System and method for applying energy to ovarian tissue

Abstract

To provide a system and a method for applying preferable energy to ovarian tissue.SOLUTION: Described herein are methods and systems 100 for performing a procedure for ovarian rebalancing. The methods and systems may be used in the treatment of polycystic ovary syndrome (PCOS). The methods and systems may also be useful in the treatment of infertility associated with PCOS.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 797,191, filed 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 that may be used in the treatment of polycystic ovarian syndrome (PCOS), infertility, and / or other diseases / disorders involving the ovaries, or to modulate ovulation. [Background technology]

[0003] In cases of disease within the ovaries and / or in cases of certain types of infertility, there may be a need to manipulate ovarian tissue, retrieve tissue, or deliver agents into a patient's ovaries. For some time now, physicians have used direct surgical access, laparoscopic access, or transvaginal ultrasound-directed needle-based methods to access the ovaries. Direct surgical access is typically obtained under anesthesia and involves a skin incision to directly expose and operate on the tissue. Laparoscopic access is typically obtained under anesthesia and involves two or more skin incisions, and further involves distending the space surrounding the ovaries with either gas or fluid, and using a camera and laparoscopic tools to visualize and operate on the tissue. Transvaginal ultrasound-directed needle-based access is often employed for the retrieval of oocytes as part of in vitro fertilization (IVF). These current approaches have several limitations. Namely, surgical and laparoscopic access methods are generally more invasive and therefore require more anesthesia and higher procedural acuity. Furthermore, while surgical and laparoscopic access methods allow direct visualization of the surface of the ovary, they offer poor ability to visualize where specific devices are deployed within the ovarian tissue. Transvaginal needle access is typically performed under ultrasound, allowing delivery of needle tips into specific locations within the ovary, which can be visualized in real time; however, current systems are limited because the needles used to access the tissue are only single or double lumen needles and cannot do more than simply aspirate. 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 a transvaginal ultrasound-guided needle route. Current systems are also not ideally suited for delivery of specific agents or energy to the ovary.

[0004] Manipulation of ovarian tissue may treat polycystic ovarian syndrome (PCOS). PCOS is an endocrine disorder first characterized by Stein and Leventhal in the 1930s. Features of the syndrome may include oligo / amenorrhea, oligo / anovulation, hirsutism, acne, obesity, and a characteristic polycystic appearance of the ovaries. PCOS generally has significant effects on reproductive health (e.g., oligo / amenorrhea and oligo / anovulation, bleeding, endometrial hyperplasia, infertility, and increased risk of endometrial cancer) as well as non-reproductive health (e.g., hyperandrogenemia, carcinoma, insulin resistance, hypercholesterolemia, hypertension, obesity, sleep apnea, and cardiovascular disease). PCOS has historically been considered in the context of hormonal dysregulation, characterized by altered gonadotropin secretion, increased androgen production, increased insulin resistance, increased cortisol production, and obesity. PCOS has also been shown to often be accompanied by increased activity of the sympathetic nervous system.

[0005] Treating PCOS can be costly for the healthcare system. The primary non-fertility treatments include oral contraceptives (for hormone 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 the first-line treatment, and second-line treatment is either gonadotropin administration or ovarian drilling (sometimes referred to as ovarian diathermy). If these treatments are unsuccessful, in vitro fertilization (IVF) is attempted. However, multiple pregnancies and live births (e.g., twins) are common with clomiphene citrate, gonadotropin, and IVF treatment. In infertility treatment, multiple pregnancies and live births are often considered unfavorable outcomes due to associated perinatal and neonatal morbidity and associated increased costs. In addition, ovarian hyperstimulation syndrome (OHSS) may be more common in women with PCOS who undergo gonadotropin or IVF treatment. OHSS is often mild and easily treated, but more severe cases may require invasive treatment.

[0007] Alternatively, ovarian drilling may be an option in treating PCOS, PCOS-related symptoms / disorders, and PCOS-related infertility. Prior to the development of ovarian drilling, other types of surgery were performed on the ovaries for the treatment of infertility. Ovarian wedge resection, an established procedure first described in the late 1940s, involves the surgical removal of a wedge of ovarian tissue from a polycystic ovary. Despite the effectiveness of the procedure, ovarian wedge resection has generally been abandoned in favor of newer techniques due to the frequent occurrence of adhesions with the technique. Other ovarian surgical procedures for infertility in PCOS that have been performed are ovarian electrocautery, ovarian laser vaporization, multiple ovarian biopsies, and others.

[0008] Ovarian drilling / diathermy (OD) was first used in the 1970s and 1980s. [ka] Developed by . In recent years, OD is the most frequently described ovarian surgery for infertility in women with PCOS. In this laparoscopic procedure, radiofrequency energy or other techniques are used to create multiple holes in the ovaries. There are common findings following the surgery, including rapid changes in ovarian and pituitary hormones followed by a prolonged reduction in circulating androgens. Randomized trials have shown that pregnancy and live birth rates are similar to those associated with gonadotropin treatment, but with a significantly reduced rate of multiple pregnancies, while allowing women to benefit from a one-time treatment and experience a natural conception.

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

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

[0011] [Patent Document 1] US Patent Application Publication No. 2016 / 0220302 [Patent Document 2] US Patent Application Publication No. 2017 / 0215949 [Patent Document 3] US Patent Application Publication No. 2018 / 0110554 Summary of the Invention [Means for solving the problem]

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

[0013] Exemplary ovarian tissues include, but are not limited to, the ovary (e.g., medulla / stroma and / or cortex), follicles / ovarian cysts, nerves associated with the ovary, suspensory ligament, ovarian ligament, uterine broad ligament, mesovarian lining, endometrial tissue within the ovary, tumors or neoplastic cells, or combinations thereof. Stromal tissue generally includes the intermediate or medullary region of the ovary. The cortex (or outer region) of the ovary is generally where follicles of different maturity tend to reside. The term "follicle" includes oocytes contained within the follicle and may specifically refer to the entire follicular structure or oocytes. These follicles are sometimes referred to as "cysts" in the setting of PCOS. In other settings, cysts may refer to a collection of fluid that may or may not be a follicle. The methods and systems may be used to rebalance the ovaries and modulate ovulation, treat one or more symptoms of polycystic ovary syndrome, including infertility, or disorders associated therewith, or treat other diseases / disorders involving the ovaries.

