Methods and systems for in-situ exchange

Abstract

The imaging assembly includes a shaft and a cavity that extends from its proximal end towards its distal end across the shaft. The cavity removably houses at least one of a plurality of different instruments. The wall of the cavity includes an elongate opening that is at least partially in communication with the exterior of the shaft along the shaft. An imaging sensor is coupled to the distal end of the shaft. The imaging sensor is advanced to a target site either alone or together with a first instrument coupled thereto. A treatment or diagnostic procedure is performed with the first instrument. The first instrument is then retracted and removed from the imaging assembly while the imaging assembly remains at the target site. A second instrument is then coupled to the imaging assembly and advanced to the target site to perform a further treatment or diagnostic procedure.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 674,479, filed May 21, 2018, the entire content of which is incorporated herein by reference. BACKGROUND OF THE INVENTION

[0003] The present disclosure relates to medical systems, devices, and methods. More particularly, the present disclosure relates to imaging components for use with therapeutic and diagnostic instruments.

[0004] Current systems, devices, and methods for imaging are less than ideal in at least some respects. For example, the flexibility of many current devices for use in various diagnostic and therapeutic procedures may be limited. For example, many current devices may not dock well with other therapeutic or diagnostic instruments. For example, many current devices may be expensive and / or difficult to clean. For example, many current devices may pose a risk of harming the patient during insertion and / or removal.

[0005] Additionally or alternatively, current systems, devices, and methods for diagnosis or providing treatment are less than ideal in at least some other respects. For example, in procedures where more than one instrument may be needed, multiple instruments may need to be inserted into or removed from the patient's lumen, and these additional insertion and removal steps may increase the risk of patient injury. Additionally or alternatively, many current methods may require the imaging component to be removed multiple times during a single procedure, and removing the imaging component may limit the ability to continuously and stably observe the surgical site during the procedure.

[0006] In view of the above, there is a need for improved systems, devices, and methods for imaging a surgical site. Such systems, devices, and methods would address at least some of the above deficiencies and, for example, would be less expensive, easier to clean, and / or capable of being used in a greater variety of therapeutic and diagnostic procedures. SUMMARY OF THE INVENTION

[0007] The present disclosure relates to an imaging assembly for use with a treatment and diagnostic instrument. Specifically, the imaging assembly disclosed herein can be placed in situ to capture images of a surgical site, while various treatment and / or diagnostic instruments can be exchanged through the imaging assembly at least in part. The imaging assembly disclosed herein can be used alone, in combination with only one instrument, or in combination with multiple instruments. An exemplary imaging assembly can include a shaft and a cavity extending across the shaft from its proximal end towards its distal end. The cavity can removably accommodate at least one of a plurality of different instruments. The wall of the cavity can include an elongated opening that is at least partially in communication with the exterior of the shaft along the shaft. An imaging sensor can be coupled to the distal end of the shaft to continuously image the surgical site when the imaging assembly is in situ. The imaging assembly can be advanced alone to a target site for imaging, or advanced to the target site together with a first instrument coupled thereto. The first instrument can be inserted in situ into the shaft of the imaging assembly. A treatment or diagnostic procedure can be performed with the first instrument. The first instrument can then be retracted and removed from the imaging assembly. Before, during, or after retracting and removing the first or other instrument, the imaging assembly can continuously and stably capture images of the surgical site. A second instrument can then be coupled to the imaging assembly and advanced to the target site to perform a further treatment or diagnostic procedure without interrupting the imaging of the surgical site. The first instrument can be a diagnostic instrument that performs a diagnostic procedure, and the second instrument can be a treatment instrument that performs a treatment procedure informed by the diagnostic procedure (or vice versa, or the first and second instruments can both be diagnostic instruments, or the first and second instruments can both be treatment instruments). After removing and retracting the second instrument, additional instruments can be coupled to the imaging sensor. For example, the diagnostic procedure can be repeated to check the treatment effect. In some cases, the imaging sensor can be used alone. In some cases, one or more disposable tubes can be coupled to the cavity to act as a sterile (and optionally, disposable) adapter for different instruments to be coupled to and advanced along the imaging assembly.

[0008] Aspects of the present disclosure provide an imaging assembly. An exemplary imaging assembly can include a shaft that includes a proximal end, a distal end, and a cavity extending across the shaft from the proximal end towards the distal end. The cavity can be configured to removably accommodate at least one of a plurality of different instruments. The wall of the cavity can include an elongated opening that is at least partially in communication with the exterior of the shaft along the shaft. The exemplary imaging assembly can further include an imaging sensor coupled to the distal end of the shaft.

[0009] The cavity may be defined by an outer surface of the shaft. The outer surface of the shaft may include only non-invasive edges. The edges of the elongate opening may curve toward the interior of the cavity. The cavity may be configured to slidably receive the instrument. A distal portion of the cavity may be angled axially relative to the shaft. The distal portion of the cavity may be angled axially relative to the shaft by about 3 to 45 degrees.

[0010] At least one of the plurality of instruments may include a tube. The tube may be aligned parallel to the shaft of the imaging assembly. The tube may be rotatable relative to the shaft while the shaft remains fixed. The tube may include a lumen configured to slidably receive a second one of the plurality of instruments. The tube may be configured to slidably receive the second instrument after the second instrument is aligned parallel to the shaft of the imaging assembly. The second instrument may be rotatable relative to the shaft while the shaft remains fixed. The tube may be disposable. The second instrument may include a tissue collector. The tissue collector may include a biopsy needle. The second instrument may include a tissue ablation element. The tissue ablation element may include one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. The second instrument may include an excision tool. The second instrument may include an instrument for implanting devices such as radiopaque markers, drug-eluting wireforms, fertility / contraceptive treatments, anchoring systems, hernia meshes, stents, or other devices. The second instrument may include an instrument for providing a detailed mapping of anatomical structures such as a laser, X-ray, secondary ultrasound, or other device. The first and second instruments may be any diagnostic or therapeutic device or a tube for receiving additional instruments.

[0011] At least one of the plurality of different instruments includes a treatment or diagnostic instrument. The treatment or diagnostic instrument may include a tissue collector, a biopsy needle, a tissue ablation element, an optical lens, an implant device, and / or a treatment electrode. The tissue ablation element may include one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element.

[0012] The shaft may be flexible. The shaft may be controllably bent along its longitudinal axis by a bending mechanism.

[0013] The imaging sensor may include an ultrasound sensor. The imaging sensor may include a light-emitting diode (LED) or a camera.

[0014] The cavity can define a circular cross-sectional area. The cavity can include a cross-sectional area that is substantially uniform along the shaft. The cavity can include an asymmetric cross-sectional area. The cavity can extend across the shaft from the proximal end to the distal end.

[0015] Aspects of the present disclosure can provide an imaging system. An exemplary imaging system can include any of the imaging components described herein and a disposable tube slidably received within a cavity of the imaging component. The system can also include a second instrument removably received within the lumen of the disposable tube. The second instrument can be a diagnostic or therapeutic instrument, a tissue collector, a biopsy needle, an optical scope, an implant device, and / or a tissue ablation element. The tissue ablation element can include one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, a cryoablation element, etc.

[0016] Aspects of the present disclosure can provide methods of performing a treatment or a diagnosis at a target site. In an exemplary method, any of the imaging components described herein can be inserted into a subject. With the imaging component in place, at least one of the plurality of instruments can be inserted into the cavity toward the target site, a treatment or a diagnosis can be performed at the target site using the instrument, and then the instrument can be removed from the cavity.

[0017] At least one of the plurality of instruments includes a tissue collector, a biopsy needle, and / or a tissue ablation element. The tissue ablation element can include one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. The instrument can include a treatment or diagnostic instrument, such as an optical scope, an implant device, or a treatment electrode.

[0018] The exemplary method can include the steps of inserting a second instrument into the cavity toward the target site, performing a treatment or a diagnosis at the target site using the second instrument, and removing the second instrument from the cavity. The second instrument can be different from at least one of the plurality of instruments. The method can be performed during a laparoscopic procedure, non-invasively, and / or during a minimally invasive procedure.

[0019] The second instrument can include a tissue collector, a biopsy needle, and / or a tissue ablation element. The tissue ablation element can include one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. The second instrument can include a treatment or diagnostic instrument, such as an optical scope, an implant device, or a treatment electrode.

[0020] Aspects of the present disclosure can provide methods for performing image-guided ablation therapy. In an exemplary method, any of the imaging components described herein can be inserted into a subject. With the imaging component in place, a biopsy needle can be inserted into the cavity, a pathological sample can be collected using the biopsy needle, the biopsy needle can be removed from the cavity, a radiofrequency (RF) ablation element can be inserted into the cavity, tissue can be ablated using the RF ablation element, the RF ablation element can be removed from the cavity, an optical mirror can be inserted into the cavity, the completion of the image-guided ablation therapy can be confirmed using the optical mirror, and the optical mirror can be removed from the cavity. The method can be performed in a laparoscopic surgery, non-invasively, and / or in a minimally invasive surgery.

[0021] Aspects of the present disclosure can provide methods for coupling instruments. An imaging component can be advanced into a surgical space. The imaging component can include a shaft that includes a proximal end and a distal end. A first instrument can be coupled to the imaging component for use in the surgical space. The first instrument can be a therapeutic or diagnostic instrument. The first instrument can be decoupled from the imaging component while the imaging component remains in the surgical space. A second instrument can be coupled to the imaging component for use in the surgical space while the imaging component remains in the surgical space. The second instrument can be a different therapeutic or diagnostic instrument from the first instrument. The imaging component can include an imaging sensor that includes an ultrasonic sensor. The method can be performed in a laparoscopic surgery, non-invasively, and / or in a minimally invasive surgery.

[0022] The coupling of the first instrument occurs when the imaging component can remain in the surgical space. Alternatively or in combination, the coupling of the first instrument occurs when the imaging component can be located outside the surgical space.

[0023] The method can further include the steps of collecting a tissue sample from the surgical space with the first instrument and / or ablating an area within the surgical space with the second instrument.

[0024] The method can further include performing a treatment or a diagnosis with the first instrument. The second instrument can be selected based on data collected from performing the treatment or the diagnosis with the first instrument. The parameters of the treatment or the diagnosis performed with the second instrument can be adjusted based on data collected from performing the treatment or the diagnosis with the first instrument. The data collected can include image data, and the parameters can be adjusted by adjusting the ablation area of the second instrument.

[0025] The imaging assembly may further include a cavity that extends from the proximal end towards the distal end across the shaft. The wall of the cavity may include an elongated opening that is at least partially in communication with the exterior of the shaft along the shaft. The cavity may be defined by the outer surface of the shaft. The outer surface of the shaft may include only non-invasive edges. The edges of the elongated opening may curve towards the interior of the cavity. The cavity may be configured to slidably receive the first instrument or the second instrument. The distal portion of the cavity may be angled axially relative to the shaft. The distal portion of the cavity may be angled axially relative to the shaft by about 3 to 45 degrees. A tube may be advanced into the cavity. The tube may be aligned parallel to the shaft of the imaging assembly. The tube may be rotatable relative to the shaft while the shaft remains fixed. The tube may include a lumen that is configured to slidably receive the first instrument or the second instrument. The tube may be configured to slidably receive the first instrument or the second instrument after the first or second instrument is aligned parallel to the shaft of the imaging assembly. The first or second instrument may be rotatable relative to the shaft while the shaft remains fixed. The tube may be disposable.

[0026] The first or second instrument may include a tissue collector, a biopsy needle, a tissue ablation element, an optical lens, an implant device, and / or a treatment electrode. The tissue ablation element may include one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element.

[0027] The shaft may be bendable. The shaft may be controllably bent along its longitudinal axis by a bending mechanism.

[0028] The imaging assembly may include an imaging sensor that includes a light-emitting diode (LED) or a camera. The cavity may define a circular cross-sectional area. The cavity may include a substantially uniform cross-sectional area along the shaft. The cavity may include an asymmetric cross-sectional area. The cavity may extend from the proximal end to the distal end across the shaft.

[0029] 1) The imaging assembly and 2) the first instrument or the second instrument may be axially coupled. 1) The imaging assembly and 2) the first instrument or the second instrument may be laterally coupled. 1) The imaging assembly and 2) the first instrument or the second instrument may be coupled by means of a magnet or an indent.

[0030] Aspects of the present disclosure provide systems for performing therapy and / or diagnostics at a target site within a patient. Exemplary systems can include a first therapy or diagnostic instrument, a second therapy or diagnostic instrument different from the first therapy and diagnostic instrument, and an imaging assembly configured to removably couple to the first and second therapy or diagnostic instruments either simultaneously or separately. The imaging assembly can be configured to be delivered to the target site within the patient (i) separately from the first and second therapy or diagnostic instruments and (ii) coupled to the first and / or second therapy or diagnostic instruments. The imaging assembly can be configured to removably couple to the first and second therapy or diagnostic instruments either simultaneously or separately after the imaging assembly is delivered to the target site within the patient. The imaging device can be used alone, in combination with only one instrument, or in combination with multiple instruments.

[0031] The first and second therapy or diagnostic instruments can include two of the following: a tissue collector, a tissue ablation element, an optical lens, or a therapy electrode. The tissue collector can include a biopsy needle. The tissue ablation element can include one or more of a radio frequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element.

[0032] The imaging assembly can include a shaft having a proximal end, a distal end, and a cavity extending from the proximal end toward the distal end across the shaft. The wall of the cavity can include an elongate opening that at least partially communicates with the exterior of the shaft along the shaft. The cavity can be defined by the outer surface of the shaft. The outer surface of the shaft can include only non-invasive edges. The edges of the elongate opening can curve toward the interior of the cavity. The cavity can be configured to slidably receive the instrument. The distal portion of the cavity can be angled axially relative to the shaft. The distal portion of the cavity can be angled axially relative to the shaft by about 3 to 45 degrees.

