Systems and methods for applying energy to ovarian tissue
Inventors
GASPERMENT, Marion • Lenihan, Tim • Osdoit, Anne
Assignees
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Publication Number
US-11564736-B2
Publication Date
2023-01-31
Expiration Date
Abstract
Described herein are methods and systems for performing a procedure for ovarian rebalancing. 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 invention provides a minimally invasive system for an ovarian procedure using a transvaginal ultrasound probe and a therapeutic needle assembly configured for use with the ultrasound probe. The therapeutic needle assembly includes an elongated shaft with a lumen, a port, and a needle tip that can pierce a vaginal wall and pierce an ovarian wall for placement of the port into an ovary.
A therapeutic portion disposed within the lumen in a retracted state can be deployed into the port such that electrodes emit energy into ovarian tissue. The system includes a conductive needle that extends through the plurality of electrodes of the therapeutic portion and forms the distal tip of the therapeutic portion, and the conductive needle is configured to sense electrical activity.
The generator processes electrical signals indicative of impedance and causes at least one electrode in the deployed state to emit energy based on the processed electrical signals indicative of impedance. The therapeutic portion is transitioned between the retracted state and the deployed state using an actuator, and a lubricant tube disposed within the lumen adjacent to the port facilitates deployment and retraction without damaging the electrodes.
The elongated shaft includes an angled interface at the lumen distal end at the port to guide the therapeutic portion to exit the lumen out the port at an angle, to facilitate positioning for treatment with the ultrasound field of view. Sensors including temperature/impedance on the electrodes enable control with predetermined thresholds, alerts, and automatic energy termination, and the adapter couples the needle assembly to a vaginal ultrasound probe while supporting reorientation/rotation to maintain the therapeutic portion within the field of view.
Claims Coverage
One independent claim is identified, covering a system for performing an ovarian procedure with an ultrasound probe. The main inventive concept includes a deployable therapeutic needle assembly with an electrode-based energy emitter, conductive needle impedance sensing for generator-controlled energy delivery, and mechanical features to deploy and position the therapeutic portion at a treatment angle for ultrasound-directed ovarian tissue treatment.
Ultrasound probe-configured ovarian procedure system
A system for performing an ovarian procedure configured for use with an ultrasound probe, comprising a therapeutic needle assembly with a proximal region and a distal region and including coupling to support the procedure in an ultrasound field of view.
Deployable electrode-based therapeutic portion through a port
A therapeutic portion disposed within a lumen of an elongated shaft in a retracted state, wherein the therapeutic portion comprises a distal tip and a plurality of electrodes configured to be deployed to extend out the port of the elongated shaft in a deployed state, and at least one of the plurality of electrodes emits energy into ovarian tissue while in the deployed state.
Conductive needle impedance sensing and generator energy control
A conductive needle extending through the plurality of electrodes and forming the distal tip of the therapeutic portion, configured to sense electrical activity; and a generator operatively coupled to the therapeutic portion and the conductive needle to receive electrical signals indicative of impedance, process the impedance signals, and cause at least one electrode in the deployed state to emit energy into the ovarian tissue based on the processed impedance signals.
Actuator-driven retraction and deployment using a lubricant tube
A handle with an actuator configured to transition the therapeutic portion between the retracted state and the deployed state when actuated, and a lubricant tube disposed within the lumen adjacent to the port, wherein the therapeutic portion transitions from the retracted state by moving within the lumen, through the lubricant tube, and out the port to the deployed state responsive to actuation, and is retracted into the port and into the lumen using the lubricant tube without damaging the plurality of electrodes.
Angled interface for ultrasound-directed positioning
An angled interface at the lumen's distal end at the port to guide the therapeutic portion to exit the lumen of the elongated shaft out the port at an angle to facilitate positioning of the therapeutic portion for treatment.
The independent claim focuses on a deployable electrode-based therapeutic needle assembly for an ultrasound-directed ovarian procedure, with a conductive needle that senses electrical activity and impedance used by a generator to control energy emission from the deployed electrodes. Mechanical deployment/retraction support is provided via an actuator and a lubricant tube, and ultrasound-directed positioning is supported via an angled interface at the port.
Stated Advantages
The lubricant tube facilitates deployment and retraction without damaging the electrodes.
Temperature/impedance sensors enable control with predetermined thresholds, alerts, and automatic energy termination.
The angled interface facilitates positioning for treatment with the ultrasound field of view.
The adapter supports reorientation/rotation to maintain the therapeutic portion within the field of view.
Documented Applications
A minimally invasive ovarian procedure using a transvaginal ultrasound probe.
Treatment of ovarian tissue to ablate stroma and reduce FSH/LH hormonal imbalance.
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