Devices, systems, and methods for treating polycystic ovary syndrome (PCOS)

Abstract

Devices and systems for treating Polycystic Ovary Syndrome (PCOS) include an elongate body having an end effector disposed at a distal end portion thereof and configured for insertion from an exterior of a patient to a treatment location at an infundibulopelvic (IP) ligament, ovarian pedicle, or ovarian hilum of the patient via percutaneous, transluminal, transvaginal, or transcervical access. The end effector assembly is configured to treat tissue at the treatment location to interrupt nerve signaling at the treatment location without permanently damaging surrounding tissue.

Description

DEVICES, SYSTEMS, AND METHODS FOR TREATING POLYCYSTIC OVARY SYNDROME (PCOS)CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of, and priority to, U.S. Provisional Patent Application No. 63 / 613,542, filed on December 21, 2023, the entire contents of which are hereby incorporated herein by reference.FIELD

[0002] The present disclosure relates to devices, systems, and methods for treating Polycystic Ovary Syndrome (PCOS).BACKGROUND

[0003] Ovarian sympathetic neural activity can cause or exacerbate several ovarian conditions, including common endocrine disorders affecting women of reproductive ages such as Polycystic Ovary Syndrome (PCOS). Scientific literature suggests that ovarian hormonal secretion is regulated by sympathetic nervous activity to the ovary. The sympathetic nervous system (SNS) is a primarily involuntary bodily control system typically associated with stress responses. Fibers of the SNS extend through tissue in almost every organ system of the human body. For example, some fibers extend from the brain, intertwine along the aorta, and branch out to various organs. As groups of fibers approach specific organs, fibers particular to the organs can separate from the groups. Signals sent via these and other fibers can affect characteristics such as pupil diameter, gut motility, and urinary output. Such regulation can have adaptive utility in maintaining homeostasis or in preparing the body for rapid response to environmental factors. Chronic activation of the SNS, however, is a common maladaptive response that can drive the progression of many disease states. Excessive activation of the ovarian SNS has been identified experimentally and in humans as a likely contributor to the complex pathophysiology ofPCOS.SUMMARY

[0004] As used herein, the term “distal” refers to the portion that is described which is farther from an operator (whether a surgeon or surgical robot), while the term “proximal” refers to the portion that is being described which is closer to the operator. Terms including “generally,”“about,” “substantially,” and the like, as utilized herein, are meant to encompass variations up to and including plus or minus 10 percent.

[0005] Provided in accordance with aspects of the present disclosure are devices, systems, and methods for treating Polycystic Ovary Syndrome (PCOS). The devices, systems, and methods of the present disclosure may be utilized to treat PCOS at various different anatomical locations, via various different approaches, and / or with various different treatment modalities. Further, the treatment outcome may be denervation (defined herein as a loss in, or damage to, nerve supply including partial or complete loss of, or damage to, nerve supply) and / or stimulation (also referred to as destimulation, both of which are defined herein as reducing or changing the neural signals transmitted along a nerve pathway to reduce or change a physiological response to the neural signals).BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The above and other aspects and features of the present disclosure will become more apparent in view of the following detailed description when taken in conjunction with the accompanying drawings wherein like reference numerals identify similar or identical elements.

[0007] FIGS. 1 and 2 are anatomical views of the human female reproductive system and associated tissues illustrating various treatment locations for treating Polycystic Ovary Syndrome (PCOS) in accordance with the present disclosure;

[0008] FIG. 3 is a side, partial cut-away view illustrating a laparoscopic approach to treating PCOS in accordance with the present disclosure;

[0009] FIG. 4 is a cross-sectional view illustrating a percutaneous or subcutaneous approach to treating PCOS in accordance with the present disclosure;

[0010] FIG. 5 is a cross-sectional view illustrating a transluminal approach to treating PCOS in accordance with the present disclosure;

[0011] FIG. 6 is an anatomical view illustrating a transvaginal approach to treating PCOS in accordance with the present disclosure;

[0012] FIG. 7 is an anatomical view illustrating a transcervical approach to treating PCOS in accordance with the present disclosure;

[0013] FIG. 8 is a robotic surgical system configured for use in treating PCOS in accordance with the present disclosure;

[0014] FIG. 9 is a side view of a chemical ablation system for use in treating PCOS in accordance with the present disclosure;

[0015] FIG. 10 is a side view of a temperature therapy system for use in treating PCOS in accordance with the present disclosure;

[0016] FIGS. 11 A-l ID are side views of various end effector configurations for use with the temperature therapy system of FIG. 10 or any other treatment device or system of the present disclosure;

[0017] FIG. 12 is a perspective view of a bipolar treatment system for use in treating PCOS in accordance with the present disclosure;

[0018] FIG. 13 is a perspective view of another bipolar treatment system for use in treating PCOS in accordance with the present disclosure;

[0019] FIGS. 14A and 14B are perspective views of still another bipolar treatment system for use in treating PCOS in accordance with the present disclosure in retracted and deployed positions, respectively;

[0020] FIGS. 15A and 15B are perspective views of a bipolar end effector for use in treating PCOS in accordance with the present disclosure in open and closed positions, respectively;

[0021] FIG. 16 is a perspective view of an ultrasonic treatment system for use in treating PCOS in accordance with the present disclosure;

[0022] FIG. 17 is a perspective view of a distal portion of another bipolar treatment device for use in treating PCOS in accordance with the present disclosure;

[0023] FIGS. 18A-18C are perspective views of mechanical treatment devices for use in treating PCOS in accordance with the present disclosure;

[0024] FIG. 19 is a perspective view of a monopolar treatment device for use in treating PCOS in accordance with the present disclosure;

[0025] FIG. 20 is a side view of yet another mechanical treatment device for use in treating PCOS in accordance with the present disclosure;

[0026] FIG. 21 is a perspective view of still another mechanical treatment device for use in treating PCOS in accordance with the present disclosure;

[0027] FIGS. 22A and 22B are top and transverse, cross-sectional views of still yet another bipolar treatment device for use in treating PCOS in accordance with the present disclosure;

[0028] FIG. 23 is a side view of a microwave treatment device for use in treating PCOS in accordance with the present disclosure;

