumen.

[0015] In another aspect of the present disclosure, the distal end portion of the shaft includes a distal foot that extends distally beyond the open distal end of the lumen. In such an aspect, the distal foot defines a distally-facing surface.

[0016] In yet another aspect of the present disclosure, the distally-facing surface at least partially surrounds the open distal end of the lumen.

[0017] In yet another aspect of the present disclosure, the distally facing surface is at least one of convex, conical, or curved.

[0018] In another aspect of the present disclosure, at least a portion of the distally facing surface is angled relative to a longitudinal axis defined through the lumen.

[0019] In still yet another aspect of the present disclosure, the distal surface of the distal end portion of the shaft is asymmetric.

[0020] Another hysteroscopic ultrasound device provided in accordance with the present disclosure includes a proximal body, a shaft extending distally from the proximal body to a distal end portion of the shaft, an ultrasound sensor assembly, and a movable sheath. The ultrasound sensor assembly is disposed on the distal end portion of the shaft and oriented toward a distal-facing surface of the distal end 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 at least pivotable relative to the shaft. The movable sheath defines a lumen therethrough configured to at least partially receive a surgical instrument. In an angled position of the movable sheath relative to the shaft, a longitudinal axis of the movable sheath is disposed at an angle relative to a longitudinal axis of the shaft.

[0021] In one aspect of the present disclosure, the movable sheath is configured to pivot and translate relative to the shaft.

[0022] In another aspect of the present disclosure, the movable sheath is coupled to the shaft via a pin and slot mechanism.

[0023] In yet another aspect of the present disclosure, the movable sheath is movable from an in-line position, wherein the longitudinal axis of the movable sheath is disposed in an angled position in a substantially coaxial orientation relative to the longitudinal axis of the shaft.

[0024] An ultrasound device provided in accordance with the present disclosure includes a frame and an ultrasound sensor assembly. The frame includes first and second rails spaced apart from one another, defining a longitudinal section defining a longitudinal axis and having a distal end portion. The ultrasound sensor assembly is configured to enable ultrasound imaging of a field of view, is attached to the distal end portion of the longitudinal section of the frame, and is oriented such that the field of view is disposed at an oblique angle relative to the longitudinal axis.

[0025] In one aspect of the present disclosure, the frame further includes an upright section disposed at an angle relative to the longitudinal section, and a bend interconnecting the upright section and a proximal end portion of the longitudinal section.

[0026] In another aspect of the present disclosure, the ultrasonic device further includes at least one spacer disposed between the first and second rails configured to secure the first and second rails to one another and maintain a spacing therebetween.

[0027] In yet another aspect of the present disclosure, the at least one spacer includes a distal spacer integrally formed with the ultrasonic sensor assembly and disposed at a distal end portion of the longitudinal section of the frame.

[0028] In yet another aspect of the present disclosure, the first and second rails are substantially parallel plates.

[0029] In still yet another aspect of the present disclosure, the ultrasound device further includes a sterility barrier disposed around the ultrasound sensor assembly and at least a portion of the longitudinal section of the frame.

[0030] In another aspect of the present disclosure, the ultrasonic sensor assembly is removable from the distal end portion of the longitudinal section of the frame. In such an aspect, a sterility barrier is provided that is disposable around the ultrasonic sensor assembly. The ultrasonic sensor assembly with the sterility barrier disposed therearound is mountable to the distal end portion of the longitudinal section of the frame.

[0031] In another aspect of the present disclosure, the ultrasound device further includes a locking mechanism configured to selectively lock a hysteroscope disposed between the first and second rails and configured to receive a surgical instrument, e.g., a working instrument extending between the first and second rails, therethrough, in a fixed position and orientation relative thereto.

[0032] In still yet another aspect of the present disclosure, the first and second rails are interconnected by a backspan along a portion of the length of the longitudinal section of the frame that is shorter than the length of the longitudinal section of the frame.

[0033] A surgical system provided in accordance with the present disclosure includes an ultrasonic device according to any of the above or other aspects herein, and a hysteroscope configured to receive a surgical instrument, e.g., a working instrument, therethrough and configured for insertion between first and second rails of a frame, whereby the first and second rails constrain lateral movement of the surgical instrument.

[0034] In one aspect of the present disclosure, a surgical instrument is insertable between the first and second rails of the frame in a bent portion of the frame or in the upright section of the frame, in an orientation parallel to or coaxial with the longitudinal axis of the longitudinal section of the frame.

[0035] In another aspect of the present disclosure, when a surgical instrument is inserted between the first and second rails, the first and second rails constrain lateral movement of the surgical instrument while allowing axial translation, axial rotation, and vertical tilt of the surgical instrument.

[0036] In yet another aspect of the present disclosure, a sterile barrier is disposed around at least a portion of the longitudinal section of the ultrasonic sensor assembly and the frame of the ultrasonic device, while when a surgical instrument is inserted between the first rail and the second rail, the surgical instrument remains outside the sterile barrier.

[0037] In yet another aspect of the present disclosure, the ultrasonic device further includes a locking mechanism disposed between the first and second rails and configured to selectively lock the surgical instrument between the first and second rails in a fixed position and orientation relative thereto.

[0038] Another surgical system provided in accordance with the present disclosure includes an ultrasonic device and a surgical instrument. The ultrasonic device includes a shaft having a body defining a longitudinal axis and including a lumen extending coaxially therethrough, and an ultrasonic sensor assembly configured to enable ultrasonic imaging of a field of view. The ultrasonic sensor assembly is disposed at a distal end portion of the shaft body and is 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 shaft body and to extend distally from the distal end portion of the shaft body.

[0039] In one aspect of the present disclosure, the shaft further includes a foot extending distally from the body. In such an aspect, the ultrasonic sensor assembly can be disposed within the foot.

[0040] In another aspect of the present disclosure, the shaft further includes a leg extending distally from the body and a foot disposed at a distal end of the leg. In such an aspect, the ultrasonic sensor assembly can be disposed in the foot.

[0041] In yet another aspect of the present disclosure, when a surgical instrument is inserted through the lumen and extends distally from the distal end portion of the body, an annular volume is defined between the innermost surface of the foot and the outermost surface of the surgical instrument. In such an aspect, the ultrasonic device may be rotatable about the surgical instrument inserted therethrough while maintaining the annular volume, regardless of the rotational orientation of the ultrasonic device relative to the surgical instrument.

[0042] In yet another aspect of the present disclosure, the field of view is offset at an oblique angle relative to the longitudinal axis, and in another aspect, at an acute angle relative to the longitudinal axis.

[0043] In another aspect of the present disclosure, the ultrasonic sensor assembly is oriented toward a distal face of the shaft that at least partially surrounds the open distal end of the lumen.

[0044] In yet another aspect of the present disclosure, the ultrasonic sensor assembly is oriented toward a distal surface of the shaft that includes at least one of a convex, conical, or curved surface portion.

[0045] In another aspect of the present disclosure, the ultrasonic sensor assembly is oriented toward a distal surface of the shaft, the distal surface being angled relative to the longitudinal axis.

[0046] The biasing assembly can be provided in several ways: The biasing assembly is configured to couple the ultrasonic device to the surgical instrument and to bias the ultrasonic device distally about and relative to the surgical instrument.

[0047] The biasing assembly may, in aspects, include a locking collar configured to fixedly engage about the surgical instrument, an outer sleeve configured to telescopically receive the shaft, and a biasing member disposed between the locking collar and the shaft to bias the shaft distally.

[0048] In aspects, an inflatable balloon can be provided disposed about the body of the shaft, and in such aspects, the ultrasound device can further include a fluid exit opening positioned distal to the inflatable balloon.

[0049] A surgical method provided in accordance with aspects of the present disclosure includes inserting an ultrasound device transvaginally to position an ultrasound sensor assembly of the ultrasound device adjacent to the exterior of the cervix of the uterus, and inserting a surgical instrument through the lumen of the ultrasound device, through the cervix, and into the uterus.

[0050] In one aspect, positioning the ultrasound sensor assembly adjacent the exterior of the uterine cervix includes positioning the ultrasound sensor assembly in contact with the vaginal vault.

[0051] In one aspect, the method further includes generating an ultrasound image of at least a portion of the uterus using an ultrasound sensor assembly.

[0052] In one aspect, the method further includes locking the surgical instrument in a fixed position relative to the ultrasonic device.

[0053] In one aspect, the method further comprises inserting a working instrument into the uterus through the surgical instrument.

