Abstract:
An improved apparatus and method of intraocular pressure determination is disclosed in which applanation tonometery is done simultaneously with pachymetry. The method allows for increased accuracy of intraocular pressure determination based upon adjustments of applanation tonometry for corneal thickness. The device allows an untrained operator to quickly and easily determine the accurate intraocular pressure.

Description:
CROSS REFERENCE TO RELATED APPLICATION  
       [0001]     This non provisional patent application claims priority to the provisional patent application having Ser. No. 60/489,681, which was filed on Jul. 24, 2003. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention is a novel applanation tonometer used to accurately measure intraocular pressures for the purpose of diagnosing and monitoring treatment for glaucoma and ocular hypertension. Specifically, the applanation is done with both an ultrasonic transducer that measures corneal thickness at the point of applanation and an intraocular pressure (IOP) measuring transducer. Since applanation pressure is a function of corneal thickness, the simultaneous determination of both variables at the same location allows for more accurate determination of intraocular pressure. The configuration of the applanation IOP measuring transducer and the ultrasonic transducer allows a minimally trained operator to determine the precise endpoint of applanation.  
       BACKGROUND OF THE INVENTION  
       [0003]     Glaucoma refers to a specific pattern of optic nerve damage and visual field loss caused by a number of different eye diseases. Frequently, these diseases are characterized by elevated intraocular pressure; a leading risk factor for development of glaucoma. Millions of people worldwide suffer from glaucoma, at least half of which do not know they have the disease because glaucoma has no symptoms until there is generally irreversible vision loss. Devices that measure intraocular pressure are referred to as tonometers.  
         [0004]     Applanation tonometery was popularized by Goldmann as an improved method of intraocular pressure determination in comparison to indentation tonometery or invasive intraocular pressure measurements. Goldmann applanation tonometery uses and indirect pressure measurement technique based on the Imbert-Fink principal which teaches that pressure inside a liquid filled sphere can be determined by measuring the force required to flatten a portion of the surface. There are several indirect measurement devices in addition to the Goldmann tonometer that have been conceived, e.g. the Mackey Marg, Perkins and Draeger to name a few. They measure either the degree of indentation of the cornea produced by an application probe or they measure the force required for the probe to flatten a defined area of the cornea. Details of such previous devices are widely available in numerous textbooks and will not be discussed herein.  
         [0005]     It will be obvious to one knowledgeable in the art that variations in thickness of the cornea would affect the accuracy of its applanation in the indirect measuring techniques. Specifically, a thinner than normal cornea would applanation easier than a normal thickness cornea, thereby generating a falsely low measure of intraocular pressure. Conversely, a thicker than normal cornea would overestimate the true intraocular pressure. Since the diagnosis of glaucoma and the assessment of the adequacy of treatment are largely dependent upon intraocular pressure, the accuracy of intraocular pressure measurements is of paramount importance. Presently, in order to determine variations in corneal thickness, prior art has used pachymetry by optical or ultrasonic means to measure corneal thickness. It is time-consuming and expensive to use a second instrument, e.g. an ultrasonic pachymeter, sequentially with the tonometer. Moreover, it is impossible to know if the portion of the cornea applanated for tonometery was the portion whose thickness was measured. Further, the determination of both applanation tonometery and corneal pachymetry requires solving and equation in order to calculate the true intraocular pressure. As a result, the correction of applanation tonometery for corneal thickness variables is generally not widely done except in academic or research circumstances.  
         [0006]     Recently, studies of ocular hypertensive patients sponsored by the National Eye Institute (NEI) of the National Institutes of Health (NIH) have demonstrated that corneal thickness is the single most important predictor of glaucoma. Corneal thickness is inversely proportional to the risk of developing glaucomatous damage. That is to say, among ocular hypertensives, the thinner the cornea the greater the risk of glaucoma.  
