Tissue ablation device with expandable element for device activity

Abstract

Aspects of the present disclosure include an expandable balloon or other expandable element to activate a working end of a tissue ablation probe in tissue ablation systems, devices, and methods.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS AND INCORPORATION BY REFERENCE

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 355,876, filed on June 27, 2022, the entire contents of which are incorporated herein by reference.

[0003] All publications, patents, and patent applications mentioned in this specification are herein 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. Background of the Invention Technical Field

[0005] The present disclosure relates to medical systems, devices and methods, particularly for ablation of uterine fibroids. More particularly, the present disclosure relates to imaging components used with therapeutic and diagnostic devices.

[0006] Description of Related Technology

[0007] Current systems, devices, and methods for imaging and / or for therapeutic procedures may be less than ideal in at least some respects. For example, many current devices may have limited flexibility in use in various diagnostic and therapeutic procedures. For example, many current devices may pose a risk of harming a patient during insertion and / or removal, or may be difficult to navigate to a target location.

[0008] Additionally or alternatively, current systems, devices, and methods for diagnosing and providing treatment may be less than ideal in at least some other respects. For example, in a procedure that may require more than one instrument, multiple instruments may need to be inserted into or removed from a patient's lumen, and these additional steps of insertion and removal may increase the risk of injury to the patient. Additionally or alternatively, many current methods may require the removal of imaging components multiple times during a single procedure, and the removal of imaging components may limit the ability to continuously and stably observe the surgical area during surgery. In addition, the ability of many current devices to articulate within a cavity or lumen in a patient's body may be limited, which may limit the ability of instruments (e.g., imaging and / or surgical instruments) to reach target tissue.

[0009] 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-mentioned shortcomings and would, for example, be more easily used in a wider variety of therapeutic and diagnostic procedures.

[0010] Overview

[0011] The embodiments disclosed herein each have several aspects, no single aspect of which is solely responsible for the desired attributes of the present disclosure. Without limiting the scope of the present disclosure, the more salient features of the present disclosure will now be briefly discussed. After considering this discussion, and particularly after reading the section entitled "Detailed Description," one will understand how the features of the embodiments described herein provide advantages over existing systems, devices, and methods.

[0012] The present disclosure relates to medical systems, devices and methods, particularly for but not limited to uterine fibroid ablation. Embodiments of the present disclosure provide an expandable element for device activity. Such an expandable element can increase ease of use and facilitate device deployment and positioning. Such an expandable element can also maintain image quality by keeping the imaging transducer of the tissue ablation device in contact with the tissue at all times.

[0013] In some embodiments, disclosed herein is a tissue ablation device comprising: a device shaft; an imaging transducer disposed at a distal end of the device shaft to provide an ultrasound tip; and an expandable element configured to move the ultrasound tip.

[0014] In the above-mentioned tissue ablation device or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the imaging transducer can pivot between a straight position in which the imaging transducer forms a straight angle with the device axis and a pivot position in which the imaging transducer is angled relative to the device axis. In some embodiments, the ultrasonic tip of the tissue ablation device includes a spring-loaded tip, and the spring-loaded tip is configured to apply a force to restore the imaging transducer from the pivot position toward the straight position. In some embodiments, the expandable element is directly connected to the device axis. In some embodiments, the imaging transducer is configured to image tissue in a forward direction, and wherein the expandable element is configured to expand in a backward direction, and the backward direction is substantially opposite to the forward direction. In some embodiments, the expandable element is a balloon. In some embodiments, the balloon includes a plurality of chambers, each of which can be controlled separately. In some embodiments, the balloon is configured to expand by filling a filler fluid. In some embodiments, the filler fluid is gaseous. In some embodiments, the filler fluid is a high temperature filler fluid. In some embodiments, the balloon is configured to expand between the imaging transducer and the tissue imaged by the imaging transducer so that the balloon acts as an acoustic standoff to couple 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 an unwinding spring. In some embodiments, the device shaft comprises a straight shaft. In some embodiments, the tissue ablation device is configured for ablation of uterine fibroids. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Certain features of the present disclosure are described below with reference to the accompanying drawings. The illustrated embodiments are intended to illustrate rather than limit the embodiments. Various features of different disclosed embodiments may be combined to form additional embodiments as part of the present disclosure.

[0017] Figure 1A A perspective view of an imaging component is shown according to some embodiments.

[0018] Figure 1B According to some embodiments Figure 1A A side sectional view of an imaging component.

[0019] Figure 1C A side cross-sectional view of an imaging component having a shaft with a circular cross-section is shown in accordance with some embodiments.

[0020] Figure 1D A side cross-sectional view of an imaging component having edges that curve inwardly toward the interior of a cavity is shown in accordance with some embodiments.

[0021] Figure 1E According to some embodiments Figure 1A An enlarged perspective view of the distal end of the imaging component including the lumen.

[0022] Figure 2A According to some embodiments Figure 1A An enlarged perspective view of the distal end of an imaging component of FIG. 1 , wherein a tissue collector instrument is disposed within the shaft of the imaging component.

[0023] Figure 2B According to some embodiments Figure 1A A side cross-sectional view of an imaging component with a biopsy instrument disposed within a shaft of the imaging component.

[0024] Figure 2C According to some embodiments Figure 1A An enlarged perspective view of the distal end of an imaging component of FIG. 1 , wherein a radiofrequency ablation device is disposed within the shaft of the imaging component.

[0025] Figure 2D According to some embodiments Figure 1A A top view of an imaging component, wherein a drug delivery device is disposed within the shaft of the imaging component.

[0026] Figure 2E According to some embodiments Figure 1A A side cross-sectional view of an imaging component, wherein a needle is disposed within a shaft of the imaging component.

[0027] Figure 3A According to some embodiments, Figure 1A An assembly view of the imaging system of the imaging components and optical microscope apparatus.

[0028] Figure 3B According to some embodiments Figure 3A An assembled view of the imaging system showing the attachment mechanisms of the system.

[0029] Figure 4 According to some embodiments Figure 1A An enlarged perspective view of a shaft of an imaging component, wherein the shaft of the imaging component is flexible.

[0030] Figure 5A A perspective view of a system for diagnosing and / or providing therapy is shown, according to some embodiments, the system including an imaging component configured to be removably coupled to a plurality of therapeutic and / or diagnostic modalities. Figure 5A Separate imaging components and therapeutic and / or diagnostic equipment are shown.

[0031] Figure 5B According to some embodiments Figure 5AA perspective view of a system of claim 1, wherein a therapeutic and / or diagnostic device is in a ready position to be removably coupled to an imaging component.

[0032] Figure 5C According to some embodiments Figure 5A A perspective view of a system in which a therapeutic and / or diagnostic device is removably coupled to an imaging component.

[0033] Figure 6 A schematic diagram of an imaging system including a digital processing device and a user-viewable display is shown according to some embodiments.

[0034] Fig. 7A A device positioned within a uterus to image tissue thereof is shown according to some embodiments. Figure 1A Schematic diagram of the imaging component.

[0035] Figure 7B According to some embodiments, Fig. 7A An image of the surgical field captured in FIG. 1 that will be visible on a display, showing safety boundaries and treatment boundaries.

[0036] Figure 7C An image of a surgical field is shown that combines a virtual image showing safety and treatment boundaries with the physical presence of an introducer in accordance with some embodiments.

[0037] Fig.7D An image of a surgical field is shown that combines a virtual image showing safety and treatment boundaries with the physical presence of an introducer and needle electrodes in accordance with some embodiments.

[0038] Figure 8A-8C A series of schematic diagrams of a tissue ablation device according to some embodiments are shown, depicting the manner in which an expandable element may be expanded within a uterus, the device being moved to approximate a side wall of the uterus.

[0039] Fig. 9 A schematic diagram of a tissue ablation device positioned within a uterus with an expandable element in an expanded configuration is shown, the tissue ablation device being moved to access the fundus of the uterus in accordance with some embodiments.

[0040] Detailed Description of the Preferred Embodiments

[0041] The various features and advantages of the present disclosure will now be described with reference to the accompanying drawings. The following description is merely illustrative in nature and is not intended to limit the present disclosure, the application or use of the present disclosure. The scope of the present disclosure exceeds the specific disclosed implementations and / or uses and their obvious modifications and equivalents. Therefore, it is intended that the scope of the present disclosure should not be limited by any specific implementation described below. As will be apparent to those of ordinary skill in the art after considering the principles disclosed herein, the features of the illustrated embodiments may be modified, combined, removed and / or replaced. In addition, the embodiments disclosed herein may include several novel features, no single feature being solely responsible for its desired attributes or being essential to practicing the systems, devices and / or methods disclosed herein.

[0042] Certain embodiments of the present disclosure relate to imaging and / or therapeutic devices and associated methods and systems that include expandable elements for improved device activity. Embodiments of these devices, methods, and systems are described in the following examples, followed by examples of how these devices, methods, and systems can be applied to uterine fibroid ablation. However, the improvements described herein are not limited to uterine fibroid ablation and can be incorporated into any imaging and / or therapeutic device described herein.

[0043] Examples of Imaging and / or Therapeutic Devices

[0044] Embodiments of the present disclosure provide an imaging component, the imaging component including a cavity extending across (e.g., along) the length of an axis, wherein the cavity can be configured to removably receive at least one of a plurality of different instruments. In some embodiments, the cavity of the imaging component can partially lead to the outside of the axis. The imaging component can include an imaging transducer at the distal end of the axis. In addition, the axis of the imaging component can be configured so that additional treatment and / or diagnostic instruments / accessories 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 when receiving and / or removing treatment and / or diagnostic instruments. In some embodiments, the imaging component can be used without additional treatment and / or diagnostic instruments being coupled thereto. In some embodiments, the imaging component can be inserted into and / or removed from a patient's lumen in the absence of treatment and / or diagnostic instruments. Such an imaging component can be used during a medical procedure, for example, during non-invasive, minimally invasive and / or laparoscopic surgery.

