Tissue ablation device with expandable elements for articulating movement of the device

Abstract

Aspects of the present disclosure include an inflatable balloon or other expandable element for articulating the working end of a tissue ablation probe in a tissue ablation system, device, and method. In one embodiment, the tissue ablation device includes a device shaft and an imaging transducer provided at a distal end of the device shaft, the imaging transducer providing an ultrasonic tip, and an expandable element configured to articulate the ultrasonic tip.

Description

Technical Field

[0001] (Cross - References to Related Applications and Incorporation by Reference) This application claims the benefit of U.S. Provisional Application No. 63 / 355,876, filed on June 27, 2022, which is hereby incorporated by reference in its entirety.

[0002] All publications, patents, and patent applications mentioned in this specification are hereby incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. (Technical Field)

[0003] The present disclosure relates, in particular, to medical systems, devices, and methods for uterine fibroid ablation. More specifically, the present disclosure relates to imaging components for use with therapeutic and diagnostic instruments.

Background Art

[0004] Current systems, devices, and methods for imaging and / or therapeutic procedures may be sub - optimal in at least some respects. For example, many current devices may have limited flexibility for use in various diagnostic and therapeutic procedures. For example, many current devices may pose a risk of injuring the patient during insertion and / or removal, or may be difficult to navigate to the target location.

[0005] In addition, or alternatively, current systems, devices, and methods for diagnosing and providing therapy may be sub-optimal with respect to at least several other aspects. For example, in procedures where two or more instruments may be required, multiple instruments may need to be inserted into or removed from a patient lumen, and these additional steps of insertion and removal can increase the risk of injury to the patient. In addition, or alternatively, many current methods may require the removal of imaging components multiple times during a single procedure, and the removal of imaging components can limit the ability to continuously and steadily visualize the surgical field during the procedure. Further, many current devices may be limited in their ability to articulate within cavities or lumens within a patient's body, which can limit the ability of instruments (e.g., imaging and / or procedural instruments) to reach target tissue.

[0006] In view of the above, improved systems, devices, and methods for imaging a surgical field are desired. Such systems, devices, and methods would address at least some of the above drawbacks and, for example, would be readily usable for a wide variety of therapeutic and diagnostic procedures. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0007] The embodiments disclosed herein each have several aspects, and no single one of them alone contributes to the desired attributes of the present disclosure. Without limiting the scope of the present disclosure, its more prominent features will be discussed briefly here. After considering this discussion, and in particular after perusing the section entitled "DETAILED DESCRIPTION," the reader will understand how the features of the embodiments described herein provide advantages over existing systems, devices, and methods.

[0008] The present disclosure relates to medical systems, devices, and methods for uterine fibroid ablation, among other things, but not limited thereto. Embodiments of the present disclosure provide expandable elements for articulation of a device. Such expandable elements can improve ease of use and device deployment and positioning. Such expandable elements can further maintain image quality by keeping the imaging transducer of the tissue ablation device in consistent contact with the tissue.

[0009] In some embodiments, a tissue ablation device is disclosed herein, the tissue ablation device comprising a device shaft, an imaging transducer provided at a distal end of the device shaft that provides an ultrasonic tip, and an expandable element configured to articulate the ultrasonic tip.

[0010] In the above-described tissue ablation device or in other embodiments as described herein, one or more of the following features may further be provided. In some embodiments, the imaging transducer is pivotable between a linear position where the imaging transducer forms a straight angle with the device shaft and a pivoted position where the imaging transducer is angled with respect to the device shaft. In some embodiments, the ultrasonic tip of the tissue ablation device comprises a spring-loaded tip, and the spring-loaded tip is configured to apply a force to restore the imaging transducer from the pivoted position towards the linear position. In some embodiments, the expandable element is directly coupled to the device shaft. In some embodiments, the imaging transducer is configured to image tissue in a forward direction, and the expandable element is configured to expand in a rearward direction, the rearward direction being substantially opposite from the forward direction. In some embodiments, the expandable element is a balloon. In some embodiments, the balloon comprises a plurality of chambers, and each chamber can be individually controlled. In some embodiments, the balloon is configured to be expanded by being filled with a filler fluid. In some embodiments, the filler fluid is gaseous. In some embodiments, the filler fluid is a hot filler fluid. In some embodiments, the balloon is configured to expand between the imaging transducer and the tissue being imaged by the imaging transducer such that the balloon functions as an acoustic stand-off for coupling the imaging transducer to the tissue. In some embodiments, the expandable element is coupled to the device shaft proximal to the imaging transducer. In some embodiments, the expandable element is a retractable spring. In some embodiments, the device shaft comprises a straight shaft. In some embodiments, the tissue ablation device is configured for uterine fibroid ablation.

Brief Description of the Drawings

[0011] Certain features of the present disclosure are described below with reference to the drawings. The illustrated implementations are intended to illustrate the implementations and not to limit them. The various features of the different disclosed implementations can be combined to form further implementations that are part of the present disclosure.

[0012]

Figure 1A

[0013]

Figure 1B

[0014]

Figure 1C

[0015]

Figure 1D

[0016]

Figure 1E

[0017]

Figure 2A

[0018]

Figure 2B

[0019]

Figure 2C

[0020]

Figure 2D

[0021]

Figure 2E

[0022]

Figure 3A

[0023]

Figure 3B

[0024]

Figure 4

[0025]

Figure 5A

[0026]

Figure 5B

[0027]

Figure 5C

[0028]

Figure 6

[0029]

Figure 7A

[0030]

Figure 7B

[0031]

Figure 7C

[0032]

Figure 7D

[0033]

Figure 8A

Figure 8B

Figure 8C

[0034]

Figure 9

[0035] Various features and advantages of the present disclosure will now be described with reference to the accompanying figures. The following description is merely illustrative in nature and is not intended to limit the present disclosure, its applications, or its use in any way. The present disclosure extends beyond the specifically disclosed implementations and / or uses and their obvious modifications and equivalents. Accordingly, it is intended that the scope of the present disclosure not be limited by any particular implementation described below. The features of the illustrated implementations can be modified, combined, removed, and / or substituted in accordance with the principles disclosed herein as would be apparent to one of ordinary skill in the art. Further, the implementations disclosed herein can include several novel features, none of which alone contributes to its desirable attributes or is essential to the practice of the systems, devices, and / or methods disclosed herein.

[0036] Certain embodiments of the present disclosure are directed to imaging and / or therapeutic devices incorporating expandable elements for improved device articulation and associated methods and systems. Examples of these devices, methods, and systems are described in the examples below, and examples of ways in which these devices, methods, and systems can be applied to uterine fibroid ablation follow. However, the improvements described herein are not limited to uterine fibroid ablation and can be incorporated into any of the imaging and / or therapeutic devices described herein. (Examples of imaging and / or therapeutic devices)

[0037] Embodiments of the present disclosure provide an imaging component having a cavity extending (e.g., along) the length of a shaft, the cavity being configured to removably receive at least one of a plurality of different instruments. In some embodiments, the cavity of the imaging component can be partially open to the exterior of the shaft. The imaging component can include an imaging transducer at the distal end of the shaft. Additionally, the shaft of the imaging component can be configured such that additional therapeutic and / or diagnostic instruments / attachments can be removed and / or received and / or inserted during a medical procedure without interfering with the imaging component. Additionally, or alternatively, the imaging component can remain in place while a therapeutic and / or diagnostic instrument is being received and / or removed. In some embodiments, the imaging component can be used without additional therapeutic and / or diagnostic instruments coupled thereto. In some embodiments, the imaging component can be inserted into and / or removed from a patient lumen without the presence of a therapeutic and / or diagnostic instrument. Such an imaging component can be used, for example, during medical procedures such as non-invasive, minimally invasive, and / or laparoscopic surgery.

[0038] Embodiments of the present disclosure may improve existing methods for imaging and treating lesions within a tissue lumen for procedures that may be required for a plurality of instruments to diagnose and / or provide therapy during a single procedure. For example, an imaging component may be used for diagnosis, then a biopsy attachment may be inserted for a pathology sample, then an ablation attachment may be inserted to ablate any lesions, and then additional attachments or instruments may be inserted to perform additional procedures such as delivery of drugs, implants, and / or therapies and / or diagnostic agents. The imaging component of the present disclosure may facilitate insertion and removal of medical instruments by providing a shaft with a non-invasive edge and a cavity configured to receive a plurality of different instruments. Additionally, or alternatively, the imaging component may be used independently of additional instruments or attachments. In such embodiments, the edge of the cavity may be smooth or rounded such that when used alone, the edge may not snag on patient tissue.

[0039] The cavity of the imaging component may improve existing methods for imaging and treatment by providing a cavity of the imaging component that may be easier to clean than components with a closed cavity or lumen. The cavity of the imaging component may improve existing methods for imaging and treatment by facilitating the manufacture of the imaging component. Embodiments of the present disclosure may reduce treatment costs by providing a disposable tube to the imaging component. Embodiments of the present disclosure may reduce treatment costs by providing a cavity into which a disposable instrument may be inserted to a reusable imaging component. Embodiments of the imaging component may provide a shaft that always aligns the instrument with an ultrasound image. Embodiments of the present disclosure may be adapted to various instruments with different sizes and shapes. Embodiments of the present disclosure may provide a scale or position information to assist in the insertion of the instrument.

[0040] The systems and methods of the present disclosure can be particularly useful in the treatment of uterine fibroids in a patient. The imaging component can be deployed transvaginally and transcervically into the uterus or, alternatively, laparoscopically into and through the exterior of the uterus or other organ or tissue duct. The imaging component can be used in conjunction with the following additional instruments: a biopsy needle; a tissue ablation element (e.g., a radiofrequency ablation element, an ultrasonic ablation element, a heat-based ablation element, a cryoablation element, etc.); and / or other instruments suitable for placement within the lumen of the imaging component. Additionally, or alternatively, additional instruments can be used to deliver a drug, implant, or other therapeutic agent to the tissue to be treated. Additionally, or alternatively, the tissue ablation element can comprise an embodiment or variation of the needle / tine assembly of U.S. Patent Nos. 8,206,300, 8,262,574, and 8,992,427, by the same applicant, the contents of which are incorporated herein by reference.