[0033] The system can further include a tube. The tube can be aligned parallel to the shaft of the imaging assembly. The tube can be rotatable relative to the shaft while the shaft remains fixed. The tube can include a lumen configured to slidably receive the first or second instrument. The tube can be configured to slidably receive the first or second instrument after the first or second instrument is aligned parallel to the shaft of the imaging assembly. The first or second instrument can be rotatable relative to the shaft while the shaft remains fixed. The tube can be disposable.

[0034] The shaft of the imaging assembly can be bendable. The shaft can be controllably bent along its longitudinal axis by a bending mechanism.

[0035] The imaging assembly may include an imaging sensor, which may include a light-emitting diode (LED) or a camera. The cavity may define a circular cross-sectional area. The cavity may include a cross-sectional area that is substantially uniform along the shaft. The cavity may include an asymmetric cross-sectional area. The cavity may extend across the shaft from the proximal end to the distal end. The imaging sensor may include an ultrasonic sensor.

[0036] Aspects of the present disclosure provide methods for performing a treatment or a diagnosis at a target site. An imaging assembly may be advanced to the target site. The imaging assembly may include 1) a shaft including a proximal end, a distal end, and a cavity extending across the shaft from the proximal end toward the distal end, wherein the wall of the cavity includes an elongate opening that at least partially communicates with the exterior of the shaft along the shaft, and 2) an imaging sensor coupled to the distal end of the shaft. A treatment or a diagnosis may be performed using a first instrument inserted into the cavity and advanced to the target site.

[0037] The method may further include the step of inserting the first instrument into the cavity before advancing the imaging assembly to the target site. The first instrument may be inserted into the cavity after advancing the imaging assembly to the target site. The first instrument may be removed from the cavity while the imaging assembly remains at the target site. A second instrument may be inserted into the cavity and advanced to the target site. A treatment or a diagnosis may be performed using the second instrument.

[0038] The cavity of the imaging assembly may be defined by the outer surface of the shaft. The outer surface of the shaft may include only non-invasive edges. The edges of the elongate opening may curve toward the interior of the cavity. The cavity may be configured to slidably receive the instrument.

[0039] The distal portion of the cavity may be angled axially relative to the shaft. The distal portion of the cavity may be angled axially relative to the shaft by about 3 to 45 degrees.

[0040] The imaging assembly may further include a tube. The tube may be aligned parallel to the shaft of the imaging assembly. The tube may be rotatable relative to the shaft while the shaft remains fixed. The tube may include an inner lumen configured to slidably receive the first instrument. The tube may be configured to slidably receive the first instrument after the second instrument is aligned parallel to the shaft of the imaging assembly. The first instrument may be rotatable relative to the shaft while the shaft remains fixed. The tube may be disposable.

[0041] The first instrument may include a tissue collector. The tissue collector may include a biopsy needle. Alternatively or in combination, the first instrument may include a tissue ablation element. The tissue ablation element may include one or more of a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, or a cryoablation element. The instrument may include an optical mirror. The instrument may include a treatment electrode.

[0042] The shaft of the imaging assembly may be bendable. The shaft may be controllably bent along its longitudinal axis by a bending mechanism.

[0043] The imaging sensor may include a light-emitting diode (LED) or a camera.

[0044] The cavity may define a circular cross-sectional area. The cavity may include a cross-sectional area that is substantially uniform along the shaft. The cavity may include an asymmetric cross-sectional area. The cavity may extend from the proximal end to the distal end across the shaft. The imaging sensor may include an ultrasound sensor.

[0045] By the following detailed description, other aspects and advantages of the present disclosure will become apparent to those skilled in the art, in which only illustrative embodiments of the present disclosure are shown and described. It will be recognized that the present disclosure is capable of having other and different embodiments, and that several details thereof can be modified in various obvious aspects, all without departing from the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0046] Incorporation by Reference

[0047] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The novel features of the present disclosure are set forth specifically in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description and the accompanying drawings, which illustrate illustrative embodiments in which the principles of the present disclosure are utilized:

[0049] Figure 1A A perspective view of an imaging assembly according to some embodiments is shown.

[0050] Figure 1B Shown is an imaging assembly according to some embodiments Figure 1A in a side cross-sectional view.

[0051] Figure 1CShows a distal end of an imaging assembly including a cavity according to some embodiments. Figure 1A The enlarged perspective view of the distal end of the imaging assembly.

[0052] Figure 2A Shows a distal end of an imaging assembly having a tissue collector instrument according to some embodiments, the tissue collector instrument being disposed within the shaft of the imaging assembly. Figure 1A The enlarged perspective view of the distal end of the imaging assembly.

[0053] Figure 2B Shows a side cross-sectional view of an imaging assembly having a biopsy instrument according to some embodiments, the biopsy instrument being disposed within the shaft of the imaging assembly. Figure 1A The side cross-sectional view of the imaging assembly.

[0054] Figure 2C Shows an enlarged perspective view of a distal end of an imaging assembly having a radiofrequency ablation instrument according to some embodiments, the radiofrequency ablation instrument being disposed within the shaft of the imaging assembly. Figure 1A The enlarged perspective view of the distal end of the imaging assembly.

[0055] Figure 2D Shows a top view of an imaging assembly having a drug delivery instrument according to some embodiments, the drug delivery instrument being disposed within the shaft of the imaging assembly. Figure 1A The top view of the imaging assembly.

[0056] Figure 2E Shows a side cross-sectional view of an imaging assembly having a needle according to some embodiments, the needle being disposed within the shaft of the imaging assembly. Figure 1A The side cross-sectional view of the imaging assembly.

[0057] Figure 3A Shows an assembled view of an imaging system including an imaging assembly and an optical mirror instrument according to some embodiments. Figure 1A The assembled view of the imaging system.

[0058] Figure 3B Shows an assembled view of an imaging system according to some embodiments. Figure 3A The assembled view of the imaging system illustrates the attachment mechanism of the system.

[0059] Figure 4 Shows an enlarged perspective view of a shaft of an imaging assembly according to some embodiments, wherein the shaft of the imaging assembly is flexible. Figure 1A The enlarged perspective view of the shaft of the imaging assembly.

[0060] Figure 5A Illustrates a perspective view of a system for diagnosis and / or providing treatment according to some embodiments, the system including an imaging assembly configured to be removably coupled to a plurality of treatment and / or diagnostic instruments. Figure 5A Shows the separated imaging assembly and the treatment and / or diagnostic instruments.

[0061] Figure 5B illustrates, according to some embodiments, Figure 5A a perspective view of a system in which a treatment and / or diagnostic instrument is in a ready position removably coupled to an imaging assembly.

[0062] Figure 5C illustrates, according to some embodiments, Figure 5A a perspective view of a system in which a treatment and / or diagnostic instrument is removably coupled to an imaging assembly.

[0063] Figure 6 shows a schematic diagram of an imaging system according to some embodiments, the imaging system including a digital processing device and a display visible to a user.

[0064] Figure 7A shows, according to some embodiments, Figure 1A a schematic diagram of an imaging assembly positioned within the uterus to image uterine tissue.

[0065] Figure 7B shows, according to some embodiments, an image of a surgical site captured as in Figure 7A which is visible on a display and shows safety and treatment boundaries.

[0066] Figure 7C shows a surgical site image according to some embodiments that combines a virtual image showing safety and treatment boundaries with the actual presence of a treatment needle.

[0067] Figure 7D shows a surgical site image according to some embodiments that combines a virtual image showing safety and treatment boundaries with the actual presence of a treatment needle and rake teeth.

[0068] Figure 8 is a flowchart showing an exemplary method of performing a treatment or diagnosis at a target site according to some embodiments.

[0069] Figure 9 is a flowchart showing an exemplary method of performing an image-guided ablation treatment according to some embodiments.

[0070] Figure 10 illustrates a schematic diagram of an exemplary digital processing device programmed or otherwise configured with an imaging assembly according to some embodiments.

[0071] Figure 11A shows a side cross-sectional view of an imaging assembly according to some embodiments having a shaft with a circular cross-section.

[0072] Figure 11BShows a side cross-sectional view of an imaging assembly according to some embodiments, the imaging assembly having an edge that curves inwardly toward the interior of the cavity.

[0073] Figure 12A Illustrates a system for diagnosis and / or providing treatment according to some embodiments, the system including an imaging assembly configured to be removably coupled in situ to a plurality of treatment and / or diagnostic instruments. Figure 12A Shows the imaging assembly separated from the treatment and / or diagnostic instrument during use.

[0074] Figure 12B Illustrates according to some embodiments Figure 12A of a system, wherein the treatment and / or diagnostic instrument is in a ready position to be removably coupled in situ to the imaging assembly.

[0075] Figure 12C Shows according to some embodiments Figure 12A of a system, wherein the treatment and / or diagnostic instrument and the imaging assembly are removably coupled to each other in situ so as to enable a treatment and / or diagnostic procedure to be performed in situ. Detailed Description

[0076] Embodiments of the present disclosure provide an imaging assembly that includes a cavity extending across (e.g., along) the length of a shaft, wherein the cavity may be configured to removably receive at least one of a plurality of different instruments. In some embodiments, the cavity of the imaging assembly may be partially open to the exterior of the shaft. The imaging assembly may also include an imaging sensor located at the distal end of the shaft. Additionally, the shaft of the imaging assembly may be configured such that additional treatment and / or diagnostic instruments / attachments may be removed and / or received and / or inserted during a medical procedure without disturbing the imaging assembly. Additionally or alternatively, the imaging assembly may remain in situ while receiving and / or removing the treatment and / or diagnostic instrument. In some embodiments, the imaging assembly may be used without an additional treatment and / or diagnostic instrument coupled thereto. In some embodiments, the imaging assembly may be inserted into and / or removed from a patient's lumen without a treatment and / or diagnostic instrument. Such an imaging assembly may be used during a medical procedure (e.g., non-invasive surgery, minimally invasive surgery, and / or laparoscopic surgery).

[0077] Embodiments of the present disclosure can improve existing methods for imaging and treating lesions in an organ tract for a procedure that may require multiple instruments to perform a diagnosis and / or provide treatment in a single procedure. For example, an imaging component can be used for diagnosis; then a biopsy attachment can be inserted to obtain a pathological sample; then an ablation attachment can be inserted for ablating any lesions; then other attachments or instruments can be inserted to perform additional procedures, such as delivering drugs, implants, and / or therapeutic and / or diagnostic agents. By providing a shaft with a non-invasive edge and a cavity configured to accommodate multiple different instruments, the imaging component of the present disclosure can facilitate the insertion and removal of medical instruments. Additionally or alternatively, the imaging component can be used independently of additional instruments or attachments. In such an embodiment, the edge of the cavity can be smooth or rounded such that when used alone, the edge does not snag on patient tissue.

[0078] By providing a cavity of the imaging component that is easier to clean than components with enclosed cavities or lumens, the cavity of the imaging component can improve existing methods for imaging and treating. By facilitating the manufacture of the imaging component, the cavity of the imaging component can improve existing methods for imaging and treating. By providing an imaging component with a disposable tube, embodiments of the present disclosure can reduce the cost of treatment. By providing a reusable imaging component with a cavity into which a disposable instrument can be inserted, embodiments of the present disclosure can reduce the cost of treatment. Embodiments of the imaging component can provide a shaft that always aligns the instrument with the ultrasound image. Embodiments of the present disclosure can accommodate a variety of instruments having different sizes and shapes. Embodiments of the present disclosure can provide scale or position information to assist in instrument insertion.

[0079] The systems and methods of the present disclosure may be particularly useful for treating fibroids in a patient's uterus. The imaging component can be deployed into the uterus transvaginally and transcervically, or in other cases, through laparoscopy and through the exterior of the uterus or other organ or tissue tract. The imaging component can be used in combination with additional instruments, such as a biopsy needle, a tissue ablation element (e.g., a radiofrequency ablation element, an ultrasound ablation element, a heat-based ablation element, a cryoablation element, etc.), and / or other instruments adapted to be disposed within the cavity of the imaging component. Additionally or alternatively, the additional instruments can be used to deliver drugs, implants, or other therapeutic agents to the tissue to be treated. Additionally or alternatively, the tissue ablation element can include embodiments or variations of the needle / rake assemblies in co-owned U.S. Patent Nos. 8,206,300, 8,262,574, and 8,992,427, the contents of which are incorporated herein by reference.

[0080] Embodiments of the present disclosure can improve at least some of the systems and methods in co-owned references by providing a shaft of an imaging component with a non-invasive edge such that the imaging component can be used alone. In some embodiments, embodiments of the present disclosure can improve the ability to remove and / or accommodate additional instruments by providing an imaging system without an attachment mechanism in at least a portion of the system to be positioned in situ. In such embodiments, the imaging component shaft can be non-cylindrically symmetric (e.g., having an elliptical or rectangular cross-section) to reference the rotation of an additional instrument relative to the imaging component shaft. In some embodiments, additionally or alternatively, the present disclosure can provide a shaft of an imaging component with a small-angle portion to minimize the risk of damage to the surface of an instrument against the surface of the imaging sensor. Additionally or alternatively, for many possible purposes, the imaging component can include a disposable tube inserted into a cavity to provide a working channel for inserting additional instruments of different diameters and making the system easier to clean.

[0081] The imaging components described herein can be used in surgical procedures to provide real-time images of a target structure to be treated, including projection safety margins and treatment margins as described in co-owned U.S. Patent Nos. 8,088,072 and 8,262,577, the contents of which are incorporated by reference. The imaging components described herein can be used for imaging and treating uterine fibroids as described in co-owned U.S. Patent No. 7,918,795, which is incorporated by reference herein. Other co-owned patents and published applications describing probes for treating uterine fibroids that can be used with the imaging components described herein include U.S. Patent Nos. 7,815,571, 7,874,986, 8,506,485, 9,357,977, and 9,517,047, which are incorporated by reference herein. Additionally, co-owned patent applications describing systems for establishing and adjusting the boundaries of safe and treatment regions for display that can be used with the imaging components described herein include: U.S. Patent Publication No. 2014 / 0073910, U.S. Patent No. 8,992,427, U.S. Patent Application No. 15 / 811,520, and PCT Application No. US2017 / 060674, each of which is incorporated by reference herein. The co-owned patent application PCT Application No. PCT / US2017 / 060674, which describes a mapping and planning system that can be used with the imaging components described herein, is also incorporated by reference herein.

