Self-inflating anorectal expulsion device

Patent metadata

Field	Value
Publication number	US-12433540-B2
Application number	US-201917274942-A
Country	US
Kind code	B2
Filing date	Sep 9, 2019
Priority date	Sep 10, 2018
Publication date	Oct 7, 2025
Grant date	Oct 7, 2025

Abstract

An anorectal expulsion device includes a balloon having a wall that extends between proximal and distal ends of the balloon and defines a balloon interior. The balloon interior contains a self-expanding, low compression-set material (e.g., open cell foam). The device also includes a catheter that extends through the proximal end of the balloon and at least a portion of the balloon interior. An interior of the catheter is in fluid communication with the balloon interior. The device also includes a termination component (e.g., a cap or a valve) coupled to the catheter at a position along the catheter that is outside of and proximal to the proximal end of the balloon (e.g., at the proximal end of the catheter). The physical configuration of the termination component is adjustable, and controls whether the balloon interior is in fluid communication with the external environment.

First claim

We claim:

1. A diagnostic device comprising:
a balloon having (i) a proximal balloon end, (ii) a distal balloon end, and (iii) a balloon wall that extends between the proximal balloon end and the distal balloon end, wherein:
the balloon wall defines a balloon interior that contains a self-expanding, low compression-set material,
a diameter or width of the self-expanding, low compression-set material has a peak value when the self-expanding, low compression-set material is in a fully expanded state, and
when the self-expanding, low compression-set material is compressed from the fully expanded state to a state in which the diameter or width has a value between 50% and 75% of the peak value, the self-expanding, low compression-set material exerts an outward force of between 0.2 and 1.0 pounds per square inch (psi);

a catheter having a proximal catheter end and a distal catheter end, wherein the catheter extends through an opening in the proximal balloon end, a lumen of the catheter is in fluid communication with the balloon interior, the self-expanding, low compression-set material has an annular shape that surrounds the catheter and extends to the balloon wall, and the balloon wall is adjacent to an environment external to the diagnostic device; and
a termination component coupled to the catheter at a position along the catheter that is proximal to the proximal balloon end, wherein (i) when the termination component is in a first physical configuration, the balloon interior is not in fluid communication with an environment external to the catheter at the proximal catheter end, and (ii) when the termination component is in a second physical configuration different than the first physical configuration, the balloon interior is in fluid communication with the environment external to the catheter at the proximal catheter end.

2. The diagnostic device of claim 1 , wherein, when the termination component is in the first physical configuration and the self-expanding, low compression-set material is in a compressed state:
manipulating the termination component into the second physical configuration causes the self-expanding, low compression-set material to expand responsively to a pressure gradient between the balloon interior and the environment external to the catheter at the proximal catheter end.

3. The diagnostic device of claim 1 , wherein the self-expanding, low compression-set material is an open cell foam.

4. The diagnostic device of claim 1 , wherein the termination component is:
a proximal cap configured to (i) manually couple to the proximal catheter end to place the termination component in the first physical configuration, and (ii) manually decouple from the proximal catheter end to place the termination component in the second physical configuration; or
a valve configured to (i) manually close to place the termination component in the first physical configuration, and (ii) manually open to place the termination component in the second physical configuration.

5. The diagnostic device of claim 4 , wherein the termination component is the proximal cap configured to (i) manually couple to the proximal catheter end to place the termination component in the first physical configuration, and (ii) manually decouple from the proximal catheter end to place the termination component in the second physical configuration.

6. The diagnostic device of claim 1 , wherein the catheter has an outer diameter between 5 and 15 millimeters, wherein an opening in a wall of the catheter connects the lumen to the balloon interior, and wherein the catheter includes no additional lumens.

7. The diagnostic device of claim 1 , wherein, when the termination component is in the second physical configuration and a steady state condition has been reached, the balloon (i) has a maximum diameter between 39 and 55 millimeters and (ii) has a length of 40 to 120 millimeters between the proximal balloon end and the distal balloon end.

8. The diagnostic device of claim 1 , wherein the catheter includes a flow sensor configured to generate signals indicative of fluid flow through the catheter, and wherein the diagnostic device further comprises:
a visual indicator component; and
a processing unit electrically coupled to the flow sensor and the visual indicator component,
wherein the processing unit is configured to, based on the signals indicative of fluid flow, cause the visual indicator component to present a visual indicator of how long it took a patient to expel at least the balloon of the diagnostic device.

9. The diagnostic device of claim 8 , wherein the processing unit is configured to, based on the signals indicative of fluid flow, cause the visual indicator component to present a binary indicator of whether the patient expelled at least the balloon within a threshold amount of time.

10. The diagnostic device of claim 8 , further comprising:
an audio indicator component; and
a processing unit electrically coupled to the flow sensor and the audio indicator component,
wherein the processing unit is configured to, based on the signals indicative of fluid flow, cause the audio indicator component to present a binary indicator of whether the patient expelled at least the balloon within a threshold amount of time.

11. The diagnostic device of claim 1 , wherein the annular shape that surrounds the catheter extends from the catheter to the balloon wall.

12. A method of testing anorectal expulsion functions of a patient, the method comprising:
inserting a diagnostic device into a rectum of the patient, wherein:
the diagnostic device includes (i) a balloon having a balloon wall that defines a balloon interior containing a self-expanding, low compression-set material in a compressed state and (ii) a catheter extending through a proximal end of the balloon,
a diameter or width of the self-expanding, low compression-set material has a peak value when the self-expanding, low compression-set material is in a fully expanded state,
when the self-expanding, low compression-set material is compressed from the fully expanded state to a state in which the diameter or width has a value between 50% and 75% of the peak value, the self-expanding, low compression-set material exerts an outward force of between 0.2 and 1.0 pounds per square inch (psi),
the self-expanding, low compression-set material has an annular shape that surrounds the catheter and extends to the balloon wall,
the balloon wall is adjacent to an environment external to the diagnostic device, and
after inserting the diagnostic device, at least a portion of the catheter remains outside of the rectum of the patient; and

manipulating either (i) a valve in the portion of the catheter, or (ii) a cap on a proximal end of the portion of the catheter, to cause the self-expanding, low compression-set material to be in fluid communication, via the catheter, with an environment external to the portion of the catheter.

13. The method of claim 12 , further comprising, prior to inserting the diagnostic device into the rectum of the patient:
manually compressing the self-expanding, low compression-set material within the balloon to cause the self-expanding, low compression-set material to enter the compressed state; and
manipulating either the valve or the cap to cause the self-expanding, low compression-set material to not be in fluid communication with the environment external to the portion of the catheter.

14. The method of claim 12 , further comprising, after manipulating either the valve or the cap to cause the self-expanding, low compression-set material to be in fluid communication with the environmen

Assignees

• Univ Michigan Regents

Inventors

• Chey William D
• Ashton-Miller James A
• Shah Eric D
• Baker Jason
• Harris Adrienne
• Parunak Gene
• Kehrer Aaron Miles

Classifications

• A61B5/4222

  Evaluating particular parts, e.g. particular organs · CPC title

• A61M25/10183

  Compressible bulbs · CPC title

• A61B5/1107

  Measuring contraction of parts of the body, e.g. organ or muscle · CPC title

• A61B5/6853 Primary

  with a balloon · CPC title

• A61B5/4255 Primary

  Intestines, colon or appendix · CPC title