[0029] FIGS. 24 and 25 are side views of stimulation devices for use in treating PCOS in accordance with the present disclosure;

[0030] FIG. 26 is a side view of a drug eluting stent for use in treating PCOS in accordance with the present disclosure;

[0031] FIG. 27A is a side view of a detection system for use in treating PCOS in accordance with the present disclosure;

[0032] FIG. 27B illustrates an example impedance map generated using the detection system of FIG. 27A;

[0033] FIG. 28 is a side view of a photoacoustic imaging system for use in treating PCOS in accordance with the present disclosure;

[0034] FIG. 29A is a top view of a detection and treatment device for use in treating PCOS in accordance with the present disclosure; and

[0035] FIGS. 29B and 29C are side views of the detection and treatment device of FIG. 29A in first and second positions, respectively.DETAILED DESCRIPTION

[0036] The present disclosure provides devices, systems, and methods for treating Polycystic Ovary Syndrome (PCOS). As detailed below, the devices, systems, and methods of the present disclosure may be utilized to treat PCOS at one or more anatomical locations, using one or more different approaches, and / or with various different treatment modalities (electrical energy, thermal energy, mechanical, chemical, etc.) Further, any or all of the devices, systems, and methods of the present disclosure may be utilized to perform denervation and / or stimulation. In aspects, without limitation, denervation may be a permanent treatment and / or a single treatment, while stimulation may be a temporary treatment and / or an ongoing or repeated treatment.

[0037] To the extent consistent, the devices, systems, and methods of the present disclosure may be utilized at any of the different anatomical locations detailed herein (or at any other suitable anatomical locations), via any of the different approaches detailed herein (or using any other suitable approach), with any of the different treatment modalities locations detailed herein(or using any other suitable treatment modality), and to achieve denervation and / or stimulation as the treatment outcome.

[0038] Referring to FIGS. 1 and 2, the human female reproductive system anatomy and associated tissues are illustrated. In accordance with the present disclosure, treatment for PCOS may be provided at one or more of locations “LI,” “L2,” or “L3.” Location “LI” is at the infundibulopelvic ligament (also referred to as the IP ligament or the suspensory ligament) and, more specifically, at or near the location where the IP ligament extends from the ovary. In aspects, location “LI” is at the ovarian pedicle, which includes the IP ligament, ovarian arteries, ovarian vessels, and ovarian nerves. Treatment at the IP ligament (and / or the ovarian pedicle) in accordance with the present disclosure may be directed at denervating and / or stimulating the ovarian nerves within the IP ligament (and / or the ovarian pedicle) without impacting ovarian blood supply. Additionally or alternatively, treatment of the uterine nerves may also be accomplished at the IP ligament and / or the ovarian pedicle (or treatment of either the uterine nerves or the ovarian nerves may be performed while inhibiting treatment of the other. The IP ligament and / or the ovarian pedicle (or structures therein such as nerves, vessels, etc.) are anatomically structured such that these tissues may be at least partially surrounded by a treatment device or portion thereof to facilitate denervating and / or stimulating, as detailed below. Alternatively, treatment may be provided on a surface of the IP ligament and / or the ovarian pedicle, by penetrating the IP ligament and / or the ovarian pedicle, or in any other suitable manner.

[0039] Location “L2” is at the ovarian hilum. The ovarian hilum includes ovarian and uterine arteries, vessels, and nerves. Treatment at the ovarian hilum in accordance with the present disclosure may be directed at denervating and / or stimulating the ovarian nerves within the ovarian hilum while inhibiting treatment of the uterine nerves and without impacting ovarian blood supply. Such treatment may be provided by at least partially surrounding the ovarian hilum, on a surface of the ovarian hilum, by penetrating the ovarian hilum, or in any other suitable manner.

[0040] Location “L3” is at the aorta and / or ovarian arteries and, more specifically, at or near where the ovarian branches branch off from the aorta. Treatment at location “L3” in accordance with the present disclosure may be directed at denervating and / or stimulating the ovarian nerves within an ovarian branch without impacting ovarian blood supply. In aspects, treatment atlocation “L3” may be provided using an endoluminal approach wherein access is provided to the aorta via the femoral artery. Such treatment may be initiated from within the aorta (and adjacent the targeted ovarian branch), which has a larger diameter than the ovarian arteries, thus providing more room for navigation of and treatment with a treatment device. However, other approaches are also contemplated, such as treatment from within the targeted ovarian branch or from within the abdominal or pelvic cavity.

[0041] Turning to FIGS. 3-7, as noted above, various different approaches may be utilized to access a treatment location (e.g., location “LI,” “L2,” “L3” (FIGS. 1 and 2), or any other suitable treatment location) in accordance with the present disclosure. For example, FIG. 3 illustrates a laparoscopic approach 300 wherein a surgical camera 310 (e.g., an endoscope) and one or more surgical instruments 320, 330 are inserted through laparoscopic trocars 312, 322, 332, respectively and into the pelvic cavity. In aspects, insufflation is utilized to facilitate navigation to and treatment of tissue at the treatment location. A laparoscopic approach, more specifically, may involve video-assisted navigation (e.g., provided by surgical camera 310) to the treatment location (e.g., the ovarian nerves), ultrasound-assisted navigation, electromagnetic (EM)-assisted navigation, and / or any other suitable systems and methods to facilitate accessing and treating the treatment location.

[0042] FIG. 4 illustrates a subcutaneous or percutaneous approach 400 wherein one or more instruments 410 (e.g., treatment instruments or instruments providing access and / or guiding treatment instruments) are inserted through the skin to a subcutaneous or percutaneous location. Treatment may be directed, from the subcutaneous or percutaneous location, to the treatment location. Alternatively, access may be provided to the subcutaneous or percutaneous location and the treatment instrument(s) may be advanced from the subcutaneous or percutaneous location to another location to provide treatment at the treatment location. In aspects, the one or more instruments 410 include a needle, antenna, and / or other suitable tool(s) configured to be advanced through the skin to enable subcutaneous and / or percutaneous treatment with the instrument 410. In aspects, the one or more instruments 410 are treatment instruments configured to deliver chemical ablation agents (e.g., alcohol) to the treatment location. In aspects, ultrasound-assisted navigation, EM-assisted navigation, and / or any other suitable systems and methods (including robotic-assisted systems and methods) to facilitate accessing and treating the treatment location are also contemplated.