[0082] In some embodiments, the systems and methods of the present disclosure can provide imaging components for use in various diagnostic and therapeutic procedures. Some embodiments can provide methods and systems for performing a treatment or a diagnosis on a volume of tissue. The volume of tissue can include a patient organ. The patient organ or body cavity can include, for example: muscle, tendon, mouth, tongue, pharynx, esophagus, stomach, intestine, anus, liver, gallbladder, pancreas, nose, larynx, trachea, lungs, kidneys, bladder, urethra, uterus, vagina, ovaries, testicles, prostate, heart, arteries, veins, spleen, glands, brain, spinal cord, nerves, and the like. Some embodiments provide systems and methods suitable for laparoscopic surgery. Some embodiments provide systems and methods suitable for non-invasive surgery. Some embodiments provide systems and methods suitable for minimally invasive surgery. Some embodiments provide systems and methods suitable for robotic surgery or robot-assisted surgery.

[0083] Reference will now be made in detail to various embodiments, examples of which are illustrated in the accompanying drawings. Numerous specific details are set forth in the following detailed description in order to provide a thorough understanding of the invention and the described embodiments. However, the invention may be practiced optionally without these specific details. In other instances, well-known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.

[0084] It should be understood that although the terms "first", "second", etc. are optionally used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, a first instrument can be referred to as an instrument sensor, and, similarly, a second instrument can be referred to as the first instrument without changing the meaning of the description, provided that all occurrences of "first instrument" are consistently renamed and all occurrences of the second instrument are consistently renamed. The first instrument and the second instrument are both instruments, but they are not the same instrument.

[0085] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the claims. As used in the description of the embodiments and the appended claims, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the term "and / or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items. It should also be understood that the terms "comprises" and / or "comprising", when used in this specification, specify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or combinations thereof.

[0086] As used herein, depending on the context, the term "if" is optionally interpreted to mean "when" or "upon" or "in response to determining" or "in accordance with a determination result" or "in response to detecting", where the prerequisite condition is true. Similarly, depending on the context, the phrase "if it is determined that [the prerequisite condition is true]" or "if [the prerequisite condition is true]" or "when [the prerequisite condition is true]" is optionally interpreted to mean "upon determining" or "in response to determining" or "in accordance with a determination result" or "upon detecting" or "in response to detecting", where the prerequisite condition is true.

[0087] For purposes of explanation, the following figures and corresponding descriptions may be described below with reference to uterine imaging, specifically in connection with the diagnosis and ablation and / or treatment of uterine fibroids. However, those skilled in the art will recognize that similar imaging components may be used with similar instruments in other therapeutic applications, such as: instruments for performing tissue biopsies, drug delivery, fluid infusion and / or aspiration, and treating cancer, tumors, fibroids, and other malignant or benign masses in any suitable body cavity.

[0088] Figure 1A A diagram of an imaging assembly 100 according to some embodiments is shown. The imaging assembly 100 may include a handle portion 101 connected to an imaging shaft 103. An imaging sensor 107 may be coupled to the distal end of the imaging shaft 103. The imaging shaft may include a proximal end and a distal end, where a cavity 105 extends from the proximal end toward the distal end across the length of the shaft. The cavity 105 may be at least partially open to the exterior of the shaft. For example, one side or wall of the cavity may include an elongated opening that communicates with the exterior of the shaft. The elongated opening at least partially communicates with the exterior of the shaft along the length of the shaft. In some embodiments, the edges of the elongated opening may curve toward the interior of the cavity of the shaft (e.g., see Figure 11B ) described further below). The length of the shaft may be long enough to fully enter the patient's uterus while the handle portion 101 remains outside the patient. Additionally or alternatively, the length of the shaft may be significantly greater than the distance sufficient to fully enter the patient's uterus. The side opening may be open along the entire length of the shaft or may be open only partially along the length of the shaft. For example, the side opening may be open for more than three-quarters of the length of the shaft, more than half of the length of the shaft, or more than one-quarter of the length of the shaft. The cavity 105 may be configured to accommodate at least one of a plurality of different additional instruments or accessories such that a first instrument may be received in the cavity, the first instrument may be removed from the cavity, and a second instrument may be received in the cavity.

[0089] The handle portion 101 can be part of a two-piece handle such that when accommodating a first instrument or a second instrument, the two handle portions can be joined to form a single handle. The interior of the handle portion 109 can include alignment elements 111 such that after instrument replacement, the first and second portions can be reproducibly aligned relative to each other. The alignment elements can be configured such that the first and second portions can be sufficiently fixed relative to each other to use the two handle portions as a single handle. In some embodiments, the alignment elements can include magnets. In other embodiments, the alignment elements can include, for example: latches, hooks, or any other mechanism that removably couples the two-piece handle. The handle portion can also include positioning elements 113 (such as slots) to accommodate complementary protrusions or other elements on opposing handle portions to provide a more secure reference between the portions of the two-piece handle. The positioning elements can include mechanical features to fix the instrument relative to the imaging assembly by restricting translation of the instrument along the axis of the shaft of the imaging assembly.

[0090] In other embodiments, the imaging assembly 100 can be configured to be used with an instrument that does not have a handle portion. In such embodiments, the handle portion 101 of the imaging assembly 100 is sufficient to be used alone during the procedure to guide the imaging assembly. In some embodiments, the imaging assembly 100 can have a scale or guide within the interior of the handle portion 109 to measure the insertion depth of the instrument. In other embodiments, the imaging assembly can be used without an instrument. In some embodiments, the scale can facilitate embodiments where the instrument does not have a handle. In other embodiments, in embodiments where the instrument has a handle, the scale can facilitate the insertion of components of the instrument.

[0091] Figure 1B A cross-sectional view of an imaging assembly 100 according to some embodiments is shown. The body of the shaft can include internal structures to carry electronics or other associated components to control the imaging sensor. The shaft can also include a wire system or other bending mechanism to allow the shaft to be controllably bent, flexed, or deflected at the distal end of the shaft. The shaft can include channels or conduits to direct fluid (e.g., water, saline, etc.) to the distal end of the shaft and onto the tissue surface. The cross-section of the imaging shaft 103 can be circular or shaped with sufficiently softened, chamfered, rounded, or beveled edges such that the edges can be non-traumatic to the patient's opening during insertion or removal of the imaging assembly, with or without an instrument. The shaft 103 can also include a smooth outer surface. The shaft 103 can be made of a material such that the surface is deformable to allow the shaft to bend or conform to the shape of a body cavity.

[0092] The cavity 105 of the imaging shaft 103 can be configured to slidably receive one or more of a plurality of instruments. In some embodiments, the cavity can be defined by the outer surface of the shaft. In some embodiments, the cavity can be partially open along a wall such that the cavity communicates with the exterior of the shaft. The opening can be sufficiently enclosed to provide structural support such that when the imaging assembly is inserted into a body cavity of a patient, the opening of the inner cavity is not significantly disturbed by the insertion or removal of an instrument. Optionally, the outer surface of the shaft can include only a trauma-free edge. The cavity 105 of the imaging shaft 103 can be sufficiently open such that when instruments of different sizes can be received in or inserted into the cavity, the cavity can allow some deformation of the cavity opening. The cavity can facilitate cleaning of the imaging assembly.

[0093] Figure 11A A cross-sectional view of an imaging assembly according to some embodiments is shown, the imaging assembly having a shaft with a circular cross-section. Figure 11A The cross-section of the imaging assembly can be sufficiently circular such that the imaging assembly can be rotated without disturbing the inner cavity of the patient. Figure 11B A cross-sectional view of an imaging assembly according to some embodiments is shown, the imaging assembly having an edge that curves inwardly towards the interior of the cavity. The inwardly curved edge 1111 of the cavity can be used to support the opening of the body cavity such that the shaft can be inserted into or removed from the body cavity without trauma, with or without an instrument.

[0094] Although the cavity of the shaft can define a circular cross-section in the illustrated example, in other embodiments the cavity can be oval or have any other geometry with sufficiently softened, rounded or chamfered edges and corners such that the insertion and removal of the shaft can be done without damaging the body cavity of the patient. In some embodiments, the cavity can be non-cylindrically symmetric. In some embodiments, the cavity can be asymmetric in order to provide an axis for aligning an instrument within it. The cross-section of the cavity can be open less than three-quarters of its perimeter, additionally or alternatively, the cavity can be open less than half of its perimeter, less than a quarter of its perimeter, and less than an eighth of its perimeter. In other embodiments, the cavity of the shaft of the imaging assembly can be closed with respect to the exterior of the shaft and the instrument can be slidably inserted fully into the interior of the shaft of the imaging assembly.

[0095] In some embodiments, the cavity may include a cross-sectional area that is substantially uniform along the shaft. In other embodiments, a portion of the shaft length may have a different cross-section than another portion of the shaft length. In one example, the proximal portion of the shaft may be asymmetrical to provide an axis for instrument alignment, and the distal portion of the shaft may have a circular cross-sectional area. In another embodiment, the cavity tapers towards the end of the shaft. In such an example, the taper may facilitate the insertion of an instrument into the cavity. In some embodiments, the cross-sectional diameter of the cavity may narrow to allow for greater flexibility of the distal end of the shaft.

[0096] In some embodiments, the imaging shaft 103 may further include a tube 115 to be positioned at the cavity 105 of the imaging shaft 103. The tube 115 may include a lumen. The lumen of the tube 115 may be configured to slidably receive one or more of a plurality of instruments. The tube 115 may be aligned parallel to the shaft of the imaging assembly such that the tube may slidably receive additional instruments / attachments. Subsequently, after being aligned parallel to the shaft of the imaging assembly, the tube 115 may slidably receive additional instruments / attachments. In some embodiments, the tube 115 may be disposable. In some embodiments, the tube 115 may be reusable, e.g., by decoupling from the imaging shaft 103, cleaning, and autoclaving. The tube 115 may have an outer surface, where the surface substantially contacts the inner wall of the cavity 105. The tube 115 may have an inner surface with a different geometry than the outer surface, which is configured to receive one or more of a plurality of instruments. In some embodiments, a second tube may be removably inserted into the first tube and the second tube may have a different lumen geometry than the first tube, thereby facilitating the insertion of one or more of a plurality of instruments. In some embodiments, the tube 115 may be rotatable relative to the imaging assembly. In some embodiments, under user control, the tube 115 may be rotated fully in either direction within the shaft of the imaging assembly relative to the imaging assembly. In some embodiments, the tube 115 may be lubricated internally or externally to facilitate the insertion or removal of instruments.

[0097] The tube 115 can be inserted in situ into the body cavity while the imaging assembly is still advancing in the body cavity. Additionally or alternatively, the tube 115 can be inserted into the shaft of the imaging assembly before the imaging assembly is inserted into the body cavity. The tube 115 can have sufficient structural integrity to support the body cavity during insertion of the imaging assembly without instrumentation. Damage to the body cavity can be minimized when additional instruments are inserted into the tube 115 or the tube 115 is inserted in situ into the imaging assembly. The tube 115 can be made of a sterilizable material. The tube 115 can be made of a material that is inexpensive enough so that it can be discarded after single use. Exemplary materials for a disposable tube can include polyimide, PTFE, polyurethane, and thermoplastics such as Pebax or Nylon. The tube 115 can be made of a material that has sufficient elasticity to accommodate an instrument that is slightly larger or smaller in circumference than the tube. In embodiments where the cavity is not circular, the tube can be shaped like the cavity or can be another shape.

[0098] The tube 115 can reduce the cost of treatment by facilitating the insertion of additional instruments into and / or removal of additional instruments from the cavity of the imaging assembly 100 and thereby preventing damage to the surface of the cavity 105 of the imaging assembly 100. The tube 115 can reduce costs by facilitating the cleaning of the cavity 105 of the imaging assembly 100. The tube 115 can reduce the cost of treatment by providing an inexpensive component that can act as an adapter for a variety of different treatment and / or diagnostic instruments / attachments, for example, by providing a way that is suitable for the various different internal geometries of different instruments / attachments but has a uniform external geometry so as to be removably coupled to the same single imaging assembly 100. For example, a disposable tube with a smaller inner diameter can facilitate the insertion and control of a needle whose outer diameter is smaller than the inner diameter of the shaft of the imaging assembly.

[0099] Figure 1C An enlarged view of the distal end of an imaging assembly including a cavity is shown according to some embodiments. The distal end of the imaging assembly can include an imaging sensor 107. The imaging sensor can include an ultrasonic sensor and / or a plurality of ultrasonic sensors. The ultrasonic sensor can operate at a frequency of 500 kHz, 1 MHz, 5 MHz, 10 MHz, 20 MHz, 100 MHz, or within a range defined by any two of the foregoing values. Some embodiments of the ultrasonic sensor can include the description of other sensors from the co-assigned references incorporated herein.

[0100] In some embodiments, the distal end 117 of the imaging sensor can further include a light-emitting diode and / or a camera to provide an image to the user. In such an embodiment, the imaging assembly can act as an optical mirror as well as an ultrasonic imaging platform. The distal end of the imaging sensor can include optical components such as optical fibers, relay lenses, objective lenses, etc.