[0054] In one aspect, the method further comprises rotating the ultrasound device around the cervix. The present invention provides, for example, the following. (Item 1) 1. An ultrasound device comprising: a frame including first and second rails spaced apart from one another, the frame defining a longitudinal section defining a longitudinal axis, the longitudinal section having a distal end portion; an ultrasonic sensor assembly configured to enable ultrasonic imaging of a field of view, the ultrasonic sensor assembly being attached to the distal end portion of the longitudinal section of the frame and oriented such that the field of view is disposed at an oblique angle relative to the longitudinal axis. (Item 2) Item 10. The ultrasound device of item 1, wherein the frame further includes an upright section disposed at an angle relative to the longitudinal section, the frame defining a bend interconnecting the upright section and a proximal end portion of the longitudinal section. (Item 3) 2. The ultrasonic device of claim 1, further comprising at least one spacer disposed between the first and second rails, the at least one spacer securing the first and second rails to one another and maintaining a distance therebetween. (Item 4) 2. The ultrasound device of claim 1, wherein the at least one spacer includes a distal spacer integrally formed with the ultrasound sensor assembly and disposed at the distal end portion of the longitudinal section of the frame. (Item 5) Item 10. The ultrasonic device of item 1, wherein the first and second rails are substantially parallel plates. (Item 6) Item 10. The ultrasound device of item 1, further comprising a sterility barrier disposed around the ultrasound sensor assembly and at least a portion of the longitudinal section of the frame. (Item 7) Item 10. The ultrasound device of item 1, wherein the ultrasound sensor assembly is removable from the distal end portion of the longitudinal section of the frame. (Item 8) 8. The ultrasound device of claim 7, further comprising a sterility barrier disposable around the ultrasound sensor assembly, the ultrasound sensor assembly having the sterility barrier disposed therearound being mountable to the distal end portion of the longitudinal section of the frame. (Item 9) Item 1. The ultrasonic device of item 1, further comprising a locking mechanism disposed between the first and second rails, the locking mechanism configured to selectively lock a surgical instrument extending between the first and second rails in a fixed position and orientation relative thereto. (Item 10) Item 1. The ultrasound device of item 1, wherein the first and second rails are interconnected by a backspan along a portion of the length of the longitudinal section of the frame that is shorter than the length of the longitudinal section of the frame. (Item 11) 1. A surgical system comprising: 1. An ultrasound device comprising: a frame including first and second rails spaced apart from one another, the frame defining a longitudinal section defining a longitudinal axis, the longitudinal section having a distal end portion; an ultrasonic sensor assembly configured to enable ultrasonic imaging of a field of view, the ultrasonic sensor assembly being attached to the distal end portion of the longitudinal section of the frame and oriented such that the field of view is disposed at an oblique angle relative to the longitudinal axis; and a surgical instrument inserted between the first and second rails of the frame, whereby the first and second rails constrain lateral movement of the surgical instrument; (Item 12) Item 12. The surgical system of item 11, wherein the frame of the ultrasonic device further includes an upright section disposed at an angle relative to the longitudinal section, and a bend interconnecting the upright section and a proximal end portion of the longitudinal section. (Item 13) Item 13. The surgical system of item 12, wherein the surgical instrument is insertable between the first and second rails of the frame at the bent portion of the frame or the upright section of the frame in a parallel or coaxial orientation to the longitudinal axis of the longitudinal section of the frame. (Item 14) Item 12. The surgical system of item 11, wherein when the surgical instrument is inserted between the first and second rails, the first and second rails constrain lateral movement of the surgical instrument while allowing axial translation, axial rotation, and vertical tilt of the surgical instrument. (Item 15) Item 12. The surgical system of item 11, further comprising at least one spacer disposed between the first and second rails, the at least one spacer securing the first and second rails to one another and maintaining the spacing therebetween. (Item 16) Item 12. The surgical system of item 11, wherein the first and second rails of the frame of the ultrasonic device are substantially parallel plates. (Item 17) Item 12. The surgical system of item 11, further comprising a sterility barrier disposed around the ultrasonic sensor assembly and at least a portion of the longitudinal section of the frame. (Item 18) 20. The surgical system of claim 17, wherein the surgical instrument remains outside the sterile barrier when inserted between the first and second rails. (Item 19) Item 12. The surgical system of item 11, further comprising a locking mechanism disposed between the first and second rails, the locking mechanism configured to selectively lock the surgical instrument between the first and second rails in a fixed position and orientation relative thereto. (Item 20) Item 12. The surgical system of item 11, wherein the surgical device is a hysteroscope configured to receive a working instrument therethrough. (Item 21) 1. A surgical system comprising: 1. An ultrasound device comprising: a shaft having a body defining a longitudinal axis and including a lumen extending coaxially therethrough; an ultrasonic sensor assembly configured to enable ultrasonic imaging of a field of view, the ultrasonic sensor assembly being disposed at a distal end portion of the body of the shaft and offset relative to the longitudinal axis, the ultrasonic sensor assembly being oriented such that the field of view is offset relative to the longitudinal axis; a surgical instrument configured to be removably inserted through the lumen of the shaft body and to extend distally from the distal end portion of the shaft body. (Item 22) 22. The surgical system of claim 21, wherein the shaft further includes a foot extending distally from the body, the ultrasonic sensor assembly being disposed within the foot. (Item 23) 22. The surgical system of claim 21, wherein the shaft further includes a leg extending distally from the body and a foot disposed at a distal end of the leg, the ultrasonic sensor assembly being disposed in the foot. (Item 24) 24. The surgical system of claim 23, wherein an annular volume is defined between an innermost surface of the foot and an outermost surface of the surgical instrument when the surgical instrument is inserted through the lumen and extends distally from the distal end portion of the body. (Item 25) 25. The surgical system of claim 24, wherein the ultrasonic device is rotatable about the surgical instrument inserted therethrough, and the annular volume is maintained regardless of rotational orientation of the ultrasonic device relative to the surgical instrument. (Item 26) 22. The surgical system of claim 21, wherein the field of view is offset at an oblique angle relative to the longitudinal axis. (Item 27) 22. The surgical system of claim 21, wherein the field of view is offset at an acute angle relative to the longitudinal axis. (Item 28) 22. The surgical system of claim 21, wherein the ultrasonic sensor assembly is oriented toward a distal surface of the shaft, the distal surface at least partially surrounding an open distal end of the lumen. (Item 29) 22. The surgical system of claim 21, wherein the ultrasonic sensor assembly is oriented toward a distal surface of the shaft, the distal surface including a portion that is at least one of convex, conical, or curved. (Item 30) 22. The surgical system of claim 21, wherein the ultrasonic sensor assembly is oriented toward a distal surface of the shaft, the distal surface being angled relative to the longitudinal axis. (Item 31) 22. The surgical system of claim 21, further comprising a biasing assembly coupling the ultrasonic device to the surgical instrument and configured to bias the ultrasonic device distally about and relative to the surgical instrument. (Item 32) 32. The surgical system of claim 31, wherein the biasing assembly includes a locking collar configured to fixedly engage about the surgical instrument, an outer sleeve configured to telescopically receive the shaft, and a biasing member disposed between the locking collar and the shaft to bias the shaft distally. (Item 33) 22. The surgical system of claim 21, wherein the ultrasonic device further comprises an inflatable balloon disposed around the body of the shaft. (Item 34) 34. The surgical instrument of claim 33, wherein the ultrasonic device further comprises a fluid exit opening positioned distal to the inflatable balloon. [Brief explanation of the drawings]

[0055] The above and other aspects and features of the present disclosure will become more apparent in light of the following detailed description when considered in conjunction with the accompanying drawings in which like reference numbers identify similar or identical elements.

[0056] [Figure 1] FIG. 1 is an exploded perspective view of a hysteroscopy system according to the present disclosure. [Figure 2] FIG. 2 is a perspective view of the distal end portion of the ultrasound device of the hysteroscope system of FIG. 1. [Figure 3] 1. FIG. 4 is a perspective view of another configuration of the distal end portion of the ultrasound device of the hysteroscope system of FIG. [Figure 4] 1. FIG. 4 is a perspective view of yet another configuration of the distal end portion of the ultrasound device of the hysteroscope system of FIG. [Figure 5] FIG. 2 is a side view of the hysteroscope system of FIG. 1 positioned within the vagina to perform a procedure on or within the uterus. [Figure 6] FIG. 2 is a side view of another ultrasound device configured for use in the hysteroscopy system of FIG. 1. [Figure 7] FIG. 7 is a side view of the ultrasound device of FIG. 6 positioned within the vagina to perform a procedure on or within the uterus utilizing a hysteroscope and working instruments. [Figure 8] FIG. 2 is a side view of another ultrasound device configured for use in the hysteroscopy system of FIG. 1. [Figure 9] FIG. 1 is a perspective view of another ultrasound device including an operably received hysteroscope. [Figure 10A] 10 is a perspective view showing the ultrasound device of FIG. 9 positioned adjacent to the cervix and the gradual insertion of the hysteroscope of FIG. 9 through the cervix and into the uterus. [Figure 10B] 10 is a perspective view showing the ultrasound device of FIG. 9 positioned adjacent to the cervix and the gradual insertion of the hysteroscope of FIG. 9 through the cervix and into the uterus. [Figure 10C] 10 is a perspective view showing the ultrasound device of FIG. 9 positioned adjacent to the cervix and the gradual insertion of the hysteroscope of FIG. 9 through the cervix and into the uterus. [Figure 11A] FIG. 10 is a perspective view of the proximal end portion of the ultrasound device of FIG. 9, including a locking mechanism. [Figure 11B] 11B is a top view of the proximal portion of the ultrasound device of FIG. 9, including the locking mechanism of FIG. 11A. [Figure 11C] 11B is a proximal end view of the ultrasound device of FIG. 9 including the locking mechanism of FIG. 11A and including a hysteroscope operably received therein in unlocked and locked states, respectively. [Figure 11D] 11B is a proximal end view of the ultrasound device of FIG. 9 including the locking mechanism of FIG. 11A and including a hysteroscope operably received therein in unlocked and locked states, respectively. [Figure 12A] FIG. 1 is an exploded perspective view of another ultrasound device according to the present disclosure including a sterility barrier disposed over an ultrasound sensor assembly. [Figure 12B] FIG. 12B is an exploded transverse cross-sectional view of the adapter component of the ultrasound device of FIG. 12A. [Figure 13A] 1A-1C are top views progressively illustrating a method for sealing a sterility barrier on an ultrasound device. [Figure 13B] 1A-1C are top views progressively illustrating a method for sealing a sterility barrier on an ultrasound device. [Figure 13C] 1A-1C are top views progressively illustrating a method for sealing a sterility barrier on an ultrasound device. [Figure 13D]1A-1C are top views progressively illustrating a method for sealing a sterility barrier on an ultrasound device. [Figure 14A] FIG. 10 is a side view of yet another ultrasound device according to the present disclosure including an operably received hysteroscope. [Figure 14B] 14B-14B and 14C-14C are cross-sectional views of FIG. 14A taken along section lines "14B-14B" and "14C-14C," respectively. [Figure 14C] 14B-14B and 14C-14C are cross-sectional views of FIG. 14A taken along section lines "14B-14B" and "14C-14C," respectively. [Figure 15] FIG. 14B is a side view of the distal portion of the ultrasound device of FIG. 14A, including a sterile barrier disposed therearound. [Figure 16] FIG. 14B is a side view of the ultrasound device of FIG. 14A, including a sterile barrier disposed thereabout and a hysteroscope inserted and operably positioned relative thereto. [Figure 17A] FIG. 1 is a perspective view of another ultrasound device including a hysteroscope and a working instrument inserted therewith. [Figure 17B] FIG. 17B is a perspective view of the ultrasound device of FIG. 17A positioned adjacent to the cervix with the hysteroscope and working instruments extending through the cervix and into the uterus. [Figure 18] FIG. 1 is a perspective view of another ultrasound device positioned adjacent to the cervix with the hysteroscope and working instrument extending through the cervix and into the uterus. [Figure 19] FIG. 1 is a perspective view of another ultrasound device positioned adjacent to the cervix with the hysteroscope and working instrument extending through the cervix and into the uterus. [Figure 20] FIG. 1 is a schematic diagram of an exemplary robotic surgical system configured for use in the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0057] Referring to FIG. 1 , a hysteroscopy system provided in accordance with the present disclosure is generally shown identified by the reference numeral 10, including a working instrument 100, e.g., a tissue resection device, ablation device, biopsy device, a hysteroscope 200, and an ultrasound device 300. The ultrasound device 300 is configured for transvaginal insertion adjacent to or against the cervix. The hysteroscope 200 is configured for insertion into the uterus through the ultrasound device 300 and the cervix. The working instrument 100 is configured to be inserted into the uterus through the hysteroscope 200 to perform a surgical procedure within the uterine cavity and / or uterine wall.

[0058] Working instrument 100 may be, as described above, a tissue resection device, an ablation device, a biopsy device, or other suitable working instrument configured for use on or within a uterus. With respect to a tissue resection device, for example, 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. Housing 110 houses drive mechanism 140 therein and functions as a handle to allow a user to grasp working instrument 100. Drive mechanism 140 includes a motor and is operably coupled to cutting member 130 to drive rotation and / or translation of cutting member 130 relative to shaft 120. Drive mechanism 140 is adapted to connect to a control unit (not shown) via cable 160 to power and control the motor, although working instrument 100 may alternatively be battery or manually powered. A suction source (not shown) integrated into the control unit (not shown), or any other suitable vacuum generating mechanism, may also be provided to facilitate the extraction of fluids, tissue, and debris through the working instrument 100 and outflow tube 150, as described in detail below.

