System and method for applying energy to ovarian tissue

Abstract

Described herein are methods and systems for performing procedures for ovarian rebalancing.These methods and systems can be used in the treatment of polycystic ovarian syndrome (PCOS).These methods and systems can also be useful in the treatment of infertility associated with PCOS.The manipulation of ovarian tissue can include delivering / applying energy, such as radiofrequency energy, microwave energy, cryoablation energy, unfocused or focused ultrasound, for ovarian rebalancing.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 797,191, filed on January 25, 2019, the entire contents of which are incorporated herein by reference.

[0002] Described herein are systems and methods for the manipulation of ovarian tissue. The systems and methods can be used in the treatment of polycystic ovary syndrome (PCOS), infertility, and / or other diseases / disorders involving the ovaries, or to modulate ovulation.

Background Art

[0003] In cases of ovarian diseases and / or in certain types of infertility, there may be a need to manipulate ovarian tissue, retrieve tissue, or deliver an agent into a patient's ovary. For some time, physicians have used direct surgical access, laparoscopic access, or transvaginal ultrasound-guided needle-based methods to access the ovary. Direct surgical access is typically obtained under anesthesia, involves an incision in the skin, and exposes the tissue directly to perform surgery on it. Laparoscopic access is typically obtained under anesthesia, involves two or more incisions in the skin, and further involves inflating the space surrounding the ovary with either gas or fluid, and using a camera and laparoscopic tools to visualize the tissue and perform surgery on it. Transvaginal ultrasound-guided needle-based access is often employed for the retrieval of oocytes as part of in vitro fertilization (IVF). These current approaches have several limitations. That is, surgical and laparoscopic access methods are generally more invasive and thus require more anesthesia and higher procedural sensitivity. Furthermore, surgical and laparoscopic access methods allow for direct visualization of the surface of the ovary, but they provide a poor ability to visualize where specific devices are deployed within the ovarian tissue. Transvaginal needle access, which is typically performed under ultrasound, allows for the delivery of the tip of the needle into specific locations within the ovary, which can be visualized in real time. However, the needles used to access the tissue are only single or double lumen needles and cannot do more than simply aspirate, so the current systems are limited. The current systems are not ideally suited for cases where it would be desirable to either deliver or remove specific tissue or other factors from the ovary via the transvaginal ultrasound-guided needle route. The current systems are also not ideally suited for the delivery of specific agents or energy to the ovary.

[0004] Manipulation of ovarian tissue may be for treating polycystic ovary syndrome (PCOS). PCOS is an endocrine disorder first characterized by Stein and Leventhal in the 1930s. The features of this syndrome may include oligomenorrhea / amenorrhea, oligo-ovulation / anovulation, hirsutism, acne, obesity, and the characteristic polycystic appearance of the ovaries. PCOS generally has a significant impact on reproductive health (e.g., oligomenorrhea / amenorrhea and oligo-ovulation / anovulation, bleeding, endometrial hyperplasia, infertility, and increased risk of endometrial cancer), as well as on non-reproductive health (e.g., hyperandrogenemia, cancer, insulin resistance, hypercholesterolemia, hypertension, obesity, sleep apnea, and cardiovascular disease). Historically, PCOS has been considered in relation to hormonal dysregulation characterized by altered gonadotropin secretion, increased androgen production, increased insulin resistance, increased cortisol production, and obesity. Also, PCOS has been shown to often be associated with increased activity of the sympathetic nervous system.

[0005] Treatment of PCOS can be expensive for the healthcare system. Major non-infertility treatments include oral contraceptives (for hormonal normalization), endometrial ablation (for anovulatory bleeding), insulin sensitizers, antihypertensives, statins, and treatments for severe acne and hirsutism.

[0006] Many women with PCOS may also require infertility treatment during their lifetime. Treatment for PCOS infertility typically follows a stepwise approach. For example, letrozole and / or clomiphene citrate are generally first-line treatments, and second-line treatments are either gonadotropin administration or ovarian perforation (sometimes also referred to as ovarian diathermy). If these treatments are unsuccessful, in vitro fertilization (IVF) is attempted. However, multiple pregnancies and births (e.g., twins) are common with clomiphene citrate, gonadotropins, and IVF treatments. In infertility treatment, multiple pregnancies and births are often considered undesirable outcomes due to the associated perinatal and neonatal morbidity and the associated increased costs. Additionally, ovarian hyperstimulation syndrome (OHSS) may be more commonly seen in women with PCOS who receive gonadotropin or IVF treatment. OHSS is often mild and easily treated, but more severe cases may require invasive treatment.

[0007] Alternatively, ovarian perforation can be an option in treating PCOS, PCOS-related symptoms / disorders, and PCOS-related infertility. Prior to the development of ovarian perforation, other types of surgery were performed on the ovaries for the treatment of infertility. Ovarian wedge resection, an established technique first described in the late 1940s, involves surgically removing a wedge-shaped piece of ovarian tissue from the polycystic ovary. Despite the effectiveness of the technique, ovarian wedge resection was generally abandoned in favor of new techniques due to the frequent occurrence of adhesions resulting from this technique. Other ovarian surgeries that have been performed for infertility in PCOS include ovarian electrocautery, ovarian laser vaporization, multiple ovarian biopsies, and others.

[0008] Ovarian perforation / diathermy (OD) was developed in the 1970s and 1980s

Chemical formula

[0009] Despite this evidence, ovarian drilling is not as frequently used in clinical practice as other treatments for PCOS infertility. This may be due to (1) the lack of a standardized and consistent method to target the ovary and perform surgery on it, (2) the invasive nature of current OD techniques, (3) the theoretical risk of adhesions from ovarian intervention, (4) the surgical access route not being a good fit for the clinical practice patterns of infertility physicians, and (5) the uncertainty of the mechanism of action. Therefore, it would be useful to have systems and methods that overcome the limitations of current surgical techniques. Such systems could be designed to consistently target ovarian tissue, reduce the level of invasiveness of the procedure, reduce the risk of adhesions, target non-specific tissue types, and improve positioning within the ovary to treat the disease. Furthermore, assuming that the ovary or elements within it can play an important role in controlling other women's health problems such as the timing of menopause, hot flashes, fibroids, hormonal regulation disorders, endometriosis, adnexal pain, the risk of endometrial cancer, glucose metabolism disorders, or cardiovascular health, it would be beneficial to have improved methods and systems for treating these symptoms and for targeting structures within or near the ovary that can enable the treatment of these symptoms.

[0010] U.S. Patent Publications Nos. 2016 / 0220302, 2017 / 0215949, and 2018 / 0110554 to Zairns (the entire contents of each are hereby incorporated by reference herein) describe improved systems and methods for manipulating ovarian tissue.

Prior Art Documents

Patent Documents

[0011]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Means for Solving the Problems

[0012] What is described herein are systems and methods for performing an ovarian procedure called ovarian rebalancing. Manipulation of ovarian tissue may include delivering / applying energy, such as radio frequency energy, microwave energy, cryoablation energy, non-focused or focused ultrasound, for ovarian rebalancing. In other variations, manipulation of ovarian tissue may include, for example, steps of retrieving tissue via aspiration or delivering an agent into a patient's ovary. Generally, the systems and methods are designed to access ovarian tissue or a target area proximate to ovarian tissue transvaginally, laparoscopically, percutaneously, via a natural orifice route through the vagina, uterus, and fallopian tubes, through an open surgical approach, or via a fully non-invasive approach. Release of energy into ovarian tissue (e.g., stroma) ablates the tissue and restores the balance of the ovary. For example, ablation is expected to reduce the hormonal imbalance between hormones such as follicle-stimulating hormone (FSH) and luteinizing hormone (LH), thereby treating infertility symptoms such as polycystic ovary syndrome (PCOS).

[0013] Exemplary ovarian tissue includes, but is not limited to, the ovary (e.g., medulla / stroma and / or cortex), follicles / ovarian cysts, nerves associated with the ovary, suspensory ligaments, ovarian ligaments, broad ligaments of the uterus, mesovarium, endometrial tissue within the ovary, tumors or neoplastic cells, or combinations thereof. Stromal tissue generally includes the middle or medullary region of the ovary. The cortex (or outer region) of the ovary is generally where follicles of different maturities tend to reside. The term "follicle" includes the oocyte contained within the follicle and specifically may refer to the entire follicular structure or the oocyte. These follicles are sometimes called "cysts" in the context of PCOS. In other settings, a cyst may refer to a collection of fluid, which may or may not be a follicle. The methods and systems may be used to treat one or more symptoms of polycystic ovary syndrome, including infertility, that restore the balance of the ovary and modulate ovulation, or disorders associated therewith, or other diseases / disorders involving the ovary.

[0014] A system for performing ovarian procedures as described herein can be advanced proximally adjacent to, or inside, the ovary, follicles / ovarian cysts in the case of PCOS, or other target tissues (e.g., stroma). Additionally, the system may be used in conjunction with an ultrasound probe. According to one aspect of the invention, the ultrasound probe may be a transvaginal ultrasound probe. According to an exemplary embodiment, a system for performing ovarian procedures includes a therapeutic needle assembly having a proximal region and a distal region. The therapeutic needle assembly includes an elongate shaft in the distal region. The elongate shaft has a lumen, a port, and a needle tip at the distal end of the elongate shaft, and the needle tip is structured to penetrate the vaginal wall and penetrate the ovarian wall for placement of the port into the ovary. For example, the needle tip may be cored out to define a cavity and facilitate penetration of the vaginal wall and the ovarian wall.

