WO1995019749A2

WO1995019749A2 - Oculopressive device and method

Info

Publication number: WO1995019749A2
Application number: PCT/US1995/000723
Authority: WO
Inventors: Joseph Nussenbaum; Irving A. Speelman
Original assignee: Propper Manufacturing Co Inc
Current assignee: Propper Manufacturing Co Inc
Priority date: 1994-01-21
Filing date: 1995-01-18
Publication date: 1995-07-27
Anticipated expiration: 1996-07-21
Also published as: WO1995019749A3; AU1569795A

Abstract

1 device for applying oscillatory pressure to an eye of a patient comprises: (a) an inflatable member (5); (b) means such as a headband (1) for holding the inflatable member (5) in position against the eye of the patient; further comprising a positioning device (4) for adjusting the position of the inflatable member in vertical, right to left and front to back directions; (c) a pressure controller (3) operatively connected to the inflatable member (5), the pressure controller (3) comprising: a compressor (114), a check valve (117) disposed between the compressor (114) and the inflatable member (5), a mechanical relief valve (110) disposed between the check valve (117) and the inflatable member (5), said valve (110) being selected to open automatically at a selected safety limit, a pressure sensor (111) disposed between the check valve (117) and the inflatable member (5), means for defining an interval of pressure oscillation (112, 113), a valve (119) for reducing pressure in the inflatable member; first control means (112) operatively coupled with the compressor and responsive to the signal for activating and deactivating the compressor for maintaining a predetermined level of pressure in the inflatable member, and second control means (112) operatively coupled to the means for defining an interval of pressure oscillation and the valve for reducing pressure in the inflatable member at defined intervals.

Description

OCULOPRESSIVE DEVICE AND METHOD

BACKGROUND OF THE INVENTION This application relates to a device for applying pressure to the eye prior to intraocular surgery.

It is known in the field of ophthalmic surgery to apply pressure to the eye prior to performing surgery. The 5 application of pressure prior to surgery actually serves to reduce the pressure within the eyeball at the time of surgery, thus reducing the risk that the contents of the eye will spurt out when an incision in the eyeball is made.

Devices for applying pressure to the eyeball have 10 been described, for example in U.S. Patents Nos. 4,175,562 to Honan and U.S. 4,303,063 to Stahl, which are incorporated herein by reference. These devices are basically an inflat¬ able member, a head band to hold the inflatable member over the eye, and a means for pumping up the inflatable member to 15 apply pressure to the eye. In the Honan patent, the means for pumping up the inflatable member is a hand-actuated squeeze bulb, and this is the mechanism which is actually employed in much surgery performed today.

When one is employing a hand-actuated squeeze bulb 20 to apply pressure to the eye, however, it is difficult to maintain a sufficient level of pressure without frequent attention from a human surgical assistant who must check the pressure at regular intervals and increase the pressure by squeezing the bulb. Heretofore, one solution- to this prob- 25 lem has been an effort to seek better seals on the apparatus so that pressure leakage would not occur. This approach has not been entirely successful, however, and it remains the case that a surgical assistant must regularly check and adjust the pressure in the device applying pressure to the •30 eye. This interrupts other preparations for surgery and may be disconcerting to the patient who frequently undergoes • intraocular surgery under only a local anesthetic, and thus is fully aware of the adjustments being made. Thus, it would be desirable to have a device which applied pressure to the eye of a patient without requiring human intervention after the initial setup of the device.

European Patent No. 266,451 discloses a device for applying pressure to the eye in which an electronic pump is utilized. The system employs a comparator which actuates either the pump or a vent in response to deviations from a desired pressure point to raise or decrease pressure, respectively. This system is relatively complex, however, and relies on the system electronics to prevent a potentially hazardous overpressure situation.

In addition to problems with the application of an appropriate pressure, it is also the case that devices for applying pressure to the human eye must by highly adjustable in order to adapt to the variety of head sizes and shapes found in human beings. Known devices for applying pressure to the human eye may be uncomfortable for some patients and difficult to adjust to maintain both comfort and the correct position between the eye and the inflatable member.

