System for monitoring fetal status

• US 20040082842A1
• Filed: 10/28/2002
• Published: 04/29/2004
• Est. Priority Date: 10/28/2002
• Status: Abandoned Application

• Current Assignee: Angela Lumba, Irwin Wunderman, John Missanelli, Mearl Naponic, Vijay K. Lumba
• Original Assignee: Angela Lumba, Irwin Wunderman, John Missanelli, Mearl Naponic, Vijay K. Lumba
• Inventors: Wunderman, Irwin, Lumba, Angela, Naponic, Mearl, Lumba, Vijay K., Missanelli, John
• Application Number:
  US10/281,041
• Publication Number:
  US 20040082842A1
• Time in Patent Office: Days
• US Class Current: 600/338
• CPC Class Codes: A61B 5/0011 Foetal or obstetric data
• CPC Class Codes: A61B 5/1464 specially adapted for foetal tissue
• CPC Class Codes: A61B 5/288 for foetal cardiography, e.g. scalp electrodes

Abstract

During childbirth, trauma to the infant can readily arise, ultimately resulting in fetal hypoxia, academia, and brain damage. Such unfavorable conditions can be best ascertained by real-time monitoring of the fetus'"'"' blood-oxygen level, heart rate monitoring, EKG and EEG waveforms. This invention describes a system of monitoring devices to implement such goals and maximize the potential welfare of the fetus. It furthermore allows the formation of a reference database that can correlate intrapartum events from prior births. The embodiments utilize a small-diameter sensor inserted into the birth canal through a tubular insertion rod. Through wire, fiber optics, and or using a radio frequency link, fetal monitor data can be analyzed, compared to existing data base, and or transmitted via internet. This patent details various apparatuses that allow important life-sign parameters of a fetus to be continuously monitored.

Claims

1. ) A means for monitoring fetal Oxygen status with a sensor;

A hollow-metal tissue-needle protruding from the sensor;

said tissue-needle with two or more optical fibers within is disposed to penetrate the fetal epidermis.

2. ) A means as in claim 1 wherein one optical fiber is arranged to emit controlled optical radiation into the fetal tissue;

the other fiber is arranged to transfer a portion of said radiation transmitted through the fetal tissue to an opto-electronic detector;

said detector generating electrical signals commensurate with the radiation received.

3. ) An apparatus as in claim 1 wherein the outer metal-tubing of the tissue needle serves as electrode for an electrical signal associated with fetal status evaluation.

4. ) A method as in claim 1 wherein an acoustical sensor in proximity to the tissue needle converts prevailing acoustical signals into commensurate electrical signals.

5. ) A method as in claim 1 wherein one of the optical fibers receives controlled wavelength radiation from 2 or more LED die.

6. ) A means as in claim 2 wherein the detector is in the sensor;

response signals from the detector are disposed to be amplified within the sensor and modulate a radio frequency transmitter within the sensor.

7. ) A means as in claim 1 where the detector-generated signals are amplified and analyzed by computer algorithm for fetal vital signs such as blood oxygenation level.

8. ) An apparatus as in claim 1 where the optical fibers emerge through the birth canal.

31. ) The method of claim 1 wherein a miniature C-MOS camera is disposed to view in the direction of the fetus enabling a display of the camera'"'"'s field of view.

9. ) A method for establishing fetal status where electrical, optical, and prevailing environmental conditions are measured and analyzed in relation to a data base derived from previous births;

said electrical and optical signals acquired from a fetal sensor attached to the fetus.

10. ) The method of claim 9 wherein the signals and data relate to one or more of the following:

date, time, place, fetal monitor employed, blood oxygen, glucose, albumen, hormones, enzymes, proteins, tissue electrical characteristics, EEG, heartbeat, images, acoustic sound, scattered light, temperature, vibration, airborne gas, atmospheric pressure, relative humidity, background magnetic, electromagnetic, ultrasound, electro kinetic signals, object accelerations, mother'"'"'s age, weight, and ethnicity;

said measured data disposed to inter-compare with data from previous births.

11. ) A method as in claim 9 wherein the Internet is utilized for data exchange.

16. ) A method as in claim 10 wherein one or more amplifier is embedded within the housing of the fetal sensor.

32. ) The method of claim 9 wherein a miniature C-MOS camera is disposed to view in the direction of the fetus enabling a display of the camera'"'"'s field of view.

12. ) A method for monitoring fetal status parameters like heart rate and blood oxygenation comprised of;

one or more partially-metalized transparent-plastic tissue needle light pipes;

wherein one or more light pipe is disposed to penetrate the epidermis of the fetus.

13. ) A method as in claim 12 wherein the light pipe connects to receiving electronics via one or more fiber optic cable that emerges from the womb through the birth canal.

14. ) A method as in claim 12 wherein metallization on a light pipe electrically connects to a signal lead that exits the birth canal.

15. ) A method as in claim 12 wherein metallization on a light pipe serves as an electrical signal conductor.

17. ) A method as in claim 12 wherein an electrical signal from a metalized light pipe is analyzed by algorithm to evaluate status of the fetus.

18. A method as in claim 12 wherein one light pipe receives controlled optical radiation from 2 or more LED die;

19. ) A method as in claim 12 wherein one light pipe is disposed to transmit optical radiation from fetal tissue to an optoelectronic detector.

20. ) An apparatus as in claim 19 where the optoelectronic detector is within the fetal sensor.

