Methods and systems for the manipulation of ovarian tissues
Inventors
ZARINS, Denise Marie • BARMAN, Neil Chand • SCHWAB, Garrett Marc • Wu, Andrew
Assignees
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Publication Number
US-12048467-B2
Publication Date
2024-07-30
Expiration Date
Abstract
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.
Core Innovation
The disclosed invention relates to systems and methods for transvaginal manipulation of ovarian tissue for treating polycystic ovary syndrome and PCOS-associated infertility. The approach advances an ovarian tissue apparatus into a vaginal canal and delivers energy to affect a volume of tissue within an ovary to treat a symptom of polycystic ovary syndrome.
The apparatus includes a docking device, an anchoring member, and a therapeutic element disposed on the anchoring member. The docking device is advanced through a vaginal wall to penetrate an ovary, and the anchoring member is deployed from the docking device to dispose the therapeutic element into the ovary in a first orientation relative to an ultrasound probe coupled to the apparatus.
The docking device is unlocked and re-locked in a second position to deploy the therapeutic element in a second orientation relative to the ultrasound probe for further energy emission into the ovary. The disclosure emphasizes maintaining visualization and deployment in relation to an ultrasound probe, including deployment in a visualization plane and the ability to change therapeutic element orientation for additional treatment zones without repositioning the docking device.
The disclosure further describes therapeutic element energy modalities and supporting control and safety features, including radiofrequency energy delivery for affecting ovarian tissue volume and optional modalities such as cryotherapy/cooling, laser, and ultrasound modalities. It also describes echogenicity enhancement for ultrasound visualization and sensing/feedback control using impedance and/or temperature sensing to enable termination of energy delivery based on measured conditions, along with anchoring/engagement and strategies intended to reduce adhesions during treatment.
Claims Coverage
The provided independent claims are clm-00001 and clm-00026. Both claims cover the same core inventive workflow: inserting an ovarian tissue apparatus transvaginally, penetrating the ovary with a docking device, deploying a therapeutic element in a first orientation under ultrasound guidance, then unlocking and re-locking to deploy the therapeutic element in a second orientation for further energy emission.
Transvaginal advancement of ovarian tissue apparatus with docking and therapeutic element
Advancing an ovarian tissue apparatus into a vaginal canal, the ovarian tissue apparatus comprising a docking device, an anchoring member, and a therapeutic element disposed on the anchoring member.
Ultrasound-guided docking-device penetration of ovary
Advancing the docking device through a vaginal wall and penetrating an ovary with the docking device.
First-orientation deployment relative to ultrasound probe using alignment adapter
Deploying the anchoring member from the docking device to dispose the therapeutic element into the ovary in a first orientation relative to an ultrasound probe coupled to the ovarian tissue apparatus, the docking device locked in a first position by mating an alignment element at a proximal region of the docking device with a receiving alignment channel of an alignment adapter for deployment in the first orientation.
Energy delivery to affect ovarian tissue volume to treat PCOS symptom
Delivering energy to affect a volume of tissue within the ovary using the therapeutic element to treat a symptom of polycystic ovary syndrome.
Unlocking and re-locking to deploy in second orientation for further energy emission
Unlocking the docking device and re-locking the docking device in a second position such that the therapeutic element is deployable in a second orientation relative to the ultrasound probe for further energy emission into the ovary.
Overall, both independent claims are directed to ultrasound-guided, transvaginal ovarian tissue treatment for polycystic ovary syndrome using a docking device that deploys a therapeutic element in a first orientation and then, after unlocking and re-locking, redeploys the therapeutic element in a second orientation for further energy emission.
Stated Advantages
Maintains therapeutic element and anchoring components in an ultrasound visualization plane while allowing controlled unlocking and locking rotation and small translational adjustments.
Supports deployment orientation changes using first and second planar orientations for further energy emission into the ovary.
Provides safety and travel-limiting control for docking device deployment and maximum distal travel distance using a zero point and limiting mechanism.
Documented Applications
Treating polycystic ovary syndrome by delivering energy into an ovary to treat a symptom of polycystic ovary syndrome.
Using the system in both non-invasive and invasive treatment system configurations with different target tissues within the ovary, including follicles, stroma, thecal cells, mesovarium, and nerves.
Performing aspiration during or after treatment.
Delivering adhesion-reduction agent options for adhesion reduction.
Repeat procedures and re-treatment concepts.
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