VACUUM DELIVERY EXTRACTOR

• US 20090254096A1
• Filed: 05/05/2009
• Published: 10/08/2009
• Est. Priority Date: 11/08/2007
• Status: Abandoned Application

• Current Assignee: Association for Public Health
• Original Assignee: Association For Public Health Service
• Inventors: PORAT, Gadi, COHEN, Yoram
• Application Number:
  US12/435,832
• Publication Number:
  US 20090254096A1
• Time in Patent Office: Days
• US Class Current: 606/123
• CPC Class Codes: A61B 17/442 without pivotal connections, e.g. using vacuum
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 5/0011 Foetal or obstetric data
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1464 specially adapted for foetal tissue
• CPC Class Codes: A61B 5/288 for foetal cardiography, e.g. scalp electrodes
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure

Abstract

A delivery extractor for use with a vacuum suction source and at least one monitor in vacuum assisted deliveries. The extractor comprises a cup-shaped element and a tubular stem joined to the cup-shaped element and in pneumatic communication with the vacuum suction source. The extractor also includes at least one non-invasive sensor positioned on and in mechanical communication with a sensor support so as to continuously contact the scalp of a fetus when the head of the fetus is positioned in the cup-shaped element. The sensor support is compressible within the cup-shaped element. The at least one sensor is in communication with the at least one monitor which monitors at least one physiological indicator of the well-being of the fetus during its transit through the birth canal. The invention also includes a system and method for using the above extractor.

Claims

1. A delivery extractor for use with a vacuum suction source and at least one monitor in a vacuum assisted delivery, said extractor comprising:

a cup-shaped element;

a tubular stem having a first end and a second end, said first end joined to said cup-shaped element and said second end in pneumatic communication with the vacuum suction source; and

at least one non-invasive, resilient sensor positioned on a sensor support, said sensor support compressible within said cup-shape element and movable therein in the direction of said tubular stem and said at least one sensor situated generally in the center of said cup-shaped element so as to be in continuous contact with the scalp of a fetus when the head of the fetus is positioned in said cup-shaped element and the vacuum suction source is activated, said at least one sensor in communication with the at least one monitor which monitors at least one physiological indicator of the well-being of the fetus during the transit of the fetus through the birth canal during a vacuum assisted delivery.

2. An extractor according to claim 1 wherein said sensor support is formed of a resilient material allowing said support to be compressed within said cup-shaped element.

3. An extractor according to claim 1 further including a spring and a sensor housing, said sensor housing being recessed in said sensor support wherein said at least one sensor is positioned in said sensor housing, said at least one sensor protruding therefrom, and said sensor support is in operative connection with a spring which allows said sensor support to be compressed within said cup-shaped element.

4. An extractor according to claim 1, wherein said at least one sensor is a sensor that measures at least one of the following physiological indicators of the well being of the fetus:

fetal heart rate (FHR), fetal pulse rate (FPR) fetal ECG, and fetal blood oxygen levels (oximetry).

5. An extractor according to claim 4, wherein said at least one sensor is an electrically conductive sensor in electrical communication with a set of isolated wires which conduct electrical signals generated by said at least one sensor when said sensor contacts the scalp of the fetus and measures at least one physiological indicator of the well-being of the fetus.

6. An extractor according to claim 5, wherein said isolated wires conduct electrical signals to a wireless transmitter, said wireless transmitter transmitting signals to a wireless receiver in communication with the at least one monitor and said wireless transmitter positioned at a location selected from the following group of locations:

within the hollow of said tubular stem of said extractor and within a grip, said grip located on said stem and operative for holding said extractor while positioning said cup.

7. A system for monitoring the condition of a fetus during the later stages of a vacuum assisted delivery, said system comprising:

a delivery extractor comprising;

a cup-shaped element;

a tubular stem having a first end and a second end, said first end joined to said cup-shaped element; and

at least one non-invasive, resilient sensor positioned on a sensor support, said sensor support compressible within said cup-shape element and movable therein in the direction of said tubular stem and said at least one sensor situated generally in the center of said cup-shaped element so as to be in continuous contact with the scalp of a fetus when the head of the fetus is positioned in said cup-shaped element and the vacuum suction source is activated;

a vacuum suction source removably connectable with said second end of said tubular stem and in pneumatic communication with said cup-shaped element; and

at least one monitor in communication with said at least one sensor and receiving signals therefrom, said at least one monitor monitoring at least one physiological indicator of the well-being of the fetus during the transit of the fetus through the birth canal during the later stages of a vacuum assisted delivery.

