Systems and methods for hysteromyoma ablation

Abstract

Various systems, devices, and methods for tissue penetration are disclosed. The system includes an ablation element that penetrates tissue and a radiofrequency generator that delivers energy to the ablation element. The radiofrequency 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 for cutting or softening tissue contacted by the ablation element. The ablation or coagulation mode is used to ablate or coagulate tissue.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS AND INCORPORATION BY REFERENCE

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 356,223, filed on June 28, 2022, the entire contents of which are incorporated herein by reference.

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

[0004] The present disclosure relates to medical systems, devices and methods, and in particular to medical systems, devices and methods for ablation of uterine fibroids. The present disclosure also relates to inserting an instrument into a target tissue. Description of Related Technology

[0005] Current medical treatments of organs and tissues within a patient's body typically use needles or other elongated bodies to deliver energy, therapeutic agents, etc. Optionally, these methods use ultrasound imaging to visualize and identify the treatment or diagnostic target and to track the position of the needle relative to the target.

[0006] Treatments for uterine fibroids have been proposed that rely on transvaginal or laparoscopic positioning of a treatment device in the patient's uterus. A radiofrequency or other energy or therapeutic delivery needle is deployed from the device into the fibroid, and energy and / or therapeutic substances are delivered to ablate or treat the fibroid. To facilitate locating the fibroid and positioning the needle within the fibroid, the device includes an ultrasound imaging array having an adjustable field of view in a generally forward or lateral direction relative to an axial shaft carrying the needle. The needle is advanced from the shaft and through the field of view so that the needle can be visualized and guided into the tissue and target fibroid.

[0007] Current systems, devices, and methods for therapeutic or diagnostic procedures (e.g., for treating uterine fibroids) may be less than ideal in at least some aspects. For example, many current devices for tissue ablation require insertion of an ablation element into a target tissue. However, the target tissue provides resistance to many current devices that are configured to penetrate into the target tissue. For example, when a user attempts to insert an instrument into a target tissue (especially a dense target tissue such as a fibroid), the force required to penetrate the target tissue may cause the target tissue to substantially deform or otherwise resist insertion of the instrument.

[0008] In view of the above, there is a need for improved systems, devices and methods for penetrating into dense target tissues such as fibroids. Such systems, devices and methods will address at least some of the above disadvantages and will, for example, be more easily used in a wider variety of therapeutic and diagnostic procedures. Overview

[0009] The embodiments disclosed herein each have several aspects, no one of which is solely responsible for the desirable attributes of the present disclosure. Without limiting the scope of the present disclosure, its more salient features will now be briefly discussed. After considering this discussion, and particularly after reading the section entitled "Detailed Description," one will understand how the features of the embodiments described herein provide advantages over existing systems, devices, and methods.

[0010] The present disclosure relates to medical systems, devices and methods, in particular but not limited to medical systems, devices and methods for ablation of uterine fibroids. Embodiments of the present disclosure provide an ablation element configured to penetrate a target tissue, and provide a radio frequency generator configured to deliver energy to the ablation element. In addition, the radio frequency generator of an embodiment of the present disclosure may include a cutting or insertion mode configured to cut through the target tissue. The cutting or insertion mode can provide a voltage oscillation that is configured to cut the tissue contacted by the ablation element when the ablation element is inserted into the target tissue before the ablation process begins. Using such a cutting or insertion mode during the insertion of the ablation element into the target tissue can reduce the force required to insert the ablation element into the target tissue, which in turn can make the insertion easier and more accurate.

[0011] In some aspects, a system for penetrating a target tissue is provided. The system may include an ablation device and a controller configured to control the delivery of energy to the ablation device, wherein the controller is configured to monitor a temperature measured by the ablation device at an interface with the target tissue and maintain the temperature between about 80° C. and about 115° C. as the ablation device penetrates into the target tissue.

[0012] The system provided in the above or other aspects as described herein may include one or more of the following features. The ablation device may include an introducer and a plurality of electrode ablation needles extendable from a retracted position within the introducer. When the plurality of electrode ablation needles are retracted within the introducer, the temperature measured by the ablation device is measured by a thermocouple located on one of the electrode ablation needles. The plurality of electrode ablation needles may include a central electrode extendable from a retracted position within the introducer, and wherein the thermocouple is positioned on the central electrode. The controller may be configured to modulate the power delivered to the ablation device when the ablation device penetrates into the target tissue to maintain the temperature between about 80°C and about 115°C. The controller may be configured to modulate the power delivered to the ablation device when the ablation device penetrates into the target tissue to provide an oscillation of temperature at the interface with the target tissue. The controller may be configured to provide an alarm when the temperature at the interface is between about 80°C and about 115°C to provide an indication of the start of penetration of the ablation device into the target tissue. The system may also include an ultrasound imaging device configured to provide visualization of the ablation device as the ablation device penetrates the target tissue. The ultrasound imaging device may be coupled to the ablation device. The controller may be configured to control the delivery of energy to the ablation device after the ablation device has penetrated into the target tissue to ablate the target tissue. The controller may be configured to control the delivery of energy to the ablation device to maintain a substantially constant temperature at the target tissue to ablate the target tissue. The system may also include a radio frequency generator configured to deliver energy to the ablation device as the ablation device penetrates into the target tissue.

[0013] In some aspects, a method of penetrating a target tissue is provided. The method may include delivering an ablation device to contact the target tissue, delivering energy to the ablation device to increase the temperature measured by the ablation device at the interface with the target tissue to between about 80°C and about 115°C, and advancing the ablation device to penetrate into the target tissue while modulating the power to maintain the temperature at the interface with the target tissue between about 80°C and about 115°C.

[0014] The method described above or in other aspects as described herein may include 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 oscillates. The method may also include ablating the target tissue by delivering energy to the ablation device to maintain the temperature at the interface with the target tissue at a substantially constant temperature. The ablation device may include an introducer and a plurality of electrode ablation needles extendable from a retracted position within the introducer, wherein the plurality of electrode ablation needles extend at least partially from the introducer while maintaining the temperature at the interface with the target tissue between about 80°C and about 115°C.

[0015] In some aspects, a system for penetrating target tissue is provided. The system may include an ablation element configured to penetrate the target tissue, a radiofrequency generator configured to deliver energy to the ablation element, wherein the radiofrequency generator includes a cutting or insertion mode configured to cut through the target tissue and an ablation or coagulation mode configured to ablate and / or coagulate the target tissue, wherein the cutting or insertion mode provides power oscillations configured to cut tissue contacted by the ablation element, and the ablation or coagulation mode provides an increase in power and then a decrease in power after the target tissue reaches a target temperature.

[0016] The system provided in the above or other aspects as described herein may include 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 radiofrequency generator may be configured to be controlled to provide a temperature limit during the cutting or insertion mode and during the ablation or coagulation mode, wherein the temperature limit during the cutting or insertion mode is lower than the temperature limit during the ablation or coagulation mode. The system may also be configured to provide mechanical vibration or cutting force during the cutting or insertion mode. The ablation element may include an introducer. The ablation element may include a plurality of electrode ablation needles. The system may also include 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 maintain the temperature between about 80°C and about 115°C when the ablation element penetrates into the target tissue. The target tissue may be a uterine fibroid.

[0017] In some aspects, a method of ablation of a uterine fibroid is provided. The method may include delivering an ablation element in contact with the uterine fibroid, delivering radiofrequency energy to the ablation element according to a cutting or insertion mode while the ablation element is in contact with the uterine fibroid, wherein in the cutting or insertion mode, a voltage or power is modulated based on a temperature measured at an interface between the ablation element and the uterine fibroid to assist the ablation element in penetrating into the uterine fibroid, and after the ablation element penetrates into the uterine fibroid, delivering radiofrequency 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 fibroid.

[0018] The method described above or in other aspects as described herein may include one or more of the following features. The voltage or power may oscillate in the cutting or insertion mode. The voltage or power may be modulated in the cutting or insertion mode to maintain the temperature at the interface between about 80°C and about 115°C. The voltage or power in the coagulation mode may be increased and then decreased after the tissue in contact with the ablation element reaches the target temperature. The delivery of radiofrequency energy according to the cutting or insertion mode may preheat the uterine fibroids. The delivery of radiofrequency energy according to the cutting or insertion mode may soften the uterine fibroids, thereby allowing the ablation element to penetrate the uterine fibroids without substantially deforming the uterine fibroids during penetration. The delivery of radiofrequency energy according to the 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 between about 80°C and about 115°C. The delivery of radiofrequency energy according to the cutting or insertion mode may be controlled to a maximum output of no more than 70 watts. The delivery of radiofrequency energy according to the cutting or insertion mode may be controlled to no more than 30 seconds. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Certain features of the present disclosure are described below with reference to the accompanying drawings. The illustrated embodiments are intended to illustrate rather than limit the embodiments. Various features of different disclosed embodiments may be combined to form additional embodiments as part of the present disclosure.

[0020] Figure 1A A perspective view of an imaging component is shown according to some embodiments.

[0021] Figure 1B According to some embodiments Figure 1A A side sectional view of an imaging component.

[0022] Figure 1C A side cross-sectional view of an imaging component having a shaft with a circular cross-section is shown in accordance with some embodiments.

[0023] Figure 1D A side cross-sectional view of an imaging component having edges that curve inwardly toward the interior of a cavity is shown in accordance with some embodiments.

[0024] Figure 1E According to some embodiments Figure 1A An enlarged perspective view of the distal end of the imaging component including the lumen.

[0025] Figure 2 According to some embodiments Figure 1A An enlarged perspective view of the distal end of an imaging component of FIG. 1 , wherein a radiofrequency ablation device is disposed within the shaft of the imaging component.

[0026] Figure 3A According to some embodiments, Figure 1AAn assembly view of the imaging system of the imaging components and optical microscope apparatus.

[0027] Figure 3B According to some embodiments Figure 3A An assembled view of the imaging system showing the attachment mechanisms of the system.

[0028] Figure 4 According to some embodiments Figure 1A An enlarged perspective view of a shaft of an imaging component, wherein the shaft of the imaging component is flexible.

[0029] Figure 5A A perspective view of a system for diagnosing and / or providing therapy is shown, according to some embodiments, the system including an imaging component configured to be removably coupled to a plurality of therapeutic and / or diagnostic modalities. Figure 5A Separate imaging components and therapeutic and / or diagnostic equipment are shown.