[0014] A system for performing ovarian procedures as described herein may be capable of being advanced adjacent to or within the ovary, or in the case of PCOS, follicles / ovarian cysts or other target tissue (e.g., stroma). Additionally, the system may be used in conjunction with an ultrasound probe. According to one aspect of the present invention, the ultrasound probe may be a vaginal 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 elongated shaft at the distal region. The elongated shaft has a lumen, a port, and a needle tip at a distal end of the elongated shaft, the needle tip being structured to penetrate the vaginal wall and penetrate the ovarian wall for placement of the port in the ovary. For example, the needle tip may be cored to define a cavity and facilitate penetration of the vaginal and ovarian walls.

[0015] The therapeutic needle assembly further includes a therapeutic portion disposed within the lumen of the elongate shaft in a retracted state, the therapeutic portion having an energy emitter that can be deployed to extend out 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. The therapeutic portion can be curved in the deployed state and can include one or more electrodes for emitting energy into the ovarian tissue. For example, the therapeutic portion can further include an active electrode and a return electrode, and the active electrode can emit continuous or pulsed radio frequency energy. The therapeutic portion can emit energy into the ovarian tissue to treat polycystic ovary syndrome (PCOS).

[0016] In addition, the therapeutic needle assembly may include a handle at a proximal region having an actuator for transitioning the therapeutic portion between a retracted state and a deployed state when actuated. According to one aspect, the actuator includes a trigger that releases or engages a locking mechanism that aids in the deployment of the therapeutic portion. The therapeutic portion may include an echogenic material or region (e.g., air / gas) for improved visibility. The therapeutic needle assembly, therapeutic portion, and other components may be made from polymeric 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 therefore will not be described in detail herein.

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

[0018] Additionally, 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 a handle, such that the therapeutic needle assembly may be coupled to the ultrasonic probe. Thus, the adapter may longitudinally align the therapeutic needle assembly with the ultrasonic probe. Additionally, 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 for receiving the elongated shaft therethrough and stabilizing the elongated shaft during the procedure. According to one aspect of the present 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 allow 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 a first orientation and may be detached from each other to allow reorientation of the therapeutic needle assembly relative to the adapter such that the adapter interface and the needle assembly interface may lock together in a second orientation. The therapeutic portion in the first orientation when in the deployed state may be offset, for example, less than or equal to 180 degrees from the therapeutic portion in the second orientation when 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, the first and second notches being structured to contact opposing surfaces of the needle assembly interface and lock the adapter interface to the needle assembly interface in the first orientation and the second orientation. Additionally, the first and second notches or opposing surfaces of the needle assembly interface, or both, may include multiple ribs to enhance locking. According to another aspect of the invention, the adapter interface and the needle assembly interface may lock together in a first orientation and allow rotation of the therapeutic needle assembly relative to the adapter such that the adapter interface and the needle assembly interface may lock together in a second orientation. According to another aspect of the invention, the adapter interface and the needle assembly interface may allow reorientation of the therapeutic needle assembly relative to the adapter between orientations beyond 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 for delivering energy to the therapeutic portion in the deployed state such that the therapeutic portion releases energy into ovarian tissue of the ovary. The generator may provide continuous or pulsed radio frequency energy, microwave energy, cryoablative energy, unfocused 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 to 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 of the predetermined range. The processor may further initiate a routine to cause the generation of an alert on a graphical user interface if the data is above a first predetermined threshold or below a second predetermined threshold. In addition, 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] Moreover, the processor may further execute instructions stored on the non-transitory computer-readable medium to store information indicative of the number of ablations per ovary or per patient, and cause the graphical user interface to display the information indicative of the number of ablations. In addition, the graphical user interface may display information indicative of at least one of an ovarian volume per ovary, an ovarian volume per patient, a recommended ablation parameter, a set ablation parameter, a power setting, a recommended number of ablations, a requested number of ablations, a recommended ovarian ablation volume, a requested ovarian ablation volume, a completed number of ablations, a remaining number of ablations, a percentage of the ovarian volume to be ablated, or a percentage of the ovarian volume not yet ablated. The information indicative of the recommended or set ablation parameters may be displayed in a table, such as a look-up table. The displayed information may be updated after each ablation. The processor may receive, for example, input data indicative of an ovarian volume, such that the information displayed on the graphical user interface is based at least in part on the input data indicative of the ovarian volume. Such information is expected to assist clinicians during procedures involving multiple ablations (e.g., 4-8 ablations per ovary based on individual ovarian volumes, typically measured by ultrasound prior to the ablation procedure).

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

[0024] For example, 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 explained above, the lubricant facilitates deployment of the therapeutic portion without damaging the energy emitters of the therapeutic portion.

[0025] Additionally, reorienting the therapeutic needle assembly while the elongated shaft port remains within the ovary may include reorienting the therapeutic needle assembly relative to the adapter. For example, reorienting the therapeutic needle assembly relative to the adapter may include removing the therapeutic needle assembly from the adapter while the elongated shaft port 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, reorienting the therapeutic needle assembly relative to the adapter may include rotating, advancing, or retracting the therapeutic needle assembly relative to the adapter while the elongated shaft port remains within the ovary.

[0026] Additionally, the method may further include retracting the therapeutic portion into the lumen of the elongate shaft, moving the elongate shaft proximally along the common needle path within the ovary to a second location, deploying the therapeutic portion from the lumen of the elongate shaft and out of a port at the second location, and releasing energy into ovarian tissue of the ovary at the second location via an energy emitter of the therapeutic portion.

[0027] For example, the therapeutic needle assembly may be moved along the same needle path (e.g., proximally without adjusting the needle angle) through a single entry point for further energy delivery. The therapeutic portion may be redeployed inside the ovary at a location proximal or distal to the initial / prior ablation site. In this manner, multiple ablations may be achieved within each ovary, such as 4 ablations in smaller ovaries, 8 ablations in larger ovaries, or sufficient ablations and power levels to achieve the desired volume of ablated ovarian tissue (as determined by the clinician from ultrasound imaging).