[0101] The imaging sensor 107 can be configured to be deflectable. The imaging sensor can be configured to deflect relative to the longitudinal axis of the shaft of the imaging assembly. In some embodiments, the distal end of the imaging assembly includes a hinge to facilitate deflection of the imaging sensor. Deflection of the imaging sensor can be controlled by a deflection lever 119 on the handle portion 101 of the imaging assembly. One or more imaging sensors can be oriented by deflection of the imaging sensor. One or more imaging sensors can be oriented by deflection of the imaging sensor to facilitate maintaining the field of view of the image during treatment. Additionally or alternatively, the ultrasound sensors can be radially and / or axially aligned to image multiple views simultaneously. To avoid instrument blockage, the imaging sensor can be directed to deflect. Additionally or alternatively, deflection of the imaging sensor can be used to deflect a flexible instrument within a cavity. The distal end of the shaft can include an interlock system, similar to the interlock system incorporated in the reference, to prevent the imaging sensor from blocking the instrument or being damaged by the sharp edges of the instrument. Actuation of the deflection lever can operate in a manner similar to that described in U.S. Patent No. 8,992,427, which is incorporated herein by reference. The deflection lever 119 can deflect the imaging sensor by less than 45 degrees, and additionally or alternatively, for example, by less than 120 degrees, less than 90 degrees, less than 60 degrees, less than 30 degrees, less than 15 degrees, and less than 5 degrees.

[0102] The distal end of the imaging assembly can include a non-traumatic edge to facilitate insertion of the imaging assembly into the cavity with or without an instrument. Additionally or alternatively, the distal end of the cavity of the imaging assembly can include a portion angled axially relative to the shaft such that when the distal end of the instrument is pushed out of the distal end of the cavity, the distal end of the instrument can be deflected upward. The distal end of the cavity of the imaging assembly can include an angled portion, where the angle is from 3 to 45 degrees. The distal end of the cavity of the imaging assembly can include an angled portion, where the angle is less than 45 degrees, and additionally or alternatively, for example, the angle is less than 90 degrees, less than 60 degrees, less than 30 degrees, less than 15 degrees, and less than 5 degrees.

[0103] The cavity of the imaging assembly can be configured to slidably receive one or more of a plurality of instruments. In some embodiments, the imaging assembly can be configured to receive one or more treatment or diagnostic instruments. In some embodiments, at least one of the plurality of instruments can be a treatment or diagnostic instrument. In some embodiments, the instruments can include instruments such as biopsy needles, optical mirrors, implant devices, treatment electrodes, tissue ablation elements (e.g., radiofrequency ablation elements, ultrasound ablation elements, heat-based ablation elements, cryoablation elements, etc.) and / or other instruments adapted to be disposed within the cavity of the imaging assembly. Additionally or alternatively, the instruments can be used to deliver drugs or other therapeutic agents to the tissue to be treated. Figures 2A - 2EAn instrument that can be slidably received by an imaging assembly is shown. One of ordinary skill in the art will recognize that many instruments, including those disclosed in the following figures, can be used with the imaging assemblies of the present disclosure.

[0104] Figure 2A An enlarged view of the distal end of an imaging assembly having a tissue collector instrument 210 is shown, according to some embodiments. The tissue collector instrument 210 is disposed within the shaft 105 of the imaging assembly 100. The tissue collector element can be used to extract tissue and / or cytopathological samples for examination by medical professionals to determine the extent of a disease. In some embodiments, the tissue collector can include a biopsy needle. The tissue collector 210 can include a shaft 211 of the tissue collector, which has a distal end and a proximal end. The shaft 211 of the tissue collector can be configured to be separated from the handle assembly of the instrument and can also be configured to be used without the handle assembly such that the tissue collector 210 can be disposable.

[0105] The shaft 211 of the tissue collector can be made of a flexible and / or bendable material such that it can be deflected by an imaging sensor and / or an angled portion within the cavity of the shaft. In the illustrated example, the distal end of the shaft of the tissue collector is deflected upward by an angled portion within the cavity of the shaft. Among other possible purposes, the distal end of the shaft of the tissue collector can be deflected upward to avoid damage to the imaging sensor. The distal end of the cavity of the imaging assembly can include a portion that is angled axially relative to the shaft such that when the distal end of the instrument is pushed out of the distal end of the cavity, the distal end of the instrument can be deflected upward. The distal end of the cavity of the imaging assembly can include an angled portion, where the angle is less than 45 degrees, and additionally or alternatively, for example, the angle is less than 90 degrees, less than 60 degrees, less than 30 degrees, less than 15 degrees, and less than 5 degrees.

[0106] Additionally or alternatively, the shaft of the imaging collector can include a wire system or other device to deflect the distal end of the tissue collector such that the distal end of the tissue collector does not damage the imaging sensor. The distal end of the tissue collector instrument can include a slot or opening 213 in which tissue can be collected. In some embodiments, the tissue collector can rotate relative to the shaft. In some embodiments, under the control of a user, the tissue collector can rotate completely in either direction within the shaft of the imaging assembly relative to the shaft while the shaft remains fixed such that the slot 213 can scrape, scoop, or otherwise collect tissue.

[0107] The shaft of the tissue collector can be longer than the shaft of the imaging sensor such that the slit or opening can collect tissue from deep within the uterus or other body cavity. In some embodiments, the shaft of the tissue collector can be two inches longer than the shaft of the imaging sensor. Additionally or alternatively, for example, the shaft of the tissue collector can be six inches longer than the shaft of the imaging sensor, can be four inches longer than the shaft of the imaging sensor, can be two inches longer than the shaft of the imaging sensor, can be the same length as the shaft of the imaging sensor, or can be within the range of any two of the foregoing values.

[0108] Figure 2B A cross-sectional view of an imaging assembly with a tissue collector instrument 211 is shown according to some embodiments, the tissue collector instrument 211 being disposed within the shaft of the imaging assembly. The tissue collector 211 can be disposed within a tube 115, the tube 115 being disposed within a cavity 105 of the imaging assembly. Additionally or alternatively, in the absence of a tube, the tissue collector 211 can be disposed within the cavity of the imaging assembly. Although the shaft of the collector instrument can be circular in the illustrated example, in other embodiments the shaft of the collector instrument can be oval or any other geometric shape such that the shaft can be inserted into or removed from the cavity of the imaging assembly. In some embodiments, the shaft of the collector can be asymmetrical to provide an axis for aligning the instrument within the cavity of the imaging assembly. In some embodiments, the cavity includes a substantially uniform cross-sectional area along the length of the shaft. In other embodiments, the cross-sectional area varies along the length of the shaft, for example, the proximal end of the shaft can be asymmetrical to provide an axis for alignment while the distal end of the shaft can be circular.

[0109] Figure 2C An enlarged view of the distal end of an imaging assembly with an ablation instrument 230 is shown according to some embodiments, the ablation instrument 230 being disposed within the shaft of the imaging assembly. The ablation instrument 230 can include a needle assembly that includes a needle 235 and optionally includes rake teeth 233. The shaft 231 of the ablation instrument can be deployed from the shaft 103 of the imaging assembly. Additionally or alternatively, the needle can be deployed from the lumen of the tube 115. The ablation instrument can include one or more of the following: for example, a radiofrequency (RF) ablation element, an ultrasound ablation element, a heat-based ablation element, a cryoablation element, and any other type of ablation element known to those of ordinary skill in the art.

[0110] The ablation instrument 230 can be disposed within the tube 115, and the tube 115 is disposed within the cavity 105 of the imaging assembly. Additionally or alternatively, without using the tube, the ablation instrument 230 can be disposed within the cavity of the imaging assembly. Although the shaft 231 of the ablation instrument can be circular in the illustrated example, in other embodiments the shaft of the ablation instrument can be elliptical or any other geometric shape such that the shaft can be inserted into or removed from the cavity of the imaging assembly. In some embodiments, the shaft of the ablation instrument can be asymmetrical to provide an axis for aligning the instrument within the cavity of the imaging assembly.

[0111] The shaft 231 of the ablation instrument can be made of a flexible and / or bendable material such that it can be deflected by the imaging sensor and / or angled portions within the cavity of the shaft. Additionally or alternatively, the shaft of the ablation instrument can include a wire system or other device to deflect the distal end of the ablation instrument such that the distal end of the ablation instrument does not damage the imaging sensor. In some embodiments, the ablation element can be rotated relative to the imaging assembly. In some embodiments, under the control of the user, the ablation instrument can be rotated completely in either direction relative to the imaging assembly within the shaft of the imaging assembly while the shaft remains fixed such that the tines can be optimally aligned.

[0112] The needle assembly can be constructed and controlled by the user, for example, as described previously in co-owned U.S. Patent Nos. 8,206,300, 8,262,574, and 8,992,427, the entire disclosures of which are incorporated herein by reference. The needle assembly can be integrated into the instrument handle such that the position and deployment of the needle and tines can be controlled by the user. The handle can be constructed, for example, as described previously in co-owned U.S. Patent No. 8,992,427, the entire disclosure of which is incorporated herein by reference. The needle assembly can be compatible with systems and methods for improving the safety margin and treatment margin during the treatment of uterine fibroids, such as those described in the incorporated references.

[0113] Figure 2DShows a view of an imaging assembly with a drug delivery instrument 240 according to some embodiments, the drug delivery instrument 240 being disposed within the shaft 105 of the imaging assembly. The drug delivery instrument can serve as a platform for injecting a therapeutic agent into a patient's tissue. Exemplary therapeutic agents can include analgesics, anesthetics, hemostatics, antibiotics, steroids, anticoagulants, anti-inflammatory agents, and the like. Additionally or alternatively, the drug delivery instrument can be configured to deliver one or more drug-eluting, drug-releasing, or other therapeutic or diagnostic seeds, pellets, or other implants to a target tissue. The drug delivery instrument can include a needle 243 disposed within the distal end of the shaft 241 of the drug delivery instrument. The shaft 241 of the drug delivery instrument can include a distal end and a proximal end. The shaft of the drug delivery instrument can be longer than the shaft of the imaging sensor such that the needle can inject a medicament deeper into the uterus. In some embodiments, the shaft of the drug delivery instrument can be two inches longer than the shaft of the imaging sensor. Additionally or alternatively, for example, the shaft of the drug delivery instrument can be six inches longer than the shaft of the imaging sensor, can be four inches longer than the shaft of the imaging sensor, can be two inches longer than the shaft of the imaging sensor, can be the same length as the shaft of the imaging sensor, or can be within the range of any two of the foregoing values.

[0114] The shaft 241 of the drug delivery instrument can be made of a flexible and / or bendable material such that it can be deflected by the imaging sensor and / or an angled portion within the cavity of the shaft. Additionally or alternatively, the shaft of the drug delivery instrument can include a wire system or other device to deflect the distal end of the drug delivery instrument such that the distal end of the drug delivery instrument does not damage the imaging sensor. In some embodiments, the drug delivery instrument can be rotated relative to the imaging assembly. In some embodiments, under the control of a user, the drug delivery instrument can be rotated completely in either direction within the shaft of the imaging assembly relative to the imaging assembly while the shaft remains fixed.

[0115] The shaft of the drug delivery instrument can be separable from the handle assembly of the instrument or can be constructed without a handle assembly such that the drug delivery instrument can be disposable. In the illustrated embodiment, the drug delivery instrument 240 does not have a handle portion. In such an embodiment, the handle portion 101 of the imaging assembly 100 can be used to guide the drug delivery instrument during the procedure. Figure 2D The illustrated imaging assembly 100 can have a scale, guide, or other markings 245 on the inner surface of the handle portion 109 to measure the insertion depth of the needle 243 of the drug delivery instrument 240.

[0116] Figure 2EA cross-sectional view of an imaging assembly having a needle is shown, the needle being disposed within a shaft 103 of the imaging assembly. A shaft 241 of a drug delivery instrument including a needle 243 may be disposed within a tube 115, the tube 115 being disposed within a cavity 105 of the imaging assembly. Additionally or alternatively, in the absence of a tube, the shaft 241 of the drug delivery instrument may be disposed within the cavity of the imaging assembly. Although the shaft of the drug delivery instrument may be circular in the illustrated example, in other embodiments the shaft of the drug delivery instrument may be elliptical or any other geometric shape such that the shaft may be inserted into or removed from the cavity of the imaging assembly. In some embodiments, the shaft of the drug delivery instrument may be asymmetrical to provide an axis for aligning the instrument within the cavity of the imaging assembly. In some embodiments, the drug delivery instrument may be rotatable relative to the imaging assembly. In other embodiments, under the control of a user, the drug delivery instrument may be rotated fully in either direction relative to the imaging assembly within the tube of the shaft of the imaging assembly while the shaft remains fixed.

[0117] Figures 2A - 2E Exemplary instruments that may be disposed within the shaft of the imaging assembly are illustrated, and these examples are not intended to be limiting. Other examples may include fluid infusion and / or aspiration instruments. Fluid infusion and / or aspiration instruments may include instruments having a shaft that includes a lumen configured to direct fluid to tissue of a patient. Fluid infusion and / or aspiration instruments may deliver fluid to cool tissue. Additionally or alternatively, fluid infusion and / or aspiration instruments may deliver fluid to clean tissue. Additionally or alternatively, fluid infusion and / or aspiration instruments may deliver fluid to inflate a body cavity. Fluid infusion and / or aspiration instruments may deliver solutions and / or suspensions including therapeutic agents such as antiseptics, anesthetics, analgesics, antibiotics, steroids, and the like. Fluid infusion and / or aspiration elements may be integrated into any of the instruments described herein. Alternatively, the fluid infusion and / or aspiration element may include an instrument that is inserted and retracted as a step in a multi-instrument procedure.

[0118] Figure 3A An assembled view of an imaging system including an imaging assembly 100 and an optical mirror instrument 300 is shown. Although an optical mirror element is shown in the illustrated embodiment, the optical mirror instrument 300 may be any other suitable instrument, such as any of the instruments disclosed herein. As Figure 3AAs shown, the imaging system can slidably accommodate a disposable tube 115 within the cavity 105 of the imaging assembly. In some embodiments, the imaging assembly can include a disposable tube slidably accommodated within the cavity of the imaging assembly. In such an embodiment, the instrument can removably accommodate the lumen of the disposable tube. Additionally or alternatively, the cavity of the imaging assembly can be configured to slidably accommodate one or more of a plurality of instruments, which can include various therapeutic and / or diagnostic instruments.