[0059] The shaft 120 of the working instrument 100 extends distally from the housing 110 and, in embodiments, is stationary relative to the housing 110, although other configurations are contemplated. The shaft 120 defines a window through its sidewall toward its distal end to provide access to a cutting member 130 that is rotatably and / or translatably disposed within the shaft 120 and operably coupled to the drive mechanism 140 as described above. The cutting member 130 defines an opening providing access to its interior and may include a serrated cutting edge surrounding the opening, although other suitable cutting edge configurations are contemplated. Alternatively or additionally, the shaft 120 may include a cutting edge defined around the window.

[0060] In use of the working instrument 100, upon activation, tissue is drawn through the window in the shaft 120 and into the opening in the cutting member 130. As the tissue is drawn into the opening in the cutting member 130, it is resected via rotation and / or translation of the cutting member 130 relative to the shaft 120, such that the resected tissue, along with fluids and debris, may be drawn proximally through the cutting member 130. The resected tissue, fluids and debris are drawn proximally through the cutting member 130, through the outflow port 150 and outflow tubing (not shown), and ultimately into one or more collection canisters of a fluid management system (not shown).

[0061] Continuing with reference to FIG. 1 , hysteroscope 200 includes an elongated tubular member 202 and a proximal body 240. Elongated tubular member 202 of hysteroscope 200 defines a working channel 204 configured to receive a working instrument, such as working instrument 100, therethrough. Working channel 204 may also function as a fluid inflow (or outflow) channel. Alternatively, or additionally, a separate fluid inflow (or outflow) channel may be provided. Elongated tubular member 200 further includes an optical system 210 extending therethrough to enable visualization at the distal end of elongated tubular member 202.

[0062] The proximal body 240 of the hysteroscope 200 includes a housing 242, a light post 244, a bulb 246, and an arm 248. The light post 244 extends from the housing 242 and is configured to connect to a light source, such as to illuminate the distal end of the elongate tubular member 202, via one or more fiber optic strands (not shown) coupled to the light post 244 and extending through the elongate tubular member 202. The bulb 246 is disposed in fluid communication with the working channel 204 and is configured to allow selective flow of fluid into and / or out of the working channel 204. In configurations in which multiple fluid channels are provided, multiple bulbs may be similarly provided. The arm 248 is configured to connect to an imaging device, such as a camera, to capture images received via the optical system 210, thereby enabling display of a video of the internal surgical site imaged by the optical system 210.

[0063] 1 , ultrasound device 300 includes a proximal body 310, a shaft 320 extending distally from proximal body 310, and an ultrasound sensor assembly 330 disposed at a distal end portion 324 of shaft 320. Ultrasound device 300 further includes a longitudinal lumen 340 defined through proximal body 310 and shaft 320 and including an open proximal end 342 and an open distal end 344. Longitudinal lumen 340 may be coaxial with the longitudinal axis defined through shaft 320 or may be offset and / or angled relative thereto. Longitudinal lumen 340 is configured to allow passage of at least a portion of an endoscopic device, for example, elongated tubular member 202 of hysteroscope 200, such that a distal portion of elongated tubular member 202 extends distally from shaft 320 through open distal end 344 of longitudinal lumen 340. Longitudinal lumen 340 may additionally or alternatively be configured to allow other instruments, such as one or more working instruments, to pass therethrough.

[0064] The proximal body 310 of the ultrasonic device 300 can be configured as a handle including, for example, a pistol-style grip 312, although other handle configurations are also contemplated, such as non-handle configurations for mounting the ultrasonic device 300 and / or attaching the ultrasonic device 300 to a surgical robotic arm (see FIG. 20 ). A cable 350 extends from the proximal body 310 to connect the ultrasonic sensor assembly 330 of the ultrasonic device 300 to an ultrasound console (not shown), for example, via a wire (not shown) extending from the ultrasonic sensor assembly 330 through the shaft 320, the proximal body 310, and the cable 350.

[0065] The shaft 320 of the ultrasound device 300 is configured for transvaginal insertion adjacent to or against the cervical canal, with the distal end 344 of the longitudinal lumen 340 oriented toward the cervical canal to permit passage of the hysteroscope 200 (or other suitable surgical instrument) through the longitudinal lumen 340, out its distal end 344, through the cervical canal, and into the uterus. The body portion 322 of the shaft 320 may define a cylindrical configuration, and / or the distal end portion 324 of the shaft 320 may be tapered, curved, and / or otherwise atraumatically configured to facilitate atraumatic insertion.

[0066] The ultrasonic sensor assembly 330 includes one or more ultrasonic sensors 332, e.g., ultrasound transducers, to enable ultrasonic imaging of tissue, e.g., the uterus. Each ultrasonic sensor 332 is configured to emit ultrasonic waves, e.g., high-frequency sound waves, and receive echo waves generated by the reflection of the ultrasound waves from various tissue structures encountered. The echo waves received by each ultrasonic sensor 332 are output to an image processing unit (not shown), e.g., via wires extending through the shaft 320, the proximal body 310, and the cable 350. In embodiments, the ultrasonic sensor assembly 330 can be configured for 2D ultrasound imaging. In other embodiments, the ultrasonic sensor assembly 330 includes multiple ultrasonic sensors 332 forming an ultrasonic sensor array, where the ultrasonic sensor array defines a partial circle, a partial polygon, a partial polygon, a partial arc configuration, or other suitable configuration that enables reconstruction of a 3D ultrasound image for 3D ultrasound imaging. In this manner, when activated, the ultrasonic sensor assembly 330 enables ultrasonic imaging of tissue, e.g., the cervix, uterus, and / or surrounding tissue.

[0067] Turning to FIG. 2 , the distal end portion 324 of the shaft 320 defines a protruding foot 360 on one side of the open distal end 344 of the longitudinal lumen 340, the protruding foot 360 projecting further distally than a distal surface portion 370 disposed on the opposite side of the distal end 344 of the longitudinal lumen 340. The protruding foot 360 defines a curved distal-facing surface 362 including one or more curved sections. For example, the distal-facing surface 362 of the protruding foot 360 may include a concave portion extending distally and outwardly from the distal end 344 of the longitudinal lumen 340, followed by a convex portion extending distally and outwardly from the concave portion. Other suitable configurations are also contemplated. Regardless of the particular configuration, the ultrasonic sensor assembly 330 is positioned within the protruding foot 360, with its sensor 332 oriented toward the distal-facing surface 362 and emitting ultrasonic waves therefrom. The protrusion foot 360 is configured to be positioned adjacent to or against the cervix, and such an ultrasound sensor assembly 330 can be utilized, for example, to image the cervix, uterus, and surrounding tissue.

[0068] 3 , in another configuration, the distal end portion 424 of the shaft 320 defines a distal face portion 470 that surrounds the open distal end 344 of the longitudinal lumen 340. The distal face portion 470 is curved to define a radially symmetric convex distal-facing surface 472, with the annular portion between the open distal end 344 of the longitudinal lumen 340 and the outer periphery of the distal end portion 424 of the shaft 320 projecting further distally than the portion of the surface 472 adjacent the open distal end 344 of the longitudinal lumen 340 and the outer periphery of the distal end portion 424 of the shaft 320. The ultrasonic sensor assembly 430 is positioned at the distal end portion 424 of the shaft 320 and can extend around part or all of the distal face portion 470. The sensor 432 of the ultrasonic sensor assembly 430 is oriented toward the surface 472 and emits ultrasonic waves therefrom, such that the ultrasonic sensor assembly 430 can be utilized to image, for example, the cervix, uterus, and surrounding tissue.

[0069] 4 , in another configuration, the distal end portion 524 of the shaft 320 defines a distal surface portion 570 surrounding the open distal end 344 of the longitudinal lumen 340, which tapers radially inward from proximal to distal. Thus, the distal surface portion 570 defines a distal-facing surface 572, with the portion adjacent the open distal end 344 of the longitudinal lumen 340 projecting further distally than the portion adjacent the outer periphery of the distal end portion 524 of the shaft 320. The ultrasonic sensor assembly 530 is positioned in the distal end portion 524 of the shaft 320 and may extend annularly around the entirety thereof (as shown) or only a portion thereof. The sensor 532 of the ultrasonic sensor assembly 530 is oriented toward and emits ultrasonic waves from the surface 572, such that the ultrasonic sensor assembly 430 can be utilized to image, for example, the cervix, uterus, and surrounding tissue.

[0070] Turning to FIG. 5 , hysteroscope system 10 is shown in use, with ultrasound device 300 inserted transvaginally through the vaginal canal “V” so that the distal end portion 324 of its shaft 320 is disposed adjacent to or against the cervix “C.” In this position, more specifically, protruding foot 360, including ultrasound sensor assembly 330, is positioned adjacent to or against the cervix “C,” enabling ultrasound imaging of a field of view “F1” that includes the uterus “U” and surrounding tissue. Furthermore, in this position, open distal end 344 of longitudinal lumen 340 is oriented with the cervical canal, and elongated tubular member 202 extends therefrom through the cervix “C” and into the uterus “U.” In this manner, hysteroscope 200 can be utilized to provide a field of view “F2” for visualization within the uterus “U,” for example, in conjunction with or separately from ultrasound imaging. The hysteroscope 200 can also be used to introduce and / or remove fluids from the uterus "U" and / or pass a working instrument 100, e.g., a tissue resection device, an ablation device, a biopsy device, etc., through the uterus "U" to perform one or more hysteroscopic procedures 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 its exterior and / or visualization of the uterus "U" from within the uterine cavity enhances visibility to perform a variety of different hysteroscopic procedures without the need to change instruments that support different imaging modalities and / or provide different imaging perspectives.

[0071] 6 and 7 illustrate another ultrasound device 600 provided in accordance with the present disclosure. The ultrasound device 600 includes a proximal body 610, a shaft 620 extending distally from the proximal body 610, an ultrasound sensor assembly 630 disposed at a distal end portion 624 of the shaft 620, and a movable sheath 660.

[0072] The proximal body 610 of the ultrasonic device 600 can be configured as a handle including, for example, a pistol-style grip 612, although other handle configurations are also contemplated, such as non-handle configurations for mounting the ultrasonic device 600 and / or attaching the ultrasonic device 600 to a surgical robotic arm (see FIG. 20 ). A cable 650 extends from the proximal body 610 to connect the ultrasonic sensor assembly 630 of the ultrasonic device 600 to an ultrasound console (not shown), for example, via a wire (not shown) extending from the ultrasonic sensor assembly 630 through the shaft 620, the proximal body 610, and the cable 650.