[0028] These system embodiments may have various effects on therapy. These system embodiments may enable a minimally invasive transvaginal approach, for example, where the ovary 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 may allow for a single entry point or fewer entry points into the ovary, reducing the risk of adhesions compared to surgical and laparoscopic approaches that involve tissue dissection and entry points for each ablation within the ovary. Once in position within the ovary, the therapeutic portion may be advanced or deployed into the tissue. Here, a releasably securable adapter allows the therapeutic portion to be flipped or rotated (e.g., 60, 90, 120, 180 degrees) so that additional areas of the ovary may 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) conscious sedation versus general anesthesia, which reduces cost and patient risk; (b) absence of external scarring; (c) less tissue manipulation resulting in lower risk of adhesions; (d) fewer access points into the ovaries resulting in lower risk of adhesions; (e) faster recovery time; (f) it is a familiar access route for obstetrician-gynecologists and infertility physicians and fits within existing treatment pathways; and (g) rebalancing the ovaries and effectively treating symptoms. The present invention provides, for example, the following: (Item 1) 1. A system for performing an ovarian procedure, the system being configured for use with an ultrasound probe, the system comprising: Therapeutic needle assembly comprising a proximal region and a distal region - Patents.com Equipped with The therapeutic needle assembly comprises: an elongate shaft at the distal region, the elongate shaft comprising a lumen, a port, and a needle tip at a distal end of the elongate shaft, the needle tip configured to penetrate a vaginal wall and an 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 be deployed to extend out 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 at the proximal region, the handle comprising an actuator configured to transition the therapeutic portion between the retracted state and the deployed state when actuated; Further equipped with The system, wherein the elongate shaft is configured to facilitate transition of the therapeutic portion between the retracted state and the deployed state in response to actuation at the actuator without damaging the energy emitter. (Item 2) 2. The system of claim 1, wherein the needle tip is cored to define a cavity and facilitate penetration through the vaginal wall and the ovarian wall. (Item 3) 2. The system of claim 1, further comprising an adapter comprising a needle assembly interface and an ultrasonic probe interface, the ultrasonic probe interface configured to be removably coupled to the ultrasonic probe, and the needle assembly interface configured to be removably coupled to an adapter interface of the handle such that the therapeutic needle assembly is coupled to the ultrasonic probe. (Item 4) 4. The system of claim 3, wherein the adapter interface and the needle assembly interface are configured to allow reorientation of the therapeutic needle assembly relative to the adapter between a first orientation and a second orientation. (Item 5) 5. The system of claim 4, wherein 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 are configured to lock together in the second orientation. (Item 6) 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) 6. The system of claim 5, wherein the therapeutic portion in the first orientation in the deployed state is offset less than or equal to 180 degrees from the therapeutic portion in the second orientation in the deployed state. (Item 8) 6. The system of claim 5, wherein the adapter interface comprises first and second notches on opposing surfaces of the handle, the first and second notches configured to contact opposing surfaces of the needle assembly interface and lock the adapter interface to the needle assembly interface in the first and second orientations. (Item 9) 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) 5. The system of claim 4, wherein the adapter interface and the needle assembly interface are configured to lock together in the first orientation and to allow rotation of the therapeutic needle assembly relative to the adapter such that the adapter interface and the needle assembly interface are configured to lock together in the second orientation. (Item 11) 4. The system of claim 3, wherein the adapter is configured to longitudinally align the therapeutic needle assembly with the ultrasound probe. (Item 12) 4. The system of claim 3, wherein the adapter ensures alignment of the therapeutic portion within a field of view of the ultrasound probe. (Item 13) a needle guide configured to be removably coupled to the ultrasonic probe, receive the elongated shaft therethrough, and stabilize the elongated shaft during a procedure; 4. The system of claim 3, wherein at least one of the therapeutic needle assembly and the needle guide or the needle guide and the adapter are formed as a single entity. (Item 14) 2. The system of claim 1, further comprising a generator operably coupled to the therapeutic portion and configured to deliver energy to the therapeutic portion in the deployed state such that the therapeutic portion releases energy into the ovarian tissue of the ovary. (Item 15) Item 15. The system of item 14, wherein the therapeutic portion comprises at least one sensor configured to generate data during emission of energy from the therapeutic portion. (Item 16) The generator includes a processor in electrical communication with the at least one sensor, the processor comprising: receiving the data from the at least one sensor; determining whether the data is within a predetermined range; instructing the generator to modify delivery of energy to the therapeutic area if the data indicates that at least one measured parameter is outside of the predetermined range; Item 16. The system of item 15, configured to execute instructions stored on a non-transitory computer-readable medium to perform the steps of: (Item 17) Item 17. The system of item 16, wherein the processor is configured to initiate a routine to cause the generation of an alert on a graphical user interface if the data exceeds a first predetermined threshold or falls below a second predetermined threshold. (Item 18) Item 16. The system of item 15, wherein the at least one sensor comprises an impedance sensor and at least one temperature sensor configured to measure temperature at one or more electrodes or a probe temperature or both. (Item 19) Item 16. The system of item 15, further comprising a graphical user interface configured to display information indicative of a treatment process based on data from the at least one sensor. (Item 20) 20. The system of claim 19, wherein the graphical user interface is configured to display information indicative of temperature and power versus time. (Item 21) Item 16. The system of item 15, wherein the generator comprises a processor in electrical communication with the at least one sensor, the processor configured to execute instructions stored on a non-transitory computer-readable medium to store information indicative of a number of ablations per ovary or per patient, and to cause a graphical user interface to display the information indicative of the number of ablations. (Item 22) 2. The system of claim 1, further comprising a graphical user interface configured to display information indicating at least one of: ovarian volume per ovary, ovarian volume per patient, recommended ablation parameters, ablation parameters to be set, power settings, recommended number of ablations, number of ablations requested, recommended ovarian ablation volume, requested 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) 23. The system of claim 22, wherein the information indicative of the recommended or set ablation parameters is displayed in a table. (Item 24) 23. The system of claim 22, wherein the displayed information is updated after each ablation. (Item 25) 23. 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 based at least in part on the input data indicative of ovarian volume. (Item 26) Item 1. The system of item 1, wherein the therapeutic portion is configured to form a curve in the deployed state. (Item 27) 2. 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) 2. The system of claim 1, wherein the therapeutic portion comprises an active electrode and a return electrode, the active electrode configured to emit continuous or pulsed radio frequency energy. (Item 29) 2. The system of claim 1, wherein the therapeutic portion is configured to emit the energy into the ovarian tissue to treat polycystic ovarian syndrome (PCOS). (Item 30) 2. The system of claim 1, further comprising a lubricant disposed within the lumen of the elongation shaft adjacent the port of the elongation shaft, the lubricant 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 31) 31. The system of claim 30, wherein the lubricant comprises at least one of a lubricous tube or coating. (Item 32) Item 1 , the system being configured for use with a vaginal ultrasound probe. (Item 33) 1. A method for performing an ovarian procedure, the method comprising: advancing a distal region of the therapeutic needle assembly into the vagina; penetrating a vaginal wall with a needle tip at a distal end of an elongated shaft of the therapeutic needle assembly; piercing the ovarian wall with the needle tip to position the elongate shaft port at a desired location within the ovary; deploying a therapeutic portion from a lumen of the elongate shaft and out of the port in a first orientation, the elongate shaft 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 via 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 elongated shaft remains within the ovary; deploying the therapeutic portion from the lumen of the elongate shaft and out of the port in a second orientation; emitting energy into ovarian tissue of the ovary via the energy emitter of the therapeutic portion in the second orientation; A method comprising: (Item 34) 34. The method of claim 33, wherein deploying the therapeutic portion from the lumen of the elongate shaft includes sliding the therapeutic portion through a lubricant in the lumen of the elongate shaft adjacent the port, the lubricant configured to facilitate deployment of the therapeutic portion without damaging the energy emitter of the therapeutic portion. (Item 35) Item 34. The method of item 33, wherein the therapeutic needle assembly is removably coupled to an ultrasound probe via an adapter, and reorienting the therapeutic needle assembly while the port of the elongated shaft remains within the ovary includes reorienting the therapeutic needle assembly relative to the adapter. (Item 36) Reorienting the therapeutic needle assembly relative to the adapter includes: removing the therapeutic needle assembly from the adapter while the port of the elongated shaft remains within the ovary; rotating the therapeutic needle assembly while the adapter remains in place; reattaching the therapeutic needle assembly to the adapter; 36. The method according to claim 35, comprising: (Item 37) Item 36. The method of item 35, wherein reorienting the therapeutic needle assembly relative to the adapter comprises rotating, advancing, or retracting the therapeutic needle assembly relative to the adapter while the port of the elongated shaft remains within the ovary. (Item 38) retracting the therapeutic portion into the lumen of the elongate shaft; moving the elongate shaft proximally along a common needle path within the ovary to a second position; deploying the therapeutic portion from the lumen of the elongate shaft and out of the port at the second location; emitting energy into ovarian tissue of the ovary at the second location via the energy emitter of the therapeutic portion; 34. The method of claim 33, further comprising: [Brief description of the drawings]