[0045] For procedures that may require multiple instruments to diagnose and / or provide treatment during a single procedure, embodiments of the present disclosure can improve existing methods for imaging and treating lesions in tissue tracts. For example, an imaging component can be used for diagnosis; a biopsy attachment can then be inserted for pathological samples; an ablation attachment can then be inserted for ablating any lesions; and additional accessories or instruments can then be inserted to perform additional procedures, such as delivering drugs, implants, and / or therapeutic and / or diagnostic agents. The imaging components of the present disclosure can facilitate the insertion and removal of medical instruments by providing a shaft with a non-destructive edge and a cavity configured to receive multiple different instruments. Additionally or alternatively, the imaging component can be used independently of additional instruments or accessories. In such an embodiment, the edges of the cavity can be smooth or rounded so that the edges do not get stuck on patient tissue when used alone.

[0046] The cavity of the imaging component can improve existing imaging and treatment methods by providing a cavity of the imaging component that can be more easily cleaned than components with closed cavities or tubular lumens. The cavity of the imaging component can improve existing methods for imaging and treatment by facilitating the manufacture of imaging components. Embodiments of the present disclosure can reduce the cost of treatment by providing an imaging component with a disposable tube. Embodiments of the present disclosure can reduce the cost of treatment by providing a reusable imaging component with a cavity into which a disposable instrument can be inserted. Embodiments of the imaging component can provide an axis that always aligns the instrument with the ultrasound image. Embodiments of the present disclosure can accommodate a variety of instruments of different sizes and shapes. Embodiments of the present disclosure can provide scales or position information to assist in the insertion of the instrument.

[0047] The systems and methods disclosed herein may be particularly useful for treating fibroids in a patient's uterus. The imaging component may be deployed into the uterus transvaginally and transcervically, or in other cases, laparoscopically to the outside of and through the uterus or other organ or tissue tract. The imaging component may be used in conjunction with additional instruments (such as a biopsy needle), tissue ablation elements (such as, for example, radiofrequency ablation elements, ultrasonic ablation elements, heat-based ablation elements, cryoablation elements, etc.), and / or other instruments suitable for being disposed within the cavity of the imaging component. Additionally or alternatively, additional instruments may be used to deliver drugs, implants, or other therapeutic agents to the tissue to be treated. Additionally or alternatively, the tissue ablation element may include embodiments or variations of the needle / tip assembly in commonly assigned U.S. Patents 8,206,300, 8,262,574, and 8,992,427, the contents of which are incorporated herein by reference.

[0048] Embodiments of the present disclosure may improve at least some of the systems and methods of the commonly assigned references by providing an axis of an imaging component having a non-destructive edge to enable the imaging component to be used 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 providing an attachment mechanism in at least the in-situ positioning portion of the system. In such embodiments, the imaging component axis may be non-cylindrical symmetric (e.g., elliptical or rectangular in cross-section) so as to reference the rotation of the additional instrument relative to the imaging component axis. In some embodiments, the present disclosure may additionally or alternatively provide an axis of an imaging component having a small angle portion to minimize the risk of damage to the surface of the imaging transducer surface by the instrument. Additionally or alternatively, the imaging component may include a disposable tube inserted into the cavity to provide a working channel for inserting additional instruments with different diameters and making the system easier to clean, among many possible purposes.

[0049] The imaging components described herein can be used in surgical procedures to provide real-time images of target structures to be treated, including projected safety margins and treatment margins as described in commonly assigned U.S. Patents 8,088,072 and 8,262,577, the contents of which are incorporated by reference. The imaging components described herein can be used to image and treat uterine fibroids, as described in commonly assigned U.S. Patent 7,918,795, which is incorporated herein by reference. Other commonly assigned patents and published applications that describe probes that can be used with the imaging components described herein and can be used to treat uterine fibroids include U.S. Patents 7,815,571, 7,874,986, 8,506,485, 9,357,977, and 9,517,047, which are incorporated herein by reference. Additional commonly assigned patent applications describing systems for establishing and adjusting displayed safe zone boundaries and treatment zone boundaries that can be used in conjunction with the imaging components described herein include: U.S. Patent Publication 2014 / 0073910 (now U.S. Patent 9,861,336); U.S. Patent Publication 2019 / 0350648; U.S. Patent 8,992,427; U.S. Patent Publication 2018 / 0132927 (now U.S. Patent 11,219,483); and PCT Publication WO2018 / 089523, each of which is incorporated herein by reference. Commonly assigned PCT Publication WO2018 / 089523 further describes a mapping and planning system that can be used in conjunction with the imaging components described herein, which is also incorporated herein by reference.

[0050] In some embodiments, the systems and methods of the present disclosure may provide imaging components to be used in various diagnostic and therapeutic procedures. Some embodiments may provide methods and systems for treating or diagnosing a volume of tissue. A volume of tissue may include a patient's organ. A patient's organ or body cavity may include, for example: muscles, tendons, mouth, tongue, pharynx, esophagus, stomach, intestines, anus, liver, gallbladder, pancreas, nose, larynx, trachea, lungs, kidneys, bladder, urethra, uterus, vagina, ovaries, testicles, prostate, heart, arteries, veins, spleen, glands, brain, spinal cord, nerves, etc. 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.

[0051] Certain embodiments of the present disclosure are configured to create a mechanism for guiding a straight portion of an imaging and / or treatment device as described herein (such as the treatment device of the Sonata system available from Gynesonics, Inc. of Redwood City, California) to a target fibroid, while serving as a movable mechanism for the ultrasonic tip to replace or substitute for the lever and push rod elements of the device. The articulated mechanism that controls the pitch angle of the ultrasonic transducer tip can be manually actuated to one of the fixed positions and locked in place. Once this step is completed, the user can orient the device to guide the straight axis directly through the widest part of the target fibroid in order to place the introducer into the mass.

[0052] 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 optionally be practiced without these specific details. In other cases, well-known methods, processes, components, and circuits are not described in detail in order to avoid unnecessarily obscuring aspects of the embodiments.

[0053] It should be understood that although the terms "first," "second," etc. are optionally used herein to describe various elements, these elements should not be limited by these terms. These terms are merely used to distinguish one element from another. For example, a first instrument may be referred to as an instrument sensor, and similarly, a second instrument may be referred to as a first instrument without changing the meaning of the description, as long as all occurrences of "first instrument" are consistently renamed and all occurrences of the second instrument are consistently renamed. The first instrument and the second instrument are both instruments, but they are not the same instrument.

[0054] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit the claims. As used in the description of the embodiments and the appended claims, unless the context clearly indicates otherwise, the singular forms "one", "an" and "the" are intended to also include plural forms. It should also be understood that, as used herein, the term "and / or" refers to and encompasses any and all possible combinations of one or more listed related items. It should be further understood that when used in this specification, the terms "include" and / or "comprising" specify the presence of stated features, wholes, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, wholes, steps, operations, elements, parts and / or combinations thereof.

[0055] As used herein, the term "if" is optionally interpreted to mean "when" or "upon" or "in response to determining" or "in accordance with a determination" or "in response to detecting" the stated condition is true, depending on the context. Similarly, the phrase "if it is determined [that a stated condition precedent is true]" or "if [a stated condition precedent is true]" or "when [a stated condition precedent is true]" is optionally interpreted to mean "upon determination" or "upon determination" or "in accordance with a determination" or "upon detection" or "in response to detecting" the stated condition is true, depending on the context.

[0056] For ease of explanation, the following figures and corresponding description may be described below with reference to uterine imaging, particularly in conjunction with the diagnosis and ablation and / or treatment of uterine fibroids. However, one skilled in the art will recognize that similar imaging components may be used with similar instruments in other therapeutic applications, such as instruments for tissue biopsy, for drug delivery, for fluid infusion and / or aspiration, and for treating cancer, tumors, fibroids, and other malignant or benign masses in any suitable body cavity.

[0057] Figure 1AAn illustration of an imaging component 100 according to some embodiments is shown. The imaging component 100 may include a handle portion 101 connected to an imaging shaft 103. At the distal end of the imaging shaft 103, an imaging transducer 107 may be coupled. The imaging shaft 103 may include a proximal end and a distal end, wherein a cavity 105 extends across 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, a 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 be at least partially connected to the exterior of the shaft 103 along the length of the shaft 103. In some embodiments, the edges of the elongated opening may be curved toward the interior of the cavity 105 of the shaft 103 (e.g., see further description below). Figure 1D ). The length of shaft 103 can be long enough to fully access the patient's uterus while handle portion 101 remains outside the patient. Additionally or alternatively, shaft 103 can include a length that is significantly longer than a distance sufficient to fully access the patient's uterus. The side opening can be open along the entire length of shaft 103, or it can be only partially open along the length of shaft 103. The side opening can, for example, be open to more than three quarters of the length of shaft 103, more than half of the length of shaft 103, or more than one quarter of the length of shaft 103. Cavity 105 can be configured to receive at least one of a plurality of different additional instruments or accessories, such that a first instrument can be received by cavity 105, a first instrument can be removed from cavity 105, and a second instrument can be received by cavity 105.

[0058] The handle portion 101 can be part of a two-part handle so that when receiving the first instrument or the second instrument, 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 so that the first and second parts of the handle can be reproducibly aligned relative to each other after replacing the instrument. The alignment element 111 can be configured so that the first and second parts can be sufficiently fixed relative to each other to use 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-part handle. The handle portion can additionally include a positioning element 113, such as a slot for accommodating a complementary protrusion or other element on the opposing handle portion, so as to provide a more secure positioning between the parts of the two-part handle. The positioning element 113 can include a mechanical feature to fix the instrument relative to the imaging component 100 by limiting the translation of the instrument on the axis of the shaft 103 of the imaging component.