[0043] With reference to FIG. 5, a transluminal approach 500 is illustrated, for example, with an instrument 510 (e.g., a treatment instrument or instrument provided access and / or guiding a treatment instrument) inserted through an ovarian vessel to reach a treatment location adjacent to an ovarian nerve (e.g., an ovarian artery). Other transluminal approaches may include utilizing the fallopian tube to reach a treatment location.

[0044] Referring to FIG. 6, in aspects, a transvaginal approach 600 may be utilized wherein a treatment instrument or instrument providing access and / or guiding a treatment instrument is inserted into the vagina and along a path “Pl” through the posterior vaginal fornix (via a preformed incision or piercing through the fornix) to enter the pelvic cavity and enable navigation to the treatment location (e.g., at the IP ligament or the ovarian hilum). Ultrasound-assisted navigation, EM-assisted navigation, and / or any other suitable systems and methods to facilitate accessing and treating the treatment location are also contemplated.

[0045] FIG. 7 illustrates a transcervical approach wherein a treatment instrument or instrument providing access and / or guiding a treatment instrument is inserted through the vagina and along a path “P2” through the cervix, uterus, and into the fallopian tube. Treatment may be provided, in aspects, from within the fallopian tube or, in other aspects, the treatment and / or access / guide instrument may pierce through or extend through a pre-formed incision withing the fallopian tube to enter the pelvic cavity and enable navigation to the treatment location (e.g., at the IP ligament, ovarian pedicle, or the ovarian hilum). Ultrasound-assisted navigation, EM- assisted navigation, and / or any other suitable systems and methods to facilitate accessing and treating the treatment location are also contemplated.

[0046] With reference to FIG. 8, a robotic surgical system 800 configured for use in accordance with the present disclosure is provided. Robotic surgical system 800 may be utilized for any of the treatment locations and / or any of the approaches detailed above. Further, any of the devices, systems and methods detailed below may be configured for use with robotic surgical system 800. Aspects and features of robotic surgical system 800 not germane to the understanding of the present disclosure are omitted to avoid obscuring the aspects and features of the present disclosure in unnecessary detail. For the purposes herein, robotic surgical system 800 is generally described.

[0047] Robotic surgical system 800 generally includes a plurality of robot arms 802, 803; a control device 804; and an operating console 805 coupled with control device 804. Operatingconsole 805 may include a display device 806, which may be set up in particular to display three- dimensional images; and manual input devices 807, 808 to enable a surgeon to telemanipulate robot arms 802, 803. Robotic surgical system 800 may be configured for use on a patient 813 lying on a patient table 812 to be treated in a minimally invasive manner. Robotic surgical system 800 may further include a database 814, in particular coupled to control device 804, in which are stored, for example, pre-operative data from patient 813 and / or anatomical atlases.

[0048] Each of the robot arms 802, 803 may include a plurality of members, which are connected through joints, and a mounted device which may be, for example, a surgical tool “ST.” One or more of the surgical tools “ST” may be, for example, any of the surgical devices and systems detailed herein, thus providing the functionality thereof on a robotic platform.

[0049] Robot arms 802, 803 may be driven by electric drives, e.g., motors, connected to control device 804. Control device 804, e.g., a computer, may be configured to activate the motors, in particular by means of a computer program, in such a way that robot arms 802, 803, and, thus, their mounted surgical tools “ST” execute a desired movement and / or function according to a corresponding input from manual input devices 807, 808, respectively. Control device 804 may also be configured in such a way that it regulates the movement of robot arms 802, 803 and / or of the motors.

[0050] Turning to FIG. 9, a chemical ablation system 900 provided in accordance with the present disclosure is shown including a chemical source 910 and a needle 920. Chemical source 910 contains an ablative chemical 930, e.g., dehydrated ethyl alcohol, configured to selectively ablate nerve fibers (thereby denervating and / or stimulating the ovarian nerves) without permanently damaging surrounding tissue. Needle 920 may be disposed at the distal end of a catheter, syringe, or other suitable device (not shown) for positioning needle 920 at the treatment location and enabling the application, e.g., injection, of the ablative chemical 930 to the treatment location. In aspects, chemical source 910 may include a pump (not shown) coupled thereto and configured to control the flow rate and / or volume of ablative chemical 930 delivered to the treatment location.

[0051] With reference to FIG. 10, a temperature therapy system 1000 provided in accordance with the present disclosure is shown. Temperature therapy system 1000 includes a generator 1010 and an instrument 1020 including a body 1030 supporting an end effector 1040 at a distal end portion thereof. Body 1030 may be rigid, flexible, steerable, malleable, or otherwiseconfigured to enable (alone or in conjunction with use of an access and / or guide device) positioning of end effector 1040 at the treatment location. End effector 1040 includes a temperature treatment element 1042 powered by generator 1010 and configured to alter a temperature of tissue adjacent end effector 1040. For example, temperature treatment element 1042 may be a heater (e.g., a resistive heater, an inductive heater, a friction heater (i.e., vibration generating element), joule heater, or any other suitable heater) configured to heat tissue at the treatment location sufficiently so as to selectively ablate nerve fibers (thereby denervating and / or stimulating the ovarian nerves) but at a sufficiently low temperature so as to avoid permanent damage to surrounding tissue. Generator 1010 controls the supply of electrical or other energy to temperature treatment element 1042 to thereby control the heating of temperature treatment element 1042. In aspects, the heater may be configured to heat the treatment location to from about 30 degrees C to about 80 degrees C; in other aspects, from about 40 degrees C to about 60 degrees C; and in still other aspects, from about 45 degrees C to about 55 degrees C.

[0052] As an alternative or in addition to temperature treatment element 1042 generating heat that is provided to the treatment location, temperature treatment element 1042 may be configured to deliver (e.g., inject, spray, coat, etc.) a heated fluid to the treatment location to heat tissue at the treatment location sufficiently so as to selectively ablate nerve fibers (thereby denervating and / or stimulating the ovarian nerves) but at a sufficiently low temperature so as to avoid permanent damage to surrounding tissue.

