System and method for simulating fetal heart rate for noninvasive intra-partum fetal monitoring

• US 10,360,816 B2
• Filed: 09/06/2016
• Issued: 07/23/2019
• 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:
  US15/257,501
• Publication Number:
  US 20180068591A1
• Time in Patent Office: 1,050 Days
• Field of Search: 434273
• CPC Class Codes: G09B 23/303 specially adapted to simulate circulation of bodily fluids

Abstract

A method and apparatus to simulate a fetal heart rate to train clinicians in using a Doppler probe. The apparatus includes an enclosure housing a bladder, with a piece of deformable material to be placed in contact with the bladder and the Doppler probe. The 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. The flow valve may be controlled by a software run on a processor to achieve pre-determined bladder pressures to mimic a fetal heart rate.

Claims

1. A device for simulating a fetal heartbeat, the device comprising:

an enclosure having an opening therethrough;

a bladder configured to be housed in the enclosure;

a deformable material at least partly housed in the enclosure, the deformable material configured to allow a plurality ultrasound waves to travel through the deformable material and reflect at least some of the plurality of ultrasound waves, the deformable material positioned between the bladder and the opening of the enclosure;

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

2. The device of claim 1, wherein the bladder is connected to a length of tubing.

3. The device of claim 1, further comprising a pressure sensor in fluid communication with the pressure release valve and the flow valve.

4. The device of claim 1, wherein the flow valve is a solenoid valve.

5. The device of claim 3, wherein the flow valve is a solenoid valve, and further comprising a processor, and wherein the processor is in communication with the solenoid valve and the pressure sensor.

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

7. The device of claim 6, wherein the software on the processor is programmed to open and close the solenoid valve to mimic one or more fetal heart beats.

8. The device of claim 1, wherein the flow valve is a digital flow valve, and further comprising a processor and a pressure sensor, and wherein the processor is in communication with the digital flow valve and the pressure sensor.

9. The device of claim 5, further comprising software on the processor programmed pressures at the pressure sensor.

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

11. The device of claim 1, further comprising a Doppler probe, the Doppler probe placed over the opening of the enclosure and in contact with the deformable material.

12. A device for training clinicians in the use of Doppler probes, the device comprising:

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

a bladder housed in the rigid frame, 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 rigid frame;

a deformable material in contact with the bladder and extending through the opening of the rigid frame, the deformable material comprising a silicone gel;

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

wherein the second end of the length of tubing is connectable to a source of compressed gas.

13. The device of claim 12, wherein the flow valve is one of a variable flow valve, a digital flow valve, a solenoid valve, a piezoelectric valve, and a fill and dump valve.

14. The device of claim 13, further comprising a processor in communication with the flow valve and the pressure sensor.

15. The device of claim 14, 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, the one or more pre-programmed pressures comprising pre-programmed pressures indicative of a fetal heart rate, where the fetal heart rate is measured in beats per minute.

16. A device for simulating a fetal heartbeat, the device comprising:

an enclosure having an opening therethrough;

an electro-mechanical device configured to simulate a fetal heartbeat housed in the enclosure;

a deformable material housed in the enclosure between the opening and the electro-mechanical device; and

a processor in communication with the electro-mechanical device.

17. The device of claim 16, further comprising software on the processor programmed to actuate the electro-mechanical device at a pre-determined rate to mimic one or more fetal heart beats.

20. The device of claim 17, wherein the electro-mechanical device includes one of a stepper motor, a gear motor, and a linear solenoid.

18. A method for training clinicians in the use of Doppler probes, 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 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;

a deformable material in contact with the bladder and extending through the opening 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 Doppler probe to the enclosure, and placing the Doppler probe in contact with the deformable material.

19. A kit containing a device for simulating a fetal heartbeat, the kit comprising:

an enclosure having an opening therethrough;

a bladder configured to be housed in the enclosure;

a deformable material configured to be at least partly housed in the enclosure between the bladder and the opening;

a second opening in the enclosure, and a length of tubing configured to be connected to the bladder through the second opening, the length of tubing having a pressure release valve and a flow valve.

21. A device for simulating a fetal heartbeat, the device comprising:

an enclosure having an opening therethrough;

a bladder configured to be fit within in the enclosure;

a deformable material at least partly housed in the enclosure between the bladder and the opening;

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

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

22. The device of claim 21, wherein the pressure release valve is configured to release pressure at pre-determined pressure thresholds.