[0073] The shaft 620 of the ultrasound device 600 is configured for transvaginal insertion adjacent to or against the cervix, whereby the ultrasound sensor assembly 630 is oriented to enable ultrasound imaging of, for example, the cervix, uterus, and surrounding tissue. More specifically, the distal end portion 624 of the shaft 620 includes the ultrasound sensor assembly 630. The ultrasound sensor assembly 630 includes one or more ultrasound sensors 632 oriented toward a distal face 672 of the distal end portion 624 of the shaft 620, whereby the ultrasound sensor assembly 630 can be utilized to image, for example, the cervix, uterus, and surrounding tissue. The ultrasound sensor assembly 630 can be configured for 2D and / or 3D imaging. The distal face 672 can define a bulbous configuration or any other configuration, such as those detailed with respect to the ultrasound devices above, to facilitate ultrasound imaging.

[0074] The shaft 620 of the ultrasonic device 600 further defines a hollow section 626 defined by a pair of spaced-apart sidewalls 627 and open upper and lower surfaces. The hollow section 626 of the shaft 620 is configured to receive a movable sheath 660 therein. A coupling mechanism 680 couples the movable sheath 660 to the shaft 620 to enable the movable sheath 660 to be moved between in-line positions, the movable sheath 660 being disposed substantially (e.g., + / - 10%) within the hollow section 626 of the shaft 620 and being substantially coaxial with the shaft 620 at an angled position, the longitudinal axes of the shaft 620 and the movable sheath 660 being disposed at an angle to each other such that the movable sheath 660 extends from the hollow section 626 of the shaft 620. In the in-line position, movable sheath 660 can be disposed completely within and not protrude from the outer annular dimension of shaft 620 (e.g., the maximum, minimum, or other outer annular dimension in embodiments where multiple dimensions are provided). Alternatively, movable sheath 660 can extend radially outward from the outer annular dimension of shaft 620 in the in-line position. In such an embodiment, movable sheath 660 in the in-line position protrudes radially outward from shaft 620 a minimal amount compared to movable sheath 660 in the angled position.

[0075] Coupling mechanism 680 may include, for example, a pin-and-slot connection to allow pivoting of movable sheath 660 relative to shaft 620 while remaining longitudinally fixed. Alternatively, as shown, coupling mechanism 680 may include a pin-and-slot connection including one or more pins 682 (e.g., a pair of pins 682 extending radially outward in opposite directions from movable sheath 660) that engage with one of shaft 620 or movable sheath 660, and one or more slots 684 (e.g., slots 684 defined in each sidewall 627) that receive the one or more pins 682 and are defined within the other of shaft 620 or movable sheath 660. In this manner, movable sheath 660 can slide longitudinally and pivot between an in-line position and an angled position relative to shaft 620. Other suitable coupling mechanisms 680 are also contemplated.

[0076] Moveable sheath 660 can be moved, e.g., pivoted and / or translated, relative to shaft 620 locally, e.g., via coupling mechanism 680, e.g., via manipulation of movable sheath 660 itself, or remotely, e.g., via manipulation of one or more remote actuators (not shown) and associated drive components (not shown) disposed on proximal body 610, e.g., shafts, cables, linkages, etc., interconnecting the remote actuators with coupling mechanism 680. Additionally, movement of movable sheath 660 relative to shaft 620 via coupling mechanism 680 can be manual or powered, e.g., via one or more motors (not shown) disposed within or otherwise positioned within proximal body 610.

[0077] Movable sheath 660 defines a longitudinal lumen 662 extending longitudinally sufficiently to permit passage of at least a portion of an endoscopic device, e.g., elongated tubular member 202 of hysteroscope 200, such that a distal portion of elongated tubular member 202 extends distally from movable sheath 660 through an open distal end 664 of longitudinal lumen 662. Longitudinal lumen 662 may additionally or alternatively be configured to allow other instruments, e.g., one or more working instruments, to pass therethrough. As an alternative to movable sheath 660 defining a linear configuration, movable sheath 660 may be curved in one or more directions or otherwise configured.

[0078] 7 , during use, the ultrasound device 600, with the movable sheath 660 disposed in an in-line position, is inserted transvaginally through the vaginal canal "V" so that the distal end portion 624 of its shaft 620 is disposed adjacent to or against the cervix "C". In this position, more specifically, the ultrasound sensor assembly 630 is positioned adjacent to or against the cervix "C", enabling ultrasound imaging of the uterus "U" and surrounding tissue. With the shaft 620 in this position, the movable sheath 660 can be moved, e.g., pivoted and / or slid, relative to the shaft 620 so 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 member 202 of the hysteroscope 200 can be inserted through the movable sheath 660, through the cervix "C," and into the uterus "U," thereby enabling the hysteroscope 200 to be utilized for visualization within the uterus "U," either in conjunction with or separate from ultrasound imaging. The hysteroscope 200 can also be used for the introduction and / or removal of fluids into and / or from the uterus "U," and / or for the passage of a working instrument 100, e.g., a tissue resection device, an ablation device, a biopsy device, etc., through the uterus "U" to perform one or more hysteroscopic procedures 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 shaft 620 positions the ultrasonic sensor assembly 630 in a first orientation to facilitate ultrasonic imaging, and allows the sheath 660 (and thus the hysteroscope 200, working instrument 100, or other instrument inserted therethrough) to be oriented in a second, different, selectable direction and passed into the uterus "U" to perform one or more surgical procedures therein.

[0079] 8, in accordance with the present disclosure, another ultrasound device 800 is provided. Ultrasonic device 800 is similar to ultrasound device 600 (FIGS. 6 and 7), and therefore only the differences therebetween will be described in detail below. Ultrasonic device 800 includes a proximal body 810, a shaft 820 extending distally from proximal body 810, and an ultrasound sensor assembly 830 disposed at a distal end portion 824 of shaft 820.

[0080] The shaft 820 of the ultrasound device 800 is configured for transvaginal insertion adjacent to or against 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 section 826 defined by a pair of spaced-apart sidewalls 827 and open upper and lower surfaces. The hollow section 826 of the shaft 820 may extend along a portion of the length of the shaft 820 or along substantially the entire length of the shaft 820.

[0081] Hollow section 826 is configured to removably receive one or more surgical instruments 860, such as a sheath, a hysteroscope, a tissue resection device, an ablation device, a biopsy device, or other suitable surgical instruments, side-by-side or telescopically relative to one another. More specifically, sidewalls 827 disposed on either side of hollow section 826 guide the insertion, longitudinal sliding, and / or pivoting of one or more surgical instruments 860 relative to shaft 620 (FIGS. 6 and 7), similar to that described above with respect to ultrasonic device 600, while also allowing for interchangeable use of different surgical instruments 860. That is, ultrasonic device 800 does not include a coupling mechanism like ultrasonic device 600 (FIGS. 6 and 7), and thus, surgical instruments 860 are removably receivable within hollow section 826 of shaft 820.

[0082] 9 and 10A-10C, another ultrasound device provided in accordance with the present disclosure is shown as generally identified by reference numeral 900, including a hysteroscope 200 operably inserted therethrough. Except where expressly contradicted below, ultrasound device 900 may include any of the features of the ultrasound devices detailed above.

[0083] The ultrasonic device 900 includes a frame 902 and an ultrasonic sensor assembly 930. The frame 902 is formed from a pair of spaced apart rails 904. The rails 904 may be configured as plates extending in a substantially parallel orientation relative to one another or in any other suitable manner. The rails 904 are bent at a bend 906 to define a more proximal upright portion 910 and a more distal longitudinal portion 920 disposed at an angle to one another. The angle may be between about 60 degrees and about 120 degrees in configurations, between about 75 degrees and about 105 degrees in other configurations, and about 90 degrees in still other configurations. Proximal spacers 912 are disposed between the rails 904 at the upright portions 910 of the frame 902, e.g., at the proximal end portions of the upright portions 910, and secured therebetween, e.g., via pins, bolts, adhesive, overmolding, or in any other suitable manner, so that the rails 904 are secured to one another and maintain the spacing therebetween along the upright portions 910. Distal spacers 922 are disposed between the rails 904 at the longitudinal portions 920 of the frame 902, e.g., at the distal end portions of the longitudinal portions 920, and secured therebetween, e.g., via pins, bolts, adhesive, overmolding, or in any other suitable manner, so that the rails 904 are secured to one another and maintain the spacing therebetween along the longitudinal portions 920. Additional or alternative spacers for similar purposes are also contemplated.

[0084] The proximal end portion of the upright portion 910 of the frame 902 may include a handle disposed thereon (e.g., similar to any of the configurations described above) to facilitate manual manipulation of the ultrasonic 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 (see FIG. 20) of a surgical system or a mounting arm of a mounting frame, thereby eliminating the need for a surgeon to manually manipulate and / or manually hold and maintain the position of the ultrasonic device 900. Suitable mounting hardware "M" may be provided integrally with or attachable to the proximal end portion of the upright portion 910 for releasably engaging the support arm "SA".

[0085] The ultrasonic sensor assembly 930 extends distally from and is secured to the distal end of the longitudinal portion 920 of the frame 902. More specifically, the ultrasonic sensor assembly 930 may be formed with, attached to, or otherwise secured to the distal spacer 922, or may be secured to the frame 902 directly, indirectly, or in any other suitable manner, such that engagement of the distal spacer 922 between the rails 904 also secures the ultrasonic sensor assembly 930 relative to the frame 902. The ultrasonic sensor assembly 930 includes one or more ultrasonic sensors 332, e.g., ultrasound transducers, and enables ultrasonic imaging of tissue, e.g., the uterus, more specifically, enabling 2D and / or 3D ultrasonic imaging. The field of view provided by the ultrasonic sensor assembly 930 may 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 so that the longitudinal axis defined by the longitudinal portion 920 of the frame 902 extends through the field of view, extends along the boundary of the field of view, or is offset from the field of view. In embodiments, the ultrasonic sensor assembly 930 is oriented so that a centerline extending from the ultrasonic sensor assembly 930 and bisecting the field of view is disposed at an oblique angle (in some embodiments, an acute angle) relative to the longitudinal axis defined by the longitudinal portion 920 of the frame 902. Other ultrasound devices can be similarly configured, for example, with the field of view for ultrasound imaging disposed at an oblique angle (in some embodiments, an acute angle) relative to the frame or shaft of the ultrasound device.

[0086] 9 and 10A-10C, the bends 906 of the frame 902 allow for insertion of the elongated tubular member 202 of the hysteroscope 200 between the 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 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 rails 904, the rails 904 act to substantially restrict 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.

[0087] 10A-10C, and initially to FIG. 10A, during use, the longitudinal portion 920 of the frame 902 of the ultrasound device 900 can first be inserted transvaginally through the vaginal canal "V" so that the ultrasound sensor assembly 930 is positioned adjacent to or abutting the cervix "C" to enable ultrasound imaging of the uterus "U" and surrounding tissue, while the upright portion 910 remains disposed externally, for example, for manual manipulation or fixation to the support arm "SA" (see FIG. 9). The elongated tubular member 202 of the hysteroscope 200 can then be inserted between the rails 904 (FIG. 9) in a substantially coaxial or parallel orientation relative to the longitudinal axis defined by the longitudinal portion 920 of the frame 902, although other suitable insertion orientations are also contemplated. Alternatively, the elongated tubular member 902 can be positioned between the rails 904 in a substantially 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 either of these ways substantially reduces the required insertion force and discomfort to the patient, as the elongated tubular member 202 is disposed within the frame 902 and therefore does not substantially interact with tissue at this point.