Accordingly, it would be desirable to have a device in which the adjustment of the device accommodated the placement of the inflatable member in essentially any position and orientation with respect to the head band, whereby accommodation for different forehead shapes and brow ridges of varying prominence could be readily made. It is an object of the present invention to provide a device for applying pressure to the eye of a patient, which device maintains a pressure within a defined range without human intervention, using an electronically simple device. It is further object of the present invention to provide a device for applying pressure to the eye of a patient in which the pressure applied to the eye varies cyclically in a manner that is readily defined by the user. It is a further object of the present invention to provide a device in which the adjustment of the device accommodated the placement of the inflatable member in essentially any position and orientation with respect to the head band, whereby accommodation for different forehead shapes and brow ridges of varying prominence could be readily made. It is still a further object of the present invention to provide a device for applying pressure to the eye of a patient which maintains a pressure within a defined range without human intervention and in which the adjustment of the device accommodated the placement of the inflatable member in essentially any position and orientation with respect to the head band, whereby accommodation for different forehead shapes and brow ridges of varying prominence could be readily made.

SUMMARY OF THE INVENTION

In accordance with the present invention, a device for applying pressure to an eye of a patient comprises:

(a) an inflatable member;

(b) means such as a headband for holding the inflatable member in position against the eye of the patient;

(c) a pressure controller operatively connected to the inflatable member, the pressure controller comprising: a compressor, a check valve disposed between the compressor and the inflatable member, a mechanical relief valve disposed between the check valve and the inflatable member, said valve being selected to open automatically at a selected safety limit, a pressure sensor disposed between the check valve and the inflatable member, and control means operatively coupled with the compressor and responsive to the signal for activating and deactivating the compressor to maintain a predetermined level of pressure in the pressure line and inflatable member. The device may further include a timer for setting the duration of the application of pressure and a mechanism such as a solenoid valve for releasing pressure from the inflatable member and deactivating the compressor at the end of the preset duration.

In accordance with the present invention, a device for applying oscillatory pressure to an eye of a patient comprises :

(a) an inflatable member;

(b) means such as a headband for holding the inflatable member in position against the eye of the patient; and (c) a pressure controller operatively connected to the inflatable member to control the pressure therein, wherein said pressure controller causes the pressure in the inflatable member to vary to a cyclically between a defined high pressure value and a lower pressure. In a preferred device in accordance with the invention the pressure controller comprises: a compressor, a check valve disposed between the compressor and the inflatable member, a mechanical relief valve disposed between the check valve and the inflatable member, a pressure sensor disposed between the check valve and the inflatable member, means for defining an interval of pressure oscillation, a valve for reducing pressure in the inflatable member; first control means operatively coupled with the compressor and responsive to the signal for activating and deactivating the compressor for maintaining a predetermined level of pressure in the inflatable member, and second control means operatively coupled to the means for defining an interval of pressure oscillation and the valve for reducing pressure in the inflatable member for reducing pressure in the inflatable member at defined intervals . The device may f rther include a timer for setting the duration of the application of pressure and a mechanism such as a solenoid valve for releasing pressure from the inflatable member and deactivating the compressor at the end of the preset duration. A further aspect of the invention is a method for use with apparatus for applying pressure, and preferably oscillatory pressure, to a region of a patient. The appara¬ tus comprising an inflatable member, holding means for holding the inflatable member to the region, a compressor, a pressure line connecting the compressor and the inflatable member, a pressure sensor connected to the pressure line and generating a signal indicative of the pressure thereof, and first control means operatively coupled with the compressor and responsive to the pressure signal. For providing con- trolled oscillatory pressure, the device further comprises second control means operatively connected to the inflatable member to cause the pressure within the inflatable member to vary cyclically between a pre-defined high pressure and a low pressure value. The method comprises the steps of: juxtaposing the inflatable member and the region; holding the inflatable member in juxtaposition with the region; selecting a desired high pressure level; actuating the compressor to increase pressure in the inflatable member; and deactuating the compressor when the pressure achieves a specified maximum level. The method may also include the step of releasing the pressure from the inflatable member at regular intervals to obtain a desired oscillation pattern.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 shows a side view of a device in accordance with the invention;

Fig. 2 shows a top view of a device in accordance with the invention; Fig. 3 shows a front view of a device in accordance with the invention;

Fig. 4 shows a pressure controller in accordance with the invention; Fig. 5 shows a top view of a novel positioning device useful in the device of the present invention;

Fig. 6 shows a side view of a novel positioning device useful in the device of the present invention; and

Fig. 7 shows the possible movements for the novel positioning device shown in Figs 5 and 6.