[0015] The therapeutic needle assembly further includes a therapeutic portion disposed within the lumen of the elongate shaft in a retracted state and deployable to extend outside the port of the elongate shaft in a deployed state and to emit energy into the ovarian tissue of the ovary while in the deployed state. The therapeutic portion includes an energy emitter. The therapeutic portion may form a curve in the deployed state and may include one or more electrodes for emitting energy into the ovarian tissue. For example, the therapeutic portion may further include an active electrode and a return electrode, and the active electrode may emit continuous or pulsed radiofrequency energy. The therapeutic portion may emit energy into the ovarian tissue and treat polycystic ovary syndrome (PCOS).

[0016] In addition, the therapy needle assembly may include a handle in the proximal region, the handle having an actuator that, when actuated, transitions the therapy portion between a retracted state and a deployed state. According to one aspect, the actuator includes a trigger that releases or engages a locking mechanism that aids in the deployment of the therapy portion. The therapy portion may include an echogenic material or region (e.g., air / gas) to improve visibility. The therapy needle assembly, the therapy portion, and other components may be made of polymer materials (e.g., PEEK, polyester, ABS, nylon), metals (e.g., stainless steel), metal alloys (e.g., platinum-iridium), and shape memory materials (e.g., nitinol, elgiloy), all of which are known in the art and thus not described in detail herein.

[0017] Further, the elongate shaft is structured to facilitate the transition of the therapy portion between a retracted state and a deployed state in response to actuation in the actuator without damaging the energy emitter. For example, the system may include a lubricant disposed within the lumen of the elongate shaft adjacent to the port of the elongate shaft to facilitate the transition of the therapy portion between a retracted state and a deployed state in response to actuation in the actuator without damaging the energy emitter. The lubricant may be, for example, a lubricious tube or coating. In addition or alternatively, the elongate shaft may include a structure or configuration such as a ramp or a radial curve to facilitate the transition of the therapy portion between a retracted state and a deployed state.

[0018] In addition, the system may further include an adapter having a needle assembly interface and an ultrasonic probe interface. The ultrasonic probe interface is structured to be removably coupled to the ultrasonic probe, and the needle assembly interface is structured to be removably coupled to an adapter interface, which may be part of the handle, such that the therapeutic needle assembly can be coupled to the ultrasonic probe. Thus, the adapter may align the therapeutic needle assembly longitudinally with the ultrasonic probe. In addition, the adapter ensures alignment of the therapeutic portion within the field of view of the ultrasonic probe. The system may further include a needle guide removably coupled to the ultrasonic probe through which the extension shaft is received and stabilized during the procedure. According to one aspect of the invention, at least one of the therapeutic needle assembly and the needle guide or the needle guide and the adapter may be formed as a single entity.

[0019] The adapter interface and the needle assembly interface may permit reorientation of the therapeutic needle assembly relative to the adapter between a first orientation and a second orientation. For example, the adapter interface and the needle assembly interface may lock together in the first orientation and may be disengaged from each other to permit reorientation of the therapeutic needle assembly relative to the adapter such that the adapter interface and the needle assembly interface can lock together in the second orientation. The therapeutic portion in the first orientation in the deployed state may be offset, for example, by less than or equal to 180 degrees from the therapeutic portion in the second orientation in the deployed state. The adapter interface and the needle assembly interface may lock together in at least one of the first orientation and the second orientation. For example, the adapter interface may include first and second notches on opposing surfaces of the handle, and the first and second notches contact opposing surfaces of the needle assembly interface and are structured to lock the adapter interface to the needle assembly interface in the first and second orientations. Further, the first and second notches or the opposing surfaces of the needle assembly interface, or both, may include a plurality of ribs to improve locking. According to another aspect of the invention, the adapter interface and the needle assembly interface may lock together in the first orientation and may permit rotation of the therapeutic needle assembly relative to the adapter such that the adapter interface and the needle assembly interface can lock together in the second orientation. According to another aspect of the invention, the adapter interface and the needle assembly interface may permit reorientation of the therapeutic needle assembly relative to the adapter between orientations above the first and second orientations, for example, a third orientation or a fourth orientation. Additionally, the adapter interface and the needle assembly interface may lock together in any orientation.

[0020] The system may further include a generator operably coupled to the therapeutic portion to deliver energy to the therapeutic portion in a deployed state such that the therapeutic portion releases energy into the ovarian tissue of the ovary. The generator may supply continuous or pulsed radiofrequency energy, microwave energy, cryoablation energy, non-focused or focused ultrasound. Thus, the therapeutic portion may include at least one sensor for generating data during the release of energy from the therapeutic portion. The at least one sensor may include an impedance sensor and at least one temperature sensor that measures temperature at one or more electrodes, or probe temperature, or both.

[0021] The generator may include a processor in electrical communication with the at least one sensor. For example, the processor may execute instructions stored on a non-transitory computer-readable medium, receive data from the at least one sensor, determine whether the data is within a predetermined range, and instruct the generator to modify the delivery of energy to the therapeutic portion if the data indicates that at least one measured parameter is outside the predetermined range. The processor may further initiate a routine to cause an alert to occur on a graphical user interface if the data exceeds a first predetermined threshold or falls below a second predetermined threshold. Additionally, the system may include a graphical user interface for displaying information indicative of the treatment process based on data from the at least one sensor. For example, the graphical user interface may display information indicative of temperature and power versus time.

[0022] Furthermore, the processor may further execute instructions stored on a non-transitory computer-readable medium, store information indicating the number of ablations per ovary or per patient, and cause the graphical user interface to display information indicating the number of ablations. Additionally, the graphical user interface may display information indicating at least one of the ovarian volume per ovary, the ovarian volume per patient, the recommended ablation parameters, the set ablation parameters, the power setting, the recommended number of ablations, the required number of ablations, the recommended ovarian ablation volume, the required ovarian ablation volume, the number of ablations completed, the remaining number of ablations, the percentage of ovarian volume ablated, or the percentage of ovarian volume not yet ablated. The information indicating the recommended or set ablation parameters may be displayed in a table such as a lookup table. The displayed information may be updated after each ablation. The processor may receive input data indicating ovarian volume, for example, such that the information displayed on the graphical user interface is at least partially based on the input data indicating ovarian volume. Such information is expected to assist the clinician during a procedure involving multiple ablations (e.g., 4 to 8 ablations per ovary based on the individual ovarian volumes typically measured by ultrasound, for example, prior to the ablation procedure).

[0023] According to another aspect of the present invention, a method for performing an ovarian procedure is provided. The method includes advancing a distal region of a therapeutic needle assembly into the vagina; penetrating the vaginal wall using a needle tip at a distal end of an elongate shaft of the therapeutic needle assembly; penetrating the ovarian wall using the needle tip and positioning a port of the elongate shaft at a desired location within the ovary; deploying a therapeutic portion out of the port in a first orientation from a lumen of the elongate shaft, wherein the elongate shaft is structured to facilitate deployment of the therapeutic portion without damaging an energy emitter of the therapeutic portion; emitting energy into ovarian tissue of the ovary through the energy emitter of the therapeutic portion in the first orientation; retracting the therapeutic portion into the lumen of the elongate shaft; reorienting the therapeutic needle assembly while the port of the elongate shaft remains within the ovary; deploying the therapeutic portion out of the port in a second orientation from the lumen of the elongate shaft; and emitting energy into ovarian tissue of the ovary through the energy emitter of the therapeutic portion in the second orientation.

[0024] For example, the step of deploying the therapeutic portion from the lumen of the elongate shaft may include sliding the therapeutic portion through a lubricant within the lumen of the elongate shaft adjacent the port. As described above, the lubricant facilitates deployment of the therapeutic portion without damaging the energy emitter of the therapeutic portion.

[0025] In addition, while the port of the extension shaft remains within the ovary, the step of reorienting the therapeutic needle assembly may include the step of reorienting the therapeutic needle assembly relative to the adapter. For example, the step of reorienting the therapeutic needle assembly relative to the adapter may include the steps of removing the therapeutic needle assembly from the adapter while the port of the extension shaft remains within the ovary, rotating the therapeutic needle assembly while the adapter remains in place, and reattaching the therapeutic needle assembly to the adapter. Alternatively, the step of reorienting the therapeutic needle assembly relative to the adapter may include the step of rotating, advancing, or retracting the therapeutic needle assembly relative to the adapter while the port of the extension shaft remains within the ovary.

[0026] Furthermore, the method may further include the steps of retracting the therapeutic portion into the lumen of the extension shaft, moving the extension shaft proximally along a common needle path within the ovary to a second position, deploying the therapeutic portion out of the port at the second position from the lumen of the extension shaft, and emitting energy through the energy emitter of the therapeutic portion into the ovarian tissue of the ovary at the second position.

[0027] For example, the therapeutic needle assembly may be moved along the same needle path (e.g., proximally without adjusting the angle of the needle) through a single entry point for further energy delivery. The therapeutic portion may be redeployed inside the ovary at a proximal or distal location relative to the initial / previous ablation site. Thus, four ablations in smaller ovaries (as determined by the clinician from ultrasound imaging), eight ablations in larger ovaries, or multiple ablations such as sufficient ablations and power levels to achieve the desired volume of ablated ovarian tissue can be achieved within each ovary.

