Tonometer system for measuring intraocular pressure by applanation and/or indentation

• US 5,830,139 A
• Filed: 09/04/1996
• Issued: 11/03/1998
• Est. Priority Date: 09/04/1996
• Status: Expired due to Term

• Current Assignee: Geelux Holdings, Ltd.
• Original Assignee: Marcio M. Abreu
• Inventors: Abreu, Marcio M.
• Primary Examiner(s): Lacyk, John P.
• Assistant Examiner(s): HUANG, STEPHEN D
• Application Number:
  US08/707,508
• Time in Patent Office: 790 Days
• Field of Search: 128/645, 128/646, 128/647, 128/648, 128/649, 128/650, 128/651, 128/652
• US Class Current: 600/405
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/0418 Pen-shaped housings
• CPC Class Codes: A61B 2562/0238 Optical sensor arrangements for performing transmission measurements on body tissue
• CPC Class Codes: A61B 3/1241 specially adapted for observation of ocular blood flow, e.g. by fluorescein angiography
• CPC Class Codes: A61B 3/16 for measuring intraocular pressure, e.g. tonometers
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14555 specially adapted for the eye fundus
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/18 for vehicle drivers or machine operators
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/416 the spleen
• CPC Class Codes: A61B 5/445 Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6814 : Head
• CPC Class Codes: A61B 8/06 : Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61F 9/0017 : implantable in, or in contact with, the eye, e.g. ocular inserts

Abstract

A tonometer system for measuring intraocular pressure by accurately providing a predetermined amount of applanation to the cornea and detecting the amount of force required to achieve the predetermined amount of applanation. The system is also capable of measuring intraocular pressure by indenting the cornea using a predetermined force applied using an indenting element and detecting the distance the indenting element moves into the cornea when the predetermined force is applied, the distance being inversely proportional to intraocular pressure. Also provided is a method of using the tonometer system to measure hydrodynamic characteristics of the eye, especially outflow facility. The tonometer system includes a contact device for placement in contact with the cornea and an actuation apparatus for actuating the contact device so that a portion thereof projects inwardly against the cornea to provide a predetermined amount of applanation. The system further includes a detecting arrangement for detecting when the predetermined amount of applanation has been achieved and a calculation unit responsive to the detecting arrangement for determining intraocular pressure based on the amount of force the contact device must apply against the cornea in order to achieve the predetermined amount of applanation. An indentation distance detection arrangement is also provided for use when intraocular pressure is to be detected by indentation. In carrying out the method, the system is used to detect intraocular pressure between successive steps of forcing intraocular fluid out from the eye.

Claims

1. A device for placement in contact with a cornea and for applanating or indenting the cornea, said device comprising:

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein;

a movable central piece slidably disposed within said hole and having a substantially flat inner side for flattening or indenting a portion of the cornea when the device is located on the cornea; and

a flexible membrane secured to said inner concave surface of the substantially rigid annular member, said flexible membrane being coextensive with at least said hole in the annular member and having at least one transparent area.

2. The device of claim 1, wherein said substantially rigid annular member has a maximum thickness at said hole and a progressively decreasing thickness toward a periphery of said substantially rigid annular member.

3. The device of claim 2, wherein said substantially rigid annular member has a substantially cylindrical wall defined circumferentially around said hole, said movable central piece being slidably disposed within said hole in a piston-like manner.

4. A system for measuring intraocular pressure by indentation, said system comprising:

an indentation device for placement in contact with a cornea and for indenting the cornea, said indentation device comprising;

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein; and

a movable central piece slidably disposed within said hole, said movable central piece being arranged so that sliding thereof toward the cornea causes indentation of a portion of the cornea when the indentation device is located on the cornea;

an actuation apparatus for actuating said movable central piece to cause sliding of said movable central piece so that said movable central piece projects inwardly against said cornea beyond a flattening of the cornea to thereby indent said portion of the cornea using a predetermined amount of force;

distance detection means for detecting a distance travelled by said movable central piece;

means for determining intraocular pressure based on the distance travelled by said movable central piece in response to said predetermined amount of force;

a display for displaying said intraocular pressure and indicating whether the intraocular pressure is within certain ranges so as to determine if action should be taken in connection with the intraocular pressure; and

said ranges being adjustable to compensate for different patient sensitivities to changes in intraocular pressure.

