Systems and Methods for Uterine Fibroid Ablation

Abstract

Various systems, devices, and methods for tissue penetration are disclosed. The system includes an ablation element for penetrating tissue and a radio frequency generator for delivering energy to the ablation element. The radio frequency generator may have two modes: a cutting or insertion mode and an ablation or coagulation mode. The cutting or insertion mode is used to cut or penetrate tissue by providing a voltage or power modulation that acts to cut or soften the tissue contacted by the ablation element. The ablation or coagulation mode is used to ablate or coagulate tissue.

Description

Technical Field

[0001] (Cross - Reference to Related Applications and Incorporation by Reference) This application claims the benefit of U.S. Provisional Application No. 63 / 356,223, filed on Jun. 28, 2022, which is hereby incorporated herein by reference in its entirety.

[0002] All publications, patents, and patent applications mentioned in this specification are hereby incorporated herein 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.

[0003] (Technical Field) The present disclosure relates, in particular, to medical systems, devices, and methods for uterine myoma ablation. The present disclosure further relates to inserting an instrument into a target tissue.

Background Art

[0004] Current medical treatments of organs and tissues within a patient's body often use needles or other elongated bodies for the delivery of energy, therapeutic agents, etc. Optionally, the method uses ultrasound imaging to observe and identify the treatment or diagnostic target and to track the position of the needle relative to the target.

[0005] Treatments for uterine myomas that rely on transvaginal or laparoscopic positioning of a treatment device into a patient's uterus have been proposed. A radiofrequency or other energy or therapeutic delivery needle is deployed from the device into the myoma, and energy and / or therapeutic substances are delivered to ablate or treat the myoma. To facilitate identifying the myoma and positioning the needle within the myoma, the device includes an ultrasound imaging array with an adjustable field of view in a generally forward or lateral direction relative to the axial shaft carrying the needle. The needle is advanced from the shaft across the field of view so that the needle can be visualized and directed into the tissue and targeted myoma.

[0006] Current systems, devices, and methods for therapeutic or diagnostic procedures for the treatment of uterine fibroids and the like can be sub-optimal in at least some respects. For example, many current devices for tissue ablation require the insertion of ablation elements into the target tissue. However, the target tissue provides resistance to many current devices configured to penetrate into the target tissue. For example, when a user attempts to insert an instrument into the target tissue, particularly a high-density target tissue such as a fibroid, the force required to penetrate the target tissue can substantially deform the target tissue or otherwise resist the insertion of the instrument.

[0007] In view of the above, improved systems, devices, and methods for penetrating into high-density target tissues such as fibroids are desired. Such systems, devices, and methods would address at least some of the above drawbacks and, for example, would be readily usable for a variety of therapeutic and diagnostic procedures. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0008] The embodiments disclosed herein each have several aspects, and no single one of them alone contributes to the desirable attributes of the present disclosure. Without limiting the scope of the present disclosure, its more prominent features will be discussed briefly here. After considering this discussion, and particularly after perusing the section entitled "DETAILED DESCRIPTION," one will understand how the features of the embodiments described herein provide advantages over existing systems, devices, and methods.

[0009] The present disclosure relates to medical systems, devices, and methods for uterine fibroid ablation, among other things, but not limited thereto. Embodiments of the present disclosure provide an ablation element configured to penetrate target tissue and a radiofrequency generator configured to deliver energy to the ablation element. Further, the radiofrequency generator of embodiments of the present disclosure can include a cutting or insertion mode configured to cut through the target tissue. The cutting or insertion mode can provide a voltage oscillation configured to cut tissue contacted by the ablation element before the ablation procedure begins, while the ablation element is inserted into the target tissue, or while the tissue is being contacted by the ablation element. Use of such a cutting or insertion mode during insertion of the ablation element into the target tissue can reduce the force required to insert the ablation element into the target tissue, which can then make the insertion easier and more accurate.

[0010] In some aspects, a system for penetrating target tissue is provided. The system can include an ablation instrument and a controller configured to control delivery of energy to the ablation instrument, the controller being configured to monitor a temperature measured by the ablation instrument at an interface with the target tissue as the ablation instrument penetrates into the target tissue and to maintain the temperature between about 80°C and about 115°C.

[0011] The systems as described above, or as provided in other aspects described herein, may comprise one or more of the following features. The ablation instrument may comprise an introducer and a plurality of electrode ablation needles extendable from a retracted position within the introducer. The temperature measured by the ablation instrument is measured by a thermocouple positioned on one of the electrode ablation needles when the plurality of electrode ablation needles are retracted within the introducer. The plurality of electrode ablation needles may comprise a central electrode extendable from a retracted position within the introducer, and the thermocouple is positioned on the central electrode. The controller may be configured to modulate the power delivered to the ablation instrument and maintain the temperature at about 80°C to about 115°C when the ablation instrument penetrates into the target tissue. The controller may be configured to modulate the power delivered to the ablation instrument and provide oscillations in temperature at the interface with the target tissue when the ablation instrument penetrates into the target tissue. The controller may be configured to provide an alert and provide an indication to initiate penetration of the ablation instrument into the target tissue when the temperature at the interface is about 80°C to about 115°C. The system may further comprise an ultrasonic imaging device configured to provide visualization of the ablation instrument when the ablation instrument penetrates the target tissue. The ultrasonic imaging device may be coupled to the ablation instrument. The controller may be configured to control the delivery of energy to the ablation instrument to ablate the target tissue after the ablation instrument penetrates into the target tissue. The controller may be configured to control the delivery of energy to the ablation instrument and maintain a substantially constant temperature in the target tissue to ablate the target tissue. The system may further comprise a radio frequency generator configured to deliver energy to the ablation instrument while the ablation instrument penetrates into the target tissue.

[0012] In some aspects, a method of penetrating a target tissue is provided. The method can include delivering an ablation device to contact the target tissue, delivering energy to the ablation device such that the temperature measured by the ablation device at the interface with the target tissue rises to about 80°C to about 115°C, and advancing the ablation device through the target tissue while modulating the power to maintain the temperature at the interface with the target tissue at about 80°C to about 115°C.

[0013] The method as described above or as described in other aspects herein can comprise one or more of the following features. The ablation device can penetrate into the target tissue while the temperature maintained at the interface with the target tissue is oscillating. The method can further include ablating the target tissue by delivering energy to the ablation device and maintaining the temperature at the interface with the target tissue at a substantially constant temperature. The ablation device can comprise an introducer and a plurality of electrode ablation needles extendable from a retracted position within the introducer, and the plurality of electrode ablation needles extend at least partially from the introducer while maintaining the temperature at the interface with the target tissue at about 80°C to about 115°C.

[0014] In some aspects, a system for penetrating a target tissue is provided. The system can comprise an ablation element configured to penetrate the target tissue and a radio frequency generator configured to deliver energy to the ablation element, the radio frequency generator having a cutting or insertion mode configured to cut through the target tissue, the cutting or insertion mode providing a power oscillation configured to cut the tissue contacted by the ablation element, and an ablation or coagulation mode configured to ablate and / or coagulate the target tissue, the ablation or coagulation mode providing an increase in power followed by a decrease in power after the target tissue reaches a target temperature.

[0015] The systems as described above or provided in other aspects described herein may comprise one or more of the following features. The cutting or insertion mode may be configured to maintain a substantially constant surface temperature of the ablation element. The cutting or insertion mode may be configured to cause a rapid increase in temperature in the tissue in contact with the ablation element. The radio frequency generator may be configured to be controlled to provide limits on the temperature during the cutting or insertion mode and during the ablation or coagulation mode, and the limits on the temperature during the cutting or insertion mode are lower than the limits on the temperature during the ablation or coagulation mode. The system may be further configured to provide mechanical vibration or cutting force during the cutting or insertion mode. The ablation element may comprise an introducer. The ablation element may comprise a plurality of electrode ablation needles. The system may further comprise a controller configured to control the delivery of energy to the ablation element, the controller monitoring the temperature measured by the ablation element at the interface with the target tissue and being configured to maintain the temperature at about 80°C to about 115°C when the ablation element penetrates into the target tissue. The target tissue may be a uterine myoma.

[0016] In some aspects, a method of uterine myoma ablation is provided. The method may include delivering an ablation element into contact with the uterine myoma and, while the ablation element is in contact with the uterine myoma, delivering radio frequency energy to the ablation element according to a cutting or insertion mode, wherein in the cutting or insertion mode, the voltage or power is modulated based on the temperature measured at the interface between the ablation element and the uterine myoma to assist the ablation element in penetrating into the uterine myoma, and after the ablation element has penetrated into the uterine myoma, delivering radio frequency energy according to a coagulation mode, wherein in the coagulation mode, the voltage or power applied to the ablation element is sufficient to ablate the uterine myoma.

[0017] The methods as described above or as described in other aspects of this specification may comprise one or more of the following features. The voltage or power may be vibrated in a cutting or insertion mode. The voltage or power may be modulated in a cutting or insertion mode to maintain the temperature at the interface at about 80°C to about 115°C. The voltage or power in a coagulation mode may increase and then decrease after the tissue in contact with the ablation element reaches a target temperature. Delivering radiofrequency energy according to a cutting or insertion mode may preheat the uterine fibroids. Delivering radiofrequency energy according to a cutting or insertion mode may soften the uterine fibroids, thereby enabling the ablation element to penetrate the uterine fibroids without substantially deforming the uterine fibroids during penetration. Delivering radiofrequency energy according to a cutting or insertion mode may maintain a substantially constant surface temperature of the ablation element. The substantially constant surface temperature of the ablation element may be about 80°C to about 115°C. Delivering radiofrequency energy according to a cutting or insertion mode may be controlled such that the maximum output does not exceed 70 watts. Delivering radiofrequency energy according to a cutting or insertion mode may be controlled not to exceed 30 seconds.

Brief Description of the Drawings

[0018] Certain features of the present disclosure are described below with reference to the drawings. The illustrated implementations are intended to illustrate the implementations and not to limit them. The various features of different disclosed implementations can be combined to form further implementations that are part of the present disclosure.

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[0041] Various features and advantages of the present disclosure will now be described with reference to the accompanying figures. The following description is merely illustrative in nature and is not intended to limit the present disclosure, its application, or its use in any way. The present disclosure extends beyond the specifically disclosed implementations and / or uses and their obvious modifications and equivalents. Accordingly, it is intended that the scope of the present disclosure should not be limited by any particular implementation described below. The features of the illustrated implementations can be modified, combined, removed, and / or substituted in accordance with the principles disclosed herein as would be apparent to one of ordinary skill in the art. Further, the implementations disclosed herein can include several novel features, none of which alone contribute to its desirable attributes or are essential to the practice of the systems, devices, and / or methods disclosed herein.