[0028] These system embodiments can have various effects on therapy. These system embodiments can enable, for example, a minimally invasive transvaginal approach where the ovaries would be accessed using a needle. The needle tip may be used to puncture through the vaginal wall and into the ovary under transvaginal image guidance. In some cases, this can allow for a single or fewer entry points into the ovary, reducing the risk of adhesions compared to surgical and laparoscopic approaches that involve tissue dissociation and entry points for each ablation within the ovary. Once in a fixed position within the ovary, the therapeutic portion may be advanced or deployed into the tissue. Here, a releasably fixable adapter allows the therapeutic portion to be inverted or rotated (e.g., 60, 90, 120, 180 degrees) so that additional areas of the ovary can be accessed and treated without removing the therapeutic needle assembly. The advantages of the transvaginal approach over surgical or laparoscopic approaches generally include one or more of the following: (a) reducing cost and patient risk, conscious sedation versus general anesthesia, (b) absence of external scarring, (c) less tissue manipulation resulting in a lower risk of adhesions, (d) fewer access points into the ovary resulting in a lower risk of adhesions, (e) faster recovery time, (f) it is an access route well-known to gynecologists and infertility specialists and fits within existing treatment pathways, and (g) restoring ovarian balance and effectively treating symptoms. The present invention provides, for example, the following. (Item 1) A system for performing an ovarian procedure, the system being configured for use in combination with an ultrasonic probe, the system comprising a therapeutic needle assembly having a proximal region and a distal region and the therapeutic needle assembly comprising an elongate shaft in the distal region, the elongate shaft comprising a lumen, a port, and a needle tip at the distal end of the elongate shaft, the needle tip being configured to penetrate the vaginal wall and penetrate the ovarian wall for placement of the port into the ovary; a therapeutic portion disposed within the lumen of the elongate shaft in a retracted state, the therapeutic portion comprising an energy emitter configured to deploy and extend outside the port of the elongate shaft in a deployed state and emit energy into ovarian tissue of the ovary while in the deployed state; a handle in the proximal region, the handle comprising an actuator configured to transition the therapeutic portion between the retracted state and the deployed state when actuated; and the elongate shaft is configured to facilitate transition of the therapeutic portion between the retracted state and the deployed state in response to actuation of the actuator without damaging the energy emitter. (Item 2) The system of item 1, wherein the needle tip is cored out to define a cavity and facilitate penetration of the vaginal wall and the ovarian wall. (Item 3) The system of item 1, further comprising an adapter comprising a needle assembly interface and an ultrasonic probe interface, the ultrasonic probe interface being configured to removably couple to the ultrasonic probe, and the needle assembly interface being configured to removably couple to an adapter interface of the handle such that the therapeutic needle assembly is coupled to the ultrasonic probe. (Item 4) The system of item 3, wherein the adapter interface and the needle assembly interface are configured to permit reorientation of the therapeutic needle assembly relative to the adapter between a first orientation and a second orientation. (Item 5) The adapter interface and the needle assembly interface are configured to allow reorientation of the therapeutic needle assembly relative to the adapter such that they lock together in the first orientation and such that the adapter interface and the needle assembly interface lock together in the second orientation. (Item 6) The system of item 5, wherein the adapter interface and the needle assembly interface lock together in at least one of the first orientation and the second orientation. (Item 7) The system of item 5, wherein the therapeutic portion in the first orientation in the deployed state is offset by less than 180 degrees or equal to 180 degrees from the therapeutic portion in the second orientation in the deployed state. (Item 8) The system of item 5, wherein the adapter interface comprises first and second notches on an opposing surface of the handle, the first and second notches contacting an opposing surface of the needle assembly interface and being configured to lock the adapter interface to the needle assembly interface in the first orientation and the second orientation. (Item 9) The system of item 8, wherein the first and second notches or the opposing surface of the needle assembly interface, or both, comprise a plurality of ribs for improving locking. (Item 10) The system of item 4, wherein the adapter interface and the needle assembly interface are configured to allow rotation of the therapeutic needle assembly relative to the adapter such that they lock together in the first orientation and such that the adapter interface and the needle assembly interface lock together in the second orientation. (Item 11) The system of item 3, wherein the adapter is configured to align the therapeutic needle assembly longitudinally with the ultrasonic probe. (Item 12) The system of item 3, wherein the adapter ensures alignment of the therapeutic portion within the field of view of the ultrasonic probe. (Item 13) Further comprising a needle guide configured to removably couple to the ultrasonic probe and receive the extension shaft therethrough and stabilize the extension shaft during the procedure. The system according to item 3, wherein at least one of the therapeutic needle assembly and the needle guide or the needle guide and the adapter is formed as a single entity. (Item 14) The system according to item 1, further comprising a generator configured to deliver the energy to the therapeutic portion in the deployed state such that the therapeutic portion is operably coupled to the therapeutic portion and the therapeutic portion releases energy into the ovarian tissue of the ovary. (Item 15) The system according to item 14, wherein the therapeutic portion comprises at least one sensor configured to generate data during the release of energy from the therapeutic portion. (Item 16) The generator comprises a processor in electrical communication with the at least one sensor, and the processor receives the data from the at least one sensor, determines whether the data is within a predetermined range, and commands the generator to modify the delivery of energy to the therapeutic portion if the data indicates that at least one measured parameter is outside the predetermined range. The system according to item 15, configured to execute instructions stored on a non-transitory computer-readable medium to perform the above. (Item 17) The system according to item 16, wherein the processor is configured to activate a routine to cause an alert to occur on a graphical user interface if the data exceeds a first predetermined threshold or falls below a second predetermined threshold. (Item 18) The system according to item 15, wherein the at least one sensor comprises an impedance sensor and at least one temperature sensor configured to measure the temperature at one or more electrodes or the probe temperature or both. (Item 19) The system according to item 15, further comprising a graphical user interface configured to display information indicative of the treatment process based on data from the at least one sensor. (Item 20) The system according to item 19, wherein the graphical user interface is configured to display information indicative of temperature and power versus time. (Item 21) The generator comprises a processor in electrical communication with the at least one sensor, the processor being configured to execute instructions stored on a non-transitory computer-readable medium and to store information indicative of the number of ablations per ovary or per patient and to cause the graphical user interface to display the information indicative of the number of ablations, the system of claim 15. (Item 22) The system of claim 1, further comprising a graphical user interface configured to display information indicative of at least one of ovarian volume per ovary, ovarian volume per patient, recommended ablation parameters, set ablation parameters, power settings, recommended number of ablations, required number of ablations, recommended ovarian ablation volume, required ovarian ablation volume, number of ablations completed, number of ablations remaining, percentage of ovarian volume ablated, or percentage of ovarian volume not yet ablated. (Item 23) The system of claim 22, wherein the information indicative of the recommended or set ablation parameters is displayed in a table. (Item 24) The system of claim 22, wherein the displayed information is updated after each ablation. (Item 25) The system of claim 22, further comprising a processor configured to execute instructions stored on a non-transitory computer-readable medium and to receive input data indicative of ovarian volume, wherein the information displayed on the graphical user interface is at least partially based on the input data indicative of ovarian volume. (Item 26) The system of claim 1, wherein the therapeutic portion is configured to form a curve in the deployed state. (Item 27) The system of claim 1, wherein the therapeutic portion comprises one or more electrodes configured to emit the energy into the ovarian tissue. (Item 28) The system of claim 1, wherein the therapeutic portion comprises an active electrode and a return electrode, the active electrode being configured to emit continuous or pulsed radiofrequency energy. (Item 29) The system of claim 1, wherein the therapeutic portion is configured to emit the energy into the ovarian tissue to treat polycystic ovary syndrome (PCOS). (Item 30) The system according to item 1, further comprising a lubricant disposed in the lumen of the extension shaft adjacent to the port of the extension shaft, the lubricant being configured to facilitate the transition of the therapeutic portion between the retracted state and the deployed state in response to actuation in the actuator without damaging the energy emitter. (Item 31) The system according to item 30, wherein the lubricant comprises at least one of a lubricious tube or a coating. (Item 32) The system according to item 1, configured for use in combination with a vaginal ultrasound probe. (Item 33) A method for performing an ovarian procedure, the method comprising: advancing a distal region of a therapeutic needle assembly into the vagina; penetrating the vaginal wall using a needle tip at a distal end of an extension shaft of the therapeutic needle assembly; penetrating the ovarian wall using the needle tip and positioning a port of the extension shaft at a desired location within the ovary; deploying a therapeutic portion out of the port in a first orientation from a lumen of the extension shaft, the extension shaft being configured to facilitate deployment of the therapeutic portion without damaging an energy emitter of the therapeutic portion; emitting energy into ovarian tissue of the ovary through the energy emitter of the therapeutic portion in the first orientation; retracting the therapeutic portion into the lumen of the extension shaft; reorienting the therapeutic needle assembly while the port of the extension shaft remains within the ovary; deploying the therapeutic portion out of the port in a second orientation from the lumen of the extension shaft; emitting energy into ovarian tissue of the ovary through the energy emitter of the therapeutic portion in the second orientation and including a method. (Item 34) Deploying the therapeutic portion from the lumen of the extension shaft includes sliding the therapeutic portion through a lubricant disposed in the lumen of the extension shaft adjacent to the port, the lubricant being configured to facilitate deployment of the therapeutic portion without damaging the energy emitter of the therapeutic portion. The method according to item 33. (Item 35) The therapeutic needle assembly is removably coupled to the ultrasonic probe via an adapter, and reorienting the therapeutic needle assembly while the port of the extension shaft remains within the ovary includes reorienting the therapeutic needle assembly relative to the adapter, the method of claim 33. (Claim 36) Reorienting the therapeutic needle assembly relative to the adapter comprises removing the therapeutic needle assembly from the adapter while the port of the extension shaft remains within the ovary, rotating the therapeutic needle assembly while the adapter remains in a fixed position, and reattaching the therapeutic needle assembly to the adapter, the method of claim 35. (Claim 37) Reorienting the therapeutic needle assembly relative to the adapter includes rotating, advancing, or retracting the therapeutic needle assembly relative to the adapter while the port of the extension shaft remains within the ovary, the method of claim 35. (Claim 38) retracting the therapeutic portion into the lumen of the extension shaft, moving the extension shaft proximally along a common needle path within the ovary to a second position, deploying the therapeutic portion out of the port at the second position from the lumen of the extension shaft, and emitting energy into the ovarian tissue of the ovary at the second position via the energy emitter of the therapeutic portion, further comprising the method of claim 33.