[0059] In other embodiments, the imaging component 100 can be configured for use with an instrument that does not have a handle portion. In such embodiments, the handle portion 101 of the imaging component 100 is sufficient alone to guide the imaging component during surgery. In some embodiments, the imaging component 100 can have a scale or guide on the inner surface of the handle portion 109 to measure 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, in embodiments where the instrument has a handle, the scale can facilitate the insertion of components of the instrument.

[0060] Figure 1B A cross-sectional view of an imaging component 100 according to some embodiments is shown. The body of the shaft 103 may include an internal structure to carry electronic devices or other associated components to control the imaging transducer 107. The shaft 103 may also include a wire system or other flexure mechanism to allow the shaft 103 to controllably bend, flex, or deflect the distal end of the shaft 103. The shaft 103 may include a channel or conduit for guiding a fluid (e.g., water, saline, etc.) to the distal end of the shaft 103 and onto the surface of the tissue. The cross-section of the imaging shaft 103 may be circular, or take a shape with sufficiently softened, chamfered, rounded, or beveled edges so that the edges can be non-destructive to the patient opening during insertion or removal of the imaging component 100 with or without an instrument. The shaft 103 may additionally include a smooth outer surface. The shaft 103 may be made of a material with a deformable surface so that the shaft 103 can bend or adapt to the shape of a body cavity.

[0061] 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 the wall so that the lumen 105 can communicate with the outside of the shaft 103. The opening can be sufficiently closed to provide structural support so that when the imaging component 100 can be inserted into the patient's body cavity, the opening of the lumen can not be significantly disturbed by the insertion or removal of the instrument. Optionally, the outer surface of the shaft 103 can include only a non-damaging edge. The lumen 105 of the imaging shaft 103 can be sufficiently open so that when instruments of different sizes can be received or inserted into the cavity, the cavity can allow some deformation of the cavity opening. The lumen 105 can facilitate cleaning of the imaging component.

[0062] Figure 1C A cross-sectional view of an imaging component having a shaft 103 with a circular cross-section is shown in accordance with some embodiments. Figure 1C The cross-section of the imaging component can be sufficiently circular so that the imaging component can be rotated without interfering with the patient's lumen. Figure 1DA cross-sectional view of an imaging component according to some embodiments is shown having an inwardly curved edge toward the interior of lumen 105. The inwardly curved edge 1111 of the lumen can be used to support the opening of a body lumen so that shaft 103 can be atraumatically inserted into or removed from the body lumen with or without instrumentation.

[0063] Although the lumen 105 of the shaft 103 in the illustrated example can define a circular cross-sectional geometry, in other embodiments, the lumen can be elliptical or any other geometry with sufficiently softened, rounded or beveled edges and corners so that insertion or removal of the shaft may not damage the patient's body cavity. In some embodiments, the lumen 105 can be non-cylindrical symmetric. In some embodiments, the lumen 105 can be asymmetric to provide an axis for the instrument to be aligned therein. The lumen 105 can be open in cross section to less than three-quarters of its circumference, and additionally or alternatively, the lumen can be open to less than half of its circumference, less than one-quarter of its circumference, and less than one-eighth of its circumference. In other embodiments, the lumen 105 of the shaft 103 of the imaging component can be closed to the outside of the shaft, and the instrument can be slidably inserted completely into the interior of the shaft of the imaging component.

[0064] In some embodiments, the cavity 105 can include a substantially uniform cross-sectional area along the shaft 103. In other embodiments, a portion of the length of the shaft 103 can have a different cross-sectional area than another portion of the length of the shaft. In one example, the proximal portion of the shaft 103 can be asymmetric to provide an axis for instrument alignment, and the distal portion of the shaft can have a circular cross-sectional area. In another embodiment, the cavity 105 tapers toward the end of the shaft 103. In such an example, this taper can facilitate feeding the instrument into the cavity 105. In some embodiments, the cross-sectional area of ​​the cavity 105 can be narrowed in diameter to allow the distal end of the shaft 103 to have greater flexibility.

[0065] In some embodiments, the imaging axis 103 may further include a tube 115 positioned at the lumen 105 of the imaging axis 103. The tube 115 may include a lumen. The lumen of the tube 115 may be configured to slidably receive one or more of a plurality of instruments. The tube 115 may be aligned parallel to the axis 103 of the imaging component so that an additional instrument / accessory may be slidably received by the tube. Subsequently, after the tube 115 has been aligned parallel to the axis 103 of the imaging component, the tube 115 may slidably receive an additional instrument / accessory. In some embodiments, the tube 115 may be disposable. In some embodiments, the tube 115 may be reusable, for example by being separated from the imaging axis 103, cleaned, and autoclaved. The tube 115 may have an outer surface, wherein the surface is substantially in contact with the inner wall of the lumen 105. The tube 115 may have an inner surface having a different geometry from the outer surface, which is configured to receive one or more of a plurality of instruments. In some embodiments, a second tube (not shown) can be removably inserted into the first tube 115, and the second tube can have a different lumen geometry than the first tube to facilitate insertion of one or more of the plurality of instruments. In some embodiments, the tube 115 can rotate relative to the imaging component. In some embodiments, the tube 115 can be fully rotated relative to the imaging component in either direction within the axis 103 of the imaging component under the control of the user. In some embodiments, the tube 115 can be internally or externally lubricated to facilitate insertion or removal of the instrument.

[0066] Tube 115 can be inserted into the body cavity in situ while the imaging component is still advancing therein. Additionally or alternatively, tube 115 can be inserted into the shaft 103 of the imaging component before the imaging component is inserted into the body cavity. Tube 115 can have enough structural integrity to support the body cavity during the insertion of the imaging component without an instrument. When additional instruments are inserted into tube 115 or tube 115 is inserted into the imaging component in situ, damage to the body cavity can be minimized. Tube 115 can be made of sterilizable materials. Tube 115 can be made of materials with low enough cost so that it can be discarded after a single use. Exemplary materials for disposable tubes can include polyimide, PTFE, polyurethane and thermoplastics such as Pebax or nylon, etc. Tube 115 can be made of materials including enough elasticity to adapt to instruments with a size slightly larger or smaller than the periphery of the tube. In embodiments where cavity 105 is not circular, tube 115 can take the shape of the cavity or it can take another shape.

[0067] The tube 115 can reduce treatment costs by facilitating the insertion and / or removal of additional instruments into and / or from the lumen 105 of the imaging component 100, thereby preventing damage to the surface of the lumen 105 of the imaging component 100. The tube 115 can reduce costs by facilitating cleaning of the lumen 105 of the imaging component 100. The tube 115 can reduce treatment costs by providing an inexpensive component that can act as an adapter for a variety of different therapeutic and / or diagnostic instruments / accessories, such as being provided in a variety of different internal geometries suitable for different instruments / accessories, but having a uniform external geometry that is removably coupled to the same single imaging component 100. For example, a disposable tube having a smaller inner diameter can facilitate the insertion and control of a needle having an outer diameter that is smaller than the inner diameter of the shaft 103 of the imaging component.

[0068] Figure 1E An enlarged view of the distal end of the imaging component 100 including the cavity 105 according to some embodiments is shown. The distal end of the imaging component 100 may include an imaging transducer 107. The imaging transducer 107 may include an ultrasonic transducer and / or multiple ultrasonic transducers. The ultrasonic transducer may operate at a frequency of 500kHz, 1MHz, 5MHz, 10MHz, 20MHz, 100MHz, or a range defined by any two of the foregoing values. Some embodiments of the ultrasonic transducer may include specifications of other transducers from commonly assigned references incorporated herein.

[0069] In some embodiments, the distal end 117 of the imaging transducer 107 may additionally include a light emitting diode and / or a camera to provide an image to a user. In such embodiments, the imaging component 100 may be used as an optical scope as well as an ultrasound imaging platform. The distal end 117 of the imaging transducer 107 may include optical components such as optical fibers, relay lenses, objective lenses, etc.

[0070] The imaging transducer 107 can be configured to be deflectable. The imaging transducer 107 can be configured to deflect relative to the longitudinal axis of the shaft 103 of the imaging component 100. In some embodiments, the distal end of the imaging component 100 includes a hinge to facilitate the deflection of the imaging transducer 107. The deflection of the imaging transducer 107 can be controlled by a deflection rod 119 on the handle portion 101 of the imaging component 100. One or more imaging transducers 107 can be oriented by the deflection of the imaging transducer. One or more imaging transducers 107 can be oriented by the deflection of the imaging transducer so as to maintain the field of view of the image during treatment. Additionally or alternatively, the imaging transducer 107 (e.g., an ultrasound transducer) can be radially and / or axially aligned to image multiple views simultaneously. The deflection of the imaging transducer 107 can be caused to avoid obstruction of the instrument. Additionally or alternatively, the deflection of the imaging transducer 107 can be used to deflect the flexible instrument in the cavity 105. The distal end of the shaft 103 may include an interlock system, similar to the interlock systems in the incorporated references, to prevent the imaging transducer 107 from obstructing the instrument or being damaged by the sharp edges of the instrument. The actuation of the deflection rod 119 may function in a manner similar to that described in U.S. Pat. No. 8,992,427, which is incorporated herein by reference. The deflection rod 119 may deflect the imaging transducer 107 by less than 45 degrees, and additionally or alternatively, for example, 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.

[0071] The distal end of the imaging component 100 may include a non-destructive edge to facilitate insertion of the imaging component with or without an instrument in the cavity 105. The distal end of the cavity 105 of the imaging component 100 may additionally or alternatively include a portion that is angled relative to the axis of the shaft 103 so that the distal end of the instrument can be deflected upward when it is pushed out of the distal end of the cavity 105. The distal end of the cavity 105 of the imaging component 100 may include an angled portion having an angle of 3 degrees to 45 degrees. The distal end of the cavity 105 of the imaging component 100 may include an angled portion having an angle 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.