[0041] Embodiments of the present disclosure provide a shaft of an imaging component with a non-traumatic edge and may improve at least some of the systems and methods of the references by the same applicant by enabling the use of the imaging component alone. In some embodiments, embodiments of the present disclosure may improve the ability to remove and / or receive additional instruments by providing an imaging system without an attachment mechanism located within at least a portion of the system to be positioned in situ. In such embodiments, the imaging component shaft may be non-cylindrically symmetric (e.g., oval or rectangular in cross-section) to reference the rotation of additional instruments relative to the imaging component shaft. In some embodiments, the present disclosure additionally or alternatively provides a shaft of an imaging component with a small angled portion, which may minimize the risk of damage to the surface of the imaging transducer surface by an instrument. Additionally or alternatively, the imaging component may include a disposable tube inserted into a cavity, among many possible purposes, to insert additional instruments with different diameters and to provide a working channel for making the system easier to clean.

[0042] The imaging components described herein can be used in surgical procedures (including projecting safety and treatment margins as described in U.S. Pat. Nos. 8,088,072 and 8,262,577 to the same applicant, the contents of which are incorporated by reference) to provide real-time images of target structures to be treated. The imaging components described herein can be useful for performing both imaging and treatment of uterine fibroids as described in U.S. Pat. No. 7,918,795 to the same applicant, which is incorporated herein by reference. Other patents and published applications by the same applicant that describe probes useful for treating uterine fibroids that can be used with the imaging components described herein include U.S. Pat. Nos. 7,815,571, 7,874,986, 8,506,485, 9,357,977, and 9,517,047, which are incorporated herein by reference. Additional patent applications by the same applicant that describe systems for establishing and adjusting the displayed safety and treatment zone margins that can be used in conjunction with the imaging components described herein include U.S. Patent Publication No. 2014 / 0073910 (now U.S. Pat. No. 9,861,336), U.S. Patent Publication No. 2019 / 0350648, U.S. Pat. No. 8,992,427, U.S. Patent Publication No. 2018 / 0132927 (now U.S. Pat. No. 11,219,483), and PCT Publication No. WO2018 / 089523, each of which is incorporated herein by reference. PCT Publication No. WO2018 / 089523 by the same applicant, which further describes a mapping and planning system that can be used in conjunction with the imaging components described herein, is further incorporated herein by reference.

[0043] In some embodiments, the systems and methods of the present disclosure may provide imaging components for use in various diagnostic and therapeutic procedures. Some embodiments may provide methods and systems for performing therapy or diagnosis on a volume of tissue. A volume of tissue may include a patient organ. Patient organs or body cavities may 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, testes, 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 or robot-assisted surgery.

[0044] Certain embodiments of the present disclosure are configured to create a mechanism for orienting a straight portion of an imaging and / or treatment device (such as the treatment device of the Sonata System available from Gynesonics, Inc. (Redwood City, CA)) as described herein to a target myoma, while serving as an articulation mechanism for the ultrasonic tip, instead of or in addition to the lever and pushrod elements of the device. An articulation mechanism that controls the pitch angle of the ultrasonic transducer tip can be actuated and locked in place at one of a number of fixed positions. Once this step is complete, the user may orient the device to directly direct a straight shaft through the widest part of the target myoma in order to place the introducer into the tumor.

[0045] Reference will now be made in detail to various embodiments, examples of which are illustrated in the accompanying drawings. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present invention and the described embodiments. However, the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, components, and circuits have not been described in detail so as not to obscure aspects of the embodiments.

[0046] The terms "first," "second," etc. are used herein optionally to describe various elements, but it should be understood that these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, as long as all occurrences of "the first device" are consistently renamed and all occurrences of "the second device" are consistently renamed, the first device may be referred to as the device sensor without changing the meaning of the description, and similarly, the second device may be referred to as the first device. The first device and the second device are both devices, but they are not the same device.

[0047] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be a limitation of 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 dictates otherwise. Further, as used herein, the term "and / or" refers to and encompasses any and all possible combinations of one or more of the associated listed items. Additionally, when the terms "comprises" and / or "comprising" are used herein, they specify the presence of the described 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 groups thereof.

[0048] As used herein, the term "when" is optionally construed, depending on the context, to mean "when" the recited precondition is true, or "in response to", or "in response to determining", or "according to a determination", or "in response to detecting". Similarly, the phrases "when [it is determined that] the recited precondition is true" or "when [the recited precondition is true]" or "when [the recited precondition is true]" are optionally construed, depending on the context, to mean "in response to determining", or "in response to detecting", or "according to a determination", or "in response to detecting", or "in response to detecting" that the recited precondition is true.

[0049] For ease of explanation, the following figures and corresponding descriptions may be described below with reference to uterine imaging, specifically in conjunction with the diagnosis and ablation and / or treatment of uterine fibroids. However, those skilled in the art will recognize that similar imaging components can be used with similar instruments in other therapeutic applications, such as for tissue biopsy within any suitable body lumen, for drug delivery, for fluid injection and / or aspiration, and for the treatment of cancer, tumors, fibroids, and other malignant or benign tumors.

[0050] Figure 1A illustrates an example of an imaging component 100 according to some embodiments. The imaging component 100 may include a handle portion 101 connected to an imaging shaft 103. An imaging transducer 107 may be coupled to the distal end of the imaging shaft 103. The imaging shaft 103 may include a proximal end and a distal end, along with a cavity 105 that extends along the length of the shaft 103 from the proximal end toward the distal end. The cavity 105 may be at least partially open to the exterior of the shaft 103. For example, the side or wall of the cavity 105 may include an elongated opening that communicates with the exterior of the shaft 103. The elongated opening may communicate with the exterior of the shaft 103 at least partially along the length of the shaft 103. In some embodiments, the edge of the elongated opening may be bent toward the interior of the cavity 105 of the shaft 103 (see, e.g., FIG. 1D further described below). The length of the shaft 103 may be long enough to provide complete access to a patient's uterus while the handle portion 101 remains outside the patient. Additionally, or alternatively, the shaft 103 may have a length that is considerably longer than a distance sufficient to provide complete access to the patient's uterus. The side opening may be open along the entire length of the shaft 103, or it may be open only partially along the length of the shaft 103. The side opening may be open, for example, more than three-quarters of the length of the shaft 103, more than half of the length of the shaft 103, or more than one-quarter of the length of the shaft 103. The cavity 105 may be configured to receive at least one of a plurality of different additional instruments or attachments such that a first instrument may be received by the cavity 105, the first instrument may be removed from the cavity 105, and a second instrument may be received by the cavity 105.

[0051] The handle portion 101 can be one of the two parts of a two-piece handle such that when the first or second instrument is received, the two handle portions can be combined to form a single handle. The inner surface of the handle portion 109 can include an alignment element 111 such that the first and second parts of the handle can be reproducibly aligned relative to each other after the instrument is exchanged. The alignment element 111 can be configured such that the first and second parts can be sufficiently fixed relative to each other for using the two handle portions as a single handle. In some embodiments, the alignment element 111 can include a magnet. In other embodiments, the alignment element 111 can include, for example, a latch, a hook, or any other mechanism suitable for removably combining the two-piece handle. The handle portion can additionally include a positioning element 113, such as a complementary protrusion or a slot for accommodating other elements on the opposite handle portion, to provide a more secure reference between the parts of the two-piece handle. The positioning element 113 can include mechanical features for fixing the instrument relative to the imaging component 100 by limiting the translational movement of the instrument along the axis of the shaft 103 of the imaging component.

[0052] In other embodiments, the imaging component 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 component 100 is sufficient to be used alone to guide the imaging component during the procedure. In some embodiments, the imaging component 100 can have a scale or a guide on the inner surface of the handle portion 109 for measuring the insertion depth of the instrument. In other embodiments, the imaging component 100 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, the scale can facilitate the insertion of the components of the instrument in embodiments where the instrument has a handle.

[0053] FIG. 1B shows a cross-sectional view of an imaging component 100 according to some embodiments. The body of the shaft 103 can have an internal structure to support electronics or other associated components for controlling the imaging transducer 107. The shaft 103 can further include a wire system or other bending mechanism to allow the shaft 103 to controllably bend, flex, or deflect the distal end of the shaft 103. The shaft 103 can include channels or ducts for directing fluid (e.g., water, saline, etc.) to the distal end of the shaft 103 and onto the tissue surface. The imaging shaft 103 can have a shape with a rounded, chamfered, rounded, or tapered edge in cross-section such that the edge can be non-traumatic to the patient's opening during insertion or removal of the imaging component 100, with or without an instrument. The shaft 103 can additionally have a smooth outer surface. The shaft 103 can be made of a material such that the surface can be deformable to allow the shaft 103 to bend or conform to the shape of a body lumen.

[0054] The lumen 105 of the imaging shaft 103 can be configured to slidably receive one or more of a plurality of instruments. In some embodiments, the lumen 105 can be defined by the outer surface of the shaft 103. In some embodiments, the lumen 105 can be partially open along a wall such that the lumen 105 can communicate with the exterior of the shaft 103. The opening can be sufficiently closed to provide structural support such that the opening of the lumen is not significantly obstructed by insertion or removal of an instrument when the imaging component 100 is inserted into the patient's body lumen. Optionally, the outer surface of the shaft 103 can have only non-traumatic edges. The lumen 105 of the imaging shaft 103 can be sufficiently open such that the lumen can allow some distortion of the lumen opening when instruments of different sizes are received or inserted into the lumen. The lumen 105 can facilitate cleaning of the imaging component.

[0055] Figure 1C shows a cross-sectional view of an imaging component having a shaft 103 with a circular cross-section according to some embodiments. The imaging component of Figure 1C can have a sufficiently circular cross-section so that the imaging component can be rotated without obstructing the patient lumen. Figure 1D shows a cross-sectional view of an imaging component with an edge bent inwardly towards the inside of the cavity 105 according to some embodiments. The inwardly bent edge 1111 of the cavity serves to support the opening of the body lumen so that the shaft 103 can be inserted into or removed from the body lumen non-invasively, with or without an instrument.

