WO2005025419A1

WO2005025419A1 - Labor contraction monitoring system with multi-function relay disk

Info

Publication number: WO2005025419A1
Application number: PCT/US2004/029365
Authority: WO
Inventors: Richard L. Watson, Jr.
Original assignee: Maternus Partners, Ltd.
Priority date: 2003-09-10
Filing date: 2004-09-09
Publication date: 2005-03-24

Abstract

A labor and delivery monitoring system having a relay disk (11) for receiving labor contraction signals, ultrasound fetal heartbeat signals, and fetal ECG signals from respective sensors (12, 14, 16) placed on or in the mother and relaying those signals to a computer processor for display on a monitor. Communication between the respective sensors (12, 14, 16) and the relay disk (11) is preferably wireless, as is the communication between the relay disk (11) and the computer processor. The relay disk (11) also preferably provides a plurality of programmable buttons (18, 20, 24) for enabling the mother to control a wide variety of equipment in the labor and delivery room, such as temperature, television, radio or stereo equipment, lights, anesthetics, and the like. The relay disk (11) also preferably includes at least one dedicated nonprogrammable button (28) for enabling the patient to alert medical personnel when the patient requires assistance.

Description

LABOR CONTRACTION MONITORING SYSTEM WITH MULTI-FUNCTION RELAY DISK INVENTOR: RICHARD L. WATSON, JR.

BACKGROUND OF THE INVENTION

Field of The Invention

This invention relates generally to labor contraction monitoring systems, and more particularly to a labor contraction monitoring system having a multifunction relay disk for receiving a plurality of signals indicative of maternal labor contractions, fetal heartbeats, and fetal electrocardiograms and relaying those signals to a monitor for display.

Background Information

In the labor and delivery medical field, various sensing devices are known for monitoring maternal labor contractions and fetal heartbeats. However, most of such devices leave the patient tethered to the respective monitors with electrical wires, which greatly restricts the ambulatory movement of the mother. Also, such instrumentation of the mother is cumbersome due to the presence of multiple wires and pieces of monitoring equipment. Generally, a labor contraction sensor is used in conjunction with either an ultrasound sensor for indirect measurement of fetal heart rate or a fetal ECG sensor for direct measurement of fetal heart rate. It would be a significant advancement in the art to provide a simplified system for monitoring labor contractions arid providing both direct and indirect measurement of fetal heart rate via an ultrasound sensor and a fetal ECG sensor, all through a centralized relay unit. Such a system would provide complete freedom of ambulatory movement of the mother by not being tethered to any of the monitoring equipment.

SUMMARY OF THE INVENTION

The present invention solves the foregoing problems in the art by providing a wireless, multi-function relay disk for receiving and sending biological data and vital signs, such as labor contraction signals, ultrasound fetal heartbeat signals, and fetal ECG signals from respective sensors placed on or in the mother and wirelessly relaying those signals to a computer processor for display on a monitor. Thus, the multi-function relay disk is in communication with biological data/vital signs monitors, and is in further communication with a monitoring device, such as a computer, video monitor, or printer. The relay disk also preferably provides a plurality of programmable controllers, such as buttons and dials, for enabling the mother to set and adjust environmental devices, media devices, and drug delivery devices. The mother is thus able to control a wide variety of equipment in the labor and delivery room, such as temperature, lights, bed position, television, radio or stereo equipment, patient administered anesthetics, and the like. The relay disk also preferably includes at least one dedicated non-programmable controller, such as a button, for issuing call-alerts, enabling the patient to alert medical personnel when the patient requires assistance.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic top view of a labor contraction monitoring system in accordance with the present invention having a multi-function relay disk in communication with a labor contraction sensor, a fetal heartbeat sensor, and a fetal ECG sensor. Figure 2 is a side view of the multi-function relay disk of Figure 1. Figure 3 is a front view of a display monitor with the multi-function relay disk of Figure 1 docked thereto. Figure 4 is a perspective view of the fetal ECG sensor of Figure 1. Figure 5 is a top view of the fetal heartbeat sensor of Figure 1. Figure 6 is a side view of the fetal heartbeat sensor of Figure 1. Figure 7 is a sectional view of the fetal heartbeat sensor of Figure 1 taken along line 7-7 of Figure 5. Figure 8 is a schematic view showing the fetal heartbeat sensor of Figure 1 placed on the abdomen of a pregnant female. Figure 9 is a top perspective view of the labor contraction sensor of Figure 1. Figure 10 is a side perspective view of the labor contraction sensor of Figure 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to the figures, Figure 1 illustrates a labor contraction monitoring system in accordance with the present invention comprises a multi-function relay disk 10, having a disk body, and in communication with a labor contraction sensor 12, a fetal heartbeat sensor 14, and a fetal ECG sensor 16. Relay disk 10 is also in communication with a display monitor 46 (see Figure 3) via a computer processor (not shown) for displaying signals representative of labor contractions, fetal heartbeats, and fetal ECGs. Labor contraction sensor 12 is preferably a beltless fiber optic labor contraction sensor as described in U.S. Patent No. 6,607,486, which is incorporated herein by reference. Fetal heartbeat sensor 14 is preferably a beltless ultrasound sensor as described below in connection with Figures 5-8. Fetal ECG sensor 16 is preferably a fetal ECG strip electrode sensor as described in U.S. Patent No. 6,594,515, which is incorporated herein by reference, except that fetal