[0072] The cavity 105 of the imaging component 100 can be configured to slidably receive one or more of a plurality of instruments. In some embodiments, the imaging component 100 can be configured to receive one or more therapeutic or diagnostic instruments. In some embodiments, at least one of the plurality of different instruments can be a therapeutic or diagnostic instrument. In some embodiments, the instruments can include instruments such as biopsy needles; optics; implant devices; treatment electrodes; tissue ablation elements, such as, for example, radiofrequency ablation elements, ultrasonic ablation elements, heat-based ablation elements, cryoablation elements, etc.; and / or other instruments suitable for being disposed within the cavity of the imaging component. Additionally or alternatively, the instruments can be used to deliver drugs or other therapeutic agents to the tissue to be treated. Figure 2A-2E An instrument that may be slidably received by the imaging component is shown.One of ordinary skill in the art will recognize that many instruments, including those disclosed in the following figures, may be used with the imaging components disclosed herein.

[0073] Figure 2A An enlarged view of the distal end of the imaging component 100 according to some embodiments is shown, wherein the tissue collector instrument 210 is disposed within the shaft 103 of the imaging component 100. The tissue collector instrument 210 can be used to extract tissue and / or cytopathology samples for examination by a medical professional to determine the extent of the disease. In some embodiments, the tissue collector instrument 210 may include a biopsy needle. The tissue collector instrument 210 may include 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 may be configured to be separated from the handle component of the instrument, or may be configured to be used without the handle component, so that the tissue collector instrument 210 may be disposable.

[0074] The shaft 211 of the tissue collector instrument 210 can be made of a pliable and / or flexible material so that it can be deflected by the imaging transducer 107 and / or the angled portion within the lumen 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 the angled portion within the lumen 105 of the shaft 103. In addition to other possible purposes, the distal end of the shaft 211 of the tissue collector instrument 210 can be deflected upward to avoid damaging the imaging transducer 107. The distal end of the lumen 105 of the imaging component 100 can include an angled portion relative to the axial direction of the shaft 103 so that the distal end of the instrument (e.g., the tissue collector instrument 210) can be deflected upward when it is pushed out of the distal end of the lumen 105. The distal end of the lumen 105 of the imaging component 100 can include an angled portion, the angle of which is 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.

[0075] Additionally or alternatively, the shaft 103 of the imaging component 100 may include a wire system or other device to deflect the distal end of the instrument (e.g., tissue collector instrument 210) so that the distal end of the instrument (e.g., tissue collector instrument 210) does not damage the imaging transducer 107. The distal end of the tissue collector instrument 210 may include a slot or opening 213 into which tissue can be collected. In some embodiments, the tissue collector instrument 210 can rotate relative to the shaft 103. In some embodiments, the tissue collector instrument 210 can be fully rotated in either direction within the shaft 103 of the imaging component 100 relative to the shaft 103 under the control of the user while the shaft 103 remains stationary so that the slot or opening 213 can scrape, scoop, or otherwise collect tissue.

[0076] The shaft 211 of the tissue collector instrument 210 can be longer than the shaft 103 of the imaging transducer 107 so 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 can be two inches longer than the shaft of the imaging transducer 107. Additionally or alternatively, for example, the shaft 211 of the tissue collector instrument 210 can be 6 inches longer, 4 inches longer, 2 inches longer, can be the same length, or can be within the range of any two of the foregoing values.

[0077] Figure 2B A cross-sectional view of an imaging component 100 is shown according to some embodiments, wherein a tissue collector instrument 210 is disposed within the shaft 103 of the imaging component 100. The tissue collector instrument 210 can be disposed within a tube 115 disposed within the lumen 105 of the imaging component 100. Additionally or alternatively, the tissue collector instrument 210 can be disposed within the lumen 105 of the imaging component 100 without using a tube. Although the shaft 211 of the tissue collector instrument 210 can define a circular geometry in the illustrated example, in other embodiments, the shaft 211 of the tissue collector instrument 210 can be any other geometry such as an ellipse, so that the shaft 211 can be inserted into or removed from the lumen 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 aligning the tissue collector instrument 210 within the lumen 105 of the imaging component 100. In some embodiments, the lumen 105 includes a substantially uniform cross-sectional area along the length of the shaft 103 of the imaging component 100. In other embodiments, the cross-sectional area of ​​the lumen 105 varies along the length of the shaft 103 of the imaging component 100, such as, for example, the proximal end of the shaft 103 may be asymmetric to provide an axis for alignment, while the distal end of the shaft 103 may be rounded.

[0078] Figure 2CAn enlarged view of the distal end of the imaging component 100 is shown according to some embodiments, wherein an ablation device 230 is disposed within the shaft 103 of the imaging component 100. The ablation device 230 can include a needle assembly including an introducer 235 and optionally a needle electrode or tip 233. The shaft 231 of the ablation device 230 can be deployed from the shaft 103 of the imaging component 100. Additionally or alternatively, the introducer 235 can be deployed from the lumen of the tube 115. The ablation device 230 can include, for example, one or more of a radio frequency (RF) ablation element, an ultrasonic ablation element, a heat-based ablation element, a cryoablation element, and any other type of ablation element known to those of ordinary skill in the art.

[0079] The ablation device 230 can be disposed within the tube 115, which is disposed within the lumen 105 of the imaging component 100. Additionally or alternatively, the ablation device 230 can be disposed within the lumen 105 of the imaging component 100 without the use of a tube. While the shaft 231 of the ablation device 230 can define a circular cross-sectional geometry in the illustrated example, in other embodiments, the shaft 231 of the ablation device 230 can be elliptical or any other geometry such that the shaft 231 can be inserted into or removed from the lumen 105 of the imaging component 100. In some embodiments, the shaft 231 of the ablation device 230 can be asymmetric to provide an axis for alignment of the device within the lumen 105 of the imaging component 100.

[0080] The shaft 231 of the ablation device 230 can be made of a pliable and / or flexible material so that it can be deflected by the imaging transducer 107 and / or the angled portion within the lumen 105 of the shaft 103 of the imaging component 100. Additionally or alternatively, the shaft 231 of the ablation device 230 can include a wire system or other means to deflect the distal end of the ablation device 230 so that the distal end of the ablation device 230 does not damage the imaging transducer 107. In some embodiments, the ablation device 230 can be rotated relative to the imaging component 100. In some embodiments, the ablation device 230 can be fully rotated in either direction within the shaft 103 of the imaging component 100 under the control of the user while the shaft 103 remains stationary so that the tip 233 can be optimally aligned.

[0081] The needle assembly can be configured and controlled by the user, for example, as previously described in co-owned U.S. Patents 8,206,300, 8,262,574, and 8,992,427, the entire disclosures of which are incorporated herein by reference. The needle assembly can be integrated into the instrument handle so that the position and deployment of the introducer 235 and the tip 233 can be controlled by the user. The handle can be configured, for example, as previously described in co-owned U.S. Patent 8,992,427, the entire disclosure of which is incorporated herein by reference. The needle assembly can be compatible with systems and methods for improving safety margins and treatment margins during the treatment of uterine fibroids, such as described in the incorporated references.

[0082] Figure 2D A view of the imaging component 100 according to some embodiments is shown, wherein the drug delivery device 240 is disposed within the shaft 103 of the imaging component 100. The drug delivery device 240 can be used as a platform for injecting therapeutic agents into patient tissue. Exemplary therapeutic agents may include analgesics, anesthetics, hemostatics, antibiotics, steroids, anticoagulants, anti-inflammatory agents, etc. Additionally or alternatively, the drug delivery device 240 can be configured to deliver one or more drug eluting, drug releasing or other therapeutic and / or diagnostic seeds, pellets or other implants to the target tissue. The drug delivery device 240 may 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 may include a distal end and a proximal end. The shaft 241 of the drug delivery device 240 may be longer than the shaft of the imaging transducer 107 so that the needle 243 can inject the agent deep into the uterus. In some embodiments, the shaft 241 of the drug delivery device 240 may be two 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 longer, 4 inches longer, 2 inches longer, can be the same length, or can be within a range of any two of the foregoing values.

[0083] The shaft 241 of the drug delivery device 240 can be made of a pliable and / or flexible material so that it can be deflected by the imaging transducer 107 and / or the angled portion within the lumen 105 of the shaft 103 of the imaging component 100. Additionally or alternatively, the shaft 241 of the drug delivery device 240 can include a wire system or other device to deflect the distal end of the drug delivery device 240 so 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 drug delivery device 240 can be fully rotated relative to the imaging component 100 in either direction within the shaft 103 of the imaging component 100 under the control of the user while the shaft 103 of the imaging component 100 remains stationary.

[0084] The shaft 241 of the drug delivery device 240 may be detachable from the handle portion of the device, or may be configured without a handle portion so that the drug delivery device 240 may 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., Figure 1A ) can be used to guide the drug delivery device 240 during surgery. Figure 2D As shown, the imaging component 100 may have graduations, guides, or other markings 245 on the inner surface of the handle portion 109 to measure the insertion depth of the needle 243 of the drug delivery device 240 .

