Systems and methods for applying energy to ovarian tissue

Abstract

Methods and systems for performing a surgical procedure for ovarian rebalancing are described herein. The methods and systems can be used to treat polycystic ovary syndrome (PCOS). The systems and methods can also be used to treat infertility associated with PCOS.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 797,191, filed on Jan. 25, 2019, the entire content of which is incorporated herein by reference. Technical Field

[0003] Described herein are systems and methods for manipulating ovarian tissue. The systems and methods can be used to treat polycystic ovary syndrome (PCOS), infertility, and / or other diseases / disorders involving the ovaries, or to regulate ovulation. Background Art

[0004] In cases of ovarian disease and / or certain types of infertility, it may be necessary to manipulate ovarian tissue, remove tissue, or deliver agents within a patient's ovary. For some time, physicians have used direct surgical access, laparoscopic access, or transvaginal ultrasound-guided needle-based methods to access the ovary. Direct surgical access is typically obtained under anesthesia and involves a skin incision to directly expose the tissue and manipulate the tissue. Laparoscopic access is typically obtained under anesthesia, involves two or more skin incisions, and further requires inflation of the space around the ovary with gas or fluid and visualization and manipulation of the tissue using a camera and laparoscopic tools. As part of in vitro fertilization (IVF), transvaginal ultrasound-guided needle-based access is typically used for oocyte retrieval. These current methods have some limitations: surgical and laparoscopic access methods are generally more invasive and thus require more anesthesia and higher nursing sensitivity. In addition, surgical and laparoscopic access methods allow direct visualization of the ovarian surface, but they have a lower ability to visualize the location of specific device deployment within the ovarian tissue. Since transvaginal needle access is typically performed under ultrasound, it allows the tip of the needle to be delivered to a specific location within the ovary and these 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 simple aspiration. Current systems are not ideally suited for situations where it is desired to deliver or remove specific tissue or other factors from the ovary via a transvaginal ultrasound-guided needle tract. Current systems are also not ideally suited for delivering specific agents or energy to the ovary.

[0005] Manipulation of ovarian tissue may be intended to treat polycystic ovary syndrome (PCOS). PCOS is an endocrine disorder first characterized by Stein & 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 often has significant effects on reproductive health (e.g., oligo / amenorrhea and oligo / anovulation, bleeding, endometrial hyperplasia, infertility, and increased risk of endometrial cancer) and non-reproductive health (e.g., hyperandrogenism, cancer, insulin resistance, hypercholesterolemia, hypertension, obesity, sleep apnea, and cardiovascular disease). PCOS has historically been thought to occur against a background of hormonal imbalance characterized by altered gonadotropin secretion, increased androgen production, increased insulin resistance, increased cortisol production, and obesity. It has also been noted that PCOS is often accompanied by increased activity of the sympathetic nervous system.

[0006] Treatment of PCOS is costly to the health care system. Key non-infertility treatments include: oral contraceptives (for hormone normalization), endometrial ablation (for anovulatory bleeding), insulin sensitizers, antihypertensives, statins, and treatment of severe acne and hirsutism.

[0007] Many women with PCOS may also need infertility treatment during their lifetime. The treatment of PCOS infertility usually follows a step-by-step approach. For example, letrozole and / or clomiphene citrate are usually first-line treatments, while second-line treatment drugs are gonadotropin administration or ovarian drilling (sometimes also referred to as ovarian diathermy). If these treatments are unsuccessful, in vitro fertilization (IVF) is attempted. However, in the case of clomiphene citrate, gonadotropin and IVF treatment, multiple pregnancies and live births (e.g., twins) are common. In infertility treatment, multiple pregnancies and live births are generally considered to be undesirable results due to associated perinatal and neonatal morbidity and associated high costs. In addition, in women with PCOS treated with gonadotropin or IVF, ovarian hyperstimulation syndrome (OHSS) may be more common. Although OHSS is usually mild and easy to treat, more severe cases may require active treatment.

[0008] Alternatively, ovarian drilling may be an option for treating PCOS, PCOS-associated symptoms / disorders, and PCOS-related infertility. Prior to the development of ovarian drilling, other types of surgeries were performed on the ovaries to treat infertility. Ovarian wedge resection was a well-established surgery first described in the late 1940s, which involved surgically removing a wedge-shaped piece of ovarian tissue from polycystic ovaries. Although the surgery was effective, ovarian wedge resection was generally abandoned in favor of new techniques due to frequent adhesions associated with the procedure. Other ovarian surgeries performed for infertility in PCOS have been ovarian electrocautery, ovarian laser vaporization, multiple ovarian biopsies, etc.

[0009] Ovarian drilling / diathermy (OD) was developed by Youssef in the 1970s and 1980s. More recently, OD is the most commonly described ovarian surgery for treating infertility in women with PCOS. In this laparoscopic procedure, radiofrequency energy or other techniques are used to drill multiple holes in the ovaries. Common findings after the surgery include a sharp change in ovarian and pituitary hormones, followed by a long-term decrease in circulating androgens. In randomized trials, it has been shown that the pregnancy rate and live birth rate are similar to those associated with gonadotropin therapy, but the multiple pregnancy rate is significantly reduced, while benefiting from a one-time treatment, thus achieving a natural pregnancy experience.

[0010] Despite this evidence, in clinical practice, the use of ovarian drilling is not as frequent as other treatments for PCOS infertility. This can be attributed to: (1) the lack of a standardized, consistent method for targeting and performing surgery on the ovaries; (2) the invasiveness of current OD techniques; (3) the theoretical risk of adhesions from ovarian intervention; (4) the surgical access path not being well-suited to the clinical practice patterns of fertility physicians; and (5) the uncertainty of the mechanism of action. Therefore, having systems and methods that overcome current surgical limitations would be useful. Such systems could be designed to consistently target ovarian tissue, reduce the level of invasiveness of the surgery, reduce the risk of adhesions, and enhance targeting within the ovaries to treat diseases with non-specific tissue types. Additionally, given that the ovaries or elements within them may play important roles in managing other women's health issues, such as menopause timing, hot flashes, uterine fibroids, hormonal imbalances, endometriosis, adnexal pain, endometrial cancer risk, glucose metabolism disorders, or cardiovascular health, having improved methods and systems for treating these diseases and targeting structures within or near the ovaries that can achieve the treatment of these diseases would be beneficial.

[0011] U.S. Patent Publication Nos. 2016 / 0220302, 2017 / 0215949, and 2018 / 0110554 to Zairns describe improved systems and methods for manipulating ovarian tissue, the entire contents of each of which are incorporated herein by reference. SUMMARY OF THE INVENTION

[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., radiofrequency energy, microwave energy, cryoablation energy, non-focused or focused ultrasound; for ovarian rebalancing. In other variations, manipulation of ovarian tissue may include removing tissue via aspiration, or delivering a pharmaceutical agent within a patient's ovary. Generally, the systems and methods are designed to access ovarian tissue or a target region adjacent to ovarian tissue via a vaginal, trans-laparoscopic, percutaneous, via a natural orifice trans-vaginal-hysteroscopic (NOTES) path, through an open surgical approach, or via a fully non-invasive approach. Energy is emitted into ovarian tissue (e.g., stroma) to ablate the tissue to effect ovarian rebalancing. For example, ablation is expected to reduce a hormonal imbalance between hormones such as follicle stimulating hormone (FSH) and luteinizing hormone (LH), thereby treating fertility disorders such as polycystic ovarian syndrome (PCOS).