ECG sensor 16 preferably has an electronic signal transmitter embedded therein as described further below. Labor contraction sensor 12, fetal heartbeat sensor 14, and fetal ECG sensor 16 are preferably in wireless communication (such as by radio frequency signals) with relay disk 10 as indicated by arrows 13, 15, and 17, respectively, but the communication between sensors 12, 14, 16 and relay disk 10 may be facilitated by electrical wires connected to jacks 38, 40, 42, respectively, as shown in Figure 2. Similarly, relay disk 10 is preferably in wireless communication with display monitor 46 (see Figure 3), but relay disk 10 may communicate with monitor 46 via electrical wires. As shown in Figures 2 and 3, relay disk 10 preferably has an electrical interface 44 for mating with a docking station 48 on monitor 46. Electrical interface 44 and docking station 48 facilitate programming and electrical charging of relay disk 10 according to methods known in the art. As shown in Figure 4, fetal ECG sensor 16 preferably comprises a thin, flexible strip 52 having an electrode 54 for picking up the electrical activity of the heart of an unborn child as described in U.S. Patent No. 6,594,515. Fetal ECG sensor 16 is placed between the head of the fetus and the uterine wall of the mother. Additionally, fetal ECG sensor 16 preferably has a wireless signal transmitter 56 embedded in one end of strip 52 for sending the resulting ECG signal to relay disk 10. Referring to Figures 5-8, fetal heartbeat sensor 14 preferably comprises a flexible patch 58 having a recess or pouch for containing an ultrasound sensor 60. Patch 58 is preferably made of soft, flexible plastic or another suitable material with adhesive on its underside surface 62 for securing sensor 14 to the abdomen 74 of a pregnant female. Patch 58 preferably has a generally elliptical shape to help conform patch 58 to the contour of the abdomen 74, but other shapes are also possible. Ultrasound sensor 60 preferably has a power source 64, a signal processor 66, one or multiple ultrasound transducers 68, a signal transmitter 70, and a gel pad 72 for contacting the skin of the abdomen 74. Gel pad 72, which may be made from defϊbrillator pads such as stock number 2346N available from 3M™, helps to facilitate the operation of ultrasound transducer 68, which produces a signal representative of the fetal heartbeat in cooperation with signal processor 66 according to methods known in the art. Signal transmitter 70 transmits the resulting signal to relay disk 10. Referring to Figures 9 and 10, labor contraction sensor 12 is preferably a beltless fiber optic labor contraction sensor as described in U.S. Patent No.