[0053] In aspects, temperature treatment element 1042 may be a cooling element (e.g., a thermoelectric cooler or other suitable cooling element) configured to cool the treatment location and / or may be configured to deliver (e.g., inject, spray, coat, etc.) a cooled fluid to the treatment location to cool tissue at the treatment location sufficiently so as to selectively ablate nerve fibers (thereby denervating and / or stimulating the ovarian nerves) but at a sufficiently high temperature so as to avoid permanent damage to surrounding tissue. Similarly as above, generator 1010 may control the supply of electrical or other energy (or the delivered cooled fluid) to temperature treatment element 1042 to thereby control the cooling of temperature treatment element 1042. In aspects, the cooler may be configured to cool the treatment location to from about 0 degrees C to about negative 50 degrees C; in other aspects, from about negative 10 degrees C to about negative 40 degrees C; and in still other aspects, from about negative 20 degrees C to about negative 30 degrees C.

[0054] In still other aspects, temperature treatment element 1042 may be a cryogenic element configured to cool to cryogenic temperatures and / or deliver cryogenically cooled fluid to the treatment location to selectively ablate nerve fibers (thereby denervating and / or stimulating the ovarian nerves). In such aspects, generator 1010 is configured as a cryogenic generator.

[0055] Referring also to FIGS. 11 A- 1 ID, in aspects, the end effector 1140a-l 140d (including the temperature treatment element) disposed at the distal end of the body 1130 may define any suitable configuration depending upon, for example, the approach utilized, the temperature feature (e.g., heating, cooling, or cryogenic), and / or anatomical considerations of the treatment location. For example, as shown in FIG. 11 A, end effector 1140a may define an asymmetric configuration oriented substantially transverse to the longitudinal extent of body 1130, e.g., to enable treating a tissue surface extending along body 1130. As another example, as shown in FIGS. 11B and 11C, end effector 1140b, 1140c may be symmetric about the longitudinal extent of body 1130 and may define any suitable configuration, e.g., spherical, cuboid, etc., to facilitate treating tissue distally and / or along body 1130 (including, for example, treating tissue from within a lumen). FIG. 11D illustrates another end effector 1140d including one or more deployable elements (sharing a common temperature treatment element or each including a temperature treatment element) configured to facilitate low profile access to the treatment location and then enable treating of a relatively larger area of tissue and / or deploying into tissue at the treatment location. The deployable elements may be utilized to better access the tissue to be treated and / or to penetrate the tissue to be treated.

[0056] Turning to FIG. 12, a bipolar treatment system 1200 provided in accordance with the present disclosure is shown. Bipolar treatment system 1200 includes a generator 1210 and an instrument 1220 including a body 1230 supporting first and second electrodes 1242, 1244 at the distal end thereof. First and second electrodes 1242, 1244 are spaced-apart and electrically isolated from one another. Body 1230 may be rigid, flexible, steerable, malleable, or otherwise configured to enable (alone or in conjunction with use of an access and / or guide device) positioning of first and second electrodes 1242, 1244 at the treatment location and to facilitate movement of first and second electrodes 1242, 1244 along a tissue surface at the treatment location. First and second electrodes 1242, 1244 may define pin-shaped configurations or any other suitable configurations to facilitate brushing or sliding along the surface of tissue at the treatment location. Generator 1210 is configured to supply bipolar radio frequency (RF) energyto first and second electrodes 1242, 1244 at different potentials such that RF energy is conducted through tissue disposed between first and second electrodes 1242, 1244 to treat the tissue. In aspects, body 1230 or another device may be configured to deliver fluid (e.g., saline) to the first and second electrodes 1242, 1244 and / or the surface of tissue to facilitate tissue treatment. With first and second electrodes 1242, 1244 moving along the same tissue surface, energy penetration depth is reduced such that nerves can be treated without permanent damage to underlying or other tissues.

[0057] As shown in FIG. 13, in aspects, a bipolar treatment system 1300 similar to bipolar treatment system 1200 (FIG. 12) is provided except that three electrodes 1342, 1344, 1346 are provided. In such aspects, two of the electrodes 1342, 1344 may be configured as ground electrodes energizable to the same potential while the third electrode 1346 is configured as a hot electrode energizable to a different potential to provide “ground-hot-ground" shielding for the bipolar RF energy circuit. Additional electrodes or other electrode configurations are also contemplated. For example, two or more electrodes may be arranged coaxially with a center electrode (as one of the electrodes) surrounded by insulation which, in turn, is surrounded by an outer electrode (as another one of the electrodes). Another outer-most insulation layer may also be provided. In aspects where the center electrode is positive and the outer electrode is negative in a bipolar configuration, the bipolar energy is substantially constrained within the outer electrode.

[0058] With reference to FIGS. 14A and 14B, another bipolar treatment system 1400 provided in accordance with the present disclosure is shown. Bipolar treatment system 1400 includes a generator (not shown) and an instrument 1420 including a body 1430 and first and second deployable electrodes 1432, 1434 electrically isolated from one another. Body 1430 may be rigid, flexible, steerable, malleable, or otherwise configured to enable (alone or in conjunction with use of an access and / or guide device) positioning of a distal end thereof at the treatment location. More specifically, body 1430 may be positioned substantially perpendicular to the treatment location (as shown) or may be positioned substantially along the treatment location. In either configuration, with first and second deployable electrodes 1432, 1434 in the retracted position at least partially retracted into body 1430, a low profile configuration is established to facilitate positioning body 1430 at the treatment location. Upon deployment of first and second deployable electrodes 1432, 1434, first and second deployable electrodes 1432, 1434 eachassume a corkscrew shape to at least partially wrap about tissue at the treatment location (e.g., at least partially around the ovarian pedicle or IP ligament). First and second deployable electrodes 1432, 1434 may be formed from shape memory material to achieve the corkscrew shape upon deployment, or in any other suitable manner. First and second electrodes 1432, 1434 are electrically isolated from one another and may at least partially wrap about tissue at the treatment location in opposite directions or in similar directions and / or in spaced apart relation or in overlapping relation. The generator is configured to supply bipolar RF energy to first and second electrodes 1432, 1434 at different potentials such that RF energy is conducted through the tissue about which first and second electrodes 1432, 1434 are wound to treat the tissue. At least in aspects where first and second electrodes 1432, 1434 are deployed along the tissue longitudinally, energy may be conducted longitudinally along the tissue, e.g., substantially parallel to a longitudinal axis defined through the tissue, while inhibiting or reducing energy conduction transversely through tissue, thereby providing relatively shallow energy penetration depths to focus the conduction of energy on nerve tissue and minimize the conduction of energy to blood vessels (thus inhibiting permanent damage thereto).