[0056] The cavity 105 of the shaft 103 in the illustrated example can define a circular cross-sectional geometry, but in other embodiments, the cavity can be elliptical, or any other geometry with sufficiently softened, rounded, or sloped edges and corners, such that insertion or removal of the shaft does not damage the patient body lumen. In some embodiments, the cavity 105 can be non-cylindrically symmetric. In some embodiments, the cavity 105 can be asymmetric to provide an axis for alignment of an instrument therein. The cavity 105 can be open for less than three-quarters of its outer perimeter, and in addition or alternatively, the cavity can be open for less than half, less than one-quarter, and less than one-eighth of its outer perimeter. In other embodiments, the cavity 105 of the shaft 103 of the imaging component can be closed to the outside of the shaft, and an instrument can be inserted fully slidably inside the shaft of the imaging component.

[0057] In some embodiments, the lumen 105 may have a substantially uniform cross-sectional area along the shaft 103. In other embodiments, a portion of the length of the shaft 103 may have a different cross-section than another portion of the length of the shaft. In one example, the proximal portion of the shaft 103 may be asymmetric in order to provide an axis for alignment of the instrument, and the distal portion of the shaft may have a circular cross-sectional area. In another embodiment, the lumen 105 tapers towards the end of the shaft 103. In such an example, tapering may facilitate feeding the instrument into the lumen 105. In some embodiments, the cross-sectional area of the lumen 105 may be smaller in diameter to allow for additional flexibility at the distal end of the shaft 103.

[0058] In some embodiments, the imaging shaft 103 may additionally comprise a tube 115 to be positioned within the cavity 105 of the imaging shaft 103. The tube 115 may comprise 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 103 of the imaging component such that additional instruments / attachments may be slidably received by the tube. Thereafter, the tube 115 may slidably receive additional instruments / attachments after being aligned such that the tube 115 is parallel to the shaft 103 of the imaging component. In some embodiments, the tube 115 may be disposable. In some embodiments, the tube 115 may be reusable by being decoupled from the imaging shaft 103, cleaned, autoclaved, etc. The tube 115 may have an outer surface that substantially contacts the inner wall of the cavity 105. The tube 115 may have an inner surface configured to receive one or more of a plurality of instruments, and the inner surface is a different geometry than the outer surface. In some embodiments, a second tube (not shown) may be removably inserted into the first tube 115, and the second tube has a different inner lumen geometry than the first tube, thereby assisting in the insertion of one or more of a plurality of instruments. In some embodiments, the tube 115 may be rotated relative to the imaging component. In some embodiments, the tube 115 may be rotated completely in either direction relative to the imaging component under user control within the shaft 103 of the imaging component. In some embodiments, the tube 115 may be made slippery internally or externally to facilitate the insertion or removal of instruments.

[0059] The tube 115 can be inserted into the body lumen in its original position with the imaging component not yet advanced therein. Additionally, or alternatively, the tube 115 can be inserted into the shaft 103 of the imaging component prior to insertion of the imaging component into the body lumen. The tube 115 can have sufficient structural integrity to support the body lumen during insertion of the imaging component without an instrument. When an additional instrument is inserted into the tube 115 or when the tube 115 is inserted into the imaging component in its original position, interference with the body lumen can be minimized. The tube 115 can be made from a sterilizable material. The tube 115 can be made from a material that is sufficiently low in cost such that it can be discarded after single use. Exemplary materials for disposable tubes can include polyimide, PTFE, urethane, and thermoplastic materials such as Pebax or nylon. The tube 115 can be made from a material having sufficient elasticity to conform to an instrument of a size slightly larger or smaller than the outer perimeter of the tube. In embodiments where the cavity 105 is not circular, the tube 115 can take the shape of the cavity or it can take another shape.

[0060] The tube 115 can reduce treatment costs by facilitating the insertion and / or removal of additional instruments into the cavity 105 of the imaging component 100, thereby preventing damage to the surface of the cavity 105 of the imaging component 100. The tube 115 can reduce costs by facilitating the cleaning of the cavity 105 of the imaging component 100. The tube 115 can reduce treatment costs by providing an inexpensive component that serves as an adapter for various different therapeutic and / or diagnostic instruments / attachments, such as being provided in a variety of different inner geometries suitable for different instruments / attachments but having a uniform outer geometry such that it can be removably coupled to the same single imaging component 100. For example, a disposable tube with a smaller inner diameter can facilitate the insertion and control of a needle having an outer diameter smaller than the inner diameter of the shaft 103 of the imaging component.

[0061] FIG. 1E shows an enlarged view of the distal end of the imaging component 100 with a cavity 105 according to some embodiments. The distal end of the imaging component 100 may comprise an imaging transducer 107. The imaging transducer 107 may comprise an ultrasonic transducer and / or a plurality of ultrasonic transducers. The ultrasonic transducer may operate at a frequency in a range defined by 500 kHz, 1 MHz, 5 MHz, 10 MHz, 20 MHz, 100 MHz, or any two of the previous values. Some embodiments of the ultrasonic transducer may comprise the specifications of other transducers from references by the same applicant incorporated herein.

[0062] In some embodiments, the distal end 117 of the imaging transducer 107 may additionally comprise a light emitting diode and / or a camera to provide an image to the user. In such embodiments, the imaging component 100 may serve not only as an optical scope but also as an ultrasonic imaging platform. The distal end 117 of the imaging transducer 107 may comprise optical components such as optical fibers, relay lenses, objective lenses, etc.

[0063] The imaging transducer 107 can be configured to be deflectable. The imaging transducer 107 can be configured to deflect with respect to the longitudinal axis of the shaft 103 of the imaging component 100. In some embodiments, the distal end of the imaging component 100 comprises a hinge for facilitating deflection of the imaging transducer 107. The deflection of the imaging transducer 107 can be controlled by a deflection lever 119 on the handle portion 101 of the imaging component 100. One or more imaging transducers 107 can be oriented by deflection of the imaging transducer. One or more imaging transducers 107 can be oriented by deflection of the imaging transducer to facilitate maintaining the field of view of the image during treatment. Additionally or alternatively, multiple imaging transducers 107 (e.g., ultrasonic transducers) can be aligned radially and / or axially to image multiple fields of view simultaneously. The deflection of the imaging transducer 107 can be caused to avoid interference with the instrument. Additionally or alternatively, the deflection of the imaging transducer 107 can be used to deflect a flexible instrument within the cavity 105. The distal end of the shaft 103 can comprise an interlock system similar to those in the incorporated references to prevent the imaging transducer 107 from interfering with the instrument or being damaged by the sharp edges of the instrument. The operation of the deflection lever 119 can function 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 transducer 107 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.

[0064] The distal end of the imaging component 100 may have a non-traumatic edge, with or without an instrument within the cavity 105, to facilitate insertion of the imaging component. The distal end of the cavity 105 of the imaging component 100 may additionally or alternatively include a portion angled axially with respect to the shaft 103 such that the distal end of the instrument can be deflected upward as it is pushed out from the distal end of the cavity 105. The distal end of the cavity 105 of the imaging component 100 may have an angled portion with an angle of 3 to 45 degrees. The distal end of the cavity 105 of the imaging component 100 may have an angled portion with an angle of less than 45 degrees, additionally or alternatively, for example, less than 90 degrees, less than 60 degrees, less than 30 degrees, less than 15 degrees, and less than 5 degrees.

[0065] The cavity 105 of the imaging component 100 may be configured to slidably receive one or more of a plurality of instruments. In some embodiments, the imaging component 100 may be configured to receive one or more therapeutic or diagnostic instruments. In some embodiments, at least one of the plurality of different instruments may be a therapeutic or diagnostic instrument. In some embodiments, the instrument may include a biopsy needle, an optical scope, an implant device, a therapy electrode, for example, a tissue ablation element such as a radiofrequency ablation element, an ultrasonic ablation element, a heat-based ablation element, a cryoablation element, etc., and / or other instruments suitable for placement within the cavity of the imaging component. Additionally or alternatively, the instrument may be used to deliver a drug or other therapeutic agent to the tissue to be treated. FIGS. 2A-2E show instruments that may be slidably received by the imaging component. Those skilled in the art will recognize that many instruments, including those disclosed in the following figures, may be used with the imaging components disclosed herein.

[0066] FIG. 2A shows an enlarged view of the distal end of the imaging component 100 with the tissue collector instrument 210 disposed within the shaft 103 of the imaging component 100, according to some embodiments. The tissue collector instrument 210 can be used to extract tissue and / or cytopathology samples for examination by medical professionals to determine the extent of a disease. In some embodiments, the tissue collector instrument 210 can comprise a biopsy needle. The tissue collector instrument 210 can comprise a shaft 211 of the tissue collector instrument 210 having a distal end and a proximal end. The shaft 211 of the tissue collector instrument 210 can be configured to be removed from the handle component of the instrument or can be configured to be used without the handle component such that the tissue collector instrument 210 can be disposable.

[0067] The shaft 211 of the tissue collector instrument 210 can be made of a compliant material and / or a flexible material such that it can be deflected by the imaging transducer 107 and / or an angled portion within the cavity 105 of the shaft 103. In the illustrated example, the distal end of the shaft 211 of the tissue collector instrument 210 is deflected upward by an angled portion within the cavity 105 of the shaft 103. The distal end of the shaft 211 of the tissue collector instrument 210 can be deflected upward, among other possible purposes, to avoid damaging the imaging transducer 107. The distal end of the cavity 105 of the imaging component 100 can comprise an axially angled portion with respect to the shaft 103 such that the distal end of the instrument (e.g., the tissue collector instrument 210) can be deflected upward as it is pushed out from the distal end of the cavity 105. The distal end of the cavity 105 of the imaging component 100 can comprise an angled portion angled less than 45 degrees, and additionally or alternatively, for example, less than 90 degrees, less than 60 degrees, less than 30 degrees, less than 15 degrees, and less than 5 degrees.

