System for measuring intraocular pressure of an eye and a MEM sensor for use therewith

• US 6,447,449 B1
• Filed: 08/21/2000
• Issued: 09/10/2002
• Est. Priority Date: 08/21/2000
• Status: Expired due to Term

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Fleischman, Aaron J., Roy, Shuvo
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/642,573
• Time in Patent Office: 750 Days
• Field of Search: 600/405
• US Class Current: 600/405
• CPC Class Codes: A61B 3/16 for measuring intraocular pressure, e.g. tonometers

Abstract

A tonometer sensor for disposition in proximity to a portion of a surface of eye comprises a substrate including a contact surface for making contact with the surface portion of the eye. The contact surface includes an outer non-compliant region and in inner compliant region fabricated as an impedance element that varies in impedance as the inner region changes shape. A first region of material is responsive to a non-invasive external force to press the contact surface against the surface portion of the eye and cause the compliant region to change shape in proportion to an intraocular pressure of the eye. A second region of conductive material is electrically coupled to the impedance element of the compliant region and is responsive to an external signal for energizing the impedance element so that the intraocular pressure may be determined.

Claims

1. A tonometer sensor for disposition in proximity to a portion of a surface of an eye, said sensor comprising:

a substrate including;

a contact surface for making contact with said surface portion of the eye, said contact surface including an outer non-compliant region and an inner compliant region fabricated as an impedance element that varies in impedance as said inner region changes shape;

a first region of material responsive to a non-invasive external force to press said contact surface against said surface portion of the eye and cause said compliant region to change shape in proportion to an intraocular pressure of the eye; and

a second region of conductive material electrically coupled to said impedance element of said compliant region and responsive to an external signal for energizing said impedance element so that said intraocular pressure may be determined.

2. The sensor of claim 1 wherein the substrate is comprised of silicon material.

3. The sensor of claim 1 wherein the compliant region comprises a diaphragm as one plate of a capacitive element, said diaphragm being separated by a dielectric region from an other plate of the capacitive element that is part of the substrate, said diaphragm flexing closer to said other plate as the contact surface is pressed against the surface portion of the eye to change the capacitance of the capacitive element in proportion to the intraocular pressure of the eye.

4. The sensor of claim 3 wherein the dielectric region comprises air.

5. The sensor of claim 3 wherein the second region of conductive material comprises an inductor coil that is electrically coupled to said capacitive element to form a resonant circuit;

and wherein the external signal comprises an electromagnetic signal that varies in frequency to cause said resonant circuit to be energized and resonate at a frequency in proportion to the capacitance of the capacitive element so that the intraocular pressure may be determined.

6. The sensor of claim 5 wherein the inductor coil is fabricated in the non-compliant region.

7. The sensor of claim 5 wherein the inductor coil is formed by disposing conductive material in a predetermined pattern in the surface of the non-compliant region about the compliant region of the contact surface.

8. The sensor of claim 1 wherein the first region of material comprises a region of magnetic material responsive to the non-invasive external force comprising a magnetic field.

9. The sensor of claim 8 wherein the strength of said magnetic field determines the force at which the contact surface is pressed against the surface portion of the eye.

10. The sensor of claim 8 wherein the substrate includes a second surface opposite the contact surface;

and wherein a layer of the magnetic material is disposed on said second surface such that its North-South poles are aligned substantially along an axis transverse to the contact surface of the substrate, whereby said layer of magnetic material is repelled by the external magnetic field to press the contact surface against the surface portion of the eye.

11. The sensor of claim 1 wherein the contact surface area of the substrate is approximately one square millimeter.

12. A flexible contact lens including a tonometer sensor for disposition in proximity to a portion of a surface of an eye, said lens comprising:

a surface contoured to said surface of the eye for disposition in proximity thereto;

a substrate disposed at said lens surface, said substrate including;

a contact surface for making contact with said surface portion of the eye, said contact surface including an outer non-compliant region and an inner compliant region fabricated as an impedance element that varies in impedance as said inner region changes shape;

a first region of material responsive to a non-invasive external force to press said contact surface against said surface portion of the eye and cause said compliant region to change shape in proportion to an intraocular pressure of the eye; and

a second region of conductive material electrically coupled to said impedance element of said compliant region and responsive to an external signal for energizing said impedance element so that said intraocular pressure may be determined.

