Granted Patent B2

US 12,376,785 · App. 18/242,584 · Granted Aug 5, 2025

Inventor: Timothy McKinney (Boca Raton, FL)

Assignee: Sentinel Medical Technologies, LLC

A61B5/4343A61B5/205A61B5/6853A61B5/0004A61M25/0026A61M25/007A61M25/1011

Abstract

Claims (32)

1. A method for measuring intra-abdominal pressure in a pregnant woman to assess occurrence or likelihood of pre-eclampsia via insertion of a pressure measuring catheter into the woman, the method comprising the steps of:

providing a catheter having a first lumen and a balloon;

inserting the catheter into the woman;

injecting gas into the first lumen of the catheter to expand the balloon from a deflated condition to a more inflated condition;

after expanding the balloon, continuously monitoring pressure to obtain multiple pressure readings based on deformation of the partially inflated balloon to thereby monitor pressure within an abdomen of the woman to assess if pre-eclampsia is occurring or likely to occur, and

transmitting the multiple pressure readings continuously to an external monitor connected to the catheter for a display of the multiple pressure readings, a pressure reading of the multiple pressure readings indicative of a presence and/or risk of pre-eclampsia based on intra-abdominal pressure to determine when intervention should occur to prevent morbidity and mortality of the woman and baby;

wherein the catheter includes an additional lumen and a stabilizing balloon, the additional lumen communicating with the stabilizing balloon to inflate the stabilizing balloon to stabilize a position of the catheter, the stabilizing balloon positioned proximal of the balloon and axially spaced from the balloon such that a distalmost end of the stabilizing balloon is spaced proximally from a proximalmost end of the balloon.

2. The method of claim 1 , wherein multiple pressure readings are taken and if one of the multiple pressure readings exceeds 25 mmHg, the intervention is implemented.

3. The method of claim 1 , further comprising the step of placing a distal region of the balloon against a wall of the rectum.

4. The method of claim 1 , wherein after initial advancement of gas into the first lumen by connection of a pressure transducer, additional air does not need to be inserted during a duration of insertion of the catheter in a body of the woman.

5. The method of claim 1 , further comprising the step of altering a position of the woman if one of the multiple pressure readings exceeds a predetermined pressure to reduce the risk of pre-eclampsia.

6. The method of claim 1 , further comprising the step of reducing fluid intake to the woman if one of the multiple pressure readings exceeds a predetermined pressure to reduce the risk of pre-eclampsia.

7. The method of claim 1 , further comprising the step of delivering the baby if one of the multiple pressure readings exceeds a predetermined pressure to reduce the risk of pre-eclampsia.

8. The method of claim 1 , wherein connection of a hub automatically connects a temperature sensor of the catheter to a connector within the hub.

9. The method of claim 1 , wherein the catheter includes an outer balloon positioned over the balloon, the outer balloon inflatable through a separate second lumen of the catheter independent of the first lumen and radially spaced from and external of the first lumen, and the outer balloon while inflated is deformable based on pressure to deform the balloon within the outer balloon to provide finer measurements of pressure, the balloon within the outer balloon having a transverse dimension in an expanded condition less than a transverse dimension of the outer balloon in an expanded condition along an entire circumference.

10. The method of claim 1 , wherein the catheter is inserted into a rectum of the woman to obtain the pressure readings.

11. The method of claim 1 , wherein the catheter is inserted into an esophagus of the woman to obtain the pressure readings.

12. The method of claim 1 , wherein a pressure sensor is positioned within the balloon.

13. The method of claim 12 , wherein pressure is measured in response to deformation of the balloon in response to pressure exerted on an outer wall of the balloon.

14. The method of claim 12 , further comprising a side opening in the catheter communicating with the bladder for drainage.

15. A method for measuring intra-abdominal pressure in a pregnant woman to assess occurrence or likelihood of pre-eclampsia via insertion of a pressure measuring catheter into a rectum of a woman, the method comprising the steps of:

providing a catheter having a first lumen and a pressure sensor,

inserting the catheter into the rectum of the woman;

inflating a balloon to provide continuity to a wall of the rectum, wherein a predetermined amount of air is advanced into the balloon prior to use of the pressure sensor,

after inflation of the balloon, continuously monitoring pressure via obtaining multiple pressure readings of the continuous pressure monitoring based on the pressure sensor to thereby monitor pressure within an abdomen of the woman to assess if pre-eclampsia is occurring or likely to occur; and

transmitting the pressure readings continuously to an external monitor connected to the catheter for a display of the pressure readings, a pressure reading of the multiple pressure readings indicative of a presence and/or risk of pre-eclampsia based on intra-abdominal pressure to determine when intervention should occur to prevent morbidity and mortality of the woman and baby;

wherein the catheter includes an additional lumen and a stabilizing balloon, the additional lumen communicating with the stabilizing balloon to inflate the stabilizing balloon to stabilize a position of the catheter, the stabilizing balloon positioned proximal of the balloon and axially spaced from the balloon such that a distalmost end of the stabilizing balloon is spaced proximally from a proximalmost end of the balloon.

16. The method of claim 15 , wherein the balloon is partially inflated and the step of obtaining pressure measurements obtains pressure readings based on deformation of the partially inflated balloon.

17. The method of claim 15 , wherein a hub contains the pressure sensor and is attachable to the first lumen, and attachment of the hub automatically connects a temperature sensor of the catheter to a connector within the hub.

18. The method of claim 15 , wherein a pressure sensor is positioned within the balloon.

19. The method of claim 18 , wherein pressure is measured in response to deformation of the balloon in response to pressure exerted on an outer wall of the balloon.

20. The method of claim 18 , further comprising a side opening in the catheter communicating with the bladder for drainage.

Assignments (1)

Continuity (3)

References Cited (325)