[0030] Figure 5B According to some embodiments Figure 5A A perspective view of a system of claim 1, wherein a therapeutic and / or diagnostic device is in a ready position to be removably coupled to an imaging component.

[0031] Figure 5C According to some embodiments Figure 5A A perspective view of a system in which a therapeutic and / or diagnostic device is removably coupled to an imaging component.

[0032] Figure 6 A schematic diagram of a system of the present invention is shown, the system including a system controller, an image display, and a treatment probe having a deployable needle assembly and an imaging transducer.

[0033] Fig. 7A A device positioned within a uterus to image tissue thereof is shown according to some embodiments. Figure 1A Schematic diagram of the imaging component.

[0034] Figure 7B According to some embodiments, Fig. 7A An image of the surgical field captured in FIG. 1 that will be visible on a display, showing safety boundaries and treatment boundaries.

[0035] Figure 7C An image of a surgical field is shown that combines a virtual image showing safety and treatment boundaries with the physical presence of an introducer in accordance with some embodiments.

[0036] Fig.7DAn image of a surgical field is shown that combines a virtual image showing safety and treatment boundaries with the physical presence of an introducer and electrode ablation needle or tine in accordance with some embodiments.

[0037] Figure 8 Shown is a graph of power versus time for each of a cutting or insertion mode and an ablation mode when treating tissue, according to some embodiments.

[0038] Fig. 9 Graphs showing power, temperature, and depth of the introducer and electrode over time during cutting or insertion mode are shown in accordance with some embodiments.

[0039] Fig.10 The present invention shows each of the cutting or insertion mode and the ablation mode when treating tissue according to some embodiments. Fig. 9 Graph of the curve.

[0040] Fig.11 A schematic side cross-sectional view of the distal tip of an introducer showing the positioning of a central electrode ablation needle in its retracted position is shown in accordance with some embodiments.

[0041] Fig.12 A flow chart depicting a method of cutting and ablating tissue according to some embodiments is shown. Detailed Description of the Preferred Embodiments

[0042] The various features and advantages of the present disclosure will now be described with reference to the accompanying drawings. The following description is merely illustrative in nature and is not intended to limit the present disclosure, the application or use of the present disclosure. The scope of the present disclosure exceeds the specific disclosed implementations and / or uses and their obvious modifications and equivalents. Therefore, it is intended that the scope of the present disclosure should not be limited by any specific implementation described below. As will be apparent to those of ordinary skill in the art after considering the principles disclosed herein, the features of the illustrated embodiments may be modified, combined, removed and / or replaced. In addition, the embodiments disclosed herein may include several novel features, wherein no single feature is solely responsible for its desired attributes or is essential for practicing the systems, devices and / or methods disclosed herein.

[0043] Certain embodiments of the present disclosure relate to therapeutic devices and related methods and systems that incorporate a cutting or insertion mode to facilitate insertion of an ablation element into a target tissue. Embodiments of these devices, methods, and systems are described in the following embodiments, followed by examples of how these devices, methods, and systems may be applied to ablation of uterine fibroids. However, the improvements described herein are not limited to ablation of uterine fibroids and may be incorporated into any diagnostic and / or therapeutic device described herein, which may also incorporate an imaging component.

[0044] Examples of diagnostic and / or therapeutic devices with imaging devices 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 may include a lumen extending across (e.g., along) the length of a shaft, wherein the lumen may be configured to removably receive a plurality of different instruments (e.g., Figure 2 ablation device 230). In some embodiments, the lumen of the imaging component may be partially open to the outside of the shaft. The imaging component may include an imaging transducer at the distal end of the shaft. In addition, the shaft of the imaging component may be configured so that additional therapeutic and / or diagnostic instruments / accessories can be removed and / or received and / or inserted during a medical procedure without interfering with the imaging component. Additionally or alternatively, the imaging component may remain in place when receiving and / or removing the therapeutic and / or diagnostic instrument. In some embodiments, the imaging component may be used without additional therapeutic and / or diagnostic instruments connected to it. In some embodiments, the imaging component may be inserted into and / or removed from a patient's lumen in the absence of a therapeutic and / or diagnostic instrument. Such an imaging component may be used during a medical procedure, such as during non-invasive, minimally invasive, and / or laparoscopic surgery.

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

[0046] The cavity of the imaging component can improve existing imaging and treatment methods by providing an imaging component cavity that can be more easily cleaned than components with closed cavities or lumens. The cavity of the imaging component can improve existing methods for imaging and treatment by facilitating the manufacture of the imaging component. Embodiments of the present disclosure can reduce the cost of treatment by providing an imaging component with a disposable tube. Embodiments of the present disclosure can reduce the cost of treatment by providing an imaging component with a disposable tube. Figure 2The invention can reduce the cost of treatment by providing a reusable imaging component that can be used to insert a cavity into which an ablation device 230 is inserted. Embodiments of the imaging component can provide an axis that allows the device to always align with the ultrasound image. Embodiments of the present disclosure can accommodate a variety of devices with different sizes and shapes. Embodiments of the present disclosure can provide scale or position information to assist in the insertion of the device.

[0047] The systems and methods of the present disclosure may be particularly useful for treating fibroids in a patient's uterus. The imaging component may be deployed transvaginally and transcervically into the uterus, or in other cases, laparoscopically to and through the exterior of the uterus or other organ or tissue tract. The imaging component may be used in conjunction with additional instruments (such as treatment electrodes), diagnostic electrodes and / or needles, tissue ablation elements (e.g., Figure 2 The ablation device 230 (such as, for example, a radiofrequency ablation element, an ultrasonic ablation element, a heat-based ablation element, a cryoablation element, etc.), and / or other devices suitable for being disposed in the cavity of the imaging component. Additionally or alternatively, the additional device can be used to deliver drugs, implants, or other therapeutic agents to the tissue to be treated. Additionally or alternatively, the tissue ablation element can include an embodiment or variation of the needle / tip assembly in commonly assigned U.S. Patents 8,206,300, 8,262,574, and 8,992,427, the contents of which are incorporated herein by reference.

[0048] Embodiments of the present disclosure may improve upon at least some of the systems and methods of the commonly assigned references by providing a shaft of an imaging component having a non-destructive edge to enable the imaging component to be used alone. In some embodiments, embodiments of the present disclosure may improve upon the removal and / or receipt of additional instruments (e.g., Figure 2 The imaging component may also include a disposable tube inserted into the cavity to provide a working channel for inserting additional instruments having different diameters and making the system easier to clean, among many possible purposes.

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

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

[0051] Reference will now be made in detail to various embodiments, examples of which are illustrated in the accompanying drawings. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present invention and the described embodiments. However, the present invention may optionally be practiced without these specific details. In other cases, well-known methods, processes, components, and circuits are not described in detail in order to avoid unnecessarily obscuring aspects of the embodiments.

[0052] It should be understood that although the terms "first," "second," etc. are optionally used herein to describe various elements, these elements should not be limited by these terms. These terms are merely used to distinguish one element from another. For example, a first instrument may be referred to as an instrument sensor, and similarly, a second instrument may be referred to as a first instrument without changing the meaning of the description, as long as all occurrences of "first instrument" are consistently renamed and all occurrences of the second instrument are consistently renamed. The first instrument and the second instrument are both instruments, but they are not the same instrument.

[0053] The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the claims. Unless the context clearly indicates otherwise, the singular forms "a", "an" and "the" used in the description of the embodiments and the appended claims are intended to include the plural forms as well. It is also to be understood that the term "and / or" as used herein refers to any and all possible combinations of one or more of the associated listed items and includes these combinations. It will be further understood that when used in this specification, the terms "comprises" and / or "comprising" specify the presence of stated features, wholes, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, wholes, steps, operations, elements, parts and / or combinations thereof.

[0054] As used herein, the term "if" is optionally interpreted as meaning "when" or "upon" or "in response to determining" or "in accordance with a determination" or "in response to detecting" the stated condition is true, depending on the context. Similarly, the phrase "if it is determined [that a stated condition precedent is true]" or "if [astated condition precedent is true]" or "when [a stated condition precedent is true]" is optionally interpreted as meaning "upon determination" or "upon determination" or "upon detection" or "in response to detecting" the stated condition is true, depending on the context.

[0055] For ease of explanation, the following figures and corresponding description may be described below with reference to uterine imaging, particularly in conjunction with the diagnosis and ablation and / or treatment of uterine fibroids. However, one skilled in the art will recognize that similar imaging components may be used with similar instruments in other therapeutic applications, such as instruments for tissue biopsy, for drug delivery, for fluid infusion and / or aspiration, and for treating cancer, tumors, fibroids, and other malignant or benign masses in any suitable body cavity.

[0056] Figure 1A An illustration of an imaging component 100 according to some embodiments is shown. The imaging component 100 may include a handle portion 101 connected to an imaging shaft 103. At the distal end of the imaging shaft 103, an imaging transducer 107 may be coupled. The imaging shaft 103 may include a proximal end and a distal end, wherein a cavity 105 extends across the length of the shaft 103 from the proximal end toward the distal end. The cavity 105 may be at least partially open to the exterior of the shaft 103. For example, a side or wall of the cavity 105 may include an elongated opening that communicates with the exterior of the shaft 103. The elongated opening may be at least partially connected to the exterior of the shaft 103 along the length of the shaft 103. In some embodiments, the edges of the elongated opening may be curved toward the interior of the cavity 105 of the shaft 103 (e.g., see further description below). Figure 1D ). The length of shaft 103 can be long enough to fully access the patient's uterus while handle portion 101 remains external to the patient. Additionally or alternatively, shaft 103 can include a length that is significantly longer than a distance sufficient to fully access the patient's uterus. The side opening can be open along the entire length of shaft 103, or it can be open only partially along the length of shaft 103. The side opening can, for example, be open more than three quarters of the length of shaft 103, more than half of the length of shaft 103, or more than one quarter of the length of shaft 103. Lumen 105 can be configured to receive a plurality of different additional instruments or accessories (e.g., Figure 2 At least one of the ablation devices 230) can be configured so that the first device can be received by the cavity 105, the first device can be removed from the cavity 105, and the second device can be received by the cavity 105.

