Granted Patent B2

US 12,502,542 · App. 17/049,881 · Granted Dec 23, 2025

Inventors: Marc D. Beer (Sudbury, MA); Jose Bohorquez (Boston, MA); Samantha J. Pulliam (Boston, MA); Jessica L. McKinney (Boston, MA)

Assignee: Axena Health, Inc.

A61N1/36135A61N1/36007A61N1/3606A61N1/37247A61B5/1104A61B5/202A61B5/6847A61B2562/0219A61B2562/028

Abstract

Claims (60)

1 . 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.

2 . The method of claim 1 , further comprising processing the positional data from the accelerometers to determine an occurrence of the movement of the one or more pelvic floor muscles.

3 . The method of claim 2 , further comprising employing the processed positional data to provide feedback to the medical device regarding the movement of the one or more pelvic floor muscles or wherein the medical device is activated to stimulate the sacral nerve based on feedback from the intravaginal device or the medical device.

4 . The method of claim 3 , wherein the feedback is determined from the positional data of the accelerometers of the intravaginal device.

5 . The method of claim 1 , wherein the accelerometers are microelectromechanical (MEM) accelerometers.

6 . The method of claim 1 , wherein the intravaginal device comprises:

i) a main body having an outer edge configured to contact a vaginal wall or vaginal fornix and an internal diameter sized to encircle a cervix or vaginal cuff; and

ii) a tether connected to the main body.

7 . The method of claim 6 , wherein the tether comprises 2 to 10 of the accelerometers or wherein the main body comprises 2 to 6 of the accelerometers.

8 . The method of claim 6 , wherein:

a) the main body has a horseshoe form or cup-shaped form;

b) the main body comprises at least one of the accelerometers;

c) one of the accelerometers is shared by the main body and the tether;

d) a length of the tether is about 3 cm to about 50 cm;

e) a circumference of the main body is about 10 cm to about 50 cm; or

f) the intravaginal device comprises two or more accelerometers on the tether and wherein the accelerometers are separated on the tether by a distance of about 0.5 cm to about 5 cm.

9 . The method of claim 8 , wherein:

i) the length of the tether is about 25.5 cm;

ii) the circumference of the main body is about 27 cm; or

iii) the distance between the accelerometers on the tether is about 1.6 cm.

10 . The method of claim 1 , wherein the intravaginal device comprises a transmitter or receiver for communicating data to an electronic device or to the medical device; or the implantable lead comprises one or more collapsible projections configured to anchor the lead to surrounding tissue.

11 . The method of claim 10 , wherein:

i) the transmitter or receiver is a radio frequency transmitter or receiver;

ii) the transmitter or receiver can wirelessly communicate the data to the electronic device or to the medical device;

iii) the transmitter or receiver are configured for use with a Bluetooth or Wi-Fi enabled electronic device;

iv) the electronic device comprises a display, wherein optionally, the display is on the graphical user interface, wherein, optionally, the graphical user interface comprises a touch user interface;

v) the electronic device is a computer, tablet, smartphone, or smart watch; or

vi) the collapsible projections are tines.

12 . The method of claim 1 , wherein:

i) the intravaginal device or the medical device comprises a battery;

ii) the medical device comprises a processor configured to receive input from a user; or

iii) the medical device comprises a transmitter or receiver for communicating data to the electronic device or to the intravaginal device.

13 . The method of claim 12 , wherein:

a) the transmitter or receiver of the medical device is a radio frequency transmitter or receiver;

b) the transmitter or receiver of the medical device can wirelessly communicate the data to the electronic device or to the intravaginal device; or

c) the transmitter or receiver of the medical device are configured for use with a Bluetooth or Wi-Fi enabled electronic device.

14 . The method of claim 1 , wherein the medical device:

i) comprises one or more electrodes;

ii) comprises a pulse generator;

iii) comprises two or more implantable leads; or

iv) generates or modulates an electrical signal in response to an input signal from the intravaginal device.

15 . 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).

16 . The method of claim 15 , further comprising treating the subject for urinary or fecal incontinence by repeatedly administering electrical stimulation to the sacral nerve of the subject with the medical device.

17 . 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).

Assignments (3)

Continuity (2)

References Cited (332)