13. The lens of claim 12 wherein the lens is comprised of a hydrogel material.

14. The lens of claim 12 wherein the substrate is affixed to the surface of the lens during the lens fabrication process.

15. The lens of claim 12 wherein the substrate is comprised of silicon material.

16. The lens of claim 12 wherein the compliant region comprises a diaphragm as one plate of a capacitive element, said diaphragm being separated by a dielectric region from an other plate of the capacitive element that is part of the substrate, said diaphragm flexing closer to said other plate as the contact surface is pressed against the surface portion of the eye to change the capacitance of the capacitive element in proportion to the intraocular pressure of the eye.

17. The lens of claim 16 wherein the dielectric region comprises air.

18. The lens of claim 16 wherein the second region of conductive material comprises an inductor coil that is electrically coupled to said capacitive element to form a resonant circuit;

and wherein the external signal comprises an electromagnetic signal that varies in frequency to cause said resonant circuit to be energized and resonate at a frequency in proportion to the capacitance of the capacitive element so that the intraocular pressure may be determined.

19. The lens of claim 18 wherein the inductor coil is fabricated in the non-compliant region.

20. The lens of claim 18 wherein the inductor coil is formed by disposing conductive material in a predetermined pattern in the surface of the non-compliant region about the compliant region of the contact surface.

21. The lens of claim 12 wherein the first region of material comprises a region of magnetic material responsive to the non-invasive external force comprising a magnetic field.

22. The lens of claim 21 wherein the strength of said magnetic field determines the force at which the contact surface is pressed against the surface portion of the eye.

23. The lens of claim 21 wherein the substrate includes a second surface opposite the contact surface;

and wherein a layer of the magnetic material is disposed on said second surface such that its North-South poles are aligned substantially along an axis transverse to the contact surface of the substrate, whereby said layer of magnetic material is repelled by the external magnetic field to press the contact surface against the surface portion of the eye.

24. The lens of claim 12 wherein the lens is caused to flex in response to the non-invasive external force to press the contact surface against the surface portion of the eye.

25. The lens of claim 12 wherein the contact surface area of the substrate is approximately one square millimeter.

26. The lens of claim 12 wherein the surface portion of the eye comprises the cornea.

27. A tonometer system comprising:

a flexible contact lens including a surface contoured to a portion of a surface of an eye for disposition in proximity thereto;

a tonometer sensor including a substrate disposed at said lens surface, said substrate including;

a contact surface for making contact with said surface portion of the eye, said contact surface including an outer non-compliant region and an inner compliant region fabricated as an impedance element that varies in impedance as said inner region changes shape;

a first region of material responsive to a non-invasive force signal to press said contact surface against said surface portion of the eye and cause said compliant region to change shape in proportion to an intraocular pressure of the eye; and

a second region of conductive material electrically coupled to said impedance element of said compliant region and responsive to an activation signal for energizing said impedance element; and

a control unit positionable in proximity to said tonometer sensor for generating said non-invasive force signal over a predetermined time interval and for generating said activation signal to measure a signal representative of said intraocular pressure.

28. The tonometer system of claim 27 wherein the first region comprises a magnetic material;

and wherein the control unit includes means for generating a magnetic field as the non-invasive force signal.

29. The tonometer system of claim 28 wherein the control unit includes means for varying the strength of the magnetic field over the predetermined time interval to cause the contact surface to be pressed against and then, released from the surface portion of the eye with a respective varying force.

30. The tonometer system of claim 27 wherein the activation signal is generated during the predetermined time interval.

31. The tonometer system of claim 27 wherein the control unit includes means for generating the activation signal superimposed on the non-invasive force signal.

32. The tonometer system of claim 27 wherein the compliant region comprises a capacitive element which changes capacitance in proportion to its change in shape;

and wherein the second region comprises an inductive coil electrically coupled to said capacitive element to form a resonant circuit; and

wherein the control unit includes;

means for generating an activation signal as an electromagnetic signal that varies over a predetermined frequency range to cause said resonant circuit to resonate; and

means for measuring the resonant frequency of said resonant circuit which is representative of the intraocular pressure of the eye.