[0013] Exemplary ovarian tissue includes (but is not limited to) the ovary (e.g., medulla / stroma and / or cortex), follicles / cysts, nerves associated with the ovary, suspensory ligaments, ovarian ligaments, broad ligaments, mesovarium, endometrial tissue within the ovary, tumors or cancer cells, or combinations thereof. Stromal tissue generally includes the middle or medullary region of the ovary. The cortex (or outer region) of the ovary is generally where follicles of varying maturity are typically located. The term "follicle" includes the oocyte contained within the follicle and may specifically refer to the entire follicle structure or the oocyte. In the case of PCOS, these follicles are sometimes referred to as "cysts". In other cases, a cyst may refer to a fluid collection that may or may not be a follicle. The methods and systems can be used to effect ovarian rebalancing to regulate ovulation, treat one or more symptoms of polycystic ovarian syndrome or associated disorders (including infertility), or treat other diseases / conditions involving the ovary.

[0014] As described herein, a system for performing ovarian surgery may be capable of advancing close to or within the ovary and, in the case of PCOS, close to follicles / cysts or other target tissues (e.g., stroma). Additionally, the system may be used in conjunction with an ultrasound probe. According to one aspect of the invention, the ultrasound probe may be a vaginal ultrasound probe. According to an exemplary embodiment, a system for performing ovarian surgery includes a treatment needle assembly having a proximal region and a distal region. The treatment needle assembly includes an elongate shaft at the distal region. The elongate shaft has a lumen, a port, and a needle tip at the distal end of the elongate shaft, the needle tip being configured to pierce the vaginal wall and the ovarian wall for placing the port into the ovary. For example, the needle tip may be cored to define a cavity to facilitate piercing the vaginal wall and the ovarian wall.

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

[0016] Additionally, the treatment needle assembly may include a handle at the proximal region, the handle having an actuator for actuating to transition the treatment portion between the retracted state and the deployed state. According to one aspect, the actuator includes a trigger for releasing or engaging a locking mechanism that assists in the deployment of the treatment portion. The treatment portion may include echo material or regions (e.g., air / gas) that enhance visibility. The treatment needle assembly, the treatment portion, and other components may be made of 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 thus are not described in detail herein.

[0017] In addition, the elongate shaft is configured to facilitate the treatment portion transitioning between a retracted state and a 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 elongate shaft adjacent a port of the elongate shaft for facilitating the treatment portion transitioning between a retracted state and a 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 elongate shaft may include a structure or configuration, such as a bevel or arcuate curve, to facilitate transitioning of the treatment portion between a retracted state and a deployed state.

[0018] Further, the system may further include an adapter having a needle assembly interface and an ultrasound probe interface. The ultrasound probe interface is configured to removably couple to an ultrasound probe, and the needle assembly interface is configured to removably couple to an adapter interface, which may be part of a handle, such that a treatment needle assembly may be coupled to the ultrasound probe. Thus, the adapter may longitudinally align the treatment needle assembly with the ultrasound probe. Additionally, the adapter ensures alignment of the treatment portion within the field of view of the ultrasound probe. The system may further include a needle guide removably coupled to the ultrasound probe for receiving the elongate shaft therethrough to stabilize the elongate shaft during a procedure. According to one aspect of the invention, at least one of the treatment 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 the treatment needle assembly to be reoriented relative to the adapter between a first orientation and a second orientation. For example, the adapter interface and the needle assembly interface may be locked together in the first orientation and may be detached from each other to allow reorientation of the treatment needle assembly relative to the adapter such that the adapter interface and the needle assembly interface may be locked together in the second orientation. The treatment portion in the first orientation in the deployed state is offset from the treatment portion in the second orientation in the deployed state by, for example, less than or equal to 180 degrees. The adapter interface and the needle assembly interface may be locked 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 opposite surfaces of the handle, the first and second notches being configured to contact opposite surfaces of the needle assembly interface to lock the adapter interface to the needle assembly interface in the first orientation and the second orientation. Additionally, the first and second notches or the opposite surfaces of the needle assembly interface or both may include multiple ribs to enhance the locking. According to another aspect of the invention, the adapter interface and the needle assembly interface may be locked together in the first orientation and allow the treatment needle assembly to rotate relative to the adapter such that the adapter interface and the needle assembly interface may be locked together in the second orientation. According to another aspect of the invention, the adapter interface and the needle assembly interface may allow the treatment needle assembly to be reoriented relative to the adapter between more orientations than the first orientation and the second orientation, for example, a third orientation or a fourth orientation. Additionally, the adapter interface and the needle assembly interface may be locked together in any orientation.

[0020] The system may further include a generator operatively coupled to the treatment portion for delivering energy to the treatment portion in the deployed state such that the treatment portion emits energy into ovarian tissue of the ovary. The generator may supply continuous or pulsed radiofrequency energy, microwave energy, cryoablation energy, non-focused or focused ultrasound. Accordingly, the treatment portion may include at least one sensor for generating data during emission of energy from the treatment 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 at least one sensor. For example, the processor may execute instructions stored on a non-transitory computer-readable medium to perform the following operations: receive data from at least one sensor; determine whether the data is within a predetermined range; and if the data indicates that at least one measured parameter is outside the predetermined range, then instruct the generator to modify the energy delivery to the treatment portion. The processor may further run a routine to cause a warning to be generated on a graphical user interface if the data is above a first predetermined threshold or below a second predetermined threshold. Additionally, the system may include a graphical user interface for displaying information indicative of a treatment process based on data from at least one sensor. For example, the graphical user interface may display information showing the variation of temperature and power over time.

[0022] In addition, the processor may further execute instructions stored on a 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. Additionally, the graphical user interface may display information indicative of at least one of the following: ovarian volume per ovary, ovarian volume per patient, recommended ablation parameters, set ablation parameters, power settings, recommended number of ablations, required number of ablations, recommended ovarian ablation volume, required ovarian ablation volume, number of ablations completed, remaining number of ablations, percentage of ovarian volume ablated, or percentage of ovarian volume yet to be ablated. Information indicative of 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 input data indicative of, for example, ovarian volume, such that the information displayed on the graphical user interface is at least partially based on the input data indicative of ovarian volume. This information is expected to assist the clinician during a procedure involving multiple ablations (e.g., 4 to 8 ablations per ovary, e.g., based on individual ovarian volumes typically measured by ultrasound prior to the ablation procedure).

[0023] According to another aspect of the present invention, a method for performing an ovarian surgery is provided. The method includes: advancing a distal region of a treatment needle assembly into the vagina; piercing the vaginal wall with a tip of the treatment needle assembly at a distal end of the elongate shaft of the treatment needle assembly; piercing the ovarian wall with the tip to position a port of the elongate shaft at a desired location within the ovary; deploying a treatment portion from a lumen of the elongate shaft and causing it to exit the port in a first orientation, the elongate shaft being configured to facilitate deployment of the treatment portion without damaging an energy emitter of the treatment portion; emitting energy into ovarian tissue of the ovary via the energy emitter of the treatment portion in the first orientation; retracting the treatment portion back into the lumen of the elongate shaft; repositioning the treatment needle assembly while the port of the elongate shaft remains within the ovary; deploying the treatment portion from the lumen of the elongate shaft and causing it to exit the port in a second orientation; and emitting energy into ovarian tissue of the ovary via the energy emitter of the treatment portion in the second orientation.