[0057] The handle portion 101 can be part of a two-part handle so that when receiving the first instrument or the second instrument, the two handle portions can be combined to form a single handle. The inner surface of the handle portion 109 can include an alignment element 111 so that the first and second parts of the handle can be reproducibly aligned relative to each other after replacing the instrument. The alignment element 111 can be configured so that the first and second parts can be sufficiently fixed relative to each other to use the two handle portions as a single handle. In some embodiments, the alignment element 111 can include a magnet. In other embodiments, the alignment element 111 can include, for example: a latch, a hook, or any other mechanism suitable for removably combining the two-part handle. The handle portion can additionally include a positioning element 113, such as a slot for accommodating a complementary protrusion or other element on the opposing handle portion, so as to provide a more secure positioning between the parts of the two-part handle. The positioning element 113 can include a mechanical feature to fix the instrument relative to the imaging component 100 by limiting the translation of the instrument on the axis of the shaft 103 of the imaging component.

[0058] In other embodiments, the imaging component 100 can be configured for use with an instrument that does not have a handle portion. In such embodiments, the handle portion 101 of the imaging component 100 is sufficient alone to guide the imaging component during surgery. In some embodiments, the imaging component 100 can have a scale or guide on the inner surface of the handle portion 109 to measure the insertion depth of the instrument. In other embodiments, the imaging component 100 can be used without an instrument. In some embodiments, the scale can facilitate embodiments where the instrument does not have a handle. In other embodiments, in embodiments where the instrument has a handle, the scale can facilitate the insertion of components of the instrument.

[0059] Figure 1B A cross-sectional view of an imaging component 100 according to some embodiments is shown. The body of the shaft 103 may include an internal structure to carry electronic devices or other associated components to control the imaging transducer 107. The shaft 103 may also include a wire system or other flexure mechanism to allow the shaft 103 to controllably bend, flex, or deflect the distal end of the shaft 103. The shaft 103 may include a channel or conduit for guiding a fluid (e.g., water, saline, etc.) to the distal end of the shaft 103 and onto the surface of the tissue. The cross-section of the imaging shaft 103 may be circular, or take a shape with sufficiently softened, chamfered, rounded, or beveled edges so that the edges can be non-destructive to the patient opening during insertion or removal of the imaging component 100 with or without an instrument. The shaft 103 may additionally include a smooth outer surface. The shaft 103 may be made of a material with a deformable surface so that the shaft 103 can bend or adapt to the shape of a body cavity.

[0060] The lumen 105 of the imaging shaft 103 may be configured to slidably receive a plurality of instruments (eg, Figure 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 so that the lumen 105 may be in communication with the outside of the shaft 103. The opening may be sufficiently closed to provide structural support so that when the imaging component 100 may be inserted into a patient's body cavity, the opening of the lumen may not be significantly disturbed by the insertion or removal of the instrument. Optionally, the outer surface of the shaft 103 may include only non-damaging edges. The lumen 105 of the imaging shaft 103 may be sufficiently open so that when instruments of different sizes may be received or inserted into the cavity, the cavity may allow some deformation of the cavity opening. The lumen 105 may facilitate cleaning of the imaging component.

[0061] Figure 1C A cross-sectional view of an imaging component having a shaft 103 with a circular cross-section is shown in accordance with some embodiments. Figure 1C The cross-section of the imaging component can be sufficiently circular so that the imaging component can be rotated without interfering with the patient's lumen. Figure 1D A cross-sectional view of an imaging component according to some embodiments is shown having an inwardly curved edge toward the interior of lumen 105. The inwardly curved edge 1111 of the lumen can be used to support the opening of a body lumen so that shaft 103 can be atraumatically inserted into or removed from the body lumen with or without instrumentation.

[0062] Although the lumen 105 of the shaft 103 may define a circular cross-sectional geometry in the illustrated example, in other embodiments, the lumen may be elliptical or any other geometry having sufficiently softened, rounded, or beveled edges and corners such that insertion or removal of the shaft may not damage the patient's body lumen. In some embodiments, the lumen 105 may be non-cylindrically symmetrical. In some embodiments, the lumen 105 may be asymmetrical to provide for insertion of an instrument (e.g., Figure 2 The ablation device 230 of the imaging component is aligned with the axis thereof. The cavity 105 can be open in cross section to less than three quarters of its circumference, additionally or alternatively, the cavity can be open to less than half of its circumference, less than one quarter of its circumference, and less than one eighth of its circumference. In other embodiments, the cavity 105 of the imaging component shaft 103 can be closed to the exterior of the shaft, and the device can be slidably inserted completely into the interior of the imaging component shaft.

[0063] In some embodiments, the cavity 105 can include a substantially uniform cross-sectional area along the shaft 103. In other embodiments, a portion of the length of the shaft 103 can have a different cross-sectional area than another portion of the length of the shaft. In one example, the proximal portion of the shaft 103 can be asymmetric to provide an axis for instrument alignment, and the distal portion of the shaft can have a circular cross-sectional area. In another embodiment, the cavity 105 tapers toward the end of the shaft 103. In such an example, this taper can facilitate feeding the instrument into the cavity 105. In some embodiments, the cross-sectional area of ​​the cavity 105 can be narrowed in diameter to allow the distal end of the shaft 103 to have greater flexibility.

[0064] In some embodiments, the imaging shaft 103 may further include a tube 115 positioned at the lumen 105 of the imaging shaft 103. The tube 115 may include a lumen. The lumen of the tube 115 may be configured to slidably receive a plurality of instruments (e.g., Figure 2 The tube 115 may be aligned parallel to the axis 103 of the imaging component so that additional instruments / accessories may be slidably received by the tube. Subsequently, after the tube 115 has been aligned parallel to the axis 103 of the imaging component, the tube 115 may slidably receive additional instruments / accessories. In some embodiments, the tube 115 may be disposable. In some embodiments, the tube 115 may be reusable, for example by being separated from the imaging axis 103, cleaned, and autoclaved. The tube 115 may have an outer surface, wherein the surface is substantially in contact with the inner wall of the cavity 105. The tube 115 may have an inner surface having a different geometry from the outer surface, which is configured to receive one or more of the plurality of instruments. 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 lumen geometry from the first tube, thereby facilitating the insertion of one or more of the plurality of instruments. In some embodiments, the tube 115 may be rotatable relative to the imaging component. In some embodiments, the tube 115 can be fully rotated in either direction relative to the imaging component within the imaging component's shaft 103 under user control. In some embodiments, the tube 115 can be internally or externally lubricated to facilitate insertion or removal of instruments.

[0065] The tube 115 can be inserted into the body cavity in situ while the imaging component is still being advanced therein. Additionally or alternatively, the tube 115 can be inserted into the shaft 103 of the imaging component prior to inserting the imaging component into the body cavity. The tube 115 can have sufficient structural integrity to support the body cavity during insertion of the imaging component without instruments. When additional instruments (e.g., Figure 2When an ablation device 230 (e.g., an ablation device 230) is inserted into tube 115 or tube 115 is inserted in situ into the imaging component, damage to the body cavity can be minimized. Tube 115 can be made of a sterilizable material. Tube 115 can be made of a material that is low enough in cost so that it can be discarded after a single use. Exemplary materials for disposable tubes can include polyimide, PTFE, polyurethane, and thermoplastics such as Pebax or nylon. Tube 115 can be made of a material that includes sufficient elasticity to accommodate instruments that are slightly larger or smaller than the periphery of the tube. In embodiments where cavity 105 is not circular, tube 115 can take the shape of the cavity or it can take another shape.

[0066] Tube 115 can be inserted through the tube to facilitate attachment of instruments (e.g. Figure 2 The tube 115 can reduce the cost of treatment by facilitating the cleaning of the lumen 105 of the imaging component 100. The tube 115 can reduce the cost of treatment by providing an inexpensive component that can act as an adapter for a variety of different therapeutic and / or diagnostic instruments / accessories, such as being provided in a variety of different internal geometries suitable for different instruments / accessories, but having a uniform external geometry that is removably coupled to the same single imaging component 100. For example, a disposable tube with a smaller inner diameter can facilitate the insertion and control of a needle having an outer diameter that is smaller than the inner diameter of the shaft 103 of the imaging component.

[0067] Figure 1E An enlarged view of the distal end of the imaging component 100 including the cavity 105 according to some embodiments is shown. The distal end of the imaging component 100 may include an imaging transducer 107. The imaging transducer 107 may include an ultrasonic transducer and / or multiple ultrasonic transducers. The ultrasonic transducer may operate at a frequency of 500kHz, 1MHz, 5MHz, 10MHz, 20MHz, 100MHz, or a range defined by any two of the foregoing values. Some embodiments of the ultrasonic transducer may include specifications of other transducers from commonly assigned references incorporated herein.

[0068] In some embodiments, the distal end 117 of the imaging transducer 107 may additionally include a light emitting diode and / or a camera to provide an image to a user. In such embodiments, the imaging component 100 may be used as an optical scope as well as an ultrasound imaging platform. The distal end 117 of the imaging transducer 107 may include optical components such as optical fibers, relay lenses, objective lenses, etc.

[0069] The imaging transducer 107 can be configured to be deflectable. The imaging transducer 107 can be configured to deflect relative to the longitudinal axis of the shaft 103 of the imaging component 100. In some embodiments, the distal end of the imaging component 100 includes a hinge to facilitate deflection of the imaging transducer 107. The deflection of the imaging transducer 107 can be controlled by a deflection rod 119 on the handle portion 101 of the imaging component 100. One or more imaging transducers 107 can be oriented by 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 ultrasound transducer) can be radially and / or axially aligned to image multiple views simultaneously. Deflection of the imaging transducer 107 can be caused to avoid the instrument (e.g., Figure 2 In addition or alternatively, 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 the interlock systems in the incorporated references, to prevent the imaging transducer 107 from obstructing the instrument or being damaged by the sharp edges of the instrument. Actuation of the deflection rod 119 can function in a manner similar to that described in U.S. Patent 8,992,427, which is incorporated herein by reference. The deflection rod 119 can deflect the imaging transducer 107 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.

[0070] The distal end of the imaging component 100 may include a non-destructive edge to facilitate insertion of the imaging component with or without an instrument in the cavity 105. The distal end of the cavity 105 of the imaging component 100 may additionally or alternatively include a portion that is angled relative to the axis of the shaft 103 so that the distal end of the instrument can be deflected upward when it is pushed out of the distal end of the cavity 105. The distal end of the cavity 105 of the imaging component 100 may include an angled portion having an angle of 3 degrees to 45 degrees. The distal end of the cavity 105 of the imaging component 100 may include an angled portion having an angle less than 45 degrees, and additionally or alternatively, for example, less than 90 degrees, less than 60 degrees, less than 30 degrees, less than 15 degrees, and less than 5 degrees.

