METHODS AND SYSTEMS FOR THE TREATMENT OF POLYCYSTIC OVARY SYNDROME
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 be useful in the treatment of infertility associated with PCOS.
1 . A system for performing an ovarian procedure, the system comprising:
a docking device having a proximal region comprising a deployment feature, a distal region configured to penetrate an ovary, an elongated body having a lumen, and an alignment element at the proximal region;
a therapeutic element slidably disposed within the lumen of the docking device and configured to be deployed from the lumen of the docking device within the ovary upon actuation of the deployment feature, the therapeutic element configured to emit energy to ablate ovarian tissue from within the ovary; and
an alignment adapter configured to be removably coupled to an ultrasound probe and to the alignment element of the docking device, the alignment adapter comprising a mechanical lock configured to transition between a locked position where the alignment element is fixed to the alignment adapter in a manner than maintains planar orientation of the docking device and therapeutic element relative to the ultrasound probe, and a partially-locked position where translation of the docking device relative to the alignment adapter is permitted.
2 . The system of claim 1 , wherein the mechanical lock is configured to fix the alignment element relative to the alignment adapter in the locked position such that the therapeutic element is deployable in a first orientation relative to the ultrasound probe.
3 . The system of claim 2 , wherein the mechanical lock is configured to transition from the locked position to the partially-unlocked position to permit translation of the docking device from a first axial position to a second axial position relative to the alignment adapter, the mechanical lock configured to fix the alignment element at the second axial position relative to the alignment adapter in the locked position such that the therapeutic element is deployable in a second orientation relative to the ultrasound probe.
4 . The system of claim 1 , wherein, when the mechanical lock is in the locked position, the docking device and therapeutic element are aligned within a visualization plane of the ultrasound transducer.
5 . The system of claim 1 , wherein, when the mechanical lock is in the partially-locked position, the docking device and therapeutic element are configured to be moved proximally or distally relative to the alignment adapter.
6 . The system of claim 1 , wherein, when the mechanical lock is in the partially-locked position, the docking device is not completely disengaged from the alignment adapter.
7 . The system of claim 1 , wherein, when the mechanical lock is in the partially-locked position, limited rotation of the docking device relative to the alignment adapter is permitted.
8 . The system of claim 1 , wherein the mechanical lock is configured to transition to an unlocked state to permit removal of the docking device from the alignment adapter.
9 . The system of claim 1 , wherein the alignment adapter comprises a notch configured to engage with the docking device to facilitate locking of the docking device to the alignment adapter.
10 . The system of claim 1 , wherein the docking device comprises a guide configured to aid alignment of the docking device as the mechanical lock is moved from the partially-locked position to the locked position.
11 . The system of claim 10 , wherein the alignment adapter comprises a cavity disposed between a main body of the alignment adapter and the guide.
12 . The system of claim 1 , wherein a proximal region of the docking device comprises a hub configured to facilitate translation of the docking device relative to the alignment adapter when the mechanical lock is in the partially-locked position.
13 . The system of claim 1 , wherein the therapeutic element comprises one or more electrodes configured to emit radiofrequency energy.
14 . The system of claim 1 , wherein the therapeutic element comprises an active electrode and a return electrode.
15 . The system of claim 1 , wherein the therapeutic element forms a curved configuration upon deployment from the lumen of the docking device within the ovary.
16 . The system of claim 1 , wherein the distal region of the docking device comprises a needle tip configured to penetrate a vaginal wall.
17 . The system of claim 1 , further comprising a generator configured to supply energy to the therapeutic element.
18 . The system of claim 17 , wherein the generator is configured to cause the therapeutic element to emit energy within the ovary to ablate 3% to 20% of the ovarian tissue to treat infertility associated with polycystic ovary syndrome.
19 . The system of claim 17 , further comprising:
a sensor configured to measure temperature at the therapeutic element during an ablation procedure,
wherein the generator is configured to execute a feedback control loop to dynamically modify a parameter of energy emission if the measured temperature received from the sensor exceeds a predetermined maximum temperature threshold.
20 . The system of claim 19 , wherein the feedback control loop is configured to terminate energy emission if the measured temperature exceeds the predetermined maximum temperature threshold.
21 . The system of claim 19 , wherein the parameter of energy emission comprises energy emission, power, voltage, current, intensity, frequency, pulse, pulse width, temperature, type of energy emission, flow rate, and/or pressure.
22 . The system of claim 1 , wherein the therapeutic element is configured to emit at least one of radiofrequency energy, direct heating, cryoablation, cooling, laser, microwave energy, unfocused ultrasound, partially-focused ultrasound, focused (HIFU) ultrasound, heated water/saline, steam, or chemical ablation energy.