DETAILED DESCRIPTION OF THE INVENTION Figs. 1-3 show a device in accordance with the present invention. The device has an adjustable headband 1 to which is mounted a mounting fixture 2. The mounting fix¬ ture 2 holds pressure controller 3 and positioning device 4. Inflatable member 5, fabricated from an elastic material, is attached to the distal portion of positioning device 4 and is connected to the pressure controller 3 by a flexible tube 6. Adjustments to the circumference of the headband may be made, for example, using a rack and pinion activated adjust¬ ment 7 of the type known for use in ophthalmoscopes. The head band may also include an adjustable crown strap 8.

Positioning device 4 is adapted to provide substan- tially free motion of the inflatable member 5 with respect to the headband 1 when locking knobs 9 and 10 are in the unlocked position. Positioning device 4 has an adjustable arm 11 having a slot 12 therein. The adjustable arm 11 is attached to a base portion 13 of the positioning device 4 by a pin 21 which passes through the slot and engages with locking knob 9. When locking knob 9 is unscrewed, the adjustable arm can be moved up and down with respect to the headband 1 and the patient's eye, as indicated by arrow A in Fig 3 by sliding it relative to pin 21, and can be rotated about the pin in a right/left rotation from the center front of the head band as indicated by arrow B in Fig. 3 by rotating it about pin 21. When locking knob 9 is tightened, it fixes the vertical position and the right/left rotational position of the adjustable arm with respect to the headband. Locking knob 9 also fixes the adjustable arm in position against the base portion 13 of the positioning device 4.

The position of the base portion 13 with respect to the headband 1, and thus of the top of the adjustable arm 11 is controlled via locking knob 10. The base portion 13 has a slot 14. A pin 20 on the mounting fixture 2 passes through the slot and engages locking knob 10. When locking knob 10 is unlocked, the base portion 13 can be moved laterally with respect to the headband 1 as indicated by arrow C in Fig. 1 by sliding it along the pin 20, and the front/back rotational position can be changed as indicated by arrow D in Fig. 1 by rotating it about the pin 20. When locking knob 10 is in the locked position, the lateral position and the front/back rotational position of the base portion 13 are fixed.

Through the use of the positioning options provided by locking knobs 9 and 10, it is possible to place the inflatable member 5 in essentially any position and orienta¬ tion with respect to the patient's eye. This allows the device of the invention to comfortably accommodate patients with varied physical characteristics, including protruding and receding foreheads, pronounced eye ridges, and eye positions which are very close to or very far from the center of the patient's head.

Fig. 4 shows in functional block diagram form the control system for an apparatus according to the invention. Pressure line 118 leads at left to the hose 6, and connects to mechanical pressure relief valve 110, which is prefer¬ ably calibrated to release pressure at 53 mm Hg. Suitable mechanical relief valves may have a spring-loaded diaphragm, where the tension of the spring sets the pressure at which the diaphragm opens, thus releasing the pressure from the system. Spring-loaded, one-way relief valves with an o-ring seal, such as Halkey-Roberts No. 750-RP are also suitable.

Line 118 also connects to piezoelectric pressure transducer 111 and to compressor 114, which has an integral check valve 117. A solenoid-activated release valve 119 may also be provided on line 118.

A microcomputerized system preferably effects control of the compressor 114, and the system is preferably built around a microcontroller 112 comprising a micro- processor and integral RAM and program ROM containing a suitable stored program. The controller 112 receives as input a pressure signal from the transducer 111. Preferably the controller 112 has an analog input line to receive the pressure signal, and has an internal analog-to-digital (A- to-D) convertor. Alternatively if a controller 112 is employed having only digital inputs, then an external A-to-D convertor would be used.