         [0007]     During Goldmann applanation tonometery, the so-called “gold standard” for measurements of intraocular pressure, a fluorescent dye is applied to the corneal surface to aid in the pressure measurement. In an upright patient, the operator looks through ocular is of a slit lamp microscope in order to obtain a clear view of the cornea through the applanation device. Under direct vision of the operator, the applanation element is momentarily pressed on to the cornea by the operator. The cornea flattens as a result of the force applied by the applanation element. This in turn causes a change in the pattern of fluorescence. The operator observes these changes and when the pattern of fluorescence reaches a predetermined endpoint the intraocular pressure is determined. This method also helps to reduce inadvertent trauma to the delicate epithelial layer of the cornea. This technique as well as measurements with the classical tonometers requires training, skill and experience. Technique is critical with present tonometery because it is important not to under applanate or over applanate the cornea. A well-trained and skilled operator is required in order to obtain accurate and repeatable results.  
         [0008]     In the U.S. Pat. No. 6,083,161 and as taught in CIP Ser. No. 10/234,294, filed on Sep. 3, 2002, O&#39;Donnell disclosed new apparatus and method which provides more accurate intraocular pressure determination. The apparatus measures conventional tonometery as well as corneal thickness using a single integrated device. Both measurements are made on the exact region of the cornea. The apparatus uses a transparent corneal applanation element for use in the determination of the applanation pressure. An ultrasonic transducer is preferably coaxial with or part of the tonometer transducer and is used to measure corneal thickness. Such a design would normally partially skewer the view of the cornea and make the measurement difficult or impossible. However the improved apparatus uses an internal reflection technique in order to view around the obscuration. However, this improved method still suffers from the difficulty of measurement as described above including use of fluorescein dye viewed through an expensive and generally non-mobile slit-lamp microscope in patients seated in an upright position. Further, it requires a well-trained and skilled operator in order to obtain accurate and repeatable results.  
         [0009]     Hyman teaches a method for determining intraocular pressure using a conventional slit lamp-based Goldmann style tonometer and a pachymeter correcting for corneal thickness. After the pachymeter signal is generated, this method requires the application probe to be moved in a direction toward the subjects&#39; eye until a measurement endpoint is observed by the observer. This method is cumbersome and costly. In addition, the method requires the application probe to be in contact with the cornea for a long time; sufficient to change between the two sensors. Contact with the cornea for an extended period of time can alter the intraocular pressure and is uncomfortable for the patient.  
         [0010]     There are instances where accurate IOP determination is required and where skilled operators are not present, e.g. examining patients during hospital rounds, emergency rooms, private ophthalmic and optometrist&#39;s offices, intern&#39;s offices, etc. Further, the use of a portable or handheld tonometer is beneficial or required when the patient is not in an upper right position, e.g. the operating room during surgery, use with children and infants and during patient rounds on the hospital floors. While there are portable tonometers available they cannot measure or correct for corneal thickness.  
         [0011]     Other prior art showing related technology can be seen in the following patents.  
                                               Patent   Pub. Date   Inventor   Assignee   Title                   4,930,512   Jun. 5, 1990   Henriksen   Sonomed, Inc.   Hand held spring-loaded                       ultrasonic probe       5,165,415   Nov. 24, 1992   Wallace   Bio-Rad Labs,   Self contained hand held                   Inc.   ultrasonic instrument for                       ophthalmic use       5,355,884   Oct. 18, 1994   Bennett       Applanation Tonometer for                       measuring intraocular pressure       5,389,848   Feb. 14, 1995   Trzaskos   General Electric,   Hybrid ultrasonic transducer                   Co.       5,474,066   Dec. 12, 1995   Grolman   Leica, Inc.   Non-contact tonometer       5,636,635   June 1997   Massie et al.   Massie Research   Non-contact tonometer                   Laboratories, Inc.       6,083,161   Jul. 4, 2000   O&#39;Donnell   Sublase, LLC   Apparatus and method for                       improved intraocular pressure                       determination       6,113,542   Sep. 5, 2000   Hyman       Diagnostic apparatus and method                       to provide effective intraocular                       pressure based on measuring                       thickness of the cornea                  
 
       SUMMARY OF THE INVENTION  
       [0012]     There exists a need, therefore, for a simple to use, portable device that does not require trained personnel to simultaneously perform tonometery and pachymetry, register more accurate intraocular pressure for general clinical use and be suitable for use in any position. The present invention applanates the cornea with an ultrasonic transducer while simultaneously recording applanation pressure and corneal thickness in the exact region of applanation. The present invention can be configured for use as either a fixed or mobile device and can be used in any position. A microprocessor converts the applanation pressure to an adjusted intraocular pressure which more accurately reflects the true intraocular pressure when compared to conventional applanation tonometery. This device and method allows for quick, convenient, easy to use, portable and precise determination of intraocular pressure.  