[0088] 10B , with the ultrasound device 900 and hysteroscope 200 inserted as described 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, via the elongated tubular member 202 being tilted perpendicularly relative to the frame 902 until the distal end of the elongated tubular member 202 is substantially aligned with the cervix "C". The ultrasound image provided by the ultrasound device 900 can be utilized to confirm proper orientation of the elongated tubular member 202.

[0089] 10C, with elongate tubular member 202 oriented as described above, elongate tubular member 202 may be slid distally (while maintaining that orientation) relative to frame 902 such that the distal end of elongate tubular member 202 extends through cervix "C" and into uterus "U" under the guidance of ultrasound imaging provided by ultrasound device 900. One or more surgical procedures, such as visualization, tissue resection, ablation, biopsy, etc., may then be performed within uterus "U" via hysteroscope 200 or working instrument 100 (FIG. 1) inserted therein, all under the guidance of ultrasound imaging provided by ultrasound device 900.

[0090] 11A-11D in conjunction with FIG. 9 , as described in detail above, with the elongated tubular member 202 of the hysteroscope 200 extending between the rails 904 of the ultrasound device 900, the rails 904 act to substantially restrict 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. Thus, the hysteroscope 200 has multiple degrees of freedom relative to the ultrasound device 900. However, in some situations, it may be desirable to selectively lock the hysteroscope 200 relative to the ultrasound device 900, for example, after a desired position and orientation has been achieved. More specifically, a locking mechanism 1100 can be provided to selectively lock the hysteroscope 200 relative to the ultrasound device 900 in any suitable position and orientation.

[0091] The locking mechanism 1100 is disposed between the rails 904 of the longitudinal portion 920 of the frame 902 of the ultrasound 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 lock lever 1144. The elastic sling 1120 is formed from a resilient material configured to resiliently resist extension of the sling 1120 from one or both ends 1122 of the sling 1120.

[0092] Each clamp bracket 1110 is disposed adjacent to one of the rails 904 on the inwardly facing surface of the rails 904 toward the proximal end of the longitudinal portion 920 of the frame 902, although other positions and / or configurations are contemplated. As noted above, the elastic sling 1120 extends between the lower ends 1112a of the clamp brackets 1110 toward their distal ends. A support bar 1114 extends proximally from each clamp bracket 1110. One or both support bars 1114 define a threaded connector 1116 at their free proximal end portion. In other configurations, the support bar 1114 is omitted and the threaded connector 1116 is defined or disposed on one or both of the clamp brackets 1110. The threaded connector 1116 may be a threaded portion of the support bar 1114, the support bar 1114 itself, a male or female threaded component attached to the support bar 1114, or any other suitable threaded component. In configurations where only one threaded connector 1116 is provided, the other support bar 1114 may include an unthreaded connector, e.g., a rotatable connector.

[0093] The engagement pin 1130 extends outwardly from the clamp bracket 1110 into a well 1132 defined in the inner surface of the rail 904. Alternatively, the engagement pin 1130 may extend outwardly from the clamp bracket 1110 into an elongated channel defined in and extending longitudinally along the inner surface of the longitudinal portion 920 of the frame 902, such that, in the unlocked state, the locking mechanism 1100 can be translated longitudinally along the longitudinal portion 920 of the frame 902.

[0094] 9, the cam screw assembly 1140 includes a screw 1142 and a cam lock lever 1144, as described above. The screw 1142 may be disposed on one or both rails 904 of the longitudinal portion 920 of the frame 902, or may extend through an opening or longitudinal slot defined in one or both rails 904 of the longitudinal portion 920 of the frame 902. In either configuration, the screw 1142 extends transversely to the rails 904 and is threadedly engaged with the threaded connectors 1116 of the support bars 1114. In a configuration in which both support bars 1114 include threaded connectors 1116, the screw 1142 is threadedly engaged with each of the threaded connectors 1116 in an opposite manner, e.g., one via a right-hand threaded engagement and the other via a left-hand threaded engagement. In a configuration in which only one support bar 1114 includes a threaded connector 1116, the unthreaded connector of the other support bar 1114 can rotatably and / or slidably receive the screw 1142.

[0095] The endstop washers 1146 are disposed toward opposite ends of the screws 1142 such that the threaded connectors 1116 (and unthreaded connectors, if provided) are disposed between the endstop washers 1146. The endstop washers 1146 can be axially fixed to the screws 1142 and can be rotatable relative to the screws 1142, or can be rotatably fixed. In configurations in which the screws 1142 extend through openings or slots defined in one or both of the rails 904 of the longitudinal portion 920 of the frame 902, one or both of the endstop washers 1146 can be disposed outside of the adjacent rail 904.

[0096] A cam lock lever 1144 is pivotally coupled to the end of the screw 1142, outwardly adjacent one of the end stop washers 1146, via a pivot 1148. The cam lock lever 1144 is positioned outboard of the rails 904 of the longitudinal portion 920 of the frame 902, allowing for its manual operation by a user. The cam lock lever 1144 defines a cam surface 1145 that extends eccentrically about a pivot 1148 such that, in the unlocked position of the cam lock lever 1144, the cam surface 1145 is displaced from an adjacent end stop washer 1146, corresponding to the unlocked state of the cam lock mechanism 1140, and the screw 1142 is rotatable (see FIG. 11C ), such that, in the locked position of the cam lock lever 1144, the second cam surface 1145 is urged into contact with the adjacent end stop washer 1146, applying a force corresponding to the locked state of the cam lock mechanism 1140 and inhibiting rotation of the screw 1142 (see FIG. 11D ). The cam lock lever 1144 is pivotable about the pivot 1148 between its unlocked and locked positions.

[0097] 11C and 11D, during use, once the longitudinal portion 920 of the frame 902 of the ultrasound device 900 is inserted into place as described above (see FIG. 10A), the elongated tubular member 202 of the hysteroscope 200 can then be inserted between the rails 904 of the frame 902, more specifically, laterally between the clamp brackets 1110 of the locking mechanism 1100 and vertically between the screw 1142 and the sling 1120 of the locking mechanism 1100. As shown in FIG. 11C, at this point, the locking mechanism 1100 is disposed in an unlocked state, allowing insertion of the elongated tubular member 202 therethrough and manipulation of the elongated tubular member 202 therein to achieve a desired orientation and position. Alternatively, the elongated tubular member 902 can be positioned between the rails 904 and within the locking mechanism 1100 prior to insertion and inserted together with the longitudinal portion 920 of the frame 902. In either configuration, once the ultrasound device 900 is positioned as desired, the elongated tubular member 202 may be manipulated, e.g., advanced distally, rotated, and / or tilted vertically relative to the ultrasound device 900, to allow the distal end of the elongated tubular member 202 to be inserted through the cervix "C" and into the uterus "U" to reach a desired position and orientation therein (see FIGS. 10B and 10C). The locking mechanism 1100, in its unlocked state, permits such advancement, rotation, and / or tilting of the elongated tubular member 202.

[0098] Once the desired orientation and position of the elongate tubular member 202 is achieved, the locking mechanism 1100 can be transitioned to a locked state, thereby locking the elongate tubular member 202 in the desired orientation and position relative to the ultrasound device 900. To transition the locking mechanism 1100 to a locked state, the screw 1142 is rotated about its axis to move one or both of the support bars 1114 (depending on whether one or both of the support bars 1114 include threaded connectors 1116) toward the other support bar 1114, thereby pulling the upper ends 1112b of one or both of the clamping brackets 1110 toward each other and engaging and clamping around the elongate tubular member 202 from opposite sides of the elongate tubular member 202, thereby securing the elongate tubular member 202 relative to the locking mechanism 1100. As the upper ends 1112b of one or both of the clamp brackets 1110 move toward one another, the lower ends 1112a of one or both of the clamp brackets 1110 move away from one another, resiliently stretching the sling 1120 from its opposite end against the bias of the sling 1120. In this manner, rotation of the screws 1142, along with the configuration of the sling 1120, tilts the clamp brackets 1110 from an orientation that is generally parallel to the rails 904 of the frame 902 and each other to an angled orientation relative to the rails 904 of the frame 902 and each other, where the upper ends 1112b of the clamp brackets 1110 are relatively close together and the lower ends 1112a are relatively far apart. This inclination of the clamp bracket 1110 relative to the rail 904 of the frame 902 causes the engagement pin 1130 to be angled within and relative to the well 1132, resulting in the engagement pin 1130 becoming jammed within the well 1132, thereby securing the engagement pin 1130, the clamp bracket 1110, and ultimately the elongated tubular member 202 relative to the rail 904 of the frame 902.

[0099] Once the above-detailed securement of the elongate tubular member 202, locking mechanism 1100, and ultrasound device 900 relative to one another has been achieved, the cam lock lever 1144 can be pivoted from the unlocked position to the locked position to apply a force to the adjacent end stop washer 1146, thereby securing the locking mechanism 1100 in a locked state and maintaining the elongate tubular member 202 in a desired orientation and position relative to the ultrasound device 900. Thus, there is no need to manually maintain (or utilize a fixture or other tool to maintain) the elongate tubular member 202 in a fixed orientation and position relative to the ultrasound device 900. With further reference to FIGS. 1 and 10C , in this locked state, the working instrument 100 can be inserted through the hysteroscope 200 (if not already inserted) and manipulated therein to perform one or more surgical tasks, all under the guidance of ultrasound imaging provided by the ultrasound device 900.

[0100] With continued reference to Figures 11C and 11D, to unlock the locking mechanism, e.g., to allow removal of the hysteroscope 200, the cam lock 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 its jamming engagement within the well 1132, allowing the sling 1120 to spring back to its resting position and releasing the clamp bracket 1110 from engagement around the elongated tubular member 202, thereby again allowing relative movement of the elongated tubular member 202 with respect to the locking mechanism 1100 and the ultrasound device 900, e.g., proximal or distal sliding, axial rotation, and / or vertical tilt.

[0101] 12A and 12B, another ultrasound device provided in accordance with the present disclosure is shown generally identified by reference numeral 1200. Except where expressly contradicted below, ultrasound device 1200 may be similar to and include any of the features of ultrasound device 900 (FIG. 9) detailed above. Accordingly, only the differences between ultrasound device 1200 and ultrasound device 900 (FIG. 9) will be described in detail below, while similarities will be summarized or omitted entirely.