[0085] Figure 2E A cross-sectional view of an imaging component 100 is shown in accordance with some embodiments, wherein a needle 243 is disposed within the shaft 103 of the imaging component 100. A shaft 241 of a drug delivery device 240 including a needle 243 may be disposed within a tube 115 disposed within a lumen 105 of the imaging component 100. Additionally or alternatively, the shaft 241 of the drug delivery device 240 may be disposed within the lumen 105 of the imaging component 100 without the use of a tube. While the shaft 241 of the drug delivery device 240 may define a circular geometry in the illustrated example, in other embodiments, the shaft 241 of the drug delivery device 240 may be an elliptical or any other geometry such that the shaft 241 of the drug delivery device 240 may be inserted into or removed from the lumen 105 of the imaging component 100. In some embodiments, the shaft 241 of the drug delivery device 240 may be asymmetric to provide an axis for aligning the device within the lumen 105 of the imaging component 100. In some embodiments, the drug delivery device 240 may be rotatable relative to the imaging component 100. In other embodiments, the drug delivery device 240 can be fully rotated in either direction relative to the imaging component 100 under user control within the tube 155 of the imaging component 100 shaft 103 while the imaging component shaft 103 remains stationary.

[0086] FIG. 2A to FIG. 2EExemplary instruments that can be set in the shaft 103 of the imaging component 100 are shown, and these examples are not intended to be limiting. Other examples may include fluid infusion and / or suction instruments. The fluid infusion and / or suction instrument may include an instrument having an axis, the axis including a lumen therein, the lumen being configured to conduct fluid to the patient's tissue. The fluid infusion and / or suction instrument may deliver fluid to cool the tissue. Additionally or alternatively, the fluid infusion and / or suction instrument may deliver fluid to clean the tissue. Additionally or alternatively, the fluid infusion and / or suction instrument may deliver fluid to expand the body cavity. The fluid infusion and / or suction instrument may deliver solutions and / or suspensions containing therapeutic agents (e.g., antiseptics, anesthetics, analgesics, antibiotics, steroids, etc.). The fluid infusion and / or suction element may be integrated into any instrument described herein. Alternatively, the fluid infusion and / or suction element may include an instrument that is inserted and retracted as a step during a multi-instrument procedure.

[0087] Figure 3A 1 shows an assembly view of an imaging system including an imaging component 100 and an optical mirror device 300 according to some embodiments. Although an optical mirror element may be shown in the illustrated embodiment, the optical mirror device 300 may be any other suitable device, for example, any device disclosed herein. Figure 3A As shown, the imaging system can slidably receive a disposable tube 115 within the lumen 105 of the imaging component 100. In some embodiments, the imaging system can include a disposable tube 115 slidably received within the lumen 105 of the imaging component 100. In such embodiments, an instrument can be removably received with the lumen of the disposable tube 115. Additionally or alternatively, the lumen 105 of the imaging component 100 can be configured to slidably receive one or more of a plurality of instruments, which can include various therapeutic and / or diagnostic instruments.

[0088] 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 treatment electrode; a tissue ablation element, such as, for example, a radiofrequency ablation element, an ultrasonic ablation element, a thermal-based ablation element, a cryoablation element, etc.; and / or other instruments suitable for being disposed within the lumen 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 Figure 2A-2E Any of the equipment shown in .

[0089] In the illustrated embodiment, the distal end 305 of the optical mirror instrument 300 may include a light emitting diode and / or a camera to provide an image to the user. In such an embodiment, the optical mirror instrument 300 may be used as an endoscope. The distal end 305 of the optical mirror instrument 300 may include optical components, such as optical fibers, relay lenses, objective lenses, etc. The optical mirror instrument 300 may include a shaft 303 of the optical mirror instrument 300 having a distal end and a proximal end. The shaft 303 of the optical mirror instrument 300 may be configured to be separated from the handle component of the instrument, or may be configured to be used without the handle component, so that the optical mirror instrument 300 may be disposable.

[0090] The shaft 303 of the opticoscope instrument 300 can be made of a pliable and / or flexible material so that it can be deflected by the imaging transducer 107 and / or the angled portion within the lumen 105 of the shaft 103 of the imaging component 100. Additionally or alternatively, the shaft 303 of the opticoscope instrument 300 can include (e.g., push, pull and / or rotate / torque) a wire system or other means for deflecting the distal end 305 of the opticoscope instrument 300. Deflection of the distal end 305 of the opticoscope instrument 300 can be used to prevent damage to the imaging transducer 107 and / or allow multiple image angles to be collected. In some embodiments, the opticoscope instrument 300 can be rotated relative to the imaging component 100. In some embodiments, the opticoscope instrument 300 can be fully rotated relative to the imaging component 100 in either direction within the shaft 103 of the imaging component 100 under the control of the user while the shaft 103 of the imaging component remains stationary so that multiple image angles can be collected.

[0091] The shaft 303 of the opticoscope instrument 300 can be longer than the shaft of the imaging transducer 107 so that images can be collected from deep within the uterus. In some embodiments, the shaft 303 of the opticoscope instrument 300 can be two inches longer than the shaft of the imaging transducer 107. Additionally or alternatively, for example, the shaft 303 can be 6 inches longer, can be 4 inches longer, can be 2 inches longer, can be the same length, or can be within the range of any two of the foregoing values.

[0092] In the illustrated embodiment, the optical mirror apparatus 300 includes a handle portion 301. Although the handle portion 301 can be shown as being connected to the optical mirror in the illustrated example, a similar handle portion can be connected to any suitable apparatus, such as those disclosed herein. The handle portion 301 can be the second portion of a two-part handle, so that when the optical mirror apparatus 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 can additionally include a positioning element 313 to provide a more secure positioning between the parts of the two-part handle. The positioning element 313 can cooperate with the positioning element 113. In such an embodiment, the handle portion can include a release control 321, which can be actuated by a user to retract the positioning element 313 into the handle and allow the two-part handle to separate.

[0093] The handle portion 301 may additionally include one or more control elements 319. The control element 319 may allow a medical professional to control the distal end of the instrument. In one example, the control element 319 controls a wire system that can reproducibly deflect or manipulate the distal end of the instrument. Additionally or alternatively, the control element 319 rotates the axis of the instrument (e.g., the axis 303 of the optical scope instrument 300) within the cavity 105 of the imaging component 100 or within the disposable tube 115. In another example, the control element scoops tissue into a tissue collector instrument. In another example, the control element 319 deploys a needle assembly including an optional tip in an ablation instrument. Additionally or alternatively, the control element 319 starts an ablation process. In another example, the control element 319 applies pressure to inject chemicals through a drug delivery device. In another example, the control element 319 starts or ends image collection in an optical scope instrument.

[0094] Figure 3BAn assembled view of an imaging system according to some embodiments is shown, which shows the attachment mechanism of the system. The interior 309 of the handle portion 301 may include an alignment element 311. The alignment element 311 may be configured so that the optical mirror instrument 300 can be reproducibly aligned relative to the imaging component 100 after replacing the instrument. Additionally or alternatively, the alignment element 311 can sufficiently fix the instrument and the imaging component 100 relative to each other to use the two handle portions 101, 301 as a single handle. In some embodiments, the alignment element 311 may include a magnet. In other embodiments, the alignment element 311 may include, for example: a latch, a hook, or any other mechanism suitable for removably combining the two-part handle. The interior 309 of the handle portion 301 may additionally include a positioning element 313 to provide a more secure positioning between the parts of the two-part handle. In such an embodiment, the handle portion may include a release control 321, which can be actuated by a user to retract the positioning element 313 into the handle and allow the two-part handle to separate.

[0095] In some embodiments, a method is provided for detecting or sensing the identification of a removable instrument when coupling an imaging component 100 and a removable instrument (e.g., an optical mirror instrument 300). The imaging component 100 may include software to identify the removable instrument and manage the interconnection between the imaging component 100 and the removable instrument. As non-limiting examples, the sensor or mechanism may be an optical, RF, magnetic, biometric, electronic, and mechanical ID and reader. The method will ensure that only qualified removable devices are received on the imaging device to ensure that only compatible devices can be used with the imaging component 100.

[0096] Figure 4 The shaft 103 of the imaging component 100 is shown according to some embodiments, wherein the shaft 103 of the imaging component 100 can be flexible. 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 to carry electronic devices or other associated components to control the imaging transducer 107. The imaging transducer 107 can include a channel or conduit for guiding 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 include a portion of the length of the shaft 103 of the imaging component 100. In some embodiments, the flexible shaft portion 403 includes less than three quarters of the length of the shaft 103. Additionally or alternatively, the flexible shaft portion 403 can include less than one quarter of the length of the shaft 103, less than one eighth of the length of the shaft 103, and the full length of the shaft 103.

[0097] The cross-sectional geometry of the flexible shaft portion 403 can continue the geometry of the shaft 103 so that no gap or traumatic edge is created between the flexible shaft portion 403 and the shaft 103. The cross-sectional geometry of the flexible shaft portion 403 can be circular, or take a shape with sufficiently softened, chamfered, rounded, or beveled edges so that the edges can be atraumatic to the patient opening during insertion or removal of the imaging component 100 with or without instruments. The flexible shaft portion 403 can additionally include a smooth outer surface. The flexible shaft portion 403 can be made of a material such that the surface can be deformed to allow the flexible shaft portion 403 to bend or conform to the shape of a body cavity.

[0098] The lumen of the flexible shaft portion 403 can be configured to slidably receive one or more of a plurality of instruments. The lumen of the flexible shaft portion 403 can be configured to continue the shape of the lumen 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 lumen of the flexible shaft portion 403 can be partially open along the wall such that the lumen of the lumen of the flexible shaft portion 403 can be in communication 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 a patient's body cavity, the opening of the lumen can not be significantly interfered with by the insertion or removal of an instrument. In some embodiments, the edge of the lumen of the flexible shaft portion 403 can bend inwardly toward the interior of the lumen, such as in Figure 1D In the embodiment shown. The inwardly curved edge of the cavity of the flexible shaft portion 403 can be used to support the opening of the body cavity so that the shaft 103 can be inserted into or removed from the body cavity without trauma with or without instruments. The cavity of the flexible shaft portion 403 can be sufficiently open so that some deformation of the cavity opening may occur when instruments of different sizes can be received or inserted into the cavity. The cavity can facilitate cleaning of the imaging component 100 by providing a path from the outside of the cavity to the inside of the cavity.