8. A system according to claim 7, wherein said sensor support is formed of a resilient material allowing said support to be compressed within said cup-shaped element.

9. A system according to claim 7, further including a spring and a sensor housing, said sensor housing being recessed in said sensor support, wherein said at least one sensor is positioned in said sensor housing said at least one sensor protruding therefrom, and said sensor support is in operative connection with the spring which allows said sensor support to be compressed within said cup-shaped element.

10. A system according to claim 7, wherein said stem is equipped with an emergency suction reduction means which can be activated to interrupt the suction produced by said vacuum suction source when said at least one sensor indicates that the fetus may be in distress or when a physician has otherwise determined that the vacuum delivery procedure must be aborted.

11. A system according to claim 7, wherein said stem is equipped with a vacuum modulating means operative to modulate the vacuum produced by said vacuum suction source when a physician has determined that the vacuum strength is to be increased or decreased during the delivery.

12. A system according to claim 7, wherein said at least one sensor is a sensor that measures at least one of the following physiological indicators of the well being of the fetus:

fetal heart rate (FHR), fetal pulse rate (FPR) fetal ECG, and blood oxygen levels (oximetry).

13. A system according to claim 7, further including a wireless transmitter in communication with said at least one sensor and receiving electrical signals therefrom so as to transmit signals to a wireless receiver in electrical communication with said at least one monitor.

14. A system according to claim 7, wherein said at least one monitor further includes a controller that disconnects said vacuum suction source when said controller detects that the measured physiological indicator of well being is greater or less than predetermined maximum and minimum values for that indicator.

15. A system according to claim 7, wherein said vacuum suction source includes a controller which is operative to disconnect said vacuum suction source when the suction produced by said source exceeds a predetermined value for the maximum suction to be applied or when the total duration during which maximum suction has been applied is greater than a predetermined value for the total duration for which the maximum suction is to be applied.

16. A method for monitoring the well-being of a fetus during a vacuum assisted delivery, said method comprising the steps of:

placing a vacuum assisted delivery extractor on the head of a fetus as it enters the birth canal, thereby to position against the scalp of the fetus at least one non-invasive monitoring sensor for monitoring at least one physiological indicator of the well-being of the fetus;

activating a vacuum suction source during the mother'"'"'s contractions for assisting movement of the fetus along the birth canal and to hold the monitoring sensor in sensory contact with the scalp of the fetus; and

monitoring the at least one physiological indicator of the well-being of the fetus via the at least one non-invasive monitoring sensor as the fetus moves along the birth canal.

17. A method according to claim 16, wherein said step of activating includes allowing the vacuum suction to reach a first value during the mother'"'"'s contractions and then allowing the vacuum suction to reach a second value between the mother'"'"'s contractions, where the second value is less than the first value.

18. A method according to claim 16, wherein said step of activating includes progressively increasing the vacuum suction until a predetermined maximum value for the vacuum suction is attained and then maintaining that value until the mandible of the fetus passes the mother'"'"'s pubic symphysis or until the physician otherwise aborts the vacuum assisted delivery.

19. A method according to claim 16, further including the step of aborting said step of activating a suction source when at least one of the following conditions is indicated:

said step of monitoring indicates that the fetus is in distress;

said step of monitoring indicates that the maximum suction being applied exceeds a predetermined value for the maximum suction to be applied; and

said step of monitoring indicates that the total duration at which the maximum suction has been applied exceeds a predetermined value for the maximum duration.

20. A method according to claim 16, further including the step of modulating the strength of the vacuum produced by the vacuum suction source when at least one of the following conditions is indicated:

said step of monitoring indicates that the fetus is in distress;

said step of monitoring indicates that the maximum suction being applied exceeds a predetermined value for the maximum suction to be applied;

said step of monitoring indicates that the total duration at which the maximum suction has been applied exceeds a predetermined value for the maximum duration; and

the physician has determined that the vacuum suction strength is to be increased or decreased.