[0071] The cavity 105 of the imaging component 100 can be configured to slidably receive a plurality of instruments (eg, Figure 2In 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 instruments may include instruments such as therapeutic electrodes; diagnostic electrodes and / or needles; tissue ablation elements, such as, for example, radiofrequency ablation elements, ultrasonic ablation elements, heat-based ablation elements, cryoablation elements, etc.; and / or other instruments suitable for being disposed within the cavity of the imaging component. Additionally or alternatively, the instruments may be used to deliver drugs or other therapeutic agents to the tissue to be treated. Figure 2 An ablation device 230 is shown that can be slidably received by the imaging component. One of ordinary skill in the art will recognize that Figure 2 Many instruments, including those disclosed in, can be used with the imaging components disclosed herein.

[0072] Figure 2 An enlarged view of the distal end of the imaging component 100 is shown according to some embodiments, wherein an ablation device 230 is disposed within the shaft 103 of the imaging component 100. The ablation device 230 can include a needle assembly including an introducer 235 and optionally an electrode ablation needle or tip 233. The shaft 231 of the ablation device 230 can be deployed from the shaft 103 of the imaging component 100. Additionally or alternatively, the introducer 235 can be deployed from the lumen of the tube 115. The ablation device 230 can include, for example, one or more of a radio frequency (RF) ablation element, an ultrasonic ablation element, a heat-based ablation element, a cryoablation element, and any other type of ablation element known to those of ordinary skill in the art.

[0073] The ablation device 230 can be disposed within the tube 115, which is disposed within the lumen 105 of the imaging component 100. Additionally or alternatively, the ablation device 230 can be disposed within the lumen 105 of the imaging component 100 without the use of a tube. While the shaft 231 of the ablation device 230 can define a circular cross-sectional geometry in the illustrated example, in other embodiments, the shaft 231 of the ablation device 230 can be elliptical or any other geometry such that the shaft 231 can be inserted into or removed from the lumen 105 of the imaging component 100. In some embodiments, the shaft 231 of the ablation device 230 can be asymmetric to provide an axis for alignment of the device within the lumen 105 of the imaging component 100.

[0074] The shaft 231 of the ablation device 230 can be made of a pliable and / or flexible material so that it can be deflected by the imaging transducer 107 and / or the angled portion within the lumen 105 of the shaft 103 of the imaging component 100. Among other possible purposes, the distal end of the shaft 231 of the ablation device 230 can be deflected upward to avoid damage to the imaging transducer 107. The distal end of the lumen 105 of the imaging component 100 can include a portion that is angled relative to the axis of the shaft 103 so that the distal end of the device (e.g., the ablation device 230) can be deflected upward when it is pushed out of the distal end of the lumen 105. The distal end of the lumen 105 of the imaging component 100 can include an angled portion, the angle of which is less than 45 degrees, and additionally or alternatively, for example, less than 90 degrees, less than 60 degrees, less than 30 degrees, less than 15 degrees, and less than 5 degrees.

[0075] Additionally or alternatively, the shaft 231 of the ablation device 230 may include a wire system or other means to deflect the distal end of the ablation device 230 so that the distal end of the ablation device 230 does not damage the imaging transducer 107. In some embodiments, the ablation device 230 can rotate relative to the imaging component 100. In some embodiments, the ablation device 230 can be fully rotated in either direction within the shaft 103 of the imaging component 100 under the control of the user, relative to the imaging component 100, while the shaft 103 remains stationary, so that the tip 233 can be optimally aligned.

[0076] The needle assembly can be configured and controlled by the user, for example, as previously described in co-owned U.S. Patents 8,206,300, 8,262,574, and 8,992,427, the entire disclosures of which are incorporated herein by reference. The needle assembly can be integrated into the instrument handle so that the position and deployment of the introducer 235 and the multiple electrode ablation needles or tips 233 can be controlled by the user. The handle can be configured, for example, as previously described in co-owned U.S. Patent 8,992,427, the entire disclosure of which is incorporated herein by reference. The needle assembly can be compatible with systems and methods for improving safety margins and treatment margins during the treatment of uterine fibroids, such as described in the incorporated references. Figure 2 Exemplary instruments that may be disposed within the shaft 103 of the imaging component 100 are shown, and this example is not intended to be limiting.

[0077] Figure 3A 1 shows an assembly view of an imaging system including an imaging component 100 and an optical mirror device 300 according to some embodiments. Although an optical mirror element may be shown in the illustrated embodiment, the optical mirror device 300 may be any other suitable device, for example, any device disclosed herein (e.g., Figure 2 ablation device 230). Figure 3AAs shown, the imaging system can slidably receive a disposable tube 115 within the lumen 105 of the imaging component 100. In some embodiments, the imaging system can include a disposable tube 115 slidably received within the lumen 105 of the imaging component 100. In such embodiments, an instrument can be removably received with the lumen of the disposable tube 115. Additionally or alternatively, the lumen 105 of the imaging component 100 can be configured to slidably receive one or more of a plurality of instruments, which can include various therapeutic and / or diagnostic instruments.

[0078] In an illustrative example, the imaging component can removably receive a device such as a treatment electrode; a diagnostic electrode and / or needle; a tissue ablation element, such as, for example, a radiofrequency ablation element, an ultrasonic ablation element, a heat-based ablation element, a cryoablation element, etc.; and / or other devices suitable for being disposed within the lumen of the imaging component. Additionally or alternatively, the device 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 a Figure 2 Ablation device 230 is shown in FIG.

[0079] In the illustrated embodiment, the distal end 305 of the optical mirror instrument 300 may include a light emitting diode and / or a camera to provide an image to the user. In such an embodiment, the optical mirror instrument 300 may be used as an endoscope. The distal end 305 of the optical mirror instrument 300 may include optical components, such as optical fibers, relay lenses, objective lenses, etc. The optical mirror instrument 300 may include a shaft 303 of the optical mirror instrument 300 having a distal end and a proximal end. The shaft 303 of the optical mirror instrument 300 may be configured to be separated from the handle component of the instrument, or may be configured to be used without the handle component, so that the optical mirror instrument 300 may be disposable.

[0080] The shaft 303 of the opticoscope instrument 300 can be made of a pliable and / or flexible material so that it can be deflected by the imaging transducer 107 and / or the angled portion within the lumen 105 of the shaft 103 of the imaging component 100. Additionally or alternatively, the shaft 303 of the opticoscope instrument 300 can include (e.g., push, pull and / or rotate / torque) a wire system or other means for deflecting the distal end 305 of the opticoscope instrument 300. Deflection of the distal end 305 of the opticoscope instrument 300 can be used to prevent damage to the imaging transducer 107 and / or allow multiple image angles to be collected. In some embodiments, the opticoscope instrument 300 can be rotated relative to the imaging component 100. In some embodiments, the opticoscope instrument 300 can be fully rotated relative to the imaging component 100 in either direction within the shaft 103 of the imaging component 100 under the control of the user while the shaft 103 of the imaging component remains stationary so that multiple image angles can be collected.

[0081] The shaft 303 of the opticoscope instrument 300 can be longer than the shaft of the imaging transducer 107 so that images can be collected from deep within the uterus. In some embodiments, the shaft 303 of the opticoscope instrument 300 can be two inches longer than the shaft of the imaging transducer 107. Additionally or alternatively, for example, the shaft 303 can be 6 inches longer, can be 4 inches longer, can be 2 inches longer, can be the same length, or can be within the range of any two of the foregoing values.

[0082] In the illustrated embodiment, the optical scope instrument 300 includes a handle portion 301. Although the handle portion 301 may be shown as being connected to an optical scope in the illustrated example, a similar handle portion may be connected to any suitable instrument (e.g., Figure 2 The ablation device 230 of the present invention can be ablated with a microscope, such as those disclosed herein. The handle portion 301 can be the second part of a two-part handle, so that when the optical scope device 300 can be slidably inserted into the imaging component 100, the two handle portions can be combined to form a single handle. The handle portion can additionally include a positioning element 313 to provide a more secure positioning between the parts of the two-part handle. The positioning element 313 can cooperate with the positioning element 113. In such an embodiment, the handle portion can include a release control 321, which can be actuated by the user to retract the positioning element 313 into the handle and allow the two-part handle to separate.

[0083] The handle portion 301 may additionally include one or more control elements 319. The control elements 319 may allow a medical professional to control the instrument (e.g., Figure 2 In one example, the control element 319 controls a wire system that can reproducibly deflect or manipulate the distal end of the instrument. Additionally or alternatively, the control element 319 rotates the axis of the instrument (e.g., the axis 303 of the optical scope instrument 300) within the cavity 105 of the imaging component 100 or within the disposable tube 115. In another example, the control element 319 scoops tissue into a tissue collector instrument. In another example, the control element 319 deploys a needle assembly including an optional tip in the ablation instrument. Additionally or alternatively, the control element 319 starts the ablation process. In another example, the control element 319 applies pressure to inject chemicals through a drug delivery device. In another example, the control element 319 starts or ends image collection in the optical scope instrument.

[0084] Figure 3BAn assembled view of an imaging system according to some embodiments is shown, which shows the attachment mechanism of the system. The interior 309 of the handle portion 301 may include an alignment element 311. The alignment element 311 may be configured so that the optical mirror instrument 300 can be reproducibly aligned relative to the imaging component 100 after the instrument is replaced. Additionally or alternatively, the alignment element 311 can enable the instrument (e.g., Figure 2 The ablation device 230) and the imaging component 100 are sufficiently fixed relative to each other to use the two handle portions 101, 301 as a single handle. In some embodiments, the alignment element 311 may include a magnet. In other embodiments, the alignment element 311 may include, for example: a latch, a hook, or any other mechanism suitable for removably combining the two-part handle. The interior 309 of the handle portion 301 may further include a positioning element 313 to provide a more secure positioning between the portions of the two-part handle. In such an embodiment, the handle portion may include a release control 321, which can be actuated by a user to retract the positioning element 313 into the handle and allow the two-part handle to separate.