[0042] Certain embodiments of the present disclosure are directed to therapeutic devices and associated methods and systems that incorporate a cutting or insertion mode for facilitating the insertion of ablation elements into a target tissue. Examples of these devices, methods, and systems are described in the examples below, 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 of the diagnostic and / or therapeutic devices, which can also incorporate the imaging components described herein. (Examples of diagnostic and / or therapeutic devices with imaging devices)

[0043] Embodiments of the present disclosure provide systems, devices, and methods for providing therapeutic and diagnostic access to tissue while the tissue is being imaged by an imaging component. The imaging component can include a lumen extending along (e.g., along) the length of the shaft, the lumen being configured to removably receive at least one of a plurality of different instruments (e.g., ablation instrument 230 of FIG. 2). In some embodiments, the lumen of the imaging component can be partially open to the exterior of the shaft. The imaging component can include an imaging transducer at the distal end of the shaft. Additionally, the shaft of the imaging component can be configured such that additional therapeutic and / or diagnostic instruments / attachments can be removed and / or received and / or inserted during a medical procedure without interfering with the imaging component. Additionally, or alternatively, the imaging component can remain in place while therapeutic and / or diagnostic instruments are being received and / or removed. In some embodiments, the imaging component can be used without additional therapeutic and / or diagnostic instruments coupled thereto. In some embodiments, the imaging component can be inserted into and / or removed from a patient lumen without the presence of therapeutic and / or diagnostic instruments. Such an imaging component can be used, for example, during medical procedures such as non-invasive, minimally invasive, and / or laparoscopic surgeries.

[0044] Embodiments of the present disclosure may improve existing methods for imaging and treating lesions within a tissue conduit for procedures that may be required for a plurality of instruments to diagnose and / or provide therapy during a single procedure. For example, an imaging component may be used for diagnosis, then a biopsy attachment may be inserted for a pathology sample, then an ablation attachment may be inserted to ablate any lesions, and then additional attachments or instruments may be inserted to perform additional procedures such as delivery of drugs, implants, and / or therapies and / or diagnostic agents. The imaging component of the present disclosure may facilitate the insertion and removal of medical instruments by providing a shaft with a non-invasive edge and a cavity configured to receive a plurality of different instruments. Additionally, or alternatively, the imaging component may be used independently of additional instruments or attachments. In such embodiments, the edge of the cavity may be smooth or rounded such that when used alone, the edge may not snag on patient tissue.

[0045] The cavity of the imaging component may improve existing methods for imaging and treatment by providing a cavity of the imaging component that may be easier to clean than a component with a closed cavity or lumen. The cavity of the imaging component may improve existing methods for imaging and treatment by facilitating the manufacture of the imaging component. Embodiments of the present disclosure may reduce treatment costs by providing a disposable tube to the imaging component. Embodiments of the present disclosure may reduce treatment costs by providing a reusable imaging component with a cavity into which a disposable instrument (e.g., ablation instrument 230 of FIG. 2) may be inserted. Embodiments of the imaging component may provide a shaft that always aligns the instrument with the ultrasound image. Embodiments of the present disclosure may accommodate various instruments with different sizes and shapes. Embodiments of the present disclosure may provide a scale or position information to assist in the insertion of the instrument.

[0046] The systems and methods of the present disclosure can be particularly useful in the treatment of fibroids within a patient's uterus. The imaging component can be deployed transvaginally, transcervically into the uterus, or in other cases, laparoscopically into and through the exterior of the uterus or other organ or tissue duct. The imaging component can be used in conjunction with additional instruments such as therapy electrodes, diagnostic electrodes, and / or needles, for example, tissue ablation elements such as radiofrequency ablation elements, ultrasonic ablation elements, heat-based ablation elements, cryoablation elements (e.g., ablation instrument 230 of FIG. 2), and / or other instruments suitable for placement within the lumen of the imaging component. Additionally, or alternatively, additional instruments can be used to deliver drugs, implants, or other therapeutic agents to the tissue to be treated. Additionally, or alternatively, the tissue ablation element can comprise an embodiment or variation of the needle / tine assembly of U.S. Pat. Nos. 8,206,300, 8,262,574, and 8,992,427, by the same applicant, the contents of which are incorporated herein by reference.

[0047] Embodiments of the present disclosure provide a shaft of an imaging component with a non-traumatic edge and may improve at least some of the systems and methods of the reference by the same applicant by enabling the use of the imaging component alone. In some embodiments, the embodiments of the present disclosure may improve the ability to remove and / or receive additional instruments (e.g., ablation instrument 230 of FIG. 2) by providing an imaging system without an attachment mechanism located within at least a portion of the system to be positioned in situ. In such embodiments, the imaging component shaft may be non-cylindrically symmetric (e.g., oval or rectangular in cross-section) to reference the rotation of an additional instrument relative to the imaging component shaft. In some embodiments, the present disclosure may additionally or alternatively provide a shaft of an imaging component with a small angled portion, which may minimize the risk of damage to the surface of the imaging transducer by an instrument. Additionally or alternatively, the imaging component may include a disposable tube inserted into a cavity, among many possible purposes, to insert additional instruments with different diameters and to provide a working channel for easier cleaning of the system.

[0048] The imaging components described herein can be used in surgical procedures to provide real-time images of a target structure to be treated, including projecting safety and treatment boundaries as described in U.S. Patent Nos. 8,088,072 and 8,262,577 by the same applicant (the contents of which are incorporated by reference). The imaging components described herein can be useful for performing both imaging and treatment of uterine fibroids as described in U.S. Patent No. 7,918,795 by the same applicant (incorporated herein by reference). Other patents and published applications by the same applicant that describe probes useful for treating uterine fibroids that can be used with the imaging components described herein include U.S. Patent Nos. 7,815,571, 7,874,986, 8,506,485, 9,357,977, and 9,517,047 (incorporated herein by reference). Additional patent applications by the same applicant that describe systems for establishing and adjusting the displayed safety and treatment zone boundaries that can be used in conjunction with the imaging components described herein include U.S. Patent Publication No. 2014 / 0073910 (now U.S. Patent No. 9,861,336), U.S. Patent Publication No. 2019 / 0350648, U.S. Patent No. 8,992,427, U.S. Patent Publication No. 2018 / 0132927 (now U.S. Patent No. 11,219,483), and PCT Publication No. WO2018 / 089523 (each incorporated herein by reference). PCT Publication No. WO2018 / 089523 by the same applicant, which further describes a mapping and planning system that can be used in conjunction with the imaging components described herein, is also further incorporated herein by reference.

[0049] 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 performing therapy or diagnosis on a volume of tissue. A volume of tissue may include a patient organ. Patient organs or body cavities may include, for example, muscle, tendon, mouth, tongue, pharynx, esophagus, stomach, intestine, anus, liver, gallbladder, pancreas, nose, larynx, trachea, lungs, kidneys, bladder, urethra, uterus, vagina, ovaries, testes, prostate, heart, arteries, veins, spleen, glands, brain, spinal cord, nerves, and the like. Some embodiments provide systems and methods suitable for laparoscopic surgery. Some embodiments provide systems and methods suitable for non-invasive surgery. Some embodiments provide systems and methods suitable for minimally invasive surgery. Some embodiments provide systems and methods suitable for robotic or robot-assisted surgery.

[0050] Here, various embodiments will be referred to in detail, and examples thereof will be 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 invention and the described embodiments. However, the invention may be practiced optionally without these specific details. In other instances, well-known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.

[0051] The terms "first," "second," etc. are optionally used herein to describe various elements, but it should be understood that these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, as long as all occurrences of "the first device" are consistently renamed and all occurrences of "the second device" are consistently renamed, the first device may be called an instrument sensor without changing the meaning of the description, and similarly, the second device may be called the first device. The first device and the second device are both instruments, but they are not the same instrument.

[0052] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be a limitation of the claims. As used in the description of the embodiments and the appended claims, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. Further, as used herein, the term "and / or" refers to and encompasses any and all possible combinations of one or more of the associated listed items. Additionally, when the terms "comprises" and / or "comprising" are used herein, they specify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0053] As used herein, the term "when" optionally, depending on the context, is construed to mean "when" the stated precondition is true, or "in response to" or "in accordance with" or "in response to determining" or "as determined by" or "in response to detecting" the stated precondition. Similarly, the phrases "when [it is determined that the stated precondition is true]" or "when [the stated precondition is true]" or "when [the stated precondition is true]" optionally, depending on the context, are construed to mean "in response to determining" or "in response to detecting" or "as determined by" or "in accordance with" or "in response to detecting" that the stated precondition is true.

[0054] For ease of explanation, the following figures and corresponding descriptions may be described below with reference to uterine imaging, specifically, in conjunction with the diagnosis and ablation and / or treatment of uterine fibroids. However, one of ordinary skill 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 within any suitable body lumen, instruments for drug delivery, instruments for fluid injection and / or aspiration, and instruments for the treatment of cancer, tumors, fibroids, and other malignant or benign tumors.

[0055] FIG. 1A shows an illustration of an imaging component 100 according to some embodiments. The imaging component 100 may comprise a handle portion 101 connected to an imaging shaft 103. An imaging transducer 107 may be coupled to the distal end of the imaging shaft 103. The imaging shaft 103 may comprise a proximal end and a distal end, along with a cavity 105 that extends along the length of the shaft 103 from the proximal end towards the distal end. The cavity 105 may be at least partially open to the outside of the shaft 103. For example, the side or wall of the cavity 105 may comprise an elongated opening that communicates with the outside of the shaft 103. The elongated opening may communicate with the outside of the shaft 103 at least partially along the length of the shaft 103. In some embodiments, the edge of the elongated opening may be bent towards the inside of the cavity 105 of the shaft 103 (see, e.g., FIG. 1D further described below). The length of the shaft 103 may be long enough to provide complete access to a patient's uterus while the handle portion 101 remains outside the patient. Additionally, or alternatively, the shaft 103 may have a length that is significantly longer than a distance sufficient to provide complete access to the patient's uterus. The side opening may be open along the entire length of the shaft 103, or it may be open only partially along the length of the shaft 103. The side opening may be open, for example, for more than three-quarters, for more than half, or for more than one-quarter of the length of the shaft 103. The cavity 105 may be configured to receive at least one of a plurality of different additional instruments or attachments (e.g., ablation instrument 230 of FIG. 2) such that a first instrument may be received by the cavity 105, the first instrument may be removed from the cavity 105, and a second instrument may be received by the cavity 105.

[0056] The handle portion 101 can be one part of a two-piece handle such that when the first or second instrument is received, the two handle portions can be combined to form a single handle. The inner surface of the handle portion 109 can include an alignment element 111 such that the first and second parts of the handle can be reproducibly aligned relative to each other after the instrument is exchanged. The alignment element 111 can be configured such that the first and second parts can be sufficiently fixed relative to each other for using the two handle portions as a single handle. In some embodiments, the alignment element 111 can include a magnet. In other embodiments, the alignment element 111 can include, for example, a latch, a hook, or any other mechanism suitable for removably combining the two-piece handle. The handle portion can additionally include a positioning element 113, such as a complementary protrusion or a slot for accommodating other elements on the opposite handle portion, to provide a more reliable reference between the parts of the two-piece handle. The positioning element 113 can have mechanical features for fixing the instrument relative to the imaging component 100 by limiting the translational movement of the instrument along the axis of the shaft 103 of the imaging component.