[0059] In aspects, a single deployable element similar to either of first and second electrodes 1432, 1434 may be provided. In such aspects, the single deployable element may include electrically isolated first and second electrodes thereon for bipolar RF tissue treatment, or may be utilized with a separate return electrode in a monopolar configuration. More than two electrodes such as, for example, four electrodes, eight electrodes, etc., in either monopolar or bipolar configurations are also contemplated.

[0060] FIGS. 15A and 15B illustrate a bipolar end effector 1500 in accordance with the present disclosure including first and second jaw members 1510, 1520 pivotably coupled to one another for movement between an open position (FIG. 15 A) and a closed position (FIG. 15B). Each jaw member 1510, 1520 includes a cavity 1512, 1522 configured to receive tissue therebetween to atraumatically surround and contact tissue disposed between jaw members 1510, 1520 (with tissue extending transversely across the jaw members 1510, 1520). Cavities 1512, 1522, as shown, define substantially hemicylindrical configurations; however, other configurations are also contemplated such as, for example, wherein cavities 1512, 1522 define hemi-oval-shaped configurations or hemi -polygonal configurations. In aspects, cavities 1512, 1522 are configured to conform about tissue disposed therein. For example, cavities 1512, 1522may be at least partially defined by a resilient material or may include a movable mechanical structure such as a plurality of overlapping leaves defining a variable lumen and configured to collapse onto tissue disposed within the lumen maintain contact with tissue without impeding blood flow.

[0061] Each jaw member 1510, 1520 includes one or more electrodes 1530 (only the electrodes of jaw member 1520 are shown). In aspects, each jaw member 1510, 1520 includes a plurality of electrodes 1530. Electrodes 1530 are disposed within cavities 1512, 1522 with at least one first electrode 1530 of a first polarity and at least one second electrode 1530 electrically isolated and spaced-apart from the at least one first electrode 1530 and of a second polarity. Thus, a generator may supply bipolar radio frequency (RF) energy to first and second electrodes 1530 at different potentials such that RF energy is conducted through the tissue disposed between jaw members 1510, 1520 (and within cavities 1512, 1522) to treat the tissue. In aspects, the electrodes 1530 of first and second jaw members 1510, 1520 may be disposed in alternating, offset relation, although other configurations are also contemplated. Further, in aspects, the electrodes 1530 are arranged such that energy is conducted transversely across jaw members 1510, 1520 and, thus, longitudinally along the tissue disposed between jaw members 1510, 1520, e g., substantially parallel to the longitudinal axis defined by the cylinder formed from cavities 1512, 1522. This configuration, similarly as detailed above, limits the depth of energy penetration to thereby facilitate treating nerves while minimizing or inhibiting damage to toher tissues.

[0062] Referring to FIG. 16, an ultrasonic treatment system 1600 in accordance with the present disclosure is shown including an ultrasonic transducer and generator system 1610, an ultrasonic instrument 1620, a fluid source 1650, and a collection device 1660. Ultrasonic transducer and generator system 1610 is configured to generate ultrasonic vibration energy for transmission along a waveguide 1630 of ultrasonic instrument 1620 for heating tissue in contact with a distal end portion of waveguide 1630. Ultrasonic transducer and generator system 1610 is configured to control the ultrasonic energy (e.g., the amplitude and / or frequency of the ultrasonic waves) to target nerve tissue while inhibiting or minimizing effects on other tissues such as blood vessels. In aspects, waveguide 1630 includes first and / or second lumens 1632, 1640 to enable irrigation of the surgical site with fluid from fluid source 1650 and / or aspiration of fluid from the surgical site to collection device 1660. First lumen 1632 may be coaxially definedthrough waveguide 1630 while second lumen 1640 extends along an outer portion of waveguide 1630, although this configuration may be reversed or any other suitable configuration may be provided, e.g., wherein only irrigation is provided. Aspiration and irrigation may also be controlled to target nerve tissue with the ultrasonic energy. For example, aspiration and irrigation may be utilized to selectively control the temperature of tissue such that nerve tissue is targeted while other tissue(s) are maintained at lower temperatures and, thus, not damaged.

[0063] With reference to FIG. 17, another treatment device 1700 in accordance with the present disclosure is shown including a body 1710 and a distal foot 1720 coupled to body 1710. Distal foot 1720 may be fixed relative to body 1710 or may be configured to pivot, articulate, and / or rotate relative to body 1710. Distal foot 1720 includes an electrode array 1730 disposed on at least a portion of an exposed face thereof. Electrode array 1730 may be a flex circuit including an insulative substrate and having printed thereon traces to form one or more first electrodes and one or more second electrodes electrically isolated from one another and configured to be energized to different potentials with bipolar RF energy. In this manner, with distal foot 1720 in contact with tissue at the treatment location, e.g., sliding along tissue at the treatment location, energy is conducted to the tissue to treat the tissue. The electrodes are interleaved with one another and disposed in close proximity to one another. This configuration limits the depth of energy penetration such that treatment can be focused on nerve tissue rather than underlying vessels or other tissues. A generator supplying the energy to electrode array 1730 may control the energy to maintain relatively low temperatures to facilitate nerve treatment without impacting other tissues.

[0064] FIGS. 18A-18C illustrate mechanical treatment devices 1800a, 1800b, 1800c, respectively, provided in accordance with the present disclosure. Mechanical treatment devices 1800a, 1800b, 1800c are configured to clamp, constrict, crush, and / or otherwise mechanically modify tissue at the treatment location under suitable force to damage nerve tissue to at least partially inhibit functionality thereof while inhibiting permanent damage to other tissues. In aspects, the mechanical treatment device 1800a may be a fastener such as a clip or a staple. In aspects, the mechanical treatment device 1800b may be a loop such as a suture, a flat band, or a zip-tie like structure. In aspects, the mechanical treatment device 1800c may be a pair of jaws configured to clamp tissue therebetween.