[0085] In some embodiments, a method is provided for detecting or sensing the identification of a removable instrument when coupling an imaging component 100 and a removable instrument (e.g., an optical mirror instrument 300). The imaging component 100 may include software to identify the removable instrument and manage the interconnection between the imaging component 100 and the removable instrument. As non-limiting examples, the sensor or mechanism may be an optical, RF, magnetic, biometric, electronic, and mechanical ID and reader. The method will ensure that only qualified removable devices are received on the imaging device to ensure that only compatible devices can be used with the imaging component 100.

[0086] Figure 4 The shaft 103 of the imaging component 100 is shown according to some embodiments, wherein the shaft 103 of the imaging component 100 can be flexible. In the illustrated embodiment, the shaft 103 of the imaging component 100 can include a flexible shaft portion 403. The body of the flexible shaft portion 403 can include an internal structure to carry electronic devices or other associated components to control the imaging transducer 107. The imaging transducer 107 can include a channel or conduit for guiding a fluid (e.g., water, saline, etc.) to the distal end of the shaft and onto the tissue surface. The flexible shaft portion 403 can include a portion of the length of the shaft 103 of the imaging component 100. In some embodiments, the flexible shaft portion 403 includes less than three quarters of the length of the shaft 103. Additionally or alternatively, the flexible shaft portion 403 can include less than one quarter of the length of the shaft 103, less than one eighth of the length of the shaft 103, and the full length of the shaft 103.

[0087] The cross-sectional geometry of the flexible shaft portion 403 can continue the geometry of the shaft 103 so that no gap or traumatic edge is created between the flexible shaft portion 403 and the shaft 103. The cross-sectional geometry of the flexible shaft portion 403 can be circular, or take a shape with sufficiently softened, chamfered, rounded, or beveled edges so that the edges can be atraumatic to the patient opening during insertion or removal of the imaging component 100 with or without instruments. The flexible shaft portion 403 can additionally include a smooth outer surface. The flexible shaft portion 403 can be made of a material such that the surface can be deformed to allow the flexible shaft portion 403 to bend or conform to the shape of a body cavity.

[0088] The lumen of the flexible shaft portion 403 can be configured to slidably receive one or more of a plurality of instruments. The lumen of the flexible shaft portion 403 can be configured to continue the shape of the lumen 105 of the shaft 103 such that no gap or traumatic edge is created between the flexible shaft portion 403 and the shaft 103. In some embodiments, the lumen of the flexible shaft portion 403 can be partially open along the wall such that the lumen of the lumen of the flexible shaft portion 403 can be in communication with the exterior of the shaft 103. The opening of the flexible shaft portion 403 can be sufficiently closed to provide structural support such that when the imaging component 100 can be inserted into a patient's body cavity, the opening of the lumen can not be significantly interfered with by the insertion or removal of an instrument. In some embodiments, the edge of the lumen of the flexible shaft portion 403 can bend inwardly toward the interior of the lumen, such as in Figure 1D In the embodiment shown. The inwardly curved edge of the cavity of the flexible shaft portion 403 can be used to support the opening of the body cavity so that the shaft 103 can be inserted into or removed from the body cavity without trauma with or without instruments. The cavity of the flexible shaft portion 403 can be sufficiently open so that some deformation of the cavity opening may occur when instruments of different sizes can be received or inserted into the cavity. The cavity can facilitate cleaning of the imaging component 100 by providing a path from the outside of the cavity to the inside of the cavity.

[0089] Although the cavity of the flexible shaft portion 403 defines a circular cross-sectional geometry in the illustrated example, in other embodiments, the cavity of the flexible shaft portion 403 can be an elliptical or any other geometry with sufficiently softened, rounded or beveled edges and corners so that the insertion or removal of the shaft of the flexible shaft portion 403 does not damage the patient's body cavity. In some embodiments, the cavity of the flexible shaft portion 403 can be asymmetric to provide an axis for the instrument to be aligned therein. The cavity of the flexible shaft portion 403 can be open to less than three-quarters of its circumference in cross section, and additionally or alternatively, the cavity can be open to less than half of its circumference, less than one-quarter of its circumference, and less than one-eighth of its circumference. In other embodiments, the cavity of the flexible shaft portion 403 can be closed to the outside of the shaft of the flexible portion, and the instrument can be slidably inserted completely into the interior of the shaft of the flexible portion.

[0090] In some embodiments, the flexible shaft portion 403 can be made of a pliable and / or flexible material so that it can bend within a patient's body cavity. In some embodiments, the shaft can be controllably flexed along its longitudinal axis via a flexure mechanism. Additionally or alternatively, the flexible shaft portion 403 can include a wire system or other flexure mechanism to allow the flexible shaft portion 403 to controllably bend, flex, or deflect the distal end of the flexible portion. The flexure mechanism can be provided by a handle portion (e.g., Figure 3A The control element on the handle part 101) shown in FIG.

[0091] In the example shown, the flexible shaft portion can be flexed axially to an angle of about 90 degrees relative to the handle. Additionally or alternatively, the flexible shaft portion can be flexed axially to, for example, less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, less than 1 degree. Additionally or alternatively, the flexible shaft portion can be flexed on the front-to-back axis relative to the handle of the imaging component 100. In some embodiments, the flexible shaft portion can be flexed on the front-to-back axis to, for example, less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, less than 1 degree. Additionally or alternatively, the flexible shaft portion can be flexed on the medial-lateral axis relative to the handle of the imaging component 100. In some embodiments, the flexible shaft portion can be flexed on the medial-lateral axis to, for example, less than 180 degrees, less than 120 degrees, less than 90 degrees, less than 45 degrees, less than 10 degrees, less than 1 degree.

[0092] Figure 5A A system for diagnosing and / or providing therapy according to some embodiments is shown, which can be removably coupled to a plurality of therapeutic and / or diagnostic devices (e.g., Figure 2 The system for performing treatment and / or diagnosis may include a treatment or diagnostic device 510 and an imaging component 520. The system for performing treatment and / or diagnosis 510 may include a treatment or diagnostic device, such as, for example, any treatment or diagnostic device described herein (e.g., Figure 2 In some embodiments, imaging component 520 can be used in conjunction with devices such as therapeutic electrodes; diagnostic electrodes and / or needles; tissue ablation elements, such as, for example, radiofrequency ablation elements, ultrasonic ablation elements, thermal-based ablation elements, cryoablation elements, etc.; and / or any other device suitable for placement within the lumen of the imaging component. Additionally or alternatively, the device can be used to deliver drugs or other therapeutic agents to the tissue to be treated. Figure 2 Exemplary instruments that may be slidably received by the imaging component are shown. In some embodiments, the system may include first and second therapeutic or diagnostic instruments. The imaging component 520 may include an imaging component, such as, for example, the examples, embodiments, and variations of the imaging components described herein.

[0093] Figure 5B A system for diagnosing and / or providing therapy is shown, according to some embodiments, wherein a therapeutic and / or diagnostic device 510 (e.g., Figure 2 The ablation device 230 of the imaging component 520 is removably coupled to the imaging component 520. As shown, the instrument 510 can be axially aligned relative to the imaging component 520. In addition, 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 so that the shaft 513 of the instrument 510 is slidably received by the cavity 525 of the imaging component 520. The instrument 510 can be slidably removed from the imaging component 520 by a similar process.

[0094] Figure 5C A system for diagnosing and / or providing treatment using a treatment and / or diagnostic device 510 removably coupled to an imaging component 520 is shown according to some embodiments. The system for diagnosing treatment may include a retaining element, such as a hook, a latch, or a mechanical feature described herein, so as to fix the device 510 to the imaging component 520. The system for diagnosing and / or providing treatment may be configured to be coupled to multiple devices. For example, a first device may be coupled to the imaging component 520, and then a second device may be coupled. The imaging component 520 may be configured to be coupled to both the first and second treatment and / or diagnostic devices simultaneously or individually. For example, if the first device is a disposable tube, the second device may be slidably inserted into the first device. In some embodiments, the imaging component 520 may be configured to be deliverable to a target site in a patient's body, which was previously coupled to a first and / or second treatment or diagnostic device outside the target site. Additionally or alternatively, the imaging component 520 may be configured to be removably coupled to both the first and second treatment or diagnostic devices simultaneously or individually after the imaging component 520 is delivered to the target site in the patient's body (for example, the device may be coupled in situ).

[0095] Figure 6 A system 600 is shown, which may include a system controller 612, an imaging display 614, and a treatment probe. Figure 6 In the embodiment, the treatment probe includes two attached sub-components of the imaging component 100 and the instrument 300. Those skilled in the art will appreciate that the instrument 300 of the treatment probe may be an ablation instrument (e.g., Figure 2618). The system controller 612 is typically a microprocessor-based controller that allows treatment parameters and imaging parameters to be set in a conventional manner. The display 614 will typically be included in a common housing 618 with the controller 612, but may also be provided in a separate housing. The treatment probe 100, 300 may include an imaging transducer 107, which may be connected to the controller 612 via an imaging cable 624 to provide images captured by the imaging component 100 to the controller 612 for display by the display 614; however, additionally or alternatively, the imaging component 100 may communicate wirelessly with the controller 612. The device 300 may be connected to and communicate with the controller 612 via the device cable 622, such as to provide one or more of a control signal, a feedback signal, a position signal, or a status signal; however, additionally or alternatively, the device 300 may communicate wirelessly with the controller 612. In embodiments where the imaging component 100 and the device 300 are connected by cables 624, 622, the controller 612 may provide power to either or both of them.

[0096] The controller 612 typically also includes an interface for the 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 panel can be part of the imaging display 614. The energy delivered to the treatment probe 100, 300 by the controller 612 can be radio frequency (RF) energy, microwave energy, therapeutic plasma, heat, cold (cryotherapy), or any other conventional energy-mediated treatment mode. Alternatively or in addition, the treatment probe 100, 300 can be adapted to deliver drugs or other therapeutic agents to the tissue anatomy to be treated. In some embodiments, the probe 100, 300 is inserted into an ultrasound system and a separate radio frequency (RF) generator. An interface line connects the ultrasound system and the RF generator. In the case where the instrument 300 is an ablation instrument (e.g., ablation instrument 230, such as Figure 2 In some embodiments (as shown), the RF generator is configured to deliver energy to the needle assembly, which can then be used to ablate the target tissue.