[0029] [Figure 1A] FIG. 1A illustrates an exemplary system for performing an ovarian procedure, constructed and operative in accordance with a non-limiting embodiment of the present invention.

[0030] [Figure 1B] FIG. 1B illustrates an exemplary therapeutic needle assembly and adapter from the system of FIG. 1A assembled with an ultrasound probe and needle guide, according to a non-limiting embodiment of the present invention.

[0031] [Figure 2A] 2A and 2B depict an exemplary therapeutic needle assembly from the system of FIG. 1A in a retracted state and a deployed state, respectively. [Figure 2B] 2A and 2B depict an exemplary therapeutic needle assembly from the system of FIG. 1A in a retracted state and a deployed state, respectively.

[0032] [Figure 2C] 2C and 2D are side and top views of an exemplary therapeutic needle assembly in a retracted state. [Figure 2D] 2C and 2D are side and top views of an exemplary therapeutic needle assembly in a retracted state.

[0033] [Figure 2E] FIG. 2E shows a side view of the handle of an exemplary therapeutic needle assembly in a retracted, locked state across a cross-sectional view along a section line.

[0034] [Figure 2F] FIG. 2F shows a side view of the handle of an exemplary therapeutic needle assembly in a retracted, unlocked state across a cross-sectional view along a section line.

[0035] [Figure 2G] 2G and 2H are side and top views of an exemplary therapeutic needle assembly in a deployed state. [Figure 2H] 2G and 2H are side and top views of an exemplary therapeutic needle assembly in a deployed state.

[0036] [Figure 2I]FIG. 2I shows a side view of the handle of an exemplary therapeutic needle assembly in a deployed state across a cross-sectional view along a section line.

[0037] [Figure 2J] FIG. 2J is a side view of the distal region of an exemplary therapeutic needle assembly, FIG. 2K shows the distal region rotated 90 degrees to show the inner components within the shaft, and FIG. 2L shows the distal region including the inner components inverted from the orientation of FIG. 2J. [Figure 2K] FIG. 2J is a side view of the distal region of an exemplary therapeutic needle assembly, FIG. 2K shows the distal region rotated 90 degrees to show the inner components within the shaft, and FIG. 2L shows the distal region including the inner components inverted from the orientation of FIG. 2J. [Figure 2L] FIG. 2J is a side view of the distal region of an exemplary therapeutic needle assembly, FIG. 2K shows the distal region rotated 90 degrees to show the inner components within the shaft, and FIG. 2L shows the distal region including the inner components inverted from the orientation of FIG. 2J.

[0038] [Figure 2M] FIG. 2M is a cross-sectional view of a distal region of an exemplary therapeutic needle showing the therapeutic portion in a deployed state.

[0039] [Figure 3A] FIG. 3A illustrates an example adapter from the system of FIG. 1A, and FIG. 3B illustrates a close-up version of an example therapeutic needle interface of the adapter. [Figure 3B] FIG. 3A illustrates an example adapter from the system of FIG. 1A, and FIG. 3B illustrates a close-up version of an example therapeutic needle interface of the adapter.

[0040] [Figure 3C] FIG. 3C is a front cross-sectional view of the field of view of an ultrasound probe illustrating reorientation of a therapeutic needle assembly within the field of view of an ultrasound transducer in accordance with the principles of the present invention.

[0041] [Figure 4] FIG. 4 shows a schematic diagram of an exemplary generator of the system of FIG. 1A.

[0042] [Diagram 5] FIG. 5 shows a schematic diagram of the functional components of exemplary generator software of the system of FIG. 1A.

[0043] [Figure 6-1] 6A-6I illustrate an exemplary method for performing an ovarian procedure, according to a non-limiting embodiment of the present invention. [Figure 6-2] 6A-6I illustrate an exemplary method for performing an ovarian procedure, according to a non-limiting embodiment of the present invention. [Figure 6-3] 6A-6I illustrate an exemplary method for performing an ovarian procedure, according to a non-limiting embodiment of the present invention.

[0044] [Figure 7] 7-9 are flow charts illustrating exemplary methods for monitoring measured parameters in a system for performing ovarian procedures. [Figure 8] 7-9 are flow charts illustrating exemplary methods for monitoring measured parameters in a system for performing ovarian procedures. [Figure 9] 7-9 are flow charts illustrating exemplary methods for monitoring measured parameters in a system for performing ovarian procedures.

[0045] [Figure 10] 10-13 are example snapshots of the graphical user interface generated by the generator software. [Figure 11] 10-13 are example snapshots of the graphical user interface generated by the generator software. [Figure 12]10-13 are example snapshots of the graphical user interface generated by the generator software. [Figure 13] 10-13 are example snapshots of the graphical user interface generated by the generator software.