[0065] Turning to FIG. 19, a monopolar treatment device 1900 for use in treating PCOS in accordance with the present disclosure is shown, although bipolar configurations are also contemplated. Monopolar treatment device 1900 includes an electrode 1910 configured to contact tissue. Electrode 1910 is configured for and connected to a generator (not shown) that supplies suitable monopolar energy for establishing arcing at the electrode / tissue interface. The arcing disrupts the electrical connections through the nerves, thereby achieving denervation and / or stimulation without permanently damaging other tissues.

[0066] Referring to FIG. 20, another mechanical treatment device 2000 for use in treating PCOS in accordance with the present disclosure is shown. Mechanical treatment device 2000 includes a body 2010 supporting an inflatable member 2020, e.g., a balloon, towards a distal end portion thereof. Body 2010 is configured for endoluminal insertion to the treatment location, e.g., within a vessel “V.” Once body 2010 is positioned such that inflatable member 2020 is disposed at the treatment location, inflatable member 2020 is inflated to provide radial outward pressure on the vessel “V,” thereby stressing the nerves “N” surrounding the vessel “V” and impacting the functionality thereof (e.g., providing denervation and / or stimulation) without permanently damaging the vessel “V” or other tissue.

[0067] FIG. 21 illustrates another mechanical treatment device 2100 in the form of shears for cutting nerve tissue “N” (after the nerve tissue “N” is exposed and / or separated from other tissues) at the treatment location, thereby providing denervation and / or stimulation.

[0068] With reference to FIGS. 22A and 22B, another bipolar treatment device 2200 is shown including a ribbon 2210 having an electrode array 2220 disposed on a face thereof. The ribbon 2210 and electrode array 2220 may define a flex circuit wherein the ribbon 2210 is an insulative substrate and wherein the electrode array 2220 is printed traces on the ribbon 2210 to form a pattern of first and second electrodes thereon. The electrodes of the electrode array 2220 may be interleaved and in close approximation, similarly as detailed above, to facilitate shallow depth tissue treatment. Bipolar treatment device 2200 may be placed on or wrapped at least partially around tissue “T” at the treatment location with the electrode array 2220 facing inwardly to contact the tissue “T.” Once this position is achieved, a generator may supply energy to the electrode array 2220 and control the energy to maintain relatively low temperatures and relatively shallow depth of energy penetration to facilitate nerve treatment without adversely impacting other tissues.

[0069] Referring to FIG. 23, a microwave treatment device 2300 for use in treating PCOS in accordance with the present disclosure is shown. Microwave treatment device 2300 includes an antenna 2310 configured for endoluminal navigation to the treatment location and having a distal treating region 2320 configured to output microwave ablation energy to tissue at the treatment location. Microwave treatment device 2300, in aspects, includes a cooling jacket to preserve the luminal vessel (a blood vessel or the fallopian tube, for example) while delivering targeted microwave ablation energy to the nerves. The ablation pattern and amount of ablation energy may be controlled by a generator to facilitate treating the nerves without permanently damaging other tissue. Further, although shown in an endoluminal, microwave treatment device 2300 may be utilized in other approaches as well, such as any of those detailed above.

[0070] Turning to FIGS. 24 and 25, stimulation devices 2400, 2500 for use in treating PCOS in accordance with the present disclosure are shown. Stimulation device 2400 is disposed on tissue of a patient (e.g., the patient’s skin or an internal tissue structure such as the IP ligament, ovarian pedicle, or other tissue structure) while stimulation device 2500 is disposed within (e.g., inserted or implanted) into tissue of a patient. Stimulation device 2400 may be configured as a patch to provide stimulation over an extended period of time, or may be placed in contact with tissue when stimulation is provided and removed when stimulation is not being provided. Stimulation device 2400 may be utilized for transcutaneous electrode nerve stimulation (TENS) of the treatment location without requiring an invasive approach. Stimulation device 2500 may be implanted to provide stimulation over an extended period of time or may be inserted for each stimulation and removed after each stimulation is complete.

[0071] In aspects, stimulation from stimulation devices 2400, 2500 may include an electrode set (e.g., eight-lead electrode, quadripolar electrode, directional multipolar electrode), configured to provide electrical stimulation sufficient to interrupt nerve signaling at the treatment location but without ablating the nerves or other tissues. Feedback may be utilized to selectively initiate and / or control stimulation as needed or based on a treatment plan.

[0072] In aspects, stimulation from stimulation devices 2400, 2500 may include a magnetic field generator configured to generate a magnetic field around nerves to interrupt nerve signaling at the treatment location but without damaging the nerves or other tissues. Feedback may be utilized to selectively initiate and / or control stimulation as needed or based on a treatment plan.

[0073] In aspects, stimulation from stimulation devices 2400, 2500 may include a passive current inhibitor such as, for example, a ferrite, positioned to inhibit current transmission along the nerves, thereby interrupting nerve signaling at the treatment location without damaging the nerves or other tissues. Active current disrupters that induce currents / voltages on the nerve are also contemplated to interrupt nerve signaling at the treatment location (based on feedback control or a determined treatment plan) without damaging the nerves or other tissues.

[0074] With reference to FIG. 26, a drug eluting stent 2600 in accordance with the present disclosure is shown positioned in a lumen, e.g., an ovarian blood vessel, a fallopian tube, etc. However, as detailed below, drug eluting stent 2600 may alternatively be positioned around tissue such as the IP ligament or on the exterior of a vessel. Drug eluting stent 2600 is configured to provide controlled release of a suitable drug that inhibits or reduces nerve signaling at the treatment location without damaging the nerves or other tissues. When positioned within a blood vessel, drug eluting stent 2600 preserves blood flow while disrupting nerve activity. In other vessels, drug eluting stent 2600 maintains the patency of the vessel. The particular release pattern, timing, and dosage of elution of the drug from stent 2600 may be selected to achieve a sustained stimulation according to a treatment plan. Drug eluting stent 2600 may be bioresorbable, may be configured for permanent implantation, or may be removed once treatment is complete. As an alternative to a stent for insertion into a lumen, a stent like structure may be disposed about tissue, e.g., the IP ligament, the ovarian pedicle, the fallopian tube, an ovarian blood vessel, etc. to similarly provide sustained drug release from the exterior. In such aspects, the stent-like structure may maintain patency and / or blood flow from the exterior. Mechanical treatment similar to that from mechanical treatment devices 1800a, 1800b, 1800c (FIGS. 18A-18C) may also be provided from the stent-like structure as an addition or an alternative to drug elution.