[0097] The device 300 may include a handle portion 301 having one or more slidably mounted control elements 319 on its upper surface. In some embodiments, the control element 319 may control the positioning of an internal stop within the handle, which may be monitored by the controller 612 in order to calculate the size and position of the boundaries of the target area and / or the safety area, which are shown on the display 614. In the case where the device 300 is an ablation device (e.g., ablation device 230, such as Figure 2 In embodiments shown in FIG. 1 , the stop may also be used to physically limit deployment of the introducer and optionally the electrode ablation needle or tip.

[0098] Some embodiments of the methods and systems of the present disclosure may be integrated with systems and methods for establishing and adjusting displayed safety zone boundaries and treatment zone boundaries. Such embodiments may include systems and methods of the incorporated references, including: U.S. Patent Publication 2014 / 0073910 (now U.S. Patent 9,861,336; U.S. Patent 8,992,427; U.S. Patent 11,219,483; and PCT Publication WO2018 / 089523, the contents of which are incorporated herein by reference. Some embodiments of the methods and systems of the present disclosure may be integrated with systems and methods for mapping and planning systems. Such embodiments may include systems and methods of the incorporated references, including PCT Publication WO2018 / 089523.

[0099] Fig. 7A An imaging component 100 is shown that can be used to treat a fibroid F located in the myometrium M beneath the uterine wall UW (endometrium) and surrounded by a serosal wall SW in the uterus U. The imaging component 100 can be introduced into the uterus U transvaginally and transcervically (or alternatively laparoscopically), and the imaging transducer 107 is deployed to image the fibroid F within the field of view indicated by the dashed line. The needle assembly is in its retracted position, so that in Fig. 7A Not shown.

[0100] Figure 7B An example of a display (eg, Figure 6 614) which shows a safety boundary and a treatment boundary. In some embodiments, once the fibroid F is located on the display 614, the controls on the handle can be used to locate and size both the treatment boundary TB and the safety boundary SB. In some embodiments, initially, the virtual boundary lines TB and SB can neither be located on the fibroid F nor be appropriately sized to treat the fibroid F. Before starting treatment, the user (e.g., a doctor) may want to locate and size the boundaries TB and SB for appropriate treatment. Since the imaging transducer 107 may already be against the uterine wall UW, the only way to advance the treatment and safety boundaries TB and SB may be to move the boundaries forward by actuating the control element 319. In some embodiments, this can cause the treatment and safety boundaries TB and SB to move forward along the axis AL, thereby translating the area to be treated. This can cause the virtual boundary on the real-time image display 614 to move on the image of the fibroid F. Additionally or alternatively, the size of the treatment boundary TB can be increased or decreased to mitigate the risk of affecting healthy and / or more sensitive tissues around the treatment area.

[0101] In embodiments where the instrument is a tissue ablation element, while holding imaging component 100 steady, the physician may then advance needle slider so that introducer 235 extends into fibroid F, as shown in FIG. Figure 7C The introducer 235 is shown in its deployed or extended position; the plurality of electrode ablation needles or tips are in their retracted position within the introducer, so that Figure 7C Not shown. Figure 7C The illustration in includes a representation of an imaging component 100, which corresponds to a physical probe present in a patient. Figure 7C The remainder of corresponds to the image present on the target display 614.

[0102] After the introducer 235 has been fully deployed by being restrained by an optional physical or virtual needle stop housing in the instrument handle 301, the electrode ablation needle or tip 233 can be deployed by advancing the tip slider. A target level of tip deployment is reached, as indicated by engagement of the tip slider with the optional tip stop or visually on the display 614. Optionally, the imaging component 100 can be rotated about a central axis (typically aligned with the axis of the introducer 235) to confirm treatment and safety margins TB, SB in all viewing planes around the fibroid F. The display 614 will show in real time the position of the treatment and safety margins TB, SB relative to the target fibroid F and serosa. Multiple electrode ablation needles or tips 233 are then configured as shown. Fig.7D As shown, power can be supplied to the tip 233 (and optionally to the introducer 235) to effect treatment within the boundaries delineated by the virtual treatment boundary TB. Fig.7D In the embodiment, the guide 235 (see Figure 7C ) and multiple electrode ablation needles or tips 233 are shown in their deployed or extended positions. It should be understood that in some ablation procedures (e.g., those with smaller target tissue sizes), the introducer 235 and / or multiple electrode ablation needles or tips 233 will only be partially deployed. It will also be understood that after the procedure is completed, the introducer 235 and multiple electrode ablation needles or tips 233 can be retracted from the fully or partially deployed position to the retracted position. Likewise, Fig.7D A virtual image to be present on the display 614 and the physical presence of the imaging component 100 are mixed.

[0103] Uterine fibroid ablation example As disclosed above and Figure 6 As shown, uterine fibroid ablation systems and devices can use RF or other energy to coagulate (e.g., ablate) uterine fibroids or other tissues. According to embodiments of the present disclosure, in addition to ablating uterine fibroids or other tissues, embodiments of such systems and devices can include a cutting or insertion mode of the treatment process that will help the ablation element (e.g., (RF or other energy) introducer and electrode) penetrate into the fibroid or tissue more easily and accurately.

[0104] Some fibroids have a hard, encapsulated surface layer or dense structure, which often leads to difficulty in tissue penetration. For example, such a surface layer can provide resistance to the penetration of an ablation needle or the like, cause deflection of such a needle when advancing toward the fibroid, and / or cause deflection of the path of such a needle during introducer deployment. These may prolong the process of positioning the ablation device and / or deployment of its electrodes, or otherwise cause inaccuracies in tissue targeting and result in process delays. Aspects of the present disclosure can soften the fibroid surface layer and / or dense tissue, reduce resistance to the introducer tip / electrode, and can improve treatment accuracy and efficiency.

[0105] According to aspects of the present disclosure, a system for penetrating a target tissue may include 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 may be a fibroid, such as a uterine fibroid. In some embodiments, the system may also include an ultrasound imaging device. And in some embodiments, the system may also include a controller designed to control the delivery of energy to the ablation element.

[0106] The ablation element may be configured to penetrate the target tissue. The ablation element may further be configured to ablate the target tissue. The ablation element may include, for example Figure 2 The needle assembly shown may further include an introducer 235 and optionally an electrode ablation needle or tip 233. Fig. 7A , Figure 7C and Fig.7D As shown, in some embodiments, an ablation element is first inserted into the target tissue and then used to ablate the target tissue.

[0107] 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 monopolar mode, the output characteristics from the RF generator may be essential to determine the specific breadth of impact on the tissue and the power performed by the instrument. Within a monopolar circuit, there is typically an active electrode in the surgical site and a return electrode in a distal site, typically located on the patient's thigh. Current can flow through the body between the electrodes.

[0108] According to aspects of the present disclosure, the RF generator may have a plurality of different modes or settings configured for different steps of the process. For example, according to the present disclosure, the RF generator may include three waveform settings: cutting, mixing and coagulation / ablation. The mixed mode and the coagulation / ablation mode are optional. Although the cutting mode and the coagulation / ablation mode are described in detail below, it will be appreciated by those skilled in the art that the mixed mode provides energy in a manner between the cutting mode and the coagulation / ablation mode. The cutting mode may also be referred to as the insertion mode herein. In some embodiments, tissue in the cutting mode or the insertion mode may not actually be cut. In some embodiments, in the cutting mode or the insertion mode, the tissue is softened to facilitate penetration.

[0109] In some embodiments, the cutting or inserting mode is configured to help the ablation element cut or penetrate the target tissue. The cutting or inserting mode can be added as a pre-ablation step to facilitate the deployment of the ablation element (e.g., an introducer or electrode ablation needle) within the target tissue. Figure 8 As shown, the cutting or insertion mode can provide power oscillations to the ablation element. In other examples described herein, the power in the cutting or insertion mode does not oscillate. The RF energy of the cutting or insertion mode can be configured to allow the ablation element to cut or soften the tissue contacted by the ablation element. When the RF generator is set to "cutting", 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 oscillate. This may cause a rapid increase in temperature in the tissue in contact with the ablation element, which may cause tissue vaporization and cutting. The oscillating power or voltage from the RF generator can heat (and in some embodiments, vaporize) the tissue in contact with the ablation element by inducing oscillations of ionized molecules within the cell. When in "cutting" mode, the RF generator can be configured to provide enough energy to cut the target tissue, but not too much energy to damage the tip of the ablation element, produce excessive carbonization (i.e., produce char) and / or cause impedance out of control.

[0110] In some embodiments, the system for penetrating the target tissue is also configured to provide mechanical vibration or cutting force to the ablation element during the cutting or insertion mode. In addition to the "cutting" mode RF energy, the additional mechanical vibration or cutting force can further facilitate the insertion of the ablation element into the target tissue. In some embodiments, when the ablation element is in contact with the target tissue (e.g., pushed into the target tissue), the system can detect the force on the ablation element; and in some embodiments, the delivery of RF energy from the RF generator to the ablation element is controlled based on the detection of the force. In such an embodiment, for example, when the ablation element is applying a forward force to the target tissue (e.g., pushed into the target tissue), RF energy can be delivered to the ablation element according to the cutting or insertion mode; then, when the pressure is temporarily removed, the delivery of RF energy to the ablation element will be temporarily stopped. This force- or pressure-based feedback mechanism can reduce the heating of the target tissue when the RF generator is in the cutting or insertion mode.

[0111] Embodiments of the "cutting" mode of the present disclosure have been validated on ablation surrogates in multiple benchmark tests. It has been observed that a "hot" tip (e.g., an ablation element receiving RF energy from an RF generator in "cutting" mode) can soften target tissue and aid in inserting the ablation element during a uterine ablation procedure. In short, the addition of a cutting or insertion mode aids in penetrating target tissue layers when the ablation element (e.g., an introducer and / or multiple electrode ablation needle) is deployed prior to ablation.

[0112] In some embodiments, the ablation / coagulation mode is configured to ablate and / or coagulate the target tissue. The ablation mode may be similar to Fig.7D In some embodiments, when set to "ablation" mode, the RF generator provides an increase in energy (e.g., an increase in voltage) until the target tissue reaches a target temperature, after which time the energy (e.g., voltage) provided to the ablation element from the RF generator is reduced. At a given target temperature setting (degrees) of the RF generator, the voltage may initially increase and begin to gradually decrease after the target temperature is reached. The result of the "ablation" mode may be a slower rise in tissue temperature, but deeper collagen denaturation compared to the "cutting" mode.