[0119] In an illustrative example, the imaging assembly can removably accommodate instruments such as biopsy needles, tissue collection instruments, optical mirrors, implant devices, treatment electrodes, tissue ablation elements (e.g., radiofrequency ablation elements, ultrasound ablation elements, heat-based ablation elements, cryoablation elements, etc.) and / or other instruments adapted to be disposed within the cavity of the imaging assembly. Additionally or alternatively, the instrument can be used to deliver a drug or other therapeutic agent to the tissue to be treated. Additionally or alternatively, with or without the disposable tube, the imaging assembly can removably accommodate Figures 2A - 2E any of the instruments shown therein.

[0120] In the illustrated embodiment, the distal end 305 of the optical mirror instrument can include a light-emitting diode and / or a camera to provide an image to the user. In such an embodiment, the optical mirror instrument can act as an endoscope. The distal end 305 of the optical mirror element can include an optical assembly, such as optical fibers, relay lenses, objective lenses, etc. The optical mirror instrument 300 can include a shaft 303 of the optical mirror instrument, which has a distal end and a proximal end. The shaft 303 of the optical mirror instrument can be configured to be separated from the handle assembly of the instrument and can also be configured to be used without the handle assembly such that the optical mirror instrument 300 can be disposable.

[0121] The shaft 303 of the optical mirror instrument can be made of a flexible and / or bendable material such that it can be deflected by an imaging sensor and / or an angled portion within the cavity of the shaft. Additionally or alternatively, the shaft of the optical mirror instrument can include (e.g., push-type, pull-type, and / or rotary / twist-type) wire systems or other devices to deflect the distal end of the optical mirror instrument. The deflection of the distal end of the optical mirror instrument can be used to prevent damage to the imaging sensor and / or to allow multiple image angles to be collected. In some embodiments, the optical mirror element can be rotated relative to the imaging assembly. In some embodiments, under the control of the user, the optical mirror instrument can be fully rotated in either direction within the shaft of the imaging assembly relative to the imaging assembly while the shaft remains fixed such that multiple image angles can be collected.

[0122] The shaft of the optical mirror instrument can be longer than the shaft of the imaging sensor, such that images can be collected from deep within the uterus. In some embodiments, the shaft of the optical mirror instrument can be two inches longer than the shaft of the imaging sensor. Additionally or alternatively, for example, the shaft of the optical mirror instrument can be six inches longer than the shaft of the imaging sensor, can be four inches longer than the shaft of the imaging sensor, can be two inches longer than the shaft of the imaging sensor, can be the same length as the shaft of the imaging sensor, or can be within the range of any two of the foregoing values.

[0123] In the illustrated embodiment, the optical mirror instrument includes a handle portion 301. Although the handle portion 301 can be shown as connected to the optical mirror in the illustrated example, a similar handle portion can be connected to any suitable instrument, such as those disclosed herein. The handle portion 301 can be the second part of a two-part handle such that when the optical mirror instrument is slidably inserted into the imaging assembly, the two handle portions can be joined to form a single handle. The handle portion can also include a positioning element 313 to provide a more secure reference between the parts of the two-part handle. The positioning element 313 can mate with a slot 113. In such an embodiment, the handle portion can include a release controller 321 that can be actuated by a user to retract the positioning element into the handle and allow the two handles to separate.

[0124] The handle portion can also include one or more control elements 319. The control elements 319 can allow a medical professional to control the distal end of the instrument. In one example, the control elements control a cable system that deflects or manipulates the distal end of the instrument reproducibly. Additionally or alternatively, the control elements can rotate the shaft of the instrument using the cavity of the imaging assembly or within a disposable tube. In another example, the control elements collect tissue in a tissue collection instrument. In another example, the control elements deploy a needle assembly including optional tines in an ablation instrument. Additionally or alternatively, the control elements initiate an ablation process. In another example, the control elements apply pressure to inject a chemical through a drug delivery instrument. In another example, the control elements start or end image collection in the optical mirror instrument.

[0125] Figure 3BShows an assembled view of an imaging system according to some embodiments, which illustrates the attachment mechanism of the system. The interior of the handle portion 309 may include alignment elements 311. The alignment elements 311 may be configured such that after replacing the instrument, the optical mirror instrument can be reproducibly aligned relative to the imaging assembly. Additionally or alternatively, the alignment elements may sufficiently fix the instrument and the imaging assembly relative to each other to use the two handle portions as a single handle. In some embodiments, the alignment elements may include magnets. In other embodiments, the alignment elements may include, for example: latches, hooks, or any other mechanism that removably couples the two-piece handle. The interior of the handle portion may also include positioning elements 313 to provide a more secure reference between the parts of the two-piece handle. In such an embodiment, the handle portion may include a release controller 321, which can be actuated by the user to retract the positioning elements into the handle and allow the two handles to separate.

[0126] In some embodiments, when coupling an imaging assembly and a removable instrument, a method for detecting or sensing the identification of the removable instrument is provided. The imaging assembly may include software for identifying the removable instrument and managing the interconnection between the imaging assembly and the removable instrument. The sensor or mechanism may be, but is not limited to, optical, RF, magnetic, biological, electronic, and mechanical ID and readers. The method will ensure that only qualified removable devices are received on the imaging device to ensure that only compatible devices can be used with the imaging assembly.

[0127] Figure 4 Illustrates a shaft of an imaging assembly according to some embodiments, wherein the shaft of the imaging assembly may be bendable. In the illustrated embodiment, the shaft of the imaging assembly may include a bendable shaft portion 403. The body of the bendable portion of the shaft may include an internal structure for carrying electronics or other associated components to control the imaging sensor. The imaging sensor may include channels or conduits for guiding a fluid (e.g., water, saline, etc.) to the distal end of the shaft and onto the tissue surface. The bendable portion may include a portion of the shaft length of the imaging assembly. In some embodiments, the bendable portion may include less than three-quarters of the shaft length. Additionally or alternatively, the bendable portion may include less than one-quarter of the shaft length, and less than one-eighth of the shaft length, and the full length of the shaft.

[0128] The cross-section of the bendable portion of the shaft can continue the geometry of the shaft such that no gap or traumatic edge is created between the bendable portion of the shaft and the shaft. The cross-section of the bendable portion can be circular or shaped with sufficiently softened, chamfered, rounded, or beveled edges such that the edges can be non-traumatic to the patient's opening during insertion or removal of the imaging assembly, with or without the instrument. The bendable portion can also include a smooth outer surface. The bendable portion can be made of a material such that the surface is deformable to allow the bendable portion to bend or conform to the shape of the body cavity.

[0129] The cavity of the bendable portion can be configured to slidably receive one or more of a plurality of instruments. The cavity of the bendable shaft portion can be configured to continue the shape of the cavity of the shaft such that no gap or traumatic edge is created between the bendable portion of the shaft and the shaft. In some embodiments, the cavity of the bendable portion can be partially open along the wall such that the inner lumen of the cavity of the bendable portion is in communication with the exterior of the shaft. The opening of the bendable portion can be sufficiently enclosed to provide structural support such that the opening of the inner lumen is not significantly disturbed by the insertion or removal of the instrument when the imaging assembly is insertable into the patient's body cavity. In some embodiments, the edge of the cavity of the bendable portion can be bent inwardly toward the interior of the cavity, such as Figure 11B in the illustrated embodiment. The inwardly bent edge of the cavity of the bendable portion can be used to support the opening of the body cavity such that the shaft can be inserted into or removed from the body cavity non-traumatically, with or without the instrument. The cavity of the bendable portion can be sufficiently open such that some deformation of the cavity opening can occur when instruments of different sizes are accommodated in or inserted into the cavity. By providing a passage from the exterior of the cavity to the interior of the cavity, the cavity can facilitate cleaning of the imaging assembly.

[0130] Although the cavity of the bendable portion defines a circular cross-section in the illustrated example, in other embodiments the cavity of the bendable portion can be oval or any other geometry with sufficiently softened, rounded, or beveled edges and corners such that insertion or removal of the shaft of the bendable portion does not damage the patient's body cavity. In some embodiments, the cavity of the bendable portion can be asymmetric to provide an axis for aligning the instrument therein. The cross-section of the cavity of the bendable portion can be open less than three-quarters of its perimeter, additionally or alternatively, the cavity of the bendable portion can be open less than one-half of its perimeter, less than one-quarter of its perimeter, and less than one-eighth of its perimeter. In other embodiments, the cavity of the bendable portion of the shaft of the bendable portion can be closed with respect to the exterior of the shaft of the bendable portion and the instrument can be slidably inserted completely inside the shaft of the bendable portion.

[0131] In some embodiments, the bendable shaft portion can be constructed of a flexible and / or bendable material such that it can be bent within a patient body cavity. In some embodiments, the shaft can be controllably bent along its longitudinal axis by a bending mechanism. Additionally or alternatively, the bendable portion of the shaft can include a wire system or other bending mechanism to allow the bendable portion to be controllably bent, flexed, or deflected at its distal end. The bending mechanism can be controlled by a control element on the handle portion of the imaging assembly.

[0132] In the illustrated example, the bendable portion can be axially bent relative to the handle by about a 90-degree angle. Additionally or alternatively, the bendable portion can be axially bent, for example, less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, less than 1 degree. Additionally or alternatively, the bendable portion can be bent along the anterior-posterior axis relative to the handle of the imaging assembly. In some embodiments, the bendable portion can be bent along the anterior-posterior axis, for example, less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, less than 1 degree. Additionally or alternatively, the bendable portion can be bent along the medial-lateral axis relative to the handle of the imaging assembly. In some embodiments, the bendable portion can be bent along the medial-lateral axis, for example, less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, less than 1 degree.

[0133] Figure 5A Illustrated is a system for diagnosis and / or providing treatment according to some embodiments, which can be removably coupled to a plurality of treatment and / or diagnostic instruments. The system for performing treatment and / or diagnosis can include a treatment or diagnostic instrument 510 and an imaging assembly 520. The instrument 510 of the system for performing treatment and / or diagnosis can include a treatment or diagnostic instrument, such as any treatment or diagnostic instrument described herein. In some embodiments, the imaging assembly can be used in combination with instruments such as biopsy needles, tissue collectors, optical scopes, implant devices, treatment electrodes, tissue ablation elements (such as radiofrequency ablation elements, ultrasound ablation elements, heat-based ablation elements, cryoablation elements, etc.) and / or any other instrument adapted to be disposed within the cavity of the imaging assembly. Additionally or alternatively, the instrument can be used to deliver a drug or other therapeutic agent to the tissue to be treated. Figures 2A - 2E An exemplary instrument that can be slidably received by the imaging assembly is shown. In some embodiments, the system can include first and second treatment or diagnostic instruments. The imaging assembly 520 can include an imaging assembly, such as an example, embodiment, and variant of the imaging assembly described herein.

[0134] Figure 5BIllustrated is a system for diagnosis and / or providing treatment using a treatment and / or diagnostic instrument removably coupled to an imaging component according to some embodiments. As shown, the instrument 510 can be axially aligned relative to the imaging component 520. Additionally, the distal end of the shaft 513 of the instrument can be inserted into the proximal end of the cavity 525 of the imaging component. Then, the instrument can be advanced toward the imaging component such that the shaft of the instrument is slidably received by the cavity of the imaging component. By a similar process, the instrument can be slidably removed from the imaging component.

[0135] Figure 5C Illustrated is a system for diagnosis and / or providing treatment using a treatment and / or diagnostic instrument removably coupled to an imaging component according to some embodiments. The system for diagnostic treatment can include retention elements, such as hooks, latches, or mechanical features described herein, to secure the instrument 510 to the imaging component 520. The system for diagnosis and / or providing treatment can be configured to couple with multiple instruments. For example, a first instrument can be coupled to the imaging component, and subsequently, a second instrument can be coupled. The imaging component can be configured to couple with the first and second treatment and / or diagnostic instruments simultaneously or separately. For example, if the first instrument is a disposable tube, the second instrument can be slidably inserted into the first instrument. In some embodiments, the imaging component can be configured to be delivered to a target site within a patient, the target site previously coupled to a first and / or second treatment or diagnostic instrument external to the target site. Additionally or alternatively, the imaging component can be configured to removably couple with the first and second treatment or diagnostic instruments simultaneously or separately after the imaging component is delivered to the target site within the patient (e.g., the instrument can be coupled in situ).

[0136] Figure 12A Illustrated is a system for diagnosis and / or providing treatment that can be removably coupled in situ to multiple treatment and / or diagnostic instruments according to some embodiments. According to some embodiments, Figure 12A Shown is an imaging component separated from a treatment and / or diagnostic instrument in use. The system for performing treatment and / or diagnosis can include a treatment or diagnostic instrument 1210 and an imaging component 1220. The instrument 1210 of the system for performing treatment and / or diagnosis can include a treatment or diagnostic instrument, such as any treatment or diagnostic instrument described herein. In some embodiments, the imaging component can be used in combination with instruments such as biopsy needles, tissue collectors, optical mirrors, implant devices, treatment electrodes, tissue ablation elements (e.g., radiofrequency ablation elements, ultrasound ablation elements, heat-based ablation elements, cryoablation elements, etc.) and / or any other instrument adapted to be disposed within the cavity of the imaging component. Additionally or alternatively, the instrument can be used to deliver a drug or other therapeutic agent to the tissue to be treated. Figures 2A - 2EAn exemplary instrument that can be slidably received by an imaging assembly is shown. In some embodiments, the system can include first and second therapeutic or diagnostic instruments. The imaging assembly 1220 can include an imaging assembly, such as examples, embodiments, and variations of the imaging assembly described herein. As shown in the illustrated embodiment, the imaging assembly 1220 can be disposed within a body cavity L of a patient without additional therapeutic and / or diagnostic instruments positioned within the shaft of the imaging assembly. In some examples, the imaging assembly 1220 can be used without therapeutic and / or diagnostic instruments.