Brief Description of the Drawings

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[0046] The foregoing and other features of the present invention will become apparent from the following description and the appended claims, taken in conjunction with the accompanying drawings. It is to be understood that these drawings depict only some embodiments in accordance with the present disclosure and are, therefore, not to be considered limiting of its scope, and that the present disclosure will be described with additional specificity and detail through the use of the accompanying drawings.

Best Mode for Carrying Out the Invention

[0047] The present invention is directed to systems and methods for performing procedures on a body such as the ovaries. As shown in FIG. 1A, a system 100 for performing an ovarian procedure is described herein. In FIG. 1A, the components of the system are not depicted to scale, either relative or absolute. A therapeutic needle assembly 200 includes a distal region 202 and a proximal region 204. The distal region 202 includes an elongate shaft 206 with a needle tip 208 at the distal end of the elongate shaft 206 and a port 210 proximal to the needle tip 208. The needle tip 208 is configured to penetrate the vaginal wall and / or ovarian wall. The therapeutic needle assembly 200 also includes a therapeutic portion 212 slidably disposed within the lumen of the elongate shaft 206. The therapeutic portion 212 may be deployed out of the port 210 and configured to emit energy therefrom (e.g., via one or more electrodes) after deployment, as shown in FIG. 1A.

[0048] The proximal region 204 of the therapeutic needle assembly 200 preferably includes a handle 214, an actuator 216, and an adapter interface 218. The actuator 216 is constructed to deploy the therapeutic portion 212 out from the port 210 when actuated. For example, the actuator 216 may include a button that, when the actuator 216 is unlocked and slid distally, moves the therapeutic portion 212 distally such that the therapeutic portion 212 is deflected and curved out from the side port 210 as shown in FIG. 1A. The adapter interface 218 is constructed to secure the therapeutic needle assembly 200 to an ultrasonic probe via an adapter 300. The adapter 300 is configured to couple to the therapeutic needle assembly 200 and to the ultrasonic probe. Advantageously, the adapter 300 cooperates with many commercially available ultrasonic probes, enabling the therapeutic needle assembly 200 to be used seamlessly with various probes. The adapter 300 preferably includes a needle assembly interface 302 configured to removably couple to the therapeutic needle assembly 200 (e.g., at the adapter interface 218) and an ultrasonic probe interface 304 configured to removably couple to a vaginal ultrasonic probe.

[0049] In addition, the system 100 includes a generator 400 constructed to communicate with the therapeutic portion 212. The generator 400 is electrically coupled to the therapeutic needle assembly 200 and is configured to deliver energy to the therapeutic portion 212 for release into tissue. In addition, the generator 400 may receive information sensed from one or more sensors of the therapeutic needle assembly 200 and monitor the operation of the assembly and the patient's anatomy during treatment. The system 100 also preferably includes generator software 500 that may be launched on the generator 400 or on a separate computer (as shown in FIG. 1A). The generator software 500 provides a user-friendly interface for a user (e.g., a clinician, gynecologist, etc.) to monitor the operation of the therapeutic needle assembly 200 and the patient's anatomy during treatment.

[0050] The therapy needle assembly 200 and / or the adapter 300 may be designed for the treatment of a single patient and then discarded, while the generator 400 and the generator software 500 are reusable and interchangeable with a plurality of therapy needle assemblies and adapters.

[0051] FIG. 1B illustrates the therapy needle assembly 200 and the adapter 300 of the system 100, both coupled together and coupled to the needle guide 600 and the ultrasonic probe 602. The needle guide 600 is configured to receive the extension shaft 206 through and coupled to the ultrasonic probe 602 to stabilize the shaft during the procedure. The needle guide 600 may be a commercially available needle guide such as a disposable endocavity needle guide available from CIVCO Medical Solutions (Coralville, Iowa). The ultrasonic probe 602 may be any commercially available ultrasonic probe for use in the vagina. For example, the ultrasonic probe 602 may be a GE RIC5-9-D, GE RIC6-12-D, or RIC5-9W-RS ultrasonic transducer available from GE Healthcare (Chicago, Illinois). As will be readily understood by those skilled in the art, the ultrasonic probe 602 may be used in combination with other ultrasonic components such as a display used in combination with the probe. The needle guide 600 preferably assists in aligning the therapy portion 212 with the ultrasonic visualization plane or field of view formed by the ultrasonic probe 602 in a manner that ensures visibility as it is deployed, which may enable the operator to more precisely position and deliver the treatment at the desired location. As will be understood by those skilled in the art, various elements such as the therapy needle assembly 200 and the needle guide 600, the needle assembly 600 and the adapter 300, and equivalents may be combined into a single entity.

[0052] Referring now to FIGS. 2A and 2B, a therapeutic needle assembly 200 is shown in a retracted state and a deployed state, respectively. The handle 214 may include a first notch 220 and a second notch 222 on opposing surfaces for locking the therapeutic needle assembly 200 to the adapter 300 via a needle assembly interface 302. A first plurality of ribs 224 along the first notch 220 and a second plurality of ribs 226 along the second notch 222 may be included to improve locking. A channel 228 may be disposed within the handle 214 such that when a trigger 230 (e.g., a button) is depressed, the actuator 216 can deploy and retract the therapeutic portion 212. FIG. 2B illustrates the position after the actuator 216 is actuated and the therapeutic portion 212 is deployed outside the port 210.

[0053] Reference is now made to FIGS. 2C-2I. The extension shaft 206 extends from the distal end of the handle 214. As described above, the adapter interface 218 on the handle 214 may include a first and second plurality of ribs 224, 226 in first and second notches 220, 222 to assist in gripping and coupling to the adapter 300. FIGS. 2C and 2D illustrate side and top views, respectively, of the therapeutic needle assembly 200. Similarly, side and top views of the therapeutic needle assembly 200 are shown in FIGS. 2G and 2H, with similar components shown with the deployed therapeutic portion 212. FIGS. 2E, 2F, and 2I illustrate details and cross-sectional views of the handle 214, with FIG. 2E illustrating the latched retracted state, FIG. 2F illustrating the unlatched retracted state, and FIG. 2I illustrating the deployed state. The handle 214 includes a trigger 230 for controlling the latching mechanism 232. When the trigger 230 is depressed, the latching mechanism 232 is released and the actuator 214 can move the forward rail 234 along the channel 228 for the purpose of deploying the therapeutic portion 212 out of the port 210. Such deployment features may include a slider, knob, wheel, crank, or the like that can be used to deploy / retract the therapeutic portion 212. A stopper 236 is disposed on the distal end of the handle 214 to prevent the actuator 216 from moving beyond a desired distal point on the handle 214. This may assist in limiting the distance that the therapeutic portion 212 can extend from the port 210.

[0054] Reference is made to FIGS. 2J - 2L depicting various views of the extension shaft 206. The extension shaft 206 includes a port 210 through which a therapeutic portion 212 can be deployed from the lumen 238. Adjacent to the port 210 is a lubricant 240, such as a lubricious tube or coating, disposed within the lumen of the extension shaft 206 proximal to the port 210. The lubricant 240 or similar feature is included to facilitate the transition of the therapeutic portion 212 from the retracted state to the deployed state. It has been found that without such a lubricant feature, a therapeutic element such as an electrode or sensor, or any component of the therapeutic portion 212, can be damaged from friction / contact with the edge of the port 210 during deployment and / or retraction. The lubricant 240 may be a lubricious tube made of a biocompatible material that minimizes friction between the therapeutic portion 212 and the extension shaft 206 and thus protects its components. Examples of such biocompatible materials may be ultra-high molecular weight polyethylene or fluoropolymers.

[0055] In addition or alternatively, the extension shaft 206 may include a structure or configuration such as a ramp or a radial curve to facilitate the transition of the therapeutic portion 212 between the retracted and deployed states. The therapeutic portion 212 is also guided by an angled interface 242 that forms the distal end of the lumen within the extension shaft 200 and also defines the distal end of the port 210. The angled interface 242 guides the therapeutic portion 212 to exit from the lumen 238 of the extension shaft 200 outside the port 210 at a desired angle and facilitates positioning the therapeutic portion 212 for treatment in its curved shape. The needle tip 208 also has a needle lumen 244 formed therein. Forming the needle lumen 244 by boring out the core of the inner portion of the needle tip 208 has been found to assist in penetrating the vaginal wall and / or ovarian wall.