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

[0025] Additionally, repositioning the treatment needle assembly while the port of the elongate shaft remains within the ovary may include repositioning the treatment needle assembly relative to an adapter. For example, reorienting the treatment needle assembly relative to the adapter may include: detaching the treatment needle assembly from the adapter while the port of the elongate shaft remains within the ovary; rotating the treatment needle assembly while the adapter remains in place; and reattaching the treatment needle assembly to the adapter. Alternatively, reorienting the treatment needle assembly relative to the adapter may include rotating, advancing, or retracting the treatment needle assembly relative to the adapter while the port of the elongate shaft remains within the ovary.

[0026] Furthermore, the method may further include retracting the treatment portion back into the lumen of the elongate shaft; moving the elongate shaft proximally to a second position within the ovary along a common needle path; deploying the treatment portion from the lumen of the elongate shaft and causing it to exit the port at the second position; and emitting energy into ovarian tissue of the ovary via the energy emitter of the treatment portion at the second position.

[0027] For example, the treatment needle assembly may be moved (e.g., proximally without adjusting the needle angle) along the same needle path via a single entry point for further energy delivery. The treatment portion may be redeployed within the ovary at a proximal or distal position relative to an initial / previous ablation site. In this way, multiple ablations may be achieved in each ovary, such as 4 ablations in a smaller ovary (determined by the clinician based on ultrasound imaging), 8 ablations in a larger ovary, or sufficient ablation and power levels to ablate the desired volume of ovarian tissue.

[0028] These system embodiments can have multiple effects on treatment. For example, these system embodiments can allow for minimally invasive transvaginal methods, where needles are used to access the ovaries. The tip of the needle can be punctured through the vaginal wall and into the ovary under transvaginal image guidance. In some cases, this can allow for a single entry point or fewer entry points into the ovary, thus reducing the risk of adhesions compared to surgical and laparoscopic methods that have tissue dissection and entry points for each ablation in the ovary. Once in the proper position in the ovary, the treatment portion can be advanced or deployed into the tissue. Here, a releasably fixed adapter allows the treatment portion to be flipped or rotated (e.g., 60, 90, 120, 180 degrees) so that additional areas of the ovary can be accessed and treated without removing the treatment needle assembly. The advantages of the transvaginal method compared to surgical or laparoscopic methods generally include one or more of the following: (a) conscious anesthesia versus general anesthesia, which reduces costs and patient risk, (b) no external scars, (c) less tissue manipulation resulting in a lower risk of adhesions, (d) fewer entry points into the ovary, thus resulting in a lower risk of adhesions, (e) faster recovery time, (f) an entry path familiar to OB / GYNs and fertility doctors and suitable for existing care pathways, and (g) rebalancing the ovaries to effectively treat the disease. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1A Illustrate an exemplary system for performing ovarian surgery constructed and operated in accordance with non-limiting embodiments of the present invention.

[0030] Figure 1B Illustrate an exemplary treatment needle assembly and adapter of a system from Figure 1A assembled with an ultrasound probe and a needle guide in accordance with non-limiting embodiments of the present invention.

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

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

[0033] Figure 2E Show a side view of the handle of an exemplary treatment needle assembly in a retracted locked state above a cross-sectional view along a section line.

[0034] Figure 2F Show a side view of the handle of an exemplary treatment needle assembly in a retracted unlocked state above a cross-sectional view along a section line.

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

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

[0037] Figure 2J is a side of the distal region of an exemplary therapeutic needle assembly, Figure 2K shows the distal region rotated 90 degrees and shows the inner component in the shaft, and Figure 2L shows the distal region flipped from the orientation in Figure 2J including the inner component.

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

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

[0040] Figure 3C is a front cross-sectional view of the field of view of a reoriented ultrasound probe showing a therapeutic needle assembly within the field of view of an ultrasound transducer according to the principles of the present invention.

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

[0042] Figure 5 Shows Figure 1A a schematic diagram of the functional components of an exemplary generator software of the system of

[0043] Figures 6A to 6I Illustrates an exemplary method for performing an ovarian surgery according to a non-limiting embodiment of the present invention.

[0044] Figures 7 to 9 is a flowchart illustrating an exemplary method for monitoring measured parameters in a system for performing an ovarian surgery.

[0045] Figures 10 to 13 is an exemplary snapshot of a 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 taken in conjunction with the accompanying drawings and the appended claims. It should be understood that these drawings depict only several embodiments in accordance with the present disclosure and should not be considered as limiting its scope, and the present disclosure will be described with additional specificity and detail by using the drawings. Detailed Description

[0047] The present invention relates to systems and methods for performing surgery on a body part such as an ovary. As shown in Figure 1A , a system 100 for performing ovarian surgery is now described. In Figure 1A , the components of the system are not described in relative or absolute scale. The treatment needle assembly 200 includes a distal region 202 and a proximal region 204. The distal region 202 includes an elongate shaft 206, where the needle tip 208 is at the distal end of the elongate shaft 206, and a port 210 is near the needle tip 208. The needle tip 208 is configured to pierce the vaginal wall and / or the ovarian wall. The treatment needle assembly 200 further includes a treatment portion 212 slidably disposed within the lumen of the elongate shaft 206. The treatment portion 212 can be deployed outside the port 210, as shown in Figure 1A , and is configured to emit energy (e.g., via one or more electrodes) after deployment.

[0048] The proximal region 204 of the treatment needle assembly 200 preferably includes a handle 214, an actuator 216, and an adapter interface 218. The actuator 216 is configured to deploy the treatment portion 212 outside the port 210 when actuated. For example, the actuator 216 can include a button that can be pressed to unlock the actuator 216 and slide the actuator 216 distally to move the treatment portion 212 distally such that the treatment portion 212 deflects out of the side port 210 and bends, as shown in Figure 1A . The adapter interface 218 is configured to secure the treatment needle assembly 200 to an ultrasound probe via an adapter 300. The adapter 300 is configured to couple to the treatment needle assembly 200 and the ultrasound probe. Advantageously, the adapter 300 works with many commercially available ultrasound probes and allows the treatment needle assembly 200 to be used seamlessly with various probes. The adapter 300 preferably includes a needle assembly interface 302 configured to removably couple to the treatment needle assembly 200 (e.g., at the adapter interface 218) and an ultrasound probe interface 304 configured to removably couple to a vaginal ultrasound probe.

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

[0050] The treatment needle assembly 200 and / or the adapter 300 may be designed for treating a single patient and then disposed of, while the generator 400 and the generator software 500 may be reused and may be interchangeable with multiple treatment needle assemblies and adapters.

[0051] Figure 1B Illustrate the treatment needle assembly 200 and the adapter 300 of the system 100 coupled together and coupled to the needle guide 600 and the ultrasound probe 602. The needle guide 600 is configured to be coupled to the ultrasound probe 602 and receive the elongate 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 endocavitary needle guide available from CIVCO Medical Solutions of 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 of Chicago, Illinois. As will be readily understood by those skilled in the art, the ultrasound probe 602 may be used in conjunction with other ultrasound components (e.g., a display) and used in combination with the probe. The needle guide 600 preferably aids in aligning the treatment portion 212 with an ultrasound visualization plane or field of view formed from the ultrasound probe 602 in a manner that ensures visibility during its deployment, which may allow the operator to more precisely position and deliver treatment at the desired location. As will be understood by those of ordinary skill in the art, various elements may be combined into a single entity, such as the treatment needle assembly 200 and the needle guide 600, the needle assembly 600 and the adapter 300, and the like.

