METHODS AND SYSTEMS FOR THE MANIPULATION OF OVARIAN TISSUES
Described here are methods and systems for the manipulation of ovarian tissues. The methods and systems may be used in the treatment of polycystic ovary syndrome (PCOS). The systems and methods may also be useful in the treatment of infertility associated with PCOS.
1 . A system for use in combination with an ultrasound probe comprising a handle for performing an ovarian procedure, the system comprising:
a docking device comprising a proximal portion, a distal portion having an opening and a distal end comprising a needle tip configured to pierce a vaginal wall and an ovarian wall, and an elongated shaft extending between the proximal and distal portions and defining a lumen therethrough;
an anchoring member disposed for reciprocation within the lumen and having a distal region configured to extend through the opening into ovarian tissue, the distal region comprising a therapeutic element configured to emit energy into the ovarian tissue;
an alignment element at the proximal portion of the docking device, the alignment element configured to lock the docking device such that the therapeutic element is deployable in a first position relative to the ultrasound probe for energy emission into the ovarian tissue and to lock the docking device such that the therapeutic element is deployable in a second position relative to the ultrasound probe for further energy emission into the ovarian tissue; and
a generator configured to supply energy to the therapeutic element to cause the therapeutic element to emit energy into the ovarian tissue for the ovarian procedure.
2 . The system of claim 1 , wherein the opening at the distal portion of the docking device is disposed proximal to the needle tip.
3 . The system of claim 1 , wherein the distal end of the docking device comprises one or more attachment elements configured to releasably secure an ovary.
4 . The system of claim 3 , wherein the one or more attachment elements comprise a hook, needle, or barb.
5 . The system of claim 1 , wherein the distal region of the anchoring member is configured to transition to a curved shape when extended through the opening into ovarian tissue.
6 . The system of claim 5 , wherein the curved shaped comprises a radius of curvature ranging between about 3 and about 16 mm.
7 . The system of claim 1 , wherein the therapeutic element comprises pair of electrodes.
8 . The system of claim 7 , wherein the pair of electrodes comprises an active electrode and a return electrode.
9 . The system of claim 1 , wherein the therapeutic element comprises an electrode, a cryoablation element, a cooling element, a laser, or a combination thereof.
10 . The system of claim 1 , wherein the therapeutic element comprises a light-based therapeutic element.
11 . The system of claim 1 , wherein the therapeutic element remains in a visualization plane of the ultrasound probe upon deployment from the docking device during the ovarian procedure.
12 . The system of claim 1 , wherein a portion of the docking device, the anchoring member, or the therapeutic element comprises an echogenic material.
13 . The system of claim 1 , wherein the generator is configured to supply the energy to the therapeutic element to cause the therapeutic element to emit the energy into the ovarian tissue to ablate a volume of the ovarian tissue.
14 . The system of claim 13 , wherein the volume of ablated ovarian tissue ranges from about 30 mm 3 to about 3000 mm 3 .
15 . The system of claim 13 , wherein the volume of ablated ovarian tissue is less than about 20% of the ovary.
16 . The system of claim 1 , wherein the generator is configured to supply radiofrequency energy at a power of between about 1 watts and 40 watts, and for a duration of about 10 to about 120 seconds.
17 . The system of claim 1 , wherein the generator is configured to supply radiofrequency energy at a power of in a range of 5 to 30 watts, and for a duration of about 10 to about 60 seconds.
18 . The system of claim 1 , wherein the generator is configured to supply radiofrequency energy at a power of between about 1 watts and 40 watts, and for a duration of about 10 to about 120 seconds.
19 . The system of claim 1 , wherein the generator is configured to supply radiofrequency energy in a continuous or pulsed manner.
20 . The system of claim 1 , wherein the generator is configured to supply the energy to the therapeutic element to cause the therapeutic element to emit the energy into the ovarian tissue to treat infertility associated with polycystic ovary syndrome.
21 . The system of claim 1 , further comprising:
an adapter configured to be removably coupled to the ultrasound probe, the adapter comprising an alignment channel configured to mate with the alignment element,
wherein the alignment element is configured to mate with the alignment channel in a first configuration to lock the docking device such that the therapeutic element is deployable in the first position, and
wherein the alignment element is configured to mate with the alignment channel in a second configuration to lock the docking device such that the therapeutic element is deployable in the second position.
22 . The system of claim 21 , wherein the alignment element is configured to be moved distally or proximally between the first and second configurations.
23 . The system of claim 21 , wherein planar orientation of the anchoring member relative to the ultrasound probe is maintained when the alignment element mates with the alignment channel in the first and second configurations.
24 . The system of claim 21 , wherein, when the docking device is in an unlocked state, the docking device is freely rotatable relative to the ultrasound probe.