[0057] In other embodiments, the imaging component 100 can be configured to be used with an instrument that does not have a handle portion. In such embodiments, the handle portion 101 of the imaging component 100 is sufficient to be used alone to guide the imaging component during the procedure. In some embodiments, the imaging component 100 can have a scale or a guide on the inner surface of the handle portion 109 for measuring the insertion depth of the instrument. In other embodiments, the imaging component 100 can be used without an instrument. In some embodiments, the scale can facilitate embodiments where the instrument does not have a handle. In other embodiments, the scale can facilitate the insertion of the components of the instrument in embodiments where the instrument has a handle.

[0058] Figure 1B shows a cross-sectional view of the imaging component 100 according to some embodiments. The body of the shaft 103 may include an internal structure for supporting electronic devices or other associated components for controlling the imaging transducer 107. The shaft 103 may further include a wire system or other bending mechanism to enable the shaft 103 to controllably bend, flex, or deflect the distal end of the shaft 103. The shaft 103 may include channels or ducts for directing fluid (e.g., water, saline, etc.) to the distal end of the shaft 103 and onto the tissue surface. The imaging shaft 103 may have a shape with a rounded cross-section, or a chamfered, rounded, or tapered edge such that the edge can be non-traumatic to the patient's opening during insertion or removal of the imaging component 100, with or without an instrument. Additionally, the shaft 103 may have a smooth outer surface. The shaft 103 may be made of a material such that the surface can be deformable to allow the shaft 103 to bend or conform to the shape of a body lumen.

[0059] The lumen 105 of the imaging shaft 103 may be configured to slidably receive one or more of a plurality of instruments (e.g., the ablation instrument 230 of FIG. 2). In some embodiments, the lumen 105 may be defined by the outer surface of the shaft 103. In some embodiments, the lumen 105 may be partially open along the wall such that the lumen 105 can communicate with the exterior of the shaft 103. The opening may be sufficiently closed to provide structural support such that the opening of the lumen is not significantly obstructed by the insertion or removal of an instrument when the imaging component 100 is inserted into the patient's body lumen. Optionally, the outer surface of the shaft 103 may include only non-traumatic edges. The lumen 105 of the imaging shaft 103 may be sufficiently open such that the lumen can allow some distortion of the lumen opening when instruments of different sizes are received or inserted into the lumen. The lumen 105 may facilitate cleaning of the imaging component.

[0060] FIG. 1C shows a cross-sectional view of an imaging component having a shaft 103 with a circular cross-section according to some embodiments. The imaging component of FIG. 1C may have a sufficiently circular cross-section such that the imaging component can be rotated without obstructing the patient lumen. FIG. 1D shows a cross-sectional view of an imaging component having an edge bent inwardly towards the interior of the cavity 105 according to some embodiments. The inwardly bent edge 1111 of the cavity serves to support the opening of the body lumen such that the shaft 103 can be non-invasively inserted into or removed from the body lumen, with or without an instrument.

[0061] The cavity 105 of the shaft 103 in the illustrated example may define a circular cross-sectional geometry, but in other embodiments, the cavity may be elliptical or any other geometry with rounded, or beveled edges and corners such that insertion or removal of the shaft does not damage the patient body lumen. In some embodiments, the cavity 105 may be non-cylindrically symmetric. In some embodiments, the cavity 105 may be asymmetric to provide an axis for alignment of an instrument (e.g., ablation instrument 230 of FIG. 2) therein. The cavity 105 may be open for less than three-quarters of its outer perimeter, and in addition or alternatively, the cavity may be open for less than half, less than one-quarter, and less than one-eighth of its outer perimeter. In other embodiments, the cavity 105 of the shaft 103 of the imaging component may be closed to the exterior of the shaft and an instrument may be inserted slidably completely within the shaft of the imaging component.

[0062] In some embodiments, the cavity 105 may have a substantially uniform cross-sectional area along the shaft 103. In other embodiments, a portion of the length of the shaft 103 may have a different cross-section than another portion of the length of the shaft. In one example, the proximal portion of the shaft 103 may be asymmetric to provide an axis for alignment of the instrument, and the distal portion of the shaft may have a circular cross-sectional area. In another embodiment, the cavity 105 tapers towards the end of the shaft 103. In such an example, tapering may facilitate feeding the instrument into the cavity 105. In some embodiments, the cross-sectional area of the cavity 105 may be small in diameter to allow for additional flexibility at the distal end of the shaft 103.

[0063] In some embodiments, the imaging shaft 103 may additionally comprise a tube 115 to be positioned within the cavity 105 of the imaging shaft 103. The tube 115 may comprise a lumen. The lumen of the tube 115 may be configured to slidably receive one or more of a plurality of instruments (e.g., ablation instrument 230 of FIG. 2). The tube 115 may be aligned parallel to the shaft 103 of the imaging component such that additional instruments / attachments may be slidably received by the tube. Subsequently, the tube 115 may be aligned so that it is parallel to the shaft 103 of the imaging component and then may slidably receive additional instruments / attachments. In some embodiments, the tube 115 may be disposable. In some embodiments, the tube 115 may be reusable, such as by being decoupled from the imaging shaft 103, cleaned, and autoclaved. The tube 115 may have an outer surface that substantially contacts the inner wall of the cavity 105. The tube 115 may have an inner surface configured to receive one or more of a plurality of instruments, and the inner surface may have a different geometry than the outer surface. In some embodiments, a second tube (not shown) may be removably inserted into the first tube 115, and the second tube may have a different inner lumen geometry than the first tube, thereby assisting in the insertion of one or more of a plurality of instruments. In some embodiments, the tube 115 may be rotated relative to the imaging component. In some embodiments, the tube 115 may be rotated completely relative to the imaging component in either direction under user control within the shaft 103 of the imaging component. In some embodiments, the tube 115 may be made slippery internally or externally to facilitate the insertion or removal of instruments.

[0064] The tube 115 can be inserted into the body lumen in its original position while the imaging component has not yet been advanced therein. Additionally, or alternatively, the tube 115 can be inserted into the shaft 103 of the imaging component prior to insertion of the imaging component into the body lumen. The tube 115 can have sufficient structural integrity to support the body lumen during insertion of the imaging component without an instrument. When an additional instrument (e.g., the ablation instrument 230 of FIG. 2) is inserted into the tube 115, or when the tube 115 is inserted into the imaging component in its original position, interference with the body lumen can be minimized. The tube 115 can be made of a sterilizable material. The tube 115 can be made of a material that is sufficiently low in cost such that it can be discarded after single use. Exemplary materials for disposable tubes can include polyimide, PTFE, urethane, and thermoplastic materials such as Pebax or nylon. The tube 115 can be made of a material having sufficient elasticity to conform to an instrument of a size slightly larger or smaller than the outer perimeter of the tube. In embodiments where the cavity 105 is not circular, the tube 115 can assume the shape of the cavity or it can assume another shape.

[0065] The tube 115 can reduce treatment costs by facilitating insertion and / or removal of an additional instrument (e.g., the ablation instrument 230 of FIG. 2) into the cavity 105 of the imaging component 100, thereby preventing damage to the surface of the cavity 105 of the imaging component 100. The tube 115 can reduce costs by facilitating cleaning of the cavity 105 of the imaging component 100. The tube 115 can reduce treatment costs by serving as an inexpensive component that provides a role as an adapter for various different therapeutic and / or diagnostic instruments / attachments, such as being provided in various different inner geometries for different instruments / attachments but having a uniform outer geometry to removably couple to the same single imaging component 100. For example, a disposable tube with a smaller inner diameter can facilitate insertion and control of a needle with an outer diameter smaller than the inner diameter of the shaft 103 of the imaging component.

[0066] FIG. 1E shows an enlarged view of the distal end of the imaging component 100 with a cavity 105 according to some embodiments. The distal end of the imaging component 100 may comprise an imaging transducer 107. The imaging transducer 107 may comprise an ultrasonic transducer and / or a plurality of ultrasonic transducers. The ultrasonic transducer may operate at a frequency within a range defined by 500 kHz, 1 MHz, 5 MHz, 10 MHz, 20 MHz, 100 MHz, or any two of the preceding values. Some embodiments of the ultrasonic transducer may comprise the specifications of other transducers from references by the same applicant incorporated herein.

[0067] In some embodiments, the distal end 117 of the imaging transducer 107 may additionally comprise a light emitting diode and / or a camera to provide an image to the user. In such embodiments, the imaging component 100 may serve not only as an optical scope but also as an ultrasonic imaging platform. The distal end 117 of the imaging transducer 107 may comprise optical components such as optical fibers, relay lenses, objective lenses, etc.

[0068] The imaging transducer 107 can be configured to be deflectable. The imaging transducer 107 can be configured to deflect with respect to the longitudinal axis of the shaft 103 of the imaging component 100. In some embodiments, the distal end of the imaging component 100 includes a hinge for facilitating deflection of the imaging transducer 107. The deflection of the imaging transducer 107 can be controlled by a deflection lever 119 on the handle portion 101 of the imaging component 100. One or more imaging transducers 107 can be oriented by deflection of the imaging transducer. One or more imaging transducers 107 can be oriented by deflection of the imaging transducer to facilitate maintaining the field of view of the image during treatment. Additionally, or alternatively, the imaging transducer 107 (e.g., an ultrasonic transducer) can be aligned radially and / or axially to image multiple fields of view simultaneously. The deflection of the imaging transducer 107 can be caused to avoid obstruction by an instrument (e.g., the ablation instrument 230 of FIG. 2). Additionally, or alternatively, the deflection of the imaging transducer 107 can be used to deflect a flexible instrument within the cavity 105. The distal end of the shaft 103 can include an interlock system similar to those in the incorporated references to prevent the imaging transducer 107 from obstructing the instrument or being damaged by a sharp edge of the instrument. The operation of the deflection lever 119 can function in a manner similar to that described in U.S. Patent No. 8,992,427, which is incorporated herein by reference. The deflection lever 119 can deflect the imaging transducer 107 by less than 45 degrees, and additionally, or alternatively, for example, 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.

[0069] The distal end of the imaging component 100 may have a non-traumatic edge to facilitate insertion of the imaging component, with or without an instrument within the cavity 105. The distal end of the cavity 105 of the imaging component 100 may additionally or alternatively comprise a portion angled axially with respect to the shaft 103 such that the distal end of the instrument can be deflected upward as it is pushed out of the distal end of the cavity 105. The distal end of the cavity 105 of the imaging component 100 may comprise an angled portion with an angle of 3 to 45 degrees. The distal end of the cavity 105 of the imaging component 100 may additionally or alternatively comprise an angled portion with an angle of less than 45 degrees, for example, less than 90 degrees, less than 60 degrees, less than 30 degrees, less than 15 degrees, and less than 5 degrees.