[0137] Figure 12B A system for diagnosis and / or providing treatment using a therapeutic and / or diagnostic instrument removably coupled in situ to an imaging assembly is illustrated. As shown, the instrument 1210 can be axially aligned relative to the imaging assembly 1220, and the imaging assembly can be disposed within a patient's lumen. Additionally, the distal end of the shaft 1213 of the instrument can be fed into the proximal end of the cavity 1225 of the imaging assembly while the imaging assembly remains in place. The instrument can then be advanced toward the imaging assembly such that the shaft of the instrument is slidably received in situ by the cavity of the imaging assembly. By a similar process, the instrument can be slidably removed from the imaging assembly. The instrument 1210 can be slidably inserted without moving the distal end of the imaging assembly. The instrument 1210 can be slidably inserted without interrupting or disrupting the imaging function of the imaging assembly 1220.

[0138] Figure 12C A system for diagnosis and / or providing treatment using a therapeutic and / or diagnostic instrument removably coupled in situ to an imaging assembly is illustrated. The system for diagnostic treatment can include retention elements, such as hooks, latches, or mechanical features described herein, to secure the instrument 1210 to the imaging assembly 1220. The system for diagnosis and / or providing treatment can be configured to couple with multiple instruments. For example, a first instrument can be coupled to the imaging assembly, and subsequently, a second instrument can be coupled. The imaging assembly can be configured to couple with the first and second therapeutic and / or diagnostic instruments simultaneously or separately; for example, if the first instrument is a disposable tube, the second instrument can be slidably inserted within the first instrument.

[0139] Figure 6 An imaging system 600 including a digital processing device 612 and a display 614 visible to a user is shown. As Figure 6As shown, the imaging system 600 may further include an imaging assembly 100 and an instrument 300. The digital processing device 612 may include one or more processors configured with instructions for setting and recording treatment parameters and imaging parameters. The display 614 may be included in a common housing 618; however, in other embodiments, the display 614 may be remote from the digital processing device and / or the imaging assembly 100. The imaging assembly 100 may be connected to the digital processing device 612 via an imaging line 624 to provide the captured images to the digital processing device 612 for display by the display 614; however, additionally or alternatively, the imaging assembly may communicate wirelessly with the digital processing device. The instrument 300 may be connected to the digital processing device 612 via an instrument line 622; however, additionally or alternatively, the instrument may communicate wirelessly with the digital processing device. In embodiments where the imaging assembly and the instrument are connected by wires, the digital processing device may power both components.

[0140] The instrument 300 may include a handle portion 301 having a control element 319 slidably mounted thereon. In some embodiments, the control element 319 may control the positioning of an internal stop within the handle, which may be monitored by the processor 612 to calculate the size and location of the boundaries of the target area and / or the safety area shown on the display 614. In embodiments where the instrument 300 is an ablation element, the stop may also be used to physically limit the deployment of the needle and optional tines.

[0141] Some embodiments of the methods and systems of the present disclosure may be integrated with systems and methods for establishing and adjusting the boundaries of the displayed safety and treatment areas. Such embodiments may include the systems and methods of the incorporated references, which include: U.S. Patent Publication No. 2014 / 0073910, U.S. Patent No. 8,992,427, U.S. Patent Application No. 15 / 811,520, and PCT Application No. US2017 / 060674, the contents of which are incorporated herein by reference. Some embodiments of the methods and systems of the present disclosure may be integrated with systems and methods for mapping and planning systems. Such embodiments may include the systems and methods of the incorporated reference, which includes PCT Application No. PCT / US2017 / 060674.

[0142] Figure 7A An imaging assembly is illustrated that may be used to treat a fibroid F in the myometrium M of the uterus U located below the uterine wall UW (endometrium) and surrounded by the serosal wall SW. The imaging assembly 100 may be introduced into the uterus transvaginally and transcervically (or alternatively laparoscopically), and the imaging sensor 107 may be deployed to image the fibroid within the field of view indicated by the dashed lines.

[0143] Figure 7B Shows an image visible on a display according to some embodiments, which shows a safety margin and a treatment margin. In some embodiments, once the fibroids are located on the display 614, the controller on the handle can be used to locate and size the treatment margin TB and the safety margin SB. In some embodiments, initially, the virtual boundary lines TB and SB may neither be located on the fibroids nor be properly sized to treat the fibroids. Before starting the treatment, the physician may wish to locate and size the boundaries TB and SB for proper treatment. Since the imaging sensor 107 may be positioned against the uterine wall UW, the only way to advance the treatment margin and the safety margin may be to move the boundaries forward by actuating the control element 319. In some embodiments, this may cause the treatment margin TB and the safety margin SB to move forward along the axis AL, thereby translating the area to be treated. This may cause the virtual boundaries on the real-time image display 614 to move over the image of the fibroids. Additionally or alternatively, the size of the treatment margin TB can be increased or decreased to reduce the risk of affecting healthy and / or more sensitive tissue around the treatment area.

[0144] In embodiments where the instrument is a tissue ablation element, as Figure 7C shown, while the imaging assembly 100 remains stable, the physician can then advance the needle slider, causing the needle 235 to extend into the fibroid F. Figure 7C The illustration of includes a representation of the imaging assembly 100, which corresponds to the physical probe present in the patient's body. Figure 7C The remainder corresponds to the image present on the target display 614.

[0145] After the needle 235 has been fully deployed as restricted by an optional physical or virtual needle stop housing in the instrument handle 301, the rake 233 can be deployed by advancing the rake slider, as indicated by the engagement of the rake slider with an optional rake stop or visually on the display, to reach the target level of rake deployment. Optionally, the imaging assembly 100 can be rotated about a central axis (generally aligned with the axis of the needle tip 235) to confirm the treatment margin and the safety margin in all viewing planes around the fibroid. The display 614 will show in real time the position of the treatment margin and the safety margin relative to the target fibroid and the serosa. Then, as Figure 7D shown, the rake is configured, and power can be supplied to the rake (and optionally to the needle) to effect treatment within the boundaries depicted by the virtual treatment margin TB. Again, Figure 7D the virtual image that will be present on the display 614 is mixed with the physical presence of the imaging assembly 100.

[0146] Embodiments of the present disclosure can provide methods for performing treatment or diagnosis at a target site. Figure 8An exemplary method 800 for performing a treatment or diagnosis at a target site according to some embodiments is shown. At step 810, an imaging assembly can be inserted into a subject. At step 820, an instrument can be inserted into a cavity towards the target site. Alternatively, the imaging assembly can be inserted into the cavity together with an additional treatment and / or diagnostic instrument that has been previously inserted into the cavity. At step 830, the instrument can be used to perform a treatment or diagnosis at the target site. At step 840, the instrument can be removed from the cavity.

[0147] In some embodiments, method 800 can further include at least steps 850, 860, 870. At step 850, the method can include inserting a second instrument into the cavity towards the target site. During step 850, the imaging assembly can remain in place. At step 860, the second instrument can be used to perform a treatment or diagnosis at the target site. At step 870, the second instrument can be removed from the cavity, where the second instrument can be different from the first instrument. In some embodiments, steps 850, 860, and 870 can be repeated using a third, fourth, or more instruments.

[0148] Method 800 can represent a general method of using an imaging assembly, and one of ordinary skill in the art will recognize many variations and modifications therefrom.

[0149] In some embodiments, the present disclosure can also provide a method for performing an image-guided ablation treatment. Figure 9 An exemplary method 900 for performing an image-guided ablation treatment according to some embodiments is shown. At step 905, an imaging assembly can be inserted into a subject; the imaging assembly is in place. At step 910, a biopsy needle can be inserted into the cavity. At step 915, a pathological sample can be collected using the biopsy needle. At step 920, the biopsy needle can be removed from the cavity. Test results obtained from the biopsy sample can be used to inform subsequent steps of the method for performing an image-guided ablation treatment. For example, one or more biopsies and / or further imaging can inform the surgeon whether and / or where tissue needs to be excised and / or ablated, where a drug and / or therapeutic agent should be delivered, and / or where additional imaging should be performed. At step 925, a radiofrequency (RF) ablation element can be inserted into the cavity. At step 930, the lesion can be ablated using the RF ablation element. At step 935, the RF ablation element can be removed from the cavity. At step 940, an optical mirror can be inserted into the cavity. At step 945, the optical mirror can be used to confirm that the image-guided ablation treatment is complete. At step 950, the optical mirror can be removed from the cavity. Alternatively or additionally to confirming ablation with an optical mirror, the RF ablation element can be replaced with a drug delivery device after tissue ablation or other treatment and / or diagnostic steps to deliver an analgesic, a hemostatic agent, and / or other therapeutic agents.

[0150] Other exemplary methods may include methods of coupling instruments, including: advancing an imaging assembly into a surgical space, wherein the imaging assembly includes a shaft having a proximal end and a distal end; coupling a first instrument to the imaging assembly for use in the surgical space, wherein the first instrument may be a therapeutic or diagnostic instrument; decoupling the first instrument from the imaging assembly while the imaging assembly remains in the surgical space; and coupling a second instrument to the imaging assembly for use in the surgical space while the imaging assembly remains in the surgical space, wherein the second instrument is a therapeutic or diagnostic instrument different from the first instrument.

[0151] In some embodiments, the method of coupling instruments further includes coupling the first instrument while the imaging assembly remains in the surgical space. In some embodiments, the method of coupling instruments further includes coupling the first instrument while the imaging assembly is located outside the surgical space. In some embodiments, the method of coupling instruments further includes collecting a tissue sample from the surgical space with the first instrument. In some embodiments, the method of coupling instruments further includes ablating an area within the surgical space with the second instrument. In some embodiments, the method of coupling instruments further includes performing a treatment or diagnosis with the first instrument. In some embodiments, the method of coupling instruments further includes selecting the second instrument based on data collected from performing the treatment or diagnosis with the first instrument. In some embodiments, the method of coupling instruments further includes adjusting parameters of the treatment or diagnosis performed with the second instrument based on data collected from performing the treatment or diagnosis with the first instrument. In such embodiments, the data collected may include image data, and adjusting the parameters may include adjusting the ablation area of the second instrument.

[0152] In another exemplary method, embodiments of the present disclosure may provide a method of performing a treatment or diagnosis at a target site. The method of performing a treatment may include: advancing an imaging assembly to the target site. The method of performing a treatment may include an imaging assembly including a shaft having a proximal end, a distal end, and a cavity extending from the proximal end toward the distal end across the shaft, wherein the wall of the cavity includes an elongate opening that at least partially communicates with the exterior of the shaft along the shaft. The method of performing a treatment may include an imaging sensor coupled to the distal end of the shaft. The method of performing a treatment may include using an instrument inserted into the cavity and advanced to the target site to perform a treatment or diagnosis.

[0153] In some embodiments, the method of performing a treatment may further comprise inserting a first instrument into the cavity before advancing the imaging component to the target site. In some embodiments, the method of performing a treatment may further comprise inserting a first instrument into the cavity after advancing the imaging component to the target site. In some embodiments, the method of performing a treatment may further comprise removing the first instrument from the cavity while the imaging component remains at the target site. In some embodiments, the method of performing a treatment may further comprise inserting a second instrument into the cavity and advancing the second instrument to the target site. In some embodiments, the method of performing a treatment may further comprise performing a treatment or a diagnosis using the second instrument.

[0154] The methods described herein can be used to perform a treatment or a diagnosis on a volume of tissue (e.g., a patient's uterus, other organs). In some embodiments, the methods described herein can be performed during a laparoscopic surgery. In such an embodiment, the methods described herein may further comprise inserting a trocar into the patient's body cavity. During laparoscopic surgery, an imaging component can be inserted into the cannula of the trocar to perform the surgical procedure. In some embodiments, the method can be performed non-invasively. In such an embodiment, the imaging component can be inserted into a pre-existing or naturally formed body cavity of the patient. Additionally or alternatively, the method can be performed during a minimally invasive surgery. In such an embodiment, a lumen can be formed within the patient's body, which can have a minimum size to accelerate the healing time and minimize surgical trauma.

[0155] The methods described herein can be implemented at least in part by the instruments described herein and, additionally or alternatively, by embodiments, variations, and / or examples of the imaging component 100. Additionally or alternatively, any other suitable imaging component and / or instrument can be used to implement the methods described herein, and the methods described herein can be facilitated by any computing and / or processing components as further described below. The methods described herein can be implemented by the system 500 and / or 1200. The imaging component can be used in combination with instruments such as biopsy needles, endoscopes, implant devices, treatment electrodes, tissue ablation elements (e.g., radiofrequency ablation elements, ultrasound ablation elements, heat-based ablation elements, cryoablation elements, etc.) and / or other instruments adapted to be disposed within the cavity of the imaging component. Additionally or alternatively, the instrument can be used to deliver a drug or other therapeutic agent or implant to the tissue to be treated. Figures 2A - 2E Exemplary instruments that can be slidably received by the imaging component are shown.

[0156] Those of ordinary skill in the art will recognize many modifications and variations to the methods described herein. Additionally, one or more steps of the method descriptions herein may be deleted or repeated, additional steps may be added, and these steps may be performed in any order. Steps described for one method may be added to or combined with another step. For example, the steps of method 900 may be added to method 800.

[0157] In some embodiments, the imaging components, systems, and methods described herein include a digital processing device or its use. In further embodiments, the digital processing device includes one or more hardware central processing units (CPUs), general-purpose graphics processing units (GPGPUs), or field-programmable gate arrays (FPGAs) that perform device functions. In still further embodiments, the digital processing device further includes an operating system that is configured to execute executable instructions. In some embodiments, the digital processing device may optionally be connected to a computer network. In further embodiments, the digital processing device is optionally connected to the Internet, enabling access to the World Wide Web. In still further embodiments, the digital processing device is optionally connected to a cloud computing infrastructure. In other embodiments, the digital processing device is optionally connected to an intranet. In other embodiments, the digital processing device is optionally connected to a data storage device.