[0099] Although the cavity of the flexible shaft portion 403 defines a circular cross-sectional geometry in the illustrated example, in other embodiments, the cavity of the flexible shaft portion 403 can be an elliptical or any other geometry with sufficiently softened, rounded or beveled edges and corners so that the insertion or removal of the shaft of the flexible shaft portion 403 does not damage the patient's body cavity. In some embodiments, the cavity of the flexible shaft portion 403 can be asymmetric to provide an axis for the instrument to be aligned therein. The cavity of the flexible shaft portion 403 can be open to less than three-quarters of its circumference in cross section, and additionally or alternatively, the cavity can be open to less than half of its circumference, less than one-quarter of its circumference, and less than one-eighth of its circumference. In other embodiments, the cavity of the flexible shaft portion 403 can be closed to the outside of the shaft of the flexible portion, and the instrument can be slidably inserted completely into the interior of the shaft of the flexible portion.

[0100] In some embodiments, the flexible shaft portion 403 can be made of a pliable and / or flexible material so that it can bend within a patient's body cavity. In some embodiments, the shaft can be controllably flexed along its longitudinal axis via a flexure mechanism. Additionally or alternatively, the flexible shaft portion 403 can include a wire system or other flexure mechanism to allow the flexible shaft portion 403 to controllably bend, flex, or deflect the distal end of the flexible portion. The flexure mechanism can be provided by a handle portion (e.g., Figure 3A The control element on the handle part 101) shown in FIG.

[0101] In the example shown, the flexible shaft portion can be flexed axially to an angle of about 90 degrees relative to the handle. Additionally or alternatively, the flexible shaft portion can be flexed axially to, for example, less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, less than 1 degree. Additionally or alternatively, the flexible shaft portion can be flexed on the front-to-back axis relative to the handle of the imaging component 100. In some embodiments, the flexible shaft portion can be flexed on the front-to-back axis to, for example, less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, less than 1 degree. Additionally or alternatively, the flexible shaft portion can be flexed on the medial-lateral axis relative to the handle of the imaging component 100. In some embodiments, the flexible shaft portion can be flexed on the medial-lateral axis to, for example, less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, less than 1 degree.

[0102] Figure 5A A system for diagnosing and / or providing treatment according to some embodiments is shown, which can be removably connected to multiple treatment and / or diagnostic instruments. The system for performing treatment and / or diagnosis can include a treatment or diagnostic instrument 510 and an imaging component 520. The instrument 510 of the system for performing treatment and / or diagnosis can include a treatment or diagnostic instrument, such as, for example, any treatment or diagnostic instrument described herein. In some embodiments, the imaging component 520 can be used in combination with instruments such as a biopsy needle; a tissue collector, an optical scope; an implant device; a treatment electrode; a tissue ablation element, such as, for example, a radiofrequency ablation element, an ultrasonic ablation element, a heat-based ablation element, a cryoablation element, etc.; 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 the tissue to be treated. Figure 2A-2E Exemplary instruments that may be slidably received by the imaging component are shown. In some embodiments, the system may include first and second therapeutic or diagnostic instruments. The imaging component 520 may include an imaging component, such as, for example, the examples, embodiments, and variations of the imaging components described herein.

[0103] Figure 5BA system for diagnosing and / or providing therapy is shown in accordance with some embodiments, wherein a therapeutic and / or diagnostic instrument 510 is removably coupled to an imaging component 520. As shown, the instrument 510 can be axially aligned relative to the imaging component 520. Additionally, the distal end of the shaft 513 of the instrument 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 process.

[0104] Figure 5C A system for diagnosing and / or providing treatment using a treatment and / or diagnostic device 510 removably coupled to an imaging component 520 is shown according to some embodiments. The system for diagnosing treatment may include a retaining element, such as a hook, a latch, or a mechanical feature described herein, so as to fix the device 510 to the imaging component 520. The system for diagnosing and / or providing treatment may be configured to be coupled to multiple devices. For example, a first device may be coupled to the imaging component 520, and then a second device may be coupled. The imaging component 520 may be configured to be coupled to both the first and second treatment and / or diagnostic devices simultaneously or individually. For example, if the first device is a disposable tube, the second device may be slidably inserted into the first device. In some embodiments, the imaging component 520 may be configured to be deliverable to a target site in a patient's body, which was previously coupled to a first and / or second treatment or diagnostic device outside the target site. Additionally or alternatively, the imaging component 520 may be configured to be removably coupled to both the first and second treatment or diagnostic devices simultaneously or individually after the imaging component 520 is delivered to the target site in the patient's body (for example, the device may be coupled in situ).

[0105] Figure 6 An imaging system 600 is shown including a digital processing device 612 and a display 614 that is visible to a user according to some embodiments. Figure 6As shown, the imaging system 600 may additionally include an imaging component 100 and an instrument 300. The digital processing device 612 may include one or more processors configured with instructions to set and record both treatment parameters and imaging parameters. The display 614 may be included in a common housing 618; however, in other embodiments, the display 614 may be remote from the digital processing device and / or the imaging component 100. The imaging component 100 may be connected to the digital processing device 612 via an imaging cable 624 to provide the captured image to the digital processing device 612 for display 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 via an instrument cable 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 via cables 624, 622, the digital processing device 612 may provide power to both components.

[0106] The device 300 may include a handle portion 301 having one or more slidably mounted control elements 319 on its upper surface. In some embodiments, the control elements 319 may control the positioning of internal stops within the handle, which may be monitored by the digital processing device 612 to calculate the size and location of the boundaries of the target area and / or safety zone shown on the display 614. In the case where the device 300 is an ablation element (e.g., ablation device 230, such as Figure 2C In embodiments shown in FIG. 1 , the stop may also be used to physically limit deployment of the introducer and optionally the tip.

[0107] Some embodiments of the methods and systems of the present disclosure may be integrated with systems and methods for establishing and adjusting displayed safety zone boundaries and treatment zone boundaries. Such embodiments may include systems and methods of incorporated references, including: U.S. Patent Publication 2014 / 0073910 (now U.S. Patent 9,861,336); U.S. Patent 8,992,427; U.S. Patent Publication 2018 / 0132927 (now U.S. Patent 11,219,483); and PCT Publication 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 systems and methods of incorporated references, including PCT Publication WO2018 / 089523.

[0108] Fig. 7AAn imaging component 100 is shown that can be used to treat a fibroid F located in the myometrium M beneath the uterine wall UW (endometrium) and surrounded by a serosal wall SW in the uterus U. The imaging component 100 can be introduced into the uterus U transvaginally and transcervically (or alternatively laparoscopically), and an imaging transducer 107 is deployed to image the fibroid F within the field of view indicated by the dashed line.

[0109] Figure 7B An example of a display (eg, Figure 6 614) which shows a safety boundary and a treatment boundary. In some embodiments, once the fibroid F is located on the display 614, the controls 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 can neither be located on the fibroid F nor be appropriately sized to treat the fibroid F. Before starting treatment, the user (e.g., a doctor) may want to locate and size the boundaries TB and SB for appropriate treatment. Since the imaging transducer 107 may already be against the uterine wall UW, the only way to advance the treatment and safety boundaries TB and SB may be to move the boundaries forward by actuating the control element 319. In some embodiments, this can cause the treatment and safety boundaries TB and SB to move forward along the axis AL, thereby translating the area to be treated. This can cause the virtual boundary on the real-time image display 614 to move on the image of the fibroid F. Additionally or alternatively, the size of the treatment boundary TB can be increased or decreased to mitigate the risk of affecting healthy and / or more sensitive tissues around the treatment area.

[0110] In embodiments where the instrument is a tissue ablation element, while holding imaging component 100 steady, the physician may then advance needle slider so that introducer 235 extends into fibroid F, as shown in FIG. Figure 7C shown. Figure 7C The illustration in includes a representation of an imaging component 100, which corresponds to a physical probe present in a patient. Figure 7C The remainder of corresponds to the image present on the target display 614.

[0111] After the introducer 235 has been fully deployed by being restrained by an optional physical or virtual needle stop housing in the instrument handle 301, the tip 233 can be deployed by advancing the tip slider. A target level of tip deployment is reached, as indicated by engagement of the tip slider with an optional tip stop or visually 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 treatment and safety margins TB, SB in all viewing planes around the fibroid F. The display 614 will show in real time the position of the treatment and safety margins TB, SB relative to the target fibroid F and the serosa. The tip 233 is then configured as shown in FIG. Fig.7D As shown, the tip 233 (and optionally the introducer 235) can be powered to achieve treatment within the boundaries delineated by the virtual treatment boundary TB. Fig.7D A virtual image to be present on the display 614 and the physical presence of the imaging component 100 are mixed.

[0112] Uterine fibroid ablation example

[0113] Figure 8A-8C Examples of systems, devices, and methods for ablation of uterine fibroids are described. The devices described herein may include an imaging component and a tissue ablation element as described above, such as a radiofrequency ablation element including an introducer and a plurality of needle electrodes or prongs. The imaging component and tissue ablation element may be coupled together for transvaginal and transcervical delivery to a patient's uterus.

[0114] As shown, tissue ablation device 800 is positioned within uterine cavity 802. In this example, tissue ablation device 800 includes an imaging component integrated into or coupled to a tissue ablation element, but in other examples, device 800 may include only an imaging component, a therapeutic component, or other devices as described above. With expandable element 808, device 800 may be better maneuvered to approach the side wall of the uterus. Figure 8A-8C Each of the depicts a fibroid F attached to or otherwise at least partially embedded within the uterine wall 801 .