[0046] The foregoing and other features of the present invention will become apparent from the following description and appended claims, taken in conjunction with the accompanying drawings, in which: The present disclosure will be described with additional specificity and detail through the use of the accompanying drawings, with the understanding that these drawings depict only some embodiments according to the present disclosure and therefore should not be considered limiting of its scope. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] The present invention is directed to systems and methods for performing procedures on the 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 drawn to scale, either in a relative or absolute sense. Therapeutic needle assembly 200 includes a distal region 202 and a proximal region 204. Distal region 202 includes an elongated shaft 206 with a needle tip 208 at a distal end of the elongated shaft 206 and a port 210 proximal to the needle tip 208. The needle tip 208 is constructed to penetrate the vaginal wall and / or the ovarian wall. The therapeutic needle assembly 200 also includes a therapeutic portion 212 that is slidably disposed within the lumen of the elongated shaft 206. The therapeutic portion 212 may be deployed out of the port 210 as shown in FIG. 1A and is configured to emit energy therefrom (e.g., via one or more electrodes) after deployment.

[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 of the port 210 when actuated. For example, the actuator 216 may include a button that is depressible to unlock the actuator 216 and slide the actuator 216 distally, moving the therapeutic portion 212 distally such that the therapeutic portion 212 is deflected and curved out of the side port 210, as shown in FIG. 1A. The adapter interface 218 is constructed to secure the therapeutic needle assembly 200 to an ultrasound probe via an adapter 300. The adapter 300 is configured to be coupled to the therapeutic needle assembly 200 and to the ultrasound probe. Advantageously, the adapter 300 works with many commercially available ultrasound probes, allowing the therapeutic needle assembly 200 to be seamlessly used with a variety of probes. The adapter 300 preferably includes a needle assembly interface 302 configured to be removably coupled to the therapeutic needle assembly 200 (e.g., at the adapter interface 218) and an ultrasound probe interface 304 configured to be removably coupled to a vaginal ultrasound probe.

[0049] In addition, the system 100 includes a generator 400 that is configured to communicate with the therapeutic portion 212. The generator 400 is electrically coupled to the therapeutic needle assembly 200 and configured to deliver energy to the therapeutic portion 212 for release into tissue. In addition, the generator 400 may receive sensed information from one or more sensors of the therapeutic needle assembly 200 to monitor the operation of the assembly and the patient's anatomy during treatment. The system 100 also preferably includes generator software 500 that may run 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., clinician, gynecologist, etc.) to monitor the operation of the therapeutic needle assembly 200 and the patient's anatomy during treatment.

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

[0051] FIG. 1B illustrates the therapeutic needle assembly 200 and adapter 300 of the system 100 coupled together and coupled to a needle guide 600 and an ultrasound probe 602. The needle guide 600 is configured to be coupled to the ultrasound probe 602 and to receive the elongated shaft 206 therethrough 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 ultrasound probe 602 may be any commercially available ultrasound probe for vaginal use. For example, the ultrasound probe 602 may be a GE RIC5-9-D, GE RIC6-12-D, or RIC5-9W-RS ultrasound transducer available from GE Healthcare (Chicago, Illinois). As would be readily understood by one of ordinary skill in the art, the ultrasound probe 602 may be used in conjunction with other ultrasound components, such as a display, used in conjunction with the probe. The needle guide 600 preferably assists in aligning the therapeutic portion 212 with the ultrasound visualization plane or field of view formed from the ultrasound probe 602 in a manner that ensures visibility as it deploys, which may allow the operator to more precisely position and deliver therapy at a desired location. As will be appreciated by one of ordinary skill in the art, various elements such as the therapeutic needle assembly 200 and needle guide 600, the needle assembly 600 and adapter 300, and the like, may be combined into a single entity.

[0052] 2A and 2B, the 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 the 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 enhance locking. A channel 228 may be disposed within the handle 214 such that the actuator 216 may deploy and retract the therapeutic portion 212 when a trigger 230 (e.g., a button) is pressed. FIG. 2B illustrates the position after the actuator 216 is actuated and the therapeutic portion 212 is deployed out of the port 210.

[0053] Reference is now made to Figures 2C-2I. The elongated shaft 206 extends from the distal end of the handle 214. As discussed above, the adapter interface 218 on the handle 214 may include first and second plurality of ribs 224, 226 in the first and second notches 220, 222 to aid in gripping and coupling to the adapter 300. Figures 2C and 2D respectively illustrate side and top views of the therapeutic needle assembly 200. Similarly, side and top views of the therapeutic needle assembly 200 are shown in Figures 2G and 2H, where similar components are shown with the therapeutic portion 212 deployed. Figures 2E, 2F, and 2I illustrate details and cross-sections of the handle 214, with Figure 2E illustrating a locked retracted state, Figure 2F illustrating an unlocked retracted state, and Figure 2I illustrating a deployed state. The handle 214 includes a trigger 230 for controlling a locking mechanism 232. When the trigger 230 is depressed, the locking mechanism 232 is released and the actuator 214 can move an advancement rail 234 along the channel 228 for purposes of deploying the therapeutic portion 212 out of the port 210. Such deployment features may include sliders, knobs, wheels, cranks, or the like, that may 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 help limit the distance the therapeutic portion 212 may extend from the port 210.

[0054] Reference is now made to FIGS. 2J-2L, which depict various views of the elongated shaft 206. The elongated shaft 206 includes a port 210 out of which the therapeutic portion 212 may be deployed from a lumen 238. Adjacent to the port 210 is a lubricant 240, e.g., a lubricous tube or coating, disposed within the lumen of the elongated 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 a retracted state to a deployed state. It has been found that without such a lubricant feature, the therapeutic elements, such as electrodes or sensors, or any components of the therapeutic portion 212 may be damaged from rubbing / contact with the edges of the port 210 during deployment and / or retraction. The lubricant 240 may be a lubricous tube made from a biocompatible material that minimizes friction between the therapeutic portion 212 and the elongated shaft 206, thus protecting the components. Examples of such biocompatible materials may be ultra-high molecular weight polyethylene or fluoropolymers.