[0068] Additionally, or alternatively, the shaft 103 of the imaging component 100 may include a wire system or other means for deflecting the distal end of an instrument (e.g., tissue collector instrument 210) so that the distal end of the instrument does not damage the imaging transducer 107. The distal end of the tissue collector instrument 210 may include a slot or opening 213 through which tissue can be collected. In some embodiments, the tissue collector instrument 210 may rotate relative to the shaft 103. In some embodiments, the tissue collector instrument 210 remains stationary while the shaft 103 of the imaging component 100 can rotate completely in either direction under user control within the shaft 103 of the imaging component 100 such that the slot or opening 213 can scrape, scoop, or otherwise collect tissue.

[0069] The shaft 211 of the tissue collector instrument 210 may be longer than the shaft 103 of the imaging transducer 107 such that the slot or opening 213 can collect tissue from deep within the uterus or other body cavity. In some embodiments, the shaft 211 of the tissue collector instrument 210 may be 2 inches longer than the shaft of the imaging transducer 107. Additionally, or alternatively, for example, the shaft 211 of the tissue collector instrument 210 may be longer than 6 inches, longer than 4 inches, longer than 2 inches, the same length, or within the range of any two of the previous values.

[0070] Figure 2B shows a cross-sectional view of the imaging component 100 with the tissue collector instrument 210 disposed within the shaft 103 of the imaging component 100, according to some embodiments. The tissue collector instrument 210 can be disposed within a tube 115 that is disposed within the cavity 105 of the imaging component 100. Additionally, or alternatively, the tissue collector instrument 210 can be disposed within the cavity 105 of the imaging component 100 without using a tube. The shaft 211 of the tissue collector instrument 210 in the illustrated example can define a circular geometry, but in other embodiments, the shaft 211 of the tissue collector instrument 210 can be elliptical or any other geometry such that the shaft 211 can be inserted into or removed from the cavity 105 of the imaging component 100. In some embodiments, the shaft 211 of the tissue collector instrument 210 can be asymmetric to provide an axis for alignment of the tissue collector instrument 210 within the cavity 105 of the imaging component 100. In some embodiments, the cavity 105 has a substantially uniform cross-sectional area along the length of the shaft 103 of the imaging component 100. In other embodiments, for example, a change in the cross-sectional area of the cavity 105 along the length of the shaft 103 of the imaging component 100, such as at the proximal end of the shaft 103, can be asymmetric to provide an axis for alignment while the distal end of the shaft 103 can be circular.

[0071] FIG. 2C shows an enlarged view of the distal end of the imaging component 100 with the ablation device 230 disposed within the shaft 103 of the imaging component 100, according to some embodiments. The ablation device 230 may include a needle assembly having an introducer 235 and optionally a needle electrode or tine 233. The shaft 231 of the ablation device 230 may be deployed from the shaft 103 of the imaging component 100. Additionally or alternatively, the introducer 235 may be deployed from the lumen of the tube 115. The ablation device 230 may comprise one or more of, for example, a radio frequency (RF) ablation element, an ultrasonic ablation element, a heat-based ablation element, a cryogenic ablation element, and any other type of ablation element known to those of skill in the art.

[0072] The ablation device 230 may be disposed within the tube 115 that is disposed within the cavity 105 of the imaging component 100. Additionally or alternatively, the ablation device 230 may be disposed within the cavity 105 of the imaging component 100 without using a tube. The shaft 231 of the ablation device 230 in the illustrated example may define a circular cross-sectional geometry, but in other embodiments, the shaft 231 of the ablation device 230 may be elliptical or any other geometry such that the shaft 231 can be inserted into or removed from the cavity 105 of the imaging component 100. In some embodiments, the shaft 231 of the ablation device 230 may be asymmetric to provide an axis for alignment of the device within the cavity 105 of the imaging component 100.

[0073] The shaft 231 of the ablation instrument 230 can be made of a compliant material and / or a flexible material such that it can be deflected within the cavity 105 of the shaft 103 of the imaging component 100 by the imaging transducer 107 and / or an angled portion. Additionally, or alternatively, the shaft 231 of the ablation instrument 230 can comprise a wire system or other means for deflecting the distal end of the ablation instrument 230 such that the distal end of the ablation instrument 230 does not damage the imaging transducer 107. In some embodiments, the ablation instrument 230 can rotate relative to the imaging component 100. In some embodiments, the ablation instrument 230 can rotate completely in any direction relative to the imaging component 100 under user control while the shaft 103 of the imaging component 100 remains stationary such that the tines 233 can be optimally aligned.

[0074] The needle assembly can be constructed and controlled by a user as already described, for example, in U.S. Pat. Nos. 8,206,300, 8,262,574, and 8,992,427 to the same applicant (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 introducer 235 and the tines 233 can be controlled by the user. The handle can be constructed as already described, for example, in U.S. Pat. No. 8,992,427 to the same applicant (the entire disclosure of which is incorporated herein by reference). The needle assembly can be compatible with systems and methods for improved safety and treatment margins during the treatment of uterine fibroids, as described, for example, in the incorporated references.

[0075] Figure 2D shows a view of the imaging component 100 with the drug delivery device 240 disposed within the shaft 103 of the imaging component 100, according to some embodiments. The drug delivery device 240 can serve as a platform for injecting a therapeutic agent into a patient's tissue. Exemplary therapeutic agents can include analgesics, anesthetics, hemostatic agents, antibiotics, steroids, anticoagulants, anti-inflammatory agents, and the like. Additionally, or alternatively, the drug delivery device 240 can be configured to deliver one or more drug eluting, drug releasing, or otherwise therapeutic and / or diagnostic seeds, pellets, or other implants to a target tissue. The drug delivery device 240 can include a needle 243 disposed inside the distal end of the shaft 241 of the drug delivery device 240. The shaft 241 of the drug delivery device 240 can include a distal end and a proximal end. The shaft 241 of the drug delivery device 240 can be longer than the shaft of the imaging transducer 107 such that the needle 243 can inject an agent deep inside the uterus. In some embodiments, the shaft 241 of the drug delivery device 240 can be 2 inches longer than the shaft of the imaging transducer 107. Additionally, or alternatively, for example, the shaft 241 of the drug delivery device 240 can be 6 inches long, 4 inches long, 2 inches long, the same length, or within a range of any two of the previous values.

[0076] The shaft 241 of the drug delivery device 240 can be made of a compliant material and / or a flexible material such that it can be deflected within the cavity 105 of the shaft 103 of the imaging component 100 by the imaging transducer 107 and / or an angled portion. Additionally, or alternatively, the shaft 241 of the drug delivery device 240 can include a wire system or other means for deflecting the distal end of the drug delivery device 240 such that the distal end of the drug delivery device 240 does not damage the imaging transducer 107. In some embodiments, the drug delivery device 240 can rotate relative to the imaging component 100. In some embodiments, the shaft 103 of the imaging component 100 remains stationary, but the drug delivery device 240 can rotate completely in any direction relative to the imaging component 100 under user control within the shaft 103 of the imaging component 100.

[0077] The shaft 241 of the drug delivery device 240 can be constructed without an associated handle component such that it can be removable from the handle component of the device or such that the drug delivery device 240 can be disposable. In the illustrated embodiment, the drug delivery device 240 does not have a handle portion. In such an embodiment, the handle portion 101 of the imaging component 100 (e.g., shown in FIG. 1A) can be used to guide the drug delivery device 240 during the procedure. As shown in FIG. 2D, the imaging component 100 can have graduations, guides, or other markings 245 on the inner surface of the handle portion 109 for measuring the depth of insertion of the needle 243 of the drug delivery device 240.

[0078] FIG. 2E shows a cross-sectional view of an imaging component 100 with a needle 243 disposed within a shaft 103 of the imaging component 100 according to some embodiments. The shaft 241 of a drug delivery device 240 that includes the needle 243 can be disposed within a tube 115 that is disposed within a cavity 105 of the imaging component 100. Additionally, or alternatively, the shaft 241 of the drug delivery device 240 can be disposed within the cavity 105 of the imaging component 100 without using a tube. The shaft 241 of the drug delivery device 240 in the illustrated example can define a circular geometry, but in other embodiments, the shaft 241 of the drug delivery device 240 can be elliptical or any other geometry such that the shaft 241 of the drug delivery device 240 can be inserted into and removed from the cavity 105 of the imaging component 100. In some embodiments, the shaft 241 of the drug delivery device 240 can be asymmetric to provide an axis for alignment of the device within the cavity 105 of the imaging component 100. In some embodiments, the drug delivery device 240 can rotate relative to the imaging component 100. In other embodiments, the drug delivery device 240 can rotate completely in either direction relative to the imaging component 100 under user control within a tube 155 of the shaft 103 of the imaging component 100 while the shaft 103 of the imaging component remains stationary.

[0079] Figures 2A-2E illustrate exemplary instruments that may be disposed within the shaft 103 of the imaging component 100, and the example is not intended to be limiting. Other examples may include fluid injection and / or aspiration instruments. The fluid injection and / or aspiration instruments may include an instrument with a shaft configured to conduct fluid to a patient's tissue, the shaft having a lumen therein. The fluid injection and / or aspiration instruments may deliver fluid for cooling tissue. Additionally, or alternatively, the fluid injection and / or aspiration instruments may deliver fluid for flushing tissue. Additionally, or alternatively, the fluid injection and / or aspiration instruments may deliver fluid for expanding a body cavity. The fluid injection and / or aspiration instruments may deliver solutions and / or suspensions comprising therapeutic agents such as disinfectants, anesthetics, analgesics, antibiotics, steroids, etc. The fluid injection and / or aspiration elements may be integrated into any of the instruments described herein. Alternatively, the fluid injection and / or aspiration elements may include an instrument that is to be inserted and retracted as a step during a multi-instrument procedure.

[0080] Figure 3A shows an assembly view of an imaging system comprising an imaging component 100 and an optical scope instrument 300 according to some embodiments. Although an optical scope element may be shown in the illustrated embodiment, the optical scope instrument 300 may be any other suitable instrument, such as any of the instruments disclosed herein. As shown in Figure 3A, the imaging system may slidably receive a disposable tube 115 within the cavity 105 of the imaging component 100. In some embodiments, the imaging system may include a disposable tube 115 that is slidably received within the cavity 105 of the imaging component 100. In such embodiments, an instrument may be removably received within the lumen of the disposable tube 115. Additionally, or alternatively, the cavity 105 of the imaging component 100 may be configured to slidably receive one or more of a plurality of instruments, which may include various therapeutic and / or diagnostic instruments.