5. The system of claim 4, wherein said movable central piece includes a magnetically responsive element arranged so as to produce sliding of said movable central piece in response to a magnetic field;

and

wherein said actuation apparatus includes means for applying a magnetic field to said movable central piece.

6. The system of claim 5, wherein:

said means for applying a magnetic field includes a coil and means for producing an electrical current through said coil in a progressively increasing manner until said predetermined amount of force is achieved, said electrical current being proportional to the amount of force applied by said movable central piece.

7. A method for non-invasively measuring outflow facility of the eye, said method comprising the steps of:

placing an indentation device in contact with a cornea;

moving at least one portion of said indentation device toward the cornea using a first predetermined amount of force to achieve indentation of the cornea;

determining an intraocular pressure based on a first distance travelled toward the cornea by said at least one portion of said indentation device during application of said first predetermined amount of force;

rapidly reciprocating said at least one portion toward and away from the cornea at a first predetermined frequency and using a second predetermined amount of force during movement toward the cornea to thereby force intraocular fluid out from the eye, said second predetermined amount of force being less than said first predetermined amount of force;

moving said at least one portion toward the cornea using a third predetermined amount of force to achieve indentation of the cornea;

determining a second intraocular pressure based on a second distance travelled toward the cornea by said at least one portion of said indentation device during application of said third predetermined amount of force;

again rapidly reciprocating said at least one portion toward and away from the cornea, at a second predetermined frequency and using a fourth predetermined amount of force during movement toward the cornea, to thereby force more intraocular fluid out from the eye, said fourth predetermined amount of force being greater than said second predetermined amount of force;

subsequently moving said at least one portion toward the cornea using a fifth predetermined amount of force to again achieve indentation of the cornea;

determining a third intraocular pressure based on a third distance travelled toward the cornea by said at least one portion of said indentation device during application of said fifth predetermined amount of force;

calculating differences between said first, second, and third distances, said differences being indicative of the amount of intraocular fluid which left the eye and therefore being indicative of the outflow facility.

8. The method of claim 7, and further comprising the steps of:

plotting the differences between the first, second, and third distances to a create a graph of said differences; and

comparing said graph of said differences to that of a normal eye to determine if any irregularities in outflow facility are present.

9. A contact device for detecting intraocular pressure, said contact device comprising:

a contact structure shaped for placement on a patient'"'"'s cornea;

a transducer disposed in said contact structure, said transducer being responsive to pressure exerted on said transducer, so as to provide an output signal indicative of said pressures transducer being responsive to pressure generated by sliding and squeezing of said transducer by an eye lid during closure of the eye lid.

15. The device of claim 9, and further comprising an annular flexible membrane connected to said substantially rigid annular member and also connected to the movable central piece in such a way that a membrane hole in said annular flexible membrane is aligned with said transparent central region of the annular magnet. applanation.

10. A method for detecting pressure comprising the steps of:

mounting, on a surface of a cornea of an eye, a pressure sensitive transducer which is responsive to pressure generated by sliding and squeezing of said pressure sensitive transducer by an eye lid during closure of said eye lid associated with said eye; and

activating said pressure sensitive transducer by sliding and squeezing of said pressure sensitive transducer by said eye lid during closure of said eye lid.

35. A method for detecting pressure as claimed in claim 10, wherein signals indicative of pressure are transmitted through the eye lid by electromagnetic waves.

11. A device for placement in contact with a cornea and for applanating or indenting the cornea, said device comprising:

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein; and

a movable central piece slidably disposed within said hole and having a substantially flat inner side for flattening or indenting a portion of the cornea when the device is located on the cornea;

said movable central piece having a substantially transparent peripheral portion.

12. A device for placement in contact with a cornea and for applanating or indenting the cornea, said device comprising:

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein; and

a movable central piece slidably disposed within said hole and having a substantially flat inner side for flattening or indenting a portion of the cornea when the device is located on the cornea; and

said movable central piece including a transparent central portion.