Another input to the controller 112 is a keyboard 113, with contacts preferably corresponding to the key deflections shown in Fig. 2. It will be understood that the keyboard may be a series of simple rocker switches with increment the value of a given parameter in the upward or downward direction, or a keypad in which specific numerical value are entered. Outputs from the controller 112 include conventional liquid crystal display (LCD) 115 displaying the character data shown in Fig. 2; a discrete output (preferably with a driver transistor external to the controller 112 omitted for clarity in Fig. 4) to compressor 114; and a discrete output (preferably with a driver transistor external to the con¬ troller 112 omitted for clarity in Fig. 4) to the solenoid of release valve 119. Finally, an optional piezoelectric beeper 116 is controlled by a single line from the control¬ ler 116, and under software control the beeper preferably emits beeps acknowledging events such as key closures, error conditions (e.g. overpressure or failure of the compressor to develop expected pressure) and normal events such as expiration of the selected time interval and the associated release of all pressure from the system by the solenoid release valve. In a preferred embodiment of the invention, the pressure controller also includes a timer which allows the user to set the duration of pressure application to the eye. The timer may be an integral part of the processor 112, or it may be a separate device within the controller. The timer is operatively connected to a means such as solenoid valve 119 for venting the system and releasing the pressure from the inflatable member 5. The timer is also operatively connected to the compressor 114 or the processor 112, such that at the end of the selected period of time, the compres- sor is not reactivated when the pressure drops below the threshold level.

As described herein, the control programming of the processor 112 is preferably such that the pressure at which the compressor 114 is turned on is somewhat lower than the pressure at which the compressor 114 is turned off, i.e there is some hysteresis in the control loop. This gives rise to a cyclically varying pressure about a desired central value. This mild oscillation of the pressure within the inflatable member simulates a more natural massage by the doctor, rather than the constant pressure applied by the prior art devices. Such hysteresis also reduces wear and tear on the compressor 114 that might otherwise occur due to frequent stops and starts.

It is assumed as a general matter that the pres- surized part of the system (line 118, hose 6, and inflatable member 5) will lose pressure over a time scale that is comparable to the duration of the treatment of the patient using the apparatus of the invention, leading to the cyclical variation in pressure just described. It will be appreciated that depending on materials and construction techniques used such pressure loss may be faster or slower. The oscillation of the applied pressure which occurs as a result of the operation of the device as described above may also be controlled in terms of duration and intensity, and the device adapted to allow control of the pattern of pressure application by the physician. Thus, as shown in Fig. 2, key deflections are provided to permit the physician to establish the maximum or set pressure of the system 213, the total or set time of pressure application 313, and the duration of each interval of pressure within the total time 413.

One method of operating the device of Figs. 1-3 can be understood with reference to Fig. 4. The physician defines the set pressure, set time and interval time using keys 213, 313 and 413 on the keypad 113. When the cycle is started, the processor 112 turns the compressor 114 on such that pressure builds up in pressure line 118. Two timers are employed which may be separate or functions of the processor 112. When the first of these timers reaches the interval time set using key deflection 413, the processor opens the solenoid valve 119 to release pressure from the system, but does not alter the functioning of the compressor 114. The first timer is then immediately reset to zero to monitor the next interval of pressure application. This pressurizing and de-pressurizing of the system continues until the second timer reaches the set time, at which point the processor opens the solenoid valve 118 and deactivates the compressor.

While the apparatus depicted in Fig. 4 can be used in this embodiment of the invention, it will be appreciated that other variations are possible. For example, a separate valve could be operatively connected to the processor 112 which would be opened in response to the first timer. This valve might release pressure from the system more slowly, such that complete depressurization of the pressure line 118 would not occur as a result of the opening of the valve. The system might also be further modified to allow the physician to define a low pressure setting. In this case, the second valve would be controlled to open only until the low pressure as set by the physician was achieved.

Those skilled in the art will have no difficulty devising obvious variations on the particular details described here, which would nonetheless provide the benefits of the system according to the invention and would not depart from the invention in any way. For example, the pressure sensor 111 need not be piezoelectric, but could be of many other technologies. The check valve 117 need not be integral with compressor 114, and indeed depending on the type of compressor employed might not be necessary at all. The system need not have an alerting device 116, and if there is an alerting device 116 it could be of many technologies other than piezoelectric; for example it could be a conventional loudspeaker. The display 115 need not be an LCD; it could be an LED display for example. The release valve 119 could be actuated by means other than a simple solenoid, for example and electronically controlled microvalve. The control path between the pressure sensor 111 and the compressor 114 is described as including a microcontroller 112, but those skilled in the art could use a fully formed multichip microprocessor system with a parallel bus connecting the processor, memory, and input- output devices. Alternatively, dedicated circuitry could be used, such as conventional analog circuitry, all without departing from the invention. Indeed a quite simple yet workable system could be constructed using a pressure switch 111 that gives an on/off signal at the desired pressure level, with the on/off signal directly controlling the compressor 114 and little or no other electronics.