[0070] The cavity 105 of the imaging component 100 may be configured to slidably receive one or more of a plurality of instruments (e.g., the ablation instrument 230 of FIG. 2). In some embodiments, the imaging component 100 may be configured to receive one or more therapeutic or diagnostic instruments. In some embodiments, at least one of the plurality of different instruments may be a therapeutic or diagnostic instrument. In some embodiments, the instrument may comprise a therapeutic electrode, a diagnostic electrode, and / or a needle, such as a tissue ablation element, e.g., a radiofrequency ablation element, an ultrasonic ablation element, a heat-based ablation element, a cryoablation element, etc., and / or other instruments suitable for placement within the cavity of the imaging component. Additionally or alternatively, the instrument may be used to deliver a drug or other therapeutic agent to the tissue to be treated. FIG. 2 shows an ablation instrument 230 that may be slidably received by the imaging component. Those skilled in the art will recognize that many instruments, including those disclosed in FIG. 2, may be used with the imaging components disclosed herein.

[0071] FIG. 2 shows an enlarged view of the distal end of the imaging component 100 with the ablation instrument 230 disposed within the shaft 103 of the imaging component 100 according to some embodiments. The ablation instrument 230 can include a needle assembly comprising an introducer 235 and optionally an electrode ablation needle or tine 233. The shaft 231 of the ablation instrument 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 instrument 230 can comprise one or more of, for example, 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 skilled in the art.

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

[0073] The shaft 231 of the ablation instrument 230 can be made of a flexible material and / or a compliant material such that it can be deflected by the imaging transducer 107 and / or an angled portion within the cavity 105 of the shaft 103 of the imaging component 100. The distal end of the shaft 231 of the ablation instrument 230 can be deflected upward, among other possible purposes, to avoid damaging the imaging transducer 107. The distal end of the cavity 105 of the imaging component 100 can include an axially angled portion relative to the shaft 103 such that the distal end of the instrument (e.g., ablation instrument 230) can be deflected upward as it is pushed out of the distal end of the cavity 105. The distal end of the cavity 105 of the imaging component 100 can include an angled portion angled less than 45 degrees, and in addition, 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.

[0074] In addition, or alternatively, the shaft 231 of the ablation instrument 230 can include a wire system or other means for deflecting the distal end of the ablation instrument 230 such that the distal end of the ablation instrument 230 does not damage the imaging transducer 107. In some embodiments, the ablation instrument 230 can rotate relative to the imaging component 100. In some embodiments, the ablation instrument 230 can rotate completely in any direction relative to the imaging component 100 under user control within the shaft 103 of the imaging component 100 while the shaft 103 remains stationary such that the tines 233 can be optimally aligned.

[0075] The needle assembly can be constructed and controlled by a user as already described, for example, in U.S. Pat. Nos. 8,206,300, 8,262,574, and 8,992,427 by the same applicant, the entire disclosures of which are incorporated herein by reference. The needle assembly can be integrated into the instrument handle such that the position and deployment of the introducer 235 and the plurality of electrode ablation needles or tines 233 can be controlled by the user. The handle can be constructed as already described, for example, in U.S. Pat. No. 8,992,427 by the same applicant, the entire disclosure of which is incorporated herein by reference. The needle assembly can be compatible with systems and methods for improved safety margins and treatment margins during the treatment of uterine fibroids, as described in the incorporated references, for example. FIG. 2 illustrates an exemplary instrument that can be disposed within the shaft 103 of the imaging component 100, which example is not intended to be limiting.

[0076] FIG. 3A shows an assembly view of an imaging system comprising an imaging component 100 and an optical scope instrument 300 according to some embodiments. Although an optical scope element can be shown in the illustrated embodiment, the optical scope instrument 300 can be any other suitable instrument, such as any of the instruments disclosed herein (e.g., the ablation instrument 230 of FIG. 2). As illustrated in FIG. 3A, the imaging system can slidably receive a disposable tube 115 within the cavity 105 of the imaging component 100. In some embodiments, the imaging system can comprise a disposable tube 115 that is slidably received within the cavity 105 of the imaging component 100. In such embodiments, the instrument can be removably received within the lumen of the disposable tube 115. Additionally or alternatively, the cavity 105 of the imaging component 100 can be configured to slidably receive one or more of a plurality of instruments, which can comprise various therapeutic and / or diagnostic instruments.

[0077] In an illustrative example, the imaging component can removably receive an instrument such as a therapy electrode, a diagnostic electrode, and / or a needle, for example, a tissue ablation element such as a radiofrequency ablation element, an ultrasonic ablation element, a heat-based ablation element, a cryogenic ablation element, etc., and / or other instruments suitable for placement 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 the ablation instrument 230 illustrated in FIG. 2.

[0078] In the illustrated embodiment, the distal end 305 of the optical scope instrument 300 can include a light emitting diode and / or a camera to provide an image to the user. In such an embodiment, the optical scope instrument 300 can serve as an endoscope. The distal end 305 of the optical scope instrument 300 can include optical components such as optical fibers, relay lenses, objective lenses, etc. The optical scope instrument 300 can include a shaft 303 of the optical scope instrument 300 having a distal end and a proximal end. The shaft 303 of the optical scope instrument 300 can be configured to be removed from the handle component of the instrument or can be configured to be used without a handle component such that the optical scope instrument 300 can be disposable.

[0079] The shaft 303 of the optical scope instrument 300 can be made of a flexible material and / or a pliable material such that it can be deflected within the cavity 105 of the shaft 103 of the imaging component 100 by the imaging transducer 107 and / or an angled portion. Additionally, or alternatively, the shaft 303 of the optical scope instrument 300 can comprise a wire system or other means (e.g., push, pull, and / or rotation / torque) for deflecting the distal end 305 of the optical scope instrument 300. The deflection of the distal end 305 of the optical scope instrument 300 can serve to prevent damage to the imaging transducer 107 and / or enable multiple image angles to be collected. In some embodiments, the optical scope instrument 300 can rotate relative to the imaging component 100. In some embodiments, the shaft 103 of the imaging component remains stationary while the optical scope instrument 300 can rotate completely in any direction relative to the imaging component 100 under user control such that multiple image angles can be collected.

[0080] The shaft 303 of the optical scope instrument 300 can be longer than the shaft of the imaging transducer 107 such that an image can be collected from deep inside the uterus. In some embodiments, the shaft 303 of the optical scope instrument 300 can be 2 inches longer than the shaft of the imaging transducer 107. Additionally, or alternatively, for example, the shaft 303 can be 6 inches long, 4 inches long, 2 inches long, the same length, or within the range of any two of the previous values.

[0081] In the illustrated embodiment, the optical scope instrument 300 includes a handle portion 301. Although the handle portion 301 can be shown connected to the optical scope in the example illustrated, a similar handle portion can be connected to any suitable instrument such as those disclosed herein (e.g., the ablation instrument 230 of FIG. 2). The handle portion 301 can be the second part of a two-piece handle such that when the optical scope instrument 300 can be slidably inserted into the imaging component 100, the two handle portions can be combined to form a single handle. The handle portion can additionally include a positioning element 313 to provide a more secure reference between the parts of the two-piece handle. The positioning element 313 can mate with the positioning element 113. In such an embodiment, the handle portion can include a release control device 321 that can be actuated by the user to retract the positioning element 313 into the handle and allow the two-piece handle to be separated.

[0082] The handle portion 301 can additionally include one or more control elements 319. The control elements 319 can enable a medical professional to control the distal end of the instrument (e.g., the ablation instrument 230 of FIG. 2). In one example, the control elements 319 control a wire system that can reproducibly deflect or steer the distal end of the instrument. Additionally or alternatively, the control elements 319 rotate the shaft of the instrument (e.g., the shaft 303 of the optical scope instrument 300) within the lumen 105 of the imaging component 100 or within the disposable tube 115. In another example, the control element scoops tissue in a tissue collection instrument. In another example, the control element 319 deploys a needle assembly with optional tines in an ablation instrument. Additionally or alternatively, the control element 319 initiates an ablation procedure. In another example, the control element 319 applies pressure to inject a chemical substance through a drug delivery instrument. In another example, the control element 319 initiates or terminates image collection in the optical scope instrument.

[0083] Figure 3B shows an assembly view of an imaging system illustrating an attachment mechanism of a system according to some embodiments. The interior 309 of the handle portion 301 may include an alignment element 311. The alignment element 311 may be configured such that the optical scope instrument 300 can be reproducibly aligned relative to the imaging component 100 after the instrument is exchanged. Additionally, or alternatively, the alignment element 311 can sufficiently fix the instrument (e.g., the ablation instrument 230 of FIG. 2) and the imaging component 100 relative to each other for using the two handle portions 101, 301 as a single handle. In some embodiments, the alignment element 311 may include a magnet. In other embodiments, the alignment element 311 may include, for example, a latch, a hook, or any other suitable mechanism for removably combining two-piece handles. The interior 309 of the handle portion 301 may additionally include a positioning element 313 to provide a more reliable reference between the parts of the two-piece handle. In such embodiments, the handle portion may include a release control device 321 that can be actuated by a user to retract the positioning element 313 into the handle and allow the two-piece handle to be separated.

[0084] In some embodiments, a method for detecting or sensing the identification of a removable instrument is provided when coupling the imaging component 100 and the removable instrument (e.g., the optical scope instrument 300). The imaging component 100 may include software for recognizing the removable instrument and managing the interconnection between the imaging component 100 and the removable instrument. The sensor or mechanism can be, by way of non-limiting example, optical, RF, magnetic, biometric, electronic, and mechanical ID and readers. The method will ensure that only a qualified removable device is received on the imaging device and that only a compatible device can be used with the imaging component 100.

[0085] Figure 4 illustrates a shaft 103 of an imaging component 100, where the shaft 103 of the imaging component 100 can be flexible according to some embodiments. In the illustrated embodiment, the shaft 103 of the imaging component 100 can include a flexible shaft portion 403. The body of the flexible shaft portion 403 can include an internal structure for supporting electronics or other associated components for controlling the imaging transducer 107. The imaging transducer 107 can include channels or ducts for directing a fluid (e.g., water, saline, etc.) to the distal end of the shaft and onto the tissue surface. The flexible shaft portion 403 can comprise a portion of the length of the shaft 103 of the imaging component 100. In some embodiments, the flexible shaft portion 403 comprises less than three-quarters of the length of the shaft 103. Additionally, or alternatively, the flexible shaft portion 403 can comprise less than one-quarter of the length of the shaft 103, and less than one-eighth of the length of the shaft 103, and the entire length of the shaft 103.

[0086] The cross-sectional geometry of the flexible shaft portion 403 can continue the geometry of the shaft 103 such that no gaps or traumatic edges are created between the flexible shaft portion 403 and the shaft 103. The flexible shaft portion 403 can take a shape with a rounded, or sufficiently softened, chamfered, rounded, or tapered edge such that the edge is non-traumatic to the patient's opening during insertion or removal of the imaging component 100, with or without an instrument. The flexible shaft portion 403 can additionally comprise a smooth outer surface. The flexible shaft portion 403 can be made from a material such that the surface is deformable to allow the flexible shaft portion 403 to bend or conform to the shape of a body lumen.