[0056] Referring now to FIG. 2M, a detailed view of the therapeutic portion 212 deployed outside the port 210 is provided. The therapeutic portion 212 preferably forms a curvilinear formation when deployed, as illustrated. The therapeutic portion 212 is configured to deliver energy after deployment and may include one or more electrodes, illustratively, a first electrode 246 and a second electrode 248. The first electrode 246 and / or the second electrode 248 may deliver energy, e.g., radio frequency energy, to effect a treatment. The first and second electrodes 246, 248 may consist of a metal band, coil, wire (e.g., wound or braided), laser cut tubing, or a slotted tubular structure. The shaft of the therapeutic portion 212 may have a pre-set shape that serves several purposes, such as anchoring the device within the ovary (to limit the risk of device movement due to patient movement or user error), orienting the therapeutic portion 212 to be more normal to the ultrasonic probe to increase echo brightness, and increasing the overall length of the therapeutic portion 212 that can be located within the ovary. The pre-set shape may also enable the therapeutic portion 212 to more easily reach different locations within the ovary compared to a more linear element, thereby reducing the amount of manipulation by the therapeutic needle assembly 200 and / or reducing the amount of puncture into the ovary. Additionally, the elongate shaft 206, the therapeutic portion 212, and / or the needle tip 208 may contain echo-source materials and / or gas to improve echo brightness.

[0057] In addition, the therapy needle assembly 200 (e.g., in the therapy portion 212) may include one or more sensors for detecting parameters such as temperature, impedance, or other parameters that may induce therapy delivery. For example, sensor 250 may be located on the inner surfaces of the first and second electrodes 246, 248 as shown. In one embodiment, sensor 250 is a thermistor used to measure temperature. A generator 400 (not shown), along with generator software 500 (described in FIGS. 7-9), may use the detected parameters sensed by the sensors to monitor the therapy needle assembly 200 and / or the patient's movement during treatment. For example, the treatment may be automatically stopped when certain temperature, time, power, and / or impedance thresholds are exceeded. The impedance value may also be used to determine the relative location of the therapy portion 212 within the ovary. The conductive needle 252 forms the distal tip of the therapy portion 212, senses electrical activity for communication with the generator 400, and may determine one or more parameters such as impedance. Advantageously, the conductive needle 252 has a sharp tip to facilitate movement through tissue during deployment of the therapy portion 212.

[0058] Referring now to FIGS. 3A and 3B, the adapter 300 of the system 100 preferably includes a needle assembly interface 302, an ultrasonic probe interface 304, and an actuator track 306. The adapter 300 is saddle-shaped and may include an ultrasonic probe interface 304 for securing the adapter 300 to the ultrasonic probe. The ultrasonic probe interface 304 is collar-shaped and may be loop-shaped around a portion of the ultrasonic probe between the proximal and distal ends of the ultrasonic probe. The side surface of the adapter 300 may be disposed around a more proximal region of the ultrasonic probe. The adapter 300 may be snap-fastened, strapped, clamped, or any similar means in order to be adaptable to various ultrasonic probes. As shown in FIGS. 3A and 3B, the needle assembly interface 302 on the proximal region of the adapter 300 includes needle assembly interface ribs 308 for gripping the therapeutic needle assembly 200 when inserted. The needle assembly interface 302 is constructed to couple with the adapter interface 218 of the therapeutic needle assembly 200 such that the therapeutic needle assembly 200 can be longitudinally attached to the ultrasonic probe and removed, rotated, and reattached again when desired during treatment. The resulting limited rotation may be useful for maintaining the therapeutic portion 212 within the ultrasonic visualization plane or field of view. When the therapeutic needle assembly 200 is inserted, the actuator track 306 facilitates smoother movement for the actuator 216.

[0059] According to another aspect of the present invention, the needle assembly interface 302 and the needle assembly 200 may be configured to allow a variable amount of rotation, or a specific rotation up to, for example, a maximum of 90 degrees or a maximum of 180 degrees, without the need to disconnect the needle assembly interface from the adapter interface. For example, as shown in FIG. 3C, the therapeutic needle assembly 200 may be rotated while the needle assembly interface 302 remains engaged with the adapter interface 218 via the handle 214 to reorient the port 210 within the field of view FOV of the ultrasonic probe. Thus, in any given orientation of the therapeutic needle assembly 200, the therapeutic portion 212 will protrude from the port 210 within the ovary within the field of view of the ultrasonic probe. The FOV is defined by the ultrasonic probe, and thus, as would be understood by one of ordinary skill in the art, the rotation of the therapeutic needle assembly 200 may be limited such that the therapeutic portion 212 will always protrude from the port 210 within the field of view of the ultrasonic probe. For example, the therapeutic needle assembly 200 may be rotated up to a maximum of 180 degrees from a first orientation to a second orientation. In some embodiments, as shown in FIG. 3C, the therapeutic needle assembly 200 may be rotated up to only a maximum of 90 degrees from a first orientation to a second orientation as long as the therapeutic portion 212 remains within the field of view of the ultrasonic transducer during operation.

[0060] According to another aspect of the present invention, the adapter interface 218 and the needle assembly interface 302 may allow reorientation of the therapeutic needle assembly 200 relative to the adapter 300 between an orientation above the first and second orientations, for example, a third or fourth orientation. Additionally, the adapter interface 218 and the needle assembly interface 302 may lock together in any orientation. In any orientation, the therapeutic needle assembly 200 may be locked in place.

[0061] Referring to FIG. 4, a generalized schematic diagram of the internal functional components of generator 400 is described herein. Generator 400 may include a programmable controller 402 operably coupled to a therapeutic energy source 404, an impedance measurement circuit 406, a temperature measurement circuit 408, a graphical user interface 410, a communication unit 412, an input / output circuit (I / O) 414, and / or a power supply 416.

[0062] The programmable controller 402 is electrically coupled to and designed to control the internal functional components of generator 400. The controller 402 may comprise one or more commercially available microcontroller units including a programmable microprocessor, volatile memory, non-volatile memory such as EEPROM for storing programming, and firmware and a non-volatile storage device such as flash memory for storing logs of system 100 operating parameters and patient data. The memory of controller 402 stores program instructions that, when executed by the processor of controller 402, provide the functionality attributed to the processor and the functional components of generator 400 herein. The controller 402 is designed to be programmable such that programming data can be stored in the memory of controller 402 and adjusted using generator software 500. For example, the memory of controller 402 may store program instructions that, when executed by the processor of controller 402, cause the processor to receive and store information indicative of, for example, a patient's ovarian volume. For example, using ultrasonic techniques known in the art, a clinician may receive a patient's ovarian volume based on measurements such as the length, width, and / or depth of the ovary. Specifically, the clinician may use a program that measures the length, width, and / or depth of the ovary by clicking on different spatial points on a graphical user interface that displays an ultrasound of the patient's ovary and calculates the ovarian volume based on the measurements.

[0063] The clinician may then provide the controller 402 with the ovarian volume as user input such that the processor can store and generate information based on the ovarian volume input. For example, the memory of the controller 402, when executed by the processor of the controller 402, may store program instructions that cause the processor to generate ablation parameters, the number of ablations recommended / required, and the volume of ovarian ablation recommended / required based on the ovarian volume and the desired outcome. Thus, for a given patient, the clinician can determine the volume of ovarian ablation required per ovary, the number of ablations required to ablate the required volume of ovarian ablation, and the content of the parameters for delivering the ablation to the patient.

[0064] Further, the processor may execute instructions to cause the graphical user interface to display the generated recommended / required ablation parameters, the number of ablations recommended / required, and / or the volume of ovarian ablation recommended / required, in addition to the ablation parameters being set, the power settings, the number of ablations completed, the number of ablations remaining, the percentage of ovarian volume ablated, and / or the percentage of ovarian volume not yet ablated. Information related to the recommended or set ablation parameters may be in the form of a table, such as a look-up table, stored in the memory and displayed to the clinician via the graphical user interface.

[0065] Furthermore, after each ablation performed by the clinician, the processor automatically recalculates any of the above information and displays the recalculated information after each ablation such that the clinician will be aware of the remaining volume of ovarian ablation required per ovary, and the number of ablations and the content of the parameters for the ablation to deliver the ablation to ablate the remaining volume of ovarian ablation required. Thus, for a given ovarian volume of a patient, the processor knows the amount of ovarian tissue volume that would be ablated for any given set of parameters, and thus, the amount of the percentage of ovarian tissue that has not yet been ablated to achieve the desired ablation therapy, for example, 5%, 7.5%, 10%, 12%, or 15% of the ovary to be ablated. For example, for a given patient's ovarian volume, the processor may determine that 5 ablations are required to ablate 5 - 10% of the ovary, and the processor communicates to the clinician the volume of ovarian tissue that would be ablated per ablation for a given set of ablation parameters, such as power level, or time and temperature. This information may be read by the clinician via a table, such as a look-up table. Thus, after 1 ablation has been performed by the clinician on the patient's ovary, the processor will adjust the data and display that 4 remaining ablations are required. Additionally, if the clinician did not complete the first ablation, for example, aborted it short, or performed the ablation with parameters other than those recommended / required by the processor, the processor will readjust and display the adjusted amount of remaining ablations to achieve the desired ablation therapy and will account for the clinician's deviation from the recommended / required settings.