[0052] Now refer to Figure 2A and 2B, respectively showing the treatment needle assembly 200 in the retracted state and the deployed state. The handle 214 may include a first notch 220 and a second notch 222 on opposite surfaces to lock the treatment 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 the locking. A channel 228 is disposed within the handle 214 such that when the trigger 230 (e.g., a button) is pressed, the actuator 216 can move longitudinally to deploy and retract the treatment portion 212. Figure 2B Illustrates the position after the actuator 216 is actuated and the treatment portion 212 is deployed outside the port 210.

[0053] Now refer to Figures 2C to 2I . The elongate shaft 206 extends from the distal end of the handle 214. As explained above, the adapter interface 218 on the handle 214 may include a first and a second plurality of ribs 224, 226 at the first and second notches 220, 222 to assist in clamping and coupling to the adapter 300. Figure 2C and 2D respectively illustrate a side view and a top view of the treatment needle assembly 200. Similarly, in Figure 2G and 2H a side view and a top view of the treatment needle assembly 200 are shown, and similar components as well as the deployed treatment portion 212 are shown. Figure 2E , 2F and 2I illustrate detailed and cross-sectional views of the handle 214: Figure 2E Illustrates the locked, retracted state, Figure 2F illustrates the unlocked, retracted state, and Figure 2I illustrates the deployed state. The handle 214 includes a trigger 230 for controlling the locking mechanism 232. When the trigger 230 is pressed, the locking mechanism 232 is released, and the actuator 214 can move the push track 234 along the channel 228 for deploying the treatment portion 212 outside the port 210. Such deployment features may include a slider, a knob, a wheel, a crank, or the like, which can be used to deploy / retract the treatment portion 212. A stop 236 is disposed on the distal end of the handle 214 to prevent the actuator 216 from moving beyond the desired distal point on the handle 214. This can assist in restricting the distance that the treatment portion 212 can extend from the port 210.

[0054] Now refer to Figures 2J to 2L, which depicts various views of the elongate shaft 206. The elongate shaft 206 includes a port 210, from which a treatment portion 212 can be deployed outside the port 210 from the lumen 238. Adjacent to the port 210 is a lubricant 240, such as a lubricating tube or coating, which is disposed within the lumen of the elongate shaft 206 proximate to the port 210. The inclusion of the lubricant 240 or similar feature facilitates the transition of the treatment portion 212 from a retracted state to a deployed state. It has been found that, in the absence of such a lubricant feature, any components of the treatment element or treatment portion 212, such as electrodes or sensors, may be damaged due to friction / contact with the edge of the port 210 during deployment and / or retraction. The lubricant 240 can be a lubricating tube made of a biocompatible material that minimizes the friction between the treatment portion 212 and the elongate shaft 206 and thus protects its components. Examples of such biocompatible materials can be ultra-high molecular weight polyethylene or fluoropolymers.

[0055] Additionally or alternatively, the elongate shaft 206 can include a structure or configuration, such as a bevel or arcuate curve, to facilitate the transition of the treatment portion 212 between a retracted state and a deployed state. The treatment portion 212 is additionally guided by an angled interface 242 that forms the distal end of the lumen within the elongate shaft 200 and also defines the distal end of the port 210. The angled interface 242 guides the treatment portion 212 away from the lumen 238 of the elongate shaft 200 at a desired angle from the port 210 to facilitate positioning the treatment portion 212 for treatment in its curved shape. A needle lumen 244 is also formed in the tip 208 of the needle. It has been found that forming the needle lumen 244 by coring the inner portion of the tip 208 of the needle aids in piercing the vaginal wall and / or ovarian wall.

[0056] Now refer to Figure 2M, provides a detailed view of the treatment portion 212 deployed external to port 210. The treatment portion 212 preferably forms a curved shape upon deployment, as illustrated. The treatment 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., radiofrequency energy) to effect treatment. The first and second electrodes 246, 248 may be composed of a metal strip, coil, wire (e.g., wound or braided), laser cut tube, or slotted tubular structure. The shaft of the treatment portion 212 may have a predefined shape that can be used for various purposes, such as anchoring the device within the ovary (to limit the risk of device movement due to patient movement or user error), orienting the treatment portion 212 more normal to the ultrasound probe to increase echoreflectivity, and increasing the total length of the treatment portion 212 that can be located within the ovary. Compared to a more straight element, the predefined shape may also enable the treatment portion 212 to more easily reach different locations within the ovary and thereby reduce the amount of manipulation performed by the treatment needle assembly 200 and / or reduce the number of punctures to the ovary. Additionally, the elongate shaft 206, the treatment portion 212, and / or the needle tip 208 may contain echogenic material and / or gas to enhance echoreflectivity.

[0057] Additionally, the treatment needle assembly 200 (e.g., at the treatment portion 212) may include one or more sensors to detect parameters such as temperature, impedance, or other parameters that may guide treatment delivery. For example, the sensor 250 may be located on the inner surfaces of the first and second electrodes 246, 248, as illustrated. In one example, the sensor 250 is a thermistor for measuring temperature. A generator 400 (not shown) may use the detected parameters sensed by the sensors and the generator software 500 ( Figures 7 to 9 described therein) to monitor the operation of the treatment needle assembly 200 and / or the patient during treatment. For example, treatment may automatically stop when a certain temperature, time, power, and / or impedance threshold is exceeded. The impedance value may also be used to determine the relative position of the treatment portion 212 within the ovary. The conductive needle 252 may form the distal tip of the treatment portion 212 to 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 treatment portion 212.

[0058] Now refer to Figure 3A and 3B, the adapter 300 of the system 100 preferably includes a needle assembly interface 302, an ultrasound probe interface 304, and an actuator track 306. The adapter 300 can be saddle-shaped and includes an ultrasound probe interface 304 for securing the adapter 300 to the ultrasound probe. The ultrasound probe interface 304 can be collar-shaped and forms a loop around a portion of the ultrasound probe between the proximal and distal ends of the ultrasound probe. The side of the adapter 300 can be placed around the more proximal region of the ultrasound probe. The adapter 300 can be fastened, strapped, clamped, or any similar means to accommodate various ultrasound probes. As shown in Figure 3A and 3B , the needle assembly interface 302 on the proximal region of the adapter 300 includes needle assembly interface ribs 308 for gripping the treatment needle assembly 200 when inserted. The needle assembly interface 302 is configured to couple with the adapter interface 218 of the treatment needle assembly 200 such that the treatment needle assembly 200 can be longitudinally attached to the ultrasound probe and can be removed, rotated, and reattached as needed during treatment. The resulting limited rotation can be used to maintain the treatment portion 212 in the ultrasound visualization plane or field of view. When the treatment needle assembly 200 is inserted, the actuator track 306 facilitates smoother movement of the actuator 216.