[0087] The cavity of the flexible shaft portion 403 can be configured to slidably receive one or more of the plurality of instruments. The cavity of the flexible shaft portion 403 can be configured to continue the shape of the cavity 105 of the shaft 103 so that no gaps or traumatic edges are created between the flexible shaft portion 403 and the shaft 103. In some embodiments, the cavity of the flexible shaft portion 403 can be partially open along the wall such that the lumen of the cavity of the flexible shaft portion 403 can communicate with the exterior of the shaft 103. The opening of the flexible shaft portion 403 can be sufficiently closed to provide structural support such that when the imaging component 100 is inserted into the patient body lumen, the opening of the lumen is not significantly obstructed by the insertion or removal of the instrument. In some embodiments, the edge of the cavity of the flexible shaft portion 403 can bend inwardly towards the interior of the cavity, as in the embodiment illustrated in FIG. 1D. The inwardly bent edge of the cavity of the flexible shaft portion 403 can serve to support the opening of the body lumen such that the shaft 103 can be inserted into or removed from the body lumen non-traumatically, with or without an instrument. The cavity of the flexible shaft portion 403 can be sufficiently open such that some distortion of the cavity opening can occur when instruments of different sizes are received or inserted into the cavity. The cavity can facilitate cleaning of the imaging component 100 by providing access from the exterior to the interior of the cavity.

[0088] The cavity of the flexible shaft portion 403 in the illustrated example defines a circular cross-sectional geometry, but in other embodiments, the cavity of the flexible shaft portion 403 can be elliptical or any other geometry with rounded, or beveled edges and corners that is sufficiently softened so that insertion or removal of the shaft of the flexible shaft portion 403 does not damage the patient body lumen. In some embodiments, the cavity of the flexible shaft portion 403 can be asymmetric to provide an axis for alignment of the instrument therein. The cavity of the flexible shaft portion 403 can be open for less than three-quarters of its outer perimeter, and in addition or alternatively, the cavity can be open for less than half, less than one-quarter, and less than one-eighth of its outer perimeter. In other embodiments, the cavity of the flexible shaft portion 403 can be closed external to the shaft of the flexible portion, and the instrument can be inserted slidably fully within the shaft of the flexible portion.

[0089] In some embodiments, the flexible shaft portion 403 can be constructed from a compliant material and / or a flexible material so that it can be bent within the patient body lumen. In some embodiments, the shaft can be controllably bent along its longitudinal axis via a bending mechanism. In addition or alternatively, the flexible shaft portion 403 can include a wire system or other bending mechanism to enable the flexible shaft portion 403 to controllably bend, flex, or deflect the distal end of the flexible portion. The bending mechanism can be controlled by a control element on the handle portion of the imaging component 100 (e.g., the handle portion 101 shown in FIG. 3A).

[0090] In the illustrated example, the flexible shaft portion can be axially bent up to an angle of about 90 degrees relative to the handle. Additionally, or alternatively, the flexible shaft portion can be axially bent, for example, up to less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, less than 1 degree. Additionally, or alternatively, the flexible shaft portion can be bent about the longitudinal axis relative to the handle of the imaging component 100. In some embodiments, the flexible shaft portion can be bent about the longitudinal axis, for example, up to less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, less than 1 degree. Additionally, or alternatively, the flexible shaft portion can be bent about the medial-lateral axis relative to the handle of the imaging component 100. In some embodiments, the flexible shaft portion can be bent about the medial-lateral axis, for example, up to less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, less than 1 degree.

[0091] FIG. 5A illustrates a system for diagnosing and / or providing a therapy that can be removably coupled to a plurality of therapeutic and / or diagnostic instruments (e.g., ablation instrument 230 of FIG. 2) according to some embodiments. The system for performing therapy and / or diagnosis can comprise a therapeutic or diagnostic instrument 510 and an imaging component 520. The instrument 510 of the system for performing therapy and / or diagnosis can comprise a therapeutic or diagnostic instrument such as, for example, any of the therapeutic or diagnostic instruments described herein (e.g., ablation instrument 230 of FIG. 2). In some embodiments, the imaging component 520 can be used in conjunction with an instrument such as a therapy electrode, a diagnostic electrode, and / or a needle, for example, a tissue ablation element such as a radiofrequency ablation element, an ultrasonic ablation element, a heat-based ablation element, a cryoablation element, and / or any other instrument suitable for placement 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. FIG. 2 shows an exemplary instrument that can be slidably received by the imaging component. In some embodiments, the system can comprise first and second therapeutic or diagnostic instruments. The imaging component 520 can comprise an imaging component such as, for example, examples, embodiments, and variations of the imaging components described herein with respect to the imaging components.

[0092] FIG. 5B illustrates a system for diagnosing and / or delivering therapy, and in some embodiments a therapeutic and / or diagnostic instrument 510 (e.g., ablation instrument 230 of FIG. 2) is being removably coupled to an imaging component 520. As shown, the instrument 510 can be axially aligned with 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 technique.

[0093] FIG. 5C illustrates a system for diagnosing and / or delivering therapy, and in some embodiments a therapeutic and / or diagnostic instrument 510 is removably coupled to an imaging component 520. The system for diagnosing therapy can include retention elements such as hooks, latches, or mechanical features described herein to fix the instrument 510 to the imaging component 520. The system for diagnosing and / or delivering therapy can be configured to couple to multiple instruments. For example, a first instrument can be coupled to the imaging component 520, and subsequently, a second instrument can be coupled. The imaging component 520 can be configured to couple to both the first and second therapeutic and / or diagnostic instruments simultaneously or individually. For example, if the first instrument is a disposable tube, the second instrument can be slidably inserted within the first instrument. In some embodiments, the imaging component 520 can be pre-coupled to the first and / or second therapeutic or diagnostic instrument external to the target site and configured to be delivered to the target site within a patient. Additionally, or alternatively, the imaging component 520 can be configured to removably couple to both the first and second therapeutic or diagnostic instruments simultaneously or individually after the imaging component 520 has been delivered to the target site within the patient (e.g., the instruments can be coupled in situ).

[0094] FIG. 6 shows a system 600, which may include a system controller 612, an imaging display 614, and a treatment probe. The treatment probe, in FIG. 6, includes two attached sub-components of an imaging component 100 and an instrument 300. Those skilled in the art will understand that the instrument 300 of the treatment probe may be an ablation instrument (e.g., the ablation instrument 230 shown in FIG. 2). The system controller 612 will typically be a microprocessor-based controller that enables both treatment parameters and imaging parameters to be set in a conventional manner. The display 614 will usually be included within a common enclosure 618 with the controller 612, but may be provided within a separate enclosure. The treatment probes 100, 300 may include an imaging transducer 107 that can be connected to the controller 612 by an imaging cable 624 to provide images captured by the imaging component 100 to the controller 612 as displayed by the display 614. However, in addition or alternatively, the imaging component 100 may communicate wirelessly with the controller 612. The instrument 300 may be connected to and communicate with the controller 612 via an instrument cable 622 to provide one or more of a control signal, a feedback signal, a position signal, or a status signal, etc. However, in addition or alternatively, the instrument 300 may communicate wirelessly with the controller 612. In embodiments where the imaging component 100 and the instrument 300 are connected by cables 624, 622, the controller 612 may supply power to one or both components.

[0095] Controller 612 will typically further include an interface for a treating physician to provide information to the controller 612, such as a keyboard, touch screen, control panel, mouse, joystick, directional pad (i.e., D-pad), etc. Optionally, the touch screen may be part of the imaging display 614. The energy delivered to the treatment probes 100, 300 by the controller 612 can be radio frequency (RF) energy, microwave energy, treatment plasma, heat, cold temperature (cryotherapy), or any other conventional energy-mediated treatment modality. Alternatively, or in addition, the treatment probes 100, 300 can be adapted to deliver drugs or other therapeutic agents to the tissue anatomical structure to be treated. In some embodiments, the probes 100, 300 are plugged into an ultrasonic system and a separate radio frequency (RF) generator. An interface line connects the ultrasonic system and the RF generator. In some embodiments where the instrument 300 is an ablation instrument (e.g., ablation instrument 230 shown in FIG. 2), the RF generator is configured to deliver energy to a needle assembly, which can then be used to ablate the target tissue.

[0096] The instrument 300 includes a handle portion 301, and the handle portion 301 has one or more slidably mounted control elements 319 on its upper surface. In some embodiments, the control element 319 can control the position of an internal stop within the handle that can be monitored by the controller 612 to calculate the size and position of the boundaries of the targeted region and / or safety region shown on the display 614. In embodiments where the instrument 300 is an ablation instrument (e.g., ablation instrument 230 shown in FIG. 2), the stop can further serve to physically limit the deployment of the introducer, optionally, the electrode ablation needle or tine.

[0097] Some embodiments of the methods and systems of the present disclosure may be integrated with systems and methods for establishing and adjusting the displayed safety and treatment zone boundaries. Such embodiments may include the systems and methods of incorporated references including U.S. Patent Publication No. 2014 / 0073910 (now U.S. Patent No. 9,861,336), U.S. Patent No. 8,992,427, U.S. Patent No. 11,219,483, and PCT Publication No. WO2018 / 089523, the contents of which are incorporated herein by reference. Some embodiments of the methods and systems of the present disclosure may be integrated with systems and methods for mapping and planning systems. Such embodiments may include the systems and methods of incorporated references including PCT Publication No. WO2018 / 089523.

[0098] FIG. 7A illustrates an imaging component 100 that can be used to treat a myoma F located within the myometrium M within the uterus U under the uterine wall UW (endometrium) and surrounded by the serosal wall SW. The imaging component 100 is introduced into the uterus U transvaginally, transcervically (or alternatively, laparoscopically), and the imaging transducer 107 can be deployed to image the myoma F within the field of view indicated by the dashed line. The needle assembly is in its retracted position and thus not shown in FIG. 7A.

[0099] FIG. 7B shows an image that would be visible on a display (e.g., display 614 shown in FIG. 6) showing safety and treatment boundaries according to some embodiments. In some embodiments, when the tumor F is located on the display 614, the control device on the handle can be used to locate and size both the treatment boundary TB and the safety boundary SB. In some embodiments, initially, the virtual boundary lines TB and SB may not be positioned over the tumor F and may not be appropriately sized for treating the tumor F. Prior to beginning therapy, the user (e.g., physician) may desire to both position and size the boundaries TB and SB for appropriate treatment. Since the imaging transducer 107 may already be positioned relative to the uterine wall UW, the only way to advance the treatment and safety boundaries TB, SB may be to move the boundaries forward by actuating the control element 319. In some embodiments, it may move the treatment and safety boundaries TB and SB forward along the axis AL, thereby translating the area to be treated. This may move the virtual boundaries on the real-time image display 614 over the image of the tumor F. Additionally or alternatively, the size of the treatment boundary TB may be enlarged or reduced to reduce the risk of affecting healthy and / or more sensitive tissue surrounding the treatment area.

[0100] In embodiments where the instrument is a tissue ablation element, while holding the imaging component 100 stable, the physician may then advance the needle slide and extend the introducer 235 into the tumor F as shown in FIG. 7C. The introducer 235 is shown in its deployed or extended position, and the plurality of electrode ablation needles or tines are in their retracted position within the introducer and thus not shown in FIG. 7C. The illustration of FIG. 7C includes a representation of the imaging component 100 corresponding to the physical probe present within the patient. The remainder of FIG. 7C corresponds to the image present on the target display 614.