Figs. 5 and 6 show a novel positioning device which can be used in place of the positioning device 4 in devices of the invention as well as in any other device in which it is desired to have two parts that are essentially freely positionable with respect to one another, yet easily locked into any given position.

Fig 5 shows a top view of a section through the positioning device. The device has a compressible body 50 with a cavity which encloses a split ball 51 having a hole which receives rod 52. Adjustment screw 53 controls the compression of the body 50. When the body 50 is in its uncompressed state, the split ball 51 can rotate within the body, and the rod 52 can move upwards or downwards within the split ball 51. In addition, when the rod 52 as shown is round, rotation of the rod with respect to the split ball is possible. This rotation is not necessary for achieving the full extent of positional adjustment, however, because the split ball 51 is freely rotatable within the compressible body 50. Thus, the rod may be square, triangular or any other shape without departing from the present invention.

When the body 50 is compressed using the screw 53, the split ball 51 is also compressed. In this way, both the split ball and the rod are locked into position by the turning of a single screw. The compressible body 50 may be fitted with screw attachment points 54 and 54' for the attachment of the positioning device to the headband of an oculopressive device.

In the positioning device of Figs. 5 and 6, the body 50 may be made from metal, such as aluminum 2024 T351 or non-brittle plastics. The split ball may be made from plastic such as nylon-66, hard rubbers or metal such as brass.

The split ball as shown in Figs. 5 and 6 is split into two equal pieces. It will be understood, however, that this is not necessary to the operation of the positioning device. Thus, the term split ball as used herein encompasses any substantially spherical member having at least one split in it to afford the compressibility needed to fix the rod in place when the compressible body is compressed. This includes split balls having a single cut along one meridian of the ball, or split balls with more than one cut made up of two or more separate pieces.

If it is not necessary for the distance between the fixed end of the rod and the attachment to the headband to be variable, the cavity in the compressible body can be substantially spherical and this configuration is preferred because it provides for the most positive locking of the ball and rod. Lateral motion of the fixed end of the rod with respect to the attachment location can be provided however by elongating the cavity. In this embodiment, the split ball 51 can slide laterally within the cavity when the compressible body is in the uncompressed configuration. Alternatively, lateral motion can be provided by affixing the compressible body to the headband on a sliding fixture. This can be achieved with the single adjustment screw 53 provided in Fig. 5 by placing with adjustment screw 53 within a slot on a mounting bracket such that tightening the screw not only compresses the compressible body 50 but also locks it into position relative to the mounting bracket. Fig. 6 shows a side view of the positioning device shown in Fig. 5. In Fig. 6, a cap 61 is shown on the top of the rod 52 to prevent the passage of the rod 52 through the uncompressed split ball 51 in one direction. At the other end of the rod from the cap, the inflatable member is attached in an oculopressive device in accordance with the invention.

It will be appreciated, that while the positioning device of Figs. 5 and 6 has been described above for use with an oculopressive device, it can in fact be used in many other applications in which an adjustable positioner is desired. Thus, instead of being screwed to a headband, the body might be screwed, glued or otherwise affixed to other supporting means, or may be attached to a clamp or other fastening device. Similarly, the distal end of the rod may be equipped with a clamp, a threaded opening, a threaded end, an adhesive pad or other fastening means. In any of these applications, the positioning device provides the versatile range of movement depicted in Fig. 7. Thus, the positioning permits rotation of the rod, and deflection of the rod from vertical in any direction and to any extent up to a maximum which depends on the point at which interfer¬ ence with the compressible body occurs.

Claims

We Claim:

1. A device for applying pressure to an eye of a patient comprising: (a) an inflatable member; (b) means for holding the inflatable member in position against the eye of the patient; (c) a pressure controller operatively connected to the inflatable member comprising: a compressor, a check valve disposed between the compressor and the inflatable member, a mechanical relief valve disposed between the check valve and the inflatable member, a pressure sensor disposed between the check valve and the inflatable member, and first control means operatively coupled with the compressor and responsive to the signal for activating and deactivating the compressor to maintain a predetermined level of pressure in the inflatable member.