[0075] Any or all of the above-detailed devices, systems, and / or methods for use in treating PCOS in accordance with the present disclosure may additionally be utilized with nerve monitoring, either incorporated into the devices or systems themselves or via separate devices or systems. Nerve monitoring may be utilized to determine a baseline prior to treatment and assess, once treatment has begun or has been at least tentatively completed, the resultant nerve function. Thus, feedback is provided as to whether the nerves have been successfully treated or whether further treatment and / or modification of treatment is required to achieve the desired result. Thenerve monitoring may be provided upstream of the treatment location and may utilize a sensor downstream or at the treatment location to determine whether nerve function is intact (and to what degree). Alternatively or additionally, nerve monitoring may be provided downstream of the treatment location and may utilize a stimulator upstream or at the treatment location to determine whether nerve function is intact (and to what degree).

[0076] Further still, rather than or in addition to nerve monitoring, other sensors may be utilized to detect nerve function and, thus, to indicate the extent to which treatment has been successful. For example, an androgen sensor may be provided to detect hyperandrogenism or changes in androgen levels, thus indicating nerve activity. The androgen sensor may be configured to determine androgen levels from subcutaneous fluid, blood, tissue at the treatment location (or a sensing location which may be any of the treatment locations noted above), ovarian tissue, etc. The sensor may be configured similar to stimulation device 2400 (FIG. 24), stimulation device 2500 (FIG. 25), or in any other suitable manner.

[0077] Turning to FIGS. 27A-29C, any or all of the above-detailed devices, systems, and / or methods for use in treating PCOS in accordance with the present disclosure may additionally be utilized with detection systems, either incorporated into the devices or systems themselves or separate therefrom. FIG. 27A illustrates a detection system 2700 incorporated into a jaw-based device 2710, e.g., any of the jaw-based devices detailed above or as a separate jaw based-device. Detection system 2700 utilizes electrical impedance tomography (EIT) to detect underlying structures (e.g., vessels, nerves, ligaments) within tissue disposed between the jaws of device 2710, thus alerting the user to the location of such hidden structures within tissue to enable accurate treatment of tissue at the treatment location and avoiding treatment of sensitive structures. An example impedance map 2720 generated by detection system 2700 is shown in FIG. 27B. In aspects, detection system 2700 first utilizes EIT to confirm that nerves are disposed between the jaws (or otherwise in contact with the device) and / or that other tissue structures are not between the jaws (or otherwise in contact with the device) and, where the appropriate tissue is determined to be between the jaws, to subsequently apply treatment energy to treat the tissue. That is, a detection energy may first be provided, followed by a treatment energy. The energies may be different modalities, power levels, etc.

[0078] FIG. 28 illustrates a photoacoustic imaging system 2800 in accordance with the present disclosure including an ultrasound probe 2810, an ultrasound system 2820, an opticalprobe 2830, and an optical system 2840. Ultrasound system 2820 and optical system 2840 are in communication to enable photoacoustic imaging. More specifically, photoacoustic imaging system 2800 enables imaging of underlying tissue structures (vessels, nerves, ligaments) within tissue, thus alerting the user to the location of such hidden structures within tissue to enable accurate treatment of tissue at the treatment location while avoiding treatment of sensitive structures.

[0079] Referring to FIGS. 29A-29C, a detection and treatment device 2900 in accordance with the present disclosure is shown including a body 2910 and an end effector 2920 supported at a distal end of the body 2910. Body 2910 may be rigid, flexible, steerable, malleable, or otherwise configured to enable (alone or in conjunction with use of an access and / or guide device) positioning of end effector 2920 at the treatment location. End effector 2920 includes a common bottom jaw 2930 and a pair of upper jaws 2940, 2950, although it is also contemplated that two bottom jaws 2930 also be provided. Upper jaws 2940, 2950 are disposed in side-by-side relation relative to one another, although other configurations are also contemplated. Upper jaws 2940, 2950 are independently movable relative to common bottom jaw 2930 between an open position and a closed position for holding tissue therebetween. First upper jaw 2940 incorporates an ultrasound sensor assembly 2960 to enable ultrasound imaging of tissue held between first upper jaw 2940 and common bottom jaw 2930 in the closed position of first upper jaw 2940 (see FIG. 29B). Thus, a user can confirm, via the ultrasound image produced from ultrasound sensor assembly 2960, that nerves are disposed between the jaws (or otherwise in contact with the device) and / or that other sensitive tissue structures are not between the jaws (or otherwise in contact with the device).

[0080] Second upper jaw 2950 includes one or more electrodes and / or common bottom jaw 2930 includes one or more electrodes such that, with second upper jaw 2950 disposed in the closed position (see FIG. 29C) holding tissue between second upper jaw 2950 and common bottom jaw 2930, bipolar RF tissue treatment can be accomplished by energizing (with RF energy from a generator) at least two of the electrodes to different potentials. Accordingly, first upper jaw 2940 may first be closed to enable determination of whether the appropriate tissue is between the jaws and, if the appropriate tissue is between the jaws, second upper jaw 2950 may then be closed and energy applied to the appropriate tissue to treat the tissue.

[0081] Aspects of this disclosure may be further described by reference to the following numbered paragraphs:

[0082] 1. A device (1020, 1220, 1420, 1500, 1620, 1700, 1800a, 1800b, 1800c, 2000, 2100,2200, 2300, 2900) for treating Polycystic Ovary Syndrome (PCOS), comprising: an elongate body (1030, 1130, 1230, 1430, 1630, 2010, 2310, 2910) configured for insertion from an exterior of a patient to a treatment location at an infundibulopelvic (IP) ligament, ovarian pedicle, or ovarian hilum of the patient via percutaneous, transluminal, transvaginal, or transcervical access; and an end effector (1040, 1140a, 1140b, 1140c, 1140d, 1720, 2220, 2330, 2920) disposed at a distal end portion of the elongate body and configured to treat tissue at the treatment location to interrupt nerve signaling at the treatment location without permanently damaging surrounding tissue.