6,607,486. Labor contraction sensor 12 preferably includes a fiber optic strain sensor 82 with a fiber optic cable or other suitable optical transmission line (not shown) embedded within a sensor cover 84 on an adhesive pad 80, which preferably has a generally elliptical shape to enhance conformance to the contour of the mother's abdomen. The fiber optic cable is connected by signal line 86 to an electronics box 78, which houses the necessary electronics (preferably including a power supply, a light source, a light detector, a signal decoder, and a signal transceiver, not shown) for generating a contraction signal in response to a labor contraction and transmitting the contraction signal to relay disk 10. Labor contraction sensor 12 is fastened to the mother's abdomen with adhesive pad 80 much like fetal heartbeat sensor 14 as discussed above. As described in U.S. Patent No. 6,607,486, labor contraction sensor 12 may embody any of a number of different configurations. In practice, relay disk 10 receives the contraction signals from contraction sensor 12, the ultrasound signals from fetal heartbeat sensor 14, and the ECG signals from fetal ECG sensor 16 and transmits all of those signals to a computer processor (not shown) for display on display monitor 46 (see Figure 3), which is connected to the computer processor. Preferably, the contraction signals, ultrasound signals, and ECG signals are all transmitted from their respective sensors to relay disk 10 wirelessly, and relay disk 10 in turn wirelessly transmits all of the signals to the computer processor. Because relay disk 10 is located on or nearby the mother and is therefore in close proximity to the sensors 12, 14, 16, very little power is required to transmit the respective signals from sensors 12, 14, 16 to relay disk 10. Such a completely wireless embodiment is very lightweight and provides the most freedom of ambulatory movement to the mother because none of the sensors are physically tethered to any equipment. Alternatively, relay disk 10 may be connected by wires to contraction sensor 12, fetal heartbeat sensor 14, and fetal ECG sensor 16 but be in wireless communication with the computer processor. This alternative embodiment also provides the mother with freedom of ambulatory movement but may be somewhat less desirable due to the presence of the connecting wires between the sensors 12, 14, 16 and the relay disk 10. Another alternative is to have relay disk 10 connected by wires to both the sensors 12, 14, 16 and the computer processor, but this alternative embodiment limits the mother's ambulatory movement because the relay disk 10 is physically tethered to the computer processor in this embodiment. Although the preferable sensors in communication with relay disk 10 are contraction sensor 12, ultrasound sensor 14, and ECG sensor 16, it will be appreciated that other sensors may be placed in communication with relay disk 10 either in addition to or in lieu of sensors 12, 14, 16. For example, other sensors for monitoring the vital signs of the mother could be used, such as maternal body temperature, heart rate, blood pressure, and blood oxygen saturation (SAO2) sensors as known in the art. As another example, after the mother gives birth to the infant, relay disk 10 could also be used to relay SAO2 signals from an infant warming and sensor mat on which the infant is placed as described in my U.S. Provisional Patent Application entitled "Infant Warming and Sensor Mat," which is filed contemporaneously herewith and incorporated herein by reference. Referring again to Figure 1, relay disk 10 preferably comprises a plurality of programmable buttons 18, 20, 24, a non-programmable dedicated button 28, a visual display 26 (such as an LCD, LED, or other suitable display), and a programming dial 22, which is preferably a potentiometer or similar regulating device. Buttons 18, 20, 24, 28 preferably have different surface features 30, 34, 36, 32, respectively, to help a user readily distinguish the various buttons by tactile feel, which is particularly useful in darkened conditions. Dedicated button 28 preferably serves as an alert button to summon medical personnel, but dedicated button 28 may serve any other predetermined function. For example, dedicated button 28 may serve as an event marker to indicate, for instance, the occurrence of a contraction felt by the patient. Such alert and event marker functions could also be assigned to one of the programmable buttons 18, 20, 24. In the preferred embodiment described herein, three programmable buttons are shown, but persons of skill in the art will recognize that fewer or more programmable buttons may be provided, depending on the number of functions desired and the acceptable size limitations. Similarly, more than one dedicated button may be provided. Also, although described herein as buttons, buttons 18, 20, 24, 28 may be any suitable type of activation switch. The programmable buttons 18, 20, 24 of relay disk 10 may also be programmed to allow the patient to control a variety of other electrical or electronic equipment, such as anesthetic administering devices (for example, an epidural anesthetic), televisions, radio or stereo equipment, thermostats for controlling room temperature, lights, and the like. Once programmable buttons 18, 20, 24 are programmed to a related environmental device, media device, or drug delivery device, the programming dial 22 is used to control, or modulate, the operating level of the particular piece of equipment assigned to a particular button when that button is selected by the patient. For example, if a button is programmed to control room temperature, dial 22 may serve to increase or decrease the temperature if that button is selected. Similarly, if a button is programmed to control a television or a stereo, dial 22 may serve to increase or decrease the channel, the volume, or both if that button is selected. Likewise, if a button is programmed to control room lights, dial 22 may serve to brighten or dim the lights, as desired. It will be appreciated that the programmable buttons could be programmed to control virtually any piece of equipment for which patient control is desirable. Relay disk 10 thereby serves as a central control unit giving the patient control over a wide variety of equipment functions. Such remote control is preferably provided by means of a computer processor (not shown) with which relay disk 10 is in communication, preferably wireless communication, and the computer processor communicates with the equipment being controlled. Display 26 is preferably used to display information associated with a particular button selected by the patient. For example, display 26 could display a bar graph or a numerical value indicative of the operating level (e.g., light intensity, sound level, channel, temperature, or the like) of the equipment associated with the selected button. Alternatively, display 26 may indicate the time elapsed since the last occurrence of a particular event, such as a labor contraction, or the time until a next event is due, such as an injection of medication. Display 26 may also be used for providing instructions to the patient, such as an appropriate time to push during labor. Display 26 may also be used to display information associated with one or more of the sensors being used on the mother or the infant, such as heart rate, oxygen saturation level, temperature, blood pressure, or the like. Although the invention has been described with reference to specific embodiments, this description is not meant to be construed in a limited sense. Various modifications of the disclosed embodiments, as well as alternative embodiments of the inventions will become apparent to persons skilled in the art upon the reference to the description of the invention. It is, therefore, contemplated that the appended claims will cover such modifications that fall within the scope of the invention.