2. A device for applying oscillatory pressure to an eye of a patient comprising: (a) an inflatable member; (b) means for holding the inflatable member in position against the eye of the patient; (c) a pressure controller operatively connected to the inflatable member comprising: a compressor, a check valve disposed between the compressor and the inflatable member, a mechanical relief valve disposed between the check valve and the inflatable member, a pressure sensor disposed between the check valve and the inflatable member, means for defining an interval of pressure oscillation, a valve for reducing pressure in the inflatable member; first control means operatively coupled with the compressor and responsive to the signal for activating and deactivating the compressor for maintaining a predetermined level of pressure in the inflatable member, and second control means operatively coupled to the means for defining an interval of pressure oscillation and the valve for reducing pressure in the inflatable member for reducing pressure in the inflatable member at defined intervals.

3. A device according to claim 1 or 2, wherein the first control means is connected to a control panel adapted to receive an input of the pressure to be maintained by the device.

4. A device according to any of claims 1-3, further comprising a timer for establishing a total duration of pressure application.

5. A device according to claim 4, wherein the timer is operatively connected to the valve for reducing pressure in the inflatable member.

6. A device according to any of claims 1-5, further comprising a second valve for reducing pressure in the inflatable member, said second valve being operatively connected to the timer for releasing pressure from the inflatable member at the end of the total duration of pressure application.

7. A device according to claim 6, wherein the valve for releasing pressure from the inflatable member at the end of the duration of pressure application is a solenoid valve.

8. A device according to any of claims 1-7, wherein the pressure controller further comprises a control panel adapted to receive an input of total duration from the user.

9. A device according to claim 8, wherein the first control means is connected to the control panel and the control panel is further adapted to receive an input of the pressure to be maintained by the device.

10. A device according to claim 9, wherein the first control means and the timer both comprise a processor executing a stored program.

11. A device according to any of claims 2-10, wherein the second control means comprises a processor executing a stored program.

12. A device according to claim 11, wherein said first control means and said second control means comprise a single processor capable of executing a plurality of stored programs.

13. A device according to any of claims 1-12, wherein the first control means comprises a processor executing a stored program, and wherein the device further comprises a keyboard, the predetermined level of pressure being adjustable by user inputs from the keyboard.

14. A device according to any of claims 2-13, wherein the second control means comprises a processor executing a stored program, and wherein the means for defining the interval of oscillation is a keyboard.

15. A device according to any of claims 1-14, wherein the inflatable member is attached at an attachment location to the means for holding the inflatable member in position against the eye of the patient by a positioning device which provides for adjustment of the position of the inflatable member relative to the attachment location in the vertical, right to left and front to back directions.

16. A device according to claim 15, wherein the positioning device comprises a base portion attached to the means for holding the inflatable member in position against the eye; an adjustable arm to which the inflatable member is attached, and first and second locking devices, said adjustable arm being slidably and rotatably affixed to the base portion whereby the inflatable member can be moved in the vertical and right to left directions with respect to the attachment location, said base portion being slidably and rotatably affixed to the means for holding the inflatable member in position against the eye of the patient, whereby the inflatable member can be moved in the lateral and front to back directions relative to the attachment location, and said first and second locking devices being effective in their locked positions to prevent the motion of adjustable arm and the base portion.

17. A device according to claim 15, wherein the positioning device comprises a base portion slidably and rotatably affixed to the attachment location via a slot extending through the base portion from a point near a first surface of the base portion, said first surface being adjacent to the means for holding the inflatable member in position against the eye, to a point near a second, opposing surface of the base portion; a locking pin, said locking pin being affixed to the second surface of the base portion and extending outward therefrom; an adjustable arm having a slot therein sized to receive the first locking pin, whereby the adjustable arm is slidably and rotatably engaged with the locking pin; and a locking knob affixed to the outward end of the locking pin, said locking knob and locking pin together being effective to prevent movement of the adjustable arm.

18. A device according to claim 15, wherein the positioning device comprises a compressible body having a cavity therein; a split ball disposed within the cavity, said split ball being sized to permit rotation thereof within the cavity, and said split ball having an opening passing therethrough; a rod extending through the opening in the split ball; and means for compressing the compressible body, whereby when the compressible body is compressed the position of the split ball in the cavity is fixed, and the split ball is compressed thereby fixing the position of the rod relative to the split ball.