[0113] Figure 8 A graph of power versus time for each of a cutting or insertion mode and an ablation or coagulation mode when treating a target tissue is shown according to some embodiments. In some embodiments, while the RF generator may be configured to be controlled to provide a temperature limit during each of the "cutting" and "ablation" modes, the temperature limit during the cutting or insertion mode may be lower than the temperature limit during the ablation or coagulation mode. Figure 8The power curves shown in highlight that, in some embodiments, when the RF generator is in the cutting mode, the ablation element (receiving oscillating power from the RF generator in this example) cuts the contacted tissue but does not substantially heat the tissue surrounding the ablation element. At the same time, when the RF generator is in the ablation mode, the ablation element heats (e.g., ablates) the tissue volume surrounding the ablation element.

[0114] In some embodiments, the system may further include an ultrasound imaging device. The ultrasound imaging device may be configured to provide visualization of the ablation device as it penetrates the target tissue. The ultrasound imaging device may be similar to the imaging transducer disclosed above (e.g., Figure 2 Imaging transducer 107 is shown. As disclosed elsewhere above, an ultrasound imaging device may be coupled to the ablation instrument. Figure 2 An example of an ultrasound imaging device coupled to an ablation instrument is shown in FIG.

[0115] In some embodiments, the system may further include a controller. The controller may be designed to control the delivery of energy to the ablation element. The controller may be similar to Figure 6 As disclosed above and Figure 6 As shown, the device 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 device at the interface with the target tissue. In some embodiments, the controller can also be configured to maintain the temperature at about, at least about, or no more than about 80°C, 85°C, 90°C, 95°C, 100°C, 105°C, 110°C, 115°C or higher or lower, and a range including any two of the foregoing values ​​when the ablation element penetrates into the target tissue. In some embodiments, the controller 612 can be configured to provide an alarm when the temperature at the interface is within a certain temperature range. The alarm can provide an indication that the ablation device begins to penetrate into the target tissue. In some embodiments, the temperature range can be, for example, between 80°C and 115°C, between 80°C and 110°C, between 80°C and 105°C, between 80°C and 100°C, or between 85°C and 105°C. An alert can be anything that a user (eg, a doctor) can notice, such as a noise, a change in illumination or color of a light bulb, or a tactile vibration.

[0116] 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, as the ablation device penetrates into the target tissue, the controller 612 can modulate the power delivered to the ablation device to provide temperature oscillations at the interface with the target tissue. In some embodiments, the controller 612 can be configured to control the delivery of energy to the ablation device to ablate 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 to ablate the target tissue can include maintaining a substantially constant temperature at the target tissue to ablate the tissue. Because the target tissue can retain heat, during tissue ablation, the energy delivered to the ablation element can be reduced in order to maintain a substantially constant temperature at the target tissue. Fig. 9 An example of this can be seen in . Fig. 9 In the example shown, after approximately 63 seconds, the power delivered to the ablation element is reduced while the temperature at the target tissue is maintained substantially constant.

[0117] In embodiments where tissue temperature is monitored, the ablation device may include one or more thermocouples. Fig.11 One example of where thermocouples may be provided is shown in FIG. Fig.11 A schematic side cross-sectional view of the distal tip of an introducer 235 is shown. The introducer 235 is shown in an at least partially extended position. The introducer 235 is disposed at the distal end of a shaft 231 of an ablation device. Fig.11 Also shown are a plurality of electrode ablation needles or tips 233, which are shown in their retracted positions within the introducer 235. The plurality of electrode ablation needles or tips 233 may include a central electrode ablation needle or tip 233'. Although the remaining electrode ablation needles or tips 233 may be at least partially deployed radially outward from the introducer 235 (e.g., Figure 2 ), but the central electrode ablation needle or tip 233 ′ can be deployed substantially parallel to the introducer 235 and in a straight line with the introducer 235.

[0118] In some embodiments, when multiple electrode ablation needles or tips 233 are retracted within introducer 235, the temperature measured by the ablation device as it penetrates the target tissue can be measured by a thermocouple located on one of the electrode ablation needles or tips 233. In some embodiments, the thermocouple is positioned on the central electrode ablation needle or tip 233'.

[0119] In some embodiments, the central electrode ablation needle or tip 233' can be in contact with tissue when in its retracted position within the introducer 235. Fig.11As shown, the central prong 233' may protrude slightly beyond the central lip 1135 of the introducer 235 into the valley surface 1130 of the introducer 235. To ensure that the central prong 233' can be deployed from within the introducer 235, a central opening may be provided in the introducer 235. The central prong 233' may be deployed from the introducer 235 through the central opening, and the central prong 233' may be retracted into the introducer 235 through the central opening. Fig.11 As shown, the distal portion of the central opening can be uncovered (e.g., exposed to contact tissue), while the proximal portion of the central opening can be covered (e.g., not exposed to contact tissue). The surface of the introducer 235 that is uncovered (e.g., exposed to contact tissue) is the valley surface 1130 of the introducer 235. The distal edge of the portion of the introducer that covers the covered portion of the central opening is the central lip 1135 of the introducer 235. In some embodiments, the central tine 233' can protrude slightly beyond the central lip 1135 of the introducer 235, so that the distal-most tip of the central tine 233' is substantially aligned with the central lip 1135 of the introducer 235 or is only slightly uncovered. This distal-most tip of the central tine 233' can be in close contact with the surrounding tissue, and a thermocouple can be positioned on the central electrode ablation needle or tine 233'.

[0120] The system for penetrating target tissue as described above can be used in a method of fibroid ablation (e.g., uterine fibroid ablation). Figure 8 , Fig. 9 , Fig.10 and Fig.12 Some embodiments of fibroid ablation treatments are depicted in . First, an ablation element is deployed into a fibroid. In some embodiments of a fibroid ablation method, an ablation element is delivered into contact with a fibroid (e.g., a uterine fibroid). When the ablation element is in contact with the fibroid, 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 oscillate to help the ablation element penetrate into the fibroid. In Figure 8An example of such power delivery variation over time is shown in the "Cutting Mode" section of FIG. In some embodiments, the delivery of RF energy according to the cutting or insertion mode is controlled to a maximum output of no more than, for example, about, at least about, or no more than about 50W, 55W, 60W, 65W, 70W, 75W, 80W. In some embodiments, the delivery of RF energy according to the cutting or insertion mode is controlled to no more than, 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 so 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, between 80°C and 115°C. In some embodiments, the substantially constant temperature maintained at the surface of the ablation element during the cutting or insertion mode is below a target temperature, wherein the target temperature is the temperature of the tissue in contact with the ablation element during ablation. During the deployment of the ablation element into the fibroid, the delivery of RF energy according to the cutting or insertion mode can soften the tissue of the fibroid. This softening of the fibroid tissue can reduce the force required for the ablation element to penetrate the fibroid. And reducing the required penetration force allows the ablation element to penetrate the fibroid without, for example, substantially deforming the fibroid upon penetration.The ablation element may be deployed into the fibroid with the aid of a cutting or insertion mode.

[0121] Fig. 9 One embodiment of a method of using a system for penetrating target tissue according to another example is shown. Fig. 9 In the embodiment depicted in , in order to start cutting or insertion, the power can be increased to increase the monitored temperature of the tissue in contact with the ablation instrument. After about 10 seconds, once the monitored temperature reaches about 90°C (or about 80°C in another example), the introducer is deployed to begin penetration into the target tissue. For example, the introducer is deployed to a position of about 33mm in about 8 seconds. Thereafter, about 4 seconds later, the monitored temperature of the tissue increases from about 80°C to about 100°C. At about 21 seconds, the electrode ablation needle or tip begins to be deployed from the introducer. In this example, the electrode ablation needle or tip advances about 12mm in about 5 seconds. As shown, the temperature can oscillate based on the modulation of the power and is not maintained constant during the cutting or insertion mode, and in one example is preferably maintained within a range between about 80°C and about 115°C during penetration of the ablation element.

[0122] It should be understood that Fig. 9 is an illustrative example. For example, although Fig. 9The cutting or insertion power is approximately 40-50W, but more or less power may be applied. In addition, the process of cutting or inserting may take more or less than 25 seconds. For example, if less power is used, the cutting or insertion may take more time, while if more power is used or if the procedure requires incomplete deployment of the electrode ablation needle, the cutting or insertion may take less time.

[0123] Secondly, once the ablation element is inserted into the target tissue, the ablation element ablates the fibroid. After the ablation element penetrates into the fibroid and is deployed in the fibroid, RF energy can be delivered to the ablation element according to a coagulation or ablation mode. In the coagulation or ablation mode, a voltage or power can be applied to the ablation element to increase and then decrease after the tissue in contact with the ablation element reaches a target temperature. In some embodiments, the target temperature can be between 80°C and 115°C, for example. In some embodiments, the fibroid is maintained at the target temperature throughout the ablation or coagulation mode. Figure 8 An example of such a power delivery variation over time is shown in the "Ablation Mode" section of FIG. Once ablation of a fibroid is complete, the system and device used can be moved to another fibroid for ablation or removed from the surgical area (e.g., removed from the uterus), for example.

[0124] Fig.10 One embodiment of a method of using a system for ablating target tissue is shown. Fig.10 The graph shown in Figure 2 shows the Fig. 9 Same example as shown in , but Fig.10 The cutting or insertion of the ablation element and the ablation process are shown. Fig.10 The first 25 seconds or so Fig. 9 At about 25 seconds, the ablation element has been inserted into the target tissue and ablation is indicated to have begun. Within about 40 seconds, the power is increased and the tissue temperature increases accordingly. Once the tissue reaches the target ablation temperature (in Fig.10 In the case of ablation, the system can modulate the energy delivered to the tissue to maintain the temperature substantially constant at the target ablation temperature. Fig.10 As shown, the power is reduced to a power of about 10 W over a period of about 40 seconds, while the monitored temperature remains substantially constant. This continues during the procedure. Once the procedure is complete, the ablation element can be retracted.

[0125] It should be understood that Fig.10 is an illustrative example. For example, Fig.10 The ablation temperatures shown in are between 100° C. and 110° C., but in accordance with the present disclosure, the temperature may be higher or lower.

[0126] Fig.10Two schemes are depicted: the first approximately 25 seconds depict a cutting or insertion mode, and the remaining time depicts an ablation or coagulation mode. It should be understood that while ablation can be performed immediately after a cutting or insertion, there may be a period of time (e.g., 30 or 60 or fewer or more seconds) after the cutting or insertion is completed before ablation is initiated. For example, this period of time can be used to plan or otherwise prepare for an ablation procedure.