[0081] In an illustrative example, the imaging component can removably receive an instrument such as a biopsy needle, a tissue collector instrument, an optical scope, an implant device, a therapy electrode, for example, a tissue ablation element such as a radiofrequency ablation element, an ultrasonic ablation element, a heat-based ablation element, a cryoablation element, etc., and / or other instruments suitable for placement 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. Additionally, or alternatively, with or without the use of a disposable tube, the imaging component can removably receive any of the instruments illustrated in FIGS. 2A-2E.

[0082] In the illustrated embodiment, the distal end 305 of the optical scope instrument 300 can include a light emitting diode and / or a camera to provide an image to the user. In such an embodiment, the optical scope instrument 300 can serve as an endoscope. The distal end 305 of the optical scope instrument 300 can include optical components such as an optical fiber, a relay lens, an objective lens, etc. The optical scope instrument 300 can include a shaft 303 of the optical scope instrument 300 having a distal end and a proximal end. The shaft 303 of the optical scope instrument 300 can be configured to be removed from the handle component of the instrument or can be configured to be used without the handle component such that the optical scope instrument 300 can be disposable.

[0083] The shaft 303 of the optical scope instrument 300 can be made of a flexible material and / or a flexible material such that it can be deflected within the cavity 105 of the shaft 103 of the imaging component 100 by the imaging transducer 107 and / or an angled portion. Additionally, or alternatively, the shaft 303 of the optical scope instrument 300 can include a wire system or other means (e.g., push, pull, and / or rotation / torque) for deflecting the distal end 305 of the optical scope instrument 300. The deflection of the distal end 305 of the optical scope instrument 300 can serve to prevent damage to the imaging transducer 107 and / or to enable multiple image angles to be collected. In some embodiments, the optical scope instrument 300 can rotate relative to the imaging component 100. In some embodiments, the shaft 103 of the imaging component remains stationary, but the imaging component 100 can rotate completely in any direction under user control within the shaft 103 of the imaging component 100 such that multiple image angles can be collected.

[0084] The shaft 303 of the optical scope instrument 300 can be longer than the shaft of the imaging transducer 107 such that an image can be collected from deep within the uterus. In some embodiments, the shaft 303 of the optical scope instrument 300 can be 2 inches longer than the shaft of the imaging transducer 107. Additionally, or alternatively, for example, the shaft 303 can be 6 inches long, 4 inches long, 2 inches long, the same length, or within the range of any two of the previous values.

[0085] In the illustrated embodiment, the endoscopic instrument 300 includes a handle portion 301. The handle portion 301 may be shown connected to the endoscope in the example shown, but a similar handle portion may be connected to any suitable instrument such as those disclosed herein. The handle portion 301 may be the second part of a two-piece handle such that when the endoscopic instrument 300 can be slidably inserted into the imaging component 100, the two handle portions can be combined to form a single handle. The handle portion may additionally include a positioning element 313 to provide a more secure reference between the parts of the two-piece handle. The positioning element 313 may mate with the positioning element 113. In such an embodiment, the handle portion may include a release control 321 that can be actuated by the user to retract the positioning element 313 into the handle and allow the two-piece handle to be separated.

[0086] The handle portion 301 may additionally include one or more control elements 319. The control elements 319 may enable a medical professional to control the distal end of the instrument. In one example, the control elements 319 control a wire system that can reproducibly deflect or steer the distal end of the instrument. Additionally or alternatively, the control elements 319 rotate the shaft of the instrument (e.g., the shaft 303 of the endoscopic instrument 300) within the lumen 105 of the imaging component 100 or within the disposable tube 115. In another example, the control element scoops tissue in a tissue collection instrument. In another example, the control element 319 deploys a needle assembly with optional tines in an ablation instrument. Additionally or alternatively, the control element 319 initiates an ablation procedure. In another example, the control element 319 applies pressure to inject a chemical through a drug delivery instrument. In another example, the control element 319 initiates or terminates image collection in an endoscopic instrument.

[0087] Figure 3B shows an assembly diagram of an imaging system illustrating the mounting mechanism of a system according to some embodiments. The interior 309 of the handle portion 301 may comprise alignment elements 311. The alignment elements 311 may be configured such that the optical scope instrument 300 can be reproducibly aligned relative to the imaging component 100 after the instrument has been exchanged. Additionally or alternatively, the alignment elements 311 may sufficiently fix the instrument and the imaging component 100 relative to each other for using the two handle portions 101, 301 as a single handle. In some embodiments, the alignment elements 311 may comprise magnets. In other embodiments, the alignment elements 311 may comprise, for example, a latch, a hook, or any other mechanism suitable for removably combining two-piece handles. The interior 309 of the handle portion 301 may additionally comprise positioning elements 313 for providing a more reliable reference between the parts of the two-piece handle. In such embodiments, the handle portion may comprise a release control device 321 that can be actuated by a user to retract the positioning element 313 into the handle and enable the two-piece handle to be separated.

[0088] In some embodiments, a method for detecting or sensing the identification of a removable instrument is provided when coupling the imaging component 100 and a removable instrument (e.g., an optical scope instrument 300). The imaging component 100 may include software for recognizing the removable instrument and managing the interconnection between the imaging component 100 and the removable instrument. The sensor or mechanism can be, by way of non-limiting example, optical, RF, magnetic, biometric, electronic, and mechanical ID and readers. The method will ensure that only a qualified removable device is received on the imaging device and that only a compatible device can be used with the imaging component 100.

[0089] Figure 4 illustrates the shaft 103 of the imaging component 100, where the shaft 103 of the imaging component 100 can be flexible according to some embodiments. In the illustrated embodiment, the shaft 103 of the imaging component 100 can include a flexible shaft portion 403. The body of the flexible shaft portion 403 can include an internal structure for supporting electronics or other associated components for controlling the imaging transducer 107. The imaging transducer 107 can include channels or ducts for directing a fluid (e.g., water, saline, etc.) to the distal end of the shaft and onto the tissue surface. The flexible shaft portion 403 can comprise a portion of the length of the shaft 103 of the imaging component 100. In some embodiments, the flexible shaft portion 403 comprises less than three - quarters of the length of the shaft 103. Additionally, or alternatively, the flexible shaft portion 403 can comprise less than one - quarter of the length of the shaft 103, and less than one - eighth of the length of the shaft 103, and the entire length of the shaft 103.

[0090] The cross - sectional geometry of the flexible shaft portion 403 can continue the geometry of the shaft 103 such that no gaps or traumatic edges are created between the flexible shaft portion 403 and the shaft 103. The flexible shaft portion 403 can have a shape with a rounded, or sufficiently softened, chamfered, rounded, or tapered edge such that the edge can be non - traumatic to the patient's opening during insertion or removal of the imaging component 100, with or without the instrument. The flexible shaft portion 403 can additionally comprise a smooth outer surface. The flexible shaft portion 403 can be made from a material such that the surface can be deformable to allow the flexible shaft portion 403 to bend or conform to the shape of a body lumen.

[0091] The cavity of the flexible shaft portion 403 can be configured to slidably receive one or more of the plurality of instruments. The cavity of the flexible shaft portion 403 can be configured to continue the shape of the cavity 105 of the shaft 103 such that no gap or traumatic edge is created between the flexible shaft portion 403 and the shaft 103. In some embodiments, the cavity of the flexible shaft portion 403 can be partially open along the wall such that the lumen of the cavity of the flexible shaft portion 403 can communicate with the exterior of the shaft 103. The opening of the flexible shaft portion 403 can be sufficiently closed to provide structural support such that when the imaging component 100 can be inserted into the patient body lumen, the opening of the lumen is not significantly obstructed by the insertion or removal of the instrument. In some embodiments, the edge of the cavity of the flexible shaft portion 403 can bend inwardly toward the interior of the cavity as in the embodiment illustrated in FIG. 1D. The inwardly bent edge of the cavity of the flexible shaft portion 403 can serve to support the opening of the body lumen such that the shaft 103 can be inserted into or removed from the body lumen, with or without an instrument, in a non-traumatic manner. The cavity of the flexible shaft portion 403 can be sufficiently open such that some distortion of the cavity opening can occur when different sized instruments are received or inserted into the cavity. The cavity can facilitate cleaning of the imaging component 100 by providing access from the exterior to the interior of the cavity.

[0092] The cavity of the flexible shaft portion 403 in the illustrated example defines a circular cross-sectional geometry, but in other embodiments, the cavity of the flexible shaft portion 403 can be elliptical or any other geometry with rounded, or beveled edges and corners that is sufficiently softened so that insertion or removal of the shaft of the flexible shaft portion 403 does not damage the patient body lumen. In some embodiments, the cavity of the flexible shaft portion 403 can be asymmetric to provide an axis for alignment of the instrument therein. The cavity of the flexible shaft portion 403 can be open for less than three-quarters of its outer perimeter, and in addition or alternatively, the cavity can be open for less than half of its outer perimeter, less than one-quarter of its outer perimeter, and less than one-eighth of its outer perimeter. In other embodiments, the cavity of the flexible shaft portion 403 can be closed external to the shaft of the flexible portion, and the instrument can be inserted fully slidably within the shaft of the flexible portion.

[0093] In some embodiments, the flexible shaft portion 403 can be constructed from a compliant material and / or a flexible material so that it can be bent within the patient body lumen. In some embodiments, the shaft can be controllably bent along its longitudinal axis via a bending mechanism. In addition or alternatively, the flexible shaft portion 403 can comprise a wire system or other bending mechanism to enable the flexible shaft portion 403 to controllably bend, flex, or deflect the distal end of the flexible portion. The bending mechanism can be controlled by a control element on the handle portion of the imaging component 100 (e.g., handle portion 101 shown in FIG. 3A).