[0066] As will be readily understood by those skilled in the art, FIG. 4 is illustrated as showing one programmable controller, although multiple programmable controllers may be utilized.

[0067] The therapeutic energy source 404 is designed to provide energy (e.g., RF energy) from the generator 400 to the therapeutic portion 212, deliver the energy to the first and second electrodes 246, 248, and treat ovarian tissue. The energy may be applied in a continuous or pulsed manner. The impedance measurement circuit 406 and the temperature measurement circuit 408 are designed to sense one or more parameters of sensors 250 and / or conductive needles 252 such as impedance or temperature. The system sensors 250 and / or conductive needles 252 may generate one or more signals indicative of the sensed parameters for transmission to the processing and / or generator software 500. Such parameters may be used to assist in the treatment or to verify the proper functioning of the system 100.

[0068] The graphical user interface 410 is optionally designed to receive user input and to display information to the user. The graphical user interface 410 may include buttons for receiving user input and a display for presenting information to the clinician (see FIGS. 10 - 13). As will be readily apparent to those skilled in the art, the graphical user interface 410 is not so limited and may use one or more of a trigger, a plunger, a touch screen, a keypad, a microphone, a speaker, a trackball, or the like.

[0069] The communication unit 412 is designed to transmit information such as signals indicative of the sensed parameters and the like to a remote location such as a computer that activates the generator software 500. Using techniques known in the art, the communication unit 412 may comprise circuitry configured for wireless communication via a network such as the Internet, a local network, or a telephone network, e.g., WiFi, Bluetooth®, and / or a cellular chipset.

[0070] The input / output circuit (I / O) 414 may include a port for data communication such as wired communication with a computer, and / or a port for receiving a removable memory, such as an SD card, in which program instructions or data related to the use of the generator 400 may be stored. In one embodiment, the I / O 414 includes a port and corresponding circuitry for receiving a cable so that the generator 400 is electrically coupled to a computer that boots the generator software 500.

[0071] The power supply 416 may power the electrical components of the generator 400 and may comprise a primary battery or cell, a secondary (rechargeable) battery or cell, or a combination of both. Alternatively, the power supply 416 may be a port that enables the generator 400 to be plugged into a conventional wall socket for powering the components and / or recharging one or more batteries of the generator 400. In one embodiment, the power supply 416 includes one or more ports and one or more cables that enable the generator to be powered from a computer, for example via a cable, and that boot the generator software 500.

[0072] Referring now to FIG. 5, the generator software 500 is described herein. The generator software 500 comprises several functional blocks, schematically depicted in FIG. 5, including a main block 502, an event logging block 504, a data download block 506, a configuration settings block 508, a user interface block 510, an alarm detection block 512, a sensor calibration block 514, a firmware upgrade block 516, and a status information block 518. The software is preferably written in C++ and adopts an object-oriented format. In one preferred embodiment, the software is configured to run on a Microsoft Windows® (a registered trademark of Microsoft Corporation, Redmond, Wash.), Mac, or Unix®-based operating system, such as those conventionally employed on desktop and laptop computers. The computer that launches the generator software 500 preferably includes a data port, such as a USB port or equivalent wireless connection, that enables the generator 400, external monitoring components, and / or a mobile device that launches a mobile application to be coupled thereto. Alternatively, or in addition, the computer may comply with, for example, the IEEE 802.11 standard, 3G, 4G, 5G, LTE, or other cellular standards, and / or the Bluetooth® standard, thereby enabling the generator 400, external monitoring components, and / or a mobile device that launches a mobile application to communicate wirelessly with the computer that launches the generator software 500, and may include a wireless circuit.

[0073] As will be readily apparent to those skilled in the art, the generator software 500 may be launched on a separate computer (such as those illustrated in FIG. 1A), such as a conventional laptop, desktop, tablet, smartphone, and the like, or on the generator 400.

[0074] The main block 502 preferably includes a main software routine that is executed on the clinician's computer and controls the overall operation of the other functional blocks. The main block 502 enables the clinician to download event data and alarm information stored on the generator 400 to his or her office computer, and also enables the generator software 500 to receive signals indicative of parameters sensed from the generator 400. The main block 502 is further configured to execute routines for calculating parameters based on the sensed parameters and / or for storing information related to the treatment. For example, the main block 502 is configured to execute a routine for measuring impedance and / or temperature using signals indicative of impedance or temperature sensed in the therapeutic portion 212. As another example, the main block 502 is configured to execute a routine for storing (and causing the display of) the number of ablations per ovary and / or per patient, and / or other information and parameters as described above. The main block 502 is further configured to execute a routine for calculating data for display based on inputs received in the user interface block 510. The main block 502 also enables the clinician to upload firmware updates and configuration data to the generator 400.

[0075] The event log block 504 is a record of the operational data downloaded from the generator 400 and may include, for example, measurement times, parameters sensed in real time, pre-sensed parameters, sensor data, battery current, battery voltage, battery status, the number of ablations per ovary and / or per patient, and the like. The event log may also include the occurrence of events such as alarms or other abnormal conditions. The event log block 504 may further include a record of data input in the user interface block 510 such as the end of treatment.

[0076] Data download block 506 is a routine that commands generator 400 to transfer data to generator software 500 for downloading after the generator 400 is coupled to a computer that launches the generator software 500. The data download block 506 may initiate the download of data stored in the event log either automatically or upon activation by a clinician via the user interface block 510.

[0077] Configuration setting block 508 is a routine that configures parameters stored within generator 400 that control the operation of individual components / applications. The parameters may be determined to alert the user when a predetermined threshold is exceeded. Such interval timing parameters may be reconfigured by block 508. The interval timing settings transmitted from generator software 500 to generator 400 may also determine the time and frequency at which event data is written to memory within individual components / applications.

[0078] User interface block 510 handles user input, such as receipt of ovarian volume, in the computer that launches the generator software 500, and displays information read from the generator 400 as well as the data download block 506, presenting that information in an intuitive and easily understood format for review by a clinician, such as numbers, waveforms, text, plots, charts, graphs, or the like. Such information may include the status of the generator 400, measurement times, parameters sensed in real time, parameters sensed previously, parameters calculated using sensed parameters, sensor data, battery current, battery voltage, battery status, and the like.

[0079] The alarm detection block 512 may include routines for evaluating data read from the generator 400 and flagging abnormal conditions for the clinician's attention. For example, the alarm detection block 512 may flag when a parameter sensed by the system sensor 250 exceeds a first predetermined threshold or falls below a second predetermined threshold, as further explained in FIGS. 7-12.

[0080] The sensor calibration block 514 may include routines for testing or measuring the drift of the system sensor 250. The block 514 may then calculate an offset value for correcting the measured data from the sensor 250 and transmit that information to the generator 400 for storage in the non-volatile memory of the controller 402.

[0081] The firmware upgrade block 516 may comprise a routine for checking the version number of the controller firmware installed on the generator 400 and may identify whether upgraded firmware exists. If so, the routine may notify the clinician and enable the clinician to download the revised firmware to the generator 400 in the non-volatile memory.

[0082] The status information block 518 comprises a routine for querying the generator 400 and reading current status data from the generator 400. Such information may include, for example, battery status, version control information for currently used firmware and hardware, and sensor data.

[0083] In addition, the generator software 500 may further include a functional block for determining whether an appropriate needle assembly is coupled to the generator. For example, when the needle assembly is disposable, the generator software 500 will ensure that the same needle assembly is not used more than once. Thus, the needle assembly may include, for example, a chip or an identification tab such as an RFID or bar code that stores information about the needle assembly, including whether it has been previously used. In response to reading the chip or identification tab of the needle assembly by the generator, the generator software 500 may allow subsequent ablation if it determines that the needle assembly is appropriate, or prevent subsequent ablation if it determines that the needle assembly is inappropriate.

[0084] Reference is made to FIGS. 6A-6F, which depict an example method for treating ovarian tissue using a therapeutic needle assembly 200 as described herein. In this example, the therapeutic needle assembly 200 is coupled to a transvaginal ultrasound probe via an adapter 300, and a needle guide 600 is used. The operator positions, under ultrasound guidance using the ultrasound probe, an elongate shaft 206 having a therapeutic portion 212 disposed therein in a retracted state into the vagina. The needle tip 208 of the elongate shaft 206 penetrates the vaginal wall V and the ovarian wall. FIG. 6A illustrates the step of accessing a target region proximate to ovarian tissue within a patient after advancing the needle tip 208 through the vaginal wall V, through the ovarian wall, and into the ovary O. Once the elongate shaft 206 is positioned in a first orientation, FIG. 6B illustrates the step of deploying the therapeutic portion 212. The operator then delivers energy to the treatment zone via the generator 400 and the therapeutic portion 212, utilizing parameters described, for example, in U.S. Patent Publications Nos. 2016 / 0220302, 2017 / 0215949, and 2018 / 0110554 to Zairns (the entire contents of each are incorporated herein by reference). The energy may be delivered to heat (e.g., ablate) tissue within the treatment zone at a level and for a duration sufficient to effect treatment. For example, the energy may be applied within the ovary over the course of multiple ablations to treat polycystic ovary syndrome (PCOS).