13. A device for placement in contact with a cornea and for applanating or indenting the cornea, said device comprising:

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein; and

a movable central piece slidably disposed within said hole and having a substantially flat inner side for flattening or indenting a portion of the cornea when the device is located on the cornea;

means for actuating said movable central piece to cause sliding of said movable central piece so that said movable central piece projects inwardly against said cornea to flatten or indent said portion of the cornea, said means for actuating being configured such that an inside of a patient'"'"'s eye remains visible during actuation.

19. The system of claim 13, wherein said means for determining intraocular pressure includes:

memory means for storing a value indicative of said amount of force when said predetermined amount of applanation is achieved; and

means for multiplying said amount of force by a conversion factor which converts said amount of force to intraocular pressure.

20. The system of claim 13, further comprising a display for displaying said intraocular pressure.

21. The system of claim 20, wherein said display is arranged so as to indicate whether the intraocular pressure is within certain ranges, each of said ranges being associated with what, if any, action should be taken in connection with the intraocular pressure, and

wherein said ranges are adjustable to compensate for different patient sensitivities to changes in intraocular pressure.

22. The system of claim 13, wherein said movable central piece includes a magnetically responsive element arranged so as to produce sliding of said movable central piece in response to a magnetic field;

and

wherein said actuation apparatus includes means for applying a magnetic field to said movable central piece.

23. The system of claim 22, wherein:

said means for applying a magnetic field includes a coil and means for producing an electrical current through said coil in a progressively increasing manner until said predetermined amount of applanation is achieved, said electrical current being proportional to the amount of force applied by said movable central piece; and

said means for determining intraocular pressure includes means for storing a current value indicative of an amount of current passing through said coil when said predetermined amount of applanation is achieved and means for converting said current value into an indication of intraocular pressure.

27. The system of claim 22, wherein said alignment means include an optical alignment mechanism.

14. A device for placement in contact with a cornea and for applanating or indenting the cornea, said device comprising:

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein;

a movable central piece slidably disposed within said hole and having a substantially flat inner side for flattening or indenting a portion of the cornea when the device is located on the cornea;

said movable central piece including a magnetically responsive element arranged so as to produce sliding of said movable central piece in response to a magnetic field, said magnetically responsive element being circumferentially surrounded by a transparent peripheral portion which permits light to pass therethrough to the cornea and permits reflection of said light from the cornea back through said transparent peripheral portion.

16. A device for placement in contact with a cornea and for applanating or indenting the cornea, said device comprising:

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein;

a movable central piece slidably disposed within said hole and having a substantially flat inner side for flattening or indenting a portion of the cornea when the device is located on the cornea;

said movable central piece including a magnetically responsive element arranged so as to produce sliding of said movable central piece in response to a magnetic field, said magnetically responsive element including an annular magnet with a transparent central region through which a patient is able to see while the device is located on the patient'"'"'s cornea and which permits light to pass therethrough to the cornea and permits reflection of said light from the cornea back through said transparent central region.

17. The device of claim 16, and further comprising an annular flexible membrane connected to said substantially rigid annular member and also connected to the movable central piece in such a way that a membrane hole in said annular flexible membrane is aligned with said transparent central region of the annular magnet.

18. A system for measuring intraocular pressure by applanation, said system comprising:

a device for placement in contact with a cornea and for applanating the cornea, said device comprising;

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein; and

a movable central piece slidably disposed within said hole and having a substantially flat inner side for flattening a portion of the cornea while the device is located on the cornea;

an actuation apparatus for actuating said movable central piece to cause sliding of said movable central piece so that said movable central piece projects inwardly against said cornea to flatten said portion of the cornea;

detection means for detecting when a predetermined amount of applanation of the cornea has been achieved; and

means for determining intraocular pressure based on an amount of force said movable central piece must apply against the cornea in order to achieve said predetermined amount of applanation;

said movable central piece including at least one transparent area, and wherein said detection means comprises an optical detection system including;

a source of light for emitting a primary beam of light toward the cornea through said at least one transparent area, said primary beam of light being reflected back through the device by the cornea, when said device is located on the cornea, in a manner indicative of the amount of applanation of the cornea; and

a light sensor arranged with respect to said reflected beam of light so as to produce an output signal indicative of the amount of applanation.