[0094] In the illustrated example, the flexible shaft portion can be axially bent up to an angle of about 90 degrees relative to the handle. Additionally, or alternatively, the flexible shaft portion can be axially bent, for example, up to 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 flexible shaft portion can be bent about the longitudinal axis relative to the handle of the imaging component 100. In some embodiments, the flexible shaft portion can be bent about the longitudinal axis, for example, up to 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 flexible shaft portion can be bent about the medial-lateral axis relative to the handle of the imaging component 100. In some embodiments, the flexible shaft portion can be bent about the medial-lateral axis, for example, up to less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, less than 1 degree.

[0095] FIG. 5A illustrates a system for diagnosing and / or providing therapies that can be removably coupled to a plurality of therapeutic and / or diagnostic instruments according to some embodiments. The system for performing therapy and / or diagnosis can comprise a therapeutic or diagnostic instrument 510 and an imaging component 520. The instrument 510 of the system for performing therapy and / or diagnosis can comprise a therapeutic or diagnostic instrument such as, for example, any of the therapeutic or diagnostic instruments described herein. In some embodiments, the imaging component 520 can be used in conjunction with an instrument such as a biopsy needle, a tissue collector, an optical scope, an implant device, a therapy electrode, for example, a tissue ablation element such as a radiofrequency ablation element, an ultrasonic ablation element, a heat-based ablation element, a cryoablation element, and / or any other instrument suitable for being 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 tissue to be treated. FIGS. 2A-2E show exemplary instruments that can be slidably received by the imaging component. In some embodiments, the system can comprise a first and a second therapeutic or diagnostic instrument. The imaging component 520 can comprise an imaging component such as, for example, an example, embodiment, and variation of the imaging component described herein.

[0096] FIG. 5B illustrates a system for diagnosing and / or providing a therapy according to some embodiments, wherein the therapeutic and / or diagnostic instrument 510 is removably coupled to the imaging component 520. As shown, the instrument 510 can be axially aligned with respect to the imaging component 520. Additionally, the distal end of the shaft 513 of the instrument 510 can be fed into the proximal end of the cavity 525 of the imaging component 520. Subsequently, the instrument 510 can be advanced toward the imaging component 520 such that the shaft 513 of the instrument 510 is slidably received by the cavity 525 of the imaging component 520. The instrument 510 can be slidably removed from the imaging component 520 by a similar procedure.

[0097] Figure 5C illustrates a system for diagnosing and / or providing therapy according to some embodiments, where a therapeutic and / or diagnostic instrument 510 is removably coupled to an imaging component 520. The system for diagnosing therapy may 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 diagnosing and / or providing therapy may be configured to couple to multiple instruments. For example, a first instrument may be coupled to the imaging component 520, and subsequently, a second instrument may be coupled. The imaging component 520 may be configured to be coupled to both the first and second therapeutic and / or diagnostic instruments simultaneously or individually. For example, if the first instrument is a disposable tube, the second instrument may be slidably inserted within the first instrument. In some embodiments, the imaging component 520 may be pre-coupled to the first and / or second therapeutic or diagnostic instruments external to the target site and configured to be delivered to the target site within the patient. Additionally, or alternatively, the imaging component 520 may be configured to be removably coupled to both the first and second therapeutic or diagnostic instruments simultaneously or individually after the imaging component 520 has been delivered to the target site within the patient (e.g., the instruments may be coupled in situ).

[0098] FIG. 6 shows an imaging system 600 comprising a digital processing device 612 and a display 614, the display 614 being visible to a user. As shown in FIG. 6, the imaging system 600 may additionally comprise an imaging component 100 and an instrument 300. The digital processing device 612 may comprise one or more processors configured with instructions for setting and recording both treatment parameters and imaging parameters. The display 614 may be included within a common enclosure 618; however, in other embodiments, the display 614 may be remote from the digital processing device and / or the imaging component 100. The imaging component 100 may be connected to the digital processing device 612 by an imaging code 624 for providing an image captured by the digital processing device 612 as displayed by the display 614; however, additionally or alternatively, the imaging component 100 may communicate wirelessly with the digital processing device 612. The instrument 300 may be connected to the digital processing device 612 by an instrument code 622; however, additionally or alternatively, the instrument 300 may communicate wirelessly with the digital processing device 612. In embodiments where the imaging component 100 and the instrument 300 are connected by the codes 624, 622, the digital processing device 612 may supply power to both components.

[0099] The instrument 300 may comprise a handle portion 301 having one or more slidably mounted control elements 319 on its upper surface. In some embodiments, the control element 319 may control the position of an internal stop within the handle, the position of which may be monitored by the digital processing device 612 for calculating the size and position of the boundaries of a targeted region and / or a safety region shown on the display 614. In embodiments where the instrument 300 is an ablation element (e.g., the ablation instrument 230 shown in FIG. 2C), the stop may further serve to physically limit the deployment of the introducer, optionally the tine.

[0100] Some embodiments of the methods and systems of the present disclosure may be integrated with systems and methods for establishing and adjusting the displayed safety and treatment zone boundaries. Such embodiments may include the systems and methods of incorporated references including U.S. Patent Publication No. 2014 / 0073910 (current U.S. Patent No. 9,861,336), U.S. Patent No. 8,992,427, U.S. Patent Publication No. 2018 / 0132927 (current U.S. Patent No. 11,219,483), and PCT Publication No. WO2018 / 089523, 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 incorporated references including PCT Publication No. WO2018 / 089523.

[0101] FIG. 7A illustrates an imaging component 100 that can be used to treat a myoma F located within the myometrium M within the uterus U below the uterine wall UW (endometrium) and surrounded by the serosal wall SW. The imaging component 100 is introduced into the uterus U transvaginally and transcervically (or alternatively, laparoscopically), and the imaging transducer 107 can be deployed to image the myoma F within the field of view indicated by the dashed line.

[0102] FIG. 7B shows an image that would be visible on a display (e.g., display 614 shown in FIG. 6) showing a treatment boundary and a safety boundary according to some embodiments. In some embodiments, when the tumor F is located on the display 614, the control device on the handle can be used to locate and size both the treatment boundary TB and the safety boundary SB. In some embodiments, initially, the virtual boundary lines TB and SB may not be positioned or sized appropriately across the tumor F for treating the tumor F. Prior to beginning therapy, the user (e.g., a physician) may desire to position and size both the boundaries TB and SB for appropriate treatment. Since the imaging transducer 107 may already be positioned relative to the uterine wall UW, the only way to advance the treatment and safety boundaries TB, SB may be to move the boundaries forward by actuating the control element 319. In some embodiments, this may move the treatment and safety boundaries TB and SB forward along the axis AL, thereby translating the area to be treated. This may move the virtual boundaries on the real-time image display 614 across the image of the tumor F. Additionally, or alternatively, the size of the treatment boundary TB may be enlarged or reduced to reduce the risk of affecting healthy and / or more sensitive tissue surrounding the treatment area.

[0103] In embodiments where the instrument is a tissue ablation element, while holding the imaging component 100 steady, the physician may then advance the needle slide and extend the introducer 235 into the tumor F as shown in FIG. 7C. The illustration of FIG. 7C includes a representation of the imaging component 100, which corresponds to the physical probe present within the patient. The remainder of FIG. 7C corresponds to the image present on the target display 614.

[0104] After the introducer 235 is fully deployed such that it is limited by an optional physical or virtual needle stop housing within the instrument handle 301, the tine 233 can be deployed by advancing the tine slide. The target level of tine deployment is reached by engagement of the tine slide with an optional tine stop or as visually indicated on the display 614. Optionally, the imaging component 100 can be rotated about a central axis (typically aligned with the axis of the introducer 235) to confirm the treatment and safety boundaries TB, SB within all view planes around the myoma F. The display 614 will show the positions of the treatment and safety boundaries TB, SB in real time with respect to the target myoma F and serosa. The tine 233 is then configured as shown in FIG. 7D and power can be supplied to the tine 233 (optionally, to the introducer 235) to achieve treatment within the boundaries depicted by the virtual treatment boundary TB. Again, FIG. 7D mixes both the virtual image that would be present on the display 614 and the physical presence of the imaging component 100. (Uterine Fibroid Ablation Example)

[0105] Figures 8A - 8C depict examples of systems, devices, and methods for uterine fibroid ablation. The devices described herein can include an imaging component and a radiofrequency ablation element comprising a tissue ablation element, such as an introducer and a plurality of needle electrodes or tines, as described above. The imaging component and the tissue ablation element can be coupled together for transvaginal, transcervical delivery into the patient's uterus.

[0106] As shown, a tissue ablation device 800 is positioned within uterine cavity 802. In this example, the tissue ablation device 800 includes an imaging component integrated with or coupled to the tissue ablation element, although in other examples, the device 800 may include only an imaging component, a therapeutic component, or other devices as described above. The device 800 can benefit from expandable element 808 to better articulate to access the uterine side wall. Each of FIGS. 8A-8C depicts a myoma F attached to or otherwise at least partially embedded within uterine wall 801.

[0107] In FIG. 8A, tissue ablation device 800 is shown with expandable element 808 for articulating rotatable distal imaging transducer 807 and ultrasonic tip 812. Expandable element 808 as shown is in a reduced or folded configuration in accordance with embodiments disclosed herein. In FIG. 8A, tissue ablation device 800 is shown within uterine cavity 802. Tissue ablation device 800 includes a device shaft 803. An imaging transducer 807 as described herein in the above embodiments is provided at the distal end of device shaft 803. A hinge 806 is provided between device shaft 803 and imaging transducer 807. An ultrasonic tip 812 is provided at the distal tip of imaging transducer 807. Tissue ablation device 800 further includes expandable element 808 configured to articulate the device and / or ultrasonic tip 812.

[0108] The device shaft 803 can comprise a straight shaft that can be rigid or can have some degree of flexibility. The device shaft 803 can comprise two attachable sub-parts such as an imaging shaft that is attached to the shaft of the instrument. An exemplary example of two attachable sub-parts of the shaft is shown in FIG. 2C, where the shaft 231 of the ablation instrument 230 is reversibly attached to the imaging shaft 103.

[0109] The imaging transducer 807 has a field of view 815 and is configured to image tissue (e.g., tumor F) in the forward direction. The forward direction is defined as the direction in which the imaging transducer 807 is configured to image tissue.