[0115] exist Fig. 8A , a tissue ablation device 800 is shown having a pivotable distal imaging transducer 807 and an expandable element 808 to enable movement of an ultrasound tip 812. According to embodiments disclosed herein, the expandable element 808 is shown in a deflated or collapsed configuration. Fig. 8A, a tissue ablation device 800 is shown within a uterine cavity 802. The tissue ablation device 800 includes a device shaft 803. An imaging transducer 807 is disposed at the distal end of the device shaft 803, as described herein in the above embodiments. A hinge 806 is disposed between the device shaft 803 and the imaging transducer 807. An ultrasound tip 812 is disposed at the distal tip of the imaging transducer 807. The tissue ablation device 800 also includes an expandable element 808, which can be configured to enable movement of the device and / or the ultrasound tip 812.

[0116] The device shaft 803 may include a straight shaft that may be rigid or may have some flexibility. The device shaft 803 may include two attached subsections, such as an imaging shaft that is attached to the shaft of the instrument. Figure 2C One illustrative example of two attached sub-portions of a shaft is shown in , where shaft 231 of ablation device 230 is reversibly attached to imaging shaft 103 .

[0117] The imaging transducer 807 has a field of view 815 and is configured to image tissue (eg, fibroid F) in a forward direction. The forward direction is defined as the direction in which the imaging transducer 807 is configured to image tissue.

[0118] Hinge 806 allows imaging transducer 807 to pivot relative to device axis 803 as described herein. Imaging transducer 807 can be reversibly pivoted between a straight position and a pivoted position. The straight position is a position where imaging transducer 807 forms a right angle (i.e., approximately 180°) with device axis 803. In contrast, the pivoted position is a position where imaging transducer 807 is angled relative to device axis 803. Figure 8B and Fig. 9 An example of the imaging transducer 807 in a pivoted position can be seen in FIG.

[0119] The ultrasonic tip 812 of the tissue ablation device 800 can include a spring-loaded tip configured to apply a force to restore the imaging transducer 807 from a pivoted position toward a straight position. In some embodiments, when the spring is unloaded, the spring-loaded tip can be completely straight, or parallel and aligned with the device axis 803. The spring-loaded tip can stabilize the imaging transducer 807 during placement and during the ablation process.

[0120] The expandable element 808 can be changed from a collapsed configuration (an example of which is shown in Fig. 8A ) reversibly expandable to an expanded configuration (an example of which is shown in Figure 8B and Figure 8C). In some embodiments, the expandable element 808 can be directly coupled to the device shaft 803, either removably or integrally. 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 in Figure 8B ), the expandable element 808 is configured to expand in a rearward direction that is substantially opposite to the forward direction.

[0121] The expandable element 808 may include, for example, a balloon (e.g. Figure 8A-8C ), deployable push rods, released springs or another actuation design. In some embodiments, the deployable push rods can be expandable elements 808, such as by being hingedly fixed to the device shaft: in the collapsed or compressed configuration, the push rods can be folded down along the device, but in the expanded configuration, the push rods can be deployed outward to push against the uterine wall. In another embodiment, the deployable push rods can be attached to the device shaft and extend out the side of the device shaft to push against the uterine wall. Figure 8A-8C and Fig. 9 The expandable element 808 depicted in the example of 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 the expansion of the balloon. In some embodiments of the balloon used as the expandable element, the balloon can include multiple chambers, and each chamber can be individually controlled according to surgical needs. In embodiments in which the expandable element is a balloon, the balloon can be expanded by filling it with a filler fluid. The balloon can expand and contract between targeting sequences. The tissue ablation device 800 may also include a reservoir 816 of filler fluid connected to the balloon fluid. In some embodiments, the filler fluid enters the balloon, thereby expanding the balloon. In some embodiments, the filler fluid is a liquid, such as water or saline. In other embodiments, the filler fluid is gaseous, such as compressed 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 filler fluid. Figure 8A-8C In FIG, the reservoir 816 is depicted as a syringe. Fig. 8A In FIG. 8 , when the balloon 808 is in its deflated or collapsed configuration, the plunger of the syringe is fully withdrawn, indicating that the system's filler fluid is in the syringe. Figure 8B 808 , the plunger of the syringe is depressed when the balloon 808 is in its expanded configuration, indicating that the system's filler fluid has moved from the syringe into the expanded balloon 808 .

[0122] Figure 8B Shows Fig. 8AThe tissue ablation device 800 has its expandable element 808 (e.g., a balloon) in its expanded configuration, which can cause the tissue ablation device 800 to move (e.g., deflect or rotate) within the uterine cavity 802. Figure 8B The balloon in is depicted as expanding in response to a filler fluid being forced from a reservoir 816 into the balloon. The pressure of the filler fluid can be regulated by sensors and control circuitry. In some embodiments, the expandable element 808 can be configured to move the ultrasonic tip 812. In some embodiments, the moving motion can be produced by expanding the expandable element 808 against a wall of the uterine cavity 802 opposite the target fibroid F. The force against the opposite wall can stabilize the tissue ablation device 800 within the uterine cavity 802 by pushing on the opposite wall and filling the space of the uterine cavity 802. The balloon can be secured to the rear (non-transducer-facing side) of the device shaft 803 and on the proximal side of the hinge 806 (such as, for example Fig. 8A ). In some embodiments, as the balloon begins to occupy space, the balloon pushes against the opposing wall and presses the device shaft 803 toward the fibroid F and may also activate the spring-loaded articulated transducer tip 812. In some embodiments, the expandable element is expanded prior to placing the tissue ablation device at the target treatment area. In practice, as Figure 8B As shown, expanding the expandable element 808 may aid in placing the tissue ablation device 800 at the target treatment area. In other embodiments (not shown), the expandable element may be expanded after the tissue ablation device is placed at the target treatment area.

[0123] In some embodiments, a tissue ablation device having an expandable element can be used to treat the endometrial surface by filling a balloon with a high temperature filler fluid. In some embodiments, such a procedure can provide endometrial ablation, which can, for example, reduce or eliminate menstrual bleeding and associated symptoms. In some embodiments, the filler fluid can be a high temperature filler fluid. In some embodiments, the high temperature filler fluid can be heated to a temperature of about, at least about, or not greater than about 75°C, 80°C, 85°C, 87°C, 90°C, 95°C, or higher or lower, and ranges including any two of the foregoing values, for the duration of the endometrial ablation procedure.

[0124] In other embodiments (not shown), an expandable balloon can be positioned in front of the imaging transducer and filled with a fluid. So configured, the expanded balloon can act as an acoustic spacer to automatically couple the transducer to the tissue, thereby improving ultrasound image quality during the treatment process.

[0125] Return to Figure 8B, expansion of the expandable element 808 (e.g., a balloon) against the opposing wall of the uterine cavity 802 can also be used to press the imaging transducer 807 more tightly against the fibroid F. In some embodiments, the force used to press the imaging transducer 807 more tightly against the fibroid F can also move the imaging transducer 807 at the hinge 806 relative to the device shaft 803 (or move the device shaft 803 at the hinge 806 relative to the imaging transducer 807).

[0126] Figure 8C Shows Figure 8B The tissue ablation device 800, wherein the ablation device (e.g., Figure 2C and Figure 7C-D The ablation device 230 in the embodiment is inserted into the fibroid F for fibroid ablation treatment, as described herein. In some embodiments, the ablation device can be attached to the tissue ablation device 800 before the expandable element 808 is expanded. In other embodiments, the ablation device can be attached to the tissue ablation device 800 after the expandable element 808 is expanded. Hereinafter, it will be understood that the tissue ablation device 800 includes an ablation device, which in turn includes a treatment element, such as an introducer 835 and optionally a plurality of needle electrodes 833. As described herein, in some embodiments, the treatment element can be inserted into the fibroid F. Inserting the treatment element into Figure 8C The approach of F in fibroids can be similar to, for example Figure 7C-D In some embodiments, movement of the imaging transducer 807 to a pivot position may allow deployment of a therapeutic element. Figure 8C In the embodiment of the present invention, the expandable element 808 can help provide additional stability to the introducer 835, the needle electrode 833, and the imaging transducer 807 used to visualize the ablation procedure.

[0127] Providing a balloon or other expandable element as described herein can provide one or more benefits, including but not limited to: (1) stabilizing the ultrasound tip within the cavity, (2) automatically pointing the device axis toward the target tissue or moving the tissue into the line of sight of the introducer without the need for deliberate pointing motion, (3) applying stabilization within the uterus and applying tension in the tissue to reduce movement during introducer and needle electrode deployment, (4) creating stabilization during ablation, and (5) in combination with a spring-loaded tip with real-time angle tracking, eliminating the need for an alignment step in the software.

[0128] Embodiments of the present disclosure are applicable to the Systems and similar systems, devices and methods described in the following commonly assigned U.S. patents and patent applications, which are incorporated herein by reference: U.S. Patent 7,918,795; U.S. Patent 9,357,977; U.S. Patent 7,815,571; U.S. Patent 7,874,986; U.S. Patent 10,058,342; U.S. Patent 8,088,072; U.S. Patent 8,206,300; U.S. Patent 9,861,336; U.S. Patent 8,992,427; U.S. Patent 11,219,483; U.S. Patent Publication 2020 / 0275975 (now U.S. Patent 11,612,431); and U.S. Patent Publication 2019 / 0350648.

[0129] Fig. 9 Similar to Figure 8C , except in Fig. 9 In some embodiments, the target tissue (e.g., fibroid F) is located at the bottom of the uterine cavity 802, rather than along the sidewalls of the uterus. In some embodiments, the expandable element 808 (e.g., a balloon) in its expanded configuration can provide stability to the tissue ablation device 800 while it images and ablates fibroids at the bottom of the uterus. One of ordinary skill in the art will appreciate that the presence of the expandable element in its expanded configuration can assist in various procedures (e.g., imaging, ablation, biopsy, injection, etc.). It will also be appreciated that after the procedure, the expandable element 808 can be emptied or otherwise collapsed, returning the expandable element to its reduced configuration, which facilitates removal of the device from the uterus.