[0101] After the introducer 235 is fully deployed such that it is limited by an optional physical or virtual needle stop housing within the instrument handle 301, the electrode ablation needle or tine 233 can be deployed by advancing the tine slide. Engagement of the tine slide with an optional tine stop, or as visually indicated on the display 614, reaches the target level of tine deployment. Optionally, the imaging component 100 can be rotated about a central axis (typically aligned with the axis of the introducer 235) to confirm the treatment and safety boundaries TB, SB within all visual planes around the myoma F. The display 614 will show the positions of the treatment and safety boundaries TB, SB in real time with respect to the target myoma F and serosa. The plurality of electrode ablation needles or tines 233 are then configured as shown in FIG. 7D and power can be supplied to the tines 233 (optionally, to the introducer 235) to achieve treatment within the boundaries depicted by the virtual treatment boundary TB. In FIG. 7D, both the introducer 235 (see FIG. 7C) and the plurality of electrode ablation needles or tines 233 are shown in their deployed or extended positions. It should be understood that in some ablation procedures (e.g., where the target tissue is small in size), the introducer 235 and / or the plurality of electrode ablation needles or tines 233 will only be partially deployed. Further, it should be understood that after the procedure is complete, the introducer 235 and the plurality of electrode ablation needles or tines 233 can be retracted from their fully or partially deployed positions to a retracted position. Again, FIG. 7D mixes both the virtual image that would be present on the display 614 and the physical presence of the imaging component 100. (Myoma cutting and ablation example)

[0102] As disclosed above and as shown in FIG. 6, the uterine fibroid ablation system and device can use RF or other energy to coagulate (e.g., ablate) uterine fibroids or other tissue. According to embodiments of the present disclosure, in addition to ablating uterine fibroids or other tissue, embodiments of such systems and devices can include a cutting or insertion mode for a therapeutic procedure, which will assist the ablation element, e.g., the (RF or other energy) introducer and electrode, in penetrating more easily and accurately into the fibroid or tissue.

[0103] Some fibroids have a hard encapsulated surface layer or a high-density structure, which frequently cause difficulties in tissue penetration. For example, such a surface layer provides resistance to penetration of an ablation needle or the like and can cause deflection of such a needle when advanced towards the fibroid; and / or can cause deflection of such a needle in such a path during introducer deployment. These can either lengthen the process of positioning the ablation device and / or deployment of its electrodes or otherwise cause inaccuracies in tissue targeting, resulting in a procedural delay. Aspects of the present disclosure can soften the fibroid surface layer and / or high-density tissue, reduce the resistance to the introducer tip / electrode, and improve treatment accuracy and efficiency.

[0104] According to an aspect of the present disclosure, a system for penetrating a target tissue can comprise an ablation element and a radio frequency (RF) generator configured to deliver energy to the ablation element. In some embodiments, the system for penetrating a target tissue is also a system for ablating the target tissue. In some embodiments, the target tissue can be a fibroid such as a uterine fibroid. In some embodiments, the system can further include an ultrasonic imaging device. Further, in some embodiments, the system can also include a controller designed to control the delivery of energy to the ablation element.

[0105] The ablation element can be configured to penetrate the target tissue. The ablation element can be further configured to ablate the target tissue. The ablation element can, for example, comprise a needle assembly as shown in FIG. 2, which can further comprise an introducer 235 and optionally an electrode ablation needle or tine 233. As shown in FIGS. 7A, 7C, and 7D, in some embodiments, the ablation element is first inserted into the target tissue and then subsequently used to ablate the target tissue.

[0106] The RF generator can be configured to deliver energy to the ablation element. The RF generator can be a monopolar RF generator. In some embodiments, the RF generator can be a bipolar RF generator. In the monopolar mode, the output characteristics from the RF generator can be essential in determining a particular extent of tissue impact and power (with which the instrument is used). Within the monopolar circuit, typically, there is an active electrode at the surgical site and a return electrode at a remote site (generally positioned on the patient's thigh). Current can flow through the body between the electrodes.

[0107] According to aspects of the present disclosure, the RF generator can have a plurality of different modes or settings configured for different steps of the procedure. For example, according to the present disclosure, the RF generator can comprise three waveform settings, namely, cut, blend, and coagulate / ablate. The blend mode and the coagulate / ablate mode are optional. Although the cut mode and the coagulate / ablate mode are detailed below, it will be understood by those skilled in the art that the blend mode provides energy in a manner between the cut mode and the coagulate / ablate mode. The cut mode may also be referred to herein as the insertion mode. In some embodiments, the tissue in the cut mode or insertion mode may not actually be cut. In some embodiments, in the cut mode or insertion mode, the tissue is softened to facilitate penetration.

[0108] In some embodiments, the cutting or insertion mode is configured to assist the ablation element in cutting or penetrating through the target tissue. The cutting or insertion mode can be added as a pre-ablation step to facilitate the deployment of the ablation element (e.g., introducer or electrode ablation needle) into the target tissue. For example, as shown in FIG. 8, the cutting or insertion mode can provide an oscillating power to the ablation element. In other examples described herein, the power in the cutting or insertion mode is not oscillated. The RF energy of the cutting or insertion mode can be configured to enable the ablation element to cut or soften the tissue contacted by the ablation element. When the RF generator settings are in "cut", in some non-limiting examples, the ablation element can maintain a substantially constant surface temperature, and the voltage and / or current and / or power can be oscillated. This can cause a rapid increase in temperature in the tissue in contact with the ablation element, which can lead to tissue evaporation and cutting. The oscillating power or voltage from the RF generator can heat (and in some embodiments, evaporate) the tissue in contact with the ablation element by inducing intracellular oscillations of ionized molecules. When in the "cut" mode, the RF generator is configured to supply enough energy to cut the target tissue, but not so much as to damage the tip of the ablation element, generate excessive carbonization (i.e., formation of carbon), and / or cause impedance runaway.

[0109] In some embodiments, the system for penetrating a target tissue is further configured to provide mechanical vibrations or cutting forces to the ablation element during a cutting or insertion mode. Special mechanical vibrations or cutting forces in addition to the "cutting" mode RF energy can further facilitate the insertion of the ablation element into the target tissue. In some embodiments, the system can detect the force on the ablation element when the ablation element is in contact with (e.g., pushed into) the target tissue, and in some embodiments, the delivery of RF energy from the RF generator to the ablation element is controlled based on the detected force. In such embodiments, for example, RF energy can be delivered to the ablation element according to a cutting or insertion mode when the ablation element is applying a forward force (e.g., being pushed) to the target tissue, and when the pressure is temporarily removed, the delivery of RF energy to the ablation element will temporarily stop. Such a force or pressure-based feedback mechanism can reduce the heating of the target tissue while the RF generator is in a cutting or insertion mode.

[0110] Embodiments of the present disclosure in the "cutting" mode have been verified on ablation surrogates in multiple bench tests. It has been observed that the "hot" tip (e.g., the ablation element that receives RF energy from the RF generator in the "cutting" mode) can soften the target tissue and assist in the insertion of the ablation element during a uterine ablation procedure. In short, the addition of a cutting or insertion mode assists the ablation element (e.g., introducer and / or multiple electrode ablation needles) in penetrating the layers of the target tissue while they are being deployed prior to ablation.

[0111] In some embodiments, the ablation / coagulation mode is configured to ablate and / or coagulate the target tissue. The ablation mode may be similar to the mode disclosed in FIG. 7D. In some embodiments, when set to the "ablation" mode, the RF generator provides an increase in energy (e.g., an increase in voltage) until the target tissue reaches the target temperature, after which time the energy (e.g., voltage) provided from the RF generator to the ablation element decreases. At a given target temperature setting (degrees) using the RF generator, the voltage may first be increased and then gradually begin to decrease after reaching the target temperature. Compared to the "cutting" mode, the results of the "ablation" mode may be slower but a deeper rise in tissue temperature and collagen denaturation.

[0112] FIG. 8 shows a graph of the power over time for each of the cutting or insertion mode and the ablation or coagulation mode in treating the target tissue according to some embodiments. In some embodiments, the RF generator can be configured to be controlled to provide limits in temperature during each of the "cutting" and "ablation" modes, but the limits in temperature during the cutting or insertion mode can be lower than the limits in temperature during the ablation or coagulation mode. The power curves shown in FIG. 8 emphasize that, in some embodiments, when the RF generator is in the cutting mode, in this example, the ablation element that receives the oscillating power from the RF generator cuts the contact tissue but does not substantially heat the tissue surrounding the ablation element. On the other hand, when the RF generator is in the ablation mode, the ablation element heats (e.g., ablates) the volume of tissue surrounding the ablation element.

[0113] In some embodiments, the system can further include an ultrasonic imaging device. The ultrasonic imaging device can be configured to provide visualization of the ablation instrument when the ablation instrument penetrates the target tissue. The ultrasonic imaging device can be similar to the imaging transducer disclosed hereinabove (e.g., the imaging transducer 107 shown in FIG. 2). As disclosed elsewhere above, the ultrasonic imaging device can be coupled to the ablation instrument. An example of an ultrasonic imaging device coupled to the ablation instrument is shown in FIG. 2.

[0114] In some embodiments, the system can further include a controller. The controller can be designed to control the delivery of energy to the ablation element. The controller can be similar to the system controller 612 shown in FIG. 6. As disclosed above and shown in FIG. 6, the instrument 300 can be connected to and communicate with the controller 612 to provide one or more of a control signal, a feedback signal, a position signal, or a status signal. In some embodiments, the controller can be configured to monitor the temperature measured by the ablation instrument at the interface with the target tissue. In some embodiments, when the ablation element penetrates into the target tissue, the controller can be further configured to maintain a temperature of about, at least about 80°C, 85°C, 90°C, 95°C, 100°C, 105°C, 110°C, 115°C, or less than or greater than that, and any range including any two of the foregoing values. In some embodiments, the controller 612 can be configured to provide an alert when the temperature at the interface is within a certain temperature range. The alert can provide an instruction to initiate penetration of the ablation instrument into the target tissue. In some embodiments, the temperature range can be, for example, 80°C to 115°C, 80°C to 110°C, 80°C to 105°C, 80°C to 100°C, or 85°C to 105°C. The alert can be anything that the user (e.g., a physician) can notice, such as a noise, illumination or color change of a light bulb, or a tactile vibration.

[0115] In some embodiments, the controller 612 can maintain the temperature measured by the ablation device by modulating the power delivered to the ablation device. In some embodiments, the controller 612 can modulate the power delivered to the ablation device and provide oscillations in temperature at the interface with the target tissue when the ablation device penetrates into the target tissue. In some embodiments, the controller 612 can be configured to control the delivery of energy to the ablation device for ablating the target tissue after the ablation device has penetrated into the target tissue. In some embodiments, controlling the delivery of energy to the ablation device for ablating the target tissue can include maintaining a substantially constant temperature in the target tissue for ablating the tissue. Since the target tissue can retain heat over the course of the target ablation, the energy delivered to the ablation element can be decreased to maintain a substantially constant temperature in the target tissue. An example of this can be seen in FIG. 9. In the example shown in FIG. 9, after about 63 seconds, the power delivered to the ablation element is decreased while the temperature in the target tissue is maintained substantially constant.

