Devices, systems, and methods for treating urinary and fecal incontinence
AssigneeAxena Health, Inc.
InventorsMarc D. Beer, Jose Bohorquez, Samantha J. Pulliam, Jessica L. McKinney
Life of this patent
Estimating the term…
Abstract
Featured are intravaginal devices and electrical stimulation devices, systems, thereof, and methods of using the devices and systems thereof to observe pelvic floor movements in order to diagnose, treat, or prevent urinary and fecal incontinence disorders (e.g., urge incontinence) and their accompanying symptoms or to diagnose and/or improve the efficacy of neuromodulation therapy.
Claims17
A method of treating urinary or fecal incontinence in a subject comprising:
- a) providing a system comprising an intravaginal device comprising a plurality of accelerometers located along a length of the device;
- and a medical device comprising an implantable lead configured to deliver electrical stimulation to a sacral nerve;
- b)
- i) inserting the intravaginal device into a vagina of the subject, and
- ii) placing the implantable lead on the sacral nerve of the subject and electrically stimulating the sacral nerve with the medical device;
- c) obtaining and visualizing on a graphical user interface positional data from the accelerometers of the intravaginal device during the electrical stimulation of the sacral nerve, wherein a position of the accelerometers on the graphical user interface is a representation of a position of the vagina during movement of one or more pelvic floor muscles of the subject resulting from the electrical stimulation of the sacral nerve;
- and
- d) repeating steps b) ii) and c) one or more times to optimize the placement of the implantable lead to increase efficacy of the electrical stimulation.
A method of detecting proper placement of an implantable lead of a medical device configured to deliver electrical stimulation to a sacral nerve of a subject comprising:
- a) providing a system comprising an intravaginal device comprising a plurality of accelerometers located along a length of the device;
- and the medical device comprising an implantable lead configured to deliver electrical stimulation to the sacral nerve;
- b) inserting the intravaginal device into a vagina of the subject and placing the implantable lead on the sacral nerve of the subject and electrically stimulating the sacral nerve with the medical device;
- c) obtaining and visualizing on a graphical user interface positional data from the accelerometers of the intravaginal device during the electrical stimulation of the sacral nerve, wherein a position of the accelerometers on the graphical user interface is a representation of a position of the vagina during movement of one or more pelvic floor muscles of the subject resulting from the electrical stimulation of the sacral nerve;
- d) processing the positional data from the accelerometers to determine an occurrence of a pelvic floor movement;
- and
- e) determining that the implantable lead of the medical device is properly placed in the sacral nerve of the subject based on the occurrence of the pelvic floor movement detected by the intravaginal device in step d).
A method of identifying a subject as responsive to treatment for urinary or fecal incontinence with a medical device configured to deliver electrical stimulation to a sacral nerve of the subject comprising:
- a) providing a system comprising an intravaginal device comprising a plurality of accelerometers located along a length of the device;
- and the medical device comprising an implantable lead configured to deliver electrical stimulation to the sacral nerve;
- b) inserting the intravaginal device into a vagina of the subject and placing the implantable lead on the sacral nerve of the subject and electrically stimulating the sacral nerve with the medical device;
- c) obtaining and visualizing on a graphical user interface positional data from the accelerometers of the intravaginal device during the electrical stimulation of the sacral nerve, wherein a position of the accelerometers on the graphical user interface is a representation of a position of the vagina during movement of one or more pelvic floor muscles of the subject resulting from the electrical stimulation of the sacral nerve;
- d) processing the positional data from the accelerometers to determine an occurrence of a pelvic floor movement;
- and
- e) determining the subject to be responsive to the treatment with the medical device based on the occurrence of the pelvic floor movement detected by the intravaginal device in step d).
Dependencies are inferred from the claim text.