[0127] While the "cutting" and "ablation" modes or protocols may differ from one another, in some embodiments, the delivery of RF energy according to the cutting or insertion mode may also preheat the uterine fibroids, which in turn may reduce the time required for the ablation procedure.

[0128] Additionally, although the "cutting" and "ablation" steps of the method are described in detail above, the ablation process may include Fig.12 In some embodiments, for example, before an ablation element can be deployed into a fibroid, the target tissue (e.g., a fibroid) is identified. In some embodiments, the ablation element can be used, for example, Figure 1A , Figure 3A , Figure 3B , Figure 4 , Figure 5A-5C and Figure 6 The imaging component 100 shown in FIG. 1 is used to identify the target tissue. In some embodiments, after the target is identified, the ablation procedure is planned. For example, appropriate equipment is prepared. In some embodiments, planning can include providing an ablation element adjacent to the fibroid. The ablation element is similar to Figure 2 In some embodiments of the ablation device 230 shown in FIG. 1 , the placement of the ablation device adjacent to the fibroid may be similar to Fig. 7A A safety check may then be performed to ensure that the target tissue can be safely penetrated and / or ablated. Figure 2 In the embodiment of the ablation device 230 shown in FIG. , the next step may include deploying an introducer ( Figure 7C Then, in some embodiments, the next step may include deploying an electrode needle or tip ( Fig.7D 233 in). Deployment of the introducer and / or deployment of the electrode needle can be accomplished in accordance with the "cutting or insertion mode" detailed above. Once the ablation element is fully deployed into the fibroid, the fibroid can be ablated, as disclosed herein. Ablation of the fibroid can be performed in accordance with the "ablation mode" detailed above. In some embodiments, once fibroid ablation is complete, the electrode needle and introducer can be retracted. The system and device can then, for example, be moved to another fibroid for ablation or removed from the surgical area (e.g., removed from the uterus).

[0129] Embodiments of the present disclosure are applicable to the Sonata® system available from Gynesonics, Inc. of Redwood City, California, and similar systems, devices, and methods described in the following commonly assigned U.S. patents and patent applications, which are incorporated herein by reference: U.S. Patent 7,918,795; U.S. Patent 9,357,977; U.S. Patent 7,815,571; U.S. Patent 7,874,986; U.S. Patent 10,058,342; U.S. Patent 8,088,072; U.S. Patent 8,206,300; U.S. Patent 9,861,336; U.S. Patent 8,992,427; U.S. Patent 11,219,483; U.S. Patent Publication 2020 / 0275975 (now U.S. Patent 11,612,431); U.S. Patent Publication 2021 / 0228179 (now U.S. Patent 11,583,243) and U.S. Patent Publication 2019 / 0350648.

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

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

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

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

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

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

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

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

[0138] In general, the language of the claims is to be interpreted broadly based on the language employed in the claims.The language of the claims is not limited to the non-exclusive embodiments and examples shown and described in the present disclosure or discussed during the prosecution of the present application.

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

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

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

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

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

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

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

[0146] The ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof. Language such as "at most," "at least," "greater than," "less than," "between," and the like includes the listed numbers. Numbers preceded by terms such as "about" or "approximately" include the listed numbers and should be interpreted based on the environment (e.g., as accurately as reasonably possible under the environment, e.g., ±5%, ±10%, ±15%, etc.). For example, "about 1V" includes "1V." Phrases preceded by terms such as "substantially" include the phrases and should be interpreted based on the environment (e.g., as reasonably as possible under the environment). For example, "substantially vertical" includes "vertical." Unless otherwise noted, all measurements are performed under standard conditions, including temperature and pressure.

Claims

1. A system for penetrating a target tissue, the system comprising: Ablation devices; and A controller configured to control the delivery of energy to the ablation device, wherein the controller is configured to monitor a temperature measured by the ablation device at an interface with the target tissue and maintain the temperature between about 80°C and about 115°C as the ablation device penetrates into the target tissue.

2. The system of claim 1, wherein the ablation device comprises an introducer and a plurality of electrode ablation needles extendable from a retracted position within the introducer.

3. The system according to claim 2, wherein: When the plurality of electrode ablation needles are retracted within the introducer, the temperature measured by the ablation device is measured by a thermocouple positioned on one of the electrode ablation needles.

4. The system of claim 3, wherein the multiple electrode ablation needle includes a central electrode extendable from a retracted position within the introducer, and wherein the thermocouple is positioned on the central electrode.

5. The system according to claim 1, wherein: The controller is configured to modulate power delivered to the ablation device to maintain the temperature between about 80°C and about 115°C as the ablation device penetrates into the target tissue.

6. The system according to claim 1, wherein: The controller is configured to modulate power delivered to the ablation device as the ablation device penetrates into the target tissue to provide oscillations in the temperature at the interface with the target tissue.

7. The system according to claim 1, wherein: The controller is configured to provide an alarm when the temperature at the interface is between about 80° C. and about 115° C. to provide an indication of initiation of penetration by the ablation device into the target tissue.

8. The system of claim 1, wherein the system further comprises an ultrasound imaging device configured to provide visualization of the ablation device as it penetrates the target tissue.

9. The system of claim 8, wherein the ultrasound imaging device is coupled to the ablation instrument.

10. The system according to claim 1, wherein: The controller is configured to control delivery of energy to the ablation device after the ablation device has penetrated into the target tissue to ablate the target tissue.

11. The system according to claim 10, wherein: The controller is configured to control delivery of energy to the ablation device to maintain a substantially constant temperature at the target tissue to ablate the target tissue.

12. The system of claim 1, further comprising a radio frequency generator configured to deliver energy to the ablation device as the ablation device penetrates into the target tissue.

13. A method for penetrating a target tissue, the method comprising: delivering an ablation device into contact with the target tissue; delivering energy to the ablation device to increase the temperature measured by the ablation device at an interface with the target tissue to between about 80° C. and about 115° C.; and The ablation device is advanced to penetrate into the target tissue while adjusting power to maintain the temperature at the interface with the target tissue between about 80°C and about 115°C.

14. The method of claim 13, wherein the ablation device penetrates into the target tissue while the temperature maintained at the interface with the target tissue oscillates.

15. The method of claim 13, further comprising ablating the target tissue by delivering energy to the ablation device to maintain the temperature at the interface with the target tissue at a substantially constant temperature.

16. A method according to claim 13, wherein the ablation device includes an introducer and a plurality of electrode ablation needles capable of extending from a retracted position within the introducer, wherein the plurality of electrode ablation needles at least partially extend from the introducer while maintaining the temperature at the interface with the target tissue between about 80°C and about 115°C.

17. A system for penetrating a target tissue, the system comprising: - an ablation element configured to penetrate the target tissue; and - a radio frequency generator configured to deliver energy to the ablation element, wherein the radio frequency generator comprises: a cutting or insertion mode configured to cut through target tissue, wherein the cutting or insertion mode provides power oscillations configured to cut tissue contacted by the ablation element; and - An ablation or coagulation mode configured to ablate and / or coagulate the target tissue, wherein the ablation or coagulation mode provides an increase in power and then a decrease in power after the target tissue reaches a target temperature.

18. The system of claim 17, wherein: The cutting or inserting mode is configured to maintain a substantially constant surface temperature of the ablation element.

19. The system of claim 17, wherein the cutting or inserting mode is configured to cause a rapid increase in temperature in tissue in contact with the ablation element.

20. The system of claim 17, wherein the RF generator is configured to be controlled to provide a temperature limit during the cutting or insertion mode and during the ablation or coagulation mode, wherein the temperature limit during the cutting or insertion mode is lower than the temperature limit during the ablation or coagulation mode.

21. The system of claim 17, further configured to provide mechanical vibration or cutting force during the cutting or inserting mode.

22. The system of claim 17, wherein the ablation element comprises an introducer.

23. The system of claim 17, wherein the ablation element comprises a plurality of electrode ablation needles.

24. The system of claim 17, further comprising a controller configured to control delivery of energy to the ablation element, wherein the controller is configured to monitor a temperature measured by the ablation element at an interface with the target tissue and maintain the temperature between approximately 80°C and approximately 115°C as the ablation element penetrates into the target tissue.

25. The system of claim 17, wherein the target tissue is a uterine fibroid.

26. A method for ablating uterine fibroids, comprising: delivering an ablative element into contact with the uterine fibroid; delivering radiofrequency energy to the ablation element when the ablation element is in contact with the uterine fibroid according to a cutting or insertion mode, wherein in the cutting or insertion mode, voltage or power is modulated based on a temperature measured at an interface between the ablation element and the uterine fibroid to assist penetration of the ablation element into the uterine fibroid; and After the ablation element penetrates into the uterine fibroid, radiofrequency energy is delivered 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 fibroid.

27. The method of claim 26, wherein the voltage or power oscillates in the cutting or inserting mode.

28. The method of claim 26, wherein the voltage or power is modulated in the cutting or inserting mode to maintain a temperature at the interface between about 80°C and about 115°C.

29. The method according to claim 26, wherein: In the coagulation mode, the voltage or power is increased and then decreased after the tissue in contact with the ablation element reaches a target temperature.

30. The method of claim 26, wherein delivering radiofrequency energy according to the cutting or inserting mode preheats the uterine fibroid.

31. The method of claim 26, wherein delivering radiofrequency energy according to the cutting or inserting mode softens the uterine fibroid, thereby allowing the ablation element to penetrate the uterine fibroid without substantially deforming the uterine fibroid upon penetration.

32. The method of claim 26, wherein delivering RF energy according to the cutting or insertion mode maintains a substantially constant surface temperature of the ablation element.

33. The method of claim 32, wherein the substantially constant surface temperature of the ablation element is between about 80°C and about 115°C.

34. The method of claim 26, wherein delivery of RF energy according to the cutting or inserting mode is controlled to a maximum output not exceeding 70 Watts.

35. The method of claim 26, wherein delivering RF energy according to the cutting or inserting mode is controlled to not exceed 30 seconds.

36. The method of claim 26, further comprising detecting a force on the ablation element when the ablation element is in contact with the uterine fibroid, and wherein delivery of RF energy according to the cutting or insertion mode is controlled based on the detection of the force.

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