Subcutaneous radiation reflection probe

• US 5,662,103 A
• Filed: 10/04/1994
• Issued: 09/02/1997
• Est. Priority Date: 02/17/1993
• Status: Expired due to Term

• Current Assignee: Utah Medical Products Incorporated
• Original Assignee: Utah Medical Products Incorporated
• Inventors: Smith, Roger E., Neese, Jon
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US08/317,858
• Time in Patent Office: 1,064 Days
• Field of Search: 128/632, 128/633, 128/634, 128/642, 128/664, 128/665, 128/670, 128/698, 607/92, 356/39-41
• US Class Current: 600/338
• 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 5/4362 Assessing foetal parameters
• CPC Class Codes: A61B 5/6839 Anchoring means, e.g. barbs
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6882 Anchoring means

Abstract

A subcutaneous radiation reflection probe for measuring oxygen saturation in living tissue includes an elongate drive shaft on one end of which is detachably coupled a mounting cup. The mounting cup includes a hollow for receiving and holding a base element on which is mounted a spiral needle which coils outwardly from the mounting cup to terminate in a pointed end. A window is formed in the spiral needle near the pointed end thereof for receiving and holding a radiation emitter, such as a light emitting diode. A radiation detector is disposed on the base element within the coil of the spiral needle. The probe may be used to measure oxygen saturation in living tissue, such as a fetal scalp, by inserting the mounting cup and drive shaft through an introducer into a woman'"'"'s vagina until the spiral needle contacts the fetal scalp. The drive shaft may then be rotated so that the spiral needle rotates into the scalp, after which energizing pulses are applied to the radiation emitter to cause it to emit radiation and illuminate the fetal scalp tissue into which the needle is inserted. The radiation detector detects a portion of this radiation, depending upon the oxygen saturation of the tissue, and develops a signal to thus provide a measure of the oxygen saturation.

Claims

1. A subcutaneous reflection probe apparatus for measuring E/M radiation from illuminated tissue comprising a probe, said probe comprising;

a hollow needle having a pointed free end for insertion in the tissue and a base end, with a window formed in a wall of the needle,

a radiation emitter means disposed in the hollow of the needle for selectively emitting radiation through the window to illuminate the tissue, the radiation emitter means comprising a radiation generating device positioned at the window,

a base element on which the base end of the needle is secured, and

a radiation detector means, disposed on the probe and toward the tissue when the free end of the needle is inserted therein, for measuring the radiation from the illuminated tissue, the radiation detector means and the radiation emitter means being positioned with respect to each other so that the radiation detector means is substantially off any optical line-of-sight with the window such that the distance traveled by the radiation between the radiation emitter means and the radiation detector means is longer than any straight-line distance between the radiation emitter means and the radiation detector means and such that the radiation received by the radiation detector means is modulated by the tissue.

2. A probe as in claim 1 wherein the needle is formed into a spiral, and wherein the window is formed at a convex curvature portion of the needle.

3. A probe as in claim 2 wherein the needle is disposed so that its imaginary spiral axis intersects the radiation detector means.

4. A probe as in claim 2 further including a transparent potting material disposed in the window of the needle over the radiation emitter means to hold the radiation emitter means in place in the needle.

5. A probe as in claim 2 further including a receptacle open at a top thereof, into which the base element disposed so that the needle extends out the top of the receptacle.

6. A probe as in claim 5 further including a transparent potting material disposed in the receptacle over the base element and about a portion of the needle to hold the base element and needle in place in the receptacle.

7. A probe as in claim 6 wherein said needle spiral comprises two turns, a first one of which is disposed in the potting material and the second of which extends from the potting material, out the receptacle.

8. A probe as in claim 2 further including a base element mounting cup comprising a body having a receiving hollow formed at a top thereof for receiving and holding the base element so that the needle extends upwardly and out of the hollow, and having a slot formed on an underside thereof for receiving an end of a drive shaft so that the mounting cup is caused to rotate as the drive shaft is rotated, the mounting cup also having a rotational resistance which has a predetermined release level.

9. A probe as in claim 8 wherein the receiving hollow is formed with opaque sidewalls which at least partially surround and block ambient light from reaching the radiation detector means disposed on the base element.

10. A probe as in claim 9 wherein the sidewalls of the hollow include an opening to allow electrical conductors connected to the base element to exit from the hollow.

11. A probe as in claim 8 wherein the slot is formed to have a generally rectangular bottom-view cross-section with a back wall, an opening opposite the back wall, and spaced-apart parallel sidewalls which slope downwardly and inwardly towards one another in a dovetail fashion, said probe further including an elongate drive shaft, one end of which is formed to have a generally rectangular end-view cross-section just dimensionally smaller than the rectangular cross-section of the slot, with upwardly and outwardly flaring sidewalls to fit snugly in the slot when slid therein through the opening.

12. A probe as in claim 11 wherein the rectangular cross-section of the end of the drive shaft having a plurality corners, each of the corners being rounded to allow slipping of the drive shaft in the slot when the rotational resistance of the mounting cup exceeds a predetermined level.

13. A probe as in claim 11 wherein the sidewalls of said one end of the drive shaft, and the sidewalls of said slot are dimensioned to allow the one end of the drive shaft to be pulled downwardly and out of the slot when a certain force is applied to the drive shaft.

14. A probe as in claim 13 wherein the force required to pull the one end of the drive shaft from slot is about one pound.

