Intrauterine pressure catheter system

• US 5,279,308 A
• Filed: 02/19/1993
• Issued: 01/18/1994
• Est. Priority Date: 02/19/1993
• Status: Expired due to Term

• Current Assignee: Graphic Controls Corporation (Nissha Co., Ltd.)
• Original Assignee: Graphic Controls Corporation (Nissha Co., Ltd.)
• Inventors: Thomas, Glenn A., Naphy, Joseph C., Allen, George R., DiSabito, David M., Hubbard, James R.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/019,862
• Time in Patent Office: 333 Days
• Field of Search: 128/675, 128/748, 128/775, 73/715
• US Class Current: 600/588
• CPC Class Codes: A61B 5/035 Intra-uterine probes therefor

Abstract

An intrauterine pressure catheter system for monitoring pressure in the uterus of a mother during labor and delivery. The system includes a reusable junction box with a needle communicating directly to a pressure transducer sensor. The sensor transmits changes in pressure to a conventional pressure monitor. A connector attached to the catheter is pushed into the junction box and is held in place by a plastic latch. Inside this connector are an elastomeric plug and an adjacent diaphragm. When the connector is installed in the junction box, the needle pierces the plug and the tip enters the air-filled volume between the plug and the diaphragm. Fluid pressure in the catheter is communicated to the diaphragm surface and, in turn, passed to the air in the volume between the diaphragm and the plug. Thus, the intrauterine pressure is transmitted directly to the sensor. The system may be zeroed to atmosphere by simply removing the connector from the junction box.

Claims

1. An intrauterine pressure catheter system for monitoring pressure in the uterus of a mother during labor and delivery, said system comprising:

a disposable catheter including a distal end adapted for insertion in the uterus and having;

(a) a lumen disposed partially inside and along the length of said catheter including first apertures located at said distal end of said catheter receiving fluid both from, and indicative of pressure changes in, the uterus, and

(b) a connector mounted on the end of said lumen of said catheter external to the uterus and including an elastomeric plug and a diaphragm, said elastomeric plug and said diaphragm defining an air-filled volume therebetween and said diaphragm communicating the pressure changes indicated by the fluid in said lumen to the air in said air-filled volume while preventing the fluid in said lumen from entering said air-filled volume;

a reusable junction box with an opening and having;

(a) a pressure transducer sensor converting physical pressure signals into corresponding electrical signals, and

(b) a hollow needle communicating directly with said sensor on one end and having a pointed opposite end adapted to pierce said elastomeric plug of said connector and enter said air-filled volume between said elastomeric plug and said diaphragm when said connector is removably inserted into said opening of said junction box, said needle communicating the pressure changes of the air in said air-filled volume to said sensor; and

a monitor receiving and displaying said electronic signals from said sensor.

2. The intrauterine pressure catheter system of claim 1 wherein said connector has a flexible latch releasably holding said connector in said junction box.

3. The intrauterine pressure catheter system of claim 1 where said catheter has a tube disposed partially inside and along the length of said catheter including second apertures located at said distal end of said catheter injecting fluid into and sampling fluid from the uterus.

4. The intrauterine pressure catheter system of claim 3 wherein said lumen and said tube are completely separate and sealed from each other.

5. The intrauterine pressure catheter system of claim 1 wherein said point of said needle is safely located in said junction box about 0.18 inches from said opening of said junction box and centered within said junction box.

6. The intrauterine pressure catheter system of claim 5 wherein said opening of said junction box has a diameter of about 0.3 inches.

7. The intrauterine pressure catheter system of claim 1 wherein said sensor is resiliently mounted in said junction box between a foam seal and a foam pad restricting movement of said sensor and isolating said sensor from mechanical abuse.

8. The intrauterine pressure catheter system of claim 7 wherein said junction box has a pair of deflection barriers further restricting movement of said sensor.

9. The intrauterine pressure catheter system of claim 1 wherein said junction box has an adhesive seal preventing fluid from entering said junction box in the region of said sensor.

10. The intrauterine pressure catheter system of claim 1 wherein said connector has:

(a) an actuator, and

(b) an actuator sleeve in which said elastomeric plug and said diaphragm of said connector are mounted, said actuator sleeve movable by said actuator between a monitor position, in which said actuator sleeve is fully inserted in said opening of said junction box and said needle point pierces said elastomeric plug and enters said air-filled volume between said elastomeric plug and said diaphragm, and a zero position, in which said actuator sleeve is only partially inserted in said opening of said junction box and said needle point is removed from said elastomeric plug and said air-filled volume and is exposed to atmospheric pressure.

11. The intrauterine pressure catheter system of claim 10 wherein said connector has an anti-return arm positioned on said actuator preventing accidental movement of said actuator and minimizing the force required to move said actuator.

12. The intrauterine pressure catheter system of claim 1 wherein said connector has means for affixing said connector to the mother.

13. The intrauterine pressure catheter system of claim 12 wherein said junction box has means for affixing said junction box to the mother.

14. The intrauterine pressure catheter system of claim 1 wherein one of said junction box and said connector has a threaded member connecting said junction box and said connector.

15. The intrauterine pressure catheter system of claim 1 wherein said connector has a self-sealing fill plug permitting access of a syringe to said tube of said

16. The intrauterine pressure catheter system of claim 1 wherein said diaphragm has a tapered conical configuration.

17. The intrauterine pressure catheter system of claim 1 wherein said diaphragm has a bellows configuration.

18. The intrauterine pressure catheter system of claim 1 wherein said diaphragm has at least two axial lobes.