19. A device according to claim 18, wherein the cavity is a substantially spherical section.

20. A method for applying oscillatory pressure to a region of a patient using an inflatable member, comprising the steps of: juxtaposing the inflatable member and the region; holding the inflatable member in juxtaposition with the region; selecting a desired high pressure level; actuating the compressor to increase pressure in the inflatable member; releasing the pressure from the inflatable member at regular intervals; and deactuating the compressor after oscillatory pressure has been applied to the region for a desired period of time.

21. A method according to claim 19, wherein the region is the exterior of the patient's eye.

22. A device according to claim 21, wherein the control means is connected to a control panel adapted to receive an input of the pressure to be maintained by the device.

23. A device for applying pressure to an eye of a patient comprising: (a) an inflatable member; (b) means for holding the inflatable member in position against the eye of the patient; and (c) means for inflating the inflatable member; wherein the inflatable member is connected to the means for holding the inflatable member in position against the eye of the patient by a positioning device positioning device which provides for adjustment of the position of the inflatable member relative to the attachment location in the vertical, right to left and front to back directions.

24. A device according to claim 23, wherein the positioning device comprises a base portion attached to the means for holding the inflatable member in position against the eye; an adjustable arm to which the inflatable member is attached, and first and second locking devices, said adjustable arm being slidably and rotatably affixed to the base portion whereby the inflatable member can be moved in the vertical and right to left directions with respect to the attachment location, said base portion being slidably and rotatably affixed to the means for holding the inflatable member in position against the eye of the patient, whereby the inflatable member can be moved in the lateral and front to back directions relative to the attachment location, and said first and second locking devices being effective in their locked positions to prevent the motion of adjustable arm and the base portion.

25. A device according to claim 23, wherein the positioning device comprises a base portion slidably and rotatably affixed to the attachment location via a slot extending through the base portion from a point near a first surface of the base portion, said first surface being adjacent to the means for holding the inflatable member in position against the eye, to a point near a second, opposing surface of the base portion; a locking pin, said locking pin being affixed to the second surface of the base portion and extending outward therefrom; an adjustable arm having a slot therein sized to receive the first locking pin, whereby the adjustable arm is slidably and rotatably engaged with the locking pin; and a locking knob affixed to the outward end of the locking pin, said locking knob and locking pin together being effective to prevent movement of the adjustable arm.

26. A device according to claim 23, wherein the positioning device comprises a compressible body having a cavity therein; a split ball disposed within the cavity, said split ball being sized to permit rotation thereof within the cavity, and said split ball having an opening passing therethrough; a rod extending through the opening in the split ball; and means for compressing the compressible body, whereby when the compressible body is compressed the position of the split ball in the cavity is fixed, and the split ball is compressed thereby fixing the position of the rod relative to the split ball.

27. A device according to claim 26, wherein the cavity is a substantially spherical section.

28. A method for use with apparatus for applying pressure to a region of a patient, the apparatus comprising an inflatable member, holding means for holding the inflatable member to the region, a compressor, a pressure line connecting the compressor and the inflatable member, a pressure sensor connected to the pressure line and generating a signal indicative of the pressure thereof, and control means operatively coupled with the compressor and responsive to the pressure signal; the method comprising the steps of: juxtaposing the inflatable member and the region; holding the inflatable member in juxtaposition with the region; selecting a desired pressure level; actuating the compressor when the pressure is in a first predetermined relationship to the desired pressure level; and deactuating the compressor when the pressure is in a second predetermined relationship to the desired pressure level.

29. A method in accordance with claim 28, further comprising the steps of: selecting a desired time interval; and deactuating the compressor upon expiration of the desired time interval.

30. A method in accordance with claim 28 or 29, further characterized in that the apparatus further comprises an electrical release valve, the method further comprising the step of opening the electrical release valve upon the expiration of the desired time interval.

31. A device for applying oscillatory pressure to an eye of a patient, comprising: (a) an inflatable member; (b) means for holding the inflatable member in position against the eye of the patient; and (c) a pressure controller operatively connected to the inflatable member to control the pressure therein, wherein said pressure controller causes the pressure within the inflatable member to vary cyclically about a predetermined value.