33. The tonometer system of claim 32 wherein the electromagnetic signal is generated to vary over the frequency range during the predetermined time interval.

34. The tonometer system of claim 32 wherein the control unit includes means for generating the electromagnetic signal superimposed on the non-invasive force signal.

35. The tonometer system of claim 27 wherein the control unit includes a processing means for measuring signals representative of intraocular pressure at different times during the predetermined time interval;

and a memory for storing the signals representative of the intraocular pressure measured at said different times.

36. The tonometer system of claim 35 wherein the control unit includes means for processing the stored measured signals representative of intraocular pressure to determine a resultant intraocular pressure (IOP) measurement.

37. The tonometer system of claim 36 wherein the control unit includes means for time marking each resultant IOP measurement with a measurement time and for storing said resultant IOP measurements with their corresponding measurement times in the memory.

38. The tonometer system of claim 37 wherein the control unit includes means for transferring the stored resultant IOP measurements and their corresponding measurement times to another system.

39. The tonometer system of claim 27 wherein the control unit includes a display for displaying the intraocular pressure measurements.

40. The tonometer system of claim 27 wherein the control unit comprises a portable, hand held unit.

41. The tonometer system of claim 27 wherein the control unit is an instrument in a doctor'"'"'s office.

42. The tonometer system of claim 27 wherein the contact lens comprises a disposable contact lens.

43. A method of measuring intraocular pressure (IOP) of an eye with a flexible contact lens having a microelectromechanical (MEM) sensor affixed thereto;

said method comprising the steps of;

disposing said contact lens in close proximity to a surface of said eye with a surface of the MEM sensor in juxtaposition with said eye surface;

generating a non-invasive force which presses and releases a compliant region of said surface of the MEM sensor against and from said surface of the eye in accordance with a predetermined force vs. time envelope causing said compliant region that is fabricated as an impedance element to change shape and vary in impedance as a result thereof;

energizing said impedance element a multiplicity of times during said force vs. time envelope;

determining a pressure representative measurement each time the impedance element is energized; and

processing said pressure representative measurements to render a resultant IOP measurement.

44. The method of claim 43 wherein the step of generating includes the steps of:

generating a magnetic field in accordance with a magnetic field strength vs. time envelope; and

causing a permanent magnet region of the MEM sensor to press the surface of the MEM sensor against the surface of the eye with a force in proportion to the magnetic strength of said field.

45. The method of claim 43 wherein the step of energizing includes the step of:

energizing an inductive region of the MEM sensor that is connected to the impedance element which is a capacitive region to cause the circuit combination to resonate.

46. The method of claim 45 wherein the step of energizing includes:

generating an electromagnetic signal with a frequency that is swept through a frequency range over a predetermined time interval, said resonant frequency of the circuit falling within said frequency range.

47. The method of claim 46 wherein the step of determining includes the steps of determining the resonant frequency of the circuit each time the circuit is energized during the force vs. time envelope, said resonant frequencies being sampled data representative of the IOP of the eye at different times.

48. The method of claim 47 wherein the step of processing includes processing the sampled data resonant frequencies to render a resultant IOP measurement.

49. The method of claim 43 including the steps of:

time marking each resultant IOP measurement; and

storing each IOP measurement along with its corresponding measurement time.

50. The method of claim 49 including the step of transmitting said stored IOP measurements and their corresponding measurement times to an external site.

51. The method of claim 43 wherein the steps of generating, energizing, determining and processing are performed autonomously by a control unit disposed in proximity to the lens and MEM sensor.

52. The method of claim 51 including the steps of;

manually positioning the control unit in close proximity to the lens and MEM sensor for measuring the intraocular pressure of the eye; and

manually initiating the steps of generating, energizing, determining and processing.

53. The method of claim 51 including the step of displaying the resultant IOP measurement on the control unit.

54. The method of claim 43 including the step of displaying the resultant IOP measurement.