[0102] The ultrasonic device 1200 includes a removable assembly 1250 that includes an ultrasonic sensor assembly 1230, a distal spacer 1222, a sterile barrier 1260, and an adapter 1270. The removable assembly 1250 further includes a connecting cable 1280 that houses one or more electrical wires, allowing the ultrasonic sensor assembly 1230 to be connected to an ultrasound console (not shown). The ultrasonic sensor assembly 1230 and the distal spacer 1222 may be integrally formed as a unit, or the distal spacer 1222 may be releasably engaged with the ultrasonic sensor assembly 1230. In either configuration, the distal spacer 1222 defines an engagement feature 1223 on its outer surface, such as, for example, an arrangement of fins projecting outwardly therefrom, although alternative or additional features, such as slots, are also contemplated. In a configuration in which the distal spacer 1222 is releasably engageable with the ultrasonic sensor assembly 1230, a variety of different ultrasonic sensor assemblies 1230 and corresponding distal spacers 1222 can be provided, allowing customization of the ultrasonic device 1200 to provide, for example, 2D ultrasound, 3D ultrasound, different sensor placements, etc.

[0103] Sterile barrier 1260 is configured to surround ultrasonic sensor assembly 1230 and distal spacer 1222. Sterile barrier 1260 maintains ultrasonic sensor assembly 1230 in a sterile state throughout its use without providing any functionality to ultrasonic sensor assembly 1230.

[0104] The adapter 1270 defines an interior receiving area 1272 including a complementary arrangement of engagement features 1274, e.g., slots, to the engagement features 1223 of the distal spacer 1222 to facilitate engagement therebetween. The interior receiving area 1272 of the adapter 1270 is more specifically configured to receive the distal spacer 1222 and engage with the distal spacer 1222 via the sterile barrier 1260 therebetween, thereby sealing the interior of the sterile barrier 1260 and thus maintaining sterility of the ultrasonic sensor assembly 1230. In some configurations, a locking screw or other suitable additional engagement feature may be provided to facilitate engagement of the distal spacer 1222 with the adapter 1270 and sealing the sterile barrier 1260 therebetween.

[0105] The adapter 1270 is engageable between the rails 1204 of the longitudinal portion 1220 of the frame 1202, for example, via a pair of pins 1276 on either side thereof (only one set of pins is shown) or other suitable releasable engagement mechanism, thereby enabling releasable fixation of the ultrasonic sensor assembly 1230 to the frame 1202 with the sterility barrier 1260 sealed around the ultrasonic sensor assembly 1230.

[0106] 13A-13D, in accordance with the present disclosure, a method of forming a sterile enclosure around an ultrasonic sensor assembly 1330 of an ultrasonic device 1300 is provided. Ultrasonic device 1300 may be similar to and include any of the features of ultrasonic device 900 (FIG. 9) detailed above. Accordingly, only the differences between ultrasonic device 1200 and ultrasonic device 900 (FIG. 9) will be described in detail below, while similarities will be summarized or omitted entirely.

[0107] 13A and 13B, a sterility barrier 1360 having an open end 1362 and a proximal end 1364 slides proximally, guided by its open end 1362, over the ultrasonic sensor assembly 1330 of the ultrasonic device 1300 and at least a portion of the frame 1302 of the ultrasonic device 1300. The sterility barrier 1360 can surround and enclose the entire ultrasonic device 1300 or a sufficient distal portion thereof to maintain the sterility of the ultrasonic device 1300 during use. More specifically, in some configurations, the sterility barrier 1360 surrounds and encloses at least a majority of the longitudinal portion 1320 of the frame 1302; in other configurations, the sterility barrier 1360 surrounds and encloses the longitudinal portion 1320 and at least a portion (not shown) of the upright portion; in still other configurations, the sterility barrier 1360 surrounds and encloses at least a majority of the longitudinal portion 1320 and the upright portion; and in still other configurations, the sterility barrier 1360 surrounds and encloses the entire frame 1302.

[0108] 13C , once the sterility barrier 1360 is positioned as described above, the portions of the sterility barrier 1360 extending laterally across the spaced apart rails 1304 of the frame 1302, e.g., across the top and bottom of the longitudinal portion 1320 of the frame 1302, are sealed along seal lines "SL," e.g., by heat sealing, ultrasonic sealing, or any other suitable method. Referring to FIG. 13D , once the seal is formed, or at a simultaneous or overlapping time relationship therewith, the sterility barrier 1360 is cut along seal lines "SL," thereby defining a gap volume "GV" that exposes the interior volume between the spaced apart rails 1304 of the longitudinal portion 1320 of the frame 1302, while maintaining the sterility barrier 1360 in a sealed arrangement around each of the ultrasonic sensor assembly 1330 and the rails 1304. Thus, the sealed barrier 1360 is configured to maintain the ultrasonic sensor assembly 1330 and at least a portion of the spaced apart rails 1304 in a sterile condition without impairing the ability of the hysteroscope 200 (FIG. 9) to be inserted between and manipulated in conjunction with the spaced apart rails 1304 throughout use of the ultrasonic device 1300.

[0109] 14A-16, yet another ultrasound device provided in accordance with the present disclosure and configured to enable sterile sealing of an ultrasound sensor assembly to maintain sterility during use is shown generally identified by reference numeral 1400. Ultrasonic device 1400 is similar to and may include any of the features of ultrasound device 900 (FIG. 9) detailed above. Accordingly, only the differences between ultrasound device 1400 and ultrasound device 900 (FIG. 9) will be described in detail below, while similarities will be summarized or omitted entirely.

[0110] 14A-14C, an ultrasonic device 1400 includes a frame 1402 formed from a pair of spaced apart rails 1404 and an ultrasonic sensor assembly 1430 disposed at a distal end portion of the frame 1402. The rails 1404 are bent at a bend 1406 to define a more proximal upright portion 1410 and a more distal longitudinal portion 1420. The longitudinal portion 1420 defines a proximal section 1424, a distal section 1426, and a connector section 1428 disposed between the proximal section 1424 and the distal section 1426, respectively. The rails 1404 are interconnected via a first backspan 1407 extending along and over an upper end of the proximal section 1424 of the longitudinal portion 1420 such that the proximal section 1424 of the longitudinal portion 1420 defines an inverted U-shaped configuration (see FIG. 14B), and a second backspan 1408 extending along and over a lower end of the distal section 1426 of the longitudinal portion 1420 such that the distal section 1426 of the longitudinal portion 1420 also defines a U-shaped configuration (see FIG. 14C). Furthermore, one of the rails 1404 defines a gap "G" along the connector section 1428 and is thus discontinuous in that it does not extend along the connector section 1428; rather, only one of the rails 1404 extends along the connector section 1428 (see also FIG. 15).

[0111] 15 and 16, the ultrasonic device 1400 is configured to receive a sterility barrier 1460 that surrounds and encases the entire ultrasonic device 1400, or a sufficient distal portion thereof, to maintain sterility of the ultrasonic device 1400 during use. More specifically, the sterility barrier 1460 is configured to extend proximally from an occluded distal end 1464 thereof around the ultrasonic sensor assembly 1430, around at least a portion of the distal section 1426 of the longitudinal portion 1420 of the frame 1402, the connector section 1428 of the longitudinal portion 1420 of the frame 1402, and the proximal section 1424 of the longitudinal portion 1420 of the frame 1402.

[0112] Despite the sterility barrier 1460 surrounding and enclosing the ultrasound sensor assembly 1430 and at least a portion of the longitudinal portion 1420 of the frame 1402, the hysteroscope 200 can still be operably coupled to the ultrasound device 1400 without compromising the sterility of the sterility barrier 1460, without compromising the functionality of the ultrasound device 1400, and without compromising the functionality or operability of the hysteroscope 200 relative to the ultrasound device 1400. More specifically, with reference to FIG. 16 , to operably couple the hysteroscope 200 to the longitudinal portion 1420 of the frame 1402, the elongated tubular member 202 of the hysteroscope 200 is first oriented in a substantially perpendicular orientation to the longitudinal portion 1420 of the frame 1402 and then moved laterally between the rails 104 of the frame 1402, through gap “G,” and into the connector section 1428 of the longitudinal portion 1240. Sterile barrier 1460 is bent inward to allow for this insertion of elongated tubular member 202 into frame 1402 .

[0113] Once the elongated tubular member 202 of the hysteroscope 200 is disposed within the connector section 1428 of the longitudinal portion 1240 of the frame 1402, the elongated tubular member 202 may be tilted vertically, for example, clockwise from the orientation shown in FIG. 16 , to a use position in which the elongated tubular member 202 is disposed at an oblique angle relative to the longitudinal axis of the frame 1402. From there, the elongated tubular member can be advanced and retracted proximally and distally, respectively, rotated about its axis, and / or further aligned vertically to facilitate its use. Upon vertical tilting and further vertical tilting of elongate tubular member 202, the more proximal portion of elongate tubular member 202 enters proximal section 1424 of longitudinal portion 1420 from its open underside (see FIG. 14B), while the more distal portion of elongate tubular member 202 enters distal section 1426 of longitudinal portion 1420 from its open upper side (see FIG. 14C). Sterility barrier 1460 is bent upward and downward to allow this tilting and insertion of the more proximal and more distal portions of elongate tubular member 202, respectively, into frame 1402. The elongated tubular member 202 may be tilted to a substantially coaxial orientation relative to the longitudinal axis defined by the longitudinal portion 1420 of the frame 1402 without compromising the sterility barrier 1460, but is prevented from tilting substantially beyond it by the presence of the first and second backspans 1407, 1408, respectively.

[0114] 17A and 17B, yet another ultrasound device provided in accordance with the present disclosure is shown generally identified by reference numeral 1700. Ultrasound device 1700 may be similar to and include any of the features of ultrasound device 300 (FIGS. 1 and 2) detailed above. Accordingly, only the differences between ultrasound device 1400 and ultrasound device 300 (FIGS. 1 and 2) will be described in detail below, while similarities will be summarized or omitted entirely.

[0115] The ultrasonic device 1700 includes a proximal body (not shown), a shaft 1720 extending distally from the proximal body, and an ultrasonic sensor assembly 1730 disposed at a distal end portion of the shaft 1720. In some configurations, the proximal body is omitted. The ultrasonic device 1700 further includes a longitudinal lumen 1740 defined through the shaft 1720 configured to allow passage of at least a portion of an endoscopic device, e.g., the elongated tubular member 202 of the hysteroscope 200. For example, a working instrument such as an ablation probe 1780 can be passed through the elongated tubular member 202 of the hysteroscope 200.

[0116] The body portion 1722 of the shaft 1720 defines a generally cylindrical configuration disposed coaxially about the lumen 1740. The shaft 1720 further includes a distal leg 1725 extending distally from its distal end portion. The distal leg 1725 defines a foot 1760 at its free end portion. The ultrasonic sensor assembly 1730 is disposed within the foot 1760 and, in embodiments, can be angled such that the field of view generated by the ultrasonic sensor assembly 1730 is centered a predetermined longitudinal distance from the distal end of the shaft 1720 along its longitudinal axis, e.g., such that the distal end of the elongate tubular member 202 and / or the distal end of the ablation probe 1780 are maintained within the field of view during manipulation within the uterus "U" and / or surrounding tissue. The distal leg 1725 and foot 1760 project distally from the distal end of the body 1722 of the shaft 1720 at a location that is radially offset relative to a longitudinal axis substantially defined by the body portion 1722 of the shaft 1720, such that an annular volume is defined between the elongate tubular member 202 (as it extends distally through the lumen 1740) and the foot 1760, regardless of the orientation of the ultrasonic device 1700 relative to the elongate tubular member 202. The distal leg 1725 and foot 1760 are configured such that the annular volume defines a substantially constant width dimension (e.g., within 10%) 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 (e.g., within 10%) along at least 50% of the longitudinal distance, at least 70% of the longitudinal distance, or at least 90% of the longitudinal distance.