[0083] 2 The device according to paragraph 1, wherein the end effector is configured to heat the tissue at the treatment location to from about 45 degrees C to about 55 degrees C.

[0084] 3. The device according to paragraph 1, wherein the end effector is configured to cool the tissue at the treatment location to from about negative 20 degrees C to about negative 30 degrees C.

[0085] 4 The device according to paragraph 1 or 2, wherein the end effector includes at least one temperature treatment element (1042) configured for at least one of: resistive heating, inductive heating, friction heating, or joule heating.

[0086] 5 The device according to paragraph 1 or 2, wherein the end effector is configured to deliver a heated fluid to the treatment location to heat the tissue at the treatment location.

[0087] 6. The device according to paragraph 1 or 2, wherein the end effector includes first and second electrodes (1242, 1244) configured to conduct energy therebetween and through the tissue at the treatment location to heat the tissue at the treatment location.

[0088] 7 The device according to paragraph 1 or 3, wherein the temperature treatment element includes a thermoelectric cooler.

[0089] 8. The device according to any preceding paragraph, wherein the end effector includes at least one movable component (1432, 1510, 1520) movable to at least partially surround the tissue at the treatment location.

[0090] 9 The device according to paragraph 8, wherein the at least one movable component includes at least one deploy able component (1432) configured to deploy to at least partially surround the tissue at the treatment location.

[0091] 10. The device according to paragraph 8, wherein the at least one movable component includes at least one pivotable jaw member (1510, 1520) pivotable to grasp and at least partially surround the tissue at the treatment location.

[0092] 11. The device according to paragraph 9 or 10, wherein the end effector is configured to atraumatically at least partially surround the tissue at the treatment location.

[0093] 12. The device according to paragraph 10, wherein the end effector is configured to mechanically modify tissue at the treatment location.

[0094] 13. The device according to any preceding paragraph, wherein at least a portion of the elongate body is flexible.

[0095] 14. A system for treating PCOS, comprising: the device according to any preceding claim; and a generator (910, 1010, 1210, 1610, 2840) coupled to the end effector.

[0096] 15. The system according to paragraph 14, wherein the generator is configured to supply energy to the end effector to treat the tissue at the treatment location.

[0097] 16. An implantable device for treating Polycystic Ovary Syndrome (PCOS), comprising: a body configured for implantation at a treatment location in a patient, wherein the treatment location is at one of an infundibulopelvic (IP) ligament, ovarian pedicle, or ovarian hilum of the patient, wherein the body is configured to interrupt nerve signaling at the treatment location without permanently damaging surrounding tissue.

[0098] 17. The implantable device according to paragraph 16, wherein the body is configured to provide electrical stimulation energy to the tissue at the treatment location.

[0099] 18. The implantable device according to paragraph 16, wherein the body is configured to generate a magnetic field within the tissue at the treatment location.

[0100] 19. The implantable device according to paragraph 16, wherein the body includes a passive current inhibitor configured to inhibit current transmission through the tissue at the treatment location.

[0101] 20. The implantable device according to paragraph 16, wherein the body is drugeluting.

[0102] 21. The implantable device according to paragraph 20, wherein the body is a stent.

[0103] From the foregoing and with reference to the various drawings, those skilled in the art will appreciate that certain modifications can be made to the present disclosure without departing from the scope of the same. While several aspects and features of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular configurations.

Claims

WHAT IS CLAIMED IS:

1. A device (1020, 1220, 1420, 1500, 1620, 1700, 1800a, 1800b, 1800c, 2000, 2100, 2200, 2300, 2900) for treating Polycystic Ovary Syndrome (PCOS), comprising: an elongate body (1030, 1130, 1230, 1430, 1630, 2010, 2310, 2910) configured for insertion from an exterior of a patient to a treatment location at an infundibulopelvic (IP) ligament, ovarian pedicle, or ovarian hilum of the patient via percutaneous, transluminal, transvaginal, or transcervical access; and an end effector (1040, 1140a, 1140b, 1140c, 1140d, 1720, 2220, 2330, 2920) disposed at a distal end portion of the elongate body and configured to treat tissue at the treatment location to interrupt nerve signaling at the treatment location without permanently damaging surrounding tissue.

2. The device according to claim 1, wherein the end effector is configured to heat the tissue at the treatment location to from about 45 degrees C to about 55 degrees C.

3. The device according to claim 1, wherein the end effector is configured to cool the tissue at the treatment location to from about negative 20 degrees C to about negative 30 degrees C.

4. The device according to claim 1 or 2, wherein the end effector includes at least one temperature treatment element (1042) configured for at least one of: resistive heating, inductive heating, friction heating, or joule heating.

5. The device according to claim 1 or 2, wherein the end effector is configured to deliver a heated fluid to the treatment location to heat the tissue at the treatment location.

6. The device according to claim 1 or 2, wherein the end effector includes first and second electrodes (1242, 1244) configured to conduct energy therebetween and through the tissue at the treatment location to heat the tissue at the treatment location.

7. The device according to claim 1 or 3, wherein the temperature treatment element includes a thermoelectric cooler.

8. The device according to any preceding claim, wherein the end effector includes at least one movable component (1432, 1510, 1520) movable to at least partially surround the tissue at the treatment location.

9. The device according to claim 8, wherein the at least one movable component includes at least one deployable component (1432) configured to deploy to at least partially surround the tissue at the treatment location.

10. The device according to claim 8, wherein the at least one movable component includes at least one pivotable jaw member (1510, 1520) pivotable to grasp and at least partially surround the tissue at the treatment location.

11. The device according to claim 9 or 10, wherein the end effector is configured to atraumatically at least partially surround the tissue at the treatment location.

12. The device according to claim 10, wherein the end effector is configured to mechanically modify tissue at the treatment location.

13. The device according to any preceding claim, wherein at least a portion of the elongate body is flexible.

14. A system for treating PCOS, comprising: the device according to any preceding claim; and a generator (910, 1010, 1210, 1610, 2840) coupled to the end effector.

15. The system according to claim 14, wherein the generator is configured to supply energy to the end effector to treat the tissue at the treatment location.

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