[0055] Additionally or alternatively, the elongate shaft 206 may include structures or configurations, such as a bevel or a radial curve, to facilitate the transition of the therapeutic portion 212 between the retracted state and the deployed state. The therapeutic portion 212 is additionally guided by an angled interface 242, which forms the distal end of the lumen in the elongate shaft 200 and also defines the distal end of the port 210. The angled interface 242 guides the therapeutic portion 212 to exit the lumen 238 of the elongate shaft 200 out of the port 210 at a desired angle, facilitating positioning the therapeutic portion 212 for treatment in its curved shape. The needle tip 208 also has a needle cavity 244 formed therein. It has been found that forming the needle cavity 244 by core-out an inner portion of the needle tip 208 aids in penetrating the vaginal wall and / or ovarian wall.

[0056] 2M, a detailed view of the therapeutic portion 212 deployed out of the port 210 is provided. The therapeutic portion 212 preferably forms a curvilinear formation when deployed, as shown. 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 therapy. The first and second electrodes 246, 248 may be comprised of metal bands, coils, wires (e.g., wound or braided), laser cut tubing, or slotted tubular structures. The shaft of the therapeutic portion 212 may have a preset shape that may serve several multiple purposes, such as anchoring the device within the ovary (so as to limit the risk of the device moving due to patient movement or user error), orienting the therapeutic portion 212 to be more normal to the ultrasound probe to increase echogenicity, and increasing the overall length of the therapeutic portion 212 that may be located within the ovary. The preset shape may also allow the therapeutic portion 212 to reach different locations within the ovary more easily compared to a more straight 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 elongated shaft 206, the therapeutic portion 212, and / or the needle tip 208 may contain echogenic materials and / or gases to enhance echogenicity.

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

[0058] 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 may be saddle-shaped and include an ultrasonic probe interface 304 for securing the adapter 300 to an ultrasonic probe. The ultrasonic probe interface 304 may be collar-shaped and looped around a portion of the ultrasonic probe between the proximal and distal ends of the ultrasonic probe. The sides of the adapter 300 may be placed around a more proximal region of the ultrasonic probe. The adapter 300 may be snapped, strapped, clamped, or any similar means 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 a needle assembly interface rib 308 for gripping the therapeutic needle assembly 200 when inserted. The needle assembly interface 302 is constructed to mate with the adapter interface 218 of the therapeutic needle assembly 200 such that the therapeutic needle assembly 200 can be attached longitudinally to an ultrasound probe and removed, rotated, and reattached as desired during treatment. The resulting limited rotation can be useful in maintaining the therapeutic portion 212 within an ultrasound visualization plane or field of view. The actuator track 306 facilitates smoother movement for the actuator 216 when the therapeutic needle assembly 200 is inserted.

[0059] According to another aspect of the invention, the needle assembly interface 302 and the needle assembly 200 may be configured to allow for variable amounts of rotation or specific rotation, for example, up to 90 degrees or up to 180 degrees, without the need to decouple 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 re-orient the port 210 within the field of view FOV of the ultrasound probe. Thus, at any given orientation of the therapeutic needle assembly 200, the therapeutic portion 212 will protrude from the port 210 in the ovary within the field of view of the ultrasound probe. The FOV is limited by the ultrasound probe and therefore, as will 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 ultrasound probe. For example, the therapeutic needle assembly 200 may be rotated up to 180 degrees from the first orientation to the second orientation. In some embodiments, as shown in FIG. 3C, the therapeutic needle assembly 200 may only be rotated up to 90 degrees from the first orientation to the second orientation as long as the therapeutic portion 212 remains within the field of view of the ultrasound transducer during operation.

[0060] In accordance with another aspect of the invention, the adapter interface 218 and the needle assembly interface 302 may permit reorientation of the therapeutic needle assembly 200 relative to the adapter 300 between orientations beyond the first and second orientations, such as a third orientation or a fourth orientation. In addition, 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] 4, a generalized schematic diagram of the internal functional components of a generator 400 will now be described. The 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, input / output circuitry (I / O) 414, and / or a power supply 416.

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

[0063] The clinician may then provide the ovarian volume as a user input to the controller 402 so that the processor may store and generate information based on the ovarian volume input. For example, the memory of the controller 402 may store program instructions that, when executed by the processor of the controller 402, cause the processor to generate recommended / requested ablation parameters, recommended / requested number of ablations, and recommended / requested ovarian ablation volume based on the ovarian volume and the desired outcome. Thus, for a given patient, the clinician can know the volume of ovarian ablation required per ovary, and the number of ablations to ablate the required ovarian ablation volume, as well as the parameters under which the ablations should be delivered to the patient.

[0064] Further, the processor may execute instructions that cause the graphical user interface to display the generated recommended / requested ablation parameters, the number of recommended / requested ablations, and / or the volume of recommended / requested ovarian ablations, in addition to the ablation parameters to be set, the power settings, the number of ablations completed, the number of ablations remaining, the percentage of the ovarian volume ablated, and / or the percentage of the ovarian volume yet to be ablated. Information related to the recommended or set ablation parameters may be in the form of a table, e.g., a look-up table, stored in memory and displayed to the clinician via the graphical user interface.

[0065] Additionally, the processor may automatically recalculate any of the above information after each ablation performed by the clinician and display the recalculated information after each ablation so that the clinician will know the remaining volume of ovarian ablation required per ovary, and the number of ablations to ablate the remaining volume of ovarian ablation required, as well as the parameters under which the ablations should be delivered to the patient. Thus, for a given ovarian volume of a patient, the processor knows the amount of volume of ovarian tissue that will be ablated for any given set of parameters, and thus the amount of the percentage of ovarian tissue that is not yet ablated to achieve the desired ablation therapy, e.g., 5%, 7.5%, 10%, 12%, or 15% of the ovary to be ablated. For example, for a given ovarian volume of a patient, 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 will be ablated per ablation for a given set of ablation parameters, e.g., power level, or time and temperature. This information may be retrieved by the clinician via a table, e.g., a look-up table. Thus, after one ablation has been performed by the clinician on the patient's ovaries, the processor will adjust the data and display that four ablations remain required. In addition, if the clinician does not complete the first ablation, e.g., interrupts it briefly, or performs the ablation at parameters other than those recommended / requested by the processor, the processor will readjust and display the adjusted amount of ablation remaining to achieve the desired ablation therapy, taking into account the clinician's deviation from the recommended / requested settings.

[0066] As will be readily appreciated by those skilled in the art, although FIG. 4 is illustrated to show one programmable controller, 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 and deliver energy to the first and second electrodes 246, 248 to treat the 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 the sensor 250 and / or conductive needle 252, such as impedance or temperature. The system sensor 250 and / or conductive needle 252 may generate one or more signals indicative of the sensed parameters for processing and / or transmission to the generator software 500. Such parameters may be used to assist in treatment or to verify proper functioning of the system 100.