[0110] The hinge 806 enables the imaging transducer 807 to pivot with respect to the device shaft 803 described herein. The imaging transducer 807 can pivot reversibly between a straight position and a pivoted position. The straight position is where the imaging transducer 807 forms a flat angle (i.e., about 180°) with the device shaft 803. In contrast, the pivoted position is where the imaging transducer 807 is angled with respect to the device shaft 803. Examples of the imaging transducer 807 in the pivoted position can be seen in FIGS. 8B and 9.

[0111] The ultrasonic tip 812 of the tissue ablation device 800 can comprise a spring-loaded tip configured to apply a force to restore the imaging transducer 807 from the pivoted position towards the straight position. In some embodiments, the spring-loaded tip can be completely straight or parallel and aligned with the device shaft 803 when the spring is unloaded. The spring-loaded tip can stabilize the imaging transducer 807 during installation and during the ablation procedure.

[0112] The expandable element 808 can be reversibly expanded from a collapsed configuration (an example of which is shown in FIG. 8A) to an expanded configuration (examples of which are shown in FIGS. 8B and 8C). In some embodiments, the expandable element 808 can be removably or integrally coupled directly to the device shaft 803. The expandable element 808 can be coupled to the device shaft 803 proximal to the imaging transducer 807. Alternatively, the expandable element 808 can be coupled to the device shaft 803 such that a portion of the expandable element 808 is proximal to the imaging transducer 807 and another portion of the expandable element 808 is coupled to the imaging transducer 807. In some embodiments (such as those in FIG. 8B), the expandable element 808 is configured to expand in a rearward direction that is substantially opposite from the forward direction.

[0113] The expandable element 808 can be provided with, for example, a balloon (such as that shown in FIGS. 8A - 8C), a deployable push rod, a retractable spring, or another type of actuating design. The deployable push rod can, in some embodiments, be the expandable element 808 by being hingedly fixed to the device shaft, for example, and in the collapsed or compressed configuration, the push rod can be bent along the device, but in the expanded configuration, the push rod can be deployed outwardly to push against the uterine wall. In another embodiment, the deployable push rod can be attached to the device shaft and extend outward from the side of the device shaft to push against the uterine wall. The expandable element 808 depicted in the examples of FIGS. 8A - 8C and FIG. 9 is a balloon 808. The shape, size, and / or material of the balloon can be configured to control the magnitude of the desired pressure from balloon inflation. In some embodiments of the balloon used as the expandable element, the balloon can include a plurality of chambers, and each chamber can be individually controlled according to the needs of the procedure. In embodiments where the expandable element is a balloon, the balloon can be expanded by being filled with a fill material fluid. The balloon can be inflated and deflated during the targeting sequence. The tissue ablation device 800 can further include a reservoir 816 for the fill material fluid that is in fluid connection with the balloon. In some embodiments, the fill material fluid enters the balloon, thereby expanding the balloon. In some embodiments, the fill material fluid is a liquid such as water or saline. In other embodiments, the fill material fluid is gaseous, such as pressurized air, oxygen, nitrogen, or an inert gas such as helium or argon. In some embodiments, the reservoir 816 can be a syringe, a tank, or any other source of the fill material fluid. In FIGS. 8A - 8C, the reservoir 816 is depicted as a syringe. In FIG. 8A, when the balloon 808 is in its reduced or folded configuration, the plunger of the syringe is fully withdrawn, indicating that the fill material fluid of the system is within the syringe.In FIG. 8B, when balloon 808 is in its expanded configuration, the plunger of the syringe is shown to be depressed and the fill fluid of the system has been moved from the syringe into the expanded balloon 808.

[0114] FIG. 8B shows tissue ablation device 800 of FIG. 8A with its expandable element 808 (e.g., balloon) in its expanded configuration that can articulate (e.g., deflect or rotate) tissue ablation device 800 within uterine cavity 802. The balloon of FIG. 8B is depicted as being expanded in response to fill fluid being pushed from reservoir 816 into the balloon. The pressure of the fill fluid can be adjusted through a sensor and control circuit. In some embodiments, expandable element 808 can be configured to articulate ultrasonic tip 812. In some embodiments, the articulation action can be caused by expanding expandable element 808 from target myoma F against the opposite wall of uterine cavity 802. The force against the opposite wall can push against the opposite wall and fill the space of uterine cavity 802 to stabilize tissue ablation device 800 within uterine cavity 802. The balloon can be fixed at the rear of device shaft 803 (the side not facing the transducer, e.g., as shown in FIG. 8A) and proximal to hinge 806. In some embodiments, as the balloon begins to occupy space, the balloon can push against the opposite wall, push device shaft 803 towards myoma F, and further articulate spring-loaded hinged transducer tip 812. In some embodiments, the expandable element is expanded before the tissue ablation device is placed in the target treatment area. Indeed, as shown in FIG. 8B, expanding expandable element 808 can serve to place tissue ablation device 800 in the target treatment area. In other embodiments (not shown), the expandable element can be expanded after the tissue ablation device has been placed in the target treatment area.

[0115] In some embodiments, a tissue ablation device with an expandable element can be used to treat the endometrial surface by filling a balloon with a hot fill fluid. In some embodiments, such a procedure can provide endometrial ablation that can, for example, reduce or eliminate menstrual blood and associated symptoms. In some embodiments, the fill fluid can be a hot fill fluid. In some embodiments, the hot fill fluid can be heated to a temperature of about, at least about 75°C, 80°C, 85°C, 87°C, 90°C, 95°C, or less, or greater than or less than that, and any range including any two of the foregoing values, over the duration of the endometrial ablation procedure.

[0116] In other embodiments (not shown), the expandable balloon can be positioned at the front of the imaging transducer and filled with a liquid. When configured in this way, the expanded balloon can serve as an acoustic stand-off for automatically coupling the transducer to the tissue and can improve the ultrasound image quality during the treatment procedure.

[0117] Looking again at FIG. 8B, the expansion of the expandable element 808 (e.g., balloon) against the opposite wall of the uterine cavity 802 can further act to press the imaging transducer 807 more closely against the fibroid F. In some embodiments, the force acting to press the imaging transducer 807 more closely against the fibroid F can further articulate the imaging transducer 807 at the hinge 806 with respect to the device shaft 803 (or articulate the device shaft 803 at the hinge 806 with respect to the imaging transducer 807).

[0118] FIG. 8C shows the tissue ablation device 800 of FIG. 8B, with an ablation instrument (e.g., the ablation instrument 230 of FIGS. 2C and 7C-7D) inserted into the tumor F for the treatment of tumor ablation as described herein. In some embodiments, the ablation instrument can be attached to the tissue ablation device 800 before the expandable element 808 is expanded. In other embodiments, the ablation instrument can be attached to the tissue ablation device 800 after the expandable element 808 has been expanded. Hereinafter, it should be understood that the tissue ablation device 800 comprises an ablation instrument, and the ablation instrument in turn comprises a introducer 835 and optionally treatment elements such as a plurality of needle electrodes 833. As described herein, in some embodiments, the treatment elements can be inserted into the tumor F. The manner in which the treatment elements of FIG. 8C are inserted into the tumor F can be similar to those shown and described in FIGS. 7C-7D, for example. In some embodiments, articulating the imaging transducer 807 to a swivel position can enable deployment of the treatment elements. In FIG. 8C, the expandable element 808 can serve to provide additional stability to the introducer 835, to the needle electrodes 833, and to the imaging transducer 807 used to visualize the ablation procedure.

[0119] Providing a balloon or other expandable element as described herein can provide one or more benefits including, but not limited to, (1) stabilizing the ultrasonic tip inside the cavity, (2) automatically pointing the device shaft towards the target tissue or moving the tissue into the line of sight with respect to the introducer instead of requiring intentional pointing movements, (3) providing stability inside the uterus and tension in the tissue, reducing movement during introducer and needle electrode deployment, (4) creating stability during ablation, and (5) eliminating the need for alignment steps in the software in conjunction with a spring-loaded tip with live angle tracking.

[0120] Embodiments of the present disclosure are applicable to the Sonata® System available from Gynesonics, Inc. (Redwood City, CA) and similar systems, devices, and methods described in the following U.S. patents and patent applications by the same applicant, which are incorporated herein by reference: U.S. Patent No. 7,918,795, U.S. Patent No. 9,357,977, U.S. Patent No. 7,815,571, U.S. Patent No. 7,874,986, U.S. Patent No. 10,058,342, U.S. Patent No. 8,088,072, U.S. Patent No. 8,206,300, U.S. Patent No. 9,861,336, U.S. Patent No. 8,992,427, U.S. Patent No. 11,219,483, U.S. Patent Publication No. 2020 / 0275975 (now U.S. Patent No. 11,612,431), and U.S. Patent Publication No. 2019 / 0350648.

[0121] FIG. 9 is similar to FIG. 8C, except that in FIG. 9, the target tissue (e.g., fibroid F) is at the bottom of the uterine cavity 802 rather than along the uterine sidewall. In some embodiments, the expandable element 808 (e.g., balloon) in its expanded configuration can provide stability to the tissue ablation device 800 when the tissue ablation device 800 images and ablates a fibroid at the bottom of the uterus. It will be understood by those skilled in the art that the presence of the expandable element in its expanded configuration can be useful for various procedures (e.g., imaging, ablation, biopsy, injection, etc.). It should also be understood that after the procedure, the expandable element 808 can be emptied or otherwise folded to return the expandable element to its reduced configuration, which facilitates removal of the device from the uterus.

[0122] The foregoing description and examples are merely described to illustrate the present disclosure and are not intended to be limiting. Each of the disclosed aspects and embodiments of the present disclosure can be considered individually or in combination with other aspects, embodiments, and variations of the present disclosure. Additionally, unless otherwise specified, none of the steps of the methods of the present disclosure are limited to any particular order of implementation. Modifications of the disclosed embodiments that incorporate the spirit and substance of the present disclosure may occur to those skilled in the art, and such modifications are within the scope of the present disclosure.