24. A system for measuring intraocular pressure by applanation, said system comprising:

a device for placement in contact with a cornea and for applanating the cornea, said device comprising;

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein; and

a movable central piece slidably disposed within said hole and having a substantially flat inner side for flattening a portion of the cornea while the device is located on the cornea;

an actuation apparatus for actuating said movable central piece to cause sliding of said movable central piece so that said movable central piece projects inwardly against said cornea to flatten said portion of the cornea;

detection means for detecting when a predetermined amount of applanation of the cornea has been achieved;

means for determining intraocular pressure based on an amount of force said movable central piece must apply against the cornea in order to achieve said predetermined amount of applanation; and

sighting means for indicating when said actuation apparatus and said detection means are properly aligned with said device.

25. A system for measuring intraocular pressure by applanation, said system comprising:

a device for placement in contact with a cornea and for applanating the cornea, said device comprising;

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein; and

a movable central piece slidably disposed within said hole and having a substantially flat inner side for flattening a portion of the cornea while the device is located on the cornea;

an actuation apparatus for actuating said movable central piece to cause sliding of said movable central piece so that said movable central piece projects inwardly against said cornea to flatten said portion of the cornea;

detection means for detecting when a predetermined amount of applanation of the cornea has been achieved;

means for determining intraocular pressure based on an amount of force said movable central piece must apply against the cornea in order to achieve said predetermined amount of applanation; and

distance measurement means for indicating whether said device is at a proper axial distance from said actuation apparatus and said detection means.

26. A system for measuring intraocular pressure by applanation, said system comprising:

a device for placement in contact with a cornea and for applanating the cornea, said device comprising;

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein; and

a movable central piece slidably disposed within said hole and having a substantially flat inner side for flattening a portion of the cornea while the device is located on the cornea;

an actuation apparatus for actuating said movable central piece to cause sliding of said movable central piece so that said movable central piece projects inwardly against said cornea to flatten said portion of the cornea;

detection means for detecting when a predetermined amount of applanation of the cornea has been achieved;

means for determining intraocular pressure based on an amount of force said movable central piece must apply against the cornea in order to achieve said predetermined amount of applanation; and

alignment means for indicating whether said device is properly aligned with said actuation apparatus and said detection means.

28. A system for measuring intraocular pressure by applanation, said system comprising:

a device for placement in contact with a cornea and for applanating the cornea, said device comprising;

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein; and

a movable central piece slidably disposed within said hole and having a substantially flat inner side for flattening a portion of the cornea while the device is located on the cornea;

an actuation apparatus for actuating said movable central piece to cause sliding of said movable central piece so that said movable central piece projects inwardly against said cornea to flatten said portion of the cornea;

detection means for detecting when a predetermined amount of applanation of the cornea has been achieved;

means for determining intraocular pressure based on an amount of force said movable central piece must apply against the cornea in order to achieve said predetermined amount of applanation; and

said actuation apparatus being configured such that an inside of a patient'"'"'s eye remains visible during actuation.

29. A system for measuring intraocular pressure by indentation, said system comprising:

an indentation device for placement in contact with a cornea and for indenting the cornea, said indentation device comprising;

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein; and

a movable central piece slidably disposed within said hole, said movable central piece being arranged so that sliding thereof toward the cornea causes indentation of a portion of the cornea when the indentation device is located on the cornea;

an actuation apparatus for actuating said movable central piece to cause sliding of said movable central piece so that said movable central piece projects inwardly against said cornea beyond a flattening of the cornea to thereby indent said portion of the cornea using a predetermined amount of force;

distance detection means for detecting a distance traveled by said movable central piece; and

means for determining intraocular pressure based on the distance traveled by said movable central piece in response to said predetermined amount of force;

said movable central piece having a substantially reflective portion and wherein said distance detection means comprises an optical distance detection system including;

a source of light for emitting a primary beam of light toward said substantially reflective portion, said primary beam of light being reflected by said substantially reflective portion in a manner indicative of the distance traveled by the movable central piece toward the cornea, to thereby produce a reflected beam of light; and

a light sensor arranged with respect to said reflected beam of light so as to produce an output signal indicative of the distance traveled.