[0116] In embodiments where the temperature of the tissue is monitored, the ablation device can comprise one or more thermocouples. An example of a location where a thermocouple can be provided is shown in FIG. 11. FIG. 11 shows a schematic side cross-sectional view of the distal tip of introducer 235. The introducer 235 is shown at least partially in an extended position. The introducer 235 is provided at the distal end of the shaft 231 of the ablation device. FIG. 11 further shows a plurality of electrode ablation needles or tines 233 shown in their retracted positions within the introducer 235. The plurality of electrode ablation needles or tines 233 can include a central electrode ablation needle or tine 233'. The remaining electrode ablation needles or tines 233 can be deployed at least partially radially outwardly from the introducer 235 (as shown in FIG. 2), while the central electrode ablation needle or tine 233' can be deployed substantially parallel and collinear with the introducer 235.

[0117] In some embodiments, the temperature measured by the ablation device as the ablation device penetrates into the target tissue can be measured by a thermocouple positioned on one of the electrode ablation needles or tines 233 when the plurality of electrode ablation needles or tines 233 are retracted within the introducer 235. In some embodiments, the thermocouple is positioned on the central electrode ablation needle or tine 233'.

[0118] In some embodiments, the central electrode ablation needle or tine 233' can contact tissue while in its retracted position within the introducer 235. In some embodiments, as shown in FIG. 11, the central tine 233' can project into the valley surface 1130 of the introducer 235 slightly beyond the central edge 1135 of the introducer 235. To ensure that the central tine 233' can be deployed from within the introducer 235, a central opening can be provided within the introducer 235. The central tine 233' can be deployed from the introducer 235 through the central opening, and the central tine 233' can be retracted back into the introducer 235 through the central opening. As shown in FIG. 11, the distal portion of the central opening can be uncovered (e.g., exposed to the contacting tissue), while the proximal portion of the central opening can be covered (e.g., not exposed to the contacting tissue). The uncovered (e.g., exposed to the contacting tissue) surface of the introducer 235 is the valley surface 1130 of the introducer 235. The distal edge of the portion of the introducer covering the covered portion of the central opening is the central edge 1135 of the introducer 235. In some embodiments, the central tine 233' can project slightly beyond the central edge 1135 of the introducer 235 such that the most distal tip of the central tine 233' is substantially in line with, or only slightly uncovered by, the central edge 1135 of the introducer 235. This most distal tip of the central tine 233' can be in intimate contact with the surrounding tissue, and the thermocouple can be positioned on the central electrode ablation needle or tine 233'.

[0119] A system for penetrating a target tissue such as that described above can be used in methods of tumor ablation (e.g., uterine fibroid ablation). Some embodiments of tumor ablation treatment are depicted in FIGS. 8, 9, 10, and 12. First, the ablation element is deployed into the tumor. In some embodiments of the method of tumor ablation, the ablation element is delivered to contact the tumor (e.g., uterine fibroid). While the ablation element is in contact with the tumor, RF energy can be delivered to the ablation element according to a cutting or insertion mode. In the cutting or insertion mode, according to some examples, the power can be vibrated to assist the ablation element in penetrating into the tumor. One embodiment of this power delivery over time is shown in the "Cutting Mode" section of FIG. 8. In some embodiments, the delivery of RF energy in the cutting or insertion mode is controlled to a maximum output so as not to exceed, for example, about, at least about 50W, 55W, 60W, 65W, 70W, 75W, 80W, or greater. In some embodiments, the delivery of RF energy in the cutting or insertion mode is controlled so as not to exceed, for example, 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, or 40 seconds. In some embodiments, RF energy is delivered to the ablation element in the cutting or insertion mode such that a substantially constant temperature is maintained at the surface of the ablation element. In some embodiments, the substantially constant temperature of the ablation element can be, for example, 80°C to 115°C. In some embodiments, the substantially constant temperature maintained at the surface of the ablation element during the cutting or insertion mode is lower than the target temperature, which is the temperature of the tissue in contact with the ablation element during ablation. The delivery of RF energy in the cutting or insertion mode during the deployment of the ablation element into the tumor can soften the tumor tissue. This softening of the tumor tissue can reduce the force required for the ablation element to penetrate the tumor. Further, reducing the required penetration force allows the ablation element to penetrate the tumor without substantially deforming the tumor, for example, during penetration.When assisted by the cutting or insertion mode, the ablation element can be deployed into the tumor.

[0120] FIG. 9 shows one embodiment of a method of using a system for penetrating a target tissue according to another example. According to the embodiment depicted in FIG. 9, in order to initiate cutting or insertion, power can be increased to increase the monitored temperature of the tissue in contact with the ablation instrument. After about 10 seconds, when the monitored temperature reaches about 90° C. (or about 80° C. in another example), the introducer begins to deploy and begins to penetrate into the target tissue. For example, the introducer is deployed to a position of about 33 mm over about 8 seconds. Over the subsequent about 4 seconds, the monitored temperature of the tissue increases from about 80° C. to about 100° C. At the 21-second mark, the electrode ablation needle or tine begins to deploy from the introducer. In this example, the electrode ablation needle or tine advances about 12 mm in about 5 seconds. As shown, the temperature can oscillate based on modulation of the power and is not maintained constant during the cutting or insertion mode, and preferably, in one example, is maintained within a range of about 80° C. to about 115° C. during penetration of the ablation element.

[0121] It should be understood that FIG. 9 is an illustrative example. For example, more or less power can be applied while the cutting or insertion power in FIG. 9 is about 40-50 W. In addition, the cutting or insertion process can require more or less than 25 seconds. For example, cutting or insertion may require more time if less power is used, while cutting or insertion may require less time if more power is used or if the procedure calls for incomplete deployment of the electrode ablation needle.

[0122] Next, when the ablation element is inserted into the target tissue, the ablation element ablates the myoma. After the ablation element penetrates into the myoma and unfolds therein, RF energy can be delivered to the ablation element according to a coagulation or ablation mode. In the coagulation or ablation mode, voltage or power can be applied to the ablation element, increased, and then decreased after the tissue in contact with the ablation element reaches the target temperature. In some embodiments, the target temperature can be, for example, 80°C to 115°C. In some embodiments, the myoma is maintained at the target temperature throughout the ablation or coagulation mode. One embodiment of this power delivery over time is shown in the "Ablation Mode" section of FIG. 8. When the ablation of the myoma is complete, the systems and devices being used can be, for example, moved to another myoma for ablation or removed from the procedure area (e.g., removed from the uterus).

[0123] FIG. 10 shows one embodiment of a method of using a system for ablating target tissue. The graph shown in FIG. 10 shows the same example as depicted in FIG. 9, but FIG. 10 shows both the cutting or insertion of the ablation element and the ablation procedure. The first approximately 25 seconds of FIG. 10 corresponds to the graph shown in FIG. 9. At approximately 25 seconds, the ablation element is shown to be inserted into the target tissue and ablation is shown to begin. Over approximately 40 seconds, the power is increased and the tissue temperature correspondingly increases. When the tissue reaches the target ablation temperature (100°C to 110°C in FIG. 10), the system can modulate the energy delivered to the tissue to keep the temperature substantially constant at the target ablation temperature. As shown in FIG. 10, the power decreases to approximately 10 W over a period of approximately 40 seconds while the monitored temperature remains substantially constant. This continues over the duration of the procedure. When the procedure is complete, the ablation element can be retracted.

[0124] It should be understood that FIG. 10 is an illustrative example. For example, the ablation temperature shown in FIG. 10 is between 100° C. and 110° C., but that temperature can be higher or lower according to the present disclosure.

[0125] FIG. 10 depicts two modes: The first approximately 25 seconds depicts a cutting or insertion mode, and the remaining time depicts an ablation or coagulation mode. It should be understood that ablation can immediately follow cutting or insertion, but there can be a period (e.g., 30 or 60 or fewer or more seconds) after cutting or insertion is complete and before ablation is initiated. This period can be used, for example, to plan or otherwise prepare for the ablation procedure.

[0126] The "cut" mode or form and the "ablate" mode or form can be different from each other, but in some embodiments, delivery of RF energy by the cutting or insertion mode can also preheat the uterine fibroids, which can then reduce the time required for the ablation procedure.

[0127] In addition, while the "cutting" and "ablation" steps of the method are detailed above, the ablation procedure may include additional steps outlined in the flowchart of FIG. 12. In some embodiments, for example, before the ablation element can be deployed into the tumor, the target tissue (e.g., the tumor) is identified. In some embodiments, the target tissue can be identified using the imaging component 100, as shown, for example, in FIGS. 1A, 3A, 3B, 4, 5A-5C, and 6. In some embodiments, after identifying the target, the ablation procedure is planned. For example, the appropriate equipment is prepared. In some embodiments, the plan can include providing the ablation element adjacent to the tumor. In some embodiments where the ablation element is an ablation instrument similar to the ablation instrument 230 shown in FIG. 2, the placement of the ablation instrument adjacent to the tumor can be as shown in FIG. 7A. A safety check can then be performed to ensure that the target tissue can be safely penetrated and / or ablated. In embodiments where the ablation element is similar to the ablation instrument 230 shown in FIG. 2, the next step can include deploying the introducer (235 in FIG. 7C). Then, in some embodiments, the next step can include deploying the electrode needle or tine (233 in FIG. 7D). Deploying the introducer and / or deploying the electrode needle can be performed according to the "cutting or insertion mode" detailed above. Once the ablation element is properly deployed into the tumor, the tumor can be ablated as disclosed herein. Ablating the tumor can be performed according to the "ablation mode" detailed above. In some embodiments, when the tumor ablation is complete, the electrode needle and introducer can be retracted. The system and device can then be moved, for example, to another tumor for ablation or removed from the procedure area (e.g., removed from the uterus).

[0128] Embodiments of the present disclosure are applicable to the Sonata® System available from Gynesonics, Inc. (Redwood City, CA) and the following U.S. patents and patent applications by the same applicant (incorporated herein by reference), namely, U.S. Patent No. 7,918,795, U.S. Patent No. 9,357,977, U.S. Patent No. 7,815,571, U.S. Patent No. 7,874,986, U.S. Patent No. 10,058,342, U.S. Patent No. 8,088,072, U.S. Patent No. 8,206,300, U.S. Patent No. 9,861,336, U.S. Patent No. 8,992,427, U.S. Patent No. 11,219,483, U.S. Patent Publication No. 2020 / 0275975 (currently U.S. Patent No. 11,612,431), U.S. Patent Publication No. 2021 / 0228179 (currently U.S. Patent No. 11,583,243), and similar systems, devices, and methods described in U.S. Patent Publication No. 2019 / 0350648.

[0129] The foregoing description and examples are merely described to illustrate the present disclosure and are not intended to be limiting. Each of the disclosed aspects and embodiments of the present disclosure can be considered individually or in combination with other aspects, embodiments, and variations of the present disclosure. Additionally, unless otherwise specified, none of the steps of the methods of the present disclosure are limited to any particular order of implementation. Modifications of the disclosed embodiments that incorporate the spirit and substance of the present disclosure may occur to those skilled in the art, and such modifications are within the scope of the present disclosure.