[0117] As a result of the above-detailed configuration in which the distal legs 1725 and feet 1760 project distally from the distal end of the body 1722 of the shaft 1720 at radially offset positions, the feet 1760 orbit annularly around the elongate tubular member 202, maintaining an annular volume therebetween, as the ultrasonic device 1700 rotates about the elongate tubular member 202. In use, as shown in FIG. 17B , the ultrasonic device 1700 can be positioned with the distal end of the body portion 1722 of the shaft 1720 abutting the cervix “C” (enabling insertion of the elongate tubular member 202 and ablation probe 1780 through the cervix “C” and into the uterus “U”), while the feet 1760 (including the ultrasound sensor assembly 1730) are maintained in contact with the vaginal vault “VF”. More specifically, the annular volume defined between the elongate tubular member 202 and the legs 1725 and foot 1760 receives the portion of the cervix "C" that protrudes into the vaginal canal "V", thereby allowing the foot 1760 to extend into contact with the vaginal vault "VF". Maintaining tissue contact ensures proper transmission contact between the ultrasound sensor assembly 1730 and the tissue, thereby facilitating ultrasound imaging. Ultrasound gel may be utilized with the ultrasound device 1700 or any other ultrasound device detailed herein to facilitate maintaining proper transmission contact.

[0118] With continued reference to FIG. 17B , the ultrasound device 1700 can be rotated about the elongated tubular member 202 to position the legs 1760 in contact with different vaginal vaults “VF.” The various different positions of the ultrasound device 1700 provide various different views and / or observation vantage points to facilitate ultrasound imaging, for example, to identify target tissue to be ablated using the ablation probe 1780, or to perform any other surgical procedure. For example, the ultrasound device 1700 can be rotated to achieve a desired view or vantage point and / or maintain it in a fixed position while performing an ablation or other surgical procedure. Alternatively, the ultrasound device 1700 can be rotated to various different rotational positions to enable an ultrasound console (not shown) to generate and display 3D images of the patient's anatomy. This can be accomplished with a robotic implementation (see FIG. 20 ), which allows for easy control of the rotation of the ultrasound device 1700, although manual implementations are also contemplated. The 3D images can be generated for later use or can be continuously updated during a procedure.

[0119] 18 , another ultrasonic device 1800 according to the present disclosure includes a shaft 1820, an ultrasonic sensor assembly 1830, and a biasing assembly 1870. The shaft 1820 and ultrasonic sensor assembly 1830 may be similar to and include any features of the shaft 1720 and ultrasonic sensor assembly 1730 of the ultrasonic device 1700 ( FIGS. 17A and 17B ), any features of other configurations detailed herein, or other suitable configurations. Thus, the shaft 1820 and ultrasonic sensor assembly 1830 will not be described in detail below.

[0120] The biasing assembly 1870 includes an outer sleeve 1872 configured to telescopically receive a proximal end portion of the body 1822 of the shaft 1820, a locking collar 1874 disposed at the proximal end of the outer sleeve 1872, a set 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 between the locking collar 1874 and a proximal end face of the body 1822 of the shaft 1820 to bias the body 1822 of the shaft 1820 distally against the locking collar 1874. The shaft 1820 and / or the body 1822 of the outer sleeve 1872 may include a stop feature (not explicitly shown) configured to prevent complete removal and uncoupling of the body 1822 of the shaft 1820 from the outer sleeve 1872. Additionally, the outer sleeve 1872, the proximal end face of the body 1822, and / or the locking collar 1874 may include retaining features (not explicitly shown) for securing an end of or otherwise retaining the biasing member 1878 relative to the outer sleeve 1872, the proximal end face of the body 1822, and / or the locking collar 1874.

[0121] The shaft 1820 of the ultrasonic device 1800 defines a longitudinal lumen 1840 configured to slidably receive at least a portion of an endoscopic device, such as the elongated tubular member 202 of the hysteroscope 200, therethrough. The biasing assembly 1870 similarly defines an internal passage aligned with the lumen 1840 to receive the elongated tubular member 202 therethrough. With the elongated tubular member 202 received through the biasing assembly 1870, a fixation screw 1876 can be tightened through the locking collar 1874 and against the elongated tubular member 202 to secure the locking collar 1874 about the elongated tubular member 202. The shaft 1820 and biasing assembly 1870 can be configured such that, during use, the locking collar 1874 remains external to the patient while the shaft 1820 extends transvaginally to a position adjacent the cervix "C", thereby allowing selective locking and unlocking of the biasing assembly 1870 with the elongate tubular member 202.

[0122] During use, the ultrasound device 1800 is positioned with the distal end of the body portion 1822 of the shaft 1820 abutting the cervix "C" and the elongate tubular member 202 (and the ablation probe 1780 therein) extending through the cervix "C" and into the uterus "U". After or before insertion, the locking screw 1876 can be tightened through the locking collar 1874 and against the elongate tubular member 202 to secure the locking collar 1874 around the elongate tubular member 202. With the locking collar 1874 in this locked position, the ultrasound device 1800 is operably coupled to the elongate tubular member 202 of the hysteroscope 200, such that the ultrasound device 1800 and the elongate tubular member 202 can be operated as a unit, for example, via one hand of a user (e.g., manipulating the handle of the hysteroscope 200). Further, in this locked state, the biasing member 1878 biases the body 1822 of the shaft 1820 distally relative to the elongate tubular member 202, such that the foot 1860 of the shaft 1820 is biased distally into contact with the vaginal vault "VF" to ensure proper transmitting contact between the ultrasound sensor assembly 1830 and the tissue. More specifically, compression (against its bias) of the biasing member 1878 allows the elongate tubular member 202 to be advanced distally further into the uterus "U" to facilitate the performance of surgical procedures within the uterus without applying excessive force to the cervix "C" or the vaginal vault "VF", thereby allowing the outer sleeve 1872 to slide distally about the body 1822 of the shaft 1820, thereby permitting distal movement of the elongate tubular member 202 relative to the shaft 1820. Additionally, adequate transmitting contact between the ultrasonic sensor assembly 1830 and the tissue is maintained despite proximal retraction of the elongate tubular member 202 from the uterus "U." That is, as the elongate tubular member 202 is proximally retracted, the biasing member 1878 (under its bias) is elastically elongated, thereby maintaining the shaft 1820 in a position in contact with the tissue despite relative proximal translation of the elongate tubular member 202 with respect to the shaft 1820.The length of outer sleeve 1872 and the length of biasing member 1878 (at rest, fully compressed, and / or fully extended positions) determine the amount of distal advancement and proximal retraction allowed and can be selected to allow sufficient distal advancement and proximal retraction, as needed, to manipulate elongate tubular member 202 relative to the uterus "U" during use.

[0123] 19, yet another ultrasonic device 1900 according to the present disclosure includes a shaft 1920, an ultrasonic sensor assembly 1930, an occlusion assembly 1970, and a fluid delivery assembly 1990. Ultrasonic device 1900 may be similar to and include any of the features of ultrasonic device 1700 (FIGS. 17A and 17B), any of the features of other ultrasonic devices detailed herein, or any other suitable configuration. Thus, only additional features of ultrasonic device 1900 are described in detail below.

[0124] The occlusion assembly 1970 of the ultrasonic device 1900 includes an inflatable balloon 1972 disposed about the body 1922 of the shaft 1920, and an inflation fluid line 1974 fluidly coupled to the inflatable balloon 1972 and extending proximally through (or along) the shaft 1920 to connect to an inflation fluid pump connected to a source of inflation fluid, e.g., an inflation fluid reservoir (not shown), to enable selective inflation and deflation of the inflatable balloon 1972. The inflatable balloon 1972 defines a donut-shaped configuration such that the inflatable balloon 1972 can be inflated using the ultrasonic device 1900 positioned within the vaginal canal "V", for example, by pumping inflation fluid through the fluid line 1974 and into the inflatable balloon 1972, thereby expanding the inflatable balloon 1972 to sealingly engage the inner walls of the vaginal canal "V" and occluding the vaginal canal "V".

[0125] The fluid delivery assembly 1990 includes an infusion fluid conduit 1992 that extends through (or along) the shaft 1920 to one or more distal openings 1994 positioned distally of the inflatable balloon 1972. The infusion fluid conduit 1992 extends proximally and is configured to connect to an infusion fluid source, for example, an infusion fluid pump connected to an infusion fluid reservoir (not shown), to enable selective infusion or withdrawal of infusion fluid into / from the obstructed portion of the vaginal canal "V" via the distal opening 1994 of the infusion fluid conduit 1992. As an alternative to a fluid delivery assembly 1990 integrated into the ultrasound device 1900, a separate fluid delivery assembly may be utilized, for example, inserted through a lumen 1940 of the shaft 1920 of the ultrasound device 1900 or through the elongated tubular member 202 of the hysteroscope 200. Pumping an insufflation fluid, such as saline or other suitable fluid, into the obstructed portion of the vaginal canal "V" provides a transmission medium for the passage of ultrasound waves from the ultrasound sensor assembly 1930 to tissue without requiring direct contact between the ultrasound sensor assembly 1930 and the tissue, thereby enhancing the positionability of the ultrasound device 1900 and allowing, for example, ultrasound visualization of the uterus "U." Such fluid insufflation may additionally or alternatively be utilized for other purposes or may be omitted, whereby the inflatable balloon 1972 is used to stabilize and maintain the position of the ultrasound device 1900 within the patient.

[0126] 20, a robotic surgical system 1000 configured for use in accordance with the present disclosure is shown. Aspects and features of the robotic surgical system 1000 that are not relevant to an understanding of the present disclosure have been omitted to avoid obscuring aspects and features of the present disclosure in unnecessary detail.

[0127] The robotic surgical system 1000 generally includes multiple robotic arms 1002, 1003, a controller 1004, and an operator console 1005 coupled to the controller 1004. The operator console 1005 may include a display device 1006, which may be set up, among other things, to display three-dimensional images, and manual input devices 1007, 1008 by which a person, e.g., a surgeon, may remotely operate the robotic arms 1002, 1003 in a first operational mode. The robotic surgical system 1000 may be configured for use with a patient 1013 lying on a patient table 1012 to be treated in a minimally invasive manner. The robotic surgical system 1000 may further include a database 1014, among other things, coupled to the controller 1004, in which, for example, preoperative data and / or anatomical charts from the patient 1013 are stored.