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

[0060] According to another aspect of the present invention, the adapter interface 218 and the needle assembly interface 302 may allow the treatment needle assembly 200 to be reoriented relative to the adapter 300 between more orientations than the first and second orientations, e.g., a third or fourth orientation. Additionally, the adapter interface 218 and the needle assembly interface 302 may lock together in any orientation. In any orientation, the treatment needle assembly 200 may be locked in place.

[0061] Reference Figure 4 , a general schematic diagram of the internal functional components of the generator 400 will now be described. The generator 400 may include a programmable controller 402, which is operatively coupled to a treatment energy source 404, an impedance measurement circuitry 406, a temperature measurement circuitry 408, a graphical user interface 410, a communication unit 412, an input and output circuitry (I / O) 414, and / or a power supply 416.

[0062] The programmable controller 402 is electrically coupled to the internal functional components of the generator 400 and is designed to control the internal functional components of the generator 400. The controller 402 may include one or more commercially available microcontroller units, which may include a programmable microprocessor, volatile memory, non-volatile memory (e.g., EEPROM for storing programming), and a non-volatile storage device (e.g., flash memory) for storing firmware and logs of the operating parameters of the system 100 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 functional components of the generator 400 to provide the functionality ascribed to them herein. The controller 402 is designed to be programmable such that programming data is stored in the memory of the controller 402 and can be 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, e.g., the ovarian volume of a patient. For example, using ultrasound techniques known in the art, a clinician may receive the ovarian volume of a patient based on measurements such as the length, width, and / or depth of the ovary. Specifically, the clinician may use a program for measuring the length, width, and / or depth of the ovary, e.g., by clicking on different spatial points on a graphical user interface displaying the ultrasound of the patient's ovary, and calculate the ovarian volume based on the measurements.

[0063] Then, a clinician may provide the ovarian volume as a user input to the controller 402 such 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 which, when executed by the processor of the controller 402, cause the processor to generate recommended / desired ablation parameters, recommended / desired ablation number, and recommended / desired ovarian ablation volume based on the ovarian volume and the desired outcome. Thus, for a given patient, the clinician may know the ovarian ablation volume required per ovary, how many ablations are needed, and at what parameters the ablation is to be delivered to the patient to ablate the required ovarian ablation volume.

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

[0065] Furthermore, 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 such that the clinician will know the remaining volume of ovarian ablation required per ovary, how many ablations are left, and at what parameters the ablation is to be delivered to the patient to ablate the remaining volume of ovarian ablation required. Thus, for a given ovarian volume of a patient, the processor knows how much volume of ovarian tissue will be ablated for any given set of parameters and, correspondingly, what percentage of the ovarian tissue remains to be ablated to achieve the desired ablation treatment, e.g., 5%, 7.5%, 10%, 12%, or 15% of the ovarian volume to be ablated. For example, for a given ovarian volume of a patient, the processor may determine that five ablations are needed to ablate 5 to 10% of the ovary and the processor conveys to the clinician how much volume of ovarian tissue will be ablated per ablation for a given set of ablation parameters (e.g., power level or time and temperature). The clinician may retrieve this information via a table (e.g., a look-up table). Thus, after the clinician performs one ablation on the patient's ovary, the processor will adjust the data and display that four ablations remain. Additionally, if the clinician does not complete the first ablation, e.g., cuts it off, or performs the ablation with parameters different from those recommended / required by the processor, the processor will readjust and display the adjusted remaining ablation amount to achieve the desired ablation treatment to account for the clinician's deviation from the recommended / required settings.

[0066] As will be readily understood by those skilled in the art, although Figure 4A programmable controller is illustrated, but multiple programmable controllers may be utilized.

[0067] The treatment energy source 404 is designed to provide energy (e.g., RF energy) from the generator 400 to the treatment portion 212 to deliver the energy to the first and second electrodes 246, 248 and treat ovarian tissue. The energy may be applied in a continuous or pulsed manner. The impedance measurement circuitry 406 and the temperature measurement circuitry 408 are designed to sense one or more parameters of the sensor 250 and / or the conductive needle 252, such as impedance or temperature. The system sensor 250 and / or the 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 the treatment or to confirm the proper operation of the system 100.

[0068] The graphical user interface 410 is designed to receive user input and optionally display information to the user. The graphical user interface 410 may include buttons for receiving user input and a display for presenting information to the clinician (see Figures 10 to 13 ). As will be readily appreciated by those skilled in the art, the graphical user interface 410 is not limited thereto and may utilize one or more of triggers, plungers, touchscreens, keyboards, microphones, speakers, trackballs, or the like.

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

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

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

[0072] Now referring to Figure 5 , the generator software 500 will now be described. The generator software 500 includes Figure 5 several functional blocks schematically depicted in TM (a registered trademark of Microsoft Corporation, Redmond, Wash.), Mac, or a Unix-based operating system, which are typically used on desktop and laptop computers. The computer running the generator software 500 preferably includes a data port, such as a USB port or a comparable wireless connection, which allows the generator 400, an external monitoring component, and / or a mobile device running a mobile application to be coupled thereto. Alternatively, or additionally, the computer may include wireless circuitry; for example, 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, an external monitoring component, and / or a mobile device running a mobile application to communicate wirelessly with the computer running the generator software 500.

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

[0074] The main block 502 preferably includes a main software routine that executes on the clinician's computer and controls the overall operation of the other functional blocks. The main block 502 enables the clinician to download event data and alarm information stored on the generator 400 to his office computer, and also allows the generator software 500 to receive signals from the generator 400 indicating the sensed parameters. The main block 502 is further configured to execute routines to calculate parameters based on the sensed parameters and / or store treatment-related information. For example, the main block 502 is configured to execute a routine to measure impedance and / or temperature using signals indicating the impedance or temperature sensed at the treatment section 212. As another example, the main block 502 is configured to execute a routine to store (and cause to be displayed) the number of ablations per ovary and / or per patient and / or other information and parameters as previously described. The main block 502 is further configured to execute a routine to calculate data for display based on inputs received at the user interface block 510. The main block 502 also enables the clinician to upload firmware updates and configuration data to the generator 400.

[0075] The event log block 504 is a record of the operation data downloaded from the generator 400 and may include, for example, the measurement time, the parameters sensed in real time, the previously sensed parameters, the sensor data, the battery pack current, the battery pack voltage, the battery pack status, the number of ablations per ovary and / or per patient, and the like. The event log may also include the occurrence of events such as alarms or other abnormal conditions. The event log block 504 may further include a record of the data input at 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 download after the generator 400 is coupled to a computer running the generator software 500. The data download block 506 can initiate the download of the data stored in the event log automatically or at the behest of the clinician via the user interface block 510.

[0077] The configuration settings block 508 is a routine that configures the parameters stored in the generator 400 that control the operation of the corresponding components / applications. If a predetermined threshold is exceeded, the parameter can determine to warn the user. Such interval timing parameters can be reconfigured by the block 508. The interval timing settings transmitted from the generator software 500 to the generator 400 can also determine the time and frequency at which the event data is written into the memory of the corresponding components / applications.

[0078] The user interface block 510 processes receiving user input (such as ovarian volume) at the computer running the generator software 500 and displays information retrieved from the generator 400 and the data download block 506, presenting the information in an intuitive and easy-to-understand format for review by a clinician, such as numbers, waveforms, text, drawings, charts, graphs, or the like. This information may include the status of the generator 400, measurement times, real-time sensed parameters, previously sensed parameters, parameters calculated using the sensed parameters, sensor data, battery pack current, battery pack voltage, battery pack status, and the like.

