Device and method to treat vaginal atrophy
Inventors
Rockweiler, Holly Elizabeth • KRONE, Ryan Taylor • STEINBERGER, Jonathan Daniel • Olson, Kathryn
Assignees
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Publication Number
US-12453870-B2
Publication Date
2025-10-28
Expiration Date
Abstract
A method of treating vaginal tissue atrophy in a female subject, the method including the steps of engaging an energy delivery element with tissue in or around the subject's vagina; applying energy to the tissue from the energy delivery element; and increasing blood flow to internal vaginal tissue to an increased level above a baseline level of blood flow to the internal vaginal tissue, the increased level of blood flow to the internal vaginal tissue persisting after the applying step ceases. The invention also provides devices for performing this therapy.
Core Innovation
The invention treats vaginal tissue atrophy by engaging an external or near-vaginal energy delivery element with tissue in or around the vagina, including ultrasound energy. Energy is applied to the tissue so that internal vaginal blood flow increases above baseline blood flow, and the elevated blood flow persists after the ultrasound energy ceases.
The disclosure provides device embodiments for delivering ultrasound energy without penetrating the vagina. An externally applied coupling pad and ultrasound transducer face interface with and conform to tissue around the subject’s vagina to enable appropriate energy conduction, and coupling medium arrangements, coupling pad structure features, and a coupling pad/transducer assembly support effective acoustic coupling.
The coupling pad comprises a main structure and a coupling structure supported by the main structure, where the coupling structure is convex and shaped to conform to tissue around the subject’s vagina. The main structure and coupling structure maintain intimate contact and interface with an ultrasound transducer face, and feedback-based mechanisms alert the subject regarding coupling/contact and support orientation of the ultrasound transducer face based on feedback during use.
Physiologic measurements are described using vaginal plethysmography to assess increased vaginal tissue blood pulse amplitude following ultrasound energy application. The elevated blood pulse amplitude and increased blood flow persist after the energy is stopped, and additional measurement and closed-loop concepts are described using physiologic parameters to guide or control feedback-driven behavior.
Claims Coverage
Independent claim coverage centers on a coupling pad for an ultrasound therapy device and its feedback-enabled coupling/conformability features, totaling one independent claim in the provided set. The inventive features address conforming external coupling to tissue around a vagina, interfacing with an ultrasound transducer face, and using feedback to alert the subject and enable orientation based on coupling/contact.
Convex coupling structure conforming to vaginal tissue
A coupling pad has a convex coupling structure adapted and shaped to conform to tissue around a subject's vagina.
Intimate-contact main structure for energy conduction
The main structure is configured to engage a subject's body to maintain intimate contact between the coupling structure and tissue around the subject's vagina, and interface with and conform to an ultrasound transducer face to allow appropriate energy conduction.
Dual-opening main structure to receive coupling structure and transducer face
The main structure comprises a top portion with a first opening adapted to receive the coupling structure and a bottom portion with a second opening adapted to receive the ultrasound transducer face.
Feedback mechanism alerting coupling/contact
Conformability of the coupling pad to the tissue and conformability to the ultrasound transducer face allows appropriate energy conduction based on a feedback mechanism configured to alert the subject regarding contact between the coupling pad and the tissue around the subject's vagina.
Mechanical mating and orientation based on feedback
The coupling pad comprises a mechanical feature configured to mate with corresponding features on the ultrasound therapy device and acoustically couple with the ultrasound transducer face, wherein the ultrasound transducer face is configured to be oriented to the coupling pad and to anatomy of the subject based on feedback during use.
The provided independent claim set is directed to an externally applied ultrasound coupling pad having a convex, conformable coupling structure that maintains intimate contact with tissue around a vagina, interfaces with an ultrasound transducer face for energy conduction, and uses a feedback mechanism to alert the subject and enable orientation based on coupling/contact.
Stated Advantages
Increases internal vaginal blood flow above baseline blood flow.
Elevated internal vaginal blood flow persists after ultrasound energy ceases.
Enables appropriate energy conduction between the ultrasound transducer face, coupling pad, and tissue around the subject's vagina.
Provides a feedback mechanism configured to alert the subject regarding coupling/contact, supporting appropriate ultrasound transducer orientation.
Documented Applications
Treating vaginal tissue atrophy by engaging an external or near-vaginal ultrasound energy delivery element with tissue in or around the vagina to increase internal vaginal blood flow.
Measuring increased vaginal tissue blood pulse amplitude using vaginal plethysmography to assess effects of ultrasound energy, including persistence after energy ceases.
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