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

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

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

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

[0072] Referring now to FIG. 5, the generator software 500 will now be described. The generator software 500 comprises several functional blocks, depicted diagrammatically 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 employs an object-oriented format. In one preferred embodiment, the software is configured to run on a Microsoft Windows® (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 running the generator software 500 preferably includes a data port, e.g., a USB port or equivalent wireless connection, that allows the generator 400, an external monitoring component, and / or a mobile device running a mobile application to be coupled thereto. Alternatively or in addition, the computer may include wireless circuitry, e.g., compliant with 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 mobile devices running mobile applications to communicate wirelessly with a computer running the generator software 500.

[0073] As would be readily apparent to one of ordinary skill in the art, the generator software 500 may run on a separate computer (as shown in FIG. 1A ), such as a conventional laptop, desktop, tablet, smartphone, and the like, or may run on the generator 400 .

[0074] The main block 502 preferably includes main software routines that run on the clinician's computer and control the overall operation of the other functional blocks. The main block 502 allows the clinician to download event data and alarm information stored on the generator 400 to his office computer, and also allows the generator software 500 to receive signals indicative of sensed parameters from the generator 400. The main block 502 is further configured to execute routines for calculating parameters based on the sensed parameters and / or storing information related to treatment. For example, the main block 502 is configured to execute routines for measuring impedance and / or temperature using signals indicative of impedance or temperature sensed at the therapeutic portion 212. As another example, the main block 502 is configured to execute routines for storing (and causing 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 routines for calculating data for display based on input received at the user interface block 510. The main block 502 also allows the clinician to upload firmware updates and configuration data to the generator 400 .

[0075] The event log block 504 is a record of operational data downloaded from the generator 400 and may include, for example, measurement times, real-time sensed parameters, previously sensed parameters, sensor data, battery current, battery voltage, battery status, 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 entered in the user interface block 510, such as treatment termination.

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

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

[0078] The user interface block 510 handles the receipt of user input, e.g., ovarian volume, and display of information read from the generator 400 and the data download block 506 in the computer running the generator software 500, and presents that information in an intuitive and easily understood format for clinician review, such as numbers, waveforms, text, plots, charts, graphs, or the like. Such information may include the status of the generator 400, measurement time, real-time sensed parameters, previously sensed parameters, parameters calculated using the 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 a 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 described in FIGS. 7-12.

[0080] The sensor calibration block 514 may include routines to test or measure drift of the system sensors 250. The block 514 may then calculate offset values ​​to correct the measured data from the sensors 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 to check the version number of the controller firmware installed on the generator 400 and identify whether upgraded firmware is present. If so, the routine may notify the clinician and allow the clinician to download the revised firmware to the generator 400 in non-volatile memory.

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

[0083] In addition, the generator software 500 may further include a functional block for determining whether a suitable 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 a chip or an identification tab, such as an RFID or barcode, that stores information about the needle assembly, including, for example, whether it has been used before. In response to the generator reading the chip or identification tab of the needle assembly, the generator software 500 may allow a subsequent ablation if it determines that the needle assembly is suitable, or prevent a subsequent ablation if it determines that the needle assembly is unsuitable.

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

[0085] After energy delivery is completed, the therapeutic portion 212 is retracted into the elongated shaft 206, as shown in FIG. 6C. Without removing the elongated shaft 206 from the ovary O, the operator may rotate the therapeutic needle assembly 200 relative to the adapter 300, or may decouple the therapeutic needle assembly 200 from the adapter 300 (e.g., by detaching the adapter interface from the therapeutic needle interface), invert / rotate the therapeutic needle assembly 200 a predetermined amount (e.g., within a rotational range extending up to 180 degrees), and reattach the adapter interface to the adapter 300 if the adapter interface was detached from the therapeutic needle interface. This inversion may occur while the distal region remains in a fixed (other than rotational) position within the ovary O.

[0086] For example, as shown in FIG. 6B, the therapeutic needle assembly 200 may be initially introduced into the ovary O along the x-axis such that the port 210 of the therapeutic needle assembly 200 points downward toward the y-axis. Thus, the therapeutic portion 212 will be deployed along the y-axis in the plane formed by the x-axis and y-axis. Upon retraction of the therapeutic portion 212 into the extension 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 in a clockwise direction about the x-axis from the position illustrated in FIG. 6C will cause the port 210 to point out of the page toward the z-axis, and rotating the therapeutic needle assembly 200 90 degrees in a counterclockwise direction about the x-axis from the initial position illustrated in FIG. 6C will cause the port 210 to point into the page toward the z-axis. Thus, the therapeutic needle assembly 200 may be rotated any amount within a general range of 180 degrees, which may be limited by the field of view of the ultrasound 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 a general range of rotation within 90 degrees, such that the port 210, and therefore the therapeutic portion 212, remains within the field of view FOV of the ultrasound probe. As will be understood by one of ordinary skill in the art, the therapeutic needle assembly 200 may be rotated to any orientation within a general range of 180 degrees and locked in the desired position while the ultrasound probe remains in place.

[0087] While FIG. 6D illustrates the elongate shaft 206 in a second orientation in a retracted state, the therapeutic portion 212 is redeployed in FIG. 6E to perform another treatment. Energy is then delivered to this second treatment zone. The therapeutic portion 212 may then be retracted to the retracted state as shown in FIG. 6F. The distal region of the therapeutic 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 entry point for further energy delivery. The therapeutic portion 212 is then redeployed in FIG. 6H to perform another treatment. Energy is then delivered to this third treatment zone. The therapeutic portion 212 may again be retracted and the therapeutic needle assembly 200 may be reversed to deliver energy in a fourth treatment zone. Additionally or alternatively, the elongate shaft 200 may be moved proximally in the retracted state one more time to deliver additional treatment. In this manner, multiple ablations may be achieved within each ovary, such as four ablations in smaller ovaries, eight ablations in larger ovaries, or an amount of ablation sufficient to achieve a desired volume of ablated ovarian tissue, such as 1%-25%, or more preferably 5%-10%, of the total ovary volume (as determined by the clinician from ultrasound imaging).

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

[0089] The delivery of energy into ovarian tissue (e.g., the stroma) ablates the tissue and re-balances the ovaries. For example, ablation is expected to reduce hormonal imbalances between hormones such as follicle stimulating hormone (FSH) and luteinizing hormone (LH), thereby treating infertility conditions such as polycystic ovarian syndrome (PCOS).