[0079] The alert detection block 512 may include routines for evaluating data retrieved from the generator 400 and flagging abnormal conditions to draw the clinician's attention. For example, as Figures 7 to 12 further explained, the alert detection block 512 may flag when a parameter sensed by the system sensor 250 is above a first predetermined threshold or below a second predetermined threshold.

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

[0081] The firmware upgrade block 516 may include routines for checking the version number of the controller firmware installed on the generator 400 and identifying whether an upgraded firmware exists. If so, the routines may notify the clinician and allow the clinician to download the modified firmware to the generator 400 in the non-volatile memory.

[0082] The status information block 518 includes routines for querying the generator 400 to retrieve current status data from the generator 400. This information may include, for example, battery pack status, version control information of the currently used firmware and hardware, and sensor data.

[0083] Additionally, the generator software 500 may further include a functional block for determining whether a proper needle assembly is coupled to the generator. For example, when the needle assembly is disposable, the generator software 500 will ensure that the same needle assembly is not used more than once. Thus, the needle assembly may include, for example, a chip or an identification tag such as an RFID or barcode that stores information about the needle assembly, the information including whether the needle assembly has been used previously. After the generator reads the chip or identification tag of the needle assembly, if the generator software 500 determines that the needle assembly is proper, then the generator software 500 may allow subsequent ablation, or if the generator software 500 determines that the needle assembly is improper, then prevent subsequent ablation.

[0084] Now refer to Figures 6A to 6F, Figures 6A to 6F An example of a method of treating ovarian tissue using the treatment needle assembly 200, as described herein. In this example, the treatment needle assembly 200 is coupled to a vaginal ultrasound probe via an adapter 300 and a needle guide 600 is used. The operator positions the elongate shaft 206 having the treatment portion 212 disposed therein in a retracted state into the vagina under ultrasound guidance using the ultrasound probe. The tip 208 of the elongate shaft 206 pierces the vaginal wall V and the ovarian wall. Figure 6A Illustrates entry into a target region of ovarian tissue adjacent the patient after the tip 208 has been advanced through the vaginal wall V, through the ovarian wall, and into the ovary O. Once the elongate shaft 206 is positioned in a first orientation, Figure 6B Illustrates deployment of the treatment portion 212. The operator then delivers energy to the treatment area via the generator 400 and the treatment portion 212 using parameters described, for example, in U.S. Patent Publication Nos. 2016 / 0220302, 2017 / 0215949, and 2018 / 0110554 to the Democratic Republic of the Congo, the entire contents of each of which are incorporated herein by reference. Energy may be delivered at a level and for a duration sufficient to effect treatment to heat (e.g., ablate) the tissue in the treatment area. For example, energy may be applied to the ovary in multiple ablation procedures to treat polycystic ovary syndrome (PCOS).

[0085] After energy delivery is complete, the treatment portion 212 is retracted into the elongate shaft 206, as Figure 6C shown. Without removing the elongate shaft 206 from the ovary O, the operator may rotate the treatment needle assembly 200 relative to the adapter 300 or may decouple the treatment needle assembly 200 from the adapter 300 (e.g., by detaching the adapter interface from the treatment needle interface), flip / rotate the treatment needle assembly 200 a predetermined amount (e.g., within a rotational range spanning up to 180 degrees), and reattach the adapter interface to the adapter 300 if the adapter interface was detached from the treatment needle interface. This flipping can occur while the distal region remains in place in the ovary O (as opposed to rotating).

[0086] For example, as shown in Figure 6B the treatment needle assembly 200 may initially be introduced into the ovary O along the x-axis such that the port 210 of the treatment needle assembly 200 points downward along the y-axis. Thus, the treatment portion 212 will be deployed in the plane formed by the x-axis and the y-axis along the y-axis. As Figure 6C shown, after the treatment portion 212 is retracted into the elongate shaft, the treatment needle assembly 200 may be rotated up to 90 degrees about the x-axis in either direction. For example, rotating the treatment needle assembly 200 about the x-axis from Figure 6CRotating the position illustrated in a clockwise direction by 90 degrees will cause port 210 to face out of the page along the z-axis, and rotating the treatment needle assembly 200 counterclockwise by 90 degrees from the initial position illustrated in Figure 6C will cause port 210 to face into the page along the z-axis. Accordingly, the treatment needle assembly 200 can be rotated any amount within a total range of 180 degrees, which may be limited by the field of view of the ultrasound probe. For example, referring back to Figure 3C , the treatment needle assembly 200 can be rotated up to 45 degrees in either direction about the x-axis, providing an overall rotation range within 90 degrees such that port 210 and thus the treatment portion 212 remain within the field of view FOV of the ultrasound probe. As will be understood by one of ordinary skill in the art, the treatment needle assembly 200 can be rotated to any orientation within the overall range of 180 degrees while the ultrasound probe remains in place and locked in the desired position.

[0087] Figure 6D illustrates the elongate shaft 206 in a second orientation in the retracted state, while the treatment portion 212 is Figure 6E redeployed in Figure 6F to perform another treatment. Energy is then delivered to this second treatment zone. The treatment portion 212 can then be retracted to the retracted state as shown in Figure 6G . The distal region of the treatment needle assembly 200 can be repositioned within the ovary O or removed after completion of treatment of the ovary O. For example, as shown in Figure 6H , the elongate shaft 206 can be moved proximally along the same needle path in the retracted state without adjusting the angle of the elongate shaft 206 via a single entry point for further energy delivery. Then the treatment portion 212 is redeployed in

[0088] Figure 6I to perform another treatment. Energy is then delivered to this third treatment zone. The treatment portion 212 is retracted again, and the treatment needle assembly 200 can be flipped to deliver energy in a fourth treatment zone. Additionally or alternatively, the elongate shaft 200 can be moved proximally again in the retracted state to deliver further treatment. In this manner, multiple ablations can be achieved in each ovary, for example 4 ablations in a smaller ovary (as determined by the clinician based on ultrasound imaging), 8 ablations in a larger ovary, or an ablation amount sufficient to ablate the desired volume of ovarian tissue, such as 1% to 25%, or more preferably 5% to 10% of the total volume of the ovary.

[0088] Figure 6I illustrates that after retracted deployment of the treatment portion 212, another location of the ovary O can be treated using a single puncture of the vaginal wall V and the ovary O. In Figure 6IIn [the example], the treatment needle assembly 200 is moved along different needle paths to different angles via the same single puncture for optional further treatment. Creating fewer punctures and minimizing the amount of device manipulation can have several benefits, including (but not limited to) reducing the patient's pain or discomfort due to reduced damage to the outer side of the ovary, and reducing the risk of adhesion formation (during or after surgery), facilitating operator use, reducing the surgical time, and / or reducing the likelihood 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 treatment element in different regions for treatment. After the first ovary is treated, the second ovary can be treated in a similar manner.

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

[0090] Now refer to Figures 7 to 9 , a method for illustrating the use of the monitoring system 100 during ovarian surgery is described. The system sensor 250 and / or the conductive needle 252 can be used to measure temperature and / or impedance. For example, a temperature sensing element can be coupled to each of the first and second electrodes 246, 248. Additionally, the system sensor 250 and / or the conductive needle 252 can also be used to detect whether the device moves inappropriately during treatment delivery. For example, device movement can be inferred by sensing sudden changes in temperature, impedance, and / or power. An increase in impedance may also mean a change in tissue properties, such as collagen denaturation, drying, or charring.

