IP Library Granted Patent US 12,496,213
Granted Patent B2
US 12,496,213 · App. 17/445,778 · Granted Dec 16, 2025

Thermally activated pessary

Inventors: Mallika Anand (Brookline, MA); Ara Nazarian (Wellesley, MA)
Assignee: Beth Israel Deaconess Medical Center, Inc.
A61F6/08A61F2/0009A61F2/005A61F6/12A61F13/26A61F2210/0014A61F2210/0023A61F2210/0028A61F2210/0033A61F2230/0091
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Quick Facts
Patent No.
US 12,496,213
App. No.
17/445,778
Granted
Dec 16, 2025
Kind
B2
Abstract

A system, method, and apparatus to insert and remove a thermally activated vaginal pessary, by employing a nitinol core material that is integrated into the construction of the thermally activated vaginal pessary and configured to increase in radial size upon contact with body temperature by undergoing a configurational phase change in the underlying nitinol core material.

Claims (25)

1 . A thermally actuated vaginal pessary comprising:

an applicator device that comprises a cooling element and a clamp having a pair of arms;

an outer surface of the vaginal pessary comprised of a biocompatible material and configured in a hemi-cylindrical shape such that the pair of arms are configured to contact the vaginal pessary to cool and radially compress the vaginal pessary for placement within, or removal from, a vagina of a body wherein the outer surface of the vaginal pessary extends along a long axis to contact surfaces of the vaginal wall to treat prolapse of surrounding tissue; and

an inner core of the vaginal pessary having a plurality of aligned ribs comprised of a shape-memory alloy wherein the cooled vaginal pessary is configured to increase in radial size in response to a warmer body temperature.

2 . The vaginal pessary of claim 1 , wherein the hemi-cylindrical shape is configured to expand in response to the body temperature upon placement along the vaginal wall.

3 . The vaginal pessary of claim 1 , wherein the plurality of aligned ribs of the inner core of the vaginal pessary comprises a set of hemi-cylindrical nitinol ribs that radially expand at the body temperature to treat at least one of the prolapse and stress incontinence.

4 . The vaginal pessary of claim 1 , wherein the inner core of the vaginal pessary comprises a plurality of nitinol elements extending along the long axis.

5 . The vaginal pessary of claim 1 , wherein the cooling element of the applicator device comprises a thermoelectric cooler.

6 . The vaginal pessary of claim 1 , wherein the biocompatible material comprises silicone.

7 . The vaginal pessary of claim 1 , wherein the inner core of the vaginal pessary comprises a set of nitinol core elements.

8 . The vaginal pessary of claim 7 , wherein the set of nitinol core elements are treated at a temperature of 805° C. at a treatment duration of 5 minutes.

9 . The vaginal pessary of claim 7 , wherein the set of nitinol core elements are treated at a temperature of 550° C. at a treatment duration of 5 minutes.

10 . The vaginal pessary of claim 7 , wherein the set of nitinol core elements are treated at a temperature of 400° C. at a treatment duration of 5 minutes.

11 . The vaginal pessary of claim 7 , wherein the set of nitinol core elements are treated at a temperature of 805° C. at a treatment duration of 30 minutes.

12 . The vaginal pessary of claim 1 further comprising a notification element to communicate a threshold temperature to a user.

13 . The vaginal pessary of claim 1 further comprising a temperature sensor.

14 . The vaginal pessary of claim 1 wherein the pair of arms has a first arm and a second arm to contact the inner core within the outer surface.

15 . The vaginal pessary of claim 1 wherein the vaginal pessary has a first state and a second state and a transition temperature to change states.

16 . A thermally actuated vaginal pessary comprising:

a vaginal pessary having an outer surface of a biocompatible material with a hemi-cylindrical shape that is configured to radially compress for manual placement in, or removal from, a vagina of a body; and

wherein the vaginal pessary has an inner core supporting the biocompatible material, the inner core having the hemi-cylindrical shape with a plurality of aligned and spatially separated ribs that comprise a shape-memory alloy wherein the ribs are configured to contract in a radial direction at a cooling temperature and expand in a radial direction at a warmer body temperature to treat prolapse of surrounding tissue.

17 . The vaginal pessary of claim 16 , further comprising a cooling element that cools the shape-memory alloy to a temperature below a body temperature.

18 . The vaginal pessary of claim 17 , wherein the cooling element comprises a plurality of arms configured to grasp the outer surface and manually compress the vaginal pessary for placement in the body.

19 . The vaginal pessary of claim 16 , wherein the shape memory material further comprises a nitinol material having a threshold temperature for transition between a first state and a second state.

20 . The vaginal pessary of claim 16 , wherein the outer surface is configured to press upon opposing surfaces of the vaginal wall to treat at least one of the prolapse and stress incontinence.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 19, 2022
From: NAZARIAN, ARA; ANAND, MALLIKA
To: BETH ISRAEL DEACONESS MEDICAL CENTER, INC.
Reel/Frame 062147/0733 →
Continuity (2)
Provisional Application 63069490 · Aug 24, 2020
Related Publication 20220054303A1 · Feb 24, 2022
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