         [0013]     It is an object of the present invention to provide a device which can easily and accurately determine intraocular pressure regardless of variations in corneal thickness.  
         [0014]     It is a further objective of the present invention to provide pachymetry determination in the exact region of cornea applanation IOP measurements.  
         [0015]     It is a further object of the present invention to use a microprocessor means to adjust the applanation pressure determination for differences in corneal thickness and to record for the clinician an adjusted intraocular pressure.  
         [0016]     It is a further object of the present invention to use an applanation component designed to allow the operator to atraumatically measure intraocular pressure without the requirement to view the corneal surface with a microscope at the point of applanation, thereby facilitating easy use of the device by minimally skilled personnel.  
         [0017]     It is a further object of the present invention to use an applanation component designed to eliminate the requirement for use of a fluorescent dye on the cornea during applanation.  
         [0018]     It is a further object of the present invention to use a non-visual means of obtaining the clinical endpoint.  
         [0019]     It is a further object of the present invention to accurately measure intraocular pressure with the patient in any position.  
         [0020]     Other objects and purposes for this invention will occur to those skilled in the art upon review of the invention as described and analyzed herein in light of its drawings and teachings. The present invention is not to be restricted in form nor limited in scope except by the claims appended hereto.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0021]     Referring to the drawings,  
         [0022]      FIG. 1  is an illustration of the present invention showing a tonometery/pachymeter system handpiece in use on a human eye according to the present invention and providing a more accurate intraocular pressure determination;  
         [0023]      FIG. 2  is a cross section of a first embodiment of a tonometer/pachymeter handpiece assembly having a pressure measurement means located proximal to the applanation surface and in functional relation to the cornea for determining uncorrected intra-ocular pressure. It is located concentrically within the distal end of the handpiece with an ultrasonic transducer and acoustic coupler for measuring corneal thickness;  
         [0024]      FIG. 3  is a partial cross-section of a second embodiment of a tonometer/pachymeter handpiece and transducer assembly having a pressure measurement means in the distal end of the probe subjacent to an ultrasonic transducer assembly showing the ultrasonic transmission and reflection signals for determination of corneal thickness  
         [0025]      FIG. 4A  is a partial cross section of a transducer assembly similar to that shown in  FIG. 2 , highlighting the pressure measurement means which includes a displacement extension rod for transferring force from the cornea to a pressure transducer;  
         [0026]      FIG. 4B  is a preferred in body meant showing a partial cross section of a transducer assembly in accordance with the present invention, highlighting a fluid relaying mechanism for transferring force from the cornea to a pressure transducer and with an external pressure coupling membrane covering the cornea contact surface;  
         [0027]      FIG. 5  is a cross section of the present invention having a displacement transducer for determining uncorrected intraocular pressure;  
         [0028]      FIG. 6  is a partial cross-section of an embodiment of the tonometer/pachymeter transducer handpiece assembly having a corneal thickness measuring ultrasonic transducer assembly concentrically located in the distal end of the probe and having a pressure transducer subjacent and centrally positioned therein along with an eye-stabilizing fixation point and pushbutton actuator;  
         [0029]      FIG. 7  is another embodiment of the present invention utilizing multiple corneal positioning sensors located within the corneal contact surface area of a tonometer/pachymeter transducer assembly;  
         [0030]      FIG. 8  is a typical pressure measurement signal collected in accordance with the present invention; and  
         [0031]      FIG. 9  is a typical ultrasound signal for cornea thickness determination collected in accordance with the present invention. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0032]     It is a preferred embodiment of the present invention to obtain more accurate intraocular pressure measurements using a solid-state, ultrasonic cornea thickness measuring means working in the 10 to 20 MHz frequency domain in functional association with a pressure sensing means as an applanation surface of predetermined area for contact with the corneal surface.  
         [0033]     In another preferred embodiment, the applanation surface is a replaceable membrane.  
         [0034]     In another preferred embodiment, the pressure sensing means is located proximal to the applanation surface and in functional relation to the corneal surface.  