[0128] Each of the robotic arms 1002, 1003 may include multiple members connected through joints and an attached device, which may be, for example, a surgical tool "ST." The surgical tool "ST" may include, for example, any of the ultrasound devices of the present disclosure, a hysteroscope (or endoscope), a working instrument, etc., thereby providing the robotic surgical system 1000 with any of the functions detailed above.

[0129] The robotic arms 1002, 1003 may be driven by powered devices, e.g., motors, connected to the controller 1004. The motors may be, for example, rotary drive motors configured to provide rotational inputs to accomplish a desired task or tasks. The controller 1004, e.g., a computer, may be configured, particularly by a computer program, to operate the motors such that the robotic arms 1002, 1003, and thus their mounted surgical tools "ST," perform desired movements and / or functions in response to corresponding inputs from the manual input devices 1007, 1008, respectively. The controller 1004 may also be configured to regulate the movement of the robotic arms 1002, 1003 and / or the motors.

[0130] The controller 1004 may more specifically control one or more of the motors based on rotation, for example, using a rotational position encoder (or Hall Effect sensor or other suitable rotational position detector) associated with the motor to determine the degree of rotational output from the motor and, therefore, the degree of rotational input provided. Alternatively or additionally, the controller 1004 may control one or more of the motors based on torque, current, or in any other suitable manner.

[0131] While several aspects of the present disclosure are shown in the drawings, it is not intended that the disclosure be limited to these embodiments, as it is believed that the disclosure should be interpreted in the broadest light permitted by the art and that the specification should be read in the same manner. Accordingly, the above description should not be construed as limiting, but merely as exemplifications of particular aspects. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims

1. 1. An ultrasound device comprising: a frame including first and second rails spaced apart from one another, the frame defining a longitudinal section defining a longitudinal axis, the longitudinal section having a distal end portion; a locking mechanism disposed between the first rail and the second rail, the locking mechanism configured to selectively lock a surgical instrument extending between the first rail and the second rail in a fixed position and orientation relative to the locking mechanism; an ultrasonic sensor assembly configured to enable ultrasonic imaging of a field of view, the ultrasonic sensor assembly being attached to the distal end portion of the longitudinal section of the frame and oriented such that the field of view is disposed at an oblique angle relative to the longitudinal axis; Equipped with the locking mechanism comprises a pair of clamp brackets configured to clamp the surgical instrument therebetween, and when the locking mechanism is in an unlocked configuration, the pair of clamp brackets are parallel to the first rail and the second rail, and when the locking mechanism is in a locked configuration, the pair of clamp brackets are angled relative to the first rail and the second rail.

2. 2. The ultrasound device of claim 1, wherein the frame further includes an upright section disposed at an angle relative to the longitudinal section, the frame defining a bend interconnecting the upright section and a proximal end portion of the longitudinal section.

3. 2. The ultrasonic device of claim 1, further comprising at least one spacer disposed between the first rail and the second rail, the at least one spacer securing the first rail and the second rail to one another and maintaining a distance between the first rail and the second rail.

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

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

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

7. The ultrasound device of claim 1 , wherein the ultrasound sensor assembly is removable from the distal end portion of the longitudinal section of the frame.

8. 8. The ultrasonic device of claim 7, further comprising a sterility barrier positionable around the ultrasonic sensor assembly, the ultrasonic sensor assembly having the sterility barrier positioned therearound, the ultrasonic sensor assembly being mountable to the distal end portion of the longitudinal section of the frame.

9. 2. The ultrasound device of claim 1, wherein the first rail and the second rail are interconnected by a backspan along a portion of the length of the longitudinal section of the frame that is less than the length of the longitudinal section of the frame.

10. 1. A surgical system comprising: the surgical system includes an ultrasonic device and a surgical instrument; The ultrasound device comprises: a frame including first and second rails spaced apart from one another, the frame defining a longitudinal section defining a longitudinal axis, the longitudinal section having a distal end portion; an ultrasonic sensor assembly configured to enable ultrasonic imaging of a field of view, the ultrasonic sensor assembly being attached to the distal end portion of the longitudinal section of the frame and oriented such that the field of view is disposed at an oblique angle relative to the longitudinal axis; Including, the surgical instrument is configured to be inserted between the first rail and the second rail of the frame, whereby the first rail and the second rail constrain lateral movement of the surgical instrument; the ultrasonic device further includes a locking mechanism disposed between the first rail and the second rail, the locking mechanism configured to selectively lock the surgical instrument between the first rail and the second rail in a fixed position and a fixed orientation relative to the locking mechanism; The surgical system, wherein the locking mechanism includes a pair of clamp brackets configured to clamp the surgical instrument therebetween, and wherein when the locking mechanism is in an unlocked configuration, the pair of clamp brackets are parallel to the first rail and the second rail, and when the locking mechanism is in a locked configuration, the pair of clamp brackets are angled relative to the first rail and the second rail.

11. 11. The surgical system of claim 10, wherein the frame of the ultrasonic device further includes an upright section disposed at an angle relative to the longitudinal section and a bend interconnecting the upright section and a proximal end portion of the longitudinal section.

12. 12. The surgical system of claim 11, wherein the surgical instrument is insertable between the first and second rails of the frame at the bent portion of the frame or at the upright section of the frame in a parallel or coaxial orientation to the longitudinal axis of the longitudinal section of the frame.

13. 11. The surgical system of claim 10, wherein when the surgical instrument is inserted between the first rail and the second rail, the first rail and the second rail constrain lateral movement of the surgical instrument while allowing axial translation, axial rotation, and vertical tilt of the surgical instrument.

14. 11. The surgical system of claim 10, wherein the ultrasonic device further includes at least one spacer disposed between the first rail and the second rail, the at least one spacer securing the first rail and the second rail to one another and maintaining a spacing between the first rail and the second rail.

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

16. The surgical system of claim 10 , wherein the ultrasonic device further includes a sterility barrier disposed around the ultrasonic sensor assembly and at least a portion of the longitudinal section of the frame.

17. 1. A surgical system comprising: the surgical system includes an ultrasonic device and a surgical instrument; The ultrasound device comprises: a frame including first and second rails spaced apart from one another, the frame defining a longitudinal section defining a longitudinal axis, the longitudinal section having a distal end portion; an ultrasonic sensor assembly configured to enable ultrasonic imaging of a field of view, the ultrasonic sensor assembly being attached to the distal end portion of the longitudinal section of the frame and oriented such that the field of view is disposed at an oblique angle relative to the longitudinal axis; Including, the surgical instrument is configured to be inserted between the first rail and the second rail of the frame, whereby the first rail and the second rail constrain lateral movement of the surgical instrument; the ultrasonic device further includes a sterility barrier disposed about the ultrasonic sensor assembly and at least a portion of the longitudinal section of the frame; The surgical system wherein the surgical instrument remains outside the sterile barrier when inserted between the first rail and the second rail.

18. The surgical system of claim 10 , wherein the surgical instrument is a hysteroscope configured to receive a working instrument therethrough.

19. 1. A surgical system comprising: the surgical system includes an ultrasonic device and a surgical instrument; The ultrasound device comprises: a shaft having a body, the body defining a longitudinal axis and including a lumen extending coaxially therethrough, the shaft including legs extending distally from the body and feet disposed at distal ends of the legs; an ultrasonic sensor assembly configured to enable ultrasonic imaging of a field of view, the ultrasonic sensor assembly being disposed within the foot and offset relative to the longitudinal axis and oriented such that the field of view is offset relative to the longitudinal axis; Including, the surgical instrument is configured to be removably inserted through the lumen of the shaft body and to extend distally from a distal end portion of the shaft body; an annular volume is defined between an innermost surface of the foot and an outermost surface of the surgical instrument when the surgical instrument is inserted through the lumen and extends distally from the distal end portion of the body; The annular volume defines a substantially constant distance from the innermost surface of the foot to the outermost surface of the surgical instrument.

20. 1. A surgical system comprising: the surgical system includes an ultrasonic device, a surgical instrument, and a biasing assembly; The ultrasound device comprises: a shaft having a body, the body defining a longitudinal axis and including a lumen extending coaxially therethrough; an ultrasonic sensor assembly configured to enable ultrasonic imaging of a field of view, the ultrasonic sensor assembly being disposed at a distal end portion of the body of the shaft and offset relative to the longitudinal axis and oriented such that the field of view is offset relative to the longitudinal axis; Including, the surgical instrument is configured to be removably inserted through the lumen of the shaft body and configured to extend distally from the distal end portion of the shaft body; The biasing assembly is configured to couple the ultrasonic device to the surgical instrument and to bias the ultrasonic device distally about and relative to the surgical instrument.

21. The surgical system of claim 20, wherein the shaft further includes a foot extending distally from the body, the ultrasonic sensor assembly being disposed within the foot.

22. 21. The surgical system of claim 20, wherein the shaft further includes a leg extending distally from the body and a foot disposed at a distal end of the leg, the ultrasonic sensor assembly being disposed in the foot.

23. 23. The surgical system of claim 22, wherein an annular volume is defined between an innermost surface of the foot and an outermost surface of the surgical instrument when the surgical instrument is inserted through the lumen and extends distally from the distal end portion of the body.

24. 24. The surgical system of claim 23, wherein the ultrasonic device is rotatable about the surgical instrument inserted therethrough, and the annular volume is maintained regardless of rotational orientation of the ultrasonic device relative to the surgical instrument.

25. The surgical system of claim 19 or claim 20, wherein the field of view is offset at an oblique angle relative to the longitudinal axis.

26. The surgical system of claim 19 or claim 20, wherein the field of view is offset at an acute angle relative to the longitudinal axis.

27. 21. The surgical system of claim 19 or claim 20, wherein the ultrasonic sensor assembly is oriented toward a distal face of the shaft, the distal face at least partially surrounding an open distal end of the lumen.

28. 21. The surgical system of claim 19 or claim 20, wherein the ultrasonic sensor assembly is oriented toward a distal surface of the shaft, the distal surface including a portion that is at least one of convex or conical or curved.

29. The surgical system of claim 19 or claim 20, wherein the ultrasonic sensor assembly is oriented toward a distal surface of the shaft, the distal surface being angled relative to the longitudinal axis.

30. 20. The surgical system of claim 19, further comprising a biasing assembly configured to couple the ultrasonic device to the surgical instrument and configured to bias the ultrasonic device about and distally relative to the surgical instrument.

31. 31. The surgical system of claim 20 or claim 30, wherein the biasing assembly includes a locking collar configured to fixedly engage about the surgical instrument, an outer sleeve configured to telescopically receive the shaft, and a biasing member disposed between the locking collar and the shaft to bias the shaft distally.

32. The surgical system of claim 19, wherein the ultrasonic device further includes an inflatable balloon disposed about the body of the shaft.

33. 33. The surgical instrument of claim 32, wherein the ultrasonic device further comprises a fluid exit opening positioned distal to the inflatable balloon.

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