System and method for simulating intrauterine contractions for noninvasive intra-partum fetal monitoring

• US 10,269,265 B2
• Filed: 09/06/2016
• Issued: 04/23/2019
• Est. Priority Date: 09/06/2016
• Status: Active Grant

• Current Assignee: Simulation, LLC
• Original Assignee: Dynasthetics, LLC
• Inventors: Orr, Joseph
• Primary Examiner(s): Lewis, David L
• Assistant Examiner(s): Hall, Shauna-Kay
• Application Number:
  US15/257,444
• Publication Number:
  US 20180068589A1
• Time in Patent Office: 959 Days
• Field of Search: 434273
• CPC Class Codes: G09B 23/281 for pregnancy, birth or obstetrics G09B23/286 takes precedence

Abstract

A method and apparatus to simulate intrauterine contractions to train clinicians in using a tocodynamometer (TOCO) transducer. The apparatus includes an enclosure housing an air bladder, with an opening in the enclosure for a TOCO transducer to be placed in contact with the air bladder. The air bladder is selectively pressurized by a source of compressed gas, the flow being controlled by a flow valve. A pressure release valve is provided to reduce pressure in the bladder. A pressure sensor monitors the bladder pressure, and can be used to calibrate the system to determine what bladder pressure produced a given uterine activity. The flow valve may be controlled by a software run on a processor to achieve particular uterine activity levels over a given period of time.

Claims

1. A device for simulating intrauterine contractions, the device comprising:

an enclosure having an opening therethrough configured to receive a force sensor of a tocodynamometer;

a bladder configured to fit within the enclosure, the bladder attached to a length of tubing, the length of tubing attached to a pressure sensor and the length of tubing configured to be attached to a source of compressed gas;

the bladder in fluid communication with a pressure release valve and a digital flow valve;

a processor in communication with the flow valve and the pressure sensor, wherein the processor is configured to receive a current pressure value from the pressure sensor, compare the current pressure value to a predetermined pressure value representative of a uterine activity, and the processor further programmed to adjust the flow valve in response to a difference between the current pressure value and the predetermined pressure value representative of a uterine activity.

2. The device of claim 1, wherein the flow valve is a variable flow valve.

3. The device of claim 1, further comprising software on the processor programmed to open and close the flow valve to achieve one or more pre-programmed pressures at the pressure sensor.

4. The device of claim 3, wherein the pre-programmed pressures are programmed to mimic one or more uterine activity levels of a pregnant patient over time.

5. The device of claim 4, further comprising software on the processor programmed to open and close the flow valve to achieve one or more pre-programmed pressures at the pressure sensor.

6. The device of claim 3, wherein the pre-programmed pressures are designed to mimic one or more uterine activity levels of a pregnant patient experiencing labor or false labor.

7. The device of claim 1, the enclosure having a hole in addition to the opening, the length of tubing passing through the hole, and the electronic flow valve external to the enclosure.

8. The device of claim 1, further comprising a tocodynamometer with a pressure-sensing portion, the pressure-sensing portion placed over the opening of the enclosure and in contact with the bladder.

9. The device of claim 1, wherein the predetermined pressure value representative of a uterine activity comprises a pressure value indicative of one or more of false labor and true labor.

10. A device for training clinicians in the use of tocodynamometers, the device comprising:

a frame, the frame having an opening on a top surface for receiving a force sensor of a tocodynamometer,

a bladder housed in the frame, the bladder in fluid communication with a pressure release valve, a pressure sensor, and a flow valve,

a processor, the processor programmed to receive a pressure sensor value from the pressure sensor, compare the pressure sensor value to a pre-programmed pressure value indicative of a uterine activity, and the processor further programmed to send a signal to the flow valve to adjust the flow valve when the pressure sensor value and the pre-programmed pressure value indicative of a uterine activity are not equal.

11. The device of claim 10, wherein the flow valve is one of a variable flow solenoid valve, a digital flow valve and a fill and dump valve.

12. The device of claim 10, further comprising a length of tubing having a first end and a second end, the bladder connected to the first end of the length of tubing, and the first end of the length of tubing passing through the frame;

and

wherein the second end of the length of tubing has a connector that is configured to connect to a source of compressed gas.

13. A method for training clinicians in the use of tocodynamometers, the method comprising:

selecting a device designed to mimic uterine contractions, the device comprising;

an enclosure, the enclosure having an opening on a top surface and a second opening on a lateral side;

a bladder housed in the enclosure, the bladder connected to a first end of a length of tubing, the first end of the length of tubing passing through the second opening on the lateral side of the enclosure;

the length of tubing having a pressure release valve proximal to the first end, a pressure sensor, and a flow valve;

connecting the second end of the length of tubing to a source of compressed gas;

connecting a tocodynamometer to the enclosure with a strap, the tocodynamometer having a pressure-sensing probe, and placing the pressure-sensing probe through the opening on the top surface of the enclosure and in contact with the bladder.

14. The method of claim 13, wherein the device further comprises a processor in connection with the pressure sensor and flow valve, and wherein the method further comprises calibrating the device by adjusting the flow valve to achieve a pre-determined uterine activity level, and recording the pre-determined activity level and a pressure on the pressure sensor at the pre-determined uterine activity level.

15. A kit containing a device for simulating intrauterine contractions, the kit comprising:

an enclosure having an opening therethrough configured to receive a pressure sensor of a tocodynamometer;

a bladder configured to be housed in the enclosure;

a length of tubing, the length of tubing having a pressure release valve and a flow valve,

a connector configured to connect the length of tubing to a source of compressed gas,

a pressure sensor connected to the length of tubing, and

a processor programmed to receive a pressure sensor value from the pressure sensor, compare the pressure sensor value to a pre-programmed pressure value indicative of a uterine activity, and the processor further programmed to send a signal to the flow valve to adjust the flow valve when the pressure sensor value and the pre-programmed pressure value indicative of a uterine activity are not equal.

16. A system for simulating intrauterine contractions, the system comprising:

an enclosure having an opening therethrough configured to receive a force sensor of a tocodynamometer;

a bladder configured to fit within the enclosure;

the bladder in fluid communication with a pressure release valve,

wherein the bladder is configured to be connected to a constant source of pressure; and

a processor, the processor programmed to receive a pressure sensor value from the pressure sensor, compare the pressure sensor value to a pre-programmed pressure value indicative of a uterine activity, and the processor further programmed to send a signal to the flow valve to adjust the flow valve when the pressure sensor value and the pre-programmed pressure value indicative of a uterine activity are not equal.

17. The device of claim 16, wherein the pressure release valve is configured to release pressure at pre-determined pressure thresholds.