         [0035]     In another preferred embodiment, the device displays a digital LED readout of the applanation pressure, the corneal thickness and the intraocular pressure adjusted for corneal thickness.  
         [0036]     It is yet a further preferred embodiment in which the measurement system incorporates a sensing means responsive to proper positioning of the system.  
       EXAMPLE 1  
       [0037]     A patient preparing for Laser Assisted In situ Keratomileusis (LASIK) photorefractive surgery for minus eight diopters (−8D) of myopia has a preoperative central corneal thickness of 452 microns. Six months following the LASIK procedure the intraocular pressure is measured as determined by Goldmann tonometery as 16 mmHg. The uncorrected intraocular pressure as determined by the present invention is also 16 mmHg. Pachymetry indicates the central corneal thickness to be 347 microns. The corrected intraocular pressure as determined by the present invention is 25 mmHg. In this example the present invention demonstrated that the intraocular pressure was higher than would be otherwise apparent; potentially masking glaucoma. The normal intraocular pressure ranges from 12 to 21 mmHg.  
       EXAMPLE 2  
       [0038]     A patient presented for a routine of found that examination has an intraocular pressure of 19 mmHg as determined by Goldmann tonometery. The uncorrected intraocular as determined by the present invention is also 19 mmHg. Pachymetry indicates the central corneal thickness to be 485 microns. The corrected intraocular pressure as determined by the present invention is 23 mmHg. In this example the present invention demonstrated that the intraocular pressure was higher than would be otherwise apparent; masking glaucoma.  
         [0039]     The apparatus of this invention described and shown herein is a novel device for simultaneous measurement, at the same locus of applanation, pressure and surface thickness of a fluid filled sphere for more accurate determination of intracavity pressure, wherein at least a portion of the applanation surface is an ultrasonic transducer. The method for utilizing this device includes the simultaneous measurement, at the same locus of applanation, intracavity pressure and surface thickness of a fluid filled sphere for more accurate determination of intracavity pressure. In addition this novel device provides for simultaneous measurement, at the same locus of applanation, tonometery and pachymetry for determination of more accurate intraocular pressure, wherein at least a portion of the applanation surface is an ultrasonic transducer. Further, the method and device of the invention herein can provide for a fixation light source to stabilize the patient eye during applanation. Further yet, this invention includes a method of simultaneous measurement, at the same locus of applanation tonometery and pachymetry for the purpose of more accurate intraocular pressure determination. The locus of applanation tonometery and pachymetry is preferably the cornea of the eye.  
         [0040]     Referring now to the drawings,  FIG. 1  illustrates a tonometer/pachymeter handpiece  10  suitable for contact by corneal contact surface  2  to cornea  4  and containing transducer assembly  12  and handpiece wand  14  according to an embodiment of the present invention. Tonometer/pachymeter transducer assembly  12  as shown in greater detail in  FIG. 2  and  FIG. 3  includes ultrasonic transducer assembly  33  and pressure transducer  20 . Ultrasonic transducer assembly  33  is comprised of ultrasonic transducer crystal  30  and acoustic coupler  32  which can be made of any material suitable to transmit ultrasonic waves. Ultrasonic waves T are generated from ultrasonic transducer crystal  30  and transmitted or intensified through acoustic coupler  32 . Ultrasonic waves R return to crystal  30  through acoustic coupler  32  following reflection or echo from distal surface of cornea  4 . Ultrasonic transducer assembly  33  is held in position by outer housing  35 . Force from cornea  4  is sensed by pressure transducer  20 .  
         [0041]     As shown in  FIG. 4A  and  FIG. 4B , pressure transducer  20  may be proximal to cornea contact surface  2  wherein relay mechanism  23  is used to transfer pressure from cornea  4  to pressure transducer  20 . Relay mechanism  23  may be air or other fluid  22  as shown in  FIG. 4A  or a solid material as shown in  FIG. 4B . Relay mechanism  23  may be comprised of displacement extension rod  26 , coupler  27  and fluid  22  or fluid  22  alone. Relay mechanism  23  may alternatively be displacement extension rod  26  coupled directly to pressure transducer  20 . In the preferred embodiment relay mechanism  23  is air or other gaseous fluid, sealed to the environment through external pressure coupling membrane  28 . External pressure coupling membrane  28  can also serve as a sterile barrier for contact with the cornea  4 . It can also be used to seal relay mechanism  23 .  