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

[0092] Figure 7An exemplary method 700 for measuring a temperature (e.g., a thermistor temperature) sensed by a treatment needle assembly 200. At 702, one or more signals indicating one or more sensed parameters (e.g., temperature) are received by a generator 400 from a sensor 250 and / or a conductive needle 252. At 704, a processor on a computer running generator software 500 can run an algorithm stored in a memory to determine whether the temperature is higher than a first predetermined temperature threshold. At 706, if the temperature is higher than the first predetermined temperature threshold, a warning indicating an event such as a probe or extension cable disconnection can be generated on a graphical user interface 410. In one embodiment, the first predetermined temperature threshold is within 115 to 125 degrees Celsius, e.g., 120 degrees Celsius. At 708, the processor determines whether energy is being delivered via execution of the algorithm. If so, the processor terminates energy delivery at 710. If not, step 720 (described below) is performed.

[0093] If the measured temperature is not higher than the first predetermined temperature threshold, the processor determines at 712 via execution of the algorithm whether the temperature is lower than a second predetermined temperature threshold or higher than a third predetermined temperature threshold. In one embodiment, the second predetermined temperature threshold is within 5 to 15 degrees Celsius, e.g., 10 degrees Celsius. The third predetermined temperature threshold can be, for example, within 40 to 50 degrees Celsius, e.g., 45 degrees Celsius. At 714, if the measured temperature is lower than the second predetermined temperature threshold or higher than the third predetermined temperature threshold, a warning indicating that the temperature is out of range can be generated on the graphical user interface 410. If not, step 720 (described below) is performed.

[0094] If it is determined that the temperature is out of range, at 716, the processor determines via execution of the algorithm whether energy is being delivered. If so, the processor terminates energy delivery at 718. If no energy is being delivered at 708 or 716, the processor can wait for a set period of time according to a protocol stored in the memory via execution of the algorithm at 720, and then return to step 702 to measure the temperature again. In this way, the temperature can be monitored throughout the use of the treatment needle assembly 200.

[0095] Figure 8is an exemplary method 800 for measuring the probe temperature. At 802, a generator 400 receives one or more signals from a sensor 250 and / or a conductive needle 252 indicating one or more sensed parameters, such as temperature. At 804, a processor on a computer running generator software 500 can run an algorithm to determine whether the temperature is below a fourth predetermined temperature threshold. In one embodiment, the fourth predetermined temperature threshold is within 15 to 25 degrees Celsius, such as 20 degrees Celsius. At 806, if the temperature is below the fourth predetermined temperature threshold, then a warning indicating an event such as a low probe temperature can be generated on the graphical user interface 410. If it is determined that the temperature is less than the fourth predetermined threshold, then at 808, the processor determines via execution of the algorithm whether energy is being delivered. If so, then the processor terminates energy delivery at 810. If the temperature is not below the fourth predetermined temperature threshold, then at 812, the processor determines via execution of the algorithm whether, when the power is increasing, the temperature exceeds a first temperature (e.g., 5 degrees Celsius) above the temperature set point for a first time period (e.g., 5 seconds). At 816, if the measured temperature exceeds the threshold within the measurement time, then a warning indicating a temperature control error will be generated on the graphical user interface 410. For example, if the measured probe temperature is 5 degrees Celsius or more higher than the temperature set point stored in the memory for 5 seconds or longer, then a warning can be generated. If so, then at 818, the processor determines via execution of the algorithm whether energy is being delivered. If so, then the processor terminates energy delivery at 820.

[0096] If the temperature is not below the fourth predetermined temperature threshold, then at 814, the processor determines via execution of the algorithm whether, when the power is increasing, the temperature exceeds a second temperature (e.g., 10 degrees Celsius) above the temperature set point for a second time period (e.g., 1 second). In this example, the second temperature is greater than the first temperature and the second time period is less than the first time period. In this way, if the temperature is too high (e.g., above the second temperature), then corrective action can be taken more immediately. Steps 816 to 820 can be repeated after it is determined at 814 that the temperature exceeds the second temperature above the temperature set point for the second time period when the power is increasing. If energy is not being delivered at 808 or 818, or the threshold is not reached at 804, 814, or 812, then the processor can wait for a set time period according to a protocol stored in the memory via execution of the algorithm at 822 and then return to step 802 to measure the temperature again. In this way, the probe temperature can be monitored throughout the use of the treatment needle assembly 200.

[0097] Figure 9is an exemplary method 900 for measuring impedance. At 902, a generator 400 receives one or more signals indicative of one or more sensed parameters (e.g., impedance) from system sensors 250 and / or conductive needles 252. At 904, a processor on a computer running generator software 500 may run an algorithm to determine whether the impedance measurement is below a first predetermined impedance threshold. In one example, the first predetermined impedance threshold is within 40 to 60 ohms, such as 50 ohms. At 906, if the impedance is below the first predetermined impedance threshold, a warning indicating a lower impedance may be generated on the graphical user interface 410. At 908, the processor determines whether energy is being delivered via execution of the algorithm. If so, the processor terminates energy delivery at 910. If the impedance is not below the first predetermined impedance threshold, the processor determines at 912 via execution of the algorithm whether the measured impedance is above a second predetermined impedance threshold. In one embodiment, the second predetermined impedance threshold is within 900 to 1100 ohms, such as 1000 ohms. At 914, if the measured impedance is above the second predetermined impedance, a warning indicating a higher impedance may be generated on the graphical user interface 410. At 916, the processor determines whether energy is being delivered via execution of the algorithm. If so, the processor terminates energy delivery at 918. If no energy is being delivered at 908 or 916, the processor may wait for a set period of time according to a protocol stored in memory via execution of the algorithm at 920, and then return to step 902 to measure the impedance again. In this way, the impedance at the treatment area can be monitored throughout the use of the treatment needle assembly 200.

[0098] Figures 10 to 13 Illustrates a graphical user interface 410 designed to communicate with the processor of the generator 400. An exemplary screenshot generated by the graphical user interface 410 shows a graphical interpretation of data received from the sensors 250 and / or conductive needles 252. The graphical user interface 410 is designed to display measured parameters such as temperature, impedance, power, and corresponding warnings, as well as information input by a clinician / operator. The graphical user interface 410 is designed to present the information in an intuitive, easy-to-understand format for operator review, such as numbers, waveforms, text, drawings, charts, graphs, or the like. The graphical user interface 410 may include buttons for receiving user input, such as patient / surgery-related information, ovarian volume, powering the device, and cleaning warnings.

[0099] Figure 10 Depicts an exemplary measurement mode screen before energy delivery. The sensors 250 and / or conductive needles 252 may be used to characterize or map the target tissue before applying treatment; for example, impedance measurements can be used to sense whether the ultrasound probe is properly positioned for treatment. Figure 11Depict exemplary temperature 1100, power reading 1102, ablation remainder 1104, and ablation volume 1106. As the tissue is heated and its properties change, the temperature may also increase. The sensor 250 and / or the conductive needle may also be used during treatment to dynamically adjust the treatment parameters. As illustrated in Figure 12 , treatment termination may also occur and result in an error message under certain conditions, as described in Figures 7 to 9 . Figure 13 Depict a table that provides ablation parameter selections for a given number of ablations and a desired ablation volume.