[0158] According to the description herein, suitable digital processing devices include, but are not limited to, server computers, desktop computers, laptop computers, notebook computers, sub-notebook computers, netbook computers, netbook tablets, set-top box computers, streaming media devices, handheld computers, Internet appliances, mobile smart phones, tablet computers, personal digital assistants, video game consoles, and vehicles. Those of skill in the art will recognize that many smart phones are suitable for the systems described herein. Those of skill in the art will also recognize that televisions, video players, and digital music players selected with optional computer connectivity are suitable for the systems described herein. Suitable tablet computers include those known to those of skill in the art having booklet, tablet, and convertible configurations.

[0159] In some embodiments, the digital processing device includes an operating system that is configured to execute executable instructions. For example, an operating system is software that includes programs and data, manages the hardware of the device, and provides services for executing applications. Those of skill in the art will recognize that suitable server operating systems include, but are not limited to, FreeBSD, OpenBSD, Linux, Mac OS X Windows and Those skilled in the art will recognize that suitable personal computer operating systems include, but are not limited to Mac OS and UNIX-like operating systems (such as ). In some embodiments, the operating system is provided by cloud computing. Those skilled in the art will also recognize that suitable mobile smart phone operating systems include, but are not limited to OS, Research In BlackBerry Windows OS, Windows OS, and Those skilled in the art will also recognize that suitable media streaming device operating systems include, but are not limited to Google Google Amazon and Those skilled in the art will also recognize that suitable video game console operating systems include, but are not limited to Xbox Microsoft Xbox One, Wii and

[0160] In some embodiments, the device includes a storage and / or memory device. The storage and / or memory device is one or more physical devices for temporarily or permanently storing data or programs. In some embodiments, the device is volatile memory and requires power to maintain the stored information. In some embodiments, the device is non-volatile memory and will retain the stored information when the digital processing device is not powered on. In further embodiments, the non-volatile memory includes flash memory. In some embodiments, the non-volatile memory includes dynamic random access memory (DRAM). In some embodiments, the non-volatile memory includes ferroelectric random access memory (FRAM). In some embodiments, the non-volatile memory includes phase change random access memory (PRAM). In other embodiments, the device is a storage device, including but not limited to CD-ROM, DVD, flash memory devices, disk drives, tape drives, optical disc drives, and cloud computing-based storage devices. In further embodiments, the storage and / or memory device is a combination of devices such as those disclosed herein.

[0161] In some embodiments, the digital processing device includes a display for sending visual information to the user. In some embodiments, the display is a cathode ray tube (CRT). In some embodiments, the display is a liquid crystal display (LCD). In further embodiments, the display is a thin film transistor liquid crystal display (TFT-LCD). In some embodiments, the display is an organic light emitting diode (OLED) display. In a plurality of further embodiments, the OLED display is a passive matrix OLED (PMOLED) or an active matrix OLED (AMOLED) display. In some embodiments, the display is a plasma display. In other embodiments, the display is a video projector. In still further embodiments, the display is a combination of devices such as those disclosed herein.

[0162] In some embodiments, the digital processing device includes an input device for receiving information from the user. In some embodiments, the input device is a keyboard. In some embodiments, the input device is a pointing device, including but not limited to a mouse, trackball, touchpad, joystick, game controller, or stylus. In some embodiments, the input device is a touchscreen or a multi-touch screen. In other embodiments, the input device is a microphone for capturing voice or other sound input. In other embodiments, the input device is a camera or other sensor for capturing motion or visual input. In further embodiments, the input device is a Kinect, Leap Motion, etc. In still further embodiments, the input device is a combination of devices such as those disclosed herein.

[0163] Refer to Figure 10, in certain embodiments, an exemplary digital processing device 612 is programmed or otherwise configured to control an imaging component and / or instrument as described herein. The device 612 may adjust aspects of the imaging components and / or instruments of the present disclosure, such as performing processing steps. In this embodiment, the digital processing device 612 includes a central processing unit (CPU, also referred to herein as a "processor" and a "computer processor") 1005, which may be a single-core or multi-core processor, or multiple processors for parallel processing. The digital processing device 612 also includes a memory or memory location 1010 (e.g., random access memory, read-only memory, flash memory), an electronic storage unit 1015 (e.g., hard disk), a communication interface 1020 for communicating with one or more other systems (e.g., network adapter), and peripheral devices 1025 (such as cache memory, other memory, data storage, and / or electronic display adapter). The memory 1010, storage unit 1015, interface 1020, and peripheral devices 1025 communicate with the CPU 1005 via a communication bus (solid line) (such as a motherboard). The storage unit 1015 may be a data storage unit (or data repository) for storing data. With the aid of the communication interface 1020, the digital processing device 612 may be operatively coupled to a computer network ("network") 1030. The network 1030 may be the Internet, an intranet, and / or an extranet, or an intranet and / or extranet communicating with the Internet. In some cases, the network 1030 is a telecommunications and / or data network. The network 1030 may include one or more computer servers, which may enable distributed computing, such as cloud computing. In some cases, the network 1030 may implement a peer-to-peer network with the aid of the device 612, which may enable devices coupled to the device 612 to act as clients or servers.

[0164] Continuing to refer to Figure 10 , the CPU 1005 may execute a series of machine-readable instructions, which may be embodied in a program or software. The instructions may be stored in a memory location, such as the memory 1010. The instructions may be directed to the CPU 1005, which may then be programmed or otherwise configured to implement the methods of the present disclosure. Examples of operations performed by the CPU 1005 may include fetch, decode, execute, and write-back. The CPU 1005 may be part of a circuit (such as an integrated circuit). One or more other components of the device 612 may be included in the circuit. In some cases, the circuit is an application-specific integrated circuit (ASIC) or a field-programmable gate array (FPGA).

[0165] Continuing to refer to Figure 10, the storage unit 1015 can store files such as drivers, libraries, and saved programs. The storage unit 1015 can store user data such as user preferences and user programs. In some cases, the digital processing device 612 can include one or more additional data storage units that are external to the digital processing device 612, such as on a remote server communicating via an intranet or the Internet. The digital processing device 612 can communicate with one or more remote computer systems via the network 1030. For example, the device 612 can communicate with the user's remote computer system.

[0166] Examples of remote computer systems include personal computers (e.g., portable PCs), tablets or tablet PCs (e.g., iPad, Galaxy Tab), phones, smartphones (e.g., iPhone, Android - enabled devices, ) or personal digital assistants.

[0167] The methods described herein can be implemented in the form of machine (e.g., computer processor) - executable code stored at an electronic storage location (e.g., on the memory 1010 or the electronic storage unit 1015) of the digital processing device 612. The machine - executable code or machine - readable code can be provided in the form of software. During use, the code can be executed by the processor 1005. In some cases, the code can be retrieved from the storage unit 1015 and stored on the memory 1010 for rapid access by the processor 1005. In some cases, the electronic storage unit 1015 can be excluded and the machine - executable instructions can be stored on the memory 1010.

[0168] The digital processing device 612 can include or communicate with an electronic display 614 that includes a user interface (UI) 1040. Examples of UIs include, but are not limited to, graphical user interfaces (GUIs) and web - based user interfaces. In some embodiments, the electronic display 614 can be connected to the computer system 612 via a network (e.g., via the network 1030).

[0169] In some embodiments, the platforms, systems, media, and methods disclosed herein include one or more non-transitory computer-readable storage media encoded with a program that includes instructions executable by an operating system of an optionally networked digital processing device. In further embodiments, the computer-readable storage media is a tangible component of the digital processing device. In still further embodiments, the computer-readable storage media is optionally removable from the digital processing device. In some embodiments, the computer-readable storage media includes, but is not limited to, CD-ROMs, DVDs, flash devices, solid state memories, disk drives, tape drives, optical disc drives, cloud computing systems and services, and the like. In some embodiments, the program and instructions are permanently, substantially permanently, semi-permanently, or non-transitorily encoded on the media.

[0170] In some embodiments, the platforms, systems, media, and methods disclosed herein include at least one computer program or its use. A computer program includes a series of instructions written to perform a specified task, which instructions are executable in the CPU of a digital processing device. The computer-readable instructions may be implemented as program modules that perform particular tasks or implement particular abstract data types, such as functions, objects, application programming interfaces (APIs), data structures, and the like. Given the disclosure provided herein, those skilled in the art will recognize that computer programs may be written in various versions of various languages.

[0171] The functionality of the computer-readable instructions may be combined or distributed as needed in various environments. In some embodiments, a computer program includes a sequence of instructions. In some embodiments, a computer program includes multiple sequences of instructions. In some embodiments, a computer program is provided from one location. In other embodiments, a computer program is provided from multiple locations. In multiple embodiments, a computer program includes one or more software modules. In multiple embodiments, a computer program partially or wholly includes one or more web applications, one or more mobile applications, one or more stand-alone applications, one or more web browser plug-ins, extensions, add-in accessories, add-on accessories, or combinations thereof.

[0172] In some embodiments, the computer program includes a web application. Given the disclosure provided herein, those skilled in the art will recognize that, in multiple embodiments, a web application utilizes one or more software frameworks and one or more database systems. In some embodiments, the web application is based on, such as created by software frameworks such as.NET or Ruby on Rails (RoR). In some embodiments, the web application utilizes one or more database systems, including but not limited to relational, non-relational, object-oriented, associative, and XML database systems. In further embodiments, suitable relational database systems include but are not limited to SQL Server, mySQL TM and Those skilled in the art will also recognize that in various embodiments, the web application is written in one or more versions of one or more languages. The web application can be written in one or more markup languages, presentation definition languages, client-side scripting languages, server-side coding languages, database query languages, or combinations thereof. In some embodiments, to some extent, the web application is written in markup languages such as Hypertext Markup Language (HTML), Extensible Hypertext Markup Language (XHTML), or Extensible Markup Language (XML). In some embodiments, to some extent, the web application is written in a presentation definition language such as Cascading Style Sheets (CSS). In some embodiments, to some extent, the web application is written in client-side scripting languages such as Asynchronous JavaScript and XML (AJAX), Actionscript, JavaScript, or etc. In some embodiments, to some extent, the web application is written in server-side coding languages such as Active Server Pages (ASP), Perl, Java TM Java Server Pages (JSP), Hypertext Preprocessor (PHP), Python TM Ruby, Tcl, Smalltalk, or Groovy. In some embodiments, to some extent, the web application is written in a database query language such as Structured Query Language (SQL). In some embodiments, the web application integrates enterprise server products, such as Lotus In some embodiments, the web application includes a media player component. In a number of further embodiments, the media player component utilizes one or more of many suitable multimedia technologies, including but not limited to HTML 5, Java TM and

[0173] In some embodiments, the computer program includes a mobile application provided to a mobile digital processing device. In some embodiments, the mobile application is provided to the mobile digital processing device at the time of manufacture. In other embodiments, the mobile application is provided to the mobile digital processing device via a computer network as described herein.

[0174] Given the disclosure provided herein, a mobile application is created using hardware, languages, and development environments known in the art by techniques known to those skilled in the art. Those skilled in the art will recognize that mobile applications are written in several languages. Suitable programming languages include, but are not limited to, C, C++, C#, Objective-C, Java TM , Javascript, Pascal, Object Pascal, Python TM , Ruby, VB.NET, WML, and XHTML / HTML with or without CSS, or combinations thereof.

[0175] Suitable mobile application development environments are available from several sources. Commercially available development environments include, but are not limited to, AirplaySDK, alcheMo, Celsius, Bedrock, Flash Lite,.NET Compact Framework, Rhomobile, and WorkLight Mobile Platform. Other development environments that are available without charge include, but are not limited to, Lazarus, MobiFlex, MoSync, and Phonegap. In addition, mobile device manufacturers distribute software developer kits, including, but not limited to, iPhone and iPad (iOS) SDK, Android TM SDK, SDK, BREW SDK, OS SDK, Symbian SDK, webOS SDK, and Mobile SDK.

[0176] Those skilled in the art will recognize that several commercial forums are available for distributing mobile applications, including, but not limited to App Store, Play, Chrome WebStore, App World, App Store for Palm devices, App Catalog for webOS, Marketplace for mobile devices , Ovi Store for devices, Apps, and DSi Shop.

[0177] In some embodiments, a computer program includes a stand-alone application, which is a program that runs as a separate computer process rather than as an add-on to an existing process (e.g., not a plug-in). A compiler is a computer program that can convert source code written in a programming language into binary object code (such as assembly language or machine code). Suitable programming languages for compilation include, but are not limited to, C, C++, Objective-C, COBOL, Delphi, Eiffel, Java TM , Lisp, Python TM , Visual Basic and VB.NET, or combinations thereof. Compilation is typically performed at least in part to create an executable program. In some embodiments, a computer program includes one or more executable compiled applications.

[0178] In some embodiments, a computer program includes a web browser plugin (e.g., an extension, etc.). In computing, a plugin can add specific functionality to one or more software components within a larger software application. The manufacturer of the software application supports the plugin to enable third-party developers to create capabilities that extend the application, to support the easy addition of new features and to reduce the application size. If supported, plugins can be used to customize the functionality of a software application. For example, plugins are commonly used in web browsers to play videos, generate interactivity, scan for viruses, and display specific file types. Those skilled in the art will be familiar with several web browser plugins, including Player, and In some embodiments, a toolbar includes one or more web browser extensions, add-in attachments, or add-on attachments. In some embodiments, a toolbar includes one or more browser bars, toolbars, or desktop bars.