[0123] Orientation terms used herein, such as "upper", "bottom", "horizontal", "vertical", "longitudinal", "lateral", and "end", are used in the context of the illustrated embodiments. However, the present disclosure should not be limited to the illustrated orientations. In fact, other orientations are also conceivable and are within the scope of the present disclosure. Terms related to circular shapes, such as diameter or radius, as used herein, should be understood not to require a complete circular structure, but rather to apply to any suitable structure with a cross-sectional area that can be measured from end to end. Generally, terms related to shapes, such as "circular", or "cylindrical", or "semicircular", or "semicylindrical", or any related or similar terms, etc., are not required to strictly conform to the mathematical definitions of circles or cylinders or other structures, and can include structures that are reasonable approximations.

[0124] In particular, conditional language used in this specification such as "can", "is capable of", "is able to", "for example", etc., generally conveys that some embodiments include a certain feature, element, and / or state, while other embodiments do not, unless specifically stated otherwise or understood in a context where it is used otherwise. Thus, such conditional language is generally not intended to imply that a feature, element, block, and / or state is required for one or more embodiments in any way, or that one or more embodiments necessarily include the logic for determining whether these features, elements, and / or states should be included or implemented in any particular embodiment, regardless of the presence or absence of the drafter's input or prompt.

[0125] Connective language such as the phrase "at least one of X, Y, and Z" is generally understood in a context where it is used as is to convey that an item, term, etc. can be any of X, Y, or Z, unless specifically stated otherwise. Thus, such connective language generally does not intend to imply that an embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0126] Terms such as "about", "approximately", and "substantially" as used in this specification represent an amount close to the recited amount that still performs the desired function or achieves the desired result. For example, in some embodiments, depending on the context, the terms "about", "approximately", and "substantially" may refer to an amount within or equal to less than 10% of the recited amount. The term "substantially" as used in this specification mainly represents a value, amount, or characteristic that includes or tends to a particular value, amount, or characteristic. As an example, in some embodiments, depending on the context, the term "substantially parallel" may refer to any deviation from exact parallelism of only less than or equal to 20 degrees.

[0127] When the term "about" is used in front of a range of two numerical values, it is intended to include the range between about the first value and about the second value, as well as the range from the defined first value to the defined second value.

[0128] Unless explicitly stated otherwise, articles such as "a" or "an" should generally be interpreted to include one or more of the items being described. Thus, phrases such as "a device configured to" are intended to include one or more of the recited devices. Such one or more recited devices can be configured collectively to perform the recited listing. For example, "a processor configured to perform listings A, B, and C" can include a first processor configured to perform listing A that cooperates with a second processor configured to perform listings B and C.

[0129] The terms "comprising", "including", "having", etc. are synonymous and are used inclusively in a non-limiting manner, not excluding additional elements, features, acts, operations, etc. Similarly, the terms "some", "a", etc. are synonymous and are used in a non-limiting manner. Further, the term "or" is used in its inclusive sense (not in its exclusive sense) when used, for example, to connect a list of elements, such that the term "or" means one, some, or all of the elements in the list.

[0130] Overall, the language of the claims is to be interpreted broadly based on the language employed in the claims. The language of the claims is not limited to the non-exclusive embodiments and examples illustrated and described in this disclosure or discussed during the examination of this application.

[0131] Intravascular implants and systems, devices, and methods for their accurate placement are disclosed in the context of certain embodiments and examples, but the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the embodiments and certain modifications and equivalents thereof. The various features and aspects of the disclosed embodiments can be combined with one another or substituted with respect to one another to form various modes of intravascular implants and systems, devices, and methods for their accurate placement. The scope of the present disclosure should not be limited by the specific disclosed embodiments described herein.

[0132] Certain features described in the context of the present disclosure in separate implementations can be implemented in combination in a single implementation. Conversely, the various features described in the context of a single implementation can be implemented separately in multiple implementations or in any suitable sub-combination. Although a feature may be described herein as acting in a certain combination, one or more features from the claimed combination can, in some cases, be deleted from the combination, and the combination can be claimed as any sub-combination or variation of any sub-combination.

[0133] The methods and devices described herein may be susceptible to various modifications and alternative forms, and specific examples thereof are shown in the drawings and described in detail herein. However, the present invention is not limited to the specific forms or methods disclosed, and on the contrary, it is to be understood that the present invention covers all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Further, the disclosure herein of any specific feature, aspect, method, property, characteristic, quality, attribute, element, or equivalent related to an embodiment can be used in all other embodiments described herein. Any method disclosed herein need not be performed in the order recited. Depending on the embodiment, one or more acts, events, or functions of any of the algorithms, methods, or processes described herein can be performed in a different sequence, added, combined, or completely omitted (e.g., not all described acts or events are necessary for the practice of the algorithm). In some embodiments, acts or events can be performed in parallel rather than sequentially, e.g., through multithreading, interrupt processing, or through multiple processors or processor cores, or on other parallel architectures. Further, no element, feature, block, or step, or group of elements, features, blocks, or steps, is necessary or essential to each embodiment. Additionally, all possible combinations, subcombinations, and rearrangements of systems, methods, features, elements, modules, blocks, etc. are within the scope of this disclosure. The use of sequential or chronological language such as "then," "next," "after," "subsequently," etc. is generally intended to facilitate the flow of the text and not to limit the sequence of operations performed, unless specifically described otherwise or understood in a context where it is used otherwise. Thus, while some embodiments may be implemented using the sequence of operations described herein, other embodiments may be implemented according to a different sequence of operations.

[0134] Furthermore, although operations may be depicted in the drawings or described herein in a particular order, to achieve the desired result, such operations need not be performed in the particular order shown or in a sequential order, and not all operations need to be performed. Other operations not depicted or described can be incorporated into the exemplary methods and processes. For example, one or more additional operations can be performed before, after, simultaneously with, or between any of the operations described. Further, the operations can be rearranged or reordered in other implementations. Additionally, the separation of various system components in the implementations described herein should not be understood as requiring such separation in all implementations, and it should be understood that the components and systems described are generally integrated together within a single product or can be packaged into multiple products. In addition, other implementations are within the scope of the present disclosure.

[0135] Some embodiments are described in relation to the accompanying drawings. A figure is drawn and / or shown to scale, but such scale is not to be limiting as other dimensions and ratios than those shown are contemplated and are within the scope of the embodiments disclosed herein. Distances, angles, etc. are illustrative only and not necessarily in strict relation to the actual dimensions and layout of the devices shown. Components can be added, removed, and / or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like related to various embodiments can be used in all other embodiments described herein. Additionally, any method described herein can be practiced using any device suitable for performing the recited steps.

[0136] The methods disclosed herein may include certain actions performed by an operator, however, the methods can further include, either explicitly or implicitly, any third party instructions of those actions. For example, an action such as "positioning an electrode" includes "issuing an instruction to position the electrode".

[0137] In summary, various embodiments and examples of intravascular implants and devices and methods for accurate placement are disclosed. Systems, devices, and methods for intravascular implants and their accurate placement are disclosed in the context of those embodiments and examples, however, the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or other uses of the embodiments, and certain modifications and equivalents thereof. The present disclosure explicitly contemplates that various features and aspects of the disclosed embodiments can be combined with one another or substituted with respect to one another. Accordingly, the scope of the present disclosure should not be limited by the specific disclosed embodiments described herein, but should be determined only by a fair reading of the following claims.

[0138] The scope disclosed herein further encompasses any and all overlaps, subranges, and combinations thereof. Language such as "maximum", "at least", "greater than", "less than", "between", etc. includes the recited numerical values. Terms such as "about" or "approximately" preceding a numerical value include the recited numerical value and should be interpreted based on the circumstances (e.g., as accurately as reasonably possible under the circumstances, e.g., ±5%, ±10%, ±15%, etc.). For example, "about 1V" includes "1V". Terms such as "substantially" preceding a phrase include the recited phrase and should be interpreted based on the circumstances (e.g., as maximally as reasonably possible under the circumstances). For example, "substantially right angle" includes "right angle". Unless stated otherwise, all measurements are at standard conditions including temperature and pressure.

Claims

**Claim 1** A tissue ablation device, wherein the tissue ablation device comprises a device shaft, and an imaging transducer provided at a distal end of the device shaft, the imaging transducer comprising an imaging transducer that provides an ultrasonic tip, and an expandable element configured to articulate the ultrasonic tip A tissue ablation device comprising. **Claim 2** The tissue ablation device according to claim 1, wherein the imaging transducer is pivotable between a straight-line position in which the imaging transducer forms a right angle with the device shaft and a pivoted position in which the imaging transducer is angled with respect to the device shaft. **Claim 3** The tissue ablation device according to claim 2, wherein the ultrasonic tip of the tissue ablation device comprises a spring-loaded tip, and the spring-loaded tip is configured to apply a force for restoring the imaging transducer from the pivoted position toward the straight-line position. **Claim 4** The tissue ablation device according to claim 1, wherein the expandable element is directly coupled to the device shaft. **Claim 5** The tissue ablation device according to claim 1, wherein the imaging transducer is configured to image tissue in a forward direction, and the expandable element is configured to expand in a rearward direction, the rearward direction being substantially opposite from the forward direction. **Claim 6** The tissue ablation device according to claim 1, wherein the expandable element is a balloon. **Claim 7** The tissue ablation device according to claim 6, wherein the balloon comprises a plurality of chambers, each chamber being individually controllable. **Claim 8** The tissue ablation device according to claim 6, wherein the balloon is configured to be expanded by being filled with a filler fluid. **Claim 9** The tissue ablation device according to claim 8, wherein the filler fluid is gaseous. **Claim 10** The tissue ablation device according to claim 8, wherein the filler fluid is a high-temperature filler fluid. **Claim 11** The balloon of claim 8, wherein the balloon is configured to expand between the imaging transducer and the tissue being imaged by the imaging transducer so as to function as an acoustic standoff for coupling the balloon to the tissue of the imaging transducer.

12. The tissue ablation device of claim 1, wherein the expandable element is coupled to the device shaft proximal to the imaging transducer.

13. The tissue ablation device of claim 1, wherein the expandable element is a retractable spring.

14. The tissue ablation device of claim 1, wherein the device shaft comprises a straight shaft.

15. The tissue ablation device of claim 1, wherein the tissue ablation device is configured for uterine fibroids ablation.

Images