Claims

I claim:

1. A labor contraction monitoring system comprising: a labor contraction sensor for generating a contraction signal in response to a labor contraction of a pregnant female; an ultrasound fetal heartbeat sensor for generating an ultrasound signal in response to the heartbeat of a fetus within the pregnant female; a fetal ECG sensor for generating an ECG signal in response to the heartbeat of the fetus; a relay disk in communication with said labor contraction sensor, said ultrasound fetal heartbeat sensor, and said fetal ECG sensor for receiving said contraction signal, said ultrasound signal, and said ECG signal and transmitting each of said signals to a computer processor; and a monitor in communication with said computer processor for displaying said contraction signal, said ultrasound signal, and said ECG signal.

2. The labor contraction monitoring system of Claim 1 wherein each of said labor contraction sensor, said ultrasound fetal heartbeat sensor, and said fetal ECG sensor communicates wirelessly with said relay disk.

3. The labor contraction monitoring system of Claim 1 wherein said relay disk communicates wirelessly with said computer processor.

4. The labor contraction monitoring system of Claim 1 wherein said relay disk comprises at least one programmable button for enabling the pregnant female to control at least one piece of equipment.

5. The labor contraction monitoring system of Claim 4 wherein said at least one piece of equipment is selected from the group consisting of lights, thermostats, televisions, radios, stereo equipment, and anesthetic administering equipment.

6. The labor contraction monitoring system of Claim 1 wherein said relay disk comprises at least one non-programmable button.

7. The labor contraction monitoring system of Claim 6 wherein said at least one non-programmable button is operable to mark an event.

8. The labor contraction monitoring system of Claim 6 wherein said at least one non-programmable button is operable to summon medical personnel.

9. The labor contraction monitoring system of Claim 1 wherein said relay disk comprises a plurality of buttons each having a different tactile feel.

10. A multi-function relay disk comprising: a disk body; said disk body in communication with a biological data/vital signs monitor wherein data retrieved by said biological data/vital signs monitor is received by said multi-function relay disk; said disk body in communication with a monitoring device wherein data retrieved by said biological data/vital signs monitor is relayed by said multi-function relay disk to said monitoring device; a programmable controller integrated in said disk body wherein said programmable controller can adjust environmental devices, media devices, or drug delivery devices; a non-programmable controller integrated in said disk body wherein said non-programmable controller can issue call-alerts; and an visual display integrated in said disk body.

11. The multi-function relay disk of Claim 10, wherein said communication between said disk body and said biological data/vital signs monitor is wireless.

12. The multi-function relay disk of Claim 10, wherein said communication between said disk body and said monitoring device is wireless.

13. The multi-function relay disk of Claim 10, wherein said communication between said disk body and said biological data/vital signs monitor is wireless, and said communication between said disk body and said monitoring device is wireless.

14. The multi-function relay disk of Claim 10, wherein said programmable controller is further comprised of: a button, wherein said button activates a related environmental device, media device, or drug delivery device; and a dial, wherein said dial modulates said related environmental device, media device, or drug delivery device.

15. The multi-function relay disk of Claim 14, wherein said programmable controller is further comprised of a plurality of buttons wherein each button is programmed to activate a related environmental device, media device, or drug delivery device.

16. The multi-function relay disk of Claim 15, wherein said buttons each have a different tactile feel.

17. The multi-function relay disk of Claim 10, wherein said programmable controller is further comprised of a button operable to mark an event.

18. The multi-function relay disk of Claim 10, wherein said programmable controller is further comprised of a button operable to summon medical personnel.

19. The multi-function relay disk of Claim 10, wherein said biological data/vital signs monitor is selected from the group consisting of a labor contraction sensor, a fetal heartbeat sensor, or a fetal ECG sensor.

20. The multi-function relay disk of Claim 12, wherein said biological data/vital signs monitor is selected from the group consisting of a labor contraction sensor, a fetal heartbeat sensor, or a fetal ECG sensor.