[0085] After energy delivery is complete, the therapeutic portion 212 is retracted into the elongate shaft 206, as shown in FIG. 6C. Without removing the elongate shaft 206 from the ovary O, the operator may rotate the therapeutic needle assembly 200 relative to the adapter 300, or disconnect the therapeutic needle assembly 200 from the adapter 300 (e.g., by removing the adapter interface from the therapeutic needle interface) and invert / rotate the therapeutic needle assembly 200 by a predetermined amount (e.g., within a range of rotation extending up to 180 degrees maximum), and if the adapter interface has been removed from the therapeutic needle interface, the adapter interface may be reattached to the adapter 300. This inversion may occur while the distal region remains in a fixed position (other than rotation) within the ovary O.

[0086] For example, as shown in FIG. 6B, the therapeutic needle assembly 200 may first be introduced into the ovary O along the x-axis such that the port 210 of the therapeutic needle assembly 200 points downward along the y-axis. Thus, the therapeutic portion 212 will be deployed along the y-axis within the plane formed by the x-axis and the y-axis. In response to retraction of the therapeutic portion 212 into the elongate shaft as shown in FIG. 6C, the therapeutic needle assembly 200 may be rotated up to 90 degrees in either direction about the x-axis. For example, rotating the therapeutic needle assembly 200 90 degrees clockwise about the x-axis from the position shown in FIG. 6C will cause the port 210 to point out of the page along the z-axis, and rotating the therapeutic needle assembly 200 90 degrees counterclockwise about the x-axis from the initial position shown in FIG. 6C will cause the port 210 to point into the page along the z-axis. Thus, the therapeutic needle assembly 200 may be rotated by any amount within an overall range of 180 degrees, which may be limited by the field of view of the ultrasonic probe. For example, referring back to FIG. 3C, the therapeutic needle assembly 200 may be rotated up to 45 degrees in either direction about the x-axis, providing an overall range of rotation within 90 degrees such that the port 210, and thus the therapeutic portion 212, remains within the field of view FOV of the ultrasonic probe. As will be appreciated by those skilled in the art, the therapeutic needle assembly 200 may be rotated to any orientation within an overall range of 180 degrees and locked in place at the desired position while the ultrasonic probe remains stationary.

[0087] FIG. 6D illustrates the elongate shaft 206 in the second orientation in the retracted state, while the therapy portion 212 is redeployed in FIG. 6E to perform another treatment. Energy is then delivered to this second treatment zone. The therapy portion 212 may then be retracted to the retracted state as shown in FIG. 6F. The distal region of the therapy needle assembly 200 may be repositioned within the ovary O or removed after completion of treatment for that ovary O. For example, as shown in FIG. 6G, the elongate shaft 206 may be moved proximally in the retracted state along the same needle path without adjusting the angle of the elongate shaft 206 through a single access point for further energy delivery. The therapy portion 212 is then redeployed in FIG. 6H to perform another treatment. Energy is then delivered to this third treatment zone. The therapy portion 212 is retracted again and the therapy needle assembly 200 may be reversed to deliver energy within a fourth treatment zone. Additionally or alternatively, the elongate shaft 200 may be moved proximally again in the retracted state to deliver further treatment. Thus, multiple ablations such as four ablations in smaller ovaries (as determined by the clinician from ultrasound imaging), eight ablations in larger ovaries, or an amount of ablation sufficient to achieve a desired volume of ablated ovarian tissue such as 1% to 25% of the total ovarian volume, or more preferably 5% to 10%, etc., can be achieved within each ovary.

[0088] Figure 6I illustrates yet another location of the ovary O that can be treated using a single puncture of the vaginal wall V and ovary O after retraction and redeployment of the therapeutic portion 212. In Figure 6I, the therapeutic needle assembly 200 is moved to different angles along different needle paths through the same single puncture for optional further treatment. Generating fewer punctures and minimizing the amount of device manipulation can have several benefits including, but not limited to, reducing patient pain or discomfort due to less damage caused outside the ovary, reducing the risk of adhesion formation (during or after the procedure), ease of use for the operator, shortening the procedure time, and / or reducing the chance of complications such as bleeding. In other embodiments, fewer or more treatments can be performed. Additionally, or alternatively, multiple punctures can be performed to position therapeutic elements within different zones for treatment. After the first ovary is treated, the second ovary may be treated in a similar manner.

[0089] The release of energy into ovarian tissue (e.g., stroma) ablates the tissue and restores the balance of the ovary. For example, ablation is expected to reduce the hormonal imbalance between hormones such as follicle stimulating hormone (FSH) and luteinizing hormone (LH), thereby treating infertility symptoms such as polycystic ovary syndrome (PCOS).

[0090] Referring now to FIGS. 7 - 9, a method for monitoring the use of the system 100 during an ovarian procedure is illustrated. System sensor 250 and / or conductive needle 252 may be used to measure temperature and / or impedance. For example, a temperature sensing element may be coupled to each of the first and second electrodes 246, 248. Additionally, system sensor 250 and / or conductive needle 252 may also be used to detect whether the device is moving inappropriately during treatment delivery. For example, device movement can be inferred by sensing sudden changes in temperature, impedance, and / or power. An increase in impedance may also represent a change in tissue properties such as collagen denaturation, drying, or carbonization.

[0091] A processor on a computer that starts the generator software 500 (which may be the generator 400 itself) may be operable to start an algorithm based on these one or more measured system parameters. When implemented, the algorithm may be designed to modify the parameters of energy delivery. For example, the system 100 may include an automatic treatment delivery algorithm that automatically responds and adjusts and / or terminates treatment in response to parameters such as temperature, impedance, treatment duration, treatment power, and / or system status. In addition, the system 100 may inform the user of the monitored parameters and / or an alarm. The alarm detection of the algorithm may include evaluating data received from the sensor 250 and / or the conductive needle 252 and a routine for alerting the operator of an abnormal condition. The alert may be displayed on the graphical user interface 410 as a numerical measurement, waveform, text, plot, chart, graph, or the like. A plurality of sensed parameters may be displayed at once, and the sensed parameters displayed may be real-time measurements. The sensed parameters may be received continuously.

[0092] FIG. 7 is an exemplary method 700 for measuring the temperature (e.g., thermistor temperature) sensed by the therapeutic needle assembly 200. At 702, one or more signals indicative of one or more sensed parameters, such as temperature, are received by the generator 400 from the sensor 250 and / or the conductive needle 252. At 704, a processor on a computer that activates the generator software 500 may activate an algorithm stored in memory to determine whether the temperature exceeds a first predetermined temperature threshold. At 706, if the temperature exceeds the first predetermined temperature threshold, an alert, e.g., indicating that the probe or extension cable is disconnected, may be generated on the graphical user interface 410. In one embodiment, the first predetermined temperature threshold is within 115 - 125 degrees Celsius, e.g., 120 degrees Celsius. At 708, the processor determines, via execution of the algorithm, whether energy is being delivered. If so, the processor causes termination of energy delivery at 710. If not, step 720 (described below) is executed.

[0093] If the measured temperature does not exceed the first predetermined temperature threshold, the processor determines, via execution of the algorithm, at 712 whether the temperature is below a second predetermined temperature threshold or above a third predetermined temperature threshold. In one embodiment, the second predetermined temperature threshold is within 5 - 15 degrees Celsius, e.g., 10 degrees Celsius. The third predetermined temperature threshold may be within 40 - 50 degrees Celsius, e.g., 45 degrees Celsius. At 714, if the measured temperature is below the second predetermined temperature threshold or above the third predetermined temperature threshold, an alert indicating that the temperature is out of range may be generated on the graphical user interface 410. If not, step 720 (described below) is executed.

[0094] If the temperature is determined to be out of range at 716, the processor determines whether energy is being delivered via execution of an algorithm. If so, the processor causes the end of energy delivery at 718. If no energy was being delivered at 708 or 716, the processor may wait for a set time period according to a protocol stored in memory via execution of an algorithm before returning to step 702 to measure the temperature again at 720. Thus, the temperature may be monitored throughout the entire process of using the therapeutic needle assembly 200.

[0095] FIG. 8 is an exemplary method 800 for measuring probe temperature. At 802, one or more signals indicative of one or more sensed parameters such as temperature are received by generator 400 from sensor 250 and / or conductive needle 252. At 804, a processor on a computer that activates generator software 500 may activate an algorithm and determine whether the temperature is below a fourth predetermined temperature threshold. In one embodiment, the fourth predetermined temperature threshold is within 15 to 25 degrees Celsius, for example, 20 degrees Celsius. At 806, if the temperature is below the fourth predetermined temperature threshold, an event, such as an alert indicating that the probe temperature is low, may be generated on graphical user interface 410. If at 808 it is determined that the temperature is below the fourth predetermined threshold, the processor determines whether energy is being delivered via execution of the algorithm. If so, the processor causes termination of energy delivery at 810. If the temperature does not fall below the fourth predetermined temperature threshold, the processor determines at 812 via execution of the algorithm whether the temperature exceeds a first temperature (e.g., 5 degrees Celsius) that exceeds the temperature set point by more than a first time period (e.g., 5 seconds) while the power is increasing. At 816, if the measured temperature exceeds the threshold over the measured time, an alert indicating a temperature control error will be generated on graphical user interface 410. For example, if the measured probe temperature exceeds the temperature set point stored in memory by 5 degrees Celsius for more than 5 seconds, an alert may be generated. If so, at 818, the processor determines whether energy is being delivered via execution of the algorithm. If so, the processor causes termination of energy delivery at 820.