30. A system for measuring intraocular pressure by applanation, said system comprising:

a device for placement in contact with a cornea and for applanating the cornea, said device comprising;

a substantially rigid annular member having an inner concave surface shaped to match an outer surface of the cornea and having a hole defined therein; and

a movable central piece slidably disposed within said hole and having a substantially flat inner side for flattening a portion of the cornea while the device is located on the cornea;

an actuation apparatus for actuating said movable central piece to cause sliding of said movable central piece so that said movable central piece projects inwardly against said cornea to flatten said portion of the cornea;

detection means for detecting when a predetermined amount of applanation of the cornea has been achieved; and

means for determining intraocular pressure based on an amount of force said movable central piece must apply against the cornea in order to achieve said predetermined amount of applanation;

said actuation apparatus being configured such that an inside of a patient'"'"'s eye remains visible during actuation.

31. A contact device for detecting intraocular pressure, said contact device comprising:

a contact structure shaped for placement on a patient'"'"'s cornea;

a transducer disposed in said contact structure, said transducer being responsive to pressure exerted on said transducer, so as to provide an output signal indicative of said pressure;

said transducer being a passive transducer having a resonant frequency which varies in accordance with said pressure.

32. A device for placement in contact with a body part and for applanating or indenting the body part, said device comprising:

a substantially rigid member having an inner surface shaped to match an outer surface of the body part and having a hole defined therein;

a movable central piece slidably disposed within said hole and having a substantially flat inner side for flattening or indenting a portion of the body part when the device is located on the body part; and

a flexible membrane secured to said inner surface of the substantially rigid member, said flexible membrane being coextensive with at least said hole in the rigid member and having at least one transparent area.

33. A system for measuring internal pressure by indentation, said system comprising:

an indentation device for placement in contact with a body part and for indenting the body part, said indentation device comprising;

a substantially rigid member having an inner surface shaped to match an outer surface of the body part and having a hole defined therein; and

a movable central piece slidably disposed within said hole, said movable central piece being arranged so that sliding thereof toward the body part causes indentation of a portion of the body part when the indentation device is located on the body part;

an actuation apparatus for actuating said movable central piece to cause sliding of said movable central piece so that said movable central piece projects inwardly against said body part beyond a flattening of the body part to thereby indent said portion of the body part using a predetermined amount of force;

distance detection means for detecting a distance traveled by said movable central piece; and

means for determining internal pressure based on the distance traveled by said movable central piece in response to said predetermined amount of force;

said movable central piece having a substantially reflective portion and wherein said distance detection means comprises an optical distance detection system including;

a source of light for emitting a primary beam of light toward said substantially reflective portion, said primary beam of light being reflected by said substantially reflective portion in a manner indicative of the distance traveled by the movable central piece toward the body part, to thereby produce a reflected beam of light; and

a light sensor arranged with respect to said reflected beam of light so as to produce an output signal indicative of the distance traveled.

34. A contact device for detecting internal pressure, said contact device comprising:

a contact structure shaped for placement on a patient'"'"'s body part;

a transducer disposed in said contact structure, said transducer being responsive to pressure exerted on said transducer, so as to provide an output signal indicative of said pressure;

said transducer being a passive transducer having a resonant frequency which varies in accordance with said pressure.

36. A method for measuring hydrodynamics and movement of fluid out of an eye, said method comprising:

rapidly reciprocating, using oscillatory motion, a device in contact with the eye at a predetermined frequency that prevents the stress relaxation of the coats of the eye, and

determining a change in pressure in the eye between the initial pressure of the eye before the oscillatory motion of the device is applied and a pressure inside the eye after the oscillatory motion of the device is applied which is indicative of an amount of outflow out of the eye.

37. A method for early detection of glaucoma, said method comprising:

progressively artificially increasing pressure in an eye, and

simultaneously measuring said pressure in the eye while identifying physical and chemical changes that occur in the eye according to each progressive level of pressure by monitoring accumulation of compounds in fluid or tissues of the eye and monitoring change in transparency in the fluid or the tissues of the eye.

38. A method for early detection of glaucoma as claimed in claim 37, wherein one of the compounds being monitored is glutamate.