Device and method to treat vaginal atrophy

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.

What is claimed is: 
     
         1 . A device for treating vaginal tissue atrophy in a female subject, comprising:
 an ultrasound transducer assembly;   a coupling pad comprising a deformable coupling structure adapted to contact external genital tissue around the subject's vagina and geometric features configured to mate the coupling pad with the ultrasound transducer assembly;   the ultrasound transducer assembly and coupling pad being adapted, when mated, to deliver ultrasound energy to the subject to increase blood flow to internal vaginal tissue to an increased level above a baseline level of blood flow to the internal vaginal tissue such that the increased level of blood flow to the internal vaginal tissue persists after energy application ceases.   
     
     
         2 . The device of  claim 1 , wherein the ultrasound transducer assembly is adapted to deliver ultrasound energy at a frequency of between about 0.5 MHz and 4 MHz. 
     
     
         3 . The device of  claim 1 , wherein the ultrasound transducer assembly is adapted to deliver ultrasound energy at an intensity of between about 0.25 W/cm 2  and 5 W/cm 2 . 
     
     
         4 . The device of  claim 1 , wherein the ultrasound transducer assembly is adapted to deliver ultrasound energy at a duty cycle in a range of about 20%-80%. 
     
     
         5 . The device of  claim 1 , further comprising a sensor adapted and configured to measure a physiologic parameter of tissue in or around the subject's vagina when the ultrasound transducer assembly is engaged with tissue in or around the subject's vagina, the device being further configured to use information from the sensor to control energy delivery from the ultrasound transducer assembly. 
     
     
         6 . The device of  claim 5 , wherein the physiologic parameter is temperature, blood flow, or vaginal lubrication. 
     
     
         7 . The device of  claim 1 , wherein the coupling pad comprises at least one of silicone rubber, soft plastics, fabrics, and flexible foams. 
     
     
         8 . The device of  claim 1 , wherein the coupling pad comprises a gel. 
     
     
         9 . The device of  claim 1 , wherein the ultrasound transducer assembly and the coupling pad are mated using at least one of adhesives, spring-loaded features, mechanical snap fits, and elastic materials that wrap around the back of the transducer. 
     
     
         10 . The device of  claim 1 , further comprising a feedback mechanism configured to provide feedback to the subject regarding quality and sufficiency of contact between the ultrasound transducer assembly and the coupling pad. 
     
     
         11 . The device of  claim 10 , wherein the feedback mechanisms comprises at least one of snap sounds and an alarm. 
     
     
         12 . The device of  claim 1 , further comprising a feedback mechanism configured to provide feedback to the subject regarding quality and sufficiency of contact between the coupling pad and the subject's tissue.