[0100] While the 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 present invention. The appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the present invention.

Claims

1. A system for performing an ovarian surgery, the system being configured to be used in cooperation with an ultrasound probe, the system comprises: A treatment needle assembly, which includes a proximal region and a distal region, and the treatment needle assembly further includes: A slender shaft, at the distal region thereof, the slender shaft includes a lumen, a port, and a needle tip at the distal end of the slender shaft, the needle tip being configured to pierce the vaginal wall and the ovarian wall for placing the port into the ovary; A treatment portion, which is disposed in the lumen of the slender shaft in a retracted state, the treatment portion includes a distal tip formed by a conductive needle and an energy emitter, the distal tip being configured to sense electrical activity, the energy emitter being configured to be deployed to extend out of the port of the slender shaft in a deployed state, and in the deployed state, emit energy into the ovarian tissue of the ovary, and the conductive needle extends through the energy emitter of the treatment portion; A handle, at the proximal region thereof, the handle includes an actuator, the actuator being configured to, when actuated, convert the treatment portion between the retracted state and the deployed state; and A lubricant disposed in the lumen of the slender shaft adjacent to the port of the slender shaft, the lubricant being configured to facilitate the conversion of the treatment portion between the retracted state and the deployed state in response to actuation at the actuator without damaging the energy emitter; and wherein the slender shaft includes an angled interface at the distal end of the lumen at the port to guide the treatment portion to exit the lumen of the slender shaft from the port at an angle, so as to facilitate the treatment portion to change from a straight shape to a curved shape; A generator, the generator being operably coupled to the treatment portion and the conductive needle to receive an electrical signal indicating impedance from the conductive needle, the generator being configured to process the electrical signal indicating impedance and deliver energy to the treatment portion in the deployed state, such that the energy emitter emits the energy into the ovarian tissue of the ovary based on the processed electrical signal indicating impedance.

2. The system according to claim 1, wherein the needle tip is cored to define a cavity to facilitate piercing the vaginal wall and the ovarian wall.

3. The system according to claim 1, further comprising an adapter, the adapter includes a needle assembly interface and an ultrasound probe interface, the ultrasound probe interface being configured to removably couple to the ultrasound probe, the needle assembly interface being configured to removably couple to the adapter interface of the handle, such that the treatment needle assembly is coupled to the ultrasound probe.

4. The system according to claim 3, wherein the adapter interface and the needle assembly interface are configured to allow the treatment needle assembly to be reoriented between a first orientation and a second orientation relative to the adapter.

5. The system according to claim 4, wherein the adapter interface and the needle assembly interface are configured to lock together in the first orientation and to allow the therapeutic needle assembly to be reoriented relative to the adapter such that the adapter interface and the needle assembly interface are configured to lock together in the second orientation.

6. The system according to claim 5, wherein the adapter interface and the needle assembly interface lock together in at least one of the first orientation and the second orientation.

7. The system according to claim 5, wherein the therapeutic portion in the first orientation in the deployed state is offset from the therapeutic portion in the second orientation in the deployed state by less than or equal to 180 degrees.

8. The system according to claim 5, wherein the adapter interface includes first and second notches on opposite surfaces of the handle, the first and second notches being configured to contact opposite surfaces of the needle assembly interface to lock the adapter interface to the needle assembly interface in the first orientation and the second orientation.

9. The system according to claim 8, wherein the first and second notches or the opposite surfaces of the needle assembly interface or both include multiple ribs to enhance the locking.

10. The system according to claim 4, wherein the adapter interface and the needle assembly interface are configured to lock together in the first orientation and to allow the therapeutic needle assembly to rotate relative to the adapter such that the adapter interface and the needle assembly interface are configured to lock together in the second orientation.

11. The system according to claim 3, wherein the adapter is configured to longitudinally align the therapeutic needle assembly with the ultrasound probe.

12. The system according to claim 3, wherein the adapter ensures that the therapeutic portion is aligned within the field of view of the ultrasound probe.

13. The system according to claim 3, further comprising a needle guide configured to removably couple to the ultrasound probe and to receive the elongate shaft therethrough to stabilize the elongate shaft during the procedure, wherein at least one of the therapeutic needle assembly and the needle guide or the needle guide and the adapter is formed as a single entity.

14. The system according to claim 1, wherein the generator is configured to terminate delivery of energy to the therapeutic portion when the impedance measurement is below a predetermined impedance threshold.

15. The system according to claim 1, wherein the therapeutic portion includes at least one sensor configured to generate data during emission of energy from the therapeutic portion.

16. The system according to claim 15, wherein the generator includes a processor in electrical communication with the at least one sensor, the processor being configured to execute instructions stored on a non-transitory computer-readable medium to: receive the data from the at least one sensor; determine whether the data is within a predetermined range; and If the data indicates that at least one measured parameter is outside the predetermined range, then the generator is instructed to modify the energy delivery to the treatment portion.

17. The system of claim 16, wherein the processor is configured to run a routine to cause a warning to be generated on the graphical user interface if the data is above a first predetermined threshold or below a second predetermined threshold.

18. The system of claim 15, wherein the at least one sensor includes an impedance sensor and at least one temperature sensor, the temperature sensor being configured to measure the temperature at one or more electrodes or probes or both.

19. The system of claim 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.

20. The system of claim 19, wherein the graphical user interface is configured to display information showing the variation of temperature and power over time.

21. The system of claim 15, wherein the generator includes a processor in electrical communication with the at least one sensor, the processor being configured to execute instructions stored on a non-transitory computer-readable medium to store information indicative of the number of ablations per ovary or per patient and to cause the graphical user interface to display the information indicative of the number of ablations.

22. The system of claim 1, further comprising a graphical user interface configured to display information indicative of at least one of: ovarian volume per ovary, ovarian volume per patient, recommended ablation parameters, set ablation parameters, power settings, recommended number of ablations, required number of ablations, recommended ovarian ablation volume, required ovarian ablation volume, number of ablations completed, remaining number of ablations, percentage of ovarian volume ablated, or percentage of ovarian volume yet to be ablated.

23. The system of claim 22, wherein the information indicative of the recommended or set ablation parameters is displayed in a table.

24. The system of claim 22, wherein the displayed information is updated after each ablation.

25. The system of claim 22, further comprising a processor configured to execute instructions stored on a non-transitory computer-readable medium to receive input data indicative of ovarian volume, wherein the information displayed on the graphical user interface is at least partially based on the input data indicative of ovarian volume.

26. The system of claim 1, wherein the treatment portion is configured to form a curve in a deployed state.

27. The system of claim 1, wherein the treatment portion includes one or more electrodes configured to emit the energy into the ovarian tissue.

28. The system of claim 1, wherein the treatment portion includes an active electrode and a return electrode, the active electrode being configured to emit continuous or pulsed radiofrequency energy.

29. The system according to claim 1, wherein the treatment portion is configured to emit the energy into the ovarian tissue to treat polycystic ovary syndrome (PCOS).

30. The system according to claim 1, wherein the lubricant comprises at least one of a lubricating tube or a coating.

31. The system according to claim 1, wherein the system is configured for use in conjunction with a vaginal ultrasound probe.

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