[0130] The foregoing description and embodiments have been set forth merely to illustrate the present disclosure and are not intended to be limiting. Each of the disclosed aspects and embodiments of the present disclosure may be considered individually or in combination with other aspects, embodiments, and variations of the present disclosure. In addition, unless otherwise indicated, the steps of the method of the present disclosure are not limited to any particular order of execution. Modifications of the disclosed embodiments incorporating the spirit and substance of the present disclosure may be envisioned by those skilled in the art, and such modifications are within the scope of the present disclosure.

[0131] As used herein, orientation terms, such as "top," "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 orientations shown. In fact, other orientations are possible and within the scope of the present disclosure. Terms related to circular shapes, such as diameter or radius, as used herein, should be understood to not require perfectly circular structures, but should apply to any suitable structure having a cross-sectional area that can be measured from one side to the other. Terms generally related to shape, such as "circular" or "cylindrical" or "semi-circular" or "semi-cylindrical" or any related or similar terms, do not necessarily strictly follow the mathematical definition of a circle or cylinder or other structure, but can include reasonably close approximate structures.

[0132] Conditional language used herein, such as "can," "might," "may," "could," "for example," and the like, among others, unless expressly stated otherwise or otherwise understood in the context of use, is generally intended to convey that some embodiments include certain features, elements, and / or states, while other embodiments do not. Thus, such conditional language is generally not intended to imply that features, elements, blocks, and / or states are in any way necessary for one or more embodiments, or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether such features, elements, and / or states are included in any particular embodiment or will be executed in any particular embodiment.

[0133] Unless specifically stated otherwise, linking language such as the phrase "at least one of X, Y, and Z" is generally understood in the context in which it is used to convey that an item, term, etc. can be X, Y, or Z. Thus, such linking language is generally not intended to imply that certain embodiments require at least one of X, at least one of Y, and at least one of Z to be present.

[0134] As used herein, the terms "approximately," "about," and "substantially" refer to an amount close to a stated amount that still performs a desired function or achieves a desired result. For example, in some embodiments, as the context may indicate, the terms "approximately," "about," and "substantially" may refer to an amount that is less than or equal to 10% of a stated amount. As used herein, the term "generally" refers to a value, amount, or feature that primarily includes or tends toward a particular value, amount, or feature. As an example, in certain embodiments, as the context may indicate, the term "substantially parallel" may refer to a deviation from exact parallelism that is less than or equal to 20 degrees.

[0135] When the term "about" is used before a range of two values, this is intended to include ranges between about the first value and about the second value, as well as ranges from the specified first value to the specified second value.

[0136] Unless expressly stated otherwise, articles such as "a" or "an" should generally be interpreted as including one or more of the described items. Thus, phrases such as "a device configured to" are intended to include one or more of the described devices. Such one or more of the described devices may be collectively configured to perform the described statements. For example, "a processor configured to perform statements A, B, and C" may include a first processor configured to perform statement A working together with a second processor configured to perform statements B and C.

[0137] The terms "comprising," "including," "having," and the like are synonymous and are used inclusively in an open manner and do not exclude additional elements, features, actions, operations, and the like. Likewise, the terms "some," "some," and the like are synonymous and are used in an open manner. Furthermore, the term "or" is used in its inclusive sense (rather than its exclusive sense) so that, for example, when used in conjunction with a list of elements, the term "or" means one, some, or all of the elements in the list.

[0138] In general, 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 shown and described in the present disclosure or discussed during the prosecution of the present application.

[0139] Although systems, devices and methods for intravascular implants and their precise placement have been disclosed in the context of certain embodiments and examples, the disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the embodiments and some modifications and equivalents thereof. The various features and aspects of the disclosed embodiments may be combined or substituted with one another to form different modes of systems, devices and methods for intravascular implants and their precise placement. The scope of the disclosure should not be limited by the specific disclosed embodiments described herein.

[0140] Certain features described in this disclosure in the context of separate implementations may be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may be implemented in multiple implementations individually or in any suitable subcombination. Although features may be described herein as functioning in certain combinations, in some cases, one or more features from a claimed combination may be deleted from the combination, and the combination may be claimed as any subcombination or variation of any subcombination.

[0141] Although the methods and devices described herein may have various modifications and alternative forms, their specific examples have been shown in the drawings and described in detail herein. However, it should be understood that the present invention is not limited to the specific forms or methods disclosed, on the contrary, the present invention covers all modifications, equivalents and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. In addition, the disclosure of any specific features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc. related to the embodiments herein can be used in all other embodiments set forth herein. Any method disclosed herein does not need to be performed in the described order. Depending on the embodiment, one or more actions, events or functions of any algorithm, method or process described herein may be performed in different orders, may be added, merged or completely omitted (for example, not all described actions or events are necessary for the practice of the algorithm). In some embodiments, actions or events may be performed simultaneously, for example, by multithreading, interrupt processing, or multiple processors or processor cores, or on other parallel architectures, rather than being performed in order. In addition, there is no element, feature, block or step or group of elements, features, blocks or steps that is necessary or indispensable for each embodiment. In addition, all possible combinations, subcombinations, and rearrangements of systems, methods, features, elements, modules, blocks, etc. are within the scope of the present disclosure. Unless otherwise specifically stated or otherwise understood in the context of use, the use of sequential or chronological language (such as "then," "next," "after," "subsequently," etc.) is generally for convenience of text and is not intended to limit the order of operations performed. Thus, some embodiments may be performed using the sequence of operations described herein, while other embodiments may be performed according to a different sequence of operations.

[0142] In addition, although operations can be depicted in the drawings or described in the specification in a particular order, such operations do not need to be performed in the particular order shown or in a sequential order, and all operations do not need to be performed to achieve the desired result. Other operations that are not depicted or described can be incorporated into the example methods and processes. For example, one or more additional operations can be performed before, after, at the same time, or during any operation described. In addition, in other embodiments, operations can be rearranged or reordered. Moreover, the separation of various system components in the implementation described herein should not be understood as requiring such separation in all implementations, and it should be understood that the components and systems described can generally be integrated together in a single product or packaged into multiple products. In addition, other implementations are also within the scope of the present disclosure.

[0143] Some embodiments have been described in conjunction with the accompanying drawings. Certain drawings are drawn and / or shown to scale, but such scale should not be restrictive, because the dimensions and ratios other than those shown are expected and within the scope of the embodiments disclosed herein. Distances, angles, etc. are merely illustrative and do not necessarily have an exact relationship with the actual size and layout of the device shown. Components can be added, removed, and / or rearranged. In addition, the disclosure of any specific features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc. associated with various embodiments herein can be used in all other embodiments set forth herein. In addition, any method described herein can be practiced using any device suitable for performing the steps.

[0144] The methods disclosed herein may include certain actions taken by a practitioner; however, the methods may also include any third-party instructions for those actions, whether explicit or implicit. For example, an action such as "positioning an electrode" includes "instructing the positioning of an electrode."

[0145] In summary, various embodiments and examples of intravascular implants and devices and methods for precise placement have been disclosed. Although systems, devices and methods for intravascular implants and precise placement thereof have been disclosed in the context of those embodiments and examples, the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or other uses of the embodiments, as well as certain modifications and equivalents thereof. The present disclosure expressly contemplates that the various features and aspects of the disclosed embodiments may be combined or substituted with one another. Therefore, the scope of the present disclosure should not be limited by the specific disclosed embodiments described herein, but should be determined solely by a fair interpretation of the appended claims.

[0146] The ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof. Language such as "at most," "at least," "greater than," "less than," "between," and the like includes the listed numbers. Numbers preceded by terms such as "about" or "approximately" include the listed numbers 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." Phrases preceded by terms such as "substantially" include the phrases and should be interpreted based on the circumstances (e.g., as accurately as reasonably possible under the circumstances). For example, "substantially perpendicular" includes "perpendicular." Unless otherwise noted, all measurements are made under standard conditions, including temperature and pressure.

Claims

1. A tissue ablation device, comprising: Device shaft; an imaging transducer disposed at the distal end of the device shaft to provide an ultrasonic tip; and An expandable element is configured to enable movement of the ultrasonic tip.

2. The tissue ablation device according to claim 1, wherein: The imaging transducer is pivotable between a straight position in which the imaging transducer forms a straight angle with the device axis and a pivoted position in which the imaging transducer is angled relative to the device axis.

3. A 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 to restore the imaging transducer from the pivoted position toward the straight position.

4. A tissue ablation device according to claim 1, wherein the expandable element is directly connected to the device shaft.

5. The tissue ablation device of claim 1, wherein the imaging transducer is configured to image tissue in a forward direction, and wherein the expandable element is configured to expand in a rearward direction that is substantially opposite to the forward direction.

6. The tissue ablation device of claim 1, wherein the expandable element is a balloon.

7. The tissue ablation device of claim 6, wherein the balloon comprises a plurality of chambers, wherein each chamber is individually controllable.

8. The tissue ablation device according to claim 6, wherein: The balloon is configured to be expanded by being filled with a filler fluid.

9. The tissue ablation device of claim 8, wherein the filler fluid is gaseous.

10. The tissue ablation device of claim 8, wherein the filler fluid is a high temperature filler fluid.

11. The tissue ablation device according to claim 8, wherein: The balloon is configured to expand between the imaging transducer and tissue being imaged by the imaging transducer such that the balloon acts as an acoustic spacer to couple the imaging transducer to the tissue.

12. The tissue ablation device according to 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 released spring.

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

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

Images