Fetal oximetry system and sensor

• US 7,469,158 B2
• Filed: 10/01/2004
• Issued: 12/23/2008
• Est. Priority Date: 06/17/1997
• Status: Expired due to Term

• Current Assignee: RIC INVESTMENTS LLC (Respironics Incorporated)
• Original Assignee: RIC INVESTMENTS LLC (Respironics Incorporated)
• Inventors: Smith, Steven R., Cutler, Christopher A., Tu, Nick, Banks, Trent W., Wallace, William D., McGraw, Daniel J., Montagnoli, Clifford G.
• Primary Examiner(s): Winakur; Eric F
• Assistant Examiner(s): Berhanu; Etsub D
• Application Number:
  US10/957,430
• Publication Number:
  US 20050283059A1
• Time in Patent Office: 1,544 Days
• Field of Search: 600/313, 600/325, 600/328, 600/338, 600/339, 600/351
• US Class Current: 600/338
• 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 5/6848 Needles
• CPC Class Codes: A61B 5/6882 Anchoring means

Abstract

An optical measuring device having multiple optical paths between one or more light emitters and one or more light detectors and/or providing at least two sets of wavelength of light along at least one path, with a final measurement being produced as a combination of measurements of the sets of wavelengths of light taken along one or more of the optical paths. Features that contribute to increased safety and ease of use include providing (1) a receiving cavity in a proximal end of an insertion rod that holds a free end of a circuit connector to keep it from becoming tangled or snagged, (2) a mechanism to keep the sensor within an introducer tube during storage and insertion and to expose a portion of the sensor only when the sensor is applied to the unborn baby, (3) a tab on the insertion rod to prevent the circuit connector from becoming tangled or snagged within the introducer tube, (4) a rotating feature whereby if a torque applied on the sensor exceeds a first predetermined amount, the sensor rotates, and a disengaging feature whereby the sensor detaches from insertion rod if a pull-off force exceeds a second predetermined amount, the rotating and disengaging features being independent of one another, (5) a circuit connector that includes at least one of the following features: (a) a stiffening member provided at the proximal end to minimize bending, (b) a shielding layer, and (c) at least one slit to increase the flexibility of the circuit connector, and (6) an interface that includes an identification element that is detected by an external circuit only if the circuit connector is connected to the interface. The present invention also pertains to a method of manufacturing a needle that is used in an invasive sensor, and preferably for fetal monitoring, that provides features not heretofore available in conventional sensors.

Claims

1. A physiological condition measuring device comprising:

an insertion rod;

a sensor selectively attached to a distal end of said insertion rod;

a circuit connector having a distal end coupled to said sensor and a proximal end that selectively couples said sensor to an external circuit;

an introducer tube selectively positioned relative to said insertion rod so as to house at least a portion of said insertion rod therein with said circuit connector extending along at least a portion of a length of said insertion rod between said insertion rod and said introducer tube, said introducer tube being moveable in an axial direction relative to said insertion rod;

a mechanism that selectively couples said insertion rod and said introducer tube to maintain said introducer tube in a first position relative to said insertion rod wherein said sensor is located entirely within said introducer tube and that permits said introducer tube to be moved to a second position relative to said insertion rod wherein at least a portion of said sensor is located outside said introducer tube;

wherein said mechanism is a deflectable tab disposed on said insertion rod, said tab being deflectable from a non-deflected position to a deflected position, in said deflected position, said tab provides a configuration that permits a first portion of said tab to insert between a portion of said introducer tube and said insertion rod, with said tab being biased into an engaged relation with said introducer tube to maintain said introducer tube in said first position, and wherein removing said tab from within said introducer tube causes said tab to move to its non-deflected position out of a path of movement of said introducer tube relative to said insertion rod to permit said introducer tube to be moved to said second position; and

further comprising a first tab provided on a side of said insertion rod opposite a side on which said deflectable tab is located, said first tab being sized and configured to provide a force on said introducer tube opposite a force provided thereon by said deflectable tab responsive to said deflectable tab being biased into said engaged relation with said introducer tube.

2. A physiological condition measuring device comprising:

an insertion rod;

a sensor selectively attached to a distal end of said insertion rod, said sensor and an associated portion of said insertion rod being sized and configured such that said sensor rotates relative to said insertion rod if a torque applied on said sensor by said insertion rod exceeds a first predetermined amount and said sensor disconnects from said distal end of said insertion rod if a pull-off force exerted on said sensor by said insertion rod exceeds a second predetermined amount, wherein said first predetermined amount of torque necessary to cause rotation is independent of said second predetermined amount of force necessary to cause said sensor to disconnect from said insertion rod;

a circuit connector having a distal end coupled to said sensor and a proximal end that selectively couples said sensor to an external circuit;

an introducer tube selectively positioned relative to said insertion rod so as to house at least a portion of said insertion rod therein with said circuit connector extending along at least a portion of a length of said insertion rod between said insertion rod and said introducer tube, said introducer tube being moveable in an axial direction relative to said insertion rod;

an applicator provide at said distal end of said insertion rod to selectively attach said sensor to said insertion rod, wherein said applicator includes a plurality of walls defining an opening, each wall being attached at its base to a remainder of said applicator and being separated from adjacent walls by a slot so that each wall is adapted to flex in a direction generally perpendicular to its base to permit rotation of said sensor within said opening if said torque applied on said sensor by said insertion rod via said applicator exceeds said first predetermined amount; and

wherein said sensor includes a cup and a needle mounted in said cup, said cup having a base portion adapted to fit within said opening defined by said plurality of walls, wherein said base portion includes at least one protrusion on a surface thereof, and wherein an interior surface of at least one of said walls includes a groove, said protrusion and said groove being sized and configured such that said grooves selectively receives said protrusion responsive to said base portion of said cup being disposed in said opening of said applicator.

3. A physiological condition measuring device according to claim 2, wherein said cup has a slit defined at a side there, said slit providing a passageway from an interior cavity of said cup to an external portion of said cup, said passageway being defined by four walls and being sized to receive said distal end of said circuit connector.