[0130] Orientation terms used in this specification, such as "upper", "bottom", "horizontal", "vertical", "longitudinal", "lateral", and "end", are used in the context of the illustrated embodiments. However, the present disclosure should not be limited to the illustrated orientations. In fact, other orientations are also conceivable and within the scope of the present disclosure. Terms related to circular shapes as used in this specification, such as diameter or radius, should be understood not to require a perfect circular structure, but rather to apply to any suitable structure with a cross-sectional area that can be measured from end to end. Generally, terms related to shapes such as "circular", or "cylindrical", or "semicircular", or "semicylindrical", or any related or similar terms, are not required to strictly conform to the mathematical definitions of circles or cylinders or other structures, and can include structures that are reasonable approximations.

[0131] In particular, conditional language used in this specification, such as "can", "may", "might", "for example", etc., generally conveys that some embodiments include a certain feature, element, and / or state, while other embodiments do not, unless specifically stated otherwise or understood in a context where it is used otherwise. Thus, such conditional language is generally not intended to imply that a feature, element, block, and / or state is required for one or more embodiments in any way, or that one or more embodiments necessarily include the logic for determining whether these features, elements, and / or states should be included or implemented in any particular embodiment, with or without the input or prompt of the drafter.

[0132] Connective language such as the phrase "at least one of X, Y, and Z" is generally understood in a context such that, unless specifically stated otherwise, it conveys that an item, term, etc. can be any of X, Y, or Z. Thus, such connective language generally does not intend to imply that an embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0133] As used herein, the terms "substantially", "about", and "approximately" represent an amount close to the recited amount that still performs the desired function or achieves the desired result. For example, in some embodiments, depending on the context, the terms "substantially", "about", and "approximately" can refer to an amount within or equal to less than 10% of the recited amount. As used herein, the term "substantially" primarily represents a value, amount, or property that includes or tends to include a particular value, amount, or property. By way of example, in some embodiments, depending on the context, the term "substantially parallel" can refer to any deviation from exact parallelism of 20 degrees or less.

[0134] When the term "about" is used in front of a range of two numerical values, it is intended to include the range between about the first value and about the second value, as well as the range from the defined first value to the defined second value.

[0135] Unless explicitly stated otherwise, articles such as "a" or "an" should generally be interpreted to include one or more of the recited items. Thus, phrases such as "a device configured to" are intended to include one or more of the recited devices. Such one or more of the recited devices can be configured collectively to perform the recited listing. For example, "a processor configured to perform listings A, B, and C" can include a first processor configured to perform listing A that cooperates with a second processor configured to perform listings B and C.

[0136] Terms such as "comprising", "including", "having", etc. are synonymous and are used inclusively in a non-restrictive manner, not excluding additional elements, features, acts, operations, etc. Similarly, terms such as "some", "a", etc. are synonymous and are used in a non-restrictive manner. Further, the term "or" is used in its inclusive sense (not in its exclusive sense) when used, for example, to connect a list of elements, such that the term "or" means one, some, or all of the elements in the list.

[0137] Overall, the language of the claims is to be construed broadly based on the language employed in the claims. The language of the claims is not limited to the non-exclusive embodiments and examples illustrated and described in this disclosure or discussed during the examination of this application.

[0138] Intravascular implants and systems, devices, and methods for their accurate placement are disclosed in the context of certain embodiments and examples, but this disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and certain modifications and equivalents thereof. The various features and aspects of the disclosed embodiments can be combined with each other or substituted with respect to each other to form various modes of intravascular implants and systems, devices, and methods for their accurate placement. The scope of this disclosure should not be limited by the specific disclosed embodiments described herein.

[0139] In the context of separate implementations, certain features described in this disclosure can be implemented in combination in a single implementation. Conversely, the various features described in the context of a single implementation can be implemented separately in multiple implementations or in any suitable sub-combination. Although a feature may be described herein as acting in a certain combination, one or more features from the claimed combination can, in some cases, be excluded from the combination, and the combination can be claimed as any suitable sub-combination or variation of any suitable sub-combination.

[0140] The methods and devices described herein may be susceptible to various modifications and alternative forms, and specific examples thereof are shown in the drawings and described in detail herein. However, the present invention is not limited to the specific forms or methods disclosed, but on the contrary, the present invention is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the various embodiments described and the appended claims. Further, the disclosure herein of any specific feature, aspect, method, property, characteristic, quality, attribute, element, etc. related to an embodiment can be used in all other embodiments described herein. Any method disclosed herein need not be performed in the order recited. Depending on the embodiment, one or more of the acts, events, or functions of any of the algorithms, methods, or processes described herein can be performed in a different sequence, added, combined, or completely omitted (e.g., not all described acts or events are necessary for the practice of the algorithm). In some embodiments, the acts or events can be performed in parallel rather than sequentially, for example, through multi-threaded processing, interrupt processing, or across multiple processors or processor cores, or on other parallel architectures. Further, no element, feature, block, or step, or group of elements, features, blocks, or steps is necessary or essential to each embodiment. Additionally, all possible combinations, sub-combinations, and rearrangements of systems, methods, features, elements, modules, blocks, etc. are within the scope of this disclosure. The use of sequential or chronological language such as "then," "next," "after," "subsequently," etc. is generally intended to facilitate the flow of the text and not to limit the sequence of the acts being performed, unless specifically described otherwise or understood in a context where it is used otherwise. Thus, while some embodiments may be implemented using the sequence of acts described herein, other embodiments may be implemented according to a different sequence of acts.

[0141] Furthermore, although operations may be depicted in the drawings or described herein in a particular order, to achieve desirable results, such operations need not be performed in the particular order shown or in sequential order, and not all operations need to be performed. Other operations not depicted or described can be incorporated into the exemplary methods and processes. For example, one or more additional operations can be performed before, after, simultaneously with, or between any of the operations described. Further, the operations can be rearranged or reordered in other implementations. Additionally, the separation of various system components in the implementations described herein should not be understood as requiring such separation in all implementations, and it should be understood that the components and systems described generally can be integrated together within a single product or packaged into multiple products. In addition, other implementations are within the scope of the present disclosure.

[0142] Some embodiments are described in relation to the accompanying drawings. Although a figure is drawn and / or shown to scale, such scale is not to be limiting as dimensions and ratios other than those shown are envisioned and are within the scope of the embodiments disclosed herein. Distances, angles, etc. are illustrative only and not necessarily in strict relation to the actual dimensions and layout of the devices shown. Components can be added, removed, and / or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc. related to the various embodiments can be used in all other embodiments described herein. In addition, any method described herein can be practiced using any suitable device for performing the recited steps.

[0143] The methods disclosed herein may include certain actions performed by an operator, however, the methods may further explicitly or implicitly include any third party order of those actions. For example, an action such as "positioning an electrode" includes "ordering the positioning of the electrode".

[0144] In summary, various embodiments and examples of intravascular implants and devices and methods for accurate placement are disclosed. Systems, devices, and methods for intravascular implants and their accurate placement are disclosed in the context of those embodiments and examples, however, the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or other uses of the embodiments, as well as certain modifications and equivalents thereof. The present disclosure explicitly contemplates that the various features and aspects of the disclosed embodiments may be combined with one another or substituted with respect to one another. Accordingly, the scope of the present disclosure should not be limited by the specific disclosed embodiments described herein, but should be determined only by a fair reading of the following claims.

[0145] The scope disclosed herein further includes any and all overlaps, subranges, and combinations thereof. Language such as "maximum", "at least", "greater than", "less than", "between", etc. includes the recited numerical values. Terms such as "about" or "approximately" preceding a numerical value include the recited numerical value and should be interpreted based on the circumstances (e.g., as accurately as reasonably possible under the circumstances, e.g., ±5%, ±10%, ±15%, etc.). For example, "about 1V" includes "1V". Terms such as "substantially" preceding a phrase include the recited phrase and should be interpreted based on the circumstances (e.g., to the maximum extent reasonably possible under the circumstances). For example, "substantially right angle" includes "right angle". Unless otherwise stated, all measurements are at standard conditions, including temperature and pressure.

Claims

1. A system for penetrating target tissue, wherein the system is an ablation element configured to penetrate the target tissue, A radio frequency generator configured to deliver energy to the ablation element and Equipped with, The aforementioned radio frequency generator is A cutting or insertion mode configured to cut through the target tissue, wherein the cutting or insertion mode provides power vibrations configured to cut the tissue in contact with the ablation element, an ablation or coagulation mode configured to ablate and / or coagulate the target tissue Equipped with, The ablation or coagulation mode provides an increase in power, followed by a decrease in power after the target tissue reaches a target temperature.

2. The system according to claim 1, wherein the cutting or insertion mode is configured to maintain a substantially constant surface temperature of the ablation element.

3. The system according to claim 1, wherein the cutting or insertion mode is configured to cause a rapid increase in temperature in the tissue in contact with the ablation element.

4. The system according to claim 1, wherein the radio frequency generator is configured to be controlled to provide temperature limits during the cutting or insertion mode and during the ablation or solidification mode, the temperature limit during the cutting or insertion mode being lower than the temperature limit during the ablation or solidification mode.

5. The system according to claim 1, further configured to provide mechanical vibration or cutting force during the cutting or insertion mode.

6. The ablation element is provided with an introduction device, according to claim 1.

7. The system according to claim 1, wherein the ablation element comprises a plurality of electrode ablation needles.

8. The system according to claim 1, further comprising a controller configured to control the delivery of energy to the ablation element, wherein the controller is configured to monitor the temperature measured by the ablation element at the interface with the target tissue and to maintain the temperature between approximately 80°C and approximately 115°C when the ablation element penetrates into the target tissue.

9. The system according to claim 1, wherein the target tissue is a uterine fibroid.

10. The system according to claim 8, wherein the controller is configured to modulate the power delivered to the ablation element when the ablation element penetrates the target tissue, and to maintain the temperature at the interface between approximately 80°C and approximately 115°C.

11. The system according to claim 8, wherein the controller is configured to modulate the power delivered to the ablation device when the ablation element penetrates the target tissue, thereby providing vibrations at the temperature at the interface with the target tissue.

12. The system according to claim 8, wherein the controller is configured to provide an alert when the temperature at the interface is between approximately 80°C and approximately 115°C, and to provide instructions to begin penetration by the ablation element into the target tissue.

13. The controller is First, the radio frequency generator is operated in the cutting or insertion mode so that it penetrates the target tissue when the ablation device comes into contact with the target tissue, Next, the radio frequency generator is operated in the ablation or coagulation mode so that the ablation instrument penetrates the target tissue and then ablates and / or coagulates the target tissue. The system according to claim 8, configured to perform the following:

14. The system according to claim 13, wherein the controller is configured to subsequently operate the radio frequency generator in the ablation or coagulation mode immediately after the completion of the operation of the radio frequency generator in the cutting or insertion mode.

15. The system according to claim 13, wherein the controller is configured to continue operating the radio frequency generator in the disconnection or insertion mode for a period of time after the completion of the operation of the radio frequency generator in the disconnection or insertion mode.

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