[0090] 7-9, a method for monitoring the use of the system 100 during an ovarian procedure is illustrated. The 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, the system sensor 250 and / or conductive needle 252 may also be used to detect if the device moves inappropriately between treatment deliveries. For example, device movement may be inferred by sensing a sudden change in temperature, impedance, and / or power. An increase in impedance may also represent a change in tissue properties, such as collagen denaturation, desiccation, or char formation.

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

[0092] FIG. 7 is an exemplary method 700 for measuring temperature (e.g., thermistor temperature) sensed by therapeutic needle assembly 200. At 702, 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 704, a processor on a computer running generator software 500 may run an algorithm stored in memory to determine if the temperature exceeds a first predetermined temperature threshold. At 706, if the temperature exceeds the first predetermined temperature threshold, an event may be generated on graphical user interface 410, e.g., an alert indicating that the probe or extension cable is disconnected. In one embodiment, the first predetermined temperature threshold is within 115-125 degrees Celsius, e.g., 120 degrees Celsius. At 708, the processor, via execution of the algorithm, determines if 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 is not above the first predetermined temperature threshold, the processor, through execution of an algorithm, determines 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 may be generated on the graphical user interface 410 indicating that the temperature is out of range. If not, step 720 (described below) is performed.

[0094] If the temperature is determined to be out of range at 716, the processor, via execution of an algorithm, determines whether energy is being delivered. If so, the processor causes termination of energy delivery at 718. If energy has not been delivered at 708 or 716, the processor, via execution of an algorithm, may wait a set period of time according to a protocol stored in memory before returning to step 702 to measure the temperature again at 720. In this manner, temperature may be monitored throughout the course 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 the generator 400 from the sensor 250 and / or conductive needle 252. At 804, a processor on a computer running the generator software 500 may run an algorithm to determine if the temperature is below a fourth predetermined temperature threshold. In one embodiment, the fourth predetermined temperature threshold is within 15-25 degrees Celsius, e.g., 20 degrees Celsius. At 806, if the temperature is below the fourth predetermined temperature threshold, an event, e.g., an alert indicating low probe temperature, may be generated on the graphical user interface 410. If the temperature is determined to be below the fourth predetermined threshold at 808, the processor, via execution of the algorithm, determines whether energy is being delivered. If so, the processor causes termination of energy delivery at 810. If the temperature has not fallen below the fourth predetermined temperature threshold, the processor, via execution of an algorithm, determines at 812 whether the temperature exceeds a first temperature (e.g., 5 degrees Celsius) above the temperature setpoint for more than a first period of time (e.g., 5 seconds) while the power is being increased. If the measured temperature exceeds the threshold for the measured time, at 816, an alert will be generated on the graphical user interface 410 indicating a temperature control error. For example, an alert may be generated if the measured probe temperature exceeds a temperature setpoint stored in memory by 5 degrees Celsius for more than 5 seconds. If so, at 818, the processor, via execution of an algorithm, determines whether energy is being delivered. If so, the processor causes termination of energy delivery at 820.

[0096] If the temperature has not fallen below the fourth predetermined temperature threshold, the processor, through execution of an algorithm, determines at 814 whether the temperature exceeds a second temperature (e.g., 10 degrees Celsius) above the temperature set point for more than a second period of time (e.g., 1 second) while the power is being increased. In this example, the second temperature exceeds the first temperature and the second period of time is less than the first period of time. In this manner, if the temperature is too high (e.g., exceeds the second temperature), corrective action may be taken more immediately. Steps 816-820 may be repeated following a determination at 814 that the temperature exceeds a second temperature above the temperature set point for more than a second period of time while the power is being increased. If energy has not been delivered at 808 or 818 or a threshold has not been met at 804, 814, or 812, the processor, through execution of an algorithm, may wait a set period of time according to a protocol stored in memory before returning to step 802 to measure the temperature again at 822. In this manner, the probe temperature may be monitored throughout the process of using the therapeutic needle assembly 200 .

[0097] FIG. 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 the generator 400 from the sensor 250 and / or conductive needle 252. At 904, a processor on a computer running the generator software 500 may run an algorithm to determine if the impedance is measured below a first predetermined temperature threshold. In one embodiment, the first predetermined impedance threshold is within 40-60 ohms, e.g., 50 ohms. At 906, if the impedance is below the first predetermined impedance threshold, an alert may be generated on the graphical user interface 410 indicating that the impedance is low. At 908, the processor, via execution of the algorithm, determines whether energy has been delivered. If so, the processor causes termination of energy delivery at 910. If the impedance has not fallen below the first predetermined impedance threshold, the processor, via execution of the algorithm, determines at 912 whether the measured impedance is above a second predetermined impedance threshold. In one embodiment, the second predetermined impedance threshold is within 900-1,100 ohms, e.g., 1,000 ohms. At 914, if the measured impedance is above the second predetermined impedance, an alert may be generated on the graphical user interface 410 indicating that the impedance is high. At 916, the processor, via execution of an algorithm, determines whether energy has been delivered. If so, the processor causes termination of energy delivery at 918. If energy has not been delivered at 908 or 916, the processor, via execution of an algorithm, may wait a set period of time according to a protocol stored in memory before returning to step 902 at 920 to measure impedance again. In this manner, impedance at the treatment area may be monitored throughout the course of using the therapeutic needle assembly 200.

[0098] 10-13 illustrate a graphical user interface 410 designed to communicate with the processor of the generator 400. Exemplary screenshots generated by the graphical user interface 410 show graphical interpretations 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 entered by the clinician / operator. The graphical user interface 410 is designed to present that information in an intuitive and easily understood format for operator review, such as numbers, waveforms, text, plots, charts, graphs, or the like. The graphical user interface 410 may include buttons to receive user inputs such as patient / procedure related information, ovarian volume, power the device, and clear alerts.

[0099] FIG. 10 depicts an exemplary measurement mode screen prior to energy delivery. The sensor 250 and / or 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. FIG. 11 depicts an exemplary temperature 1100, power reading 1102, remaining ablation 1104, and ablation volume 1106. As the tissue heats up and changes its properties, the temperature may also increase. The sensor 250 and / or conductive needle may also be used during treatment to dynamically adjust treatment parameters. Treatment termination may also occur, as illustrated in FIG. 12, and may result in an error message in the event that certain conditions are met, as described in FIGS. 7-9. FIG. 13 depicts a table for providing ablation parameter selection for a given number of ablations and desired ablation volume.

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

Claims

[Claim 1] The invention described in this specification.

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