[0179] In view of the disclosure provided herein, those skilled in the art will recognize that several plugin frameworks can be used to develop plugins in various programming languages, including but not limited to C++, Delphi, Java TM , PHP, Python TM and VB.NET, or combinations thereof.

[0180] A web browser (also known as an Internet browser) is a software application designed to be used with a network-connected digital processing device for retrieving, presenting, and traversing information resources on the World Wide Web. Suitable web browsers include, but are not limited to Internet Chrome, Opera and KDE Konqueror. In some embodiments, the web browser is a mobile web browser. Mobile web browsers (also known as micro browsers, mini browsers, and wireless browsers) are designed for use on mobile digital processing devices, including but not limited to palmtop computers, tablet computers, netbook computers, subnotebook computers, smart phones, music players, personal digital assistants (PDAs), and handheld video game systems. Suitable mobile web browsers include but are not limited to Browser, RIM Browser, Blazer, Browser, for mobile devices Internet Mobile, Basic Web, Browser, Opera Mobile and PSP TM Browser.

[0181] Software modules

[0182] In some embodiments, the platforms, systems, media, and methods disclosed herein include software, server, and / or database modules or their use. Given the disclosure provided herein, software modules are created by those skilled in the art using techniques known in the art with machines, software, and languages known in the art. The software modules disclosed herein are implemented in a variety of ways. In multiple embodiments, software modules include files, code segments, programming objects, programming constructs, or combinations thereof. In further multiple embodiments, software modules include multiple files, multiple code segments, multiple programming objects, multiple programming constructs, or combinations thereof. In multiple embodiments, one or more software modules include but are not limited to web applications, mobile applications, and stand-alone applications. In some embodiments, software modules are located in one computer program or application. In other embodiments, software modules are located in more than one computer program or application. In some embodiments, software modules are hosted on one machine. In other embodiments, software modules are hosted on more than one machine. In further embodiments, software modules are hosted on a cloud computing platform. In some embodiments, software modules are hosted on one or more machines at one location. In other embodiments, software modules are hosted on one or more machines at more than one location.

[0183] In some embodiments, the platforms, systems, media, and methods disclosed herein include one or more databases or their use. Given the disclosure provided herein, those skilled in the art will recognize that many databases are suitable for the storage and retrieval of information. In various embodiments, suitable databases include, but are not limited to, relational databases, non-relational databases, object-oriented databases, object databases, entity-relationship model databases, associative databases, and XML databases. Further non-limiting examples include SQL, PostgreSQL, MySQL, Oracle, DB2, and Sybase. In some embodiments, the database is Internet-based. In further embodiments, the database is web-based. In still further embodiments, the database is cloud-based. In other embodiments, the database is based on one or more local computer storage devices.

[0184] While the preferred embodiments of the invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will occur to those skilled in the art that do not depart from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. The following claims are intended to define the scope of the invention and, therefore, cover the methods and structures within the scope of these claims and their equivalents.

Claims

1. An imaging assembly, comprising: A shaft, the shaft including a proximal end, a distal end, and a cavity extending across the shaft from the proximal end toward the distal end, wherein the cavity is configured to removably and interchangeably in situ receive at least one of a plurality of different instruments; And An imaging sensor coupled to the distal end of the shaft; An imaging assembly handle coupled to the proximal end of the shaft, wherein the wall of the cavity includes an elongate opening that at least partially communicates with the exterior of the shaft along the shaft, wherein removably and interchangeably in situ receiving the at least one of the plurality of different instruments does not interrupt imaging by the imaging sensor, and wherein, when the cavity of the shaft interchangeably receives the at least one of the plurality of different instruments, the at least one of the plurality of different instruments is configured to be removably coupled to the imaging assembly handle.

2. The assembly according to claim 1, wherein the cavity is defined by an outer surface of the shaft.

3. The assembly according to claim 2, wherein the outer surface of the shaft comprises only non-invasive edges.

4. The assembly according to claim 2, wherein an edge of the elongated opening curves towards an interior of the cavity.

5. The assembly according to claim 1, wherein the cavity is configured to slidably receive the instrument.

6. The assembly according to claim 1, wherein a distal portion of the cavity is angled axially relative to the shaft.

7. The assembly according to claim 6, wherein the distal portion of the cavity is angled axially relative to the shaft by 3 to 45 degrees.

8. The assembly according to claim 1, wherein at least one of the plurality of different instruments comprises a tube.

9. The assembly according to claim 8, wherein the tube is aligned parallel to the shaft of the imaging assembly.

10. The assembly according to claim 9, wherein the tube is rotatable relative to the shaft when the shaft is held stationary.

11. The assembly according to claim 8, wherein the tube comprises a lumen configured to slidably receive a second instrument of the plurality of different instruments.

12. The assembly according to claim 11, wherein the tube is configured to slidably receive the second instrument after the second instrument is aligned parallel to the shaft of the imaging assembly.

13. The assembly according to claim 12, wherein the second instrument is rotatable relative to the shaft when the shaft is held stationary.

14. The assembly according to claim 8, wherein the tube is disposable.

15. The assembly according to claim 11, wherein the second instrument comprises a tissue collector.

16. The assembly according to claim 15, wherein the tissue collector comprises a biopsy needle.

17. The component according to claim 11, wherein the second instrument includes a tissue ablation element.

18. The component according to claim 1, wherein at least one of the plurality of different instruments includes a therapeutic or diagnostic instrument.

19. The component according to claim 18, wherein the therapeutic or diagnostic instrument includes a tissue collector.

20. The component according to claim 19, wherein the therapeutic or diagnostic instrument includes a biopsy needle.

21. The component according to claim 18, wherein the therapeutic or diagnostic instrument includes a tissue ablation element.

22. The component according to claim 17 or 21, wherein the tissue ablation element includes one or more of a heat-based ablation element or a cryoablation element.

23. The component according to claim 22, wherein the heat-based ablation element includes one or more of a radiofrequency (RF) ablation element or an ultrasound ablation element.

24. The component according to claim 18, wherein the therapeutic or diagnostic instrument includes an optical mirror.

25. The component according to claim 18, wherein the therapeutic or diagnostic instrument includes a therapeutic electrode.

26. The component according to claim 18, wherein the therapeutic or diagnostic instrument includes an implant device.

27. The component according to claim 18, wherein the therapeutic or diagnostic instrument includes an instrument for providing a detailed image of an anatomical structure.

28. The component according to claim 27, wherein the anatomical structure to be imaged is the uterus.

29. The component according to claim 1, wherein the shaft is bendable.

30. The component according to claim 29, wherein the shaft is controllably bent along the longitudinal axis of the shaft by a bending mechanism.

31. The component according to claim 1, wherein the imaging sensor includes an ultrasonic sensor.

32. The component according to claim 1, wherein the imaging sensor includes a light emitting diode (LED) or a camera.

33. The component according to claim 1, wherein the cavity defines a circular cross-sectional area.

34. The component according to claim 1, wherein the cavity includes a substantially uniform cross-sectional area along the shaft.

35. The component according to claim 1, wherein the cavity includes an asymmetric cross-sectional area.

36. The assembly according to claim 1, wherein the cavity extends from the proximal end to the distal end across the shaft.

37. The assembly according to claim 1, wherein the cavity is configured to allow a first one of the plurality of different instruments to be replaced in situ with a second one of the plurality of different instruments.

38. The assembly according to claim 1, wherein the elongated opening extends along a majority of the shaft.

39. The assembly according to claim 1, wherein at least one of the plurality of different instruments is at least partially exchangeable through the imaging assembly.

40. The assembly according to claim 1, wherein each of the plurality of different instruments includes an instrument handle.

41. The assembly according to claim 40, further comprising a positioning element configured to secure the coupling between the imaging assembly handle and the instrument handle.

42. The assembly according to claim 41, further comprising a release controller configured to be actuated by a user to retract the positioning element and decouple the imaging assembly handle and the instrument handle.

43. The assembly according to claim 42, wherein the imaging assembly handle and the instrument handle are configured to decouple when at least one of the plurality of different instruments and the shaft are in situ, and wherein at least one of the plurality of different instruments is configured to be removed from the body when decoupled from the shaft while the shaft is in situ.

44. The assembly according to claim 40, wherein the imaging assembly handle and the instrument handle are coupled together to form a two-piece handle.

45. The assembly according to claim 40, wherein the instrument handle includes a control element configured to control the distal end of the instrument of the plurality of different instruments.

46. The assembly according to claim 45, wherein the control element is configured to control a wire system configured to reproducibly deflect or manipulate the distal end of the instrument, and wherein, The control element is further configured to rotate the shaft of the instrument using the cavity.

47. The assembly according to claim 1, wherein when the cavity of the shaft exchangeably receives at least one of the plurality of different instruments, at least one of the plurality of different instruments is configured to be detachably coupled to the proximal end of the shaft.

48. The assembly according to claim 1, wherein when the cavity of the shaft exchangeably receives at least one of the plurality of different instruments, at least one of the plurality of different instruments is configured to be detachably coupled to the distal end of the shaft.

49. An imaging system, comprising: The imaging assembly according to any one of claims 1-48; And A disposable tube slidably received within the cavity of the imaging assembly.

50. The imaging system according to claim 49, further comprising a second instrument removably received within the lumen of the disposable tube.

51. The imaging system according to claim 50, wherein the second instrument is a diagnostic or therapeutic instrument.

52. The imaging system according to claim 50, wherein the second instrument is a tissue collector.

53. The imaging system according to claim 50, wherein the second instrument is a biopsy needle.

54. The imaging system according to claim 50, wherein the second instrument is an optical mirror.

55. The imaging system according to claim 50, wherein the second instrument is an implant device.

56. The imaging system according to claim 50, wherein the second instrument comprises an instrument for providing a detailed image of an anatomical structure.

57. The imaging system according to claim 56, wherein the anatomical structure of the image is the uterus.

58. The imaging system according to claim 50, wherein the second instrument comprises a tissue ablation element.

59. The imaging system according to claim 58, wherein the tissue ablation element comprises one or more of a heat-based ablation element or a cryoablation element.

60. The imaging system according to claim 59, wherein the heat-based ablation element comprises one or more of a radiofrequency (RF) ablation element or an ultrasound ablation element.

61. A system for performing a treatment or a diagnosis at a target site, the system comprising: The imaging assembly according to any one of claims 1-48, wherein the imaging assembly is configured to be inserted into a subject; A plurality of instruments, wherein at least one of the plurality of instruments is configured to: be inserted into the cavity toward a target site with the imaging assembly in situ, perform a treatment or diagnosis at the target site, and be removed from the cavity.

62. The system according to claim 61, wherein at least one of the plurality of instruments comprises a tissue collector.

63. The system according to claim 62, wherein the tissue collector comprises a biopsy needle.

64. The system according to claim 61, wherein at least one of the plurality of instruments comprises a tissue ablation element.

65. The system according to claim 61, wherein the tissue ablation element comprises one or more of a heat-based ablation element or a cryoablation element.

66. The system according to claim 65, wherein the heat-based ablation element comprises one or more of a radiofrequency (RF) ablation element or an ultrasound ablation element.

67. The system according to claim 61, wherein at least one of the plurality of instruments comprises a therapeutic or diagnostic instrument.

68. The system according to claim 61, wherein the therapeutic or diagnostic instrument comprises an optical mirror.

69. The system according to claim 61, wherein the therapeutic or diagnostic instrument comprises an implant device.

70. The system according to claim 61, wherein the therapeutic or diagnostic instrument comprises an instrument for providing a detailed image of an anatomical structure.

71. The system according to claim 70, wherein the anatomical structure of the image is the uterus.

72. The system according to claim 61, wherein the therapeutic or diagnostic instrument comprises a therapeutic electrode.

73. The system according to claim 61, wherein the plurality of instruments comprises: A first instrument; And A second instrument, wherein the first instrument includes the at least one of the plurality of instruments, wherein the second instrument is configured to be inserted into the cavity toward the target site, perform a treatment or diagnosis at the target site, and be removed from the cavity, and wherein the second instrument is different from the first instrument.

74. The system according to claim 61, wherein the system is used in laparoscopic surgery.

75. The system according to claim 61, wherein the system is used non-invasively.

76. The system according to claim 61, wherein the system is used in minimally invasive surgery.

77. The system according to claim 73, wherein the second instrument comprises a tissue collector.

78. The system according to claim 77, wherein the tissue collector comprises a biopsy needle.

79. The system according to claim 73, wherein the second instrument comprises a tissue ablation element.

80. The system according to claim 79, wherein the tissue ablation element comprises one or more of a heat-based ablation element or a cryoablation element.

81. The system according to claim 80, wherein the heat-based ablation element comprises one or more of a radiofrequency (RF) ablation element or an ultrasound ablation element.

82. The system according to claim 73, wherein the second instrument comprises an optical mirror.

83. The system according to claim 73, wherein the second instrument includes an implant device.

84. The system according to claim 73, wherein the second instrument includes an instrument for providing a detailed image of an anatomical structure.

85. The system according to claim 84, wherein the anatomical structure to be imaged is the uterus.

86. The system according to claim 73, wherein the second instrument includes a treatment electrode.

87. A system for performing image-guided ablation therapy, the system comprising: The imaging assembly according to any one of claims 1-48; A biopsy needle, wherein the biopsy needle is configured to: be inserted into the cavity with the imaging assembly in situ, collect a pathological sample using the biopsy needle, and be removed from the cavity; A plurality of radiofrequency (RF) ablation elements, wherein the plurality of RF ablation elements are configured to: be inserted into the cavity with the imaging assembly in situ, ablate tissue, and be removed from the cavity; An optical mirror, wherein the optical mirror is configured to: be inserted into the cavity with the imaging assembly in situ, confirm completion of the image-guided ablation treatment, and be removed from the cavity.

88. The system according to claim 87, wherein the system is used in laparoscopic surgery.

89. The system according to claim 87, wherein the system is used non-invasively.

90. The system according to claim 87, wherein the system is used in minimally invasive surgery.

Images