[0096] If the temperature does not fall below the fourth predetermined temperature threshold, the processor, via execution of the algorithm, determines at 814 whether, while the power is increasing, the temperature exceeds a second temperature (e.g., 10 degrees Celsius) that exceeds the temperature set point for a second time period (e.g., 1 second). In this embodiment, the second temperature exceeds the first temperature and the second time period is less than the first time period. Thus, if the temperature is too high (e.g., exceeds the second temperature), corrective measures may be taken more immediately. Steps 816 - 820 may be repeated following the determination at 814 that, while the power is increasing, the temperature exceeds a second temperature that exceeds the temperature set point for a second time period. If no energy has been delivered at 808 or 818, or if the threshold has not been met at 804, 814, or 812, the processor, via execution of the algorithm, may wait for a set time period at 822, in accordance with the protocol stored in memory, before returning to step 802 to measure the temperature again. Thus, the probe temperature may be monitored throughout the entire process of using the therapeutic needle assembly 200.

[0097] Figure 9 is an exemplary method 900 for measuring impedance. At 902, one or more signals indicative of one or more sensed parameters such as impedance are received by generator 400 from sensor 250 and / or conductive needle 252. At 904, a processor on a computer that activates generator software 500 may activate an algorithm and determine whether the measurement is such that the impedance is below a first predetermined temperature threshold. In one embodiment, the first predetermined impedance threshold is within 40 to 60 ohms, for example, 50 ohms. At 906, if the impedance is below the first predetermined impedance threshold, an alert indicating that the impedance is low may be generated on graphical user interface 410. At 908, the processor determines whether energy has been delivered via execution of the algorithm. If so, the processor causes termination of energy delivery at 910. If the impedance does not fall below the first predetermined impedance threshold, the processor determines at 912 via execution of the algorithm whether the measured impedance exceeds a second predetermined impedance threshold. In one embodiment, the second predetermined impedance threshold is within 900 to 1,100 ohms, for example, 1,000 ohms. At 914, if the measured impedance exceeds the second predetermined impedance, an alert indicating that the impedance is high may be generated on graphical user interface 410. At 916, the processor determines whether energy has been delivered via execution of the algorithm. If so, the processor causes termination of energy delivery at 918. At 908 or 916, if energy has not been delivered, the processor may wait for a set time period according to a protocol stored in memory at 920 before returning to step 902 to measure the impedance again via execution of the algorithm. Thus, the impedance at the treatment area may be monitored throughout the process of using therapy needle assembly 200.

[0098] Figures 10-13 illustrate a graphical user interface 410 designed to communicate with the processor of the generator 400. The exemplary screen shots generated by the graphical user interface 410 show a graphical interpretation of data received from the sensor 250 and / or the conductive needle 252. The graphical user interface 410 is designed to display measured parameters such as temperature, impedance, power, and corresponding alerts, as well as information input by the clinician / operator. The graphical user interface 410 is designed to present that information in an intuitive and easily understandable format for operator scrutiny, such as numbers, waveforms, text, plots, charts, graphs, or the like. The graphical user interface 410 may include buttons for receiving patient / procedure related information, user inputs such as ovarian volume, powering the device, and dismissing alerts.

[0099] Figure 10 depicts an exemplary measurement mode screen prior to energy delivery. The sensor 250 and / or the conductive needle 252 may be used before treatment is applied to characterize or map the target tissue. For example, impedance measurements may be used to sense whether the ultrasound probe is properly positioned for treatment. Figure 11 depicts an exemplary temperature 1100, power reading 1102, remaining ablation 1104, and ablation volume 1106. As the tissue heats and its properties change, the temperature may also increase. The sensor 250 and / or the conductive needle may also be used during treatment to dynamically adjust the treatment parameters. As illustrated in Figure 12, treatment end may also occur, resulting in an error message if certain conditions are met, as described in Figures 7-9. Figure 13 depicts a table for providing selection of ablation parameters for a given number of ablations and a desired ablation volume.

[0100] Preferred exemplary embodiments of the present invention have been described above, but it will be apparent to those skilled in the art that various changes and modifications can be made thereto without departing from the present invention. The appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the present invention.

Claims

A system for performing an ovarian procedure, the system being configured for use in combination with an ultrasonic probe, the system comprising: a therapeutic needle assembly having a proximal region and a distal region; an adapter having a needle assembly interface and an ultrasonic probe interface; and; wherein the therapeutic needle assembly comprises: an elongate shaft in the distal region, the elongate shaft comprising a lumen, a port, a needle tip at the distal end of the elongate shaft, and an angled interface, the angled interface forming the distal end of the lumen within the elongate shaft, defining the distal end of the port, and the needle tip being configured to penetrate the vaginal wall and the ovarian wall for placement of the port into the ovary; a therapeutic portion disposed within the lumen of the elongate shaft in a retracted state, the therapeutic portion comprising an energy emitter, the energy emitter being configured to deploy and extend outside of the port of the elongate shaft in a deployed state and to emit energy into ovarian tissue of the ovary while in the deployed state; a handle in the proximal region, the handle comprising an actuator, the actuator being configured to transition the therapeutic portion between the retracted state and the deployed state when actuated; a lubricant disposed within the lumen of the elongate shaft adjacent to the port of the elongate shaft; and further comprising; the lubricant being configured to facilitate transition of the therapeutic portion between the retracted state and the deployed state in response to actuation of the actuator without damaging the energy emitter; the ultrasonic probe interface being configured to removably couple to the ultrasonic probe, and the needle assembly interface being configured to removably couple to an adapter interface of the handle such that the therapeutic needle assembly is coupled to the ultrasonic probe; the adapter interface and the needle assembly interface being configured to permit reorientation of the therapeutic needle assembly relative to the adapter between a first orientation and a second orientation; The adapter interface and the needle assembly interface are configured to lock together in the first orientation and to allow reorientation of the therapeutic needle assembly relative to the adapter such that the adapter interface and the needle assembly interface lock together in the second orientation. The adapter interface includes first and second notches on an opposing surface of the handle, and a distance between surfaces of the first and second notches is narrower than a diameter of the handle. The needle assembly interface includes a pair of protrusions, each protrusion of the pair of protrusions having a surface facing a surface of the other protrusion, the surfaces of the protrusions facing each other defining opposing surfaces of the needle assembly interface, and a distance between surfaces of the first and second notches corresponding to a distance between the opposing surfaces of the needle assembly interface, and when the adapter interface is coupled to the needle assembly interface, the surfaces of the first and second notches are configured to contact the opposing surfaces of the needle assembly interface to lock the adapter interface to the needle assembly interface in the first and second orientations relative to the needle assembly interface. **Claim 2** The system of claim 1, wherein each of the first and second notches and the opposing surfaces of the needle assembly interface includes a plurality of ribs for improving locking. **Claim 3** A system for performing an ovarian procedure, the system configured for use in combination with an ultrasonic probe, the system comprising a therapeutic needle assembly having a proximal region and a distal region, a generator and wherein the therapeutic needle assembly includes an elongate shaft in the distal region, the elongate shaft including a lumen, a port, a needle tip at a distal end of the elongate shaft, and an angled interface, the angled interface forming a distal end of the lumen within the elongate shaft and defining a distal end of the port, the needle tip configured to penetrate a vaginal wall and penetrate an ovarian wall for placement of the port into the ovary. A therapeutic portion disposed within the lumen of the extension shaft in the retracted state, the therapeutic portion comprising an energy emitter, the energy emitter being configured to be deployed and extend outside the port of the extension shaft in the deployed state and to emit energy into the ovarian tissue of the ovary while in the deployed state, the therapeutic portion; At least one sensor configured to generate data during the emission of energy from the therapeutic portion, the at least one sensor comprising an impedance sensor and at least one temperature sensor configured to measure the temperature at one or more electrodes or the probe temperature or both, the at least one sensor; A handle in the proximal region, the handle comprising an actuator, the actuator being configured to transition the therapeutic portion between the retracted state and the deployed state when actuated, the handle; A lubricant disposed within the lumen of the extension shaft adjacent to the port of the extension shaft further comprising The lubricant is configured to facilitate the transition of the therapeutic portion between the retracted state and the deployed state in response to actuation of the actuator without damaging the energy emitter. The generator is operably coupled to the therapeutic portion and is configured to deliver the energy to the therapeutic portion in the deployed state such that the therapeutic portion emits energy into the ovarian tissue of the ovary. The generator comprises a processor in electrical communication with the at least one sensor, the processor executing instructions stored on a non-transitory computer-readable medium and configured to store information indicating the number of ablations per ovary or per patient and to display the information indicating the number of ablations on a graphical user interface, the system. **Claim 4** The processor receiving the data from the at least one sensor; determining whether the data is within a predetermined range; commanding the generator to modify the delivery of energy to the therapeutic portion if the data indicates that at least one measured parameter is outside the predetermined range The system according to claim 3, configured to execute instructions stored on a non-transitory computer-readable medium so as to perform **Claim 5** The system according to claim 4, wherein the processor is configured to activate a routine for causing an alert to occur on the graphical user interface when the data exceeds a first predetermined threshold or falls below a second predetermined threshold. **Claim 6** The system according to claim 3, further comprising the graphical user interface configured to display information indicating a treatment process based on data from the at least one sensor. **Claim 7** The system according to claim 6, wherein the graphical user interface is configured to display information indicating temperature and power over time.

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