21. ) An apparatus as in claim 19 where optical signals from the detector are amplified;

discriminant analysis type procedures to establish fetus status being brought to bear on said amplified signals.

22. ) A device for monitoring pulse oxygenation and fetal heart rate comprised of one or more fiber optic type light guide each surrounded by a hollow-metal tissue-needle disposed to penetrate fetal tissue.

23. ) The method of claim 22 wherein the light pipes have barbs to increase their adherence to the fetus when impressed upon its epidermis.

24. ) A method as in claim 22 wherein optical radiation from one light guide is disposed to impinge upon an optoelectronic detector.

25. ) An apparatus as in claim 22 wherein one light guide within the hollow-metal tissue-needle is an optical fiber that exits the birth canal.

26. ) An apparatus as in claim 22 where one light guide is disposed to emit optical radiation into fetal tissue;

a second light pipe is disposed to detect a portion of said radiation from the fetal tissue.

27. ) An apparatus as in claim 22 wherein one or more hollow-metal tissue-needle electrically connects to an amplifier input.

28. ) An apparatus as in claim 22 wherein one or more hollow-metal tissue-needle electrically connects to a lead wire exiting the birth canal.

29. ) An apparatus as in claim 22 wherein an optoelectronic detector is embedded within a sensor housing.

30. ) An apparatus as in claim 22 wherein two or more LED'"'"'s emit controlled optical radiation into one or more fiber optic type light guide;

33. ) The method of claim 22 wherein a miniature C-MOS camera is disposed to view in the direction of the fetus enabling a display of the camera'"'"'s field of view.

34. ) A method for fabricating a sensor used to ascertain optical and electrical properties of an object, wherein;

conductive metallization on a single partially-metalized transparent-plastic part is rigidly embedded within said sensor'"'"'s housing;

said plastic part is then mechanically severed into two or more separate light pipes each respectively possessing a surrounding metallized conductor;

the distal end of said light pipes and electrodes being disposed to contact the test object.

35. ) The method of claim 34 wherein the sensor sends data to a receiver through a radio frequency link.

36. ) The method of claim 34 wherein the test object is a fetus.

37. ) The method of claim 34 wherein the mechanically severed light pipes with metallization are disposed to penetrate the surface of the test object.

38. ) The method of claim 37 wherein the severed light pipes penetrating the surface of the test object have barbs to increase adherence of the sensor to the object.

39. ) An apparatus to non-invasively monitor fetal status comprised of a bandage type sensor housing with two or more peripheral flaps;

said flaps disposed with adhesive to help bond the sensor to the fetus.

40. ) The apparatus of claim 39 wherein two or more LED die emit controlled wavelength radiation into the fetus through the front contact surface of the sensor;

an embedded optoelectronic sensor facing the front contact surface is disposed to detect a retro-reflected portion of said radiation.

41. ) The apparatus of claim 39 wherein battery power, control circuitry and an RF transmitter are disposed within the housing;

said circuitry enabling the processing of electrical signals to establish fetal status information at the receiving electronics.

42. ) The apparatus of claim 39 wherein Velcro-like fine wire needles pointing toward the fetus are embedded within the adhesive on the flaps of the sensor;

said wire needles disposed to increase adhesion to the fetus.

43. ) The apparatus of claim 39 wherein metallization on the front contact surface of the flaps serve as independent contacting electrodes to monitor heartbeat signals and brain wave type electrical signals of the fetus.

44. ) A method for inserting a bandage type sensor onto a fetus wherein the sensor is inserted into the womb with the flaps folded back parallel to the length of the insertion tool;

after contact of the sensor with the fetus, spring-like-extensions holding the flaps parallel to the insertion tool enable release of the flaps;

the outer concentric portion of the insertion tool is disposed to subsequently allow its distal end to pressure the flap'"'"'s adhesive into improved contact with the fetus.

45. ) A method of fetal oxygen monitoring wherein two or more optical light guides pierce the fetal epidermis.

46. ) The method of claim 45 wherein one or more electrode is disposed to surround a portion of optical light guide;

47. ) A method for monitoring blood oxygenation utilizing hinged flaps with adhesive to hold the sensor onto the test subject.

48. ) A method of inserting a bandage type fetal sensor into the birth canal using an insertion tool;

wherein the Band-Aid type hinged flap extensions with contact-surface-adhesive can be subsequently pressed to the fetus.

49. ) A method of attaching a fetal-monitor sensor;

wherein one or more appendage tissue-needle on the sensor is constructed with sufficient flex that it can be spring loaded prior to fetal attachment;

spring pressure of said tissue-needle being directed toward entering fetal tissue partially transverse to the direction of sensor approach to the fetus upon contact with the fetus;

said transverse penetration of fetal tissue employed to hold the sensor onto the fetus.

50. ) A method for fabricating a sharp point on a hollow metal tissue needle filled with clear solid dielectric;

said method consisting of slicing said tissue-needle at a steep oblique-wedge angle relative to its axis to obtain a keen pointed edge.

51. ) A method of applying optical radiation to a fetus from one or more LED die within a sensor housing;

wherein the sensor adheres to the fetus via a tissue-needle.

52. A method of fetal monitoring and analysis utilizing the procedures indicated in U.S. Pat. No. 6,122,042.

53. ) A method of attaching a sensor to a fetus using one or more plastic tubes through the birth canal;

wherein at least one of said tubes serves as a light pipe illuminating the distal end.