15. A probe as in claim 11 wherein said drive shaft is generally laterally flexible and longitudinally and torsionally inflexible.

16. A probe as in claim 1 wherein the radiation emitter means comprises first and second radiation emitters disposed side by side in the window of the needle for alternately emitting radiation.

17. A probe as in claim 16 wherein the radiation emitters comprise light-emitting diodes.

18. A probe as in claim 17 wherein one light-emitting diode is a red light emitter, and wherein the other light-emitting diode is an infrared light emitter.

19. A probe as in claim 17 wherein one light-emitting diode is of a first polarity, and wherein the other light-emitting diode is of a second polarity, opposite the first polarity, said radiation emitter means further comprising means for supplying alternating current to the two light-emitting diodes to cause the light-emitting diodes to alternately emit light.

20. A probe as in claim 19 wherein said radiation emitter means further includes a flexible, elongate insulator, wherein said alternating current supplying means includes a pair of conductors disposed in parallel on the insulator, and wherein the two light-emitting diodes are disposed in line with one another and with the two conductors on the insulator at one end thereof, and are coupled to the conductors.

21. A probe as in claim 20 wherein said radiation emitter means further includes an insulative coating disposed over the conductors, light-emitting diodes, and insulator.

22. A probe as in claim 1 further including

an elongate multiple-conductor flexible circuit, one end of which is coupled to the radiation emitter means for delivering electrical signals thereto, and to the radiation detector means for carrying signals therefrom, and

clip means for coupling electrically to the other end of the flexible circuit and to a plurality of conductors thereof.

23. A probe as in claim 22 wherein said clip means comprises

a base plate including a groove for receiving said other end of the flexible circuit, and

an angled pivot finger pivotally joined to the base plate, said pivot finger having a first branch which is biased to lie flat over a portion of the base plate, and a second branch which extends at an angle upwardly from the first branch and which, when pressed downwardly, causes the first branch to pivot away from the base plate.

24. A probe as in claim 23 wherein said flexible circuit includes a multiplicity of electrical contact pads disposed at said other end and connected to respective conductors of the flexible circuit, and wherein said clip means further includes a multiplicity of electrical contact pins disposed in the groove of the base plate of the second finger to contact respective contact pads when said one end of the flexible circuit is placed in the groove, and the first branch is biased into contact with the base plate.

25. A probe as in claim 24 wherein the flexible circuit further includes an alignment hole therein, located at said other end, and wherein the clip means further includes an alignment pin in said groove for insertion into the alignment hole when said other end of the flexible circuit is placed in the groove of the base plate.

26. A probe as in claim 22 further including an elongate tubular member having a bore with a generally oval cross-section, and wherein said flexible circuit is generally flat to fit snugly into the bore of the tubular member so that when the tubular member is rotated, the flexible circuit is caused to rotate.

27. A probe as in claim 22 further including an elongate drive shaft, one end for joining to the base element and the other end for gripping to enable manually pushing said one end and base element, with the flexible circuit, through a tubular guide, said drive shaft including an enlargement located between said one end and other end.

28. A probe as in claim 27 wherein said other end of the drive shaft includes a handle for gripping by a user, said handle including a retainer means for holding the flexible circuit at the other end thereof in a fixed position relative to the handle.

29. A probe as in claim 28 wherein said retainer means comprises a groove into which the flexible circuit may be inserted for retention, and a keeper means for releasably holding the flexible circuit in the groove.

30. A probe as in claim 22 wherein said flexible circuit further includes a reference electrode conductor, and a heart rate conductor coupled to the needle, and wherein said probe further includes an insulative covering disposed over the flexible circuit except for said reference electrode conductor.

31. A probe as in claim 30 wherein said flexible circuit comprises

an elongate, generally flat insulator,

a plurality of conductors disposed in parallel on the insulator, wherein said reference electrode conductor is disposed on the insulator generally in parallel with said plurality of conductors, and

an insulative covering disposed over said plurality of conductors and the insulator, leaving said reference electrode conductor exposed.

32. A probe as in claim 31 wherein said reference electrode conductor comprises a gold-plated copper trace.

33. A subcutaneous reflectance oximeter comprising

an elongate shaft having a grasping end and a probe end,

a base mounted on the probe end of the shaft such that the base may be removed from the shaft,

a spiral needle mounted on the base to coil outwardly therefrom about an axis which is generally collinear with a long axis of the shaft, said needle terminating in a point and including an opening in a side thereof,

light emitting means disposed in the needle for selectively emitting light through the opening into tissue in which the needle is inserted, the light emitting means comprising a light generating device positioned at the opening, and

light detecting means, attached to the base, for detecting light reaching the detecting means from illuminated tissue, the opening being positioned on the spiral needle so that the light detecting means is substantially off any optical line-of-sight with the opening and so that light emitted from the light emitting means must travel a path from the light emitting means to the light detecting means which is longer than any straight-line distance between the light emitting means and the light detecting means and such that light received by the light detecting means is modulated by the tissue.

34. An oximeter as in claim 33 wherein said opening in the needle is disposed on a convex portion of the needle to face radially outwardly from the needle axis, and wherein the detecting means is disposed on the base generally coincident with the needle axis to face outwardly in a direction in which the needle coils.

35. An oximeter as in claim 33 wherein the light emitting means comprises a pair of light-emitting elements for alternately emitting light, each of different wavelength.