         [0042]     As shown in  FIG. 3  force transducer  20  may be embedded in and subjacent to acoustic coupler  32  in the distal end of assembly  12  and make up a portion of cornea contact surface  2 . When cornea contact surface  2  of transducer assembly  12  is gently pressed or applanated and momentarily flattens cornea  4  to an area beyond pressure sensitive area  16 , the only force sensed will be the intraocular pressure. If pressure sensitive area  16  is 3.06 mm in diameter, the measured IOP is the same as that from a Goldmann instrument without orbit furry corrections. It should be noted that while any size pressure sensitive area  16  can be used, the smaller the surface area the least traumatic for the patient.  
         [0043]     Alternatively as shown in  FIG. 5  determination of IOP can be accomplished by use of displacement transducer  219  and displacement extension rod  226  that will generate a signal proportional to the indentation of pressure sensitive area  216 . Cornea contact surface  2  creates an ultrasonic junction with cornea  4  that transmits ultrasonic transducer crystal  30  signals to and communicates reflected ultrasound signals from cornea  4 . The ultrasonic signal reflected from the posterior surface of cornea  4  and communicated back through acoustic coupler  32  and detected by ultrasonic transducer crystal  30  is proportional to the thickness of the cornea. Transducer assembly  12  is preferably positioned at the geometric center of corneal cornea  4 . Signal conditioning electronics and microprocessor (not shown) are programmed to receive output signals from ultrasonic transducer crystal  30  and pressure transducer  20  and display intraocular pressure measurements corrected for corneal thickness; the true intra-cavity pressure.  
         [0044]      FIG. 6  illustrates another embodiment of the interior elements of tonometer/pachymeter handpiece  110  in accordance with the present invention. In this configuration contact surface  102  is formed from the tapered distal portion of outer jacket  135 , acoustic coupler  132 , pressure transducer  120  and fixation point  158 . Fixation point  158  is shown as the distal end of optical coupler  150 . Optical coupler  150  is shown as a short length of fiber optic but can be any other optical transmitting material or air. It is illuminated by a light emitting diode  155  or similarly functional illuminating device.  
         [0045]      FIG. 7A  and  FIG. 7B  show a cross-section and end view, respectively, of an ultrasonic transducer assembly  333  consistent with the teaching of the invention in which multiple cornea positioning transducer  321  are shown. In the illustrated embodiment, three cornea positioning transducer  321  are concentrically located 120° around pressure transducer  20 . However, positioning transducer&#39;s  321  can be any distal location provided they are selected to be responsive to contact with cornea  4 . In this configuration signals can be produced indicating that cornea contact surface  2  is uniformly and perpendicularly in contact with cornea  4 .  
         [0046]      FIG. 8  is data representative of a typical pressure measurement signal generated using the configuration shown in  FIG. 4A  where pressure signal  60  is a pressure versus time tracing of pressure exerted on pressure transducer  20  resulting from applanation of cornea contact surface  2  on cornea  4 . Pressure signal  60  at time ‘A’ represents initial depression of cornea contact surface  2  to cornea  4 . ‘B’ represents a signal overshoot, ‘C’ represents true applanation pressure not corrected for thickness of cornea  4  and ‘D’ represents buckling of cornea  4  resulting from excessive force on cornea contact surface  2 . Signal conditioning electronics (not shown) assess the data representative of pressure measurements and extracts and display true intraocular pressure ‘C’.  
         [0047]      FIG. 9  is data representative of ultrasonic waves generated by ultrasonic transducer crystal  30  and reflecting from cornea contact surface  2  (signal ‘T’ in  FIG. 3 ) and shown as peak intensity ‘A’ and ultrasonic waves reflecting from the distal surface of cornea  4  (signal ‘R’ in  FIG. 3 ) and shown as peak intensity ‘B’. Time difference between peak intensity ‘A’ and ‘B’ is proportional to thickness of cornea  4 .  
         [0048]     Variations or modifications to the subject matter of this invention may occur to those skilled in the art upon review of the summary provided herein, in addition to the description of its preferred embodiment, in light of the drawings. Such variations, if within the spirit of